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110th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     110-762

======================================================================



 
           FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

                                _______
                                

 July 17, 2008.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

 Mr. Dingell, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                             together with

                            DISSENTING VIEWS

                        [To accompany H.R. 1108]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 1108) to protect the public health by providing 
the Food and Drug Administration with certain authority to 
regulate tobacco products, having considered the same, report 
favorably thereon with an amendment and recommend that the bill 
as amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     2
Purpose and Summary..............................................    48
Background and Need for Legislation..............................    48
Hearings.........................................................    50
Committee Consideration..........................................    51
Committee Votes..................................................    51
Committee Oversight Findings.....................................    57
Statement of General Performance Goals and Objectives............    57
New Budget Authority, Entitlement Authority, and Tax Expenditures    57
Earmarks and Tax and Tariff Benefits.............................    57
Committee Cost Estimate..........................................    57
Congressional Budget Office Estimate.............................    57
Federal Mandates Statement.......................................    68
Advisory Committee Statement.....................................    68
Constitutional Authority Statement...............................    68
Applicability to Legislative Branch..............................    68
Exchange of Committee Letters....................................    69
Section-by-Section Analysis of the Legislation...................    72
Changes in Existing Law Made by the Bill, as Reported............    89
Dissenting Views.................................................   158

                               Amendment

    The amendment is as follows:
    Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

  (a) Short Title.--This Act may be cited as the ``Family Smoking 
Prevention and Tobacco Control Act''.
  (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.

         TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION

Sec. 101. Amendment of Federal Food, Drug, and Cosmetic Act.
Sec. 102. Final rule.
Sec. 103. Conforming and other amendments to general provisions.
Sec. 104. Study on raising the minimum age to purchase tobacco 
products.
Sec. 105. Tobacco industry concentration.

 TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT 
                               DISCLOSURE

Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Authority to revise cigarette warning label statements.
Sec. 203. State regulation of cigarette advertising and promotion.
Sec. 204. Smokeless tobacco labels and advertising warnings.
Sec. 205. Authority to revise smokeless tobacco product warning label 
statements.
Sec. 206. Tar, nicotine, and other smoke constituent disclosure to the 
public.

       TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS

Sec. 301. Labeling, recordkeeping, records inspection.
Sec. 302. Study and report.

SEC. 2. FINDINGS.

  The Congress finds the following:
          (1) The use of tobacco products by the Nation's children is a 
        pediatric disease of considerable proportions that results in 
        new generations of tobacco-dependent children and adults.
          (2) A consensus exists within the scientific and medical 
        communities that tobacco products are inherently dangerous and 
        cause cancer, heart disease, and other serious adverse health 
        effects.
          (3) Nicotine is an addictive drug.
          (4) Virtually all new users of tobacco products are under the 
        minimum legal age to purchase such products.
          (5) Tobacco advertising and marketing contribute 
        significantly to the use of nicotine-containing tobacco 
        products by adolescents.
          (6) Because past efforts to restrict advertising and 
        marketing of tobacco products have failed adequately to curb 
        tobacco use by adolescents, comprehensive restrictions on the 
        sale, promotion, and distribution of such products are needed.
          (7) Federal and State governments have lacked the legal and 
        regulatory authority and resources they need to address 
        comprehensively the public health and societal problems caused 
        by the use of tobacco products.
          (8) Federal and State public health officials, the public 
        health community, and the public at large recognize that the 
        tobacco industry should be subject to ongoing oversight.
          (9) Under article I, section 8 of the Constitution, the 
        Congress is vested with the responsibility for regulating 
        interstate commerce and commerce with Indian tribes.
          (10) The sale, distribution, marketing, advertising, and use 
        of tobacco products are activities in and substantially 
        affecting interstate commerce because they are sold, marketed, 
        advertised, and distributed in interstate commerce on a 
        nationwide basis, and have a substantial effect on the Nation's 
        economy.
          (11) The sale, distribution, marketing, advertising, and use 
        of such products substantially affect interstate commerce 
        through the health care and other costs attributable to the use 
        of tobacco products.
          (12) It is in the public interest for Congress to enact 
        legislation that provides the Food and Drug Administration with 
        the authority to regulate tobacco products and the advertising 
        and promotion of such products. The benefits to the American 
        people from enacting such legislation would be significant in 
        human and economic terms.
          (13) Tobacco use is the foremost preventable cause of 
        premature death in America. It causes over 400,000 deaths in 
        the United States each year, and approximately 8,600,000 
        Americans have chronic illnesses related to smoking.
          (14) Reducing the use of tobacco by minors by 50 percent 
        would prevent well over 10,000,000 of today's children from 
        becoming regular, daily smokers, saving over 3,000,000 of them 
        from premature death due to tobacco-induced disease. Such a 
        reduction in youth smoking would also result in approximately 
        $75,000,000,000 in savings attributable to reduced health care 
        costs.
          (15) Advertising, marketing, and promotion of tobacco 
        products have been especially directed to attract young persons 
        to use tobacco products, and these efforts have resulted in 
        increased use of such products by youth. Past efforts to 
        oversee these activities have not been successful in adequately 
        preventing such increased use.
          (16) In 2005, the cigarette manufacturers spent more than 
        $13,000,000,000 to attract new users, retain current users, 
        increase current consumption, and generate favorable long-term 
        attitudes toward smoking and tobacco use.
          (17) Tobacco product advertising often misleadingly portrays 
        the use of tobacco as socially acceptable and healthful to 
        minors.
          (18) Tobacco product advertising is regularly seen by persons 
        under the age of 18, and persons under the age of 18 are 
        regularly exposed to tobacco product promotional efforts.
          (19) Through advertisements during and sponsorship of 
        sporting events, tobacco has become strongly associated with 
        sports and has become portrayed as an integral part of sports 
        and the healthy lifestyle associated with rigorous sporting 
        activity.
          (20) Children are exposed to substantial and unavoidable 
        tobacco advertising that leads to favorable beliefs about 
        tobacco use, plays a role in leading young people to 
        overestimate the prevalence of tobacco use, and increases the 
        number of young people who begin to use tobacco.
          (21) The use of tobacco products in motion pictures and other 
        mass media glamorizes its use for young people and encourages 
        them to use tobacco products.
          (22) Tobacco advertising expands the size of the tobacco 
        market by increasing consumption of tobacco products including 
        tobacco use by young people.
          (23) Children are more influenced by tobacco marketing than 
        adults: more than 80 percent of youth smoke three heavily 
        marketed brands, while only 54 percent of adults, 26 and older, 
        smoke these same brands.
          (24) Tobacco company documents indicate that young people are 
        an important and often crucial segment of the tobacco market. 
        Children, who tend to be more price sensitive than adults, are 
        influenced by advertising and promotion practices that result 
        in drastically reduced cigarette prices.
          (25) Comprehensive advertising restrictions will have a 
        positive effect on the smoking rates of young people.
          (26) Restrictions on advertising are necessary to prevent 
        unrestricted tobacco advertising from undermining legislation 
        prohibiting access to young people and providing for education 
        about tobacco use.
          (27) International experience shows that advertising 
        regulations that are stringent and comprehensive have a greater 
        impact on overall tobacco use and young people's use than 
        weaker or less comprehensive ones.
          (28) Text only requirements, although not as stringent as a 
        ban, will help reduce underage use of tobacco products while 
        preserving the informational function of advertising.
          (29) It is in the public interest for Congress to adopt 
        legislation to address the public health crisis created by 
        actions of the tobacco industry.
          (30) The final regulations promulgated by the Secretary of 
        Health and Human Services in the August 28, 1996, issue of the 
        Federal Register (61 Fed. Reg. 44615-44618) for inclusion as 
        part 897 of title 21, Code of Federal Regulations, are 
        consistent with the first amendment to the United States 
        Constitution and with the standards set forth in the amendments 
        made by this subtitle for the regulation of tobacco products by 
        the Food and Drug Administration, and the restriction on the 
        sale and distribution of, including access to and the 
        advertising and promotion of, tobacco products contained in 
        such regulations are substantially related to accomplishing the 
        public health goals of this Act.
          (31) The regulations described in paragraph (30) will 
        directly and materially advance the Federal Government's 
        substantial interest in reducing the number of children and 
        adolescents who use cigarettes and smokeless tobacco and in 
        preventing the life-threatening health consequences associated 
        with tobacco use. An overwhelming majority of Americans who use 
        tobacco products begin using such products while they are 
        minors and become addicted to the nicotine in those products 
        before reaching the age of 18. Tobacco advertising and 
        promotion play a crucial role in the decision of these minors 
        to begin using tobacco products. Less restrictive and less 
        comprehensive approaches have not and will not be effective in 
        reducing the problems addressed by such regulations. The 
        reasonable restrictions on the advertising and promotion of 
        tobacco products contained in such regulations will lead to a 
        significant decrease in the number of minors using and becoming 
        addicted to those products.
          (32) The regulations described in paragraph (30) impose no 
        more extensive restrictions on communication by tobacco 
        manufacturers and sellers than are necessary to reduce the 
        number of children and adolescents who use cigarettes and 
        smokeless tobacco and to prevent the life-threatening health 
        consequences associated with tobacco use. Such regulations are 
        narrowly tailored to restrict those advertising and promotional 
        practices which are most likely to be seen or heard by youth 
        and most likely to entice them into tobacco use, while 
        affording tobacco manufacturers and sellers ample opportunity 
        to convey information about their products to adult consumers.
          (33) Tobacco dependence is a chronic disease, one that 
        typically requires repeated interventions to achieve long-term 
        or permanent abstinence.
          (34) Because the only known safe alternative to smoking is 
        cessation, interventions should target all smokers to help them 
        quit completely.
          (35) Tobacco products have been used to facilitate and 
        finance criminal activities both domestically and 
        internationally. Illicit trade of tobacco products has been 
        linked to organized crime and terrorist groups.
          (36) It is essential that the Food and Drug Administration 
        review products sold or distributed for use to reduce risks or 
        exposures associated with tobacco products and that it be 
        empowered to review any advertising and labeling for such 
        products. It is also essential that manufacturers, prior to 
        marketing such products, be required to demonstrate that such 
        products will meet a series of rigorous criteria, and will 
        benefit the health of the population as a whole, taking into 
        account both users of tobacco products and persons who do not 
        currently use tobacco products.
          (37) Unless tobacco products that purport to reduce the risks 
        to the public of tobacco use actually reduce such risks, those 
        products can cause substantial harm to the public health to the 
        extent that the individuals, who would otherwise not consume 
        tobacco products or would consume such products less, use 
        tobacco products purporting to reduce risk. Those who use 
        products sold or distributed as modified risk products that do 
        not in fact reduce risk, rather than quitting or reducing their 
        use of tobacco products, have a substantially increased 
        likelihood of suffering disability and premature death. The 
        costs to society of the widespread use of products sold or 
        distributed as modified risk products that do not in fact 
        reduce risk or that increase risk include thousands of 
        unnecessary deaths and injuries and huge costs to our health 
        care system.
          (38) As the National Cancer Institute has found, many smokers 
        mistakenly believe that ``low tar'' and ``light'' cigarettes 
        cause fewer health problems than other cigarettes. As the 
        National Cancer Institute has also found, mistaken beliefs 
        about the health consequences of smoking ``low tar'' and 
        ``light'' cigarettes can reduce the motivation to quit smoking 
        entirely and thereby lead to disease and death.
          (39) Recent studies have demonstrated that there has been no 
        reduction in risk on a population-wide basis from ``low tar'' 
        and ``light'' cigarettes, and such products may actually 
        increase the risk of tobacco use.
          (40) The dangers of products sold or distributed as modified 
        risk tobacco products that do not in fact reduce risk are so 
        high that there is a compelling governmental interest in 
        ensuring that statements about modified risk tobacco products 
        are complete, accurate, and relate to the overall disease risk 
        of the product.
          (41) As the Federal Trade Commission has found, consumers 
        have misinterpreted advertisements in which one product is 
        claimed to be less harmful than a comparable product, even in 
        the presence of disclosures and advisories intended to provide 
        clarification.
          (42) Permitting manufacturers to make unsubstantiated 
        statements concerning modified risk tobacco products, whether 
        express or implied, even if accompanied by disclaimers would be 
        detrimental to the public health.
          (43) The only way to effectively protect the public health 
        from the dangers of unsubstantiated modified risk tobacco 
        products is to empower the Food and Drug Administration to 
        require that products that tobacco manufacturers sold or 
        distributed for risk reduction be reviewed in advance of 
        marketing, and to require that the evidence relied on to 
        support claims be fully verified.
          (44) The Food and Drug Administration is a regulatory agency 
        with the scientific expertise to identify harmful substances in 
        products to which consumers are exposed, to design standards to 
        limit exposure to those substances, to evaluate scientific 
        studies supporting claims about the safety of products, and to 
        evaluate the impact of labels, labeling, and advertising on 
        consumer behavior in order to reduce the risk of harm and 
        promote understanding of the impact of the product on health. 
        In connection with its mandate to promote health and reduce the 
        risk of harm, the Food and Drug Administration routinely makes 
        decisions about whether and how products may be marketed in the 
        United States.
          (45) The Federal Trade Commission was created to protect 
        consumers from unfair or deceptive acts or practices, and to 
        regulate unfair methods of competition. Its focus is on those 
        marketplace practices that deceive or mislead consumers, and 
        those that give some competitors an unfair advantage. Its 
        mission is to regulate activities in the marketplace. Neither 
        the Federal Trade Commission nor any other Federal agency 
        except the Food and Drug Administration possesses the 
        scientific expertise needed to implement effectively all 
        provisions of the Family Smoking Prevention and Tobacco Control 
        Act.
          (46) If manufacturers state or imply in communications 
        directed to consumers through the media or through a label, 
        labeling, or advertising, that a tobacco product is approved or 
        inspected by the Food and Drug Administration or complies with 
        Food and Drug Administration standards, consumers are likely to 
        be confused and misled. Depending upon the particular language 
        used and its context, such a statement could result in 
        consumers being misled into believing that the product is 
        endorsed by the Food and Drug Administration for use or in 
        consumers being misled about the harmfulness of the product 
        because of such regulation, inspection, approval, or 
        compliance.
          (47) If manufacturers are permitted to state or imply in 
        communications directed to consumers that a tobacco product is 
        approved or inspected by the Food and Drug Administration or 
        complies with Food and Drug Administration standards, consumers 
        are likely to be confused and misled. Such a statement could 
        result in consumers being misled into believing that the 
        product is endorsed by the Food and Drug Administration for use 
        or in consumers being misled about the harmfulness of the 
        product because of such regulation, inspection, or compliance.
          (48) In August 2006 a United States district court judge 
        found that the major United States cigarette companies continue 
        to target and market to youth. USA v Philip Morris, USA, Inc., 
        et al. (Civil Action No. 99-2496 (GK), August 17, 2006).
          (49) In August 2006 a United States district court judge 
        found that the major United States cigarette companies 
        dramatically increased their advertising and promotional 
        spending in ways that encourage youth to start smoking 
        subsequent to the signing of the Master Settlement Agreement in 
        1998. USA v Philip Morris, USA, Inc., et al. (Civil Action No. 
        99-2496 (GK), August 17, 2006).
          (50) In August 2006 a United States district court judge 
        found that the major United States cigarette companies have 
        designed their cigarettes to precisely control nicotine 
        delivery levels and provide doses of nicotine sufficient to 
        create and sustain addiction while also concealing much of 
        their nicotine-related research. USA v Philip Morris, USA, 
        Inc., et al. (Civil Action No. 99-2496 (GK), August 17, 2006).

SEC. 3. PURPOSE.

  The purposes of this Act are--
          (1) to provide authority to the Food and Drug Administration 
        to regulate tobacco products under the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 301 et seq.), by recognizing it as the 
        primary Federal regulatory authority with respect to the 
        manufacture, marketing, and distribution of tobacco products as 
        provided for in this Act;
          (2) to ensure that the Food and Drug Administration has the 
        authority to address issues of particular concern to public 
        health officials, especially the use of tobacco by young people 
        and dependence on tobacco;
          (3) to authorize the Food and Drug Administration to set 
        national standards controlling the manufacture of tobacco 
        products and the identity, public disclosure, and amount of 
        ingredients used in such products;
          (4) to provide new and flexible enforcement authority to 
        ensure that there is effective oversight of the tobacco 
        industry's efforts to develop, introduce, and promote less 
        harmful tobacco products;
          (5) to vest the Food and Drug Administration with the 
        authority to regulate the levels of tar, nicotine, and other 
        harmful components of tobacco products;
          (6) in order to ensure that consumers are better informed, to 
        require tobacco product manufacturers to disclose research 
        which has not previously been made available, as well as 
        research generated in the future, relating to the health and 
        dependency effects or safety of tobacco products;
          (7) to continue to permit the sale of tobacco products to 
        adults in conjunction with measures to ensure that they are not 
        sold or accessible to underage purchasers;
          (8) to impose appropriate regulatory controls on the tobacco 
        industry;
          (9) to promote cessation to reduce disease risk and the 
        social costs associated with tobacco-related diseases; and
          (10) to strengthen legislation against illicit trade in 
        tobacco products.

SEC. 4. SCOPE AND EFFECT.

  (a) Intended Effect.--Nothing in this Act (or an amendment made by 
this Act) shall be construed to--
          (1) establish a precedent with regard to any other industry, 
        situation, circumstance, or legal action; or
          (2) affect any action pending in Federal, State, or Tribal 
        court, or any agreement, consent decree, or contract of any 
        kind.
  (b) Agricultural Activities.--The provisions of this Act (or an 
amendment made by this Act) which authorize the Secretary to take 
certain actions with regard to tobacco and tobacco products shall not 
be construed to affect any authority of the Secretary of Agriculture 
under existing law regarding the growing, cultivation, or curing of raw 
tobacco.
  (c) Revenue Activities.--The provisions of this Act (or an amendment 
made by this Act) which authorize the Secretary to take certain actions 
with regard to tobacco products shall not be construed to affect any 
authority of the Secretary of the Treasury under chapter 52 of the 
Internal Revenue Code of 1986.

SEC. 5. SEVERABILITY.

  If any provision of this Act, the amendments made by this Act, or the 
application of any provision of this Act to any person or circumstance 
is held to be invalid, the remainder of this Act, the amendments made 
by this Act, and the application of the provisions of this Act to any 
other person or circumstance shall not be affected and shall continue 
to be enforced to the fullest extent possible.

         TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION

SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.

  (a) Definition of Tobacco Products.--Section 201 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end 
the following:
  ``(rr)(1) The term `tobacco product' means any product made or 
derived from tobacco that is intended for human consumption, including 
any component, part, or accessory of a tobacco product (except for raw 
materials other than tobacco used in manufacturing a component, part, 
or accessory of a tobacco product).
  ``(2) The term `tobacco product' does not mean an article that is a 
drug under subsection (g)(1), a device under subsection (h), or a 
combination product described in section 503(g).
  ``(3) The products described in paragraph (2) shall be subject to 
chapter V of this Act.
  ``(4) A tobacco product may not be marketed in combination with any 
other article or product regulated under this Act (including a drug, 
biologic, food, cosmetic, medical device, or a dietary supplement).''.
  (b) FDA Authority Over Tobacco Products.--The Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
          (1) by redesignating chapter IX as chapter X;
          (2) by redesignating sections 901 through 910 as sections 
        1001 through 1010; and
          (3) by inserting after chapter VIII the following:

                     ``CHAPTER IX--TOBACCO PRODUCTS

``SEC. 900. DEFINITIONS.

  ``In this chapter:
          ``(1) Additive.--The term `additive' means any substance the 
        intended use of which results or may reasonably be expected to 
        result, directly or indirectly, in its becoming a component or 
        otherwise affecting the characteristic of any tobacco product 
        (including any substances intended for use as a flavoring or 
        coloring or in producing, manufacturing, packing, processing, 
        preparing, treating, packaging, transporting, or holding), 
        except that such term does not include tobacco or a pesticide 
        chemical residue in or on raw tobacco or a pesticide chemical.
          ``(2) Brand.--The term `brand' means a variety of tobacco 
        product distinguished by the tobacco used, tar content, 
        nicotine content, flavoring used, size, filtration, packaging, 
        logo, registered trademark, brand name, identifiable pattern of 
        colors, or any combination of such attributes.
          ``(3) Cigarette.--The term `cigarette'--
                  ``(A) means a product that--
                          ``(i) is a tobacco product; and
                          ``(ii) meets the definition of the term 
                        `cigarette' in section 3(1) of the Federal 
                        Cigarette Labeling and Advertising Act; and
                  ``(B) includes tobacco, in any form, that is 
                functional in the product, which, because of its 
                appearance, the type of tobacco used in the filler, or 
                its packaging and labeling, is likely to be offered to, 
                or purchased by, consumers as a cigarette or as roll-
                your-own tobacco.
          ``(4) Cigarette tobacco.--The term `cigarette tobacco' means 
        any product that consists of loose tobacco that is intended for 
        use by consumers in a cigarette. Unless otherwise stated, the 
        requirements applicable to cigarettes under this chapter shall 
        also apply to cigarette tobacco.
          ``(5) Commerce.--The term `commerce' has the meaning given 
        that term by section 3(2) of the Federal Cigarette Labeling and 
        Advertising Act.
          ``(6) Counterfeit tobacco product.--The term `counterfeit 
        tobacco product' means a tobacco product (or the container or 
        labeling of such a product) that, without authorization, bears 
        the trademark, trade name, or other identifying mark, imprint, 
        or device, or any likeness thereof, of a tobacco product listed 
        in a registration under section 905(i)(1).
          ``(7) Distributor.--The term `distributor' as regards a 
        tobacco product means any person who furthers the distribution 
        of a tobacco product, whether domestic or imported, at any 
        point from the original place of manufacture to the person who 
        sells or distributes the product to individuals for personal 
        consumption. Common carriers are not considered distributors 
        for purposes of this chapter.
          ``(8) Illicit trade.--The term `illicit trade' means any 
        practice or conduct prohibited by law which relates to 
        production, shipment, receipt, possession, distribution, sale, 
        or purchase of tobacco products including any practice or 
        conduct intended to facilitate such activity.
          ``(9) Indian tribe.--The term `Indian tribe' has the meaning 
        given such term in section 4(e) of the Indian Self-
        Determination and Education Assistance Act.
          ``(10) Little cigar.--The term `little cigar' means a product 
        that--
                  ``(A) is a tobacco product; and
                  ``(B) meets the definition of the term `little cigar' 
                in section 3(7) of the Federal Cigarette Labeling and 
                Advertising Act.
          ``(11) Nicotine.--The term `nicotine' means the chemical 
        substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or 
        C[10]H[14]N[2], including any salt or complex of nicotine.
          ``(12) Package.--The term `package' means a pack, box, 
        carton, or container of any kind or, if no other container, any 
        wrapping (including cellophane), in which a tobacco product is 
        offered for sale, sold, or otherwise distributed to consumers.
          ``(13) Retailer.--The term `retailer' means any person, 
        government, or entity who sells tobacco products to individuals 
        for personal consumption, or who operates a facility where 
        self-service displays of tobacco products are permitted.
          ``(14) Roll-your-own tobacco.--The term `roll-your-own 
        tobacco' means any tobacco product which, because of its 
        appearance, type, packaging, or labeling, is suitable for use 
        and likely to be offered to, or purchased by, consumers as 
        tobacco for making cigarettes.
          ``(15) Small tobacco product manufacturer.--The term `small 
        tobacco product manufacturer' means a tobacco product 
        manufacturer that employs fewer than 350 employees. For 
        purposes of determining the number of employees of a 
        manufacturer under the preceding sentence, the employees of a 
        manufacturer are deemed to include the employees of each entity 
        that controls, is controlled by, or is under common control 
        with such manufacturer.
          ``(16) Smoke constituent.--The term `smoke constituent' means 
        any chemical or chemical compound in mainstream or sidestream 
        tobacco smoke that either transfers from any component of the 
        cigarette to the smoke or that is formed by the combustion or 
        heating of tobacco, additives, or other component of the 
        tobacco product.
          ``(17) Smokeless tobacco.--The term `smokeless tobacco' means 
        any tobacco product that consists of cut, ground, powdered, or 
        leaf tobacco and that is intended to be placed in the oral or 
        nasal cavity.
          ``(18) State; territory.--The terms `State' and `Territory' 
        shall have the meanings given to such terms in section 201.
          ``(19) Tobacco product manufacturer.--The term `tobacco 
        product manufacturer' means any person, including any repacker 
        or relabeler, who--
                  ``(A) manufactures, fabricates, assembles, processes, 
                or labels a tobacco product; or
                  ``(B) imports a finished tobacco product for sale or 
                distribution in the United States.
          ``(20) Tobacco warehouse.--
                  ``(A) Subject to subparagraphs (B) and (C), the term 
                `tobacco warehouse' includes any person--
                          ``(i) who--
                                  ``(I) removes foreign material from 
                                tobacco leaf through nothing other than 
                                a mechanical process;
                                  ``(II) humidifies tobacco leaf with 
                                nothing other than potable water in the 
                                form of steam or mist; or
                                  ``(III) de-stems, dries, and packs 
                                tobacco leaf for storage and shipment;
                          ``(ii) who performs no other actions with 
                        respect to tobacco leaf; and
                          ``(iii) who provides to any manufacturer to 
                        whom the person sells tobacco all information 
                        related to the person's actions described in 
                        clause (i) that is necessary for compliance 
                        with this Act.
                  ``(B) The term `tobacco warehouse' excludes any 
                person who--
                          ``(i) reconstitutes tobacco leaf;
                          ``(ii) is a manufacturer, distributor, or 
                        retailer of a tobacco product; or
                          ``(iii) applies any chemical, additive, or 
                        substance to the tobacco leaf other than 
                        potable water in the form of steam or mist.
                  ``(C) The definition of the term `tobacco warehouse' 
                in subparagraph (A) shall not apply to the extent to 
                which the Secretary determines, through rulemaking, 
                that regulation under this chapter of the actions 
                described in such subparagraph is appropriate for the 
                protection of the public health.
          ``(21) United states.--The term `United States' means the 50 
        States of the United States of America and the District of 
        Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin 
        Islands, American Samoa, Wake Island, Midway Islands, Kingman 
        Reef, Johnston Atoll, the Northern Mariana Islands, and any 
        other trust territory or possession of the United States.

``SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.

  ``(a) In General.--Tobacco products, including modified risk tobacco 
products for which an order has been issued in accordance with section 
911, shall be regulated by the Secretary under this chapter and shall 
not be subject to the provisions of chapter V.
  ``(b) Applicability.--This chapter shall apply to all cigarettes, 
cigarette tobacco, and smokeless tobacco and to any other tobacco 
products that the Secretary by regulation deems to be subject to this 
chapter.
  ``(c) Scope.--
          ``(1) In general.--Nothing in this chapter, or any policy 
        issued or regulation promulgated thereunder, or in sections 
        101(a), 102, or 103 of title I, title II, or title III of the 
        Family Smoking Prevention and Tobacco Control Act, shall be 
        construed to affect, expand, or limit the Secretary's authority 
        over (including the authority to determine whether products may 
        be regulated), or the regulation of, products under this Act 
        that are not tobacco products under chapter V or any other 
        chapter.
          ``(2) Limitation of authority.--
                  ``(A) In general.--The provisions of this chapter 
                shall not apply to tobacco leaf that is not in the 
                possession of a manufacturer of tobacco products, or to 
                the producers of tobacco leaf, including tobacco 
                growers, tobacco warehouses, and tobacco grower 
                cooperatives, nor shall any employee of the Food and 
                Drug Administration have any authority to enter onto a 
                farm owned by a producer of tobacco leaf without the 
                written consent of such producer.
                  ``(B) Exception.--Notwithstanding subparagraph (A), 
                if a producer of tobacco leaf is also a tobacco product 
                manufacturer or controlled by a tobacco product 
                manufacturer, the producer shall be subject to this 
                chapter in the producer's capacity as a manufacturer. 
                The exception in this subparagraph shall not apply to a 
                producer of tobacco leaf who grows tobacco under a 
                contract with a tobacco product manufacturer and who is 
                not otherwise engaged in the manufacturing process.
                  ``(C) Rule of construction.--Nothing in this chapter 
                shall be construed to grant the Secretary authority to 
                promulgate regulations on any matter that involves the 
                production of tobacco leaf or a producer thereof, other 
                than activities by a manufacturer affecting production.
  ``(d) Rulemaking Procedures.--Each rulemaking under this chapter 
shall be in accordance with chapter 5 of title 5, United States Code. 
This subsection shall not be construed to affect the rulemaking 
provisions of section 102(a) of the Family Smoking Prevention and 
Tobacco Control Act.
  ``(e) Center for Tobacco Products.--Not later than 90 days after the 
date of enactment of this chapter, the Secretary shall establish within 
the Food and Drug Administration the Center for Tobacco Products, which 
shall report to the Commissioner of Food and Drugs in the same manner 
as the other agency centers within the Food and Drug Administration. 
The Center shall be responsible for the implementation of this chapter 
and related matters assigned by the Commissioner.
  ``(f) Office to Assist Small Tobacco Product Manufacturers.--The 
Secretary shall establish within the Food and Drug Administration an 
identifiable office to provide technical and other nonfinancial 
assistance to small tobacco product manufacturers to assist them in 
complying with the requirements of this Act.
  ``(g) Consultation Prior to Rulemaking.--Prior to promulgating rules 
under this chapter, the Secretary shall endeavor to consult with other 
Federal agencies as appropriate.

``SEC. 902. ADULTERATED TOBACCO PRODUCTS.

  ``A tobacco product shall be deemed to be adulterated if--
          ``(1) it consists in whole or in part of any filthy, putrid, 
        or decomposed substance, or is otherwise contaminated by any 
        added poisonous or added deleterious substance that may render 
        the product injurious to health;
          ``(2) it has been prepared, packed, or held under insanitary 
        conditions whereby it may have been contaminated with filth, or 
        whereby it may have been rendered injurious to health;
          ``(3) its package is composed, in whole or in part, of any 
        poisonous or deleterious substance which may render the 
        contents injurious to health;
          ``(4) the manufacturer or importer of the tobacco product 
        fails to pay a user fee assessed to such manufacturer or 
        importer pursuant to section 919 by the date specified in 
        section 919 or by the 30th day after final agency action on a 
        resolution of any dispute as to the amount of such fee;
          ``(5) it is, or purports to be or is represented as, a 
        tobacco product which is subject to a tobacco product standard 
        established under section 907 unless such tobacco product is in 
        all respects in conformity with such standard;
          ``(6)(A) it is required by section 910(a) to have premarket 
        review and does not have an order in effect under section 
        910(c)(1)(A)(i); or
          ``(B) it is in violation of an order under section 
        910(c)(1)(A);
          ``(7) the methods used in, or the facilities or controls used 
        for, its manufacture, packing, or storage are not in conformity 
        with applicable requirements under section 906(e)(1) or an 
        applicable condition prescribed by an order under section 
        906(e)(2); or
          ``(8) it is in violation of section 911.

``SEC. 903. MISBRANDED TOBACCO PRODUCTS.

  ``(a) In General.--A tobacco product shall be deemed to be 
misbranded--
          ``(1) if its labeling is false or misleading in any 
        particular;
          ``(2) if in package form unless it bears a label containing--
                  ``(A) the name and place of business of the tobacco 
                product manufacturer, packer, or distributor;
                  ``(B) an accurate statement of the quantity of the 
                contents in terms of weight, measure, or numerical 
                count;
                  ``(C) an accurate statement of the percentage of the 
                tobacco used in the product that is domestically grown 
                tobacco and the percentage that is foreign grown 
                tobacco; and
                  ``(D) the statement required under section 920(a),
        except that under subparagraph (B) reasonable variations shall 
        be permitted, and exemptions as to small packages shall be 
        established, by regulations prescribed by the Secretary;
          ``(3) if any word, statement, or other information required 
        by or under authority of this chapter to appear on the label or 
        labeling is not prominently placed thereon with such 
        conspicuousness (as compared with other words, statements, or 
        designs in the labeling) and in such terms as to render it 
        likely to be read and understood by the ordinary individual 
        under customary conditions of purchase and use;
          ``(4) if it has an established name, unless its label bears, 
        to the exclusion of any other nonproprietary name, its 
        established name prominently printed in type as required by the 
        Secretary by regulation;
          ``(5) if the Secretary has issued regulations requiring that 
        its labeling bear adequate directions for use, or adequate 
        warnings against use by children, that are necessary for the 
        protection of users unless its labeling conforms in all 
        respects to such regulations;
          ``(6) if it was manufactured, prepared, propagated, 
        compounded, or processed in an establishment not duly 
        registered under section 905(b), 905(c), 905(d), or 905(h), if 
        it was not included in a list required by section 905(i), if a 
        notice or other information respecting it was not provided as 
        required by such section or section 905(j), or if it does not 
        bear such symbols from the uniform system for identification of 
        tobacco products prescribed under section 905(e) as the 
        Secretary by regulation requires;
          ``(7) if, in the case of any tobacco product distributed or 
        offered for sale in any State--
                  ``(A) its advertising is false or misleading in any 
                particular; or
                  ``(B) it is sold or distributed in violation of 
                regulations prescribed under section 906(d);
          ``(8) unless, in the case of any tobacco product distributed 
        or offered for sale in any State, the manufacturer, packer, or 
        distributor thereof includes in all advertisements and other 
        descriptive printed matter issued or caused to be issued by the 
        manufacturer, packer, or distributor with respect to that 
        tobacco product--
                  ``(A) a true statement of the tobacco product's 
                established name as described in paragraph (4), printed 
                prominently; and
                  ``(B) a brief statement of--
                          ``(i) the uses of the tobacco product and 
                        relevant warnings, precautions, side effects, 
                        and contraindications; and
                          ``(ii) in the case of specific tobacco 
                        products made subject to a finding by the 
                        Secretary after notice and opportunity for 
                        comment that such action is appropriate to 
                        protect the public health, a full description 
                        of the components of such tobacco product or 
                        the formula showing quantitatively each 
                        ingredient of such tobacco product to the 
                        extent required in regulations which shall be 
                        issued by the Secretary after an opportunity 
                        for a hearing;
          ``(9) if it is a tobacco product subject to a tobacco product 
        standard established under section 907, unless it bears such 
        labeling as may be prescribed in such tobacco product standard; 
        or
          ``(10) if there was a failure or refusal--
                  ``(A) to comply with any requirement prescribed under 
                section 904 or 908; or
                  ``(B) to furnish any material or information required 
                under section 909.
  ``(b) Prior Approval of Label Statements.--The Secretary may, by 
regulation, require prior approval of statements made on the label of a 
tobacco product. No regulation issued under this subsection may require 
prior approval by the Secretary of the content of any advertisement, 
except for modified risk tobacco products as provided in section 911. 
No advertisement of a tobacco product published after the date of 
enactment of the Family Smoking Prevention and Tobacco Control Act 
shall, with respect to the language of label statements as prescribed 
under section 4 of the Federal Cigarette Labeling and Advertising Act 
and section 3 of the Comprehensive Smokeless Tobacco Health Education 
Act of 1986 or the regulations issued under such sections, be subject 
to the provisions of sections 12 through 15 of the Federal Trade 
Commission Act.

``SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE SECRETARY.

  ``(a) Requirement.--Each tobacco product manufacturer or importer, or 
agents thereof, shall submit to the Secretary the following 
information:
          ``(1) Not later than 6 months after the date of enactment of 
        the Family Smoking Prevention and Tobacco Control Act, a 
        listing of all ingredients, including tobacco, substances, 
        compounds, and additives that are, as of such date, added by 
        the manufacturer to the tobacco, paper, filter, or other part 
        of each tobacco product by brand and by quantity in each brand 
        and subbrand.
          ``(2) A description of the content, delivery, and form of 
        nicotine in each tobacco product measured in milligrams of 
        nicotine in accordance with regulations promulgated by the 
        Secretary in accordance with section 4(e) of the Federal 
        Cigarette Labeling and Advertising Act.
          ``(3) Beginning 3 years after the date of enactment of this 
        Act, a listing of all constituents, including smoke 
        constituents as applicable, identified by the Secretary as 
        harmful or potentially harmful to health in each tobacco 
        product, and as applicable in the smoke of each tobacco 
        product, by brand and by quantity in each brand and subbrand. 
        Effective beginning 3 years after the date of enactment of this 
        chapter, the manufacturer, importer, or agent shall comply with 
        regulations promulgated under section 915 in reporting 
        information under this paragraph, where applicable.
          ``(4) Beginning 6 months after the date of enactment of the 
        Family Smoking Prevention and Tobacco Control Act, all 
        documents developed after the date of enactment of the Family 
        Smoking Prevention and Tobacco Control Act that relate to 
        health, toxicological, behavioral, or physiologic effects of 
        current or future tobacco products, their constituents 
        (including smoke constituents), ingredients, components, and 
        additives.
  ``(b) Data Submission.--At the request of the Secretary, each tobacco 
product manufacturer or importer of tobacco products, or agents 
thereof, shall submit the following:
          ``(1) Any or all documents (including underlying scientific 
        information) relating to research activities, and research 
        findings, conducted, supported, or possessed by the 
        manufacturer (or agents thereof) on the health, toxicological, 
        behavioral, or physiologic effects of tobacco products and 
        their constituents (including smoke constituents), ingredients, 
        components, and additives.
          ``(2) Any or all documents (including underlying scientific 
        information) relating to research activities, and research 
        findings, conducted, supported, or possessed by the 
        manufacturer (or agents thereof) that relate to the issue of 
        whether a reduction in risk to health from tobacco products can 
        occur upon the employment of technology available or known to 
        the manufacturer.
          ``(3) Any or all documents (including underlying scientific 
        or financial information) relating to marketing research 
        involving the use of tobacco products or marketing practices 
        and the effectiveness of such practices used by tobacco 
        manufacturers and distributors.
An importer of a tobacco product not manufactured in the United States 
shall supply the information required of a tobacco product manufacturer 
under this subsection.
  ``(c) Time for Submission.--
          ``(1) In general.--At least 90 days prior to the delivery for 
        introduction into interstate commerce of a tobacco product not 
        on the market on the date of enactment of the Family Smoking 
        Prevention and Tobacco Control Act, the manufacturer of such 
        product shall provide the information required under subsection 
        (a).
          ``(2) Disclosure of additive.--If at any time a tobacco 
        product manufacturer adds to its tobacco products a new tobacco 
        additive or increases the quantity of an existing tobacco 
        additive, the manufacturer shall, except as provided in 
        paragraph (3), at least 90 days prior to such action so advise 
        the Secretary in writing.
          ``(3) Disclosure of other actions.--If at any time a tobacco 
        product manufacturer eliminates or decreases an existing 
        additive, or adds or increases an additive that has by 
        regulation been designated by the Secretary as an additive that 
        is not a human or animal carcinogen, or otherwise harmful to 
        health under intended conditions of use, the manufacturer shall 
        within 60 days of such action so advise the Secretary in 
        writing.
  ``(d) Data List.--
          ``(1) In general.--Not later than 3 years after the date of 
        enactment of the Family Smoking Prevention and Tobacco Control 
        Act, and annually thereafter, the Secretary shall publish in a 
        format that is understandable and not misleading to a lay 
        person, and place on public display (in a manner determined by 
        the Secretary) the list established under subsection (e).
          ``(2) Consumer research.--The Secretary shall conduct 
        periodic consumer research to ensure that the list published 
        under paragraph (1) is not misleading to lay persons. Not later 
        than 5 years after the date of enactment of the Family Smoking 
        Prevention and Tobacco Control Act, the Secretary shall submit 
        to the appropriate committees of Congress a report on the 
        results of such research, together with recommendations on 
        whether such publication should be continued or modified.
  ``(e) Data Collection.--Not later than 24 months after the date of 
enactment of the Family Smoking Prevention and Tobacco Control Act, the 
Secretary shall establish, and periodically revise as appropriate, a 
list of harmful and potentially harmful constituents, including smoke 
constituents, to health in each tobacco product by brand and by 
quantity in each brand and subbrand. The Secretary shall publish a 
public notice requesting the submission by interested persons of 
scientific and other information concerning the harmful and potentially 
harmful constituents in tobacco products and tobacco smoke.

``SEC. 905. ANNUAL REGISTRATION.

  ``(a) Definitions.--In this section:
          ``(1) Manufacture, preparation, compounding, or processing.--
        The term `manufacture, preparation, compounding, or processing' 
        shall include repackaging or otherwise changing the container, 
        wrapper, or labeling of any tobacco product package in 
        furtherance of the distribution of the tobacco product from the 
        original place of manufacture to the person who makes final 
        delivery or sale to the ultimate consumer or user.
          ``(2) Name.--The term `name' shall include in the case of a 
        partnership the name of each partner and, in the case of a 
        corporation, the name of each corporate officer and director, 
        and the State of incorporation.
  ``(b) Registration by Owners and Operators.--On or before December 31 
of each year, every person who owns or operates any establishment in 
any State engaged in the manufacture, preparation, compounding, or 
processing of a tobacco product or tobacco products shall register with 
the Secretary the name, places of business, and all such establishments 
of that person. If the enactment of this Act occurs in the second half 
of the calendar year, the Secretary shall designate a date no later 
than 6 months into the subsequent calendar year by which registration 
pursuant to this subsection shall occur.
  ``(c) Registration by New Owners and Operators.--Every person upon 
first engaging in the manufacture, preparation, compounding, or 
processing of a tobacco product or tobacco products in any 
establishment owned or operated in any State by that person shall 
immediately register with the Secretary that person's name, place of 
business, and such establishment.
  ``(d) Registration of Added Establishments.--Every person required to 
register under subsection (b) or (c) shall immediately register with 
the Secretary any additional establishment which that person owns or 
operates in any State and in which that person begins the manufacture, 
preparation, compounding, or processing of a tobacco product or tobacco 
products.
  ``(e) Uniform Product Identification System.--The Secretary may by 
regulation prescribe a uniform system for the identification of tobacco 
products and may require that persons who are required to list such 
tobacco products under subsection (i) shall list such tobacco products 
in accordance with such system.
  ``(f) Public Access to Registration Information.--The Secretary shall 
make available for inspection, to any person so requesting, any 
registration filed under this section.
  ``(g) Biennial Inspection of Registered Establishments.--Every 
establishment registered with the Secretary under this section shall be 
subject to inspection under section 704 or subsection (h), and every 
such establishment engaged in the manufacture, compounding, or 
processing of a tobacco product or tobacco products shall be so 
inspected by 1 or more officers or employees duly designated by the 
Secretary at least once in the 2-year period beginning with the date of 
registration of such establishment under this section and at least once 
in every successive 2-year period thereafter.
  ``(h) Registration by Foreign Establishments.--Any establishment 
within any foreign country engaged in the manufacture, preparation, 
compounding, or processing of a tobacco product or tobacco products, 
shall register under this section under regulations promulgated by the 
Secretary. Such regulations shall require such establishment to provide 
the information required by subsection (i) and shall include provisions 
for registration of any such establishment upon condition that adequate 
and effective means are available, by arrangement with the government 
of such foreign country or otherwise, to enable the Secretary to 
determine from time to time whether tobacco products manufactured, 
prepared, compounded, or processed in such establishment, if imported 
or offered for import into the United States, shall be refused 
admission on any of the grounds set forth in section 801(a).
  ``(i) Registration Information.--
          ``(1) Product list.--Every person who registers with the 
        Secretary under subsection (b), (c), (d), or (h) shall, at the 
        time of registration under any such subsection, file with the 
        Secretary a list of all tobacco products which are being 
        manufactured, prepared, compounded, or processed by that person 
        for commercial distribution and which have not been included in 
        any list of tobacco products filed by that person with the 
        Secretary under this paragraph or paragraph (2) before such 
        time of registration. Such list shall be prepared in such form 
        and manner as the Secretary may prescribe and shall be 
        accompanied by--
                  ``(A) in the case of a tobacco product contained in 
                the applicable list with respect to which a tobacco 
                product standard has been established under section 907 
                or which is subject to section 910, a reference to the 
                authority for the marketing of such tobacco product and 
                a copy of all labeling for such tobacco product;
                  ``(B) in the case of any other tobacco product 
                contained in an applicable list, a copy of all consumer 
                information and other labeling for such tobacco 
                product, a representative sampling of advertisements 
                for such tobacco product, and, upon request made by the 
                Secretary for good cause, a copy of all advertisements 
                for a particular tobacco product; and
                  ``(C) if the registrant filing a list has determined 
                that a tobacco product contained in such list is not 
                subject to a tobacco product standard established under 
                section 907, a brief statement of the basis upon which 
                the registrant made such determination if the Secretary 
                requests such a statement with respect to that 
                particular tobacco product.
          ``(2) Consultation with respect to forms.--The Secretary 
        shall consult with the Secretary of the Treasury in developing 
        the forms to be used for registration under this section to 
        minimize the burden on those persons required to register with 
        both the Secretary and the Tax and Trade Bureau of the 
        Department of the Treasury.
          ``(3) Biannual report of any change in product list.--Each 
        person who registers with the Secretary under this section 
        shall report to the Secretary once during the month of June of 
        each year and once during the month of December of each year 
        the following:
                  ``(A) A list of each tobacco product introduced by 
                the registrant for commercial distribution which has 
                not been included in any list previously filed by that 
                person with the Secretary under this subparagraph or 
                paragraph (1). A list under this subparagraph shall 
                list a tobacco product by its established name and 
                shall be accompanied by the other information required 
                by paragraph (1).
                  ``(B) If since the date the registrant last made a 
                report under this paragraph that person has 
                discontinued the manufacture, preparation, compounding, 
                or processing for commercial distribution of a tobacco 
                product included in a list filed under subparagraph (A) 
                or paragraph (1), notice of such discontinuance, the 
                date of such discontinuance, and the identity of its 
                established name.
                  ``(C) If since the date the registrant reported under 
                subparagraph (B) a notice of discontinuance that person 
                has resumed the manufacture, preparation, compounding, 
                or processing for commercial distribution of the 
                tobacco product with respect to which such notice of 
                discontinuance was reported, notice of such resumption, 
                the date of such resumption, the identity of such 
                tobacco product by established name, and other 
                information required by paragraph (1), unless the 
                registrant has previously reported such resumption to 
                the Secretary under this subparagraph.
                  ``(D) Any material change in any information 
                previously submitted under this paragraph or paragraph 
                (1).
  ``(j) Report Preceding Introduction of Certain Substantially 
Equivalent Products Into Interstate Commerce.--
          ``(1) In general.--Each person who is required to register 
        under this section and who proposes to begin the introduction 
        or delivery for introduction into interstate commerce for 
        commercial distribution of a tobacco product intended for human 
        use that was not commercially marketed (other than for test 
        marketing) in the United States as of February 15, 2007, shall, 
        at least 90 days prior to making such introduction or delivery, 
        report to the Secretary (in such form and manner as the 
        Secretary shall prescribe)--
                  ``(A) the basis for such person's determination 
                that--
                          ``(i) the tobacco product is substantially 
                        equivalent, within the meaning of section 910, 
                        to a tobacco product commercially marketed 
                        (other than for test marketing) in the United 
                        States as of February 15, 2007, or to a tobacco 
                        product that the Secretary has previously 
                        determined, pursuant to subsection (a)(3) of 
                        section 910, is substantially equivalent and 
                        that is in compliance with the requirements of 
                        this Act; or
                          ``(ii) the tobacco product is modified within 
                        the meaning of paragraph (3), the modifications 
                        are to a product that is commercially marketed 
                        and in compliance with the requirements of this 
                        Act, and all of the modifications are covered 
                        by exemptions granted by the Secretary pursuant 
                        to paragraph (3); and
                  ``(B) action taken by such person to comply with the 
                requirements under section 907 that are applicable to 
                the tobacco product.
          ``(2) Application to certain post-february 15, 2007, 
        products.--A report under this subsection for a tobacco product 
        that was first introduced or delivered for introduction into 
        interstate commerce for commercial distribution in the United 
        States after February 15, 2007, and prior to the date that is 
        21 months after the date of enactment of the Family Smoking 
        Prevention and Tobacco Control Act shall be submitted to the 
        Secretary not later than 21 months after such date of 
        enactment.
          ``(3) Exemptions.--
                  ``(A) In general.--The Secretary may exempt from the 
                requirements of this subsection relating to the 
                demonstration that a tobacco product is substantially 
                equivalent within the meaning of section 910, tobacco 
                products that are modified by adding or deleting a 
                tobacco additive, or increasing or decreasing the 
                quantity of an existing tobacco additive, if the 
                Secretary determines that--
                          ``(i) such modification would be a minor 
                        modification of a tobacco product that can be 
                        sold under this Act;
                          ``(ii) a report under this subsection is not 
                        necessary to ensure that permitting the tobacco 
                        product to be marketed would be appropriate for 
                        protection of the public health; and
                          ``(iii) an exemption is otherwise 
                        appropriate.
                  ``(B) Regulations.--Not later than 15 months after 
                the date of enactment of the Family Smoking Prevention 
                and Tobacco Control Act, the Secretary shall issue 
                regulations to implement this paragraph.

``SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO PRODUCTS.

  ``(a) In General.--Any requirement established by or under section 
902, 903, 905, or 909 applicable to a tobacco product shall apply to 
such tobacco product until the applicability of the requirement to the 
tobacco product has been changed by action taken under section 907, 
section 910, section 911, or subsection (d) of this section, and any 
requirement established by or under section 902, 903, 905, or 909 which 
is inconsistent with a requirement imposed on such tobacco product 
under section 907, section 910, section 911, or subsection (d) of this 
section shall not apply to such tobacco product.
  ``(b) Information on Public Access and Comment.--Each notice of 
proposed rulemaking or other notification under section 907, 908, 909, 
910, or 911 or under this section, any other notice which is published 
in the Federal Register with respect to any other action taken under 
any such section and which states the reasons for such action, and each 
publication of findings required to be made in connection with 
rulemaking under any such section shall set forth--
          ``(1) the manner in which interested persons may examine data 
        and other information on which the notice or findings is based; 
        and
          ``(2) the period within which interested persons may present 
        their comments on the notice or findings (including the need 
        therefore) orally or in writing, which period shall be at least 
        60 days but may not exceed 90 days unless the time is extended 
        by the Secretary by a notice published in the Federal Register 
        stating good cause therefore.
  ``(c) Limited Confidentiality of Information.--Any information 
reported to or otherwise obtained by the Secretary or the Secretary's 
representative under section 903, 904, 907, 908, 909, 910, 911, or 704, 
or under subsection (e) or (f) of this section, which is exempt from 
disclosure under subsection (a) of section 552 of title 5, United 
States Code, by reason of subsection (b)(4) of that section shall be 
considered confidential and shall not be disclosed, except that the 
information may be disclosed to other officers or employees concerned 
with carrying out this chapter, or when relevant in any proceeding 
under this chapter.
  ``(d) Restrictions.--
          ``(1) In general.--The Secretary may by regulation require 
        restrictions on the sale and distribution of a tobacco product, 
        including restrictions on the access to, and the advertising 
        and promotion of, the tobacco product, if the Secretary 
        determines that such regulation would be appropriate for the 
        protection of the public health. The Secretary may by 
        regulation impose restrictions on the advertising and promotion 
        of a tobacco product consistent with and to full extent 
        permitted by the first amendment to the Constitution. The 
        finding as to whether such regulation would be appropriate for 
        the protection of the public health shall be determined with 
        respect to the risks and benefits to the population as a whole, 
        including users and nonusers of the tobacco product, and taking 
        into account--
                  ``(A) the increased or decreased likelihood that 
                existing users of tobacco products will stop using such 
                products; and
                  ``(B) the increased or decreased likelihood that 
                those who do not use tobacco products will start using 
                such products.
        No such regulation may require that the sale or distribution of 
        a tobacco product be limited to the written or oral 
        authorization of a practitioner licensed by law to prescribe 
        medical products.
          ``(2) Label statements.--The label of a tobacco product shall 
        bear such appropriate statements of the restrictions required 
        by a regulation under subsection (a) as the Secretary may in 
        such regulation prescribe.
          ``(3) Limitations.--
                  ``(A) In general.--No restrictions under paragraph 
                (1) may--
                          ``(i) prohibit the sale of any tobacco 
                        product in face-to-face transactions by a 
                        specific category of retail outlets; or
                          ``(ii) establish a minimum age of sale of 
                        tobacco products to any person older than 18 
                        years of age.
                  ``(B) Matchbooks.--For purposes of any regulations 
                issued by the Secretary, matchbooks of conventional 
                size containing not more than 20 paper matches, and 
                which are customarily given away for free with the 
                purchase of tobacco products, shall be considered as 
                adult-written publications which shall be permitted to 
                contain advertising. Notwithstanding the preceding 
                sentence, if the Secretary finds that such treatment of 
                matchbooks is not appropriate for the protection of the 
                public health, the Secretary may determine by 
                regulation that matchbooks shall not be considered 
                adult-written publications.
          ``(4) Remote sales.--
                  ``(A) In general.--The Secretary shall--
                          ``(i) within 18 months after the date of 
                        enactment of this chapter, promulgate 
                        regulations regarding the sale and distribution 
                        of tobacco products that occur through means 
                        other than a direct, face-to-face exchange 
                        between a retailer and a consumer in order to 
                        prevent the sale and distribution of tobacco 
                        products to individuals who have not attained 
                        the minimum age established by applicable law 
                        for the purchase of such products, including 
                        requirements for age verification; and
                          ``(ii) within 2 years after such date of 
                        enactment, issue regulations to address the 
                        promotion and marketing of tobacco products 
                        that are sold or distributed through means 
                        other than a direct, face-to-face exchange 
                        between a retailer and a consumer in order to 
                        protect individuals who have not attained the 
                        minimum age established by applicable law for 
                        the purchase of such products.
                  ``(B) Relation to other authority.--Nothing in this 
                paragraph limits the authority of the Secretary to take 
                additional actions under the other paragraphs of this 
                subsection.
  ``(e) Good Manufacturing Practice Requirements.--
          ``(1) Methods, facilities, and controls to conform.--
                  ``(A) In general.--In applying manufacturing 
                restrictions to tobacco, the Secretary shall, in 
                accordance with subparagraph (B), prescribe regulations 
                (which may differ based on the type of tobacco product 
                involved) requiring that the methods used in, and the 
                facilities and controls used for, the manufacture, 
                preproduction design validation (including a process to 
                assess the performance of a tobacco product), packing, 
                and storage of a tobacco product conform to current 
                good manufacturing practice, or hazard analysis and 
                critical control point methodology, as prescribed in 
                such regulations to assure that the public health is 
                protected and that the tobacco product is in compliance 
                with this chapter. Such regulations may provide for the 
                testing of raw tobacco for pesticide chemical residues 
                regardless of whether a tolerance for such chemical 
                residues has been established.
                  ``(B) Requirements.--The Secretary shall--
                          ``(i) before promulgating any regulation 
                        under subparagraph (A), afford the Tobacco 
                        Products Scientific Advisory Committee an 
                        opportunity to submit recommendations with 
                        respect to the regulation proposed to be 
                        promulgated;
                          ``(ii) before promulgating any regulation 
                        under subparagraph (A), afford opportunity for 
                        an oral hearing;
                          ``(iii) provide the Tobacco Products 
                        Scientific Advisory Committee a reasonable time 
                        to make its recommendation with respect to 
                        proposed regulations under subparagraph (A);
                          ``(iv) in establishing the effective date of 
                        a regulation promulgated under this subsection, 
                        take into account the differences in the manner 
                        in which the different types of tobacco 
                        products have historically been produced, the 
                        financial resources of the different tobacco 
                        product manufacturers, and the state of their 
                        existing manufacturing facilities, and shall 
                        provide for a reasonable period of time for 
                        such manufacturers to conform to good 
                        manufacturing practices; and
                          ``(v) not require any small tobacco product 
                        manufacturer to comply with a regulation under 
                        subparagraph (A) for at least 4 years following 
                        the effective date established by the Secretary 
                        for such regulation.
          ``(2) Exemptions; variances.--
                  ``(A) Petition.--Any person subject to any 
                requirement prescribed under paragraph (1) may petition 
                the Secretary for a permanent or temporary exemption or 
                variance from such requirement. Such a petition shall 
                be submitted to the Secretary in such form and manner 
                as the Secretary shall prescribe and shall--
                          ``(i) in the case of a petition for an 
                        exemption from a requirement, set forth the 
                        basis for the petitioner's determination that 
                        compliance with the requirement is not required 
                        to assure that the tobacco product will be in 
                        compliance with this chapter;
                          ``(ii) in the case of a petition for a 
                        variance from a requirement, set forth the 
                        methods proposed to be used in, and the 
                        facilities and controls proposed to be used 
                        for, the manufacture, packing, and storage of 
                        the tobacco product in lieu of the methods, 
                        facilities, and controls prescribed by the 
                        requirement; and
                          ``(iii) contain such other information as the 
                        Secretary shall prescribe.
                  ``(B) Referral to the tobacco products scientific 
                advisory committee.--The Secretary may refer to the 
                Tobacco Products Scientific Advisory Committee any 
                petition submitted under subparagraph (A). The Tobacco 
                Products Scientific Advisory Committee shall report its 
                recommendations to the Secretary with respect to a 
                petition referred to it within 60 days after the date 
                of the petition's referral. Within 60 days after--
                          ``(i) the date the petition was submitted to 
                        the Secretary under subparagraph (A); or
                          ``(ii) the day after the petition was 
                        referred to the Tobacco Products Scientific 
                        Advisory Committee,
                whichever occurs later, the Secretary shall by order 
                either deny the petition or approve it.
                  ``(C) Approval.--The Secretary may approve--
                          ``(i) a petition for an exemption for a 
                        tobacco product from a requirement if the 
                        Secretary determines that compliance with such 
                        requirement is not required to assure that the 
                        tobacco product will be in compliance with this 
                        chapter; and
                          ``(ii) a petition for a variance for a 
                        tobacco product from a requirement if the 
                        Secretary determines that the methods to be 
                        used in, and the facilities and controls to be 
                        used for, the manufacture, packing, and storage 
                        of the tobacco product in lieu of the methods, 
                        facilities, and controls prescribed by the 
                        requirement are sufficient to assure that the 
                        tobacco product will be in compliance with this 
                        chapter.
                  ``(D) Conditions.--An order of the Secretary 
                approving a petition for a variance shall prescribe 
                such conditions respecting the methods used in, and the 
                facilities and controls used for, the manufacture, 
                packing, and storage of the tobacco product to be 
                granted the variance under the petition as may be 
                necessary to assure that the tobacco product will be in 
                compliance with this chapter.
                  ``(E) Hearing.--After the issuance of an order under 
                subparagraph (B) respecting a petition, the petitioner 
                shall have an opportunity for an informal hearing on 
                such order.
          ``(3) Compliance.--Compliance with requirements under this 
        subsection shall not be required before the end of the 3-year 
        period following the date of enactment of the Family Smoking 
        Prevention and Tobacco Control Act.
  ``(f) Research and Development.--The Secretary may enter into 
contracts for research, testing, and demonstrations respecting tobacco 
products and may obtain tobacco products for research, testing, and 
demonstration purposes.

``SEC. 907. TOBACCO PRODUCT STANDARDS.

  ``(a) In General.--
          ``(1) Special rules.--
                  ``(A) Special rule for cigarettes.--Beginning 3 
                months after the date of enactment of the Family 
                Smoking Prevention and Tobacco Control Act, a cigarette 
                or any of its component parts (including the tobacco, 
                filter, or paper) shall not contain, as a constituent 
                (including a smoke constituent) or additive, an 
                artificial or natural flavor (other than tobacco or 
                menthol) or an herb or spice, including strawberry, 
                grape, orange, clove, cinnamon, pineapple, vanilla, 
                coconut, licorice, cocoa, chocolate, cherry, or coffee, 
                that is a characterizing flavor of the tobacco product 
                or tobacco smoke. Nothing in this subparagraph shall be 
                construed to limit the Secretary's authority to take 
                action under this section or other sections of this Act 
                applicable to menthol or any artificial or natural 
                flavor, herb, or spice not specified in this 
                subparagraph. For purposes of this section, a cigarette 
                or any of its component parts has a characterizing 
                flavor if the cigarette, its tobacco smoke, or the 
                component part imparts a distinguishable taste or aroma 
                other than tobacco or menthol either prior to 
                consumption or during consumption, or is advertised or 
                marketed as having or producing a flavor, taste, or 
                aroma other than tobacco or menthol.
                  ``(B) Additional special rule.--No tobacco product 
                manufactured in or imported into the United States 
                shall contain foreign-grown tobacco that--
                          ``(i) contains a level of any pesticide 
                        chemical residue in excess of any maximum 
                        permissible residue level that is applicable to 
                        domestically grown tobacco; or
                          ``(ii) was grown or processed using any 
                        pesticide chemical not approved under Federal 
                        law for use in domestic tobacco farming or 
                        processing.
          ``(2) Revision of tobacco product standards.--The Secretary 
        may revise the tobacco product standards in paragraph (1) in 
        accordance with subsection (c).
          ``(3) Tobacco product standards.--
                  ``(A) In general.--The Secretary may adopt tobacco 
                product standards in addition to those in paragraph (1) 
                if the Secretary finds that a tobacco product standard 
                is appropriate for the protection of the public health.
                  ``(B) Determinations.--
                          ``(i) Considerations.--In making a finding 
                        described in subparagraph (A), the Secretary 
                        shall consider scientific evidence concerning--
                                  ``(I) the risks and benefits to the 
                                population as a whole, including users 
                                and nonusers of tobacco products, of 
                                the proposed standard;
                                  ``(II) the increased or decreased 
                                likelihood that existing users of 
                                tobacco products will stop using such 
                                products; and
                                  ``(III) the increased or decreased 
                                likelihood that those who do not use 
                                tobacco products will start using such 
                                products.
                          ``(ii) Additional considerations.--In the 
                        event that the Secretary makes a determination, 
                        set forth in a proposed tobacco product 
                        standard in a proposed rule, that it is 
                        appropriate for the protection of public health 
                        to require the reduction or elimination of an 
                        additive, constituent (including a smoke 
                        constituent), or other component of a tobacco 
                        product because the Secretary has found that 
                        the additive, constituent, or other component 
                        is or may be harmful, any party objecting to 
                        the proposed standard on the ground that the 
                        proposed standard will not reduce or eliminate 
                        the risk of illness or injury may provide for 
                        the Secretary's consideration scientific 
                        evidence that demonstrates that the proposed 
                        standard will not reduce or eliminate the risk 
                        of illness or injury.
          ``(4) Content of tobacco product standards.--A tobacco 
        product standard established under this section for a tobacco 
        product--
                  ``(A) shall include provisions that are appropriate 
                for the protection of the public health, including 
                provisions, where appropriate--
                          ``(i) for nicotine yields of the product;
                          ``(ii) for the reduction or elimination of 
                        other constituents, including smoke 
                        constituents, or harmful components of the 
                        product; or
                          ``(iii) relating to any other requirement 
                        under subparagraph (B);
                  ``(B) shall, where appropriate for the protection of 
                the public health, include--
                          ``(i) provisions respecting the construction, 
                        components, ingredients, additives, 
                        constituents, including smoke constituents, and 
                        properties of the tobacco product;
                          ``(ii) provisions for the testing (on a 
                        sample basis or, if necessary, on an individual 
                        basis) of the tobacco product;
                          ``(iii) provisions for the measurement of the 
                        tobacco product characteristics of the tobacco 
                        product;
                          ``(iv) provisions requiring that the results 
                        of each or of certain of the tests of the 
                        tobacco product required to be made under 
                        clause (ii) show that the tobacco product is in 
                        conformity with the portions of the standard 
                        for which the test or tests were required; and
                          ``(v) a provision requiring that the sale and 
                        distribution of the tobacco product be 
                        restricted but only to the extent that the sale 
                        and distribution of a tobacco product may be 
                        restricted under a regulation under section 
                        906(d);
                  ``(C) shall, where appropriate, require the use and 
                prescribe the form and content of labeling for the 
                proper use of the tobacco product; and
                  ``(D) shall require tobacco products containing 
                foreign-grown tobacco to meet the same standards 
                applicable to tobacco products containing domestically 
                grown tobacco.
          ``(5) Periodic reevaluation of tobacco product standards.--
        The Secretary shall provide for periodic evaluation of tobacco 
        product standards established under this section to determine 
        whether such standards should be changed to reflect new 
        medical, scientific, or other technological data. The Secretary 
        may provide for testing under paragraph (4)(B) by any person.
          ``(6) Involvement of other agencies; informed persons.--In 
        carrying out duties under this section, the Secretary shall 
        endeavor to--
                  ``(A) use personnel, facilities, and other technical 
                support available in other Federal agencies;
                  ``(B) consult with other Federal agencies concerned 
                with standard setting and other nationally or 
                internationally recognized standard-setting entities; 
                and
                  ``(C) invite appropriate participation, through joint 
                or other conferences, workshops, or other means, by 
                informed persons representative of scientific, 
                professional, industry, agricultural, or consumer 
                organizations who in the Secretary's judgment can make 
                a significant contribution.
  ``(b) Considerations by Secretary.--
          ``(1) Technical achievability.--The Secretary shall consider 
        information submitted in connection with a proposed standard 
        regarding the technical achievability of compliance with such 
        standard.
          ``(2) Other considerations.--The Secretary shall consider all 
        other information submitted in connection with a proposed 
        standard, including information concerning the countervailing 
        effects of the tobacco product standard on the health of 
        adolescent tobacco users, adult tobacco users, or nontobacco 
        users, such as the creation of a significant demand for 
        contraband or other tobacco products that do not meet the 
        requirements of this chapter and the significance of such 
        demand.
  ``(c) Proposed Standards.--
          ``(1) In general.--The Secretary shall publish in the Federal 
        Register a notice of proposed rulemaking for the establishment, 
        amendment, or revocation of any tobacco product standard.
          ``(2) Requirements of notice.--A notice of proposed 
        rulemaking for the establishment or amendment of a tobacco 
        product standard for a tobacco product shall--
                  ``(A) set forth a finding with supporting 
                justification that the tobacco product standard is 
                appropriate for the protection of the public health;
                  ``(B) invite interested persons to submit a draft or 
                proposed tobacco product standard for consideration by 
                the Secretary;
                  ``(C) invite interested persons to submit comments on 
                structuring the standard so that it does not advantage 
                foreign-grown tobacco over domestically grown tobacco; 
                and
                  ``(D) invite the Secretary of Agriculture to provide 
                any information or analysis which the Secretary of 
                Agriculture believes is relevant to the proposed 
                tobacco product standard.
          ``(3) Finding.--A notice of proposed rulemaking for the 
        revocation of a tobacco product standard shall set forth a 
        finding with supporting justification that the tobacco product 
        standard is no longer appropriate for the protection of the 
        public health.
          ``(4) Comment.--The Secretary shall provide for a comment 
        period of not less than 60 days.
  ``(d) Promulgation.--
          ``(1) In general.--After the expiration of the period for 
        comment on a notice of proposed rulemaking published under 
        subsection (c) respecting a tobacco product standard and after 
        consideration of comments submitted under subsections (b) and 
        (c) and any report from the Tobacco Products Scientific 
        Advisory Committee, if the Secretary determines that the 
        standard would be appropriate for the protection of the public 
        health, the Secretary shall--
                  ``(A) promulgate a regulation establishing a tobacco 
                product standard and publish in the Federal Register 
                findings on the matters referred to in subsection (c); 
                or
                  ``(B) publish a notice terminating the proceeding for 
                the development of the standard together with the 
                reasons for such termination.
          ``(2) Effective date.--A regulation establishing a tobacco 
        product standard shall set forth the date or dates upon which 
        the standard shall take effect, but no such regulation may take 
        effect before 1 year after the date of its publication unless 
        the Secretary determines that an earlier effective date is 
        necessary for the protection of the public health. Such date or 
        dates shall be established so as to minimize, consistent with 
        the public health, economic loss to, and disruption or 
        dislocation of, domestic and international trade. In 
        establishing such effective date or dates, the Secretary shall 
        consider information submitted in connection with a proposed 
        product standard by interested parties, including manufacturers 
        and tobacco growers, regarding the technical achievability of 
        compliance with the standard, and including information 
        concerning the existence of patents that make it impossible to 
        comply in the timeframe envisioned in the proposed standard. If 
        the Secretary determines, based on the Secretary's evaluation 
        of submitted comments, that a product standard can be met only 
        by manufacturers requiring substantial changes to the methods 
        of farming the domestically grown tobacco used by the 
        manufacturer, the effective date of that product standard shall 
        be not less than 2 years after the date of publication of the 
        final regulation establishing the standard.
          ``(3) Limitation on power granted to the food and drug 
        administration.--Because of the importance of a decision of the 
        Secretary to issue a regulation--
                  ``(A) banning all cigarettes, all smokeless tobacco 
                products, all little cigars, all cigars other than 
                little cigars, all pipe tobacco, or all roll-your-own 
                tobacco products; or
                  ``(B) requiring the reduction of nicotine yields of a 
                tobacco product to zero,
        the Secretary is prohibited from taking such actions under this 
        Act.
          ``(4) Amendment; revocation.--
                  ``(A) Authority.--The Secretary, upon the Secretary's 
                own initiative or upon petition of an interested 
                person, may by a regulation, promulgated in accordance 
                with the requirements of subsection (c) and paragraph 
                (2), amend or revoke a tobacco product standard.
                  ``(B) Effective date.--The Secretary may declare a 
                proposed amendment of a tobacco product standard to be 
                effective on and after its publication in the Federal 
                Register and until the effective date of any final 
                action taken on such amendment if the Secretary 
                determines that making it so effective is in the public 
                interest.
          ``(5) Referral to advisory committee.--
                  ``(A) In general.--The Secretary may refer a proposed 
                regulation for the establishment, amendment, or 
                revocation of a tobacco product standard to the Tobacco 
                Products Scientific Advisory Committee for a report and 
                recommendation with respect to any matter involved in 
                the proposed regulation which requires the exercise of 
                scientific judgment.
                  ``(B) Initiation of referral.--The Secretary may make 
                a referral under this paragraph--
                          ``(i) on the Secretary's own initiative; or
                          ``(ii) upon the request of an interested 
                        person that--
                                  ``(I) demonstrates good cause for the 
                                referral; and
                                  ``(II) is made before the expiration 
                                of the period for submission of 
                                comments on the proposed regulation.
                  ``(C) Provision of data.--If a proposed regulation is 
                referred under this paragraph to the Tobacco Products 
                Scientific Advisory Committee, the Secretary shall 
                provide the Advisory Committee with the data and 
                information on which such proposed regulation is based.
                  ``(D) Report and recommendation.--The Tobacco 
                Products Scientific Advisory Committee shall, within 60 
                days after the referral of a proposed regulation under 
                this paragraph and after independent study of the data 
                and information furnished to it by the Secretary and 
                other data and information before it, submit to the 
                Secretary a report and recommendation respecting such 
                regulation, together with all underlying data and 
                information and a statement of the reason or basis for 
                the recommendation.
                  ``(E) Public availability.--The Secretary shall make 
                a copy of each report and recommendation under 
                subparagraph (D) publicly available.

``SEC. 908. NOTIFICATION AND OTHER REMEDIES.

  ``(a) Notification.--If the Secretary determines that--
          ``(1) a tobacco product which is introduced or delivered for 
        introduction into interstate commerce for commercial 
        distribution presents an unreasonable risk of substantial harm 
        to the public health; and
          ``(2) notification under this subsection is necessary to 
        eliminate the unreasonable risk of such harm and no more 
        practicable means is available under the provisions of this 
        chapter (other than this section) to eliminate such risk,
the Secretary may issue such order as may be necessary to assure that 
adequate notification is provided in an appropriate form, by the 
persons and means best suited under the circumstances involved, to all 
persons who should properly receive such notification in order to 
eliminate such risk. The Secretary may order notification by any 
appropriate means, including public service announcements. Before 
issuing an order under this subsection, the Secretary shall consult 
with the persons who are to give notice under the order.
  ``(b) No Exemption From Other Liability.--Compliance with an order 
issued under this section shall not relieve any person from liability 
under Federal or State law. In awarding damages for economic loss in an 
action brought for the enforcement of any such liability, the value to 
the plaintiff in such action of any remedy provided under such order 
shall be taken into account.
  ``(c) Recall Authority.--
          ``(1) In general.--If the Secretary finds that there is a 
        reasonable probability that a tobacco product contains a 
        manufacturing or other defect not ordinarily contained in 
        tobacco products on the market that would cause serious, 
        adverse health consequences or death, the Secretary shall issue 
        an order requiring the appropriate person (including the 
        manufacturers, importers, distributors, or retailers of the 
        tobacco product) to immediately cease distribution of such 
        tobacco product. The order shall provide the person subject to 
        the order with an opportunity for an informal hearing, to be 
        held not later than 10 days after the date of the issuance of 
        the order, on the actions required by the order and on whether 
        the order should be amended to require a recall of such tobacco 
        product. If, after providing an opportunity for such a hearing, 
        the Secretary determines that inadequate grounds exist to 
        support the actions required by the order, the Secretary shall 
        vacate the order.
          ``(2) Amendment of order to require recall.--
                  ``(A) In general.--If, after providing an opportunity 
                for an informal hearing under paragraph (1), the 
                Secretary determines that the order should be amended 
                to include a recall of the tobacco product with respect 
                to which the order was issued, the Secretary shall, 
                except as provided in subparagraph (B), amend the order 
                to require a recall. The Secretary shall specify a 
                timetable in which the tobacco product recall will 
                occur and shall require periodic reports to the 
                Secretary describing the progress of the recall.
                  ``(B) Notice.--An amended order under subparagraph 
                (A)--
                          ``(i) shall not include recall of a tobacco 
                        product from individuals; and
                          ``(ii) shall provide for notice to persons 
                        subject to the risks associated with the use of 
                        such tobacco product.
                In providing the notice required by clause (ii), the 
                Secretary may use the assistance of retailers and other 
                persons who distributed such tobacco product. If a 
                significant number of such persons cannot be 
                identified, the Secretary shall notify such persons 
                under section 705(b).
          ``(3) Remedy not exclusive.--The remedy provided by this 
        subsection shall be in addition to remedies provided by 
        subsection (a).

``SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS.

  ``(a) In General.--Every person who is a tobacco product manufacturer 
or importer of a tobacco product shall establish and maintain such 
records, make such reports, and provide such information, as the 
Secretary may by regulation reasonably require to assure that such 
tobacco product is not adulterated or misbranded and to otherwise 
protect public health. Regulations prescribed under the preceding 
sentence--
          ``(1) may require a tobacco product manufacturer or importer 
        to report to the Secretary whenever the manufacturer or 
        importer receives or otherwise becomes aware of information 
        that reasonably suggests that one of its marketed tobacco 
        products may have caused or contributed to a serious unexpected 
        adverse experience associated with the use of the product or 
        any significant increase in the frequency of a serious, 
        expected adverse product experience;
          ``(2) shall require reporting of other significant adverse 
        tobacco product experiences as determined by the Secretary to 
        be necessary to be reported;
          ``(3) shall not impose requirements unduly burdensome to a 
        tobacco product manufacturer or importer, taking into account 
        the cost of complying with such requirements and the need for 
        the protection of the public health and the implementation of 
        this chapter;
          ``(4) when prescribing the procedure for making requests for 
        reports or information, shall require that each request made 
        under such regulations for submission of a report or 
        information to the Secretary state the reason or purpose for 
        such request and identify to the fullest extent practicable 
        such report or information;
          ``(5) when requiring submission of a report or information to 
        the Secretary, shall state the reason or purpose for the 
        submission of such report or information and identify to the 
        fullest extent practicable such report or information; and
          ``(6) may not require that the identity of any patient or 
        user be disclosed in records, reports, or information required 
        under this subsection unless required for the medical welfare 
        of an individual, to determine risks to public health of a 
        tobacco product, or to verify a record, report, or information 
        submitted under this chapter.
In prescribing regulations under this subsection, the Secretary shall 
have due regard for the professional ethics of the medical profession 
and the interests of patients. The prohibitions of paragraph (6) 
continue to apply to records, reports, and information concerning any 
individual who has been a patient, irrespective of whether or when he 
ceases to be a patient.
  ``(b) Reports of Removals and Corrections.--
          ``(1) In general.--Except as provided in paragraph (2), the 
        Secretary shall by regulation require a tobacco product 
        manufacturer or importer of a tobacco product to report 
        promptly to the Secretary any corrective action taken or 
        removal from the market of a tobacco product undertaken by such 
        manufacturer or importer if the removal or correction was 
        undertaken--
                  ``(A) to reduce a risk to health posed by the tobacco 
                product; or
                  ``(B) to remedy a violation of this chapter caused by 
                the tobacco product which may present a risk to health.
        A tobacco product manufacturer or importer of a tobacco product 
        who undertakes a corrective action or removal from the market 
        of a tobacco product which is not required to be reported under 
        this subsection shall keep a record of such correction or 
        removal.
          ``(2) Exception.--No report of the corrective action or 
        removal of a tobacco product may be required under paragraph 
        (1) if a report of the corrective action or removal is required 
        and has been submitted under subsection (a).

``SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TOBACCO PRODUCTS.

  ``(a) In General.--
          ``(1) New tobacco product defined.--For purposes of this 
        section the term `new tobacco product' means--
                  ``(A) any tobacco product (including those products 
                in test markets) that was not commercially marketed in 
                the United States as of February 15, 2007; or
                  ``(B) any modification (including a change in design, 
                any component, any part, or any constituent, including 
                a smoke constituent, or in the content, delivery or 
                form of nicotine, or any other additive or ingredient) 
                of a tobacco product where the modified product was 
                commercially marketed in the United States after 
                February 15, 2007.
          ``(2) Premarket review required.--
                  ``(A) New products.--An order under subsection 
                (c)(1)(A)(i) for a new tobacco product is required 
                unless--
                          ``(i) the manufacturer has submitted a report 
                        under section 905(j); and the Secretary has 
                        issued an order that the tobacco product--
                                  ``(I) is substantially equivalent to 
                                a tobacco product commercially marketed 
                                (other than for test marketing) in the 
                                United States as of February 15, 2007; 
                                and
                                  ``(II) is in compliance with the 
                                requirements of this Act; or
                          ``(ii) the tobacco product is exempt from the 
                        requirements of section 905(j) pursuant to a 
                        regulation issued under section 905(j)(3).
                  ``(B) Application to certain post-february 15, 2007, 
                products.--Subparagraph (A) shall not apply to a 
                tobacco product--
                          ``(i) that was first introduced or delivered 
                        for introduction into interstate commerce for 
                        commercial distribution in the United States 
                        after February 15, 2007, and prior to the date 
                        that is 21 months after the date of enactment 
                        of the Family Smoking Prevention and Tobacco 
                        Control Act; and
                          ``(ii) for which a report was submitted under 
                        section 905(j) within such 21-month period,
                except that subparagraph (A) shall apply to the tobacco 
                product if the Secretary issues an order that the 
                tobacco product is not substantially equivalent.
          ``(3) Substantially equivalent defined.--
                  ``(A) In general.--In this section and section 
                905(j), the term `substantially equivalent' or 
                `substantial equivalence' means, with respect to the 
                tobacco product being compared to the predicate tobacco 
                product, that the Secretary by order has found that the 
                tobacco product--
                          ``(i) has the same characteristics as the 
                        predicate tobacco product; or
                          ``(ii) has different characteristics and the 
                        information submitted contains information, 
                        including clinical data if deemed necessary by 
                        the Secretary, that demonstrates that it is not 
                        appropriate to regulate the product under this 
                        section because the product does not raise 
                        different questions of public health.
                  ``(B) Characteristics.--In subparagraph (A), the term 
                `characteristics' means the materials, ingredients, 
                design, composition, heating source, or other features 
                of a tobacco product.
                  ``(C) Limitation.--A tobacco product may not be found 
                to be substantially equivalent to a predicate tobacco 
                product that has been removed from the market at the 
                initiative of the Secretary or that has been determined 
                by a judicial order to be misbranded or adulterated.
          ``(4) Health information.--
                  ``(A) Summary.--As part of a submission under section 
                905(j) respecting a tobacco product, the person 
                required to file a premarket notification under such 
                section shall provide an adequate summary of any health 
                information related to the tobacco product or state 
                that such information will be made available upon 
                request by any person.
                  ``(B) Required information.--Any summary under 
                subparagraph (A) respecting a tobacco product shall 
                contain detailed information regarding data concerning 
                adverse health effects and shall be made available to 
                the public by the Secretary within 30 days of the 
                issuance of a determination that such tobacco product 
                is substantially equivalent to another tobacco product.
  ``(b) Application.--
          ``(1) Contents.--An application under this section shall 
        contain--
                  ``(A) full reports of all information, published or 
                known to, or which should reasonably be known to, the 
                applicant, concerning investigations which have been 
                made to show the health risks of such tobacco product 
                and whether such tobacco product presents less risk 
                than other tobacco products;
                  ``(B) a full statement of the components, 
                ingredients, additives, and properties, and of the 
                principle or principles of operation, of such tobacco 
                product;
                  ``(C) a full description of the methods used in, and 
                the facilities and controls used for, the manufacture, 
                processing, and, when relevant, packing and 
                installation of, such tobacco product;
                  ``(D) an identifying reference to any tobacco product 
                standard under section 907 which would be applicable to 
                any aspect of such tobacco product, and either adequate 
                information to show that such aspect of such tobacco 
                product fully meets such tobacco product standard or 
                adequate information to justify any deviation from such 
                standard;
                  ``(E) such samples of such tobacco product and of 
                components thereof as the Secretary may reasonably 
                require;
                  ``(F) specimens of the labeling proposed to be used 
                for such tobacco product; and
                  ``(G) such other information relevant to the subject 
                matter of the application as the Secretary may require.
          ``(2) Referral to tobacco products scientific advisory 
        committee.--Upon receipt of an application meeting the 
        requirements set forth in paragraph (1), the Secretary--
                  ``(A) may, on the Secretary's own initiative; or
                  ``(B) may, upon the request of an applicant,
        refer such application to the Tobacco Products Scientific 
        Advisory Committee for reference and for submission (within 
        such period as the Secretary may establish) of a report and 
        recommendation respecting the application, together with all 
        underlying data and the reasons or basis for the 
        recommendation.
  ``(c) Action on Application.--
          ``(1) Deadline.--
                  ``(A) In general.--As promptly as possible, but in no 
                event later than 180 days after the receipt of an 
                application under subsection (b), the Secretary, after 
                considering the report and recommendation submitted 
                under subsection (b)(2), shall--
                          ``(i) issue an order that the new product may 
                        be introduced or delivered for introduction 
                        into interstate commerce if the Secretary finds 
                        that none of the grounds specified in paragraph 
                        (2) of this subsection applies; or
                          ``(ii) issue an order that the new product 
                        may not be introduced or delivered for 
                        introduction into interstate commerce if the 
                        Secretary finds (and sets forth the basis for 
                        such finding as part of or accompanying such 
                        denial) that 1 or more grounds for denial 
                        specified in paragraph (2) of this subsection 
                        apply.
                  ``(B) Restrictions on sale and distribution.--An 
                order under subparagraph (A)(i) may require that the 
                sale and distribution of the tobacco product be 
                restricted but only to the extent that the sale and 
                distribution of a tobacco product may be restricted 
                under a regulation under section 906(d).
          ``(2) Denial of application.--The Secretary shall deny an 
        application submitted under subsection (b) if, upon the basis 
        of the information submitted to the Secretary as part of the 
        application and any other information before the Secretary with 
        respect to such tobacco product, the Secretary finds that--
                  ``(A) there is a lack of a showing that permitting 
                such tobacco product to be marketed would be 
                appropriate for the protection of the public health;
                  ``(B) the methods used in, or the facilities or 
                controls used for, the manufacture, processing, or 
                packing of such tobacco product do not conform to the 
                requirements of section 906(e);
                  ``(C) based on a fair evaluation of all material 
                facts, the proposed labeling is false or misleading in 
                any particular; or
                  ``(D) such tobacco product is not shown to conform in 
                all respects to a tobacco product standard in effect 
                under section 907, and there is a lack of adequate 
                information to justify the deviation from such 
                standard.
          ``(3) Denial information.--Any denial of an application 
        shall, insofar as the Secretary determines to be practicable, 
        be accompanied by a statement informing the applicant of the 
        measures required to remove such application from deniable form 
        (which measures may include further research by the applicant 
        in accordance with 1 or more protocols prescribed by the 
        Secretary).
          ``(4) Basis for finding.--For purposes of this section, the 
        finding as to whether the marketing of a tobacco product for 
        which an application has been submitted is appropriate for the 
        protection of the public health shall be determined with 
        respect to the risks and benefits to the population as a whole, 
        including users and nonusers of the tobacco product, and taking 
        into account--
                  ``(A) the increased or decreased likelihood that 
                existing users of tobacco products will stop using such 
                products; and
                  ``(B) the increased or decreased likelihood that 
                those who do not use tobacco products will start using 
                such products.
          ``(5) Basis for action.--
                  ``(A) Investigations.--For purposes of paragraph 
                (2)(A), whether permitting a tobacco product to be 
                marketed would be appropriate for the protection of the 
                public health shall, when appropriate, be determined on 
                the basis of well-controlled investigations, which may 
                include 1 or more clinical investigations by experts 
                qualified by training and experience to evaluate the 
                tobacco product.
                  ``(B) Other evidence.--If the Secretary determines 
                that there exists valid scientific evidence (other than 
                evidence derived from investigations described in 
                subparagraph (A)) which is sufficient to evaluate the 
                tobacco product, the Secretary may authorize that the 
                determination for purposes of paragraph (2)(A) be made 
                on the basis of such evidence.
  ``(d) Withdrawal and Temporary Suspension.--
          ``(1) In general.--The Secretary shall, upon obtaining, where 
        appropriate, advice on scientific matters from the Tobacco 
        Products Scientific Advisory Committee, and after due notice 
        and opportunity for informal hearing for a tobacco product for 
        which an order was issued under subsection (c)(1)(A)(i), issue 
        an order withdrawing the order if the Secretary finds--
                  ``(A) that the continued marketing of such tobacco 
                product no longer is appropriate for the protection of 
                the public health;
                  ``(B) that the application contained or was 
                accompanied by an untrue statement of a material fact;
                  ``(C) that the applicant--
                          ``(i) has failed to establish a system for 
                        maintaining records, or has repeatedly or 
                        deliberately failed to maintain records or to 
                        make reports, required by an applicable 
                        regulation under section 909;
                          ``(ii) has refused to permit access to, or 
                        copying or verification of, such records as 
                        required by section 704; or
                          ``(iii) has not complied with the 
                        requirements of section 905;
                  ``(D) on the basis of new information before the 
                Secretary with respect to such tobacco product, 
                evaluated together with the evidence before the 
                Secretary when the application was reviewed, that the 
                methods used in, or the facilities and controls used 
                for, the manufacture, processing, packing, or 
                installation of such tobacco product do not conform 
                with the requirements of section 906(e) and were not 
                brought into conformity with such requirements within a 
                reasonable time after receipt of written notice from 
                the Secretary of nonconformity;
                  ``(E) on the basis of new information before the 
                Secretary, evaluated together with the evidence before 
                the Secretary when the application was reviewed, that 
                the labeling of such tobacco product, based on a fair 
                evaluation of all material facts, is false or 
                misleading in any particular and was not corrected 
                within a reasonable time after receipt of written 
                notice from the Secretary of such fact; or
                  ``(F) on the basis of new information before the 
                Secretary, evaluated together with the evidence before 
                the Secretary when such order was issued, that such 
                tobacco product is not shown to conform in all respects 
                to a tobacco product standard which is in effect under 
                section 907, compliance with which was a condition to 
                the issuance of an order relating to the application, 
                and that there is a lack of adequate information to 
                justify the deviation from such standard.
          ``(2) Appeal.--The holder of an application subject to an 
        order issued under paragraph (1) withdrawing an order issued 
        pursuant to subsection (c)(1)(A)(i) may, by petition filed on 
        or before the 30th day after the date upon which such holder 
        receives notice of such withdrawal, obtain review thereof in 
        accordance with section 912.
          ``(3) Temporary suspension.--If, after providing an 
        opportunity for an informal hearing, the Secretary determines 
        there is reasonable probability that the continuation of 
        distribution of a tobacco product under an order would cause 
        serious, adverse health consequences or death, that is greater 
        than ordinarily caused by tobacco products on the market, the 
        Secretary shall by order temporarily suspend the authority of 
        the manufacturer to market the product. If the Secretary issues 
        such an order, the Secretary shall proceed expeditiously under 
        paragraph (1) to withdraw such application.
  ``(e) Service of Order.--An order issued by the Secretary under this 
section shall be served--
          ``(1) in person by any officer or employee of the department 
        designated by the Secretary; or
          ``(2) by mailing the order by registered mail or certified 
        mail addressed to the applicant at the applicant's last known 
        address in the records of the Secretary.
  ``(f) Records.--
          ``(1) Additional information.--In the case of any tobacco 
        product for which an order issued pursuant to subsection 
        (c)(1)(A)(i) for an application filed under subsection (b) is 
        in effect, the applicant shall establish and maintain such 
        records, and make such reports to the Secretary, as the 
        Secretary may by regulation, or by order with respect to such 
        application, prescribe on the basis of a finding that such 
        records and reports are necessary in order to enable the 
        Secretary to determine, or facilitate a determination of, 
        whether there is or may be grounds for withdrawing or 
        temporarily suspending such order.
          ``(2) Access to records.--Each person required under this 
        section to maintain records, and each person in charge of 
        custody thereof, shall, upon request of an officer or employee 
        designated by the Secretary, permit such officer or employee at 
        all reasonable times to have access to and copy and verify such 
        records.
  ``(g) Investigational Tobacco Product Exemption for Investigational 
Use.--The Secretary may exempt tobacco products intended for 
investigational use from the provisions of this chapter under such 
conditions as the Secretary may by regulation prescribe.

``SEC. 911. MODIFIED RISK TOBACCO PRODUCTS.

  ``(a) In General.--No person may introduce or deliver for 
introduction into interstate commerce any modified risk tobacco product 
unless an order issued pursuant to subsection (g) is effective with 
respect to such product.
  ``(b) Definitions.--In this section:
          ``(1) Modified risk tobacco product.--The term `modified risk 
        tobacco product' means any tobacco product that is sold or 
        distributed for use to reduce harm or the risk of tobacco-
        related disease associated with commercially marketed tobacco 
        products.
          ``(2) Sold or distributed.--
                  ``(A) In general.--With respect to a tobacco product, 
                the term `sold or distributed for use to reduce harm or 
                the risk of tobacco-related disease associated with 
                commercially marketed tobacco products' means a tobacco 
                product--
                          ``(i) the label, labeling, or advertising of 
                        which represents explicitly or implicitly 
                        that--
                                  ``(I) the tobacco product presents a 
                                lower risk of tobacco-related disease 
                                or is less harmful than one or more 
                                other commercially marketed tobacco 
                                products;
                                  ``(II) the tobacco product or its 
                                smoke contains a reduced level of a 
                                substance or presents a reduced 
                                exposure to a substance; or
                                  ``(III) the tobacco product or its 
                                smoke does not contain or is free of a 
                                substance;
                          ``(ii) the label, labeling, or advertising of 
                        which uses the descriptors `light', `mild', or 
                        `low' or similar descriptors; or
                          ``(iii) the tobacco product manufacturer of 
                        which has taken any action directed to 
                        consumers through the media or otherwise, other 
                        than by means of the tobacco product's label, 
                        labeling, or advertising, after the date of 
                        enactment of the Family Smoking Prevention and 
                        Tobacco Control Act, respecting the product 
                        that would be reasonably expected to result in 
                        consumers believing that the tobacco product or 
                        its smoke may present a lower risk of disease 
                        or is less harmful than one or more 
                        commercially marketed tobacco products, or 
                        presents a reduced exposure to, or does not 
                        contain or is free of, a substance or 
                        substances.
                  ``(B) Limitation.--No tobacco product shall be 
                considered to be `sold or distributed for use to reduce 
                harm or the risk of tobacco-related disease associated 
                with commercially marketed tobacco products', except as 
                described in subparagraph (A).
                  ``(C) Smokeless tobacco product.--No smokeless 
                tobacco product shall be considered to be `sold or 
                distributed for use to reduce harm or the risk of 
                tobacco-related disease associated with commercially 
                marketed tobacco products' solely because its label, 
                labeling, or advertising uses the following phrases to 
                describe such product and its use: `smokeless tobacco', 
                `smokeless tobacco product', `not consumed by smoking', 
                `does not produce smoke', `smokefree', `smoke-free', 
                `without smoke', `no smoke', or `not smoke'.
          ``(3) Effective date.--The provisions of paragraph (2)(A)(ii) 
        shall take effect 12 months after the date of enactment of the 
        Family Smoking Prevention and Tobacco Control Act for those 
        products whose label, labeling, or advertising contains the 
        terms described in such paragraph on such date of enactment. 
        The effective date shall be with respect to the date of 
        manufacture, provided that, in any case, 30 days after such 
        effective date, a manufacturer shall not introduce into the 
        domestic commerce of the United States any product that is not 
        in conformance with paragraph (2)(A)(ii).
  ``(c) Tobacco Dependence Products.--A product that is intended to be 
used for the treatment of tobacco dependence, including smoking 
cessation, is not a modified risk tobacco product under this section if 
it has been approved as a drug or device by the Food and Drug 
Administration and is subject to the requirements of chapter V.
  ``(d) Filing.--Any person may file with the Secretary an application 
for a modified risk tobacco product. Such application shall include--
          ``(1) a description of the proposed product and any proposed 
        advertising and labeling;
          ``(2) the conditions for using the product;
          ``(3) the formulation of the product;
          ``(4) sample product labels and labeling;
          ``(5) all documents (including underlying scientific 
        information) relating to research findings conducted, 
        supported, or possessed by the tobacco product manufacturer 
        relating to the effect of the product on tobacco-related 
        diseases and health-related conditions, including information 
        both favorable and unfavorable to the ability of the product to 
        reduce risk or exposure and relating to human health;
          ``(6) data and information on how consumers actually use the 
        tobacco product; and
          ``(7) such other information as the Secretary may require.
  ``(e) Public Availability.--The Secretary shall make the application 
described in subsection (d) publicly available (except matters in the 
application which are trade secrets or otherwise confidential, 
commercial information) and shall request comments by interested 
persons on the information contained in the application and on the 
label, labeling, and advertising accompanying such application.
  ``(f) Advisory Committee.--
          ``(1) In general.--The Secretary shall refer to the Tobacco 
        Products Scientific Advisory Committee any application 
        submitted under this section.
          ``(2) Recommendations.--Not later than 60 days after the date 
        an application is referred to the Tobacco Products Scientific 
        Advisory Committee under paragraph (1), the Advisory Committee 
        shall report its recommendations on the application to the 
        Secretary.
  ``(g) Marketing.--
          ``(1) Modified risk products.--Except as provided in 
        paragraph (2), the Secretary shall, with respect to an 
        application submitted under this section, issue an order that a 
        modified risk product may be commercially marketed only if the 
        Secretary determines that the applicant has demonstrated that 
        such product, as it is actually used by consumers, will--
                  ``(A) significantly reduce harm and the risk of 
                tobacco-related disease to individual tobacco users; 
                and
                  ``(B) benefit the health of the population as a whole 
                taking into account both users of tobacco products and 
                persons who do not currently use tobacco products.
          ``(2) Special rule for certain products.--
                  ``(A) In general.--The Secretary may issue an order 
                that a tobacco product may be introduced or delivered 
                for introduction into interstate commerce, pursuant to 
                an application under this section, with respect to a 
                tobacco product that may not be commercially marketed 
                under paragraph (1) if the Secretary makes the findings 
                required under this paragraph and determines that the 
                applicant has demonstrated that--
                          ``(i) such order would be appropriate to 
                        promote the public health;
                          ``(ii) any aspect of the label, labeling, and 
                        advertising for such product that would cause 
                        the tobacco product to be a modified risk 
                        tobacco product under subsection (b) is limited 
                        to an explicit or implicit representation that 
                        such tobacco product or its smoke does not 
                        contain or is free of a substance or contains a 
                        reduced level of a substance, or presents a 
                        reduced exposure to a substance in tobacco 
                        smoke;
                          ``(iii) scientific evidence is not available 
                        and, using the best available scientific 
                        methods, cannot be made available without 
                        conducting long-term epidemiological studies 
                        for an application to meet the standards set 
                        forth in paragraph (1); and
                          ``(iv) the scientific evidence that is 
                        available without conducting long-term 
                        epidemiological studies demonstrates that a 
                        measurable and substantial reduction in 
                        morbidity or mortality among individual tobacco 
                        users is reasonably likely in subsequent 
                        studies.
                  ``(B) Additional findings required.--To issue an 
                order under subparagraph (A) the Secretary must also 
                find that the applicant has demonstrated that--
                          ``(i) the magnitude of the overall reductions 
                        in exposure to the substance or substances 
                        which are the subject of the application is 
                        substantial, such substance or substances are 
                        harmful, and the product as actually used 
                        exposes consumers to the specified reduced 
                        level of the substance or substances;
                          ``(ii) the product as actually used by 
                        consumers will not expose them to higher levels 
                        of other harmful substances compared to the 
                        similar types of tobacco products then on the 
                        market unless such increases are minimal and 
                        the reasonably likely overall impact of use of 
                        the product remains a substantial and 
                        measurable reduction in overall morbidity and 
                        mortality among individual tobacco users;
                          ``(iii) testing of actual consumer perception 
                        shows that, as the applicant proposes to label 
                        and market the product, consumers will not be 
                        misled into believing that the product--
                                  ``(I) is or has been demonstrated to 
                                be less harmful; or
                                  ``(II) presents or has been 
                                demonstrated to present less of a risk 
                                of disease than 1 or more other 
                                commercially marketed tobacco products; 
                                and
                          ``(iv) issuance of an order with respect to 
                        the application is expected to benefit the 
                        health of the population as a whole taking into 
                        account both users of tobacco products and 
                        persons who do not currently use tobacco 
                        products.
                  ``(C) Conditions of marketing.--
                          ``(i) In general.--Applications subject to an 
                        order under this paragraph shall be limited to 
                        a term of not more than 5 years, but may be 
                        renewed upon a finding by the Secretary that 
                        the requirements of this paragraph continue to 
                        be satisfied based on the filing of a new 
                        application.
                          ``(ii) Agreements by applicant.--An order 
                        under this paragraph shall be conditioned on 
                        the applicant's agreement to conduct postmarket 
                        surveillance and studies and to submit to the 
                        Secretary the results of such surveillance and 
                        studies to determine the impact of the order on 
                        consumer perception, behavior, and health and 
                        to enable the Secretary to review the accuracy 
                        of the determinations upon which the order was 
                        based in accordance with a protocol approved by 
                        the Secretary.
                          ``(iii) Annual submission.--The results of 
                        such postmarket surveillance and studies 
                        described in clause (ii) shall be submitted 
                        annually.
          ``(3) Basis.--The determinations under paragraphs (1) and (2) 
        shall be based on--
                  ``(A) the scientific evidence submitted by the 
                applicant; and
                  ``(B) scientific evidence and other information that 
                is made available to the Secretary.
          ``(4) Benefit to health of individuals and of population as a 
        whole.--In making the determinations under paragraphs (1) and 
        (2), the Secretary shall take into account--
                  ``(A) the relative health risks to individuals of the 
                tobacco product that is the subject of the application;
                  ``(B) the increased or decreased likelihood that 
                existing users of tobacco products who would otherwise 
                stop using such products will switch to the tobacco 
                product that is the subject of the application;
                  ``(C) the increased or decreased likelihood that 
                persons who do not use tobacco products will start 
                using the tobacco product that is the subject of the 
                application;
                  ``(D) the risks and benefits to persons from the use 
                of the tobacco product that is the subject of the 
                application as compared to the use of products for 
                smoking cessation approved under chapter V to treat 
                nicotine dependence; and
                  ``(E) comments, data, and information submitted by 
                interested persons.
  ``(h) Additional Conditions for Marketing.--
          ``(1) Modified risk products.--The Secretary shall require 
        for the marketing of a product under this section that any 
        advertising or labeling concerning modified risk products 
        enable the public to comprehend the information concerning 
        modified risk and to understand the relative significance of 
        such information in the context of total health and in relation 
        to all of the diseases and health-related conditions associated 
        with the use of tobacco products.
          ``(2) Comparative claims.--
                  ``(A) In general.--The Secretary may require for the 
                marketing of a product under this subsection that a 
                claim comparing a tobacco product to 1 or more other 
                commercially marketed tobacco products shall compare 
                the tobacco product to a commercially marketed tobacco 
                product that is representative of that type of tobacco 
                product on the market (for example the average value of 
                the top 3 brands of an established regular tobacco 
                product).
                  ``(B) Quantitative comparisons.--The Secretary may 
                also require, for purposes of subparagraph (A), that 
                the percent (or fraction) of change and identity of the 
                reference tobacco product and a quantitative comparison 
                of the amount of the substance claimed to be reduced 
                shall be stated in immediate proximity to the most 
                prominent claim.
          ``(3) Label disclosure.--
                  ``(A) In general.--The Secretary may require the 
                disclosure on the label of other substances in the 
                tobacco product, or substances that may be produced by 
                the consumption of that tobacco product, that may 
                affect a disease or health-related condition or may 
                increase the risk of other diseases or health-related 
                conditions associated with the use of tobacco products.
                  ``(B) Conditions of use.--If the conditions of use of 
                the tobacco product may affect the risk of the product 
                to human health, the Secretary may require the labeling 
                of conditions of use.
          ``(4) Time.--An order issued under subsection (g)(1) shall be 
        effective for a specified period of time.
          ``(5) Advertising.--The Secretary may require, with respect 
        to a product for which an applicant obtained an order under 
        subsection (g)(1), that the product comply with requirements 
        relating to advertising and promotion of the tobacco product.
  ``(i) Postmarket Surveillance and Studies.--
          ``(1) In general.--The Secretary shall require, with respect 
        to a product for which an applicant obtained an order under 
        subsection (g)(1), that the applicant conduct postmarket 
        surveillance and studies for such a tobacco product to 
        determine the impact of the order issuance on consumer 
        perception, behavior, and health, to enable the Secretary to 
        review the accuracy of the determinations upon which the order 
        was based, and to provide information that the Secretary 
        determines is otherwise necessary regarding the use or health 
        risks involving the tobacco product. The results of postmarket 
        surveillance and studies shall be submitted to the Secretary on 
        an annual basis.
          ``(2) Surveillance protocol.--Each applicant required to 
        conduct a surveillance of a tobacco product under paragraph (1) 
        shall, within 30 days after receiving notice that the applicant 
        is required to conduct such surveillance, submit, for the 
        approval of the Secretary, a protocol for the required 
        surveillance. The Secretary, within 60 days of the receipt of 
        such protocol, shall determine if the principal investigator 
        proposed to be used in the surveillance has sufficient 
        qualifications and experience to conduct such surveillance and 
        if such protocol will result in collection of the data or other 
        information designated by the Secretary as necessary to protect 
        the public health.
  ``(j) Withdrawal of Authorization.--The Secretary, after an 
opportunity for an informal hearing, shall withdraw an order under 
subsection (g) if the Secretary determines that--
          ``(1) the applicant, based on new information, can no longer 
        make the demonstrations required under subsection (g), or the 
        Secretary can no longer make the determinations required under 
        subsection (g);
          ``(2) the application failed to include material information 
        or included any untrue statement of material fact;
          ``(3) any explicit or implicit representation that the 
        product reduces risk or exposure is no longer valid, including 
        if--
                  ``(A) a tobacco product standard is established 
                pursuant to section 907;
                  ``(B) an action is taken that affects the risks 
                presented by other commercially marketed tobacco 
                products that were compared to the product that is the 
                subject of the application; or
                  ``(C) any postmarket surveillance or studies reveal 
                that the order is no longer consistent with the 
                protection of the public health;
          ``(4) the applicant failed to conduct or submit the 
        postmarket surveillance and studies required under subsection 
        (g)(2)(C)(ii) or subsection (i); or
          ``(5) the applicant failed to meet a condition imposed under 
        subsection (h).
  ``(k) Chapter IV or V.--A product for which the Secretary has issued 
an order pursuant to subsection (g) shall not be subject to chapter IV 
or V.
  ``(l) Implementing Regulations or Guidance.--
          ``(1) Scientific evidence.--Not later than 2 years after the 
        date of enactment of the Family Smoking Prevention and Tobacco 
        Control Act, the Secretary shall issue regulations or guidance 
        (or any combination thereof) on the scientific evidence 
        required for assessment and ongoing review of modified risk 
        tobacco products. Such regulations or guidance shall--
                  ``(A) to the extent that adequate scientific evidence 
                exists, establish minimum standards for scientific 
                studies needed prior to issuing an order under 
                subsection (g) to show that a substantial reduction in 
                morbidity or mortality among individual tobacco users 
                occurs for products described in subsection (g)(1) or 
                is reasonably likely for products described in 
                subsection (g)(2);
                  ``(B) include validated biomarkers, intermediate 
                clinical endpoints, and other feasible outcome 
                measures, as appropriate;
                  ``(C) establish minimum standards for postmarket 
                studies, that shall include regular and long-term 
                assessments of health outcomes and mortality, 
                intermediate clinical endpoints, consumer perception of 
                harm reduction, and the impact on quitting behavior and 
                new use of tobacco products, as appropriate;
                  ``(D) establish minimum standards for required 
                postmarket surveillance, including ongoing assessments 
                of consumer perception;
                  ``(E) require that data from the required studies and 
                surveillance be made available to the Secretary prior 
                to the decision on renewal of a modified risk tobacco 
                product; and
                  ``(F) establish a reasonable timetable for the 
                Secretary to review an application under this section.
          ``(2) Consultation.--The regulations or guidance issued under 
        paragraph (1) shall be developed in consultation with the 
        Institute of Medicine, and with the input of other appropriate 
        scientific and medical experts, on the design and conduct of 
        such studies and surveillance.
          ``(3) Revision.--The regulations or guidance under paragraph 
        (1) shall be revised on a regular basis as new scientific 
        information becomes available.
          ``(4) New tobacco products.--Not later than 2 years after the 
        date of enactment of the Family Smoking Prevention and Tobacco 
        Control Act, the Secretary shall issue a regulation or guidance 
        that permits the filing of a single application for any tobacco 
        product that is a new tobacco product under section 910 and 
        which the applicant seeks to commercially market under this 
        section.
  ``(m) Distributors.--Except as provided in this section, no 
distributor may take any action, after the date of enactment of the 
Family Smoking Prevention and Tobacco Control Act, with respect to a 
tobacco product that would reasonably be expected to result in 
consumers believing that the tobacco product or its smoke may present a 
lower risk of disease or is less harmful than one or more commercially 
marketed tobacco products, or presents a reduced exposure to, or does 
not contain or is free of, a substance or substances.

``SEC. 912. JUDICIAL REVIEW.

  ``(a) Right To Review.--
          ``(1) In general.--Not later than 30 days after--
                  ``(A) the promulgation of a regulation under section 
                907 establishing, amending, or revoking a tobacco 
                product standard; or
                  ``(B) a denial of an application under section 
                910(c),
        any person adversely affected by such regulation or denial may 
        file a petition for judicial review of such regulation or 
        denial with the United States Court of Appeals for the District 
        of Columbia Circuit or for the circuit in which such person 
        resides or has their principal place of business.
          ``(2) Requirements.--
                  ``(A) Copy of petition.--A copy of the petition filed 
                under paragraph (1) shall be transmitted by the clerk 
                of the court involved to the Secretary.
                  ``(B) Record of proceedings.--On receipt of a 
                petition under subparagraph (A), the Secretary shall 
                file in the court in which such petition was filed--
                          ``(i) the record of the proceedings on which 
                        the regulation or order was based; and
                          ``(ii) a statement of the reasons for the 
                        issuance of such a regulation or order.
                  ``(C) Definition of record.--In this section, the 
                term `record' means--
                          ``(i) all notices and other matter published 
                        in the Federal Register with respect to the 
                        regulation or order reviewed;
                          ``(ii) all information submitted to the 
                        Secretary with respect to such regulation or 
                        order;
                          ``(iii) proceedings of any panel or advisory 
                        committee with respect to such regulation or 
                        order;
                          ``(iv) any hearing held with respect to such 
                        regulation or order; and
                          ``(v) any other information identified by the 
                        Secretary, in the administrative proceeding 
                        held with respect to such regulation or order, 
                        as being relevant to such regulation or order.
  ``(b) Standard of Review.--Upon the filing of the petition under 
subsection (a) for judicial review of a regulation or order, the court 
shall have jurisdiction to review the regulation or order in accordance 
with chapter 7 of title 5, United States Code, and to grant appropriate 
relief, including interim relief, as provided for in such chapter. A 
regulation or denial described in subsection (a) shall be reviewed in 
accordance with section 706(2)(A) of title 5, United States Code.
  ``(c) Finality of Judgment.--The judgment of the court affirming or 
setting aside, in whole or in part, any regulation or order shall be 
final, subject to review by the Supreme Court of the United States upon 
certiorari or certification, as provided in section 1254 of title 28, 
United States Code.
  ``(d) Other Remedies.--The remedies provided for in this section 
shall be in addition to, and not in lieu of, any other remedies 
provided by law.
  ``(e) Regulations and Orders Must Recite Basis in Record.--To 
facilitate judicial review, a regulation or order issued under section 
906, 907, 908, 909, 910, or 916 shall contain a statement of the 
reasons for the issuance of such regulation or order in the record of 
the proceedings held in connection with its issuance.

``SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS.

  ``The Secretary shall issue regulations to require that retail 
establishments for which the predominant business is the sale of 
tobacco products comply with any advertising restrictions applicable to 
retail establishments accessible to individuals under the age of 18.

``SEC. 914. JURISDICTION OF AND COORDINATION WITH THE FEDERAL TRADE 
                    COMMISSION.

  ``(a) Jurisdiction.--
          ``(1) In general.--Except where expressly provided in this 
        chapter, nothing in this chapter shall be construed as limiting 
        or diminishing the authority of the Federal Trade Commission to 
        enforce the laws under its jurisdiction with respect to the 
        advertising, sale, or distribution of tobacco products.
          ``(2) Enforcement.--Any advertising that violates this 
        chapter or a provision of the regulations referred to in 
        section 102 of the Family Smoking Prevention and Tobacco 
        Control Act, is an unfair or deceptive act or practice under 
        section 5(a) of the Federal Trade Commission Act and shall be 
        considered a violation of a rule promulgated under section 18 
        of that Act.
  ``(b) Coordination.--With respect to the requirements of section 4 of 
the Federal Cigarette Labeling and Advertising Act and section 3 of the 
Comprehensive Smokeless Tobacco Health Education Act of 1986--
          ``(1) the Chairman of the Federal Trade Commission shall 
        coordinate with the Secretary concerning the enforcement of 
        such Act as such enforcement relates to unfair or deceptive 
        acts or practices in the advertising of cigarettes or smokeless 
        tobacco; and
          ``(2) the Secretary shall consult with the Chairman of such 
        Commission in revising the label statements and requirements 
        under such sections.

``SEC. 915. REGULATION REQUIREMENT.

  ``(a) Testing, Reporting, and Disclosure.--Not later than 36 months 
after the date of enactment of the Family Smoking Prevention and 
Tobacco Control Act, the Secretary shall promulgate regulations under 
this Act that meet the requirements of subsection (b).
  ``(b) Contents of Rules.--The regulations promulgated under 
subsection (a)--
          ``(1) shall require testing and reporting of tobacco product 
        constituents, ingredients, and additives, including smoke 
        constituents, by brand and subbrand that the Secretary 
        determines should be tested to protect the public health; and
          ``(2) may require that tobacco product manufacturers, 
        packagers, or importers make disclosures relating to the 
        results of the testing of tar and nicotine through labels or 
        advertising or other appropriate means, and make disclosures 
        regarding the results of the testing of other constituents, 
        including smoke constituents, ingredients, or additives, that 
        the Secretary determines should be disclosed to the public to 
        protect the public health and will not mislead consumers about 
        the risk of tobacco-related disease.
  ``(c) Authority.--The Secretary shall have the authority under this 
chapter to conduct or to require the testing, reporting, or disclosure 
of tobacco product constituents, including smoke constituents.
  ``(d) Small Tobacco Product Manufacturers.--
          ``(1) First compliance date.--The initial regulations 
        promulgated under subsection (a) shall not impose requirements 
        on small tobacco product manufacturers before the later of--
                  ``(A) the end of the 2-year period following the 
                final promulgation of such regulations; and
                  ``(B) the initial date set by the Secretary for 
                compliance with such regulations by manufacturers that 
                are not small tobacco product manufacturers.
          ``(2) Testing and reporting initial compliance period.--
                  ``(A) 4-year period.--The initial regulations 
                promulgated under subsection (a) shall give each small 
                tobacco product manufacturer a 4-year period over which 
                to conduct testing and reporting for all of its tobacco 
                products. Subject to paragraph (1), the end of the 
                first year of such 4-year period shall coincide with 
                the initial date of compliance under this section set 
                by the Secretary with respect to manufacturers that are 
                not small tobacco product manufacturers or the end of 
                the 2-year period following the final promulgation of 
                such regulations, as described in paragraph (1)(A). A 
                small tobacco product manufacturer shall be required--
                          ``(i) to conduct such testing and reporting 
                        for 25 percent of its tobacco products during 
                        each year of such 4-year period; and
                          ``(ii) to conduct such testing and reporting 
                        for its largest-selling tobacco products (as 
                        determined by the Secretary) before its other 
                        tobacco products, or in such other order of 
                        priority as determined by the Secretary.
                  ``(B) Case-by-case delay.--Notwithstanding 
                subparagraph (A), the Secretary may, on a case-by-case 
                basis, delay the date by which an individual small 
                tobacco product manufacturer must conduct testing and 
                reporting for its tobacco products under this section 
                based upon a showing of undue hardship to such 
                manufacturer. Notwithstanding the preceding sentence, 
                the Secretary shall not extend the deadline for a small 
                tobacco product manufacturer to conduct testing and 
                reporting for all of its tobacco products beyond a 
                total of 5 years after the initial date of compliance 
                under this section set by the Secretary with respect to 
                manufacturers that are not small tobacco product 
                manufacturers.
          ``(3) Subsequent and additional testing and reporting.--The 
        regulations promulgated under subsection (a) shall provide 
        that, with respect to any subsequent or additional testing and 
        reporting of tobacco products required under this section, such 
        testing and reporting by a small tobacco product manufacturer 
        shall be conducted in accordance with the timeframes described 
        in paragraph (2)(A), except that, in the case of a new product, 
        or if there has been a modification described in section 
        910(a)(1)(B) of any product of a small tobacco product 
        manufacturer since the last testing and reporting required 
        under this section, the Secretary shall require that any 
        subsequent or additional testing and reporting be conducted in 
        accordance with the same timeframe applicable to manufacturers 
        that are not small tobacco product manufacturers.
          ``(4) Joint laboratory testing services.--The Secretary shall 
        allow any 2 or more small tobacco product manufacturers to join 
        together to purchase laboratory testing services required by 
        this section on a group basis in order to ensure that such 
        manufacturers receive access to, and fair pricing of, such 
        testing services.
  ``(e) Extensions for Limited Laboratory Capacity.--
          ``(1) In general.--The regulations promulgated under 
        subsection (a) shall provide that a small tobacco product 
        manufacturer shall not be considered to be in violation of this 
        section before the deadline applicable under paragraphs (3) and 
        (4), if--
                  ``(A) the tobacco products of such manufacturer are 
                in compliance with all other requirements of this 
                chapter; and
                  ``(B) the conditions described in paragraph (2) are 
                met.
          ``(2) Conditions.--Notwithstanding the requirements of this 
        section, the Secretary may delay the date by which a small 
        tobacco product manufacturer must be in compliance with the 
        testing and reporting required by this section until such time 
        as the testing is reported if, not later than 90 days before 
        the deadline for reporting in accordance with this section, a 
        small tobacco product manufacturer provides evidence to the 
        Secretary demonstrating that--
                  ``(A) the manufacturer has submitted the required 
                products for testing to a laboratory and has done so 
                sufficiently in advance of the deadline to create a 
                reasonable expectation of completion by the deadline;
                  ``(B) the products currently are awaiting testing by 
                the laboratory; and
                  ``(C) neither that laboratory nor any other 
                laboratory is able to complete testing by the deadline 
                at customary, nonexpedited testing fees.
          ``(3) Extension.--The Secretary, taking into account the 
        laboratory testing capacity that is available to tobacco 
        product manufacturers, shall review and verify the evidence 
        submitted by a small tobacco product manufacturer in accordance 
        with paragraph (2). If the Secretary finds that the conditions 
        described in such paragraph are met, the Secretary shall notify 
        the small tobacco product manufacturer that the manufacturer 
        shall not be considered to be in violation of the testing and 
        reporting requirements of this section until the testing is 
        reported or until 1 year after the reporting deadline has 
        passed, whichever occurs sooner. If, however, the Secretary has 
        not made a finding before the reporting deadline, the 
        manufacturer shall not be considered to be in violation of such 
        requirements until the Secretary finds that the conditions 
        described in paragraph (2) have not been met, or until 1 year 
        after the reporting deadline, whichever occurs sooner.
          ``(4) Additional extension.--In addition to the time that may 
        be provided under paragraph (3), the Secretary may provide 
        further extensions of time, in increments of no more than 1 
        year, for required testing and reporting to occur if the 
        Secretary determines, based on evidence properly and timely 
        submitted by a small tobacco product manufacturer in accordance 
        with paragraph (2), that a lack of available laboratory 
        capacity prevents the manufacturer from completing the required 
        testing during the period described in paragraph (3).
  ``(f) Rule of Construction.--Nothing in subsection (d) or (e) shall 
be construed to authorize the extension of any deadline, or to 
otherwise affect any timeframe, under any provision of this Act or the 
Family Smoking Prevention and Tobacco Control Act other than this 
section.

``SEC. 916. PRESERVATION OF STATE AND LOCAL AUTHORITY.

  ``(a) In General.--
          ``(1) Preservation.--Except as provided in paragraph (2)(A), 
        nothing in this chapter, or rules promulgated under this 
        chapter, shall be construed to limit the authority of a Federal 
        agency (including the Armed Forces), a State or political 
        subdivision of a State, or the government of an Indian tribe to 
        enact, adopt, promulgate, and enforce any law, rule, 
        regulation, or other measure with respect to tobacco products 
        that is in addition to, or more stringent than, requirements 
        established under this chapter, including a law, rule, 
        regulation, or other measure relating to or prohibiting the 
        sale, distribution, possession, exposure to, access to, 
        advertising and promotion of, or use of tobacco products by 
        individuals of any age, information reporting to the State, or 
        measures relating to fire safety standards for tobacco 
        products. No provision of this chapter shall limit or otherwise 
        affect any State, Tribal, or local taxation of tobacco 
        products.
          ``(2) Preemption of certain state and local requirements.--
                  ``(A) In general.--No State or political subdivision 
                of a State may establish or continue in effect with 
                respect to a tobacco product any requirement which is 
                different from, or in addition to, any requirement 
                under the provisions of this chapter relating to 
                tobacco product standards, premarket review, 
                adulteration, misbranding, labeling, registration, good 
                manufacturing standards, or modified risk tobacco 
                products.
                  ``(B) Exception.--Subparagraph (A) does not apply to 
                requirements relating to the sale, distribution, 
                possession, information reporting to the State, 
                exposure to, access to, the advertising and promotion 
                of, or use of, tobacco products by individuals of any 
                age, or relating to fire safety standards for tobacco 
                products. Information disclosed to a State under 
                subparagraph (A) that is exempt from disclosure under 
                section 552(b)(4) of title 5, United States Code, shall 
                be treated as a trade secret and confidential 
                information by the State.
  ``(b) Rule of Construction Regarding Product Liability.--No provision 
of this chapter relating to a tobacco product shall be construed to 
modify or otherwise affect any action or the liability of any person 
under the product liability law of any State.

``SEC. 917. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.

  ``(a) Establishment.--Not later than 1 year after the date of 
enactment of the Family Smoking Prevention and Tobacco Control Act, the 
Secretary shall establish a 12-member advisory committee, to be known 
as the Tobacco Products Scientific Advisory Committee (in this section 
referred to as the `Advisory Committee').
  ``(b) Membership.--
          ``(1) In general.--
                  ``(A) Members.--The Secretary shall appoint as 
                members of the Tobacco Products Scientific Advisory 
                Committee individuals who are technically qualified by 
                training and experience in medicine, medical ethics, 
                science, or technology involving the manufacture, 
                evaluation, or use of tobacco products, who are of 
                appropriately diversified professional backgrounds. The 
                committee shall be composed of--
                          ``(i) 7 individuals who are physicians, 
                        dentists, scientists, or health care 
                        professionals practicing in the area of 
                        oncology, pulmonology, cardiology, toxicology, 
                        pharmacology, addiction, or any other relevant 
                        specialty;
                          ``(ii) 1 individual who is an officer or 
                        employee of a State or local government or of 
                        the Federal Government;
                          ``(iii) 1 individual as a representative of 
                        the general public;
                          ``(iv) 1 individual as a representative of 
                        the interests of the tobacco manufacturing 
                        industry;
                          ``(v) 1 individual as a representative of the 
                        interests of the small business tobacco 
                        manufacturing industry, which position may be 
                        filled on a rotating, sequential basis by 
                        representatives of different small business 
                        tobacco manufacturers based on areas of 
                        expertise relevant to the topics being 
                        considered by the Advisory Committee; and
                          ``(vi) 1 individual as a representative of 
                        the interests of the tobacco growers.
                  ``(B) Nonvoting members.--The members of the 
                committee appointed under clauses (iv), (v), and (vi) 
                of subparagraph (A) shall serve as consultants to those 
                described in clauses (i) through (iii) of subparagraph 
                (A) and shall be nonvoting representatives.
                  ``(C) Conflicts of interest.--No members of the 
                committee, other than members appointed pursuant to 
                clauses (iv), (v), and (vi) of subparagraph (A) shall, 
                during the member's tenure on the committee or for the 
                18-month period prior to becoming such a member, 
                receive any salary, grants, or other payments or 
                support from any business that manufactures, 
                distributes, markets, or sells cigarettes or other 
                tobacco products.
          ``(2) Limitation.--The Secretary may not appoint to the 
        Advisory Committee any individual who is in the regular full-
        time employ of the Food and Drug Administration or any agency 
        responsible for the enforcement of this Act. The Secretary may 
        appoint Federal officials as ex officio members.
          ``(3) Chairperson.--The Secretary shall designate 1 of the 
        members appointed under clauses (i), (ii), and (iii) of 
        paragraph (1)(A) to serve as chairperson.
  ``(c) Duties.--The Tobacco Products Scientific Advisory Committee 
shall provide advice, information, and recommendations to the 
Secretary--
          ``(1) as provided in this chapter;
          ``(2) on the effects of the alteration of the nicotine yields 
        from tobacco products;
          ``(3) on whether there is a threshold level below which 
        nicotine yields do not produce dependence on the tobacco 
        product involved; and
          ``(4) on its review of other safety, dependence, or health 
        issues relating to tobacco products as requested by the 
        Secretary.
  ``(d) Compensation; Support; FACA.--
          ``(1) Compensation and travel.--Members of the Advisory 
        Committee who are not officers or employees of the United 
        States, while attending conferences or meetings of the 
        committee or otherwise engaged in its business, shall be 
        entitled to receive compensation at rates to be fixed by the 
        Secretary, which may not exceed the daily equivalent of the 
        rate in effect under the Senior Executive Schedule under 
        section 5382 of title 5, United States Code, for each day 
        (including travel time) they are so engaged; and while so 
        serving away from their homes or regular places of business 
        each member may be allowed travel expenses, including per diem 
        in lieu of subsistence, as authorized by section 5703 of title 
        5, United States Code, for persons in the Government service 
        employed intermittently.
          ``(2) Administrative support.--The Secretary shall furnish 
        the Advisory Committee clerical and other assistance.
          ``(3) Nonapplication of faca.--Section 14 of the Federal 
        Advisory Committee Act does not apply to the Advisory 
        Committee.
  ``(e) Proceedings of Advisory Panels and Committees.--The Advisory 
Committee shall make and maintain a transcript of any proceeding of the 
panel or committee. Each such panel and committee shall delete from any 
transcript made under this subsection information which is exempt from 
disclosure under section 552(b) of title 5, United States Code.

``SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.

  ``(a) In General.--The Secretary shall--
          ``(1) at the request of the applicant, consider designating 
        products for smoking cessation, including nicotine replacement 
        products as fast track research and approval products within 
        the meaning of section 506;
          ``(2) consider approving the extended use of nicotine 
        replacement products (such as nicotine patches, nicotine gum, 
        and nicotine lozenges) for the treatment of tobacco dependence; 
        and
          ``(3) review and consider the evidence for additional 
        indications for nicotine replacement products, such as for 
        craving relief or relapse prevention.
  ``(b) Report on Innovative Products.--
          ``(1) In general.--Not later than 3 years after the date of 
        enactment of the Family Smoking Prevention and Tobacco Control 
        Act, the Secretary, after consultation with recognized 
        scientific, medical, and public health experts (including both 
        Federal agencies and nongovernmental entities, the Institute of 
        Medicine of the National Academy of Sciences, and the Society 
        for Research on Nicotine and Tobacco), shall submit to the 
        Congress a report that examines how best to regulate, promote, 
        and encourage the development of innovative products and 
        treatments (including nicotine-based and non-nicotine-based 
        products and treatments) to better achieve, in a manner that 
        best protects and promotes the public health--
                  ``(A) total abstinence from tobacco use;
                  ``(B) reductions in consumption of tobacco; and
                  ``(C) reductions in the harm associated with 
                continued tobacco use.
          ``(2) Recommendations.--The report under paragraph (1) shall 
        include the recommendations of the Secretary on how the Food 
        and Drug Administration should coordinate and facilitate the 
        exchange of information on such innovative products and 
        treatments among relevant offices and centers within the 
        Administration and within the National Institutes of Health, 
        the Centers for Disease Control and Prevention, and other 
        relevant agencies.

``SEC. 919. USER FEE.

  ``(a) Establishment of Quarterly User Fee.--The Secretary shall 
assess a quarterly user fee with respect to every quarter of each 
fiscal year commencing fiscal year 2008, calculated in accordance with 
this section, upon each manufacturer and importer of tobacco products 
subject to this chapter.
  ``(b) Funding of FDA Regulation of Tobacco Products.--
          ``(1) In general.--The Secretary shall make user fees 
        collected pursuant to subsection (c)(1) available to pay, in 
        each fiscal year beginning with fiscal year 2008, for the costs 
        of the activities of the Food and Drug Administration related 
        to the regulation of tobacco products under this chapter and 
        the Family Smoking Prevention and Tobacco Control Act. No fees 
        collected pursuant to subsection (c)(1) may be used by the 
        Secretary for any other costs.
          ``(2) Availability.--Subject to paragraph (1), fees collected 
        pursuant to subsection (c)(1) shall be available to the 
        Secretary without further appropriation in the following 
        amounts:
                  ``(A) For fiscal year 2008, $85,000,000.
                  ``(B) For fiscal year 2009, $235,000,000.
                  ``(C) For fiscal year 2010, $450,000,000.
                  ``(D) For fiscal year 2011, $477,000,000.
                  ``(E) For fiscal year 2012, $505,000,000.
                  ``(F) For fiscal year 2013, $534,000,000.
                  ``(G) For fiscal year 2014, $566,000,000.
                  ``(H) For fiscal year 2015, $599,000,000.
                  ``(I) For fiscal year 2016, $635,000,000.
                  ``(J) For fiscal year 2017, $672,000,000.
                  ``(K) For fiscal year 2018 and each subsequent fiscal 
                year, $712,000,000.
        Fees made available to the Secretary under this paragraph shall 
        remain available until expended.
          ``(3) Offsetting receipts.--Fees collected pursuant to 
        subsection (c)(1) shall be recorded as offsetting receipts.
          ``(4) Prohibition against use of other funds.--
                  ``(A) In general.--Except as provided in subparagraph 
                (B), fees collected pursuant to this section shall be 
                the only funds used to pay the costs of the activities 
                of the Food and Drug Administration related to the 
                regulation of tobacco products under this chapter and 
                the Family Smoking Prevention and Tobacco Control Act.
                  ``(B) Startup costs.--Subparagraph (A) shall not 
                apply until the date on which the Secretary has 
                collected fees pursuant to this section for 2 fiscal 
                year quarters. Until such date, amounts available to 
                the Food and Drug Administration (other than fees 
                collected pursuant to this section) may be used to pay 
                the costs described in subparagraph (A), provided that 
                such amounts are reimbursed through such fees.
  ``(c) Assessment of User Fee.--
          ``(1) Amount of assessment.--The assessment under this 
        section for--
                  ``(A) fiscal year 2008 shall be $90,100,000;
                  ``(B) fiscal year 2009 shall be $249,100,000;
                  ``(C) fiscal year 2010 shall be $477,000,000;
                  ``(D) fiscal year 2011 shall be $505,620,000;
                  ``(E) fiscal year 2012 shall be $535,300,000;
                  ``(F) fiscal year 2013 shall be $566,040,000;
                  ``(G) fiscal year 2014 shall be $599,960,000;
                  ``(H) fiscal year 2015 shall be $634,940,000;
                  ``(I) fiscal year 2016 shall be $673,100,000;
                  ``(J) fiscal year 2017 shall be $712,320,000; and
                  ``(K) fiscal year 2018 and each subsequent fiscal 
                year shall be $754,720,000.
          ``(2) Allocations of assessment by class of tobacco 
        products.--
                  ``(A) In general.--The total user fees assessed each 
                fiscal year with respect to each class of tobacco 
                products shall be an amount that is equal to the 
                applicable percentage of each class multiplied by the 
                amount specified in paragraph (1) for each fiscal year.
                  ``(B) Applicable percentage.--
                          ``(i) In general.--For purposes of 
                        subparagraph (A), the applicable percentage for 
                        a fiscal year for each of the following classes 
                        of tobacco products shall be determined in 
                        accordance with clause (ii):
                                  ``(I) Cigarettes.
                                  ``(II) Cigars, including small cigars 
                                and cigars other than small cigars.
                                  ``(III) Snuff.
                                  ``(IV) Chewing tobacco.
                                  ``(V) Pipe tobacco.
                                  ``(VI) Roll-your-own tobacco.
                          ``(ii) Allocations.--The applicable 
                        percentage of each class of tobacco product 
                        described in clause (i) for a fiscal year shall 
                        be the percentage determined under section 
                        625(c) of Public Law 108-357 for each such 
                        class of product for such fiscal year.
                          ``(iii) Requirement of regulations.--
                        Notwithstanding clause (ii), no user fees shall 
                        be assessed on a class of tobacco products 
                        unless such class of tobacco products is listed 
                        in section 901(b) or is deemed by the Secretary 
                        in a regulation under section 901(b) to be 
                        subject to this chapter.
                          ``(iv) Reallocations.--In the case of a class 
                        of tobacco products that is not listed in 
                        section 901(b) or deemed by the Secretary in a 
                        regulation under section 901(b) to be subject 
                        to this chapter, the amount of user fees that 
                        would otherwise be assessed to such class of 
                        tobacco products shall be reallocated to such 
                        other classes of tobacco products that are 
                        subject to this chapter in the same manner and 
                        based on the same relative percentages 
                        otherwise determined under clause (ii).
          ``(3) Determination of user fee by company.--
                  ``(A) In general.--The total user fee to be paid by 
                each manufacturer or importer of a particular class of 
                tobacco products shall be determined in each quarter by 
                multiplying--
                          ``(i) such manufacturer's or importer's 
                        percentage share as determined under paragraph 
                        (4); by
                          ``(ii) the portion of the user fee amount for 
                        the current quarter to be assessed on all 
                        manufacturers and importers of such class of 
                        tobacco products as determined under paragraph 
                        (2).
                  ``(B) No fee in excess of percentage share.--No 
                manufacturer or importer of tobacco products shall be 
                required to pay a user fee in excess of the percentage 
                share of such manufacturer or importer.
          ``(4) Allocation of assessment within each class of tobacco 
        product.--The percentage share of each manufacturer or importer 
        of a particular class of tobacco products of the total user fee 
        to be paid by all manufacturers or importers of that class of 
        tobacco products shall be the percentage determined for 
        purposes of allocations under subsections (e) through (h) of 
        section 625 of Public Law 108-357.
          ``(5) Allocation for cigars.--Notwithstanding paragraph (4), 
        if a user fee assessment is imposed on cigars, the percentage 
        share of each manufacturer or importer of cigars shall be based 
        on the excise taxes paid by such manufacturer or importer 
        during the prior fiscal year.
  ``(d) Timing of User Fee Assessment.--The Secretary shall notify each 
manufacturer and importer of tobacco products subject to this section 
of the amount of the quarterly assessment imposed on such manufacturer 
or importer under subsection (c) during each quarter of each fiscal 
year. Such notifications shall occur not later than 30 days prior to 
the end of the quarter for which such assessment is made, and payments 
of all assessments shall be made by the last day of the quarter 
involved.
  ``(e) Memorandum of Understanding.--
          ``(1) In general.--The Secretary shall request the 
        appropriate Federal agency to enter into a memorandum of 
        understanding that provides for the regular and timely transfer 
        from the head of such agency to the Secretary of the 
        information described in paragraphs (2)(B)(ii) and (4) of 
        subsection (c) and all necessary information regarding all 
        tobacco product manufacturers and importers required to pay 
        user fees. The Secretary shall maintain all disclosure 
        restrictions established by the head of such agency regarding 
        the information provided under the memorandum of understanding.
          ``(2) Assurances.--Beginning not later than fiscal year 2015, 
        and for each subsequent fiscal year, the Secretary shall ensure 
        that the Food and Drug Administration is able to determine the 
        applicable percentages described in subsection (c)(2) and the 
        percentage shares described in subsection (c)(4). The Secretary 
        may carry out this paragraph by entering into a contract with 
        the head of the Federal agency referred to in paragraph (1) to 
        continue to provide the necessary information.
  ``(f) Effective Date.--
          ``(1) In general.--The user fees prescribed by this section 
        shall be assessed in fiscal year 2008, and shall be assessed in 
        each fiscal year thereafter.
          ``(2) Special rule.--If the date of enactment of the Family 
        Smoking Prevention and Tobacco Control Act occurs during a 
        quarter of fiscal year 2008, the user fees for the portion of 
        the quarter that occurs after such date of enactment shall be 
        assessed during the next full quarter.
  ``(g) Study by GAO.--
          ``(1) In general.--The Comptroller General of the United 
        States shall conduct a study on--
                  ``(A) the prevalence of youth tobacco use and the 
                brands and subbrands that individuals under the age of 
                18 consume;
                  ``(B) the feasibility of structuring the user fees or 
                a portion of the user fees collected under this section 
                on the youth market share of a manufacturer or year to 
                year changes in a manufacturer's share of youth market; 
                and
                  ``(C) the potential effects of tobacco marketing to 
                youth audiences if user fees were calculated in whole 
                or in part on youth market share.
          ``(2) Report.--The Comptroller General shall submit to the 
        Energy and Commerce Committee of the House of Representatives 
        and the Health, Education, Labor, and Pensions Committee of the 
        Senate a report on the study conducted under paragraph (1) by 
        not later than 3 years after the date of enactment of the 
        Family Smoking Prevention and Tobacco Control Act.''.

SEC. 102. FINAL RULE.

  (a) Cigarettes and Smokeless Tobacco.--
          (1) In general.--On the first day of publication of the 
        Federal Register that is 180 days or more after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall publish in the Federal Register a final rule 
        regarding cigarettes and smokeless tobacco, which--
                  (A) is deemed to be issued under chapter 9 of the 
                Federal Food, Drug, and Cosmetic Act, as added by 
                section 101 of this Act; and
                  (B) shall be deemed to be in compliance with all 
                applicable provisions of chapter 5 of title 5, United 
                States Code, and all other provisions of law relating 
                to rulemaking procedures.
          (2) Contents of rule.--Except as provided in this subsection, 
        the final rule published under paragraph (1), shall be 
        identical in its provisions to part 897 of the regulations 
        promulgated by the Secretary of Health and Human Services in 
        the August 28, 1996, issue of the Federal Register (61 Fed. 
        Reg., 44615-44618). Such rule shall--
                  (A) provide for the designation of jurisdictional 
                authority that is in accordance with this subsection in 
                accordance with this Act and the amendments made by 
                this Act;
                  (B) strike Subpart C--Labels and section 897.32(c);
                  (C) strike paragraphs (a), (b), and (i) of section 
                897.3 and insert definitions of the terms 
                ``cigarette'', ``cigarette tobacco,'', and ``smokeless 
                tobacco'' as defined in section 900 of the Federal 
                Food, Drug, and Cosmetic Act;
                  (D) insert ``or roll-your-own paper'' in section 
                897.34(a) after ``other than cigarettes or smokeless 
                tobacco'';
                  (E) become effective on the date that is 1 year after 
                the date of enactment of this Act; and
                  (F) amend paragraph (d) of section 897.16 to read as 
                follows:
  ``(d)(1) Except as provided in subparagraph (2), no manufacturer, 
distributor, or retailer may distribute or cause to be distributed any 
free samples of cigarettes, smokeless tobacco, or other tobacco 
products (as such term is defined in section 201 of the Federal Food, 
Drug, and Cosmetic Act).
  ``(2)(A) Subparagraph (1) does not prohibit a manufacturer, 
distributor, or retailer from distributing or causing to be distributed 
free samples of smokeless tobacco in a qualified adult-only facility.
  ``(B) This subparagraph does not affect the authority of a State or 
local government to prohibit or otherwise restrict the distribution of 
free samples of smokeless tobacco.
  ``(C) For purposes of this paragraph, the term `qualified adult-only 
facility' means a facility or restricted area that--
          ``(i) requires each person present to provide to a law 
        enforcement officer (whether on or off duty) or to a security 
        guard licensed by a governmental entity government-issued 
        identification showing a photograph and at least the minimum 
        age established by applicable law for the purchase of smokeless 
        tobacco;
          ``(ii) does not sell, serve, or distribute alcohol;
          ``(iii) is not located adjacent to or immediately across from 
        (in any direction) a space that is used primarily for youth-
        oriented marketing, promotional, or other activities;
          ``(iv) is a temporary structure constructed, designated, and 
        operated as a distinct enclosed area for the purpose of 
        distributing free samples of smokeless tobacco in accordance 
        with this subparagraph; and
          ``(v) is enclosed by a barrier that--
                  ``(I) is constructed of, or covered with, an opaque 
                material (except for entrances and exits);
                  ``(II) extends from no more than 12 inches above the 
                ground or floor (which area at the bottom of the 
                barrier must be covered with material that restricts 
                visibility but may allow airflow) to at least 8 feet 
                above the ground or floor (or to the ceiling); and
                  ``(III) prevents persons outside the qualified adult-
                only facility from seeing into the qualified adult-only 
                facility, unless they make unreasonable efforts to do 
                so; and
          ``(vi) does not display on its exterior--
                  ``(I) any tobacco product advertising;
                  ``(II) a brand name other than in conjunction with 
                words for an area or enclosure to identify an adult-
                only facility; or
                  ``(III) any combination of words that would imply to 
                a reasonable observer that the manufacturer, 
                distributor, or retailer has a sponsorship that would 
                violate section 897.34(c).
  ``(D) Distribution of samples of smokeless tobacco under this 
subparagraph permitted to be taken out of the qualified adult-only 
facility shall be limited to 1 package per adult consumer containing no 
more than 0.53 ounces (15 grams) of smokeless tobacco. If such package 
of smokeless tobacco contains individual portions of smokeless tobacco, 
the individual portions of smokeless tobacco shall not exceed 8 
individual portions and the collective weight of such individual 
portions shall not exceed 0.53 ounces (15 grams). Any manufacturer, 
distributor, or retailer who distributes or causes to be distributed 
free samples also shall take reasonable steps to ensure that the above 
amounts are limited to one such package per adult consumer per day.
  ``(3) Notwithstanding subparagraph (2), no manufacturer, distributor, 
or retailer may distribute or cause to be distributed any free samples 
of smokeless tobacco--
          ``(A) to a sports team or entertainment group; or
          ``(B) at any football, basketball, baseball, soccer, or 
        hockey event or any other sporting or entertainment event 
        determined by the Secretary to be covered by this subparagraph.
  ``(4) The Secretary shall implement a program to ensure compliance 
with this paragraph and submit a report to the Congress on such 
compliance not later than 18 months after the date of enactment of the 
Family Smoking Prevention and Tobacco Control Act.
  ``(5) Nothing in this paragraph shall be construed to authorize any 
person to distribute or cause to be distributed any sample of a tobacco 
product to any individual who has not attained the minimum age 
established by applicable law for the purchase of such product.''.
          (3) Amendments to rule.--Prior to making amendments to the 
        rule published under paragraph (1), the Secretary shall 
        promulgate a proposed rule in accordance with chapter 5 of 
        title 5, United States Code.
          (4) Rule of construction.--Except as provided in paragraph 
        (3), nothing in this section shall be construed to limit the 
        authority of the Secretary to amend, in accordance with chapter 
        5 of title 5, United States Code, the regulation promulgated 
        pursuant to this section, including the provisions of such 
        regulation relating to distribution of free samples.
          (5) Enforcement of retail sale provisions.--The Secretary of 
        Health and Human Services shall ensure that the provisions of 
        this Act, the amendments made by this Act, and the implementing 
        regulations (including such provisions, amendments, and 
        regulations relating to the retail sale of tobacco products) 
        are enforced with respect to the United States and Indian 
        tribes.
          (6) Qualified adult-only facility.--A qualified adult-only 
        facility (as such term is defined in section 897.16(d) of the 
        final rule published under paragraph (1)) that is also a 
        retailer and that commits a violation as a retailer shall not 
        be subject to the limitations in section 103(q) and shall be 
        subject to penalties applicable to a qualified adult-only 
        facility.
          (7) Congressional review provisions.--Section 801 of title 5, 
        United States Code, shall not apply to the final rule published 
        under paragraph (1).
  (b) Limitation on Advisory Opinions.--As of the date of enactment of 
this Act, the following documents issued by the Food and Drug 
Administration shall not constitute advisory opinions under section 
10.85(d)(1) of title 21, Code of Federal Regulations, except as they 
apply to tobacco products, and shall not be cited by the Secretary of 
Health and Human Services or the Food and Drug Administration as 
binding precedent:
          (1) The preamble to the proposed rule in the document titled 
        ``Regulations Restricting the Sale and Distribution of 
        Cigarettes and Smokeless Tobacco Products to Protect Children 
        and Adolescents'' (60 Fed. Reg. 41314-41372 (August 11, 1995)).
          (2) The document titled ``Nicotine in Cigarettes and 
        Smokeless Tobacco Products is a Drug and These Products Are 
        Nicotine Delivery Devices Under the Federal Food, Drug, and 
        Cosmetic Act'' (60 Fed. Reg. 41453-41787 (August 11, 1995)).
          (3) The preamble to the final rule in the document titled 
        ``Regulations Restricting the Sale and Distribution of 
        Cigarettes and Smokeless Tobacco to Protect Children and 
        Adolescents'' (61 Fed. Reg. 44396-44615 (August 28, 1996)).
          (4) The document titled ``Nicotine in Cigarettes and 
        Smokeless Tobacco is a Drug and These Products are Nicotine 
        Delivery Devices Under the Federal Food, Drug, and Cosmetic 
        Act; Jurisdictional Determination'' (61 Fed. Reg. 44619-45318 
        (August 28, 1996)).

SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL PROVISIONS.

  (a) Amendment of Federal Food, Drug, and Cosmetic Act.--Except as 
otherwise expressly provided, whenever in this section an amendment is 
expressed in terms of an amendment to, or repeal of, a section or other 
provision, the reference is to a section or other provision of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
  (b) Section 301.--Section 301 (21 U.S.C. 331) is amended--
          (1) in subsection (a), by inserting ``tobacco product,'' 
        after ``device,'';
          (2) in subsection (b), by inserting ``tobacco product,'' 
        after ``device,'';
          (3) in subsection (c), by inserting ``tobacco product,'' 
        after ``device,'';
          (4) in subsection (e)--
                  (A) by striking the period after ``572(i)''; and
                  (B) by striking ``or 761 or the refusal to permit 
                access to'' and inserting ``761, 909, or 921 or the 
                refusal to permit access to'';
          (5) in subsection (g), by inserting ``tobacco product,'' 
        after ``device,'';
          (6) in subsection (h), by inserting ``tobacco product,'' 
        after ``device,'';
          (7) in subsection (j)--
                  (A) by striking the period after ``573''; and
                  (B) by striking ``708, or 721'' and inserting ``708, 
                721, 904, 905, 906, 907, 908, 909, or 921(b)'';
          (8) in subsection (k), by inserting ``tobacco product,'' 
        after ``device,'';
          (9) by striking subsection (p) and inserting the following:
  ``(p) The failure to register in accordance with section 510 or 905, 
the failure to provide any information required by section 510(j), 
510(k), 905(i), or 905(j), or the failure to provide a notice required 
by section 510(j)(2) or 905(i)(3).'';
          (10) by striking subsection (q)(1) and inserting the 
        following:
  ``(q)(1) The failure or refusal--
          ``(A) to comply with any requirement prescribed under section 
        518, 520(g), 903(b), 907, 908, or 916;
          ``(B) to furnish any notification or other material or 
        information required by or under section 519, 520(g), 904, 909, 
        or 921; or
          ``(C) to comply with a requirement under section 522 or 
        913.'';
          (11) in subsection (q)(2), by striking ``device,'' and 
        inserting ``device or tobacco product,'';
          (12) in subsection (r), by inserting ``or tobacco product'' 
        after the term ``device'' each time that such term appears; and
          (13) by adding at the end the following:
  ``(oo) The sale of tobacco products in violation of a no-tobacco-sale 
order issued under section 303(f).
  ``(pp) The introduction or delivery for introduction into interstate 
commerce of a tobacco product in violation of section 911.
  ``(qq)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, stamp 
(including tax stamp), tag, label, or other identification device upon 
any tobacco product or container or labeling thereof so as to render 
such tobacco product a counterfeit tobacco product.
  ``(2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, stone, or 
other item that is designed to print, imprint, or reproduce the 
trademark, trade name, or other identifying mark, imprint, or device of 
another or any likeness of any of the foregoing upon any tobacco 
product or container or labeling thereof so as to render such tobacco 
product a counterfeit tobacco product.
  ``(3) The doing of any act that causes a tobacco product to be a 
counterfeit tobacco product, or the sale or dispensing, or the holding 
for sale or dispensing, of a counterfeit tobacco product.
  ``(rr) The charitable distribution of tobacco products.
  ``(ss) The failure of a manufacturer or distributor to notify the 
Attorney General and the Secretary of the Treasury of their knowledge 
of tobacco products used in illicit trade.
  ``(tt) With respect to a tobacco product, any statement directed to 
consumers through the media or through the label, labeling, or 
advertising that would reasonably be expected to result in consumers 
believing that the product is regulated, inspected or approved by the 
Food and Drug Administration, or that the product complies with the 
requirements of the Food and Drug Administration, including a statement 
or implication in the label, labeling, or advertising of such product, 
and that could result in consumers believing that the product is 
endorsed for use by the Food and Drug Administration or in consumers 
being misled about the harmfulness of the product because of such 
regulation, inspection, or compliance.''.
  (c) Section 303.--Section 303(f) (21 U.S.C. 333(f)) is amended--
          (1) in paragraph (1)(A), by inserting ``or tobacco products'' 
        after the term ``devices'' each place such term appears;
          (2) in paragraph (5)--
                  (A) in subparagraph (A)--
                          (i) by striking ``assessed'' the first time 
                        it appears and inserting ``assessed, or a no-
                        tobacco-sale order may be imposed,''; and
                          (ii) by striking ``penalty'' the second time 
                        it appears and inserting ``penalty, or upon 
                        whom a no-tobacco-sale order is to be 
                        imposed,'';
                  (B) in subparagraph (B)--
                          (i) by inserting after ``penalty,'' the 
                        following: ``or the period to be covered by a 
                        no-tobacco-sale order,''; and
                          (ii) by adding at the end the following: ``A 
                        no-tobacco-sale order permanently prohibiting 
                        an individual retail outlet from selling 
                        tobacco products shall include provisions that 
                        allow the outlet, after a specified period of 
                        time, to request that the Secretary compromise, 
                        modify, or terminate the order.''; and
                  (C) by adding at the end the following:
  ``(D) The Secretary may compromise, modify, or terminate, with or 
without conditions, any no-tobacco-sale order.'';
          (3) in paragraph (6)--
                  (A) by inserting ``or the imposition of a no-tobacco-
                sale order'' after the term ``penalty'' each place such 
                term appears; and
                  (B) by striking ``issued.'' and inserting ``issued, 
                or on which the no-tobacco-sale order was imposed, as 
                the case may be.''; and
          (4) by adding at the end the following:
          ``(8) If the Secretary finds that a person has committed 
        repeated violations of restrictions promulgated under section 
        906(d) at a particular retail outlet then the Secretary may 
        impose a no-tobacco-sale order on that person prohibiting the 
        sale of tobacco products in that outlet. A no-tobacco-sale 
        order may be imposed with a civil penalty under paragraph (1). 
        Prior to the entry of a no-sale order under this paragraph, a 
        person shall be entitled to a hearing pursuant to the 
        procedures established through regulations of the Food and Drug 
        Administration for assessing civil money penalties, including 
        at a retailer's request a hearing by telephone, or at the 
        nearest regional or field office of the Food and Drug 
        Administration, or at a Federal, State, or county facility 
        within 100 miles from the location of the retail outlet, if 
        such a facility is available.''.
  (d) Section 304.--Section 304 (21 U.S.C. 334) is amended--
          (1) in subsection (a)(2)--
                  (A) by striking ``and'' before ``(D)''; and
                  (B) by striking ``device.'' and inserting the 
                following: ``device, and (E) Any adulterated or 
                misbranded tobacco product.'';
          (2) in subsection (d)(1), by inserting ``tobacco product,'' 
        after ``device,'';
          (3) in subsection (g)(1), by inserting ``or tobacco product'' 
        after the term ``device'' each place such term appears; and
          (4) in subsection (g)(2)(A), by inserting ``or tobacco 
        product'' after ``device''.
  (e) Section 505.--Section 505(n)(2) (21 U.S.C. 355(n)(2)) is amended 
by striking ``section 904'' and inserting ``section 1004''.
  (f) Section 523.--Section 523(b)(2)(D) (21 U.S.C. 360m(b)(2)(D)) is 
amended by striking ``section 903(g)'' and inserting ``section 
1003(g)''.
  (g) Section 702.--Section 702(a) (21 U.S.C. 372(a)) is amended by 
adding at the end of paragraph (1) the following: ``For a tobacco 
product, to the extent feasible, the Secretary shall contract with the 
States in accordance with this paragraph to carry out inspections of 
retailers within that State in connection with the enforcement of this 
Act.''.
  (h) Section 703.--Section 703 (21 U.S.C. 373) is amended--
          (1) by inserting ``tobacco product,'' after the term 
        ``device,'' each place such term appears; and
          (2) by inserting ``tobacco products,'' after the term 
        ``devices,'' each place such term appears.
  (i) Section 704.--Section 704 (21 U.S.C. 374) is amended--
          (1) in subsection (a)(1)(A), by inserting ``tobacco 
        products,'' after the term ``devices,'' each place such term 
        appears;
          (2) in subsection (a)(1)(B), by inserting ``or tobacco 
        products'' after the term ``restricted devices'' each place 
        such term appears;
          (3) in subsection (b), by inserting ``tobacco product,'' 
        after ``device,''; and
          (4) in subsection (g)(13), by striking ``section 903(g)'' and 
        inserting ``section 1003(g)''.
  (j) Section 705.--Section 705(b) (21 U.S.C. 375(b)) is amended by 
inserting ``tobacco products,'' after ``devices,''.
  (k) Section 709.--Section 709 (21 U.S.C. 379a) is amended by 
inserting ``tobacco product,'' after ``device,''.
  (l) Section 801.--Section 801 (21 U.S.C. 381) is amended--
          (1) in subsection (a)--
                  (A) by inserting ``tobacco products,'' after the term 
                ``devices,'';
                  (B) by inserting ``or section 905(h)'' after 
                ``section 510''; and
                  (C) by striking the term ``drugs or devices'' each 
                time such term appears and inserting ``drugs, devices, 
                or tobacco products'';
          (2) in subsection (e)(1), by inserting ``tobacco product,'' 
        after ``device,''; and
          (3) by adding at the end the following:
  ``(p)(1) Not later than 36 months after the date of enactment of the 
Family Smoking Prevention and Tobacco Control Act, and annually 
thereafter, the Secretary shall submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives, a report 
regarding--
          ``(A) the nature, extent, and destination of United States 
        tobacco product exports that do not conform to tobacco product 
        standards established pursuant to this Act;
          ``(B) the public health implications of such exports, 
        including any evidence of a negative public health impact; and
          ``(C) recommendations or assessments of policy alternatives 
        available to Congress and the executive branch to reduce any 
        negative public health impact caused by such exports.
  ``(2) The Secretary is authorized to establish appropriate 
information disclosure requirements to carry out this subsection.''.
  (m) Section 1003.--Section 1003(d)(2)(C) (as redesignated by section 
101(b)) is amended--
          (1) by striking ``and'' after ``cosmetics,''; and
          (2) inserting ``, and tobacco products'' after ``devices''.
  (n) Section 1009.--Section 1009(b) (as redesignated by section 
101(b)) is amended by striking ``section 908'' and inserting ``section 
1008''.
  (o) Section 409 of the Federal Meat Inspection Act.--Section 409(a) 
of the Federal Meat Inspection Act (21 U.S.C. 679(a)) is amended by 
striking ``section 902(b)'' and inserting ``section 1002(b)''.
  (p) Rule of Construction.--Nothing in this section is intended or 
shall be construed to expand, contract, or otherwise modify or amend 
the existing limitations on State government authority over tribal 
restricted fee or trust lands.
  (q) Guidance and Effective Dates.--
          (1) In general.--The Secretary of Health and Human Services 
        shall issue guidance--
                  (A) defining the term ``repeated violation'', as used 
                in section 303(f)(8) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 333(f)(8)) as amended by 
                subsection (c), as including at least 5 violations of 
                particular requirements over a 36-month period at a 
                particular retail outlet that constitute a repeated 
                violation and providing for civil penalties in 
                accordance with paragraph (2);
                  (B) providing for timely and effective notice by 
                certified or registered mail or personal delivery to 
                the retailer of each alleged violation at a particular 
                retail outlet prior to conducting a followup compliance 
                check, such notice to be sent to the location specified 
                on the retailer's registration or to the retailer's 
                registered agent if the retailer has provider such 
                agent information to the Food and Drug Administration 
                prior to the violation;
                  (C) providing for a hearing pursuant to the 
                procedures established through regulations of the Food 
                and Drug Administration for assessing civil money 
                penalties, including at a retailer's request a hearing 
                by telephone or at the nearest regional or field office 
                of the Food and Drug Administration, and providing for 
                an expedited procedure for the administrative appeal of 
                an alleged violation;
                  (D) providing that a person may not be charged with a 
                violation at a particular retail outlet unless the 
                Secretary has provided notice to the retailer of all 
                previous violations at that outlet;
                  (E) establishing that civil money penalties for 
                multiple violations shall increase from one violation 
                to the next violation pursuant to paragraph (2) within 
                the time periods provided for in such paragraph;
                  (F) providing that good faith reliance on the 
                presentation of a false government-issued photographic 
                identification that contains a date of birth does not 
                constitute a violation of any minimum age requirement 
                for the sale of tobacco products if the retailer has 
                taken effective steps to prevent such violations, 
                including--
                          (i) adopting and enforcing a written policy 
                        against sales to minors;
                          (ii) informing its employees of all 
                        applicable laws;
                          (iii) establishing disciplinary sanctions for 
                        employee noncompliance; and
                          (iv) requiring its employees to verify age by 
                        way of photographic identification or 
                        electronic scanning device; and
                  (G) providing for the Secretary, in determining 
                whether to impose a no-tobacco-sale order and in 
                determining whether to compromise, modify, or terminate 
                such an order, to consider whether the retailer has 
                taken effective steps to prevent violations of the 
                minimum age requirements for the sale of tobacco 
                products, including the steps listed in subparagraph 
                (F).
          (2) Penalties for violations.--
                  (A) In general.--The amount of the civil penalty to 
                be applied for violations of restrictions promulgated 
                under section 906(d), as described in paragraph (1), 
                shall be as follows:
                          (i) With respect to a retailer with an 
                        approved training program, the amount of the 
                        civil penalty shall not exceed--
                                  (I) in the case of the first 
                                violation, $0.00 together with the 
                                issuance of a warning letter to the 
                                retailer;
                                  (II) in the case of a second 
                                violation within a 12-month period, 
                                $250;
                                  (III) in the case of a third 
                                violation within a 24-month period, 
                                $500;
                                  (IV) in the case of a fourth 
                                violation within a 24-month period, 
                                $2,000;
                                  (V) in the case of a fifth violation 
                                within a 36-month period, $5,000; and
                                  (VI) in the case of a sixth or 
                                subsequent violation within a 48-month 
                                period, $10,000 as determined by the 
                                Secretary on a case-by-case basis.
                          (ii) With respect to a retailer that does not 
                        have an approved training program, the amount 
                        of the civil penalty shall not exceed--
                                  (I) in the case of the first 
                                violation, $250;
                                  (II) in the case of a second 
                                violation within a 12-month period, 
                                $500;
                                  (III) in the case of a third 
                                violation within a 24-month period, 
                                $1,000;
                                  (IV) in the case of a fourth 
                                violation within a 24-month period, 
                                $2,000;
                                  (V) in the case of a fifth violation 
                                within a 36-month period, $5,000; and
                                  (VI) in the case of a sixth or 
                                subsequent violation within a 48-month 
                                period, $10,000 as determined by the 
                                Secretary on a case-by-case basis.
                  (B) Training program.--For purposes of subparagraph 
                (A), the term ``approved training program'' means a 
                training program that complies with standards developed 
                by the Food and Drug Administration for such programs.
                  (C) Consideration of state penalties.--The Secretary 
                shall coordinate with the States in enforcing the 
                provisions of this Act and, for purposes of mitigating 
                a civil penalty to be applied for a violation by a 
                retailer of any restriction promulgated under section 
                906(d), shall consider the amount of any penalties paid 
                by the retailer to a State for the same violation.
          (3) General effective date.--The amendments made by 
        paragraphs (2), (3), and (4) of subsection (c) shall take 
        effect upon the issuance of guidance described in paragraph (1) 
        of this subsection.
          (4) Special effective date.--The amendment made by subsection 
        (c)(1) shall take effect on the date of enactment of this Act.
          (5) Package label requirements.--The package label 
        requirements of paragraphs (2), (3), and (4) of section 903(a) 
        of the Federal Food, Drug, and Cosmetic Act (as amended by this 
        Act) shall take effect on the date that is 12 months after the 
        date of enactment of this Act. The effective date shall be with 
        respect to the date of manufacture, provided that, in any case, 
        30 days after such effective date, a manufacturer shall not 
        introduce into the domestic commerce of the United States any 
        product that is not in conformance with section 903(a)(2), (3), 
        and (4) and section 920(a) of the Federal Food, Drug, and 
        Cosmetic Act.
          (6) Advertising requirements.--The advertising requirements 
        of section 903(a)(8) of the Federal Food, Drug, and Cosmetic 
        Act (as amended by this Act) shall take effect on the date that 
        is 12 months after the date of enactment of this Act.

SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PURCHASE TOBACCO 
                    PRODUCTS.

  The Secretary of Health and Human Services shall--
          (1) convene an expert panel to conduct a study on the public 
        health implications of raising the minimum age to purchase 
        tobacco products; and
          (2) not later than 5 years after the date of the enactment of 
        this Act, submit a report to the Congress on the results of 
        such study.

SEC. 105. TOBACCO INDUSTRY CONCENTRATION.

  (a) Study.--The Federal Trade Commission shall conduct a study on the 
causes and effects of concentration in the tobacco industry.
  (b) Public Report.--The Federal Trade Commission shall transmit to 
Congress a report not later than 5 years after the date of enactment of 
this Act, and a subsequent report on the date that is 10 years after 
the date of enactment of this Act. Such reports shall include--
          (1) an analysis of trends in the market share of any dominant 
        tobacco product manufacturer in any class of tobacco products; 
        or
          (2) an analysis of trends in competition or the emergence of 
        a monopoly; and
          (3) recommendations to Congress on any corrective actions 
        that should be taken to address tobacco industry concentration.

 TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT 
                               DISCLOSURE

SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.

  (a) Amendment.--Section 4 of the Federal Cigarette Labeling and 
Advertising Act (15 U.S.C. 1333) is amended to read as follows:

``SEC. 4. LABELING.

  ``(a) Label Requirements.--
          ``(1) In general.--It shall be unlawful for any person to 
        manufacture, package, sell, offer to sell, distribute, or 
        import for sale or distribution within the United States any 
        cigarettes the package of which fails to bear, in accordance 
        with the requirements of this section, one of the following 
        labels:
                  ``WARNING: Cigarettes are addictive.
                  ``WARNING: Tobacco smoke can harm your children.
                  ``WARNING: Cigarettes cause fatal lung disease.
                  ``WARNING: Cigarettes cause cancer.
                  ``WARNING: Cigarettes cause strokes and heart 
                disease.
                  ``WARNING: Smoking during pregnancy can harm your 
                baby.
                  ``WARNING: Smoking can kill you.
                  ``WARNING: Tobacco smoke causes fatal lung disease in 
                nonsmokers.
                  ``WARNING: Quitting smoking now greatly reduces 
                serious risks to your health.
          ``(2) Placement; typography; etc.--Each label statement 
        required by paragraph (1) shall be located in the upper portion 
        of the front and rear panels of the package, directly on the 
        package underneath the cellophane or other clear wrapping. Each 
        label statement shall comprise at least the top 30 percent of 
        the front and rear panels of the package. The word `WARNING' 
        shall appear in capital letters and all text shall be in 
        conspicuous and legible 17-point type, unless the text of the 
        label statement would occupy more than 70 percent of such area, 
        in which case the text may be in a smaller conspicuous and 
        legible type size, provided that at least 60 percent of such 
        area is occupied by required text. The text shall be black on a 
        white background, or white on a black background, in a manner 
        that contrasts, by typography, layout, or color, with all other 
        printed material on the package, in an alternating fashion 
        under the plan submitted under subsection (c).
          ``(3) Does not apply to foreign distribution.--The provisions 
        of this subsection do not apply to a tobacco product 
        manufacturer or distributor of cigarettes which does not 
        manufacture, package, or import cigarettes for sale or 
        distribution within the United States.
          ``(4) Applicability to retailers.--A retailer of cigarettes 
        shall not be in violation of this subsection for packaging 
        that--
                  ``(A) contains a warning label;
                  ``(B) is supplied to the retailer by a license- or 
                permit-holding tobacco product manufacturer, importer, 
                or distributor; and
                  ``(C) is not altered by the retailer in a way that is 
                material to the requirements of this subsection.
  ``(b) Advertising Requirements.--
          ``(1) In general.--It shall be unlawful for any tobacco 
        product manufacturer, importer, distributor, or retailer of 
        cigarettes to advertise or cause to be advertised within the 
        United States any cigarette unless its advertising bears, in 
        accordance with the requirements of this section, one of the 
        labels specified in subsection (a).
          ``(2) Typography, etc.--Each label statement required by 
        subsection (a) in cigarette advertising shall comply with the 
        standards set forth in this paragraph. For press and poster 
        advertisements, each such statement and (where applicable) any 
        required statement relating to tar, nicotine, or other 
        constituent (including a smoke constituent) yield shall 
        comprise at least 20 percent of the area of the advertisement 
        and shall appear in a conspicuous and prominent format and 
        location at the top of each advertisement within the trim area. 
        The Secretary may revise the required type sizes in such area 
        in such manner as the Secretary determines appropriate. The 
        word `WARNING' shall appear in capital letters, and each label 
        statement shall appear in conspicuous and legible type. The 
        text of the label statement shall be black if the background is 
        white and white if the background is black, under the plan 
        submitted under subsection (c). The label statements shall be 
        enclosed by a rectangular border that is the same color as the 
        letters of the statements and that is the width of the first 
        downstroke of the capital `W' of the word `WARNING' in the 
        label statements. The text of such label statements shall be in 
        a typeface pro rata to the following requirements: 45-point 
        type for a whole-page broadsheet newspaper advertisement; 39-
        point type for a half-page broadsheet newspaper advertisement; 
        39-point type for a whole-page tabloid newspaper advertisement; 
        27-point type for a half-page tabloid newspaper advertisement; 
        31.5-point type for a double page spread magazine or whole-page 
        magazine advertisement; 22.5-point type for a 28 centimeter by 
        3 column advertisement; and 15-point type for a 20 centimeter 
        by 2 column advertisement. The label statements shall be in 
        English, except that--
                  ``(A) in the case of an advertisement that appears in 
                a newspaper, magazine, periodical, or other publication 
                that is not in English, the statements shall appear in 
                the predominant language of the publication; and
                  ``(B) in the case of any other advertisement that is 
                not in English, the statements shall appear in the same 
                language as that principally used in the advertisement.
          ``(3) Matchbooks.--Notwithstanding paragraph (2), for 
        matchbooks (defined as containing not more than 20 matches) 
        customarily given away with the purchase of tobacco products, 
        each label statement required by subsection (a) may be printed 
        on the inside cover of the matchbook.
          ``(4) Adjustment by secretary.--The Secretary may, through a 
        rulemaking under section 553 of title 5, United States Code, 
        adjust the format and type sizes for the label statements 
        required by this section; the text, format, and type sizes of 
        any required tar, nicotine yield, or other constituent 
        (including smoke constituent) disclosures; or the text, format, 
        and type sizes for any other disclosures required under the 
        Federal Food, Drug, and Cosmetic Act. The text of any such 
        label statements or disclosures shall be required to appear 
        only within the 20 percent area of cigarette advertisements 
        provided by paragraph (2). The Secretary shall promulgate 
        regulations which provide for adjustments in the format and 
        type sizes of any text required to appear in such area to 
        ensure that the total text required to appear by law will fit 
        within such area.
  ``(c) Marketing Requirements.--
          ``(1) Random display.--The label statements specified in 
        subsection (a)(1) shall be randomly displayed in each 12-month 
        period, in as equal a number of times as is possible on each 
        brand of the product and be randomly distributed in all areas 
        of the United States in which the product is marketed in 
        accordance with a plan submitted by the tobacco product 
        manufacturer, importer, distributor, or retailer and approved 
        by the Secretary.
          ``(2) Rotation.--The label statements specified in subsection 
        (a)(1) shall be rotated quarterly in alternating sequence in 
        advertisements for each brand of cigarettes in accordance with 
        a plan submitted by the tobacco product manufacturer, importer, 
        distributor, or retailer to, and approved by, the Secretary.
          ``(3) Review.--The Secretary shall review each plan submitted 
        under paragraph (2) and approve it if the plan--
                  ``(A) will provide for the equal distribution and 
                display on packaging and the rotation required in 
                advertising under this subsection; and
                  ``(B) assures that all of the labels required under 
                this section will be displayed by the tobacco product 
                manufacturer, importer, distributor, or retailer at the 
                same time.
          ``(4) Applicability to retailers.--This subsection and 
        subsection (b) apply to a retailer only if that retailer is 
        responsible for or directs the label statements required under 
        this section except that this paragraph shall not relieve a 
        retailer of liability if the retailer displays, in a location 
        open to the public, an advertisement that does not contain a 
        warning label or has been altered by the retailer in a way that 
        is material to the requirements of this subsection and 
        subsection (b).''.
  (b) Effective Date.--The amendments made by this title to section 4 
of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) 
shall take effect on the date that is 1 year after the date of 
enactment of this Act.

SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING LABEL STATEMENTS.

  Section 4 of the Federal Cigarette Labeling and Advertising Act (15 
U.S.C. 1333), as amended by section 201, is further amended by adding 
at the end the following:
  ``(d) Change in Required Statements.--The Secretary may, by a 
rulemaking conducted under section 553 of title 5, United States Code, 
adjust the format, type size, and text of any of the label 
requirements, require color graphics to accompany the text, increase 
the required label area from 30 percent up to 50 percent of the front 
and rear panels of the package, or establish the format, type size, and 
text of any other disclosures required under the Federal Food, Drug, 
and Cosmetic Act, if the Secretary finds that such a change would 
promote greater public understanding of the risks associated with the 
use of tobacco products.''.

SEC. 203. STATE REGULATION OF CIGARETTE ADVERTISING AND PROMOTION.

  Section 5 of the Federal Cigarette Labeling and Advertising Act (15 
U.S.C. 1334) is amended by adding at the end the following:
  ``(c) Exception.--Notwithstanding subsection (b), a State or locality 
may enact statutes and promulgate regulations, based on smoking and 
health, that take effect after the effective date of the Family Smoking 
Prevention and Tobacco Control Act, imposing specific bans or 
restrictions on the time, place, and manner, but not content, of the 
advertising or promotion of any cigarettes.''.

SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING WARNINGS.

  (a) Amendment.--Section 3 of the Comprehensive Smokeless Tobacco 
Health Education Act of 1986 (15 U.S.C. 4402) is amended to read as 
follows:

``SEC. 3. SMOKELESS TOBACCO WARNING.

  ``(a) General Rule.--
          ``(1) It shall be unlawful for any person to manufacture, 
        package, sell, offer to sell, distribute, or import for sale or 
        distribution within the United States any smokeless tobacco 
        product unless the product package bears, in accordance with 
        the requirements of this Act, one of the following labels:
                  ``WARNING: This product can cause mouth cancer.
                  ``WARNING: This product can cause gum disease and 
                tooth loss.
                  ``WARNING: This product is not a safe alternative to 
                cigarettes.
                  ``WARNING: Smokeless tobacco is addictive.
          ``(2) Each label statement required by paragraph (1) shall 
        be--
                  ``(A) located on the 2 principal display panels of 
                the package, and each label statement shall comprise at 
                least 30 percent of each such display panel; and
                  ``(B) in 17-point conspicuous and legible type and in 
                black text on a white background, or white text on a 
                black background, in a manner that contrasts by 
                typography, layout, or color, with all other printed 
                material on the package, in an alternating fashion 
                under the plan submitted under subsection (b)(3), 
                except that if the text of a label statement would 
                occupy more than 70 percent of the area specified by 
                subparagraph (A), such text may appear in a smaller 
                type size, so long as at least 60 percent of such 
                warning area is occupied by the label statement.
          ``(3) The label statements required by paragraph (1) shall be 
        introduced by each tobacco product manufacturer, packager, 
        importer, distributor, or retailer of smokeless tobacco 
        products concurrently into the distribution chain of such 
        products.
          ``(4) The provisions of this subsection do not apply to a 
        tobacco product manufacturer or distributor of any smokeless 
        tobacco product that does not manufacture, package, or import 
        smokeless tobacco products for sale or distribution within the 
        United States.
          ``(5) A retailer of smokeless tobacco products shall not be 
        in violation of this subsection for packaging that--
                  ``(A) contains a warning label;
                  ``(B) is supplied to the retailer by a license- or 
                permit-holding tobacco product manufacturer, importer, 
                or distributor; and
                  ``(C) is not altered by the retailer in a way that is 
                material to the requirements of this subsection.
  ``(b) Required Labels.--
          ``(1) It shall be unlawful for any tobacco product 
        manufacturer, packager, importer, distributor, or retailer of 
        smokeless tobacco products to advertise or cause to be 
        advertised within the United States any smokeless tobacco 
        product unless its advertising bears, in accordance with the 
        requirements of this section, one of the labels specified in 
        subsection (a).
          ``(2) Each label statement required by subsection (a) in 
        smokeless tobacco advertising shall comply with the standards 
        set forth in this paragraph. For press and poster 
        advertisements, each such statement and (where applicable) any 
        required statement relating to tar, nicotine, or other 
        constituent yield shall--
                  ``(A) comprise at least 20 percent of the area of the 
                advertisement, and the warning area shall be delineated 
                by a dividing line of contrasting color from the 
                advertisement; and
                  ``(B) the word `WARNING' shall appear in capital 
                letters and each label statement shall appear in 
                conspicuous and legible type. The text of the label 
                statement shall be black on a white background, or 
                white on a black background, in an alternating fashion 
                under the plan submitted under paragraph (3).
          ``(3)(A) The label statements specified in subsection (a)(1) 
        shall be randomly displayed in each 12-month period, in as 
        equal a number of times as is possible on each brand of the 
        product and be randomly distributed in all areas of the United 
        States in which the product is marketed in accordance with a 
        plan submitted by the tobacco product manufacturer, importer, 
        distributor, or retailer and approved by the Secretary.
          ``(B) The label statements specified in subsection (a)(1) 
        shall be rotated quarterly in alternating sequence in 
        advertisements for each brand of smokeless tobacco product in 
        accordance with a plan submitted by the tobacco product 
        manufacturer, importer, distributor, or retailer to, and 
        approved by, the Secretary.
          ``(C) The Secretary shall review each plan submitted under 
        subparagraphs (A) and (B) and approve it if the plan--
                  ``(i) will provide for the equal distribution and 
                display on packaging and the rotation required in 
                advertising under this subsection; and
                  ``(ii) assures that all of the labels required under 
                this section will be displayed by the tobacco product 
                manufacturer, importer, distributor, or retailer at the 
                same time.
          ``(D) This paragraph applies to a retailer only if that 
        retailer is responsible for or directs the label statements 
        under this section, unless the retailer displays, in a location 
        open to the public, an advertisement that does not contain a 
        warning label or has been altered by the retailer in a way that 
        is material to the requirements of this subsection.
          ``(4) The Secretary may, through a rulemaking under section 
        553 of title 5, United States Code, adjust the format and type 
        sizes for the label statements required by this section; the 
        text, format, and type sizes of any required tar, nicotine 
        yield, or other constituent disclosures; or the text, format, 
        and type sizes for any other disclosures required under the 
        Federal Food, Drug, and Cosmetic Act. The text of any such 
        label statements or disclosures shall be required to appear 
        only within the 20 percent area of advertisements provided by 
        paragraph (2). The Secretary shall promulgate regulations which 
        provide for adjustments in the format and type sizes of any 
        text required to appear in such area to ensure that the total 
        text required to appear by law will fit within such area.
  ``(c) Television and Radio Advertising.--It is unlawful to advertise 
smokeless tobacco on any medium of electronic communications subject to 
the jurisdiction of the Federal Communications Commission.''.
  (b) Effective Date.--The amendments made by this title to section 3 
of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 
U.S.C. 4402) shall take effect on the date that is 1 year after the 
date of enactment of this Act.

SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT WARNING LABEL 
                    STATEMENTS.

  (a) In General.--Section 3 of the Comprehensive Smokeless Tobacco 
Health Education Act of 1986 (15 U.S.C. 4402), as amended by section 
204, is further amended by adding at the end the following:
  ``(d) Authority To Revise Warning Label Statements.--The Secretary 
may, by a rulemaking conducted under section 553 of title 5, United 
States Code, adjust the format, type size, and text of any of the label 
requirements, require color graphics to accompany the text, increase 
the required label area from 30 percent up to 50 percent of the front 
and rear panels of the package, or establish the format, type size, and 
text of any other disclosures required under the Federal Food, Drug, 
and Cosmetic Act, if the Secretary finds that such a change would 
promote greater public understanding of the risks associated with the 
use of smokeless tobacco products.''.
  (b) Preemption.--Section 7(a) of the Comprehensive Smokeless Tobacco 
Health Education Act of 1986 (15 U.S.C. 4406(a)) is amended by striking 
``No'' and inserting ``Except as provided in the Family Smoking 
Prevention and Tobacco Control Act (and the amendments made by that 
Act), no''.

SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT DISCLOSURE TO THE 
                    PUBLIC.

  Section 4 of the Federal Cigarette Labeling and Advertising Act (15 
U.S.C. 1333), as amended by sections 201 and 202, is further amended by 
adding at the end the following:
  ``(e) Tar, Nicotine, and Other Smoke Constituent Disclosure.--
          ``(1) In general.--The Secretary shall, by a rulemaking 
        conducted under section 553 of title 5, United States Code, 
        determine (in the Secretary's sole discretion) whether 
        cigarette and other tobacco product manufacturers shall be 
        required to include in the area of each cigarette advertisement 
        specified by subsection (b) of this section, or on the package 
        label, or both, the tar and nicotine yields of the advertised 
        or packaged brand. Any such disclosure shall be in accordance 
        with the methodology established under such regulations, shall 
        conform to the type size requirements of subsection (b) of this 
        section, and shall appear within the area specified in 
        subsection (b) of this section.
          ``(2) Resolution of differences.--Any differences between the 
        requirements established by the Secretary under paragraph (1) 
        and tar and nicotine yield reporting requirements established 
        by the Federal Trade Commission shall be resolved by a 
        memorandum of understanding between the Secretary and the 
        Federal Trade Commission.
          ``(3) Cigarette and other tobacco product constituents.--In 
        addition to the disclosures required by paragraph (1), the 
        Secretary may, under a rulemaking conducted under section 553 
        of title 5, United States Code, prescribe disclosure 
        requirements regarding the level of any cigarette or other 
        tobacco product constituent including any smoke constituent. 
        Any such disclosure may be required if the Secretary determines 
        that disclosure would be of benefit to the public health, or 
        otherwise would increase consumer awareness of the health 
        consequences of the use of tobacco products, except that no 
        such prescribed disclosure shall be required on the face of any 
        cigarette package or advertisement. Nothing in this section 
        shall prohibit the Secretary from requiring such prescribed 
        disclosure through a cigarette or other tobacco product package 
        or advertisement insert, or by any other means under the 
        Federal Food, Drug, and Cosmetic Act.
          ``(4) Retailers.--This subsection applies to a retailer only 
        if that retailer is responsible for or directs the label 
        statements required under this section.''.

       TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS

SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPECTION.

  Chapter IX of the Federal Food, Drug, and Cosmetic Act, as added by 
section 101, is further amended by adding at the end the following:

``SEC. 920. LABELING, RECORDKEEPING, RECORDS INSPECTION.

  ``(a) Origin Labeling.--Beginning 1 year after the date of enactment 
of the Family Smoking Prevention and Tobacco Control Act, the label, 
packaging, and shipping containers of tobacco products for introduction 
or delivery for introduction into interstate commerce in the United 
States shall bear the statement `sale only allowed in the United 
States'.
  ``(b) Regulations Concerning Recordkeeping for Tracking and 
Tracing.--
          ``(1) In general.--The Secretary shall promulgate regulations 
        regarding the establishment and maintenance of records by any 
        person who manufactures, processes, transports, distributes, 
        receives, packages, holds, exports, or imports tobacco 
        products.
          ``(2) Inspection.--In promulgating the regulations described 
        in paragraph (1), the Secretary shall consider which records 
        are needed for inspection to monitor the movement of tobacco 
        products from the point of manufacture through distribution to 
        retail outlets to assist in investigating potential illicit 
        trade, smuggling, or counterfeiting of tobacco products.
          ``(3) Codes.--The Secretary may require codes on the labels 
        of tobacco products or other designs or devices for the purpose 
        of tracking or tracing the tobacco product through the 
        distribution system.
          ``(4) Size of business.--The Secretary shall take into 
        account the size of a business in promulgating regulations 
        under this section.
          ``(5) Recordkeeping by retailers.--The Secretary shall not 
        require any retailer to maintain records relating to individual 
        purchasers of tobacco products for personal consumption.
  ``(c) Records Inspection.--If the Secretary has a reasonable belief 
that a tobacco product is part of an illicit trade or smuggling or is a 
counterfeit product, each person who manufactures, processes, 
transports, distributes, receives, holds, packages, exports, or imports 
tobacco products shall, at the request of an officer or employee duly 
designated by the Secretary, permit such officer or employee, at 
reasonable times and within reasonable limits and in a reasonable 
manner, upon the presentation of appropriate credentials and a written 
notice to such person, to have access to and copy all records 
(including financial records) relating to such article that are needed 
to assist the Secretary in investigating potential illicit trade, 
smuggling, or counterfeiting of tobacco products.
  ``(d) Knowledge of Illegal Transaction.--
          ``(1) Notification.--If the manufacturer or distributor of a 
        tobacco product has knowledge which reasonably supports the 
        conclusion that a tobacco product manufactured or distributed 
        by such manufacturer or distributor that has left the control 
        of such person may be or has been--
                  ``(A) imported, exported, distributed, or offered for 
                sale in interstate commerce by a person without paying 
                duties or taxes required by law; or
                  ``(B) imported, exported, distributed, or diverted 
                for possible illicit marketing,
        the manufacturer or distributor shall promptly notify the 
        Attorney General and the Secretary of the Treasury of such 
        knowledge.
          ``(2) Knowledge defined.--For purposes of this subsection, 
        the term `knowledge' as applied to a manufacturer or 
        distributor means--
                  ``(A) the actual knowledge that the manufacturer or 
                distributor had; or
                  ``(B) the knowledge which a reasonable person would 
                have had under like circumstances or which would have 
                been obtained upon the exercise of due care.''.

SEC. 302. STUDY AND REPORT.

  (a) Study.--The Comptroller General of the United States shall 
conduct a study of cross-border trade in tobacco products to--
          (1) collect data on cross-border trade in tobacco products, 
        including illicit trade and trade of counterfeit tobacco 
        products and make recommendations on the monitoring of such 
        trade;
          (2) collect data on cross-border advertising (any advertising 
        intended to be broadcast, transmitted, or distributed from the 
        United States to another country) of tobacco products and make 
        recommendations on how to prevent or eliminate, and what 
        technologies could help facilitate the elimination of, cross-
        border advertising; and
          (3) collect data on the health effects (particularly with 
        respect to individuals under 18 years of age) resulting from 
        cross-border trade in tobacco products, including the health 
        effects resulting from--
                  (A) the illicit trade of tobacco products and the 
                trade of counterfeit tobacco products; and
                  (B) the differing tax rates applicable to tobacco 
                products.
  (b) Report.--Not later than 18 months after the date of enactment of 
this Act, the Comptroller General of the United States shall submit to 
the Committee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives a report on the study described in subsection (a).
  (c) Definition.--In this section:
          (1) The term ``cross-border trade'' means trade across a 
        border of the United States, a State or Territory, or Indian 
        country.
          (2) The term ``Indian country'' has the meaning given to that 
        term in section 1151 of title 18, United States Code.
          (3) The terms ``State'' and ``Territory'' have the meanings 
        given to those terms in section 201 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 321).

                          Purpose and Summary

    The purpose of H.R. 1108, the ``Family Smoking Prevention 
and Tobacco Control Act'', is to amend the Federal Food, Drug, 
and Cosmetic Act (FFDCA) to grant the Food and Drug 
Administration (FDA) the authority to regulate tobacco 
products.
    H.R. 1108 allows the Secretary to restrict the sale and 
distribution of tobacco products, including advertising and 
promotion, if the Secretary determines that such regulation 
would be appropriate for the protection of the public health. 
The legislation also allows the Secretary to take specified 
actions, including public notification and recall, against 
unreasonably harmful products.
    H.R. 1108 requires the Secretary to establish tobacco 
product standards to protect the public health, but prohibits 
the Secretary from banning a class of tobacco products, such as 
all cigarettes, or reducing the nicotine level to zero. The 
legislation sets forth standards for the sale of modified-risk 
tobacco products and prohibits cigarettes from containing, as a 
characterizing flavor, any artificial or natural flavor (other 
than tobacco or menthol).
    H.R. 1108 sets forth provisions regarding: (1) judicial 
review, (2) coordination with the Federal Trade Commission, (3) 
Congressional review of regulations, and (4) State and local 
authority. The legislation also requires the Secretary to 
establish a Tobacco Products Scientific Advisory Committee.
    H.R. 1108 amends the Federal Cigarette Labeling and 
Advertising Act to change cigarette warning label and 
advertising requirements. In addition, the legislation amends 
the Comprehensive Smokeless Tobacco Health Education Act of 
1986 to change smokeless tobacco warning label and advertising 
requirements.

                  Background and Need for Legislation

    The prevalence of tobacco use and its toll on human lives 
has long been a public health concern. The Centers for Disease 
Control and Prevention (CDC) estimates that 21 percent of U.S. 
adults (approximately 45.1 million people) are cigarette 
smokers. Current trends suggest that the annual rate of 
cessation among smokers remains fairly low, that the decline in 
the initiation rate may have slowed, and that overall adult 
prevalence may be flattening out at around 20 percent. In 
addition to the prevalence of tobacco use in the adult 
population, CDC estimates that 23 percent of U.S. high school 
students are cigarette smokers.
    Cigarette smoking is the leading preventable cause of death 
in the United States. It is responsible for about 1 in 5 deaths 
annually, or about 438,000 deaths per year according to CDC. 
According to the Institute of Medicine, smoking-related deaths 
account for more deaths than AIDS, alcohol, cocaine, heroin, 
homicide, suicide, motor vehicle crashes, and fires combined. 
Smoking harms nearly every organ of the body, causing many 
diseases and reducing the health of smokers in general. Cancer, 
the second leading cause of death, was among the first diseases 
causally linked to smoking. Approximately 8.6 million Americans 
suffer from chronic illnesses related to smoking. Smoking also 
increases the prevalence of cardiovascular and respiratory 
disease. Smokeless tobacco use has also negatively affected the 
health of many Americans. According to the National Cancer 
Institute, smokeless tobacco contains 28 carcinogens and 
consumers of smokeless tobacco products increase their risk for 
certain cancers, including oral cancer.
    In addition to the lives lost to tobacco, the financial 
losses amount to billions of dollars. CDC estimates that 
cigarette smoking costs more than $167.5 billion annually, 
based on lost productivity ($92 billion) and healthcare 
expenditures ($75.5 billion).
    The Food and Drug Administration made its first attempt to 
address the public health concerns associated with tobacco use 
in 1996. On August 28, 1996, FDA asserted jurisdiction over 
tobacco products under authority of the FFDCA and issued a 
final rule aimed at reducing underage smoking and use of 
smokeless tobacco products. The tobacco industry challenged 
this rule in court, claiming that FDA had exceeded its 
authority. A resulting Supreme Court decision in 2000, while 
acknowledging that tobacco use posed ``perhaps the single most 
significant threat to public health in the United States,'' 
found that Congress had not given FDA authority over tobacco 
products as part of the FFDCA.
    H.R. 1108 gives FDA explicit authority over tobacco 
products in a new chapter of the FFDCA relating solely to 
tobacco and authorizes FDA to regulate tobacco products ``as 
appropriate for the protection of the public health.'' This new 
standard is more appropriate for inherently dangerous tobacco 
products than the standards of ``safe'' or ``safe and 
effective,'' which apply to other FDA-regulated products.
    Almost 80 percent of new users of tobacco products began 
when they were under the minimum legal age to purchase them. 
The use of tobacco products by the Nation's children is a 
pediatric disease of considerable proportions that results in 
new generations of tobacco-dependent children. Every day, 
approximately 4,000 youth try a cigarette for the first time, 
and another 1,000 will become new, regular daily smokers. One-
third of these youth will eventually die prematurely as a 
result. Tobacco advertising and marketing contribute 
significantly to the use of tobacco products by children and 
adolescents, who are more influenced by tobacco marketing than 
adults, and are exposed to substantial and unavoidable 
advertising that leads to favorable attitudes about tobacco 
use. Past efforts to restrict the advertising and marketing of 
tobacco products to youth have failed to adequately curb 
tobacco use by adolescents. H.R. 1108 provides FDA with the 
authority it needs to promulgate comprehensive restrictions on 
the sale, promotion, and distribution of tobacco products, 
actions that most public health experts agree can significantly 
reduce the number of people who start to use tobacco and 
significantly increase the number of people who quit using 
tobacco.
    H.R. 1108 also grants FDA the authority to strictly 
regulate so-called ``reduced harm'' products and to prohibit 
unproven health claims by tobacco product manufacturers. This 
legislation prohibits the use of descriptors such as ``light,'' 
``mild,'' and ``low'' to characterize the level of a substance 
in a product in labels or in advertising. As the National 
Cancer Institute found, these descriptors have led consumers to 
believe mistakenly that the products are less harmful than 
other tobacco products. The National Cancer Institute also 
found that these mistaken beliefs can reduce the motivation to 
quit smoking.
    The current lack of Government regulation has allowed the 
tobacco industry to design new products or modify existing ones 
in ways that increase their appeal to children and that 
contribute to the risk and incidence of disease. Flavors and 
product modification not only make the products more appealing 
to youth, but often result in exposure to additional 
carcinogens and other toxic constituents. The manipulation of 
nicotine and other chemical levels increases addictiveness and 
harm. H.R. 1108 grants FDA the authority to require product 
changes in current and future tobacco products, such as the 
reduction or elimination of harmful ingredients, additives, and 
constituents (including smoke constituents). In addition, H.R. 
1108 requires manufacturers to provide detailed disclosure of 
ingredients, nicotine levels, and harmful smoke constituents.
    The current Surgeon General warnings on tobacco products 
are ineffective in providing adequate warnings about the 
dangers of tobacco products. This legislation requires stronger 
and more specific health warnings immediately upon enactment 
and gives FDA the authority to enlarge them further and to 
incorporate color graphics.
    For too long, the tobacco industry in the United States has 
escaped the type of ordinary product regulation that applies to 
most other consumer products. This legislation levels the 
playing field with respect to tobacco products so that public 
health may be protected and improved.

                                Hearings

    The Subcommittee on Health held a legislative hearing on 
H.R. 1108 on October 3, 2007. The Subcommittee heard from two 
panels of witnesses and experts. The first panel consisted of 
Fred Jacobs, M.D., J.D., Commissioner, New Jersey Department of 
Health and Senior Services; and Richard J. Bonnie, L.L.B., John 
S. Battle Professor of Law and Director, Institute of Law, 
Psychiatry and Public Policy, University of Virginia, Chair, 
Committee on Reducing Tobacco Use: Strategies, Barriers, and 
Consequences, Institute of Medicine. The second panel consisted 
of Risa Lavizzo-Mourey, M.D., M.B.A., President and CEO, Robert 
Wood Johnson Foundation; Scott Ballin, J.D., Steering Committee 
Member, Alliance for Health Economic and Agricultural 
Development; Mr. James Winkler, General Board of Church and 
Society, United Methodist Church; Mr. Henry Armour, President 
and CEO, National Association of Convenience Stores; Alan Blum, 
M.D., Professor, Wallace Endowed Chair, Director, Center for 
the Study of Tobacco and Society, College of Community Health 
Sciences, The University of Alabama; William Corr, Executive 
Director, Campaign for Tobacco Free Kids; and Jack E. 
Henningfield, Ph.D., Vice President, Research and Health Policy 
Pinney Associates.

                        Committee Consideration

    On Thursday, March 6, 2008, the Subcommittee on Health met 
in open markup session and considered H.R. 1108. On Tuesday, 
March 11, 2008, the Subcommittee reconvened in open markup 
session and favorably forwarded the bill, amended, to the full 
Committee for consideration, by a record vote. On Wednesday, 
April 2, 2008, the full Committee met in open markup session 
and ordered H.R. 1108 favorably reported to the House, amended, 
by a record vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. A 
motion by Mr. Dingell to order H.R. 1108 favorably reported to 
the House, amended, was agreed to by a record vote of 38 yeas 
and 12 nays. The following are the recorded votes taken on the 
motion and amendments, including the names of those Members 
voting for and against:


         Statement of General Performance Goals and Objectives

    The objectives of H.R. 1108 are to provide the Secretary 
with the proper authority over tobacco products in order to 
protect the public health and to reduce the number of 
individuals under 18 years of age who use tobacco products.

                      Committee Oversight Findings

    Regarding clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Subcommittee on Health held a 
legislative hearing on H.R. 1108, and the oversight findings of 
the Committee regarding the bill are reflected in this report.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Regarding compliance with clause 3(c)(2) of rule XIII of 
the Rules of the House of Representatives, the Committee adopts 
as its own the estimate of budget authority and revenues 
regarding H.R. 1108 prepared by the Director of the 
Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974. The Committee finds that H.R. 
1108 would result in no new or increased entitlement authority 
or tax expenditures.

                  Earmarks and Tax and Tariff Benefits

    Regarding compliance with clause 9 of rule XXI of the Rules 
of the House of Representatives, H.R. 1108 does not contain any 
congressional earmarks, limited tax benefits, or limited tariff 
benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate on H.R. 
1108 prepared by the Director of the Congressional Budget 
Office pursuant to section 402 of the Congressional Budget Act 
of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate on 
H.R. 1108 provided by the Congressional Budget Office pursuant 
to section 402 of the Congressional Budget Act of 1974:
                                     U.S. Congress,
                               Congressional Budget Office,
                                     Washington, DC, June 18, 2008.
Hon. John D. Dingell,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 1108, the Family 
Smoking Prevention and Tobacco Control Act.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Julia 
Christensen.
            Sincerely,
                                           Peter R. Orszag,
                                                          Director.
    Enclosure.

H.R. 1108--Family Smoking Prevention and Tobacco Control Act

    Summary: H.R. 1108 would authorize the Food and Drug 
Administration (FDA) to regulate tobacco products, and would 
require FDA to assess fees on manufacturers and importers of 
tobacco products primarily to cover the cost of FDA's new 
regulatory activities authorized by the bill. CBO estimates 
that:
     Enacting H.R. 1108 would reduce direct spending, 
on net, by $0.3 billion over the 2009-2013 period and by $0.5 
billion over the 2009-2018 period.
     Federal revenues would decline by $0.1 billion 
over the 2009-2013 period and by $0.4 billion over the 2009-
2018 period.
     Considering both the revenue and direct spending 
effects, enacting the bill would reduce budget deficits (or 
increase surpluses) by a total of $0.2 billion over the 2009-
2013 period and $31 million over the 2009-2018 period.
     In addition, CBO estimates that implementing the 
bill would increase spending subject to appropriation by about 
$3 million over the 2009-2013 period, assuming the availability 
of the necessary funds.
    H.R. 1108 contains intergovernmental mandates as defined in 
the Unfunded Mandates Reform Act (UMRA) because it would 
preempt certain state laws governing tobacco products and 
require tribal governments that manufacture or distribute 
tobacco products to comply with new federal regulations. CBO 
estimates, however, that the costs to state, local, and tribal 
governments to comply with the mandates in the bill would be 
small and would not exceed the threshold established in UMRA 
($68 million in 2008, adjusted annually for inflation).
    CBO also expects that the federal regulations authorized by 
this bill would result in lower consumption of tobacco products 
and thus would reduce the amount of tax revenues and settlement 
funds collected by state and local governments. However, those 
declines in revenues, estimated to total more than $1.1 billion 
during the 2009-2013 period, would not result from 
intergovernmental mandates.
    A decline in smoking among pregnant individuals is expected 
to result in healthier birth outcomes. CBO therefore estimates 
that state spending for Medicaid would decrease by about $14 
million over the 2009-2013 period.
    H.R. 1108 would impose a number of mandates on private-
sector entities. Among other things, the bill would assess a 
fee on companies that manufacture or import tobacco products, 
impose new restrictions on the sale, distribution, and 
marketing of tobacco products, mandate disclosure of product 
information, and grant FDA authority to regulate tobacco 
products. CBO estimates that the aggregate direct cost of 
complying with those mandates would exceed the threshold 
established by UMRA for private-sector mandates ($136 million 
in 2008, adjusted annually for inflation) in fiscal year 2009 
and in each subsequent year.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of H.R. 1108 is shown in the following table. 
The costs of this legislation fall primarily within budget 
functions 370 (commerce and housing credit) and 550 (health).
    Basis of estimate: For this estimate, CBO assumes that H.R. 
1108 will be enacted near the start of fiscal year 2009, that 
the full amounts authorized will be collected (starting in 
fiscal year 2009) to fund FDA's regulatory activities 
authorized under the bill, and that outlays will follow 
historical patterns for similar activities.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             By fiscal year, in millions of dollars--
                                         ---------------------------------------------------------------------------------------------------------------
                                            2009     2010     2011     2012     2013     2014     2015     2016     2017     2018   2009-2013  2009-2018
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               CHANGES IN DIRECT SPENDING

Collection of New Fees:\1\
    Estimated Budget Authority..........     -249     -477     -506     -535     -566     -600     -635     -673     -712     -755     -2,333     -5,708
    Estimated Outlays...................     -249     -477     -506     -535     -566     -600     -635     -673     -712     -755     -2,333     -5,708
Spending of Fees by FDA to Regulate
 Tobacco Products:
    Estimated Budget Authority..........      235      450      477      505      534      566      599      635      672      712      2,201      5,385
    Estimated Outlays...................       50      275      498      610      619      627      629      631      668      708      2,052      5,315
Medicaid:
    Estimated Budget Authority..........       -1       -2       -4       -6       -8       -9      -11      -13      -14      -16        -19        -82
    Estimated Outlays...................       -1       -2       -4       -6       -8       -9      -11      -13      -14      -16        -19        -82
    Total Changes:
        Estimated Budget Authority......      -15      -29      -33      -36      -40      -43      -47      -51      -54      -59       -151       -405
        Estimated Outlays...............     -200     -204      -12       69       45       18      -17      -55      -58      -63       -302       -477

                                                                   CHANGES IN REVENUES

Estimated Revenues......................       -6      -14      -23      -31      -40      -49      -58      -67      -75      -83       -114       -446
                                                           NET IMPACT ON THE FEDERAL BUDGET\2\

Estimated Net Effect\3\.................     -194     -190       11      100       85       67       41       12       17       20       -188        -31
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes: FDA = Food and Drug Administration. Components may not sum to totals because of rounding.
\1\H.R. 1108 would specify that assessments on manufacturers and importers of tobacco products be recorded in the federal budget as offsetting receipts
  (a credit against direct spending).
\2\In addition to the direct spending and revenue effects shown in the table, CBO estimates that implementing H.R. 1108 would have discretionary costs
  of about $3 million over the 2009-2013 period, assuming the availability of appropriated funds.
\3\Negative numbers indicate a reduction in the deficit (or an increase in the surplus); positive numbers indicate the opposite.

    H.R. 1108 would authorize FDA to regulate tobacco products. 
Such authority would include:
         Setting national standards for tobacco 
        products;
         Implementing new restrictions on the sale, 
        distribution, and marketing of tobacco products;
         Requiring manufacturers of certain tobacco 
        products to submit a marketing application to FDA and 
        requiring manufacturers of certain products that are 
        ``substantially equivalent'' to ones already on the 
        market before a particular date to notify FDA by 
        submitting a report with specified information before 
        entering the market;
         Directing manufacturers and importers of 
        tobacco products to adhere to new labeling requirements 
        and to submit specific information, including health-
        related research, to the FDA about their products;
         Mandating the annual registration of all 
        establishments that manufacture, prepare, compound, or 
        process tobacco products and specifying certain 
        inspection, recordkeeping and reporting requirements 
        for manufacturers and importers; and
         Enforcing compliance with requirements 
        specified in the bill.
    H.R. 1108 would establish the Center for Tobacco Products 
within the FDA. It also would require FDA to reinstate certain 
regulations issued in 1996 intended to limit tobacco sales and 
marketing, especially to children. (The Supreme Court ruled in 
2000 that the FDA did not have the authority to issue such 
regulations.) The bill explicitly would prohibit FDA from 
banning certain tobacco products or requiring the reduction of 
nicotene yields of tobacco products to zero. The legislation 
also would mandate that FDA issue new regulations relating to 
the testing and reporting of tobacco product information. Such 
regulations may also include public disclosure requirements. 
Among other things, H.R. 1108 would require the Secretary of 
Health and Human Services (HHS) to publish a list of the 
amounts of harmful and potentially harmful constituents of each 
tobacco product.

Impact of FDA regulation of tobacco on the use of tobacco products in 
        the United States

    CBO estimates that consumption of tobacco products in the 
United States would decline as a result of enacting H.R. 1108. 
The expected effect of the legislation on the use of tobacco 
products stems from a combination of regulatory and economic 
factors. The regulatory changes with the largest potential to 
reduce smoking include: restricting access to tobacco by 
youths, requiring an increase in the size of warning labels on 
certain tobacco packaging (and authorizing the Secretary of HHS 
to mandate further changes to augment warning labels), limiting 
certain marketing and advertising activities (especially those 
that target youths), and requiring FDA permission before 
manufacturers can market tobacco products that suggest reduced 
health risks or exposure to particular substances.\1\ In 
addition, tobacco consumption would decline because the 
assessment of new fees on manufacturers and importers of 
tobacco products would probably result in higher prices of 
tobacco products.
---------------------------------------------------------------------------
    \1\For example, pursuant to a timeline specified in the bill, 
descriptors on a tobacco product such as ``low,'' ``light,'' or 
``mild'' would be prohibited and certain health-related claims not 
allowed unless manufacturers receive FDA's permission to market the 
product with that claim. Sponsors of the so-called ``modified risk 
products'' would have to prove to FDA's satisfaction that they would 
reduce harm to individuals and produce certain benefits to the public 
health, and comply with other requirements in the bill.
---------------------------------------------------------------------------
    The effect of regulatory activities authorized under the 
bill on the use of tobacco products is uncertain because 
ongoing initiatives to reduce the use of tobacco products are 
expected to continue under current law. Public health efforts 
by federal, state, and local governments and private entities 
have contributed to a substantial reduction in underage smoking 
in recent years. For example, the proportion of 17 year-olds 
who smoke declined from 19 percent in 1995 to 10 percent in 
2005. Significant efforts to reduce underage smoking (the group 
most directly targeted by many of the interventions envisioned 
under the bill) have been taken as a result of the Master 
Settlement Agreement (MSA) in 1998 between major tobacco 
manufacturers and settling states. States and localities also 
continue to pursue public health initiatives independent of the 
MSA to reduce smoking and to limit health risks to the public 
associated with smoking. (However, funding for such activities 
is subject to the fiscal constraints of state and local 
budgets.) Public health efforts funded by federal programs and 
expanding coverage of smoking cessation therapies under certain 
public programs also aim to reduce the use of tobacco under 
current law.
    Based on information from academic and other researchers, 
CBO estimates that H.R. 1108 would result in a further 
reduction in the number of underage tobacco users of roughly 10 
percent. CBO also estimates that, as a consequence of this 
legislation, smoking by adults overall would decline by amounts 
reaching about 2 percent after 10 years. CBO incorporates these 
projected changes in its estimates of the impact of the bill on 
Medicaid spending and on receipts from excise taxes on tobacco 
products.

Direct spending

    CBO estimates that enacting H.R. 1108 would reduce direct 
spending, on net, by $0.3 billion over the 2009-2013 period and 
by $0.5 billion over the 2009-2018 period. The legislation 
would affect direct spending in three ways:
         Requiring FDA to assess fees on tobacco 
        manufacturers and importers primarily to cover the cost 
        of FDA's new activities related to regulating tobacco 
        products would increase mandatory offsetting receipts;
         Spending of those fees by FDA to regulate 
        tobacco products as authorized by the bill would 
        increase direct spending for such activities; and
         Authorizing FDA regulation of tobacco products 
        and changes relating to such products required by the 
        bill would lower consumption of tobacco and would 
        generate savings to the Medicaid program.
    Collection of New Fees. To fund FDA's administrative costs 
for new regulatory activities relating to tobacco products 
authorized by the bill, H.R. 1108 would require the quarterly 
assessment of fees on manufacturers and importers of such 
products approximately equal to $90.1 million in 2008, $249.1 
million in 2009, $477.0 million in 2010, $505.6 million in 
2011, $535.3 million in 2012, $566.0 million in 2013, $600.0 
million in 2014, $634.9 million in 2015, $673.1 million in 
2016, $712.3 million in 2017, and $754.7 million in 2018 and 
each subsequent year. H.R. 1108 would specify that such 
collections be recorded in the federal budget as offsetting 
receipts. (Offsetting receipts are a credit against direct 
spending.) Fees collected in excess of the amounts authorized 
to pay for FDA's administrative costs would be deposited in the 
general fund of the Treasury. For the purpose of this estimate, 
we assume that H.R. 1108 will be enacted near the start of 
fiscal year 2009; as a result, we estimate that no fees would 
be collected for fiscal year 2008.
    In total, we estimate that enacting the bill would increase 
offsetting receipts from assessments on manufacturers and 
importers of tobacco products by $2.3 billion over the 2009-
2013 period and by $5.7 billion over the 2009-2018 period.
    Spending of Fees by FDA to Regulate Tobacco Products. 
Spending of the new fees assessed by FDA to regulate tobacco 
products would be classified as direct spending because the 
authorized amounts would be available for obligation without 
further appropriation action. The bill would authorize the 
following amounts to fund FDA's costs associated with 
regulating tobacco products: $85.0 million in 2008, $235.0 
million in 2009, $450.0 million in 2010, $477.0 million in 
2011, $505.0 million in 2012, $534.0 million in 2013, $566.0 
million in 2014, $599.0 million in 2015, $635.0 million in 
2016, $672.0 million in 2017, and $712.0 million in 2018 and 
each subsequent year. Such amounts would be available for 
obligation to cover FDA's administrative costs to regulate 
tobacco products at any point in the future.
    Given the uncertainty surrounding how the FDA would 
implement such a large expansion of its regulatory activities, 
it is difficult to estimate the resources necessary--
particularly in the early years--to implement the bill. We 
anticipate that, over the initial five-year period after 
enactment, FDA would actively develop the necessary 
infrastructure to operate the new tobacco program and that its 
ability to enter into obligations and disburse funds would grow 
rapidly. (The legislation would limit the budget for the new 
program to the aggregate amount of fees collected for such 
purpose.) CBO estimates FDA's activities required by the bill 
would increase direct spending by $2.1 billion over the 2009-
2013 period and $5.3 billion over the 2009-2018 period.
    After accounting for the offsetting receipts collected from 
assessments on manufacturers and importers of tobacco products 
authorized by the bill, CBO estimates that implementing the new 
regulatory program established by the bill would reduce direct 
spending for FDA activities, on net, by almost $0.3 billion 
over the 2009-2013 period and by $0.4 billion over the 2009-
2018 period.
    Impact of FDA Regulation of Tobacco on Medicaid. CBO 
anticipates that the decline in smoking due to FDA's regulation 
of tobacco products also would reduce the number of women on 
Medicaid who smoke during pregnancy. (See the discussion of the 
effect of the bill on tobacco use in the section entitled 
``Impact of FDA Regulation of Tobacco on the Use of Tobacco 
Products in the United States.'') This reduction would lead to 
lower spending by the Medicaid program--which covers about 40 
percent of all pregnancies in the United States--because women 
who do not smoke are less likely to have miscarriages, 
experience complications during pregnancy, and give birth to 
children with low birth weights.
    A variety of research indicates that children with low 
birth weights have higher medical costs, particularly at birth, 
but also later in life. Savings of some such costs would be 
partly offset by higher costs for additional live births 
because of the decline in miscarriages. On net, CBO estimates 
that FDA's regulation of tobacco products would reduce federal 
Medicaid spending by $19 million over the 2009-2013 period and 
by $82 million over the 2009-2018 period.
    Other Effects on Direct Spending. Under H.R. 1108, FDA 
would have the discretion to impose criminal fines on entities 
convicted of violating certain new requirements established by 
the bill. Collections of criminal fines are recorded in the 
budget as revenues, deposited in the Crime Victims Fund, and 
later spent. Such expenditures are classified as direct 
spending. CBO expects that relatively few cases would result in 
such criminal fines. Therefore, CBO estimates that enacting 
H.R. 1108 would not have a significant effect on direct 
spending from the collection of criminal fines over the 2009-
2018 period.

Revenues

    CBO estimates that enacting H.R. 1108 would decrease 
federal revenues, on net, by $0.1 billion over the 2009-2013 
period and by $0.4 billion over the 2009-2018 period. That 
estimate reflects two effects of the bill:
           Authorizing FDA oversight of tobacco 
        products and changes relating to such products required 
        by the bill would lower consumption of tobacco and 
        reduce receipts of federal excise taxes on those 
        products, and
           Fines associated with violations of certain 
        new requirements imposed by the bill would be recorded 
        as revenues in the federal budget.
    Excise Taxes. CBO expects that enacting H.R. 1108 would 
reduce the consumption of tobacco products in the United 
States, which in turn would reduce the collection of federal 
excise taxes. As a result, CBO estimates that the legislation 
would reduce federal revenues by $0.1 billion over the 2009-
2013 period and $0.5 billion over the 2009-2018 period, net of 
increases to income and payroll taxes. Over the 10-year period, 
the reduction in receipts would amount to less than 1 percent 
of receipts from excise taxes on tobacco expected under current 
law.
    Collection of Fines. The effects on federal revenues also 
include relatively small effects from provisions that would 
allow the Secretary of HHS to levy fines against sponsors of 
misbranded and adulterated tobacco products, sellers of tobacco 
to underage individuals, and for other violations. The Federal 
Trade Commission (FTC) would also be authorized to assess fines 
for certain violations of tobacco-related requirements enforced 
by the commission. We estimate that revenues associated with 
the collection of fines authorized under H.R. 1108 would be 
roughly $1 million annually.
    Effects of Fees on Taxes. The imposition of fees to fund 
FDA's activities under the bill would have the effect of 
reducing collections from federal corporate, individual, and 
payroll taxes. This would result from the effect of the fees on 
taxable income. The resulting reduction in federal receipts 
would be approximately 25 percent of the fee imposed. However, 
because the legislation designates the fee as an ``offsetting 
receipt,'' this effect is not included in the estimate pursuant 
to longstanding Congressional scorekeeping procedures.

Spending subject to appropriation

    CBO estimates that implementing H.R. 1108 would increase 
spending subject to appropriation by about $3 million over the 
2009-2013 period for the FTC and the Government Accountability 
Office (GAO) to conduct studies required by the bill, assuming 
the availability of the necessary funds. The costs for FDA to 
administer the new regulatory activities authorized under H.R. 
1108 would be covered by fees assessed on manufacturers and 
importers of tobacco products, would not be subject to 
appropriation, and therefore are classified as direct spending. 
We expect that the legislation would not have a significant 
effect on spending by other federal programs whose funding is 
subject to appropriation.
    Federal Trade Commission. The bill would authorize the FTC 
to enforce provisions in the bill relating to advertising that 
would be considered unfair or deceptive trade practices under 
the Federal Trade Commission Act. Currently, the FTC enforces 
certain laws governing warnings printed on labels of cigarettes 
and smokeless tobacco, among other things. H.R. 1108 would 
transfer some of that regulatory authority to FDA. Based on 
information from the FTC, CBO expects that any additional costs 
incurred by the FTC to enforce the new requirements would be 
offset by savings that result from transferring some of the 
FTC's current authority to FDA. In addition, the bill would 
require that the FTC conduct a study on the tobacco industry 
and issue two separate reports within 10 years of enactment. 
Over the 2009-2013 period, CBO estimates that completing the 
first report would cost about $2 million, assuming the 
availability of the necessary funds.
    Other Provisions. H.R. 1108 would require GAO to conduct 
two studies: one on cross-border trade in tobacco products and 
one on the use of tobacco products by youth and certain issues 
related to the fee program. CBO estimates that conducting such 
studies would cost roughly $1 million, assuming the 
availability of the necessary funds. CBO also anticipates that 
any additional costs for other federal agencies that might 
assist FDA with implementing certain requirements under the 
bill would not be significant.
    Estimated impact on state, local, and tribal governments: 
H.R. 1108 contains intergovernmental mandates as defined in 
UMRA. CBO estimates that the costs of those mandates to state, 
local, and tribal governments would be small and would not 
exceed the threshold established in UMRA ($68 million in 2008, 
adjusted annually for inflation).
    The bill would preempt state laws governing tobacco 
products that are different from or in addition to the federal 
regulations authorized by the bill, including laws governing:
           Product standards
           Premarket review
           Adulteration
           Misbranding
           Labeling
           Registration
           Good manufacturing standards, or
           Modified-risk tobacco products.
    That preemption would be an intergovernmental mandate as 
defined in UMRA. However, because the preemption would simply 
limit the application of state and local laws, CBO estimates 
that it would not impose significant costs on state or local 
governments.
    H.R. 1108 would require manufacturers of tobacco products 
to register annually with FDA and pay fees assessed by the 
agency. The bill would require both manufacturers and 
distributors of tobacco products to comply with federal 
regulations relating to the content, labeling, and marketing of 
those products. CBO has identified two tribal governments that 
manufacture and distribute tobacco products. Because those 
governments would be required to comply with federal 
regulations authorized by the bill, they would face 
intergovernmental mandates as defined in UMRA. Based on 
information from tribal and federal officials, CBO estimates 
that the costs to tribal governments to comply with the bill 
would be small and would not exceed the threshold for 
intergovernmental mandates ($68 million in 2008, adjusted 
annually for inflation).

Other impacts

    CBO also estimates that the federal regulations authorized 
by this bill would result in lower consumption of tobacco 
products and thus would reduce the amount of tax revenues and 
settlement funds collected by state and local governments. 
However, those declines in revenues, estimated to total more 
than $1.1 billion during the 2009-2013 period, would not result 
from intergovernmental mandates.
    In 2006, state and local governments collected about $20 
billion in revenues from excise and general sales taxes levied 
on tobacco products. CBO estimates that this bill would lower 
consumption of those products and that excise taxes collected 
by state and local governments would fall by about $20 million 
in 2009, with that reduction growing to almost $340 million 
2013. Similarly, CBO estimates that state and local governments 
would see a decline in sales-tax revenues of about $190 million 
over the 2009-2013 period.
    Forty-six states, the District of Columbia, and five U.S. 
territories receive annual payments from tobacco manufacturers 
that are parties to the tobacco Master Settlement Agreement. In 
2006, those payments totaled over $7 billion. Under the terms 
of the MSA, those payments are adjusted annually to account for 
changes in the volume of cigarette sales in the United States 
of participating manufacturers. Because CBO estimates that 
enacting this legislation would result in lower consumption of 
tobacco products, CBO estimates that the annual payments to 
states under the MSA also would decline by over $155 million 
over the 2009-2013 period.
    A decline in smoking among pregnant individuals is expected 
to result in healthier birth outcomes under the bill. CBO 
therefore estimates that state spending for Medicaid would 
decrease by about $14 million over the 2009-2013 period.
    Estimated impact on the private sector: H.R. 1108 would 
impose a number of private-sector mandates, as defined in UMRA, 
on companies that manufacture or import tobacco products. CBO 
estimates that the total direct cost of these mandates would 
exceed the threshold established by UMRA ($136 million in 2008, 
adjusted annually for inflation) in fiscal year 2009 and in 
each subsequent year.
    The bill would assess a fee on manufacturers and importers 
of tobacco products to cover the cost to FDA of regulating 
those products. The aggregate payments would be approximately 
equal to $249.1 million in fiscal year 2009, $477.0 million in 
fiscal year 2010, $505.6 million in fiscal year 2011, $535.3 
million in fiscal year 2012, and $566.0 million in fiscal year 
2013.
    The bill would impose new requirements related to the 
labeling and advertising of cigarette and smokeless tobacco 
products. New warnings on packaging and advertisements would 
have to be larger. The bill would also prohibit cigarettes or 
any of their component parts from containing certain additives 
or artificial or natural flavors (other than tobacco or 
menthol) that are a characterizing flavor of the tobacco 
product or tobacco smoke. CBO has not been able to determine 
whether the direct cost of these provisions would be 
significant.
    The bill would require that FDA publish a final rule on 
tobacco products that would be similar to part 897 of the 
tobacco regulations promulgated by the Secretary of HHS in 1996 
and subsequently invalidated by the Supreme Court. Many 
restrictions that would be in that rule already exist under 
current federal and state law or are included in the 1998 
Master Settlement Agreement between major tobacco manufacturers 
and settling states. As a result, and based on information from 
industry sources, CBO estimates that the incremental direct 
cost of these restrictions to manufacturers and importers of 
tobacco products would be small.
    In addition, the bill would give FDA the authority to 
regulate the sale, distribution, advertising, promotion, and 
use of tobacco products if such actions would be in the 
interest of the public health. FDA would also have the 
authority to set product standards that reduce quantities of 
nicotine and other harmful constituents or otherwise alter the 
composition and testing of tobacco products. CBO cannot 
estimate the potential cost of these provisions because we have 
no basis for predicting how they would be implemented.
    Finally, the bill would require that companies that 
manufacture or import tobacco products disclose information to 
the Secretary of HHS about those products. That information, 
among other things, would include a listing of all ingredients 
and additives, a description of nicotine content, delivery, and 
form, and a listing of all potentially harmful constituents 
found in the tobacco product. Required information would also 
include any and all documents regarding research on risks to 
health of tobacco products, methods for reducing those risks, 
and the effectiveness of marketing practices. used by companies 
that manufacture or distribute tobacco products. Such 
information would include both research activities and the 
findings associated with that research. CBO estimates that the 
direct cost of complying with these requirements would be 
small.
    Previous CBO estimate: On January 30, 2008, CBO transmitted 
a cost estimate for S. 625, the Family Smoking Prevention and 
Tobacco Control Act, as ordered reported by the Senate 
Committee on Health, Education, Labor, and Pensions on August 
1, 2007. CBO estimated that enacting S. 625 would have no net 
budgetary impact over the 2009-2018 period, considering both 
the effects on revenue and direct spending. The difference in 
the estimates reflects differences in the bills.
    Estimate prepared by: Federal Spending: Food and Drug 
Administration--Julia Christensen, Medicaid--Robert Stewart, 
Federal Trade Commission--Susan Willie, Federal Revenues: 
Andrew Langan; Impact on State, Local, and Tribal Governments: 
Lisa Ramirez-Branum; Impact on the Private Sector: Patrick 
Bernhardt.
    Estimate approved by: G. Thomas Woodward, Assistant 
Director for Tax Analysis; Keith J. Fontenot, Deputy Assistant 
Director for Health and Human Resources, Budget Analysis 
Division.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates regarding H.R. 1108 prepared by the Director of the 
Congressional Budget Office pursuant to section 423 of the 
Unfunded Mandates Reform Act.

                      Advisory Committee Statement

    Regarding section 5(b) of the Federal Advisory Committee 
Act, H.R. 1108 requires the establishment of an advisory 
committee regarding tobacco products. See section 917 in the 
chapter IX that section 101(b) of the bill adds to the Federal 
Food, Drug, and Cosmetic Act. The Committee finds that 
establishing the advisory committee is the most efficient way 
of carrying out the policies involved.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for H.R. 1108 is provided in Article 
I, section 8, clause 3, which grants Congress the power to 
regulate commerce with foreign nations, among the several 
States, and with the Indian Tribes, and in the provisions of 
Article I, section 8, clause 1, that relate to expending funds 
to provide for the general welfare of the United States.

                  Applicability to Legislative Branch

    The Committee finds that H.R. 1108 does not relate to the 
terms and conditions of employment or access to public services 
or accommodations within the meaning of section 102(b)(3) of 
the Congressional Accountability Act of 1995.


             Section-by-Section Analysis of the Legislation


Section 1. Short title; table of contents

    The short title is designated as the ``Family Smoking 
Prevention and Tobacco Control Act''. This section also 
includes the Act's table of contents.

Section 2. Findings

    Section 2 provides findings relating to tobacco use in the 
United States and the need for regulation.
    A number of the findings included in the legislation 
address the constitutionality of the legislation. The Committee 
finds that the legislation is fully consistent with the First 
Amendment of the U.S. Constitution. Specifically, the 
reasonable restrictions on advertising and promotion of tobacco 
products are both necessary and narrowly tailored to protect a 
compelling Federal interest.
    In finding 31, Congress finds that the regulations 
promulgated by the Secretary of Health and Human Services in 
August 1996 and described in finding 30 will directly and 
materially advance the Federal Government's substantial 
interest in reducing the number of children and adolescents who 
use cigarettes and smokeless tobacco and in preventing the 
life-threatening health consequences associated with tobacco 
use. This is based on the evidence cited by FDA in support of 
the 1996 regulation referenced in finding 30 and on numerous 
studies that have been conducted since 1996. For example, 
several studies have shown that exposure to tobacco advertising 
substantially increases the likelihood that children and 
adolescents will smoke. One such study, published in 1996 in 
the Archives of Pediatrics and Adolescent Medicine, found that 
tobacco marketing doubles the odds that children under 18 years 
of age will become tobacco users. Additionally, a 2002 study 
published in the Archives of Pediatrics and Adolescent Medicine 
and a 1998 study published in the Journal of the American 
Medical Association showed that the greatest impact was on 
influencing non-susceptible youth to become susceptible to 
smoking, though at least one study, published in 2006 in the 
Archives of Pediatrics and Adolescent Medicine, also showed 
that tobacco marketing leads children who already smoke to 
smoke more heavily. Even before some of the more recent studies 
were conducted, the National Cancer Institute found in 2001, 
based on a review of then existing research, that ``the 
conclusion that there is a causal relationship between tobacco 
marketing and smoking initiation seems unassailable.''
    In finding 31, Congress also finds that less restrictive 
and less comprehensive approaches have not been and will not be 
effective in reducing the problems addressed by the regulations 
described in finding 30. For example, the Master Settlement 
Agreement (MSA) between the States and some of the major 
tobacco companies has been in effect since 1998. The Centers 
for Disease Control and Prevention has found that the 
percentage of high school students who smoke increased from 
21.9 percent in 2003 to 23 percent in 2005. The rates are 
particularly alarming given all the State excise tax increases, 
prevention and cessation programs, and smokefree air laws, 
which cumulatively should have forced youth smoking rates down 
below the current level.
    In finding 31, Congress also finds that reasonable 
restrictions on the advertising and promotion of tobacco 
products contained in the 1996 regulation will lead to a 
significant decrease in the number of minors using and becoming 
addicted to those products. This too is based on the evidence 
cited by FDA in support of the 1996 regulation and on more 
recent studies and findings. For example, an article in the 
Archives of Pediatrics and Adolescent Medicine, published just 
last year, found that restricting retail marketing practices 
would reduce youth smoking.
    In finding 32, Congress finds that the regulations 
described in paragraph 30 impose no more extensive restrictions 
on communication by tobacco manufacturers and sellers than are 
necessary to reduce the number of children and adolescents who 
use cigarettes and smokeless tobacco and to prevent the life-
threatening health consequences associated with tobacco use. 
The regulation is carefully tailored to focus on the types of 
advertising that will have the greatest impact on youth. The 
requirements are tailored to allow companies to advertise to 
adults in ways that provide information on what they are 
selling, for what reason, and for what price. There are no 
limits on print advertising in publications with adult 
readership and adult establishments, such as bars.

Section 3. Purpose

    Section 3 provides the purpose of the bill, which is to 
provide authority to the Food and Drug Administration to 
regulate tobacco products under the Federal Food, Drug, and 
Cosmetic Act. FDA would be given authority to set national 
product standards; ensure effective oversight; regulate the 
levels of tar, nicotine, and other harmful components of 
tobacco products as appropriate for the protection of the 
public health; require tobacco product manufacturers to 
disclose research; continue to permit the sale of tobacco 
products to adults; promote cessation; and strengthen 
protections against illicit trade in tobacco products.

Section 4. Scope and effect

    Section 4 states that nothing in this Act shall be 
construed to establish a precedent with regard to any other 
industry or affect any pending court action. This Act is also 
not intended to affect the authority of the Secretary of 
Agriculture regarding raw tobacco nor is it intended to affect 
any authority of the Secretary of the Treasury.

Section 5. Severability

    Section 5 states that if any provision of this Act is held 
to be invalid, the remainder of this Act shall not be affected 
and shall continue to be enforced.

         Title I. Authority of the Food and Drug Administration


Section 101. Amendment of Federal Food, Drug, and Cosmetic Act

            Chapter IX (in the FFDCA)--Tobacco products
    The bill creates a new chapter within the FFDCA to regulate 
tobacco products.

Section 900. Definitions

    Section 900 defines the following terms: additive; brand; 
cigarette; cigarette tobacco; commerce; counterfeit tobacco 
product; distributor; illicit trade; Indian tribe; little 
cigar; nicotine; package; retailer; roll-your-own tobacco; 
small tobacco product manufacturer; smoke constituent; 
smokeless tobacco; State, territory; tobacco product 
manufacturer; tobacco warehouse; and United States.
    The Committee notes that ``small tobacco product 
manufacturer'' (STPM) is defined. The Committee believes that 
an entity that qualifies as an STPM has access to fewer 
economic resources and, therefore, needs the special 
considerations provided for STPMs in certain portions of the 
Act [e.g., Sec. 901(f) and Sec. 906(e)(1)(B)(v)]. Accordingly, 
the term ``employees'' includes not only those persons 
considered employees under labor or tax laws, but also any 
other person working full-time for a manufacturer doing the 
work of a regular employee (e.g., under a services contract or 
consulting agreement). Without this understanding of the term 
``employee,'' some manufacturers would be able to qualify 
wrongfully as STPMs by replacing a number of their formal 
employees with consultants or contract workers or by changing 
their relationships with existing workers from a formal 
employer-employee relationship to an independent contractor 
relationship. The Food and Drug Administration should review 
annually the documentation of any company that qualifies as a 
small manufacturer to ensure that the number of its employees, 
taking into account employees of each entity it controls, is 
controlled by or is under common control, does not exceed 350. 
For purposes of determining the number of employees under the 
preceding sentence, the employees of a company that owns, has a 
substantial ownership interest in, or is owned by such 
manufacturer shall be included.

Section 901. FDA authority over tobacco products

    Section 901(c) limits the scope of FDA's authority to 
regulate manufacturers of tobacco products, making clear that 
FDA does not have the authority to regulate tobacco growers. If 
a producer of tobacco leaf, however, is also a tobacco product 
manufacturer, the producer shall be subject to regulation in 
the producer's capacity as a manufacturer. The Committee notes 
that the phrase ``in the producer's capacity as a 
manufacturer'' refers to the actual process of manufacturing a 
tobacco product. While it covers a tobacco cooperative that 
operates as a tobacco product manufacturer, it does not refer 
to a tobacco producer who merely sells raw tobacco to a tobacco 
cooperative which operates a tobacco product manufacturing 
facility or to a tobacco producer who merely serves on the 
board of directors of such a cooperative.
    Section 901(e) directs FDA to establish a separate Center 
for Tobacco Products.
    Section 901(f) directs FDA to establish an Office to Assist 
Small Manufacturers of Tobacco Products to provide technical 
assistance to small manufacturers in complying with the 
requirements of this Act.

Section 902. Adulterated tobacco products

    Section 902 lays out guidelines for determining whether 
tobacco products are adulterated. Filthy, decomposed, or 
otherwise contaminated substances in tobacco products, the 
preparation of such products, or the packaging of such products 
will cause them to be deemed adulterated. Tobacco products held 
under unsanitary conditions or manufactured, packed, or stored 
in violation of good manufacturing practices will likewise be 
deemed adulterated. A tobacco product will also be deemed 
adulterated if the manufacturer of it fails to pay required 
user fees, if it does not meet the product standards 
established for the product, or if the product is required to 
have premarket review and an order in effect under section 910 
or to have an order in effect as a modified risk product under 
section 911 and does not have such an order in effect.

Section 903. Misbranded tobacco products

    Section 903(a) states that tobacco products will be deemed 
misbranded if their label is false or misleading, if they are 
not correctly labeled (e.g., with the percentage of 
domestically grown versus foreign tobacco, proper warning 
labels, the name of the manufacturer, or in accordance with 
other requirements of the Secretary) or advertised, or if the 
manufacturing, distribution, or selling of the product does not 
comply with other parts of the Act.
    Section 903(b) provides that the Secretary is specifically 
authorized to require prior approval of statements made on the 
label of a tobacco product.

Section 904. Submission of health information to the Secretary

    Section 904(a) requires, within six months of passage, 
submission to the Secretary by brand and quantity of 
ingredients, compounds, substances, and additives that are 
added to the tobacco, paper, filter, or other part of the 
tobacco product. This section also requires a description of 
the content, delivery, and form of nicotine, as well as 
documents developed after enactment that relate to health, 
toxicological, behavioral, or physiologic effects of tobacco 
products. This information is required of all current tobacco 
products as well as any tobacco products introduced after 
enactment. Further, three years after enactment, a list of 
constituents, including smoke constituents, identified by the 
Secretary as harmful or potentially harmful, is required to be 
submitted to the Secretary.
    Section 904(b) provides the Secretary with the authority to 
request documents and information relating to research 
activities and findings, scientific information on reduced risk 
products/technology, and marketing research. This provision 
applies to both foreign and domestic manufacturers.
    Section 904(c) requires a written notice to the Secretary 
at least 90 days prior to marketing if a tobacco manufacturer 
adds a new additive to their product or increases the amount of 
an additive. This section requires a written notice to the 
Secretary at least 60 days prior to marketing if a tobacco 
manufacturer eliminates or decreases an existing additive.
    Section 904(d)(1) requires within three years of passage, 
and annually thereafter, the Secretary must publish in an 
easily available and understood format a list of harmful and 
potentially harmful constituents in each brand.
    Section 904(d)(2) requires the Secretary to also conduct 
consumer research to ensure that publication of the list is not 
misleading to lay persons. After 5 years, the Secretary must 
report to Congress on the results of the consumer research, and 
provide a recommendation on whether or not publication of the 
list should continue or be modified.

Section 905. Annual registration

    Section 905 requires registration of every entity that owns 
or operates in any State any establishment engaged in the 
manufacture, preparation, compounding, or processing of tobacco 
products. The same requirement extends to foreign 
establishments. At the time of this registration, a listing is 
required of all tobacco products, which are being manufactured, 
prepared, compounded, or processed. Once registered, every 
establishment is subject to an inspection once every two years.
    Section 905(e) allows the Secretary to create a uniform 
system for identification of tobacco products.
    Section 905(j) requires a report to the Secretary 90 days 
prior to the introduction of a new tobacco product 
demonstrating that the product is substantially equivalent to a 
tobacco product already on the market and therefore not subject 
to premarket review. If the new product is not substantially 
equivalent to a product already on the market, the new product 
must be reviewed pursuant to Section 910. Section 905(j) 
requires reports on products first marketed between February 
16, 2007, and 21 months after enactment. Additionally, section 
905(j) authorizes the Secretary to issue regulations creating 
exemptions from premarket notification for minor modifications 
of existing products or where otherwise appropriate.

Section 906. General provisions respecting control of tobacco products

    Section 906(b) provides for notice and comment rulemaking.
    Section 906(c) ensures limited confidentiality of certain 
information reported to the Secretary. Section 906(d) 
authorizes the Secretary to issue regulations restricting the 
sale and distribution of tobacco products, including access to, 
advertising, and promotion of tobacco products, if the 
Secretary determines that the regulations would be appropriate 
to protect the public health, taking into account factors 
specified in the provision.
    Advertising and promotion restrictions are permitted to the 
full extent consistent with the First Amendment. The Committee 
notes Section 906(d) authorizes the Secretary to impose 
restrictions on the advertising and promotion of tobacco 
products within retail establishments that limit admittance to 
persons over age 18 where the Secretary finds that such 
restrictions would be ``appropriate for the protection of the 
public health,'' based on the factors laid out in Section 
906(d)(1)(A) and (B), and where consistent with the First 
Amendment to the Constitution.
    Section 906(d) does not permit the Secretary to prohibit 
the face-to-face sale of any tobacco product by a specific 
category of retail outlets, or to establish a national minimum 
age of greater than 18 years to purchase tobacco products. 
Section 906(d) requires the Secretary, however, to regulate the 
sale, distribution, promotion, and marketing of tobacco 
products that are sold through means other than a direct, face-
to-face exchange. Section 906(d) permits advertising on 
conventional matchbooks to the extent permitted in adult 
publications, unless the Secretary determines that such 
treatment of matchbooks is not appropriate for the protection 
of the public health.
    Section 906(e) allows for regulations requiring that 
tobacco products conform to specified good manufacturing 
practices or hazard analysis and critical control point 
methodology (with input from the public and interested parties, 
and from the Tobacco Products Scientific Advisory Committee). 
This section exempts small tobacco manufacturers from the above 
requirements for at least four years following the effective 
date of the Secretary's regulation. Section 906(e)(2) provides 
for a petition process for a temporary or permanent exemption 
or variance from the regulation.

Section 907. Tobacco product standards

    Consistent with the overall intent of the bill to reduce 
the number of children and adolescents who smoke cigarettes, 
section 907(a)(1) is intended to prohibit the manufacture and 
sale of cigarettes with certain ``characterizing flavors'' that 
appeal to youth. Examples of these products include, but are 
not limited to, those introduced in recent years such as 
``Mandalay Lime,'' ``Warm Winter Toffee,'' ``Mocha Taboo,'' and 
``Midnight Berry,'' which were the subject of an investigation 
and subsequent settlement agreement between one cigarette 
manufacturer and the Attorneys General of 40 States in October 
2006.
    Accordingly, this section prohibits the use of any 
constituent or additive that causes a cigarette or its smoke to 
have a characterizing flavor other than menthol or tobacco. 
Section 907(a)(1) is not intended to prohibit the use of 
specific ingredients, including those found in some American 
blend cigarettes, so long as those additives or constituents 
are not a characterizing flavor (other than tobacco or menthol) 
of the cigarette or its smoke. A cigarette (including any 
component of the cigarette) or its smoke should not be 
determined to have a prohibited characterizing flavor based 
solely on the presence of an ingredient in the product or its 
smoke.
    The Committee recognizes the unique issues surrounding 
menthol cigarettes and urges the Secretary to address these 
issues as quickly as practicable. The Committee is especially 
concerned about proportionately higher rates of menthol 
cigarette use among African American smokers, as well as the 
historic targeting of African Americans for menthol cigarette 
use by tobacco companies. While it is unclear what effect the 
presence of menthol in cigarettes may have on addictiveness, 
toxicity, or other qualities of cigarettes, the Committee 
recognizes that menthol cigarettes may pose unique health risks 
to those who smoke them. Given the high rates of use among 
African American smokers, including African American youth, as 
well as higher rates of lung cancer documented among African 
American smokers as compared to non-African American smokers, 
the Committee believes that it is critical for the Secretary to 
move quickly to address the unique public health issues posed 
by menthol cigarettes.
    Menthol cigarettes currently represent over one quarter of 
all cigarettes smoked in the United States, representing more 
than 12 million individual smokers. Additionally, nearly 7 in 
10 African Americans who smoke choose to smoke menthol 
cigarettes. Given the number of open questions related to 
menthol cigarettes, the legislation authorizes the Secretary to 
ban or modify the use of menthol in cigarettes based on 
scientific evidence. Given the large number of Americans who 
smoke menthol, the disproportionate prevalence of menthol 
cigarettes among African Americans, the racial and ethnic 
differences in lung cancer incidence, and the uncertainty about 
the potentially negative consequences of an immediate menthol 
ban, the Committee believes that this approach ensures that FDA 
has the scientific evidence necessary to make the best 
decisions to protect the public health.
    Section 907 allows the Secretary to adopt, through notice 
and comment rulemaking, a product standard for tobacco products 
if the Secretary determines that such standard is appropriate 
for the protection of the public health. ``Appropriate for the 
protection of public health'' is used because tobacco products 
are not ``safe'' or ``safe and effective,'' the standards used 
by FDA for foods, drugs, and medical devices. The public health 
standard is intended to be a flexible standard that focuses on 
the overall goal of reducing the number of individuals who die 
or are harmed by tobacco products. Standard(s) could include 
provisions to alter nicotine yields, to reduce or eliminate 
other constituents or harmful components, or other aspects of 
the construction, constituents, properties, and labeling of the 
tobacco product.
    Section 907 (a)(3) provides that the Secretary may adopt a 
tobacco product standard if the Secretary finds that it is 
appropriate for the protection of the public health. Section 
907(a)(3)(B) sets forth certain considerations with respect to 
that finding and additional considerations with respect to a 
standard that would reduce or eliminate an additive, 
constituent (including a smoke constituent), or other component 
of a tobacco product. In the event that the Secretary has 
proposed the adoption of such a standard because the Secretary 
has found that the additive, constituent, or other component is 
or may be harmful, an objecting party may, in response to such 
finding, provide for the Secretary's consideration scientific 
evidence that demonstrates that the proposed standard will not 
reduce or eliminate the risk of illness or injury. In issuing a 
final standard as with any rulemaking, the Secretary shall 
review and consider all information and scientific evidence and 
data, presented by any party that comments on the proposed 
standard, including any information, evidence, or other 
documentation that is submitted concerning the population 
impact or any other matter related to the proposed standard. 
The Committee intends that the Secretary will base his or her 
determinations on sound information and scientific evidence and 
data when issuing the proposed standard that is appropriate for 
the protection of the public health.
    The Committee also intends for the agency to have authority 
to establish product standards regarding the testing and 
measurement of products, nicotine yields, constituents, 
construction, components, ingredients, additives, and all other 
properties of the tobacco product, including the form and 
content of the labeling. This authority is limited in 907(d)(3) 
to prohibit FDA from banning all cigarettes, all smokeless 
tobacco products, all little cigars, all cigars, all pipe 
tobacco, or all ``roll your own'' tobacco products, or 
requiring the reduction of nicotine levels to zero.
    It is the Committee's intent that there be a level playing 
field between domestic tobacco growers and foreign tobacco 
growers with regard to the development and implementation of 
any tobacco product standard. No manufactured tobacco product 
shall contain foreign tobacco that contains a pesticide that is 
not approved under applicable Federal law for use in 
domestically grown tobacco. No manufactured tobacco product 
shall contain foreign tobacco that was grown or processed using 
an approved pesticide in a manner inconsistent with the 
approved labeling for use of the pesticide in domestic tobacco 
farming and processing.
    The Secretary is required to review periodically the 
product standards, taking into consideration new medical, 
scientific, or other technological data. In creating rules, the 
Secretary is required to consult with other Federal agencies 
and invite appropriate persons to provide their input before 
issuing a rule. The Secretary may also refer a proposed rule to 
the Tobacco Products Scientific Advisory Committee for 
collecting additional data and creating a report on the issue, 
which would then be made public.

Section 908. Notification and other remedies

    Section 908(a) provides authority for the Secretary to give 
notice (e.g., through public service announcements) if a 
tobacco product presents an ``unreasonable risk of substantial 
harm'', and notification is necessary and the most practicable 
means available to eliminate the unreasonable risk.
    Section 908(c) authorizes the Secretary to recall a tobacco 
product, after an opportunity for an informal hearing, if the 
product contains a manufacturing or other defect that would 
cause serious adverse health consequences or death and is not 
ordinarily contained in tobacco products on the market.

Section 909. Records and reports on tobacco products

    Section 909(a) requires tobacco manufacturers and importers 
to establish and maintain records and submit them to the 
Secretary, if required by the Secretary by regulation, to 
ensure that tobacco products are not adulterated or misbranded.
    Section 909(a) allows the Secretary to also require 
manufacturers and importers to report serious unexpected 
adverse reactions caused by the use of a tobacco product. The 
Secretary may also require the reporting of other significant 
adverse reactions, if necessary, and of actions taken to 
correct or remove products from the market when undertaken to 
reduce a health risk.
    Section 909(a) states that reports required under this 
section shall not be unduly burdensome, nor require the 
disclosure of the identity of patients or users unless required 
for reasons specified in the provision.

Section 910. Application for review of certain tobacco products

    Section 910(a) requires premarket review for all new 
tobacco products entering the market, unless the Secretary 
determines that the product is substantially equivalent to an 
existing product. Section 910(a) defines substantial 
equivalence to mean that the product has the same 
characteristics as a marketed product, or has different 
characteristics, but does not raise different public health 
questions. Section 910(a)(4) specifies information that must be 
provided under section 905(j) to establish substantial 
equivalence, including detailed information on adverse health 
effects, and provides that such information be made public 
within 30 days of a determination of substantial equivalence.
    Section 910(b) requires an application for premarket review 
to contain all information published, known, or which should 
reasonably be known, to the applicant concerning studies on the 
health risks of the product. The application also must contain 
a listing of components, ingredients, and composition of 
products; how the product is operated or used; a description of 
the methods used to manufacture or produce the product; and 
samples of the product and the product's proposed labeling. The 
Secretary may refer the application to the Tobacco Products 
Advisory Committee.
    Section 910(c) requires the Secretary, within 180 days, to 
make a determination of whether to allow the new product to 
enter the market or deny the application. The Secretary may 
deny the application if the Secretary finds that the applicant 
has not shown that marketing of the product would be 
appropriate for the protection of the public health, or if the 
Secretary finds that the making and handling of the product do 
not conform to good manufacturing practices, the labeling is 
false or misleading, or the product fails to conform to an 
applicable product standard promulgated under section 907 
without justification.
    Section 910(d) provides the Secretary authority to withdraw 
or suspend an order pertaining to a new product for a number of 
reasons, including that continued marketing is no longer 
appropriate for the protection of public health; the 
application contained a materially false statement; the 
applicant has failed to maintain records or make reports; the 
labeling becomes false or misleading; or the product does not 
conform to a tobacco standard without appropriate 
justification. Section 910(f) authorizes the Secretary to 
require the maintenance of records and the making of reports as 
necessary to permit the Secretary to determine whether to 
withdraw or suspend the order pertaining to a new product.

Section 911. Modified risk tobacco products

    Section 911 prohibits a person from selling or distributing 
a modified-risk tobacco product without having obtained an 
order pertaining to the product from FDA. Section 911(b) 
specifically defines the sale or distribution of these products 
to include labeling or advertising that states or implies that 
the product presents a reduced risk of harm or of tobacco-
related disease, or that there is reduced exposure to a 
substance, or that uses the words ``light'', ``mild'', or 
``low'', or similar descriptors. This definition also includes 
any action taken by the manufacturer after passage of the 
legislation directed to consumers through the media or 
otherwise, other than by means of the tobacco product's label, 
labeling, or advertising, which would be reasonably expected to 
result in consumers believing that the tobacco product or its 
smoke may present a lower risk of disease, lower exposure to a 
substance, or is less harmful.
    Section 911(b)(2)(C) makes clear that the use of the 
following phrases on the label or advertising for a product 
does not constitute a reduced-harm claim: ``smokeless 
tobacco''; ``smokeless tobacco product''; ``not consumed by 
smoking''; ``does not produce smoke''; ``smokefree''; ``smoke-
free''; ``without smoke''; ``no smoke''; or ``not smoke''. 
Products intended for use in the treatment of tobacco 
dependence are not modified-risk tobacco products and are 
subject to Chapter V of the FFDCA.
    Section 911(d) also outlines the specific requirements that 
tobacco manufacturers must meet before receiving an order 
permitting the sale or distribution of modified-risk tobacco 
products. An application for such an order must include a 
description of the product; the conditions for using the 
product with respect to the claim; formulation of the product; 
sample labels; all documents relating to research regarding the 
product (e.g., effect on tobacco-related diseases and other 
health-related conditions); data on how consumers actually use 
the product; and any other information required by the 
Secretary. Section 911(e) requires the Secretary to make the 
application and all of its contents (except trade secrets and 
confidential commercial information) public and seek public 
comment. The application must be referred to the Tobacco 
Products Advisory Committee for its recommendations.
    Section 911(g)(1) states that the Secretary shall issue an 
order that a product may be commercially marketed. This order 
shall be issued only if the Secretary determines that the 
applicant has demonstrated that the product will significantly 
reduce harm and the risk of tobacco-related disease to 
individual users, and benefit the health of the population as a 
whole.
    Section 911(g)(2) creates a special rule for allowing the 
sale and distribution of certain products, if the Secretary 
determines that (1) it would be appropriate for the protection 
of the public health; (2) the product's label, labeling, or 
advertising explicitly or implicitly claims only that the 
product contains a reduced level of a substance, or presents a 
reduced exposure to a substance; (3) scientific evidence of 
reduced harm is not, or cannot be made, available, using the 
best available scientific methods and cannot be made available 
without conducting long-term epidemiological studies; (4) such 
data as currently exists predicts substantially reduced 
morbidity or mortality among individual tobacco users; (5) the 
magnitude of the overall reductions in exposure to such 
substances is substantial and will not expose users to higher 
levels of other harmful substances; and (6) testing of actual 
consumer perceptions shows that consumers will not be misled 
into believing that the product is or has been demonstrated to 
be less harmful or presents less of a risk than one or more 
other commercially marketed tobacco products. These products 
are limited to a distribution term of 5 years, but that term 
may be renewed.
    Section 911(h) states that the Secretary may require a 
manufacturer of a modified-risk product subject to an order 
under this section to comply with requirements relating to 
labeling, advertising, and promotion of the tobacco product, 
and the Secretary must require postmarket surveillance.
    Section 911(h) states the Secretary has discretion to 
require that a modified-risk tobacco product making a 
comparative claim compare the tobacco product to a commercially 
marketed tobacco product that is representative of that type of 
tobacco product on the market (e.g. the average value of the 
top three brands). The Secretary may also require quantitative 
comparisons of the amount of the substance reduced. This 
information must be placed near the most prominent claim.
    Section 911(j) states that the Secretary may withdraw the 
order pertaining to a modified risk product if: he or she can 
no longer make the findings on which the order was based; the 
application contained a material false statement; product 
representations about reduced risk or exposure are no longer 
valid; the applicant failed to conduct required postmarket 
studies and surveillance; or the applicant failed to meet any 
other condition of the order.
    Section 911(l) requires the Secretary, within 2 years after 
enactment, to issue guidance or regulations on the scientific 
evidence required for assessment and ongoing review of 
modified-risk tobacco products. The regulations or guidance 
shall be developed by the Secretary in consultation with the 
Institute of Medicine (IOM).

Section 912. Judicial review

    Section 912 states that any person adversely affected by an 
FDA regulation relating to performance standards or premarket 
review may, within 30 days, file a petition for judicial review 
of such regulation with a United States Court of Appeals. The 
remedies provided shall be in addition to, not in lieu of, any 
other remedies provided by law. Judgment by the appellate court 
shall be final, subject to review by the Supreme Court.

Section 913. Equal treatment of retail outlets

    Section 913 seeks to ensure a level playing field among all 
retailers, and requires the Secretary to issue regulations 
requiring that retail establishments whose predominant business 
is the sale of tobacco products comply with any advertising 
restriction applicable to retail establishments accessible to 
individuals under the age of 18. This provision is necessary 
because the final rule promulgated by FDA on tobacco products, 
which is required to be reinstated under section 102 of the 
Committee's bill, exempted adult-only establishments from 
advertising restrictions applicable to retail outlets where 
persons younger than 18 years of age are allowed. This section 
is intended to level the playing field for all retailers, 
applying the restrictions on advertising equally across the 
board.

Section 914. Jurisdiction of and coordination with the Federal Trade 
        Commission

    Section 914(a) clarifies that the Federal Trade 
Commission's (FTC) authority regarding the advertising, sale, 
or distribution of tobacco products is not limited or 
diminished by the Act, and that violations of this Act related 
to advertising will also be considered unfair or deceptive 
practices under the Federal Trade Commission Act.
    Section 914(b) states that the Secretary and the Chairman 
of the FTC are to coordinate enforcement of section 4 of the 
Federal Cigarette Labeling and Advertising Act and section 3 of 
the Comprehensive Smokeless Tobacco Health Education Act.

Section 915. Regulation requirement

    Section 915 requires the Secretary, within 36 months of 
enactment, to issue regulations that require the testing and 
reporting of tobacco product smoke constituents, ingredients, 
and additives that the Secretary determines should be tested in 
order to protect public health. Regulations may require 
disclosure of the test results relating to tar and nicotine in 
labeling or advertising, and make disclosures regarding the 
results of the testing of other constituents that the Secretary 
determines should be disclosed to the public to protect the 
public health and will not mislead consumers.
    Section 915(d) states that for small tobacco product 
manufacturers, the compliance times are delayed by at least 2 
years and the testing and reporting requirements are delayed 
for 4 years. Additionally, two or more small tobacco product 
manufacturers may join together to purchase laboratory testing 
services. The Secretary may also delay the deadline for testing 
and reporting on a case-by-case basis.
    Section 915(d)(2)(A) of the Act provides that testing 
regulations promulgated by FDA under Section 915 only shall 
provide an extended time period for small tobacco product 
manufacturers to complete product testing required by FDA. FDA 
regulations shall provide for such testing by small 
manufacturers to be conducted over a 4-year period, with each 
manufacturer testing 25 percent of its products per year. If 
product testing, however, is necessary due to the actions of a 
small manufacturer in seeking to market a new product within 
the definition of section 910(a)(1)(B), or modifying an 
existing product within the definition of section 910(a)(1)(B), 
that testing must be conducted within the same time frame 
applicable to non-small manufacturers under FDA rules. The 
Committee believes that commonly occurring natural variations 
in the tobacco leaf--meaning only those variations that result 
directly from geological, meteorological, or similar factors 
not under the control of and not the result of decisions by the 
tobacco grower, processor, or manufacturer--should not 
constitute a new product or a product modification for purposes 
of determining what time frames to apply for completion of 
testing.
    Section 915(e) states that FDA regulations are required to 
provide an extension to a small tobacco product manufacturer 
for testing and reporting in the event that the manufacturer 
demonstrates an inability to gain access to an independent 
testing laboratory to conduct product testing in time to meet 
regulatory deadlines. This delay is conditioned, in part, on 
evidence provided to FDA that: (1) the products were submitted 
sufficiently in advance to meet regulatory deadlines; (2) the 
products are currently awaiting testing; and (3) neither that 
laboratory, nor any other laboratory, is able to complete 
testing by the deadline at customary, non-expedited testing 
fees.
    The Committee believes that, in seeking an extension of 
time under this subsection, a small manufacturer should be 
required only to consult laboratories that are legitimate and 
that possess the expertise to produce meaningful and reliable 
testing reports. Therefore, we anticipate that FDA will assist 
small manufacturers in this regard through its Office to Assist 
Small Tobacco Product Manufacturers. The Committee expects that 
the Office will produce a list of testing laboratories with 
which a small manufacturer can check for testing capacity and 
availability. The list should include a description of testing 
services, an address, and known contact information for each 
laboratory. While FDA's production of this list will not 
eliminate the duty of each small manufacturer to use its best 
efforts to identify such laboratories on its own, the list will 
provide great assistance to small manufacturers in fulfilling 
that duty.
    As stated in this subsection, FDA's authority to extend 
deadlines based on a demonstrated lack of laboratory capacity 
extends only to testing and reporting required under Section 
915.

Section 916. Preservation of State and local authority

    Section 916(a) states that State authority is preserved, 
with no Federal preemption, with regard to enacting, adopting, 
promulgating, and enforcing any law, rule, or regulation in 
critical areas with respect to tobacco products that is in 
addition to or more stringent than required under this Act, 
including measures relating to or prohibiting the sale, 
distribution, possession, exposure to, access to, advertising, 
and promotion of, or use of, tobacco products by individuals of 
any age, information reporting to the State, or measures 
relating to fire safety standards for cigarettes.
    Section 916(a)(2)(A) states that States are generally 
preempted from establishing or continuing any requirement that 
is different from or in addition to any FDA requirement 
relating to specified and limited areas, including tobacco 
product standards, premarket review, adulteration, misbranding, 
labeling, registration, reporting, good manufacturing 
standards, and modified risk tobacco products.
    Section 916(b) also states that product liability actions 
under State law are not modified or otherwise affected by this 
bill.

Section 917. Tobacco Products Scientific Advisory Committee

    Section 917 establishes a 12-member advisory committee 
representing the public, tobacco growers, the health community, 
and tobacco manufacturers, including one member solely and 
specifically representing the interests of small manufacturers 
of tobacco products. The small manufacturers' position may be 
filled by different persons, one at a time, based on different 
areas of expertise relevant to the topics being discussed. 
Representatives of the tobacco industry and growers will be 
non-voting.
    Section 917(c) states that this Committee will provide 
advice and guidance to the Secretary on the effects of 
alteration of the nicotine yields from tobacco products; the 
threshold level at which nicotine becomes addictive; and other 
health issues as requested by the Secretary.

Section 918. Drug products used to treat tobacco dependence

    Section 918 requires the Secretary to consider designating 
nicotine replacement products, regulated under title V of the 
FFDCA, as fast-track research and approval products.
    Section 918(a) requires the Commissioner of Food and Drugs 
to consider approving the extended use of over-the-counter 
nicotine replacement products, and to consider other issues 
relating to the approval of nicotine replacement therapies.
    The Committee notes that the fees collected under section 
919 of this Act shall not be used for the purposes of 
designating nicotine replacement products as fast-track 
research and approval products, or approving the extended use 
of over-the-counter nicotine replacement products, or to 
consider other issues relating to the approval of nicotine 
replacement therapies. The Committee notes that these 
activities are regulated under the authority of title V of the 
FFDCA.
    The Committee has found that public health officials and 
other interested parties are not widely aware that FDA does not 
currently prohibit the sales of over-the-counter smoking 
cessation products--such as certain nicotine replacement 
products--in retail settings where age verification takes 
place. The Committee urges FDA to communicate its policy on 
such sales to the regulated community and public health 
officials through simple and effective means, such as through 
posting a statement of policy on the Food and Drug 
Administration's Web site.
    Section 918(b) requires the Secretary to report to Congress 
within 3 years on how best to regulate, promote, and encourage 
development of innovative products and treatments to promote 
abstinence from tobacco use, reductions in consumption, and 
reductions in the harm associated with tobacco use. Cessation 
assistance is a critical component of the fight against the 
tobacco epidemic. Accordingly, the Committee believes that it 
is important for health insurers--public and private--to cover 
effective cessation treatments for those addicted to tobacco, 
including both medications and counseling. While it is clear to 
the Committee that the benefits of such coverage greatly 
outweigh the costs both in terms of human health and in terms 
of financial savings, private and public insurer coverage of 
such services remains less than comprehensive. For example, as 
CDC reported in 2006, only 38 of 50 State Medicaid programs 
provided coverage for any cessation benefits to tobacco users, 
with only one State providing all benefits recommended under 
applicable Public Health Service treatment guidelines. In 
addition, it is unknown to what extent private insurers are 
choosing to cover such benefits.
    In light of the critical importance of insurer coverage of 
cessation treatment for those suffering from nicotine addition, 
the Committee urges the Secretary to examine this issue and to 
review the extent to which private insurers are covering 
effective cessation treatment for tobacco users. In conducting 
this examination, the Secretary should consider the potential 
cost savings of such coverage, taking into account not only the 
reduction of healthcare costs that would result, but also the 
gain in individual life years, improvements in quality of life, 
and increased productivity that would be achieved by such 
coverage.

Section 919. User fee

    Section 919(a) requires the Secretary to assess a quarterly 
fee from tobacco product manufacturers and importers to cover 
the costs of the activities of the Food and Drug Administration 
related to the regulation of tobacco products under the Act. 
Section 919(b)(4) makes clear that only the funds provided for 
in this chapter will be used to pay for FDA tobacco regulation. 
In addition, none of the funds provided for in this chapter may 
be used to pay for activities not related to FDA's regulation 
of tobacco. The method of assessing fees shall be the same as 
that currently used by United States Department of Agriculture 
for all tobacco manufacturers and importers to fund the 2004 
legislation providing transitional payments to tobacco grower 
quota holders.
    Section 919(c)(3)(B) states that no manufacturer or 
importer shall be required to pay a user fee in excess of their 
percentage market share. Section 919(c)(2)(B) also limits the 
imposition of user fees to cigarettes, smokeless, and roll-
your-own tobacco until the Secretary exercises jurisdiction 
over other tobacco products.
    Section 919(g) requires a report by the Government 
Accountability Office, within 3 years of enactment, that 
studies the prevalence of youth tobacco use and the brands that 
individuals under the age of 18 consume; the feasibility of 
structuring a user fee based on youth market share of a 
manufacturer; and the potential effects of tobacco marketing to 
youth if user fees were calculated based on youth market share.

Section 102. Final rule

    Section 102 states that on the first day of publication of 
the Federal Register that is 6 months or more after the 
enactment of this Act, the Secretary shall publish a final rule 
on the advertising of, and access to, tobacco products, which 
shall become effective 1 year after passage of the bill.
    The final rule is deemed to be in compliance with the 
Administrative Procedure Act. The final rule shall be identical 
in its provisions to the advertising and access regulations 
promulgated by FDA in 1996, except where specifically provided 
in this Act. Prior to making any amendments to the published 
rule, the Secretary will be required to promulgate a proposed 
rule.
    The final rule also includes a provision that allows the 
restricted distribution of smokeless tobacco products in 
qualified, adult-only facilities. In 1996, the Food and Drug 
Administration concluded that teens obtain free samples of 
tobacco products despite laws that prohibit the free 
distribution to minors. In the August 1996 rule, FDA wrote that 
``free samples represent a `risk-free and cost-free' way for 
young people to obtain and possibly use cigarettes or smokeless 
tobacco and that, when free samples are distributed at cultural 
or social events, peer pressure may lead some young people to 
accept and to use the free samples.'' The Committee's intent in 
section 102 (a)(2) is to modify the final rule to allow free 
sampling of smokeless tobacco products only to adults in 
secured, enclosed, adult-only facilities or areas. The 
Committee expects FDA to monitor aggressively smokeless free-
sampling facilities to assure that all requirements are being 
followed and that youth do not obtain the samples of smokeless 
tobacco that are being distributed. The Committee notes that 
this narrowly tailored sampling provision does not preclude the 
Secretary from taking further action related to the regulation 
or ban of free sampling of smokeless tobacco products.
    The Secretary shall ensure that this Act, amendments made 
by the Act, and the implementing regulations, including such 
provisions, amendments, and regulations relating to the retail 
sale of tobacco products, are enforced with respect to the 
United States and Indian tribes.

Section 103. Conforming and other amendments to general provisions

    Section 103 includes a number of export provisions and 
retailer/licensing provisions. Section 103 contains retailer 
procedural protections and requires FDA, to the greatest extent 
possible, to contract with the States for retailer enforcement.
    As reflected in its Findings, the Committee is concerned 
that, depending on the particular language, communications 
directed to consumers by tobacco manufacturers about the impact 
of the authority granted to FDA under this legislation could 
confuse or mislead consumers. The Committee recognizes that 
unlike most products regulated by FDA, tobacco products will 
remain harmful. Therefore, section 103(b)(13) of the bill, in a 
new subsection (tt) of Section 301 of the FFDCA, prohibits 
statements directed to consumers through the media or through 
the label, labeling, or advertising that would reasonably be 
expected to result in a consumer believing that the product is 
regulated, inspected, or approved by FDA, or that the product 
complies with requirements imposed by FDA, and that could 
result in consumers believing that the product is endorsed for 
use by FDA or that otherwise could result in consumers being 
misled about the harmfulness of the product because of the 
authority given to FDA by this legislation. The Committee did 
not attempt to identify every situation in which such specific 
statements would reasonably be expected to mislead consumers, 
instead giving FDA the authority to analyze any specific 
examples presented to it. This section was carefully written so 
that it involves only communications directed to consumers and 
does not therefore, for example, involve communications to 
Government agencies, such as reports to the Securities and 
Exchange Commission, or as part of judicial or Congressional 
proceedings, in formal documents that companies provide to 
shareholders in the ordinary course of business, or in 
scientific articles that appear in scientific journals.
    Section 103(q)(2)(C) is designed to protect retailers 
against the imposition of double penalties based on a single 
violation of any restriction under section 906(d) by directing 
the Secretary to consider the amount of penalties paid to a 
State by a retailer for the same violation. This provision is 
not meant to change the system of setting penalties in any 
other area within the jurisdiction of the Food and Drug 
Administration.

Section 104. Study on raising the minimum age to purchase tobacco 
        products

    Section 104 requires the Secretary to submit to Congress, 
within 5 years after enactment of this Act, a report on a study 
of the public health implications of raising the minimum age to 
purchase tobacco products.

Section 105. Tobacco industry concentration

    Section 105 requires the FTC to submit to Congress, within 
5 years after the enactment of this Act, a report on the causes 
and effects of concentration in the tobacco industry.

 Title II. Tobacco Product Warnings; Constituent and Smoke Constituent 
                               Disclosure


Section 201. Cigarette label and advertising warnings

    Section 201(a) amends section 4 of the Federal Cigarette 
Labeling and Advertising Act to specify nine new required 
warning labels, one of which must appear on cigarette packages 
and advertisements within 1 year of enactment of this Act. The 
warning must comprise at least the top 30 percent of the front 
and rear panels of the package, and at least 20 percent of the 
related advertisements. Retailers will not be held responsible 
for packages and advertisements bearing a warning label that 
they do not create or alter.
    Section 201(c) requires that all warnings be displayed on 
all brands and be randomly distributed in all areas of the 
United States where the product is distributed and requires 
that a plan be submitted to the Secretary to ensure that the 
statements in product advertising are equally distributed and 
rotated quarterly and that all required label statements be 
displayed at the same time.

Section 202. Authority to revise cigarette warning label statements

    Section 202 amends section 4 of the Federal Cigarette 
Labeling and Advertising Act to provide the Secretary with 
authority, by rulemaking, to adjust format, type size, and text 
of any label requirements, as well as to increase the required 
label area from 30 percent up to 50 percent of the front and 
rear panels.

Section 203. State regulation of cigarette advertising and promotion

    Section 203 amends section 5 of the Federal Cigarette 
Labeling and Advertising Act to allow States or localities to 
enact statutes and promulgate regulations based on smoking and 
health, imposing specific bans or restrictions on the time, 
place, and manner. States or localities may not restrict the 
content of advertisements or promotions of any cigarettes.

Section 204. Smokeless tobacco labels and advertising warnings

    Section 204(a) amends section 3 of the Comprehensive 
Smokeless Tobacco Health Education Act of 1986 to specify the 
required warning labels that must appear on smokeless tobacco 
product labels and advertisements, and imposes minimum size and 
text requirements.
    Section 204(b) requires that all warnings be displayed on 
all brands and be randomly distributed in all areas of the 
United States where the product is distributed and requires 
that a plan be submitted to the Secretary to ensure that the 
statements in product advertising are equally distributed and 
rotated quarterly, and that all required label statements are 
displayed at the same time.

Section 205. Authority to revise smokeless tobacco warning label 
        statements

    Section 205 amends section 3 of the Comprehensive Smokeless 
Tobacco Health Education Act of 1986 to provide the Secretary 
with authority, by rulemaking, to adjust format, type size, and 
text of any label requirements, as well as to increase the 
required label area from 30 percent up to 50 percent of the 
front and rear panels.

Section 206. Tar, nicotine, and other smoke constituent disclosure to 
        the public

    Section 206 amends section 4 of the Federal Cigarette 
Labeling and Advertising Act to require the Secretary to 
determine, using his or her sole discretion, whether cigarette 
and other tobacco product manufacturers should be required to 
include in each advertisement, package, label, or both, the tar 
and nicotine yields of a tobacco product, and whether the 
yields of other constituents will be required to be disclosed 
by appropriate means.
    This section requires that any differences between the 
requirements established by the Secretary and tar and nicotine 
disclosure reporting requirements established by the Federal 
Trade Commission be resolved by a memorandum of understanding.

       Title III. Prevention of Illicit Trade in Tobacco Products


Section 301. Labeling, recordkeeping, records inspection

    Section 301 further amends new title IX of the Federal 
Food, Drug, and Cosmetic Act by adding a new section 920.
    New section 920(a) requires the label, packaging, and 
shipping containers of tobacco products to bear a statement 
``sale only allowed in the United States''.
    New section 920(b) directs the Secretary to issue 
regulations regarding the establishment and maintenance of 
records by any person who manufacturers, processes, transports, 
distributes, receives, packages, holds, exports, or imports 
tobacco products. These records will be used to track and 
assist in the investigation of illicit trade, smuggling, or 
counterfeiting of tobacco products. Retailers will not be 
required to maintain records of sales made to consumers.
    New section 920(c) authorizes the Secretary to inspect and 
copy all records, including financial records, of each person 
who manufacturers, processes, transports, distributes, 
receives, holds, packages, exports, or imports a tobacco 
product that the Secretary has a reasonable belief is part of 
illicit trade, or smuggling, or is counterfeit.
    New section 920(d) requires manufacturers and distributors 
to report to the Attorney General any knowledge that a tobacco 
product it manufactures or distributes has been imported, 
exported, distributed, or offered for sale (1) without payment 
of duties or taxes, or (2) for possible illicit marketing.

Section 302. Study and report

    Section 302 requires the Comptroller General to conduct a 
study of cross-border trade in tobacco products, including 
illicit trade, cross-border advertising, and the health effects 
resulting from cross-border trade. This section also requires 
the Comptroller General to submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives a report 
on the study described in this section no later than 18 months 
after enactment. Section 302(c) provides a definition for 
``cross-border trade'', and states that the terms ``Indian 
country'', ``State'', and ``Territory'' share the same 
definitions found in current law.

         Changes in Existing Law Made by the Bill, as Reported

    In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

                  FEDERAL FOOD, DRUG, AND COSMETIC ACT




           *       *       *       *       *       *       *
                        CHAPTER II--DEFINITIONS

  Sec. 201. For the purposes of this Act--
  (a) * * *

           *       *       *       *       *       *       *

  (rr)(1) The term ``tobacco product'' means any product made 
or derived from tobacco that is intended for human consumption, 
including any component, part, or accessory of a tobacco 
product (except for raw materials other than tobacco used in 
manufacturing a component, part, or accessory of a tobacco 
product).
  (2) The term ``tobacco product'' does not mean an article 
that is a drug under subsection (g)(1), a device under 
subsection (h), or a combination product described in section 
503(g).
  (3) The products described in paragraph (2) shall be subject 
to chapter V of this Act.
  (4) A tobacco product may not be marketed in combination with 
any other article or product regulated under this Act 
(including a drug, biologic, food, cosmetic, medical device, or 
a dietary supplement).

               CHAPTER III--PROHIBITED ACTS AND PENALTIES

                            PROHIBITED ACTS

  Sec. 301. The following acts and the causing thereof are 
hereby prohibited:
  (a) The introduction or delivery for introduction into 
interstate commerce of any food, drug, device, tobacco product, 
or cosmetic that is adulterated or misbranded.
  (b) The adulteration or misbranding of any food, drug, 
device, tobacco product, or cosmetic in interstate commerce.
  (c) The receipt in interstate commerce of any food, drug, 
device, tobacco product, or cosmetic that is adulterated or 
misbranded, and the delivery or proffered delivery thereof for 
pay or otherwise.

           *       *       *       *       *       *       *

  (e) The refusal to permit access to or copying of any record 
as required by section 412, 414, 417(g), 416, 504, 564, 703, 
704(a), 760, or 761; or the failure to establish or maintain 
any record, or make any report, required under section 412, 
414(b), 417, 416, 504, 505 (i) or (k), 512(a)(4)(C), 512 (j), 
(l) or (m), 572(i)[.], 515(f), 519, 564, 760, [or 761 or the 
refusal to permit access to] 761, 909, or 921 or the refusal to 
permit access to or verification or copying of any such 
required record.

           *       *       *       *       *       *       *

  (g) The manufacture within any Territory of any food, drug, 
device, tobacco product, or cosmetic that is adulterated or 
misbranded.
  (h) The giving of a guaranty or undertaking referred to in 
section 303(c)(2), which guaranty or undertaking is false, 
except by a person who relied upon a guaranty or undertaking to 
the same effect signed by, and containing the name and address 
of, the person residing in the United States from whom he 
received in good faith the food, drug, device, tobacco product, 
or cosmetic; or the giving of a guaranty or undertaking 
referred to in section 303(c)(3), which guaranty or undertaking 
is false.

           *       *       *       *       *       *       *

  (j) The using by any person to his own advantage, or 
revealing, other than to the Secretary or officers or employees 
of the Department, or to the courts when relevant in any 
judicial proceeding under this Act, any information acquired 
under authority of section 404, 409, 412, 414, 505, 510, 512, 
513, 514, 515, 516, 518, 519, 520, 571, 572, 573[.], 704, [708, 
or 721] 708, 721, 904, 905, 906, 907, 908, 909, or 921(b) 
concerning any method or process which as a trade secret is 
entitled to protection; or the violating of section 408(i)(2) 
or any regulation issued under that section.. This paragraph 
does not authorize the withholding of information from either 
House of Congress or from, to the extent of matter within its 
jurisdiction, any committee or subcommittee of such committee 
or any joint committee of Congress or any subcommittee of such 
joint committee.
  (k) The alteration, mutilation, destruction, obliteration, or 
removal of the whole or any part of the labeling of, or the 
doing of any other act with respect to, a food, drug, device, 
tobacco product, or cosmetic, if such act is done while such 
article is held for sale (whether or not the first sale) after 
shipment in interstate commerce and results in such article 
being adulterated or misbranded.

           *       *       *       *       *       *       *

  [(p) The failure to register in accordance with section 510, 
the failure to provide any information required by section 
510(j) or 510(k); or the failure to provide a notice required 
by section 510(j)(2).]
  (p) The failure to register in accordance with section 510 or 
905, the failure to provide any information required by section 
510(j), 510(k), 905(i), or 905(j), or the failure to provide a 
notice required by section 510(j)(2) or 905(i)(3).
  (q)[(1) The failure or refusal to (A) comply with any 
requirement prescribed under section 518 or 520(g), (B) furnish 
any notification or other material or information required by 
or under section 519 or 520(g), or (C) comply with a 
requirement under section 522.] (1) The failure or refusal--
          (A) to comply with any requirement prescribed under 
        section 518, 520(g), 903(b), 907, 908, or 916;
          (B) to furnish any notification or other material or 
        information required by or under section 519, 520(g), 
        904, 909, or 921; or
          (C) to comply with a requirement under section 522 or 
        913.
  (2) With respect to any [device,] device or tobacco product, 
the submission of any report that is required by or under this 
Act that is false or misleading in any material respect.
  (r) The movement of a device or tobacco product in violation 
of an order under section 304(g) or the removal or alteration 
of any mark or label required by the order to identify the 
device or tobacco product as detained.

           *       *       *       *       *       *       *

  (oo) The sale of tobacco products in violation of a no-
tobacco-sale order issued under section 303(f).
  (pp) The introduction or delivery for introduction into 
interstate commerce of a tobacco product in violation of 
section 911.
  (qq)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, stamp 
(including tax stamp), tag, label, or other identification 
device upon any tobacco product or container or labeling 
thereof so as to render such tobacco product a counterfeit 
tobacco product.
  (2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, 
stone, or other item that is designed to print, imprint, or 
reproduce the trademark, trade name, or other identifying mark, 
imprint, or device of another or any likeness of any of the 
foregoing upon any tobacco product or container or labeling 
thereof so as to render such tobacco product a counterfeit 
tobacco product.
  (3) The doing of any act that causes a tobacco product to be 
a counterfeit tobacco product, or the sale or dispensing, or 
the holding for sale or dispensing, of a counterfeit tobacco 
product.
  (rr) The charitable distribution of tobacco products.
  (ss) The failure of a manufacturer or distributor to notify 
the Attorney General and the Secretary of the Treasury of their 
knowledge of tobacco products used in illicit trade.
  (tt) With respect to a tobacco product, any statement 
directed to consumers through the media or through the label, 
labeling, or advertising that would reasonably be expected to 
result in consumers believing that the product is regulated, 
inspected or approved by the Food and Drug Administration, or 
that the product complies with the requirements of the Food and 
Drug Administration, including a statement or implication in 
the label, labeling, or advertising of such product, and that 
could result in consumers believing that the product is 
endorsed for use by the Food and Drug Administration or in 
consumers being misled about the harmfulness of the product 
because of such regulation, inspection, or compliance.

           *       *       *       *       *       *       *


                               PENALTIES

  Sec. 303. (a) * * *

           *       *       *       *       *       *       *

  (f)(1)(A) Except as provided in subparagraph (B), any person 
who violates a requirement of this Act which relates to devices 
or tobacco products shall be liable to the United States for a 
civil penalty in an amount not to exceed $15,000 for each such 
violation, and not to exceed $1,000,000 for all such violations 
adjudicated in a single proceeding. For purposes of the 
preceding sentence, a person accredited under paragraph (2) of 
section 704(g) who is substantially not in compliance with the 
standards of accreditation under such section, or who poses a 
threat to public health or fails to act in a manner that is 
consistent with the purposes of such section, shall be 
considered to have violated a requirement of this Act that 
relates to devices or tobacco products.

           *       *       *       *       *       *       *

  (5)(A) A civil penalty under paragraph (1), (2), (3), or (4) 
shall be [assessed] assessed, or a no-tobacco-sale order may be 
imposed, by the Secretary by an order made on the record after 
opportunity for a hearing provided in accordance with this 
subparagraph and section 554 of title 5, United States Code. 
Before issuing such an order, the Secretary shall give written 
notice to the person to be assessed a civil [penalty] penalty, 
or upon whom a no-tobacco-sale order is to be imposed, under 
such order of the Secretary's proposal to issue such order and 
provide such person an opportunity for a hearing on the order. 
In the course of any investigation, the Secretary may issue 
subpoenas requiring the attendance and testimony of witnesses 
and the production of evidence that relates to the matter under 
investigation.
  (B) In determining the amount of a civil penalty, or the 
period to be covered by a no-tobacco-sale order, the Secretary 
shall take into account the nature, circumstances, extent, and 
gravity of the violation or violations and, with respect to the 
violator, ability to pay, effect on ability to continue to do 
business, any history of prior such violations, the degree of 
culpability, and such other matters as justice may require. A 
no-tobacco-sale order permanently prohibiting an individual 
retail outlet from selling tobacco products shall include 
provisions that allow the outlet, after a specified period of 
time, to request that the Secretary compromise, modify, or 
terminate the order.

           *       *       *       *       *       *       *

  (D) The Secretary may compromise, modify, or terminate, with 
or without conditions, any no-tobacco-sale order.
  (6) Any person who requested, in accordance with paragraph 
(5)(A), a hearing respecting the assessment of a civil penalty 
or the imposition of a no-tobacco-sale order and who is 
aggrieved by an order assessing a civil penalty or the 
imposition of a no-tobacco-sale order may file a petition for 
judicial review of such order with the United States Court of 
Appeals for the District of Columbia Circuit or for any other 
circuit in which such person resides or transacts business. 
Such a petition may only be filed within the 60-day period 
beginning on the date the order making such assessment was 
[issued.] issued, or on which the no-tobacco-sale order was 
imposed, as the case may be.

           *       *       *       *       *       *       *

  (8) If the Secretary finds that a person has committed 
repeated violations of restrictions promulgated under section 
906(d) at a particular retail outlet then the Secretary may 
impose a no-tobacco-sale order on that person prohibiting the 
sale of tobacco products in that outlet. A no-tobacco-sale 
order may be imposed with a civil penalty under paragraph (1). 
Prior to the entry of a no-sale order under this paragraph, a 
person shall be entitled to a hearing pursuant to the 
procedures established through regulations of the Food and Drug 
Administration for assessing civil money penalties, including 
at a retailer's request a hearing by telephone, or at the 
nearest regional or field office of the Food and Drug 
Administration, or at a Federal, State, or county facility 
within 100 miles from the location of the retail outlet, if 
such a facility is available.

           *       *       *       *       *       *       *


                                SEIZURE

  Sec. 304. (a)(1) * * *
  [(2)] The following shall be liable to be proceeded against 
at any time on libel of information and condemned in any 
district court of the United States or United States court of a 
Territory within the jurisdiction of which they are found: (A) 
Any drug that is a counterfeit drug, (B) Any container of a 
counterfeit drug, (C) Any punch, die, plate, stone, labeling, 
container, or other thing used or designed for use in making a 
counterfeit drug or drugs, [and] (D) Any adulterated or 
misbranded [device.] device, and (E) Any adulterated or 
misbranded tobacco product.

           *       *       *       *       *       *       *

  (d)(1) Any food, drug, device, tobacco product, or cosmetic 
condemned under this section shall, after entry of the decree, 
be disposed of by destruction or sale as the court may, in 
accordance with the provisions of this section, direct and the 
proceeds thereof, if sold, less the legal costs and charges, 
shall be paid into the Treasury of the United States; but such 
article shall not be sold under such decree contrary to the 
provisions of this Act or the laws of the jurisdiction in which 
sold. After entry of the decree and upon the payment of the 
costs of such proceedings and the execution of a good and 
sufficient bond conditioned that such article shall not be sold 
or disposed of contrary to the provisions of this Act or the 
laws of any State or Territory in which sold, the court may by 
order direct that such article be delivered to the owner 
thereof to be destroyed or brought into compliance with the 
provisions of this Act under the supervision of an officer or 
employee duly designated by the Secretary, and the expenses of 
such supervision shall be paid by the person obtaining release 
of the article under bond. If the article was imported into the 
United States and the person seeking its release establishes 
(A) that the adulteration, misbranding, or violation did not 
occur after the article was imported, and (B) that he had no 
cause for believing that it was adulterated, misbranded, or in 
violation before it was released from customs custody, the 
court may permit the article to be delivered to the owner for 
exportation in lieu of destruction upon a showing by the owner 
that all of the conditions of section 801(e) can and will be 
met. The provisions of this sentence shall not apply where 
condemnation is based upon violation of section 402(a) (1), 
(2), or (6), section 501(a)(3), section 502(j), or section 601 
(a) or (d). Where such exportation is made to the original 
foreign supplier, then subparagraphs (A) and (B) of section 
801(e)(1) and the preceding sentence shall not be applicable; 
and in all cases of exportation the bond shall be conditioned 
that the article shall not be sold or disposed of until the 
applicable conditions of section 801(e) have been met. Any 
person seeking to export an imported article pursuant to any of 
the provisions of this subsection shall establish that the 
article was intended for export at the time the article entered 
commerce. Any article condemned by reason of its being an 
article which may not, under section 404 or 505, be introduced 
into interstate commerce, shall be disposed of by destruction.

           *       *       *       *       *       *       *

  (g)(1) If during an inspection conducted under section 704 of 
a facility or a vehicle, a device or tobacco product which the 
officer or employee making the inspection has reason to believe 
is adulterated or misbranded is found in such facility or 
vehicle, such officer or employee may order the device or 
tobacco product detained (in accordance with regulations 
prescribed by the Secretary) for a reasonable period which may 
not exceed twenty days unless the Secretary determines that a 
period of detention greater than twenty days is required to 
institute an action under subsection (a) or section 302, in 
which case he may authorize a detention period of not to exceed 
thirty days. Regulations of the Secretary prescribed under this 
paragraph shall require that before a device or tobacco product 
may be ordered detained under this paragraph the Secretary or 
an officer or employee designated by the Secretary approve such 
order. A detention order under this paragraph may require the 
labeling or marking of a device or tobacco product during the 
period of its detention for the purpose of identifying the 
device or tobacco product as detained. Any person who would be 
entitled to claim a device or tobacco product if it were seized 
under subsection (a) may appeal to the Secretary a detention of 
such device or tobacco product under this paragraph. Within 
five days of the date an appeal of a detention is filed with 
the Secretary, the Secretary shall after affording opportunity 
for an informal hearing by order confirm the detention or 
revoke it.
  (2)(A) Except as authorized by subparagraph (B), a device or 
tobacco product subject to a detention order issued under 
paragraph (1) shall not be moved by any person from the place 
at which it is ordered detained until--
          (i) * * *

           *       *       *       *       *       *       *


                      CHAPTER V--DRUGS AND DEVICES

Subchapter A--Drugs and Devices

           *       *       *       *       *       *       *


                               NEW DRUGS

  Sec. 505. (a) * * *

           *       *       *       *       *       *       *

  (n)(1) * * *
  (2) The Secretary may delegate the appointment and oversight 
authority granted under [section 904] section 1004 to a 
director of a center or successor entity within the Food and 
Drug Administration.

           *       *       *       *       *       *       *


SEC. 523. ACCREDITED PERSONS.

  (a) * * *
  (b) Accreditation.--
          (1) * * *
          (2) Accreditation.--
                  (A) * * *

           *       *       *       *       *       *       *

                  (D) Annual report.--The Secretary shall 
                include in the annual report required under 
                [section 903(g)] section 1003(g) the names of 
                all accredited persons and the particular 
                activities under subsection (a) for which each 
                such person is accredited and the name of each 
                accredited person whose accreditation has been 
                withdrawn during the year.

           *       *       *       *       *       *       *


                     CHAPTER VII--GENERAL AUTHORITY

Subchapter A--General Administrative Provisions

           *       *       *       *       *       *       *


                    EXAMINATIONS AND INVESTIGATIONS

  Sec. 702. (a)(1) The Secretary is authorized to conduct 
examinations and investigations for the purposes of this Act 
through officers and employees of the Department or through any 
health, food, or drug officer or employee of any State, 
Territory, or political subdivision thereof, duly commissioned 
by the Secretary as an officer of the Department. For a tobacco 
product, to the extent feasible, the Secretary shall contract 
with the States in accordance with this paragraph to carry out 
inspections of retailers within that State in connection with 
the enforcement of this Act.

           *       *       *       *       *       *       *


SEC. 703. RECORDS.

  (a) In General.--For the purpose of enforcing the provisions 
of this Act, carriers engaged in interstate commerce, and 
persons receiving food, drugs, devices, tobacco products, or 
cosmetics in interstate commerce or holding such articles so 
received, shall, upon the request of an officer or employee 
duly designated by the Secretary, permit such officer or 
employee, at reasonable times, to have access to and to copy 
all records showing the movement in interstate commerce of any 
food, drug, device, tobacco product, or cosmetic, or the 
holding thereof during or after such movement, and the 
quantity, shipper, and consignee thereof; and it shall be 
unlawful for any such carrier or person to fail to permit such 
access to and copying of any such record so requested when such 
request is accompanied by a statement in writing specifying the 
nature or kind of food, drug, device, tobacco product, or 
cosmetic to which such request relates, except that evidence 
obtained under this section, or any evidence which is directly 
or indirectly derived from such evidence, shall not be used in 
a criminal prosecution of the person from whom obtained, and 
except that carriers shall not be subject to the other 
provisions of this Act by reason of their receipt, carriage, 
holding, or delivery of food, drugs, devices, tobacco products, 
or cosmetics in the usual course of business as carriers, 
except as provided in subsection (b).

           *       *       *       *       *       *       *


                           FACTORY INSPECTION

  Sec. 704. (a)(1) For purposes of enforcement of this Act, 
officers or employees duly designated by the Secretary, upon 
presenting appropriate credentials and a written notice to the 
owner, operator, or agent in charge, are authorized (A) to 
enter, at reasonable times, any factory, warehouse, or 
establishment in which food, drugs, devices, tobacco products, 
or cosmetics are manufactured, processed, packed, or held, for 
introduction into interstate commerce or after such 
introduction, or to enter any vehicle, being used to transport 
or hold such food, drugs, devices, tobacco products, or 
cosmetics in interstate commerce; and (B) to inspect, at 
reasonable times and within reasonable limits and in a 
reasonable manner, such factory, warehouse, establishment, or 
vehicle and all pertinent equipment, finished and unfinished 
materials, containers, and labeling therein. In the case of any 
person (excluding farms and restaurants) who manufactures, 
processes, packs, transports, distributes, holds, or imports 
foods, the inspection shall extend to all records and other 
information described in section 414 when the Secretary has a 
reasonable belief that an article of food is adulterated and 
presents a threat of serious adverse health consequences or 
death to humans or animals, subject to the limitations 
established in section 414(d). In the case of any factory, 
warehouse, establishment, or consulting laboratory in which 
prescription drugs, nonprescription drugs intended for human 
use, or restricted devices or tobacco products are 
manufactured, processed, packed, or held, inspection shall 
extend to all things therein (including records, files, papers, 
processes, controls, and facilities) bearing on whether 
prescription drugs, nonprescription drugs intended for human 
use, or restricted devices or tobacco products which are 
adulterated or misbranded within the meaning of this Act, or 
which may not be manufactured, introduced into interstate 
commerce, or sold, or offered for sale by reason of any 
provision of this Act, have been or are being manufactured, 
processed, packed, transported, or held in any such place, or 
otherwise bearing on violation of this Act. No inspection 
authorized by the preceding sentence or by paragraph (3) shall 
extend to financial data, sales data other than shipment data, 
pricing data, personnel data (other than data as to 
qualifications of technical and professional personnel 
performing functions subject to this Act), and research data 
(other than data relating to new drugs, antibiotic drugs, and 
devices and subject to reporting and inspection under 
regulations lawfully issued pursuant to section 505(i) or (k) 
section 519, or 520(g), and data relating to other drugs or 
devices which in the case of a new drug would be subject to 
reporting or inspection under lawful regulations issued 
pursuant to section 505(j)). A separate notice shall be given 
for each such inspection, but a notice shall not be required 
for each entry made during the period covered by the 
inspection. Each such inspection shall be commenced and 
completed with reasonable promptness.

           *       *       *       *       *       *       *

  (b) Upon completion of any such inspection of a factory, 
warehouse, consulting laboratory, or other establishment, and 
prior to leaving the premises, the officer or employee making 
the inspection shall give to the owner, operator, or agent in 
charge a report in writing setting forth any conditions or 
practices observed by him which, in his judgment, indicate that 
any food, drug, device, tobacco product, or cosmetic in such 
establishment (1) consists in whole or in part of any filthy, 
putrid, or decomposed substance, or (2) has been prepared, 
packed, or held under insanitary conditions whereby it may have 
become contaminated with filth, or whereby it may have been 
rendered injurious to health. A copy of such report shall be 
sent promptly to the Secretary.

           *       *       *       *       *       *       *

  (g)(1) * * *

           *       *       *       *       *       *       *

  (13) The Secretary shall include in the annual report 
required under [section 903(g)] section 1003(g) the names of 
all accredited persons and the particular activities under this 
subsection for which each such person is accredited and the 
name of each accredited person whose accreditation has been 
withdrawn during the year.

           *       *       *       *       *       *       *


                               PUBLICITY

  Sec. 705. (a) * * *
  (b) The Secretary may also cause to be disseminated 
information regarding food, drugs, devices, tobacco products, 
or cosmetics in situations involving, in the opinion of the 
Secretary, imminent danger to health, or gross deception of the 
consumer. Nothing in this section shall be construed to 
prohibit the Secretary from collecting, reporting, and 
illustrating the results of the investigations of the 
Department.

           *       *       *       *       *       *       *


                              PRESUMPTION

  Sec. 709. In any action to enforce the requirements of this 
Act respecting a device, tobacco product, food, drug, or 
cosmetic the connection with interstate commerce required for 
jurisdiction in such action shall be presumed to exist.

           *       *       *       *       *       *       *


                   CHAPTER VIII--IMPORTS AND EXPORTS

                          IMPORTS AND EXPORTS

  Sec. 801. (a) The Secretary of the Treasury shall deliver to 
the Secretary of Health and Human Services, upon his request, 
samples of food, drugs, devices, tobacco products, and 
cosmetics which are being imported or offered for import into 
the United States, giving notice thereof to the owner or 
consignee, who may appear before the Secretary of Health and 
Human Services and have the right to introduce testimony. The 
Secretary of Health and Human Services shall furnish to the 
Secretary of the Treasury a list of establishments registered 
pursuant to subsection (i) of section 510 or section 905(h) and 
shall request that if any [drugs or devices] drugs, devices, or 
tobacco products manufactured, prepared, propagated, 
compounded, or processed in an establishment not so registered 
are imported or offered for import into the United States, 
samples of such [drugs or devices] drugs, devices, or tobacco 
products be delivered to the Secretary of Health and Human 
Services, with notice of such delivery to the owner or 
consignee, who may appear before the Secretary of Health and 
Human Services and have the right to introduce testimony. If it 
appears from the examination of such samples or otherwise that 
(1) such article has been manufactured, processed, or packed 
under insanitary conditions or, in the case of a device, the 
methods used in, or the facilities or controls used for, the 
manufacture, packing, storage, or installation of the device do 
not conform to the requirements of section 520(f), or (2) such 
article is forbidden or restricted in sale in the country in 
which it was produced or from which it was exported, or (3) 
such article is adulterated, misbranded, or in violation of 
section 505, or prohibited from introduction or delivery for 
introduction into interstate commerce under section 301(ll), 
then such article shall be refused admission, except as 
provided in subsection (b) of this section. If such article is 
subject to a requirement under section 760 or 761 and if the 
Secretary has credible evidence or information indicating that 
the responsible person (as defined in such section 760 or 761) 
has not complied with a requirement of such section 760 or 761 
with respect to any such article, or has not allowed access to 
records described in such section 760 or 761, then such article 
shall be refused admission, except as provided in subsection 
(b) of this section. The Secretary of the Treasury shall cause 
the destruction of any such article refused admission unless 
such article is exported, under regulations prescribed by the 
Secretary of the Treasury, within ninety days of the date of 
notice of such refusal or within such additional time as may be 
permitted pursuant to such regulations. Clause (2) of the third 
sentence of this paragraph shall not be construed to prohibit 
the admission of narcotic drugs the importation of which is 
permitted under the Controlled Substances Import and Export 
Act.

           *       *       *       *       *       *       *

  (e)(1) A food, drug, device, tobacco product, or cosmetic 
intended for export shall not be deemed to be adulterated or 
misbranded under this Act if it--
          (A) * * *

           *       *       *       *       *       *       *

  (p)(1) Not later than 36 months after the date of enactment 
of the Family Smoking Prevention and Tobacco Control Act, and 
annually thereafter, the Secretary shall submit to the 
Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the House of 
Representatives, a report regarding--
          (A) the nature, extent, and destination of United 
        States tobacco product exports that do not conform to 
        tobacco product standards established pursuant to this 
        Act;
          (B) the public health implications of such exports, 
        including any evidence of a negative public health 
        impact; and
          (C) recommendations or assessments of policy 
        alternatives available to Congress and the executive 
        branch to reduce any negative public health impact 
        caused by such exports.
  (2) The Secretary is authorized to establish appropriate 
information disclosure requirements to carry out this 
subsection.

           *       *       *       *       *       *       *


                      CHAPTER IX--TOBACCO PRODUCTS

SEC. 900. DEFINITIONS.

  In this chapter:
          (1) Additive.--The term ``additive'' means any 
        substance the intended use of which results or may 
        reasonably be expected to result, directly or 
        indirectly, in its becoming a component or otherwise 
        affecting the characteristic of any tobacco product 
        (including any substances intended for use as a 
        flavoring or coloring or in producing, manufacturing, 
        packing, processing, preparing, treating, packaging, 
        transporting, or holding), except that such term does 
        not include tobacco or a pesticide chemical residue in 
        or on raw tobacco or a pesticide chemical.
          (2) Brand.--The term ``brand'' means a variety of 
        tobacco product distinguished by the tobacco used, tar 
        content, nicotine content, flavoring used, size, 
        filtration, packaging, logo, registered trademark, 
        brand name, identifiable pattern of colors, or any 
        combination of such attributes.
          (3) Cigarette.--The term ``cigarette''--
                  (A) means a product that--
                          (i) is a tobacco product; and
                          (ii) meets the definition of the term 
                        ``cigarette'' in section 3(1) of the 
                        Federal Cigarette Labeling and 
                        Advertising Act; and
                  (B) includes tobacco, in any form, that is 
                functional in the product, which, because of 
                its appearance, the type of tobacco used in the 
                filler, or its packaging and labeling, is 
                likely to be offered to, or purchased by, 
                consumers as a cigarette or as roll-your-own 
                tobacco.
          (4) Cigarette tobacco.--The term ``cigarette 
        tobacco'' means any product that consists of loose 
        tobacco that is intended for use by consumers in a 
        cigarette. Unless otherwise stated, the requirements 
        applicable to cigarettes under this chapter shall also 
        apply to cigarette tobacco.
          (5) Commerce.--The term ``commerce'' has the meaning 
        given that term by section 3(2) of the Federal 
        Cigarette Labeling and Advertising Act.
          (6) Counterfeit tobacco product.--The term 
        ``counterfeit tobacco product'' means a tobacco product 
        (or the container or labeling of such a product) that, 
        without authorization, bears the trademark, trade name, 
        or other identifying mark, imprint, or device, or any 
        likeness thereof, of a tobacco product listed in a 
        registration under section 905(i)(1).
          (7) Distributor.--The term ``distributor'' as regards 
        a tobacco product means any person who furthers the 
        distribution of a tobacco product, whether domestic or 
        imported, at any point from the original place of 
        manufacture to the person who sells or distributes the 
        product to individuals for personal consumption. Common 
        carriers are not considered distributors for purposes 
        of this chapter.
          (8) Illicit trade.--The term ``illicit trade'' means 
        any practice or conduct prohibited by law which relates 
        to production, shipment, receipt, possession, 
        distribution, sale, or purchase of tobacco products 
        including any practice or conduct intended to 
        facilitate such activity.
          (9) Indian tribe.--The term ``Indian tribe'' has the 
        meaning given such term in section 4(e) of the Indian 
        Self-Determination and Education Assistance Act.
          (10) Little cigar.--The term ``little cigar'' means a 
        product that--
                  (A) is a tobacco product; and
                  (B) meets the definition of the term ``little 
                cigar'' in section 3(7) of the Federal 
                Cigarette Labeling and Advertising Act.
          (11) Nicotine.--The term ``nicotine'' means the 
        chemical substance named 3-(1-Methyl-2-pyrrolidinyl) 
        pyridine or C[10]H[14]N[2], including any salt or 
        complex of nicotine.
          (12) Package.--The term ``package'' means a pack, 
        box, carton, or container of any kind or, if no other 
        container, any wrapping (including cellophane), in 
        which a tobacco product is offered for sale, sold, or 
        otherwise distributed to consumers.
          (13) Retailer.--The term ``retailer'' means any 
        person, government, or entity who sells tobacco 
        products to individuals for personal consumption, or 
        who operates a facility where self-service displays of 
        tobacco products are permitted.
          (14) Roll-your-own tobacco.--The term ``roll-your-own 
        tobacco'' means any tobacco product which, because of 
        its appearance, type, packaging, or labeling, is 
        suitable for use and likely to be offered to, or 
        purchased by, consumers as tobacco for making 
        cigarettes.
          (15) Small tobacco product manufacturer.--The term 
        ``small tobacco product manufacturer'' means a tobacco 
        product manufacturer that employs fewer than 350 
        employees. For purposes of determining the number of 
        employees of a manufacturer under the preceding 
        sentence, the employees of a manufacturer are deemed to 
        include the employees of each entity that controls, is 
        controlled by, or is under common control with such 
        manufacturer.
          (16) Smoke constituent.--The term ``smoke 
        constituent'' means any chemical or chemical compound 
        in mainstream or sidestream tobacco smoke that either 
        transfers from any component of the cigarette to the 
        smoke or that is formed by the combustion or heating of 
        tobacco, additives, or other component of the tobacco 
        product.
          (17) Smokeless tobacco.--The term ``smokeless 
        tobacco'' means any tobacco product that consists of 
        cut, ground, powdered, or leaf tobacco and that is 
        intended to be placed in the oral or nasal cavity.
          (18) State; territory.--The terms ``State'' and 
        ``Territory'' shall have the meanings given to such 
        terms in section 201.
          (19) Tobacco product manufacturer.--The term 
        ``tobacco product manufacturer'' means any person, 
        including any repacker or relabeler, who--
                  (A) manufactures, fabricates, assembles, 
                processes, or labels a tobacco product; or
                  (B) imports a finished tobacco product for 
                sale or distribution in the United States.
          (20) Tobacco warehouse.--
                  (A) Subject to subparagraphs (B) and (C), the 
                term ``tobacco warehouse'' includes any 
                person--
                          (i) who--
                                  (I) removes foreign material 
                                from tobacco leaf through 
                                nothing other than a mechanical 
                                process;
                                  (II) humidifies tobacco leaf 
                                with nothing other than potable 
                                water in the form of steam or 
                                mist; or
                                  (III) de-stems, dries, and 
                                packs tobacco leaf for storage 
                                and shipment;
                          (ii) who performs no other actions 
                        with respect to tobacco leaf; and
                          (iii) who provides to any 
                        manufacturer to whom the person sells 
                        tobacco all information related to the 
                        person's actions described in clause 
                        (i) that is necessary for compliance 
                        with this Act.
                  (B) The term ``tobacco warehouse'' excludes 
                any person who--
                          (i) reconstitutes tobacco leaf;
                          (ii) is a manufacturer, distributor, 
                        or retailer of a tobacco product; or
                          (iii) applies any chemical, additive, 
                        or substance to the tobacco leaf other 
                        than potable water in the form of steam 
                        or mist.
                  (C) The definition of the term ``tobacco 
                warehouse'' in subparagraph (A) shall not apply 
                to the extent to which the Secretary 
                determines, through rulemaking, that regulation 
                under this chapter of the actions described in 
                such subparagraph is appropriate for the 
                protection of the public health.
          (21) United states.--The term ``United States'' means 
        the 50 States of the United States of America and the 
        District of Columbia, the Commonwealth of Puerto Rico, 
        Guam, the Virgin Islands, American Samoa, Wake Island, 
        Midway Islands, Kingman Reef, Johnston Atoll, the 
        Northern Mariana Islands, and any other trust territory 
        or possession of the United States.

SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.

  (a) In General.--Tobacco products, including modified risk 
tobacco products for which an order has been issued in 
accordance with section 911, shall be regulated by the 
Secretary under this chapter and shall not be subject to the 
provisions of chapter V.
  (b) Applicability.--This chapter shall apply to all 
cigarettes, cigarette tobacco, and smokeless tobacco and to any 
other tobacco products that the Secretary by regulation deems 
to be subject to this chapter.
  (c) Scope.--
          (1) In general.--Nothing in this chapter, or any 
        policy issued or regulation promulgated thereunder, or 
        in sections 101(a), 102, or 103 of title I, title II, 
        or title III of the Family Smoking Prevention and 
        Tobacco Control Act, shall be construed to affect, 
        expand, or limit the Secretary's authority over 
        (including the authority to determine whether products 
        may be regulated), or the regulation of, products under 
        this Act that are not tobacco products under chapter V 
        or any other chapter.
          (2) Limitation of authority.--
                  (A) In general.--The provisions of this 
                chapter shall not apply to tobacco leaf that is 
                not in the possession of a manufacturer of 
                tobacco products, or to the producers of 
                tobacco leaf, including tobacco growers, 
                tobacco warehouses, and tobacco grower 
                cooperatives, nor shall any employee of the 
                Food and Drug Administration have any authority 
                to enter onto a farm owned by a producer of 
                tobacco leaf without the written consent of 
                such producer.
                  (B) Exception.--Notwithstanding subparagraph 
                (A), if a producer of tobacco leaf is also a 
                tobacco product manufacturer or controlled by a 
                tobacco product manufacturer, the producer 
                shall be subject to this chapter in the 
                producer's capacity as a manufacturer. The 
                exception in this subparagraph shall not apply 
                to a producer of tobacco leaf who grows tobacco 
                under a contract with a tobacco product 
                manufacturer and who is not otherwise engaged 
                in the manufacturing process.
                  (C) Rule of construction.--Nothing in this 
                chapter shall be construed to grant the 
                Secretary authority to promulgate regulations 
                on any matter that involves the production of 
                tobacco leaf or a producer thereof, other than 
                activities by a manufacturer affecting 
                production.
  (d) Rulemaking Procedures.--Each rulemaking under this 
chapter shall be in accordance with chapter 5 of title 5, 
United States Code. This subsection shall not be construed to 
affect the rulemaking provisions of section 102(a) of the 
Family Smoking Prevention and Tobacco Control Act.
  (e) Center for Tobacco Products.--Not later than 90 days 
after the date of enactment of this chapter, the Secretary 
shall establish within the Food and Drug Administration the 
Center for Tobacco Products, which shall report to the 
Commissioner of Food and Drugs in the same manner as the other 
agency centers within the Food and Drug Administration. The 
Center shall be responsible for the implementation of this 
chapter and related matters assigned by the Commissioner.
  (f) Office to Assist Small Tobacco Product Manufacturers.--
The Secretary shall establish within the Food and Drug 
Administration an identifiable office to provide technical and 
other nonfinancial assistance to small tobacco product 
manufacturers to assist them in complying with the requirements 
of this Act.
  (g) Consultation Prior to Rulemaking.--Prior to promulgating 
rules under this chapter, the Secretary shall endeavor to 
consult with other Federal agencies as appropriate.

SEC. 902. ADULTERATED TOBACCO PRODUCTS.

  A tobacco product shall be deemed to be adulterated if--
          (1) it consists in whole or in part of any filthy, 
        putrid, or decomposed substance, or is otherwise 
        contaminated by any added poisonous or added 
        deleterious substance that may render the product 
        injurious to health;
          (2) it has been prepared, packed, or held under 
        insanitary conditions whereby it may have been 
        contaminated with filth, or whereby it may have been 
        rendered injurious to health;
          (3) its package is composed, in whole or in part, of 
        any poisonous or deleterious substance which may render 
        the contents injurious to health;
          (4) the manufacturer or importer of the tobacco 
        product fails to pay a user fee assessed to such 
        manufacturer or importer pursuant to section 919 by the 
        date specified in section 919 or by the 30th day after 
        final agency action on a resolution of any dispute as 
        to the amount of such fee;
          (5) it is, or purports to be or is represented as, a 
        tobacco product which is subject to a tobacco product 
        standard established under section 907 unless such 
        tobacco product is in all respects in conformity with 
        such standard;
          (6)(A) it is required by section 910(a) to have 
        premarket review and does not have an order in effect 
        under section 910(c)(1)(A)(i); or
          (B) it is in violation of an order under section 
        910(c)(1)(A);
          (7) the methods used in, or the facilities or 
        controls used for, its manufacture, packing, or storage 
        are not in conformity with applicable requirements 
        under section 906(e)(1) or an applicable condition 
        prescribed by an order under section 906(e)(2); or
          (8) it is in violation of section 911.

SEC. 903. MISBRANDED TOBACCO PRODUCTS.

  (a) In General.--A tobacco product shall be deemed to be 
misbranded--
          (1) if its labeling is false or misleading in any 
        particular;
          (2) if in package form unless it bears a label 
        containing--
                  (A) the name and place of business of the 
                tobacco product manufacturer, packer, or 
                distributor;
                  (B) an accurate statement of the quantity of 
                the contents in terms of weight, measure, or 
                numerical count;
                  (C) an accurate statement of the percentage 
                of the tobacco used in the product that is 
                domestically grown tobacco and the percentage 
                that is foreign grown tobacco; and
                  (D) the statement required under section 
                920(a),
        except that under subparagraph (B) reasonable 
        variations shall be permitted, and exemptions as to 
        small packages shall be established, by regulations 
        prescribed by the Secretary;
          (3) if any word, statement, or other information 
        required by or under authority of this chapter to 
        appear on the label or labeling is not prominently 
        placed thereon with such conspicuousness (as compared 
        with other words, statements, or designs in the 
        labeling) and in such terms as to render it likely to 
        be read and understood by the ordinary individual under 
        customary conditions of purchase and use;
          (4) if it has an established name, unless its label 
        bears, to the exclusion of any other nonproprietary 
        name, its established name prominently printed in type 
        as required by the Secretary by regulation;
          (5) if the Secretary has issued regulations requiring 
        that its labeling bear adequate directions for use, or 
        adequate warnings against use by children, that are 
        necessary for the protection of users unless its 
        labeling conforms in all respects to such regulations;
          (6) if it was manufactured, prepared, propagated, 
        compounded, or processed in an establishment not duly 
        registered under section 905(b), 905(c), 905(d), or 
        905(h), if it was not included in a list required by 
        section 905(i), if a notice or other information 
        respecting it was not provided as required by such 
        section or section 905(j), or if it does not bear such 
        symbols from the uniform system for identification of 
        tobacco products prescribed under section 905(e) as the 
        Secretary by regulation requires;
          (7) if, in the case of any tobacco product 
        distributed or offered for sale in any State--
                  (A) its advertising is false or misleading in 
                any particular; or
                  (B) it is sold or distributed in violation of 
                regulations prescribed under section 906(d);
          (8) unless, in the case of any tobacco product 
        distributed or offered for sale in any State, the 
        manufacturer, packer, or distributor thereof includes 
        in all advertisements and other descriptive printed 
        matter issued or caused to be issued by the 
        manufacturer, packer, or distributor with respect to 
        that tobacco product--
                  (A) a true statement of the tobacco product's 
                established name as described in paragraph (4), 
                printed prominently; and
                  (B) a brief statement of--
                          (i) the uses of the tobacco product 
                        and relevant warnings, precautions, 
                        side effects, and contraindications; 
                        and
                          (ii) in the case of specific tobacco 
                        products made subject to a finding by 
                        the Secretary after notice and 
                        opportunity for comment that such 
                        action is appropriate to protect the 
                        public health, a full description of 
                        the components of such tobacco product 
                        or the formula showing quantitatively 
                        each ingredient of such tobacco product 
                        to the extent required in regulations 
                        which shall be issued by the Secretary 
                        after an opportunity for a hearing;
          (9) if it is a tobacco product subject to a tobacco 
        product standard established under section 907, unless 
        it bears such labeling as may be prescribed in such 
        tobacco product standard; or
          (10) if there was a failure or refusal--
                  (A) to comply with any requirement prescribed 
                under section 904 or 908; or
                  (B) to furnish any material or information 
                required under section 909.
  (b) Prior Approval of Label Statements.--The Secretary may, 
by regulation, require prior approval of statements made on the 
label of a tobacco product. No regulation issued under this 
subsection may require prior approval by the Secretary of the 
content of any advertisement, except for modified risk tobacco 
products as provided in section 911. No advertisement of a 
tobacco product published after the date of enactment of the 
Family Smoking Prevention and Tobacco Control Act shall, with 
respect to the language of label statements as prescribed under 
section 4 of the Federal Cigarette Labeling and Advertising Act 
and section 3 of the Comprehensive Smokeless Tobacco Health 
Education Act of 1986 or the regulations issued under such 
sections, be subject to the provisions of sections 12 through 
15 of the Federal Trade Commission Act.

SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE SECRETARY.

  (a) Requirement.--Each tobacco product manufacturer or 
importer, or agents thereof, shall submit to the Secretary the 
following information:
          (1) Not later than 6 months after the date of 
        enactment of the Family Smoking Prevention and Tobacco 
        Control Act, a listing of all ingredients, including 
        tobacco, substances, compounds, and additives that are, 
        as of such date, added by the manufacturer to the 
        tobacco, paper, filter, or other part of each tobacco 
        product by brand and by quantity in each brand and 
        subbrand.
          (2) A description of the content, delivery, and form 
        of nicotine in each tobacco product measured in 
        milligrams of nicotine in accordance with regulations 
        promulgated by the Secretary in accordance with section 
        4(e) of the Federal Cigarette Labeling and Advertising 
        Act.
          (3) Beginning 3 years after the date of enactment of 
        this Act, a listing of all constituents, including 
        smoke constituents as applicable, identified by the 
        Secretary as harmful or potentially harmful to health 
        in each tobacco product, and as applicable in the smoke 
        of each tobacco product, by brand and by quantity in 
        each brand and subbrand. Effective beginning 3 years 
        after the date of enactment of this chapter, the 
        manufacturer, importer, or agent shall comply with 
        regulations promulgated under section 915 in reporting 
        information under this paragraph, where applicable.
          (4) Beginning 6 months after the date of enactment of 
        the Family Smoking Prevention and Tobacco Control Act, 
        all documents developed after the date of enactment of 
        the Family Smoking Prevention and Tobacco Control Act 
        that relate to health, toxicological, behavioral, or 
        physiologic effects of current or future tobacco 
        products, their constituents (including smoke 
        constituents), ingredients, components, and additives.
  (b) Data Submission.--At the request of the Secretary, each 
tobacco product manufacturer or importer of tobacco products, 
or agents thereof, shall submit the following:
          (1) Any or all documents (including underlying 
        scientific information) relating to research 
        activities, and research findings, conducted, 
        supported, or possessed by the manufacturer (or agents 
        thereof) on the health, toxicological, behavioral, or 
        physiologic effects of tobacco products and their 
        constituents (including smoke constituents), 
        ingredients, components, and additives.
          (2) Any or all documents (including underlying 
        scientific information) relating to research 
        activities, and research findings, conducted, 
        supported, or possessed by the manufacturer (or agents 
        thereof) that relate to the issue of whether a 
        reduction in risk to health from tobacco products can 
        occur upon the employment of technology available or 
        known to the manufacturer.
          (3) Any or all documents (including underlying 
        scientific or financial information) relating to 
        marketing research involving the use of tobacco 
        products or marketing practices and the effectiveness 
        of such practices used by tobacco manufacturers and 
        distributors.
An importer of a tobacco product not manufactured in the United 
States shall supply the information required of a tobacco 
product manufacturer under this subsection.
  (c) Time for Submission.--
          (1) In general.--At least 90 days prior to the 
        delivery for introduction into interstate commerce of a 
        tobacco product not on the market on the date of 
        enactment of the Family Smoking Prevention and Tobacco 
        Control Act, the manufacturer of such product shall 
        provide the information required under subsection (a).
          (2) Disclosure of additive.--If at any time a tobacco 
        product manufacturer adds to its tobacco products a new 
        tobacco additive or increases the quantity of an 
        existing tobacco additive, the manufacturer shall, 
        except as provided in paragraph (3), at least 90 days 
        prior to such action so advise the Secretary in 
        writing.
          (3) Disclosure of other actions.--If at any time a 
        tobacco product manufacturer eliminates or decreases an 
        existing additive, or adds or increases an additive 
        that has by regulation been designated by the Secretary 
        as an additive that is not a human or animal 
        carcinogen, or otherwise harmful to health under 
        intended conditions of use, the manufacturer shall 
        within 60 days of such action so advise the Secretary 
        in writing.
  (d) Data List.--
          (1) In general.--Not later than 3 years after the 
        date of enactment of the Family Smoking Prevention and 
        Tobacco Control Act, and annually thereafter, the 
        Secretary shall publish in a format that is 
        understandable and not misleading to a lay person, and 
        place on public display (in a manner determined by the 
        Secretary) the list established under subsection (e).
          (2) Consumer research.--The Secretary shall conduct 
        periodic consumer research to ensure that the list 
        published under paragraph (1) is not misleading to lay 
        persons. Not later than 5 years after the date of 
        enactment of the Family Smoking Prevention and Tobacco 
        Control Act, the Secretary shall submit to the 
        appropriate committees of Congress a report on the 
        results of such research, together with recommendations 
        on whether such publication should be continued or 
        modified.
  (e) Data Collection.--Not later than 24 months after the date 
of enactment of the Family Smoking Prevention and Tobacco 
Control Act, the Secretary shall establish, and periodically 
revise as appropriate, a list of harmful and potentially 
harmful constituents, including smoke constituents, to health 
in each tobacco product by brand and by quantity in each brand 
and subbrand. The Secretary shall publish a public notice 
requesting the submission by interested persons of scientific 
and other information concerning the harmful and potentially 
harmful constituents in tobacco products and tobacco smoke.

SEC. 905. ANNUAL REGISTRATION.

  (a) Definitions.--In this section:
          (1) Manufacture, preparation, compounding, or 
        processing.--The term ``manufacture, preparation, 
        compounding, or processing'' shall include repackaging 
        or otherwise changing the container, wrapper, or 
        labeling of any tobacco product package in furtherance 
        of the distribution of the tobacco product from the 
        original place of manufacture to the person who makes 
        final delivery or sale to the ultimate consumer or 
        user.
          (2) Name.--The term ``name'' shall include in the 
        case of a partnership the name of each partner and, in 
        the case of a corporation, the name of each corporate 
        officer and director, and the State of incorporation.
  (b) Registration by Owners and Operators.--On or before 
December 31 of each year, every person who owns or operates any 
establishment in any State engaged in the manufacture, 
preparation, compounding, or processing of a tobacco product or 
tobacco products shall register with the Secretary the name, 
places of business, and all such establishments of that person. 
If the enactment of this Act occurs in the second half of the 
calendar year, the Secretary shall designate a date no later 
than 6 months into the subsequent calendar year by which 
registration pursuant to this subsection shall occur.
  (c) Registration by New Owners and Operators.--Every person 
upon first engaging in the manufacture, preparation, 
compounding, or processing of a tobacco product or tobacco 
products in any establishment owned or operated in any State by 
that person shall immediately register with the Secretary that 
person's name, place of business, and such establishment.
  (d) Registration of Added Establishments.--Every person 
required to register under subsection (b) or (c) shall 
immediately register with the Secretary any additional 
establishment which that person owns or operates in any State 
and in which that person begins the manufacture, preparation, 
compounding, or processing of a tobacco product or tobacco 
products.
  (e) Uniform Product Identification System.--The Secretary may 
by regulation prescribe a uniform system for the identification 
of tobacco products and may require that persons who are 
required to list such tobacco products under subsection (i) 
shall list such tobacco products in accordance with such 
system.
  (f) Public Access to Registration Information.--The Secretary 
shall make available for inspection, to any person so 
requesting, any registration filed under this section.
  (g) Biennial Inspection of Registered Establishments.--Every 
establishment registered with the Secretary under this section 
shall be subject to inspection under section 704 or subsection 
(h), and every such establishment engaged in the manufacture, 
compounding, or processing of a tobacco product or tobacco 
products shall be so inspected by 1 or more officers or 
employees duly designated by the Secretary at least once in the 
2-year period beginning with the date of registration of such 
establishment under this section and at least once in every 
successive 2-year period thereafter.
  (h) Registration by Foreign Establishments.--Any 
establishment within any foreign country engaged in the 
manufacture, preparation, compounding, or processing of a 
tobacco product or tobacco products, shall register under this 
section under regulations promulgated by the Secretary. Such 
regulations shall require such establishment to provide the 
information required by subsection (i) and shall include 
provisions for registration of any such establishment upon 
condition that adequate and effective means are available, by 
arrangement with the government of such foreign country or 
otherwise, to enable the Secretary to determine from time to 
time whether tobacco products manufactured, prepared, 
compounded, or processed in such establishment, if imported or 
offered for import into the United States, shall be refused 
admission on any of the grounds set forth in section 801(a).
  (i) Registration Information.--
          (1) Product list.--Every person who registers with 
        the Secretary under subsection (b), (c), (d), or (h) 
        shall, at the time of registration under any such 
        subsection, file with the Secretary a list of all 
        tobacco products which are being manufactured, 
        prepared, compounded, or processed by that person for 
        commercial distribution and which have not been 
        included in any list of tobacco products filed by that 
        person with the Secretary under this paragraph or 
        paragraph (2) before such time of registration. Such 
        list shall be prepared in such form and manner as the 
        Secretary may prescribe and shall be accompanied by--
                  (A) in the case of a tobacco product 
                contained in the applicable list with respect 
                to which a tobacco product standard has been 
                established under section 907 or which is 
                subject to section 910, a reference to the 
                authority for the marketing of such tobacco 
                product and a copy of all labeling for such 
                tobacco product;
                  (B) in the case of any other tobacco product 
                contained in an applicable list, a copy of all 
                consumer information and other labeling for 
                such tobacco product, a representative sampling 
                of advertisements for such tobacco product, 
                and, upon request made by the Secretary for 
                good cause, a copy of all advertisements for a 
                particular tobacco product; and
                  (C) if the registrant filing a list has 
                determined that a tobacco product contained in 
                such list is not subject to a tobacco product 
                standard established under section 907, a brief 
                statement of the basis upon which the 
                registrant made such determination if the 
                Secretary requests such a statement with 
                respect to that particular tobacco product.
          (2) Consultation with respect to forms.--The 
        Secretary shall consult with the Secretary of the 
        Treasury in developing the forms to be used for 
        registration under this section to minimize the burden 
        on those persons required to register with both the 
        Secretary and the Tax and Trade Bureau of the 
        Department of the Treasury.
          (3) Biannual report of any change in product list.--
        Each person who registers with the Secretary under this 
        section shall report to the Secretary once during the 
        month of June of each year and once during the month of 
        December of each year the following:
                  (A) A list of each tobacco product introduced 
                by the registrant for commercial distribution 
                which has not been included in any list 
                previously filed by that person with the 
                Secretary under this subparagraph or paragraph 
                (1). A list under this subparagraph shall list 
                a tobacco product by its established name and 
                shall be accompanied by the other information 
                required by paragraph (1).
                  (B) If since the date the registrant last 
                made a report under this paragraph that person 
                has discontinued the manufacture, preparation, 
                compounding, or processing for commercial 
                distribution of a tobacco product included in a 
                list filed under subparagraph (A) or paragraph 
                (1), notice of such discontinuance, the date of 
                such discontinuance, and the identity of its 
                established name.
                  (C) If since the date the registrant reported 
                under subparagraph (B) a notice of 
                discontinuance that person has resumed the 
                manufacture, preparation, compounding, or 
                processing for commercial distribution of the 
                tobacco product with respect to which such 
                notice of discontinuance was reported, notice 
                of such resumption, the date of such 
                resumption, the identity of such tobacco 
                product by established name, and other 
                information required by paragraph (1), unless 
                the registrant has previously reported such 
                resumption to the Secretary under this 
                subparagraph.
                  (D) Any material change in any information 
                previously submitted under this paragraph or 
                paragraph (1).
  (j) Report Preceding Introduction of Certain Substantially 
Equivalent Products Into Interstate Commerce.--
          (1) In general.--Each person who is required to 
        register under this section and who proposes to begin 
        the introduction or delivery for introduction into 
        interstate commerce for commercial distribution of a 
        tobacco product intended for human use that was not 
        commercially marketed (other than for test marketing) 
        in the United States as of February 15, 2007, shall, at 
        least 90 days prior to making such introduction or 
        delivery, report to the Secretary (in such form and 
        manner as the Secretary shall prescribe)--
                  (A) the basis for such person's determination 
                that--
                          (i) the tobacco product is 
                        substantially equivalent, within the 
                        meaning of section 910, to a tobacco 
                        product commercially marketed (other 
                        than for test marketing) in the United 
                        States as of February 15, 2007, or to a 
                        tobacco product that the Secretary has 
                        previously determined, pursuant to 
                        subsection (a)(3) of section 910, is 
                        substantially equivalent and that is in 
                        compliance with the requirements of 
                        this Act; or
                          (ii) the tobacco product is modified 
                        within the meaning of paragraph (3), 
                        the modifications are to a product that 
                        is commercially marketed and in 
                        compliance with the requirements of 
                        this Act, and all of the modifications 
                        are covered by exemptions granted by 
                        the Secretary pursuant to paragraph 
                        (3); and
                  (B) action taken by such person to comply 
                with the requirements under section 907 that 
                are applicable to the tobacco product.
          (2) Application to certain post-february 15, 2007, 
        products.--A report under this subsection for a tobacco 
        product that was first introduced or delivered for 
        introduction into interstate commerce for commercial 
        distribution in the United States after February 15, 
        2007, and prior to the date that is 21 months after the 
        date of enactment of the Family Smoking Prevention and 
        Tobacco Control Act shall be submitted to the Secretary 
        not later than 21 months after such date of enactment.
          (3) Exemptions.--
                  (A) In general.--The Secretary may exempt 
                from the requirements of this subsection 
                relating to the demonstration that a tobacco 
                product is substantially equivalent within the 
                meaning of section 910, tobacco products that 
                are modified by adding or deleting a tobacco 
                additive, or increasing or decreasing the 
                quantity of an existing tobacco additive, if 
                the Secretary determines that--
                          (i) such modification would be a 
                        minor modification of a tobacco product 
                        that can be sold under this Act;
                          (ii) a report under this subsection 
                        is not necessary to ensure that 
                        permitting the tobacco product to be 
                        marketed would be appropriate for 
                        protection of the public health; and
                          (iii) an exemption is otherwise 
                        appropriate.
                  (B) Regulations.--Not later than 15 months 
                after the date of enactment of the Family 
                Smoking Prevention and Tobacco Control Act, the 
                Secretary shall issue regulations to implement 
                this paragraph.

SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO PRODUCTS.

  (a) In General.--Any requirement established by or under 
section 902, 903, 905, or 909 applicable to a tobacco product 
shall apply to such tobacco product until the applicability of 
the requirement to the tobacco product has been changed by 
action taken under section 907, section 910, section 911, or 
subsection (d) of this section, and any requirement established 
by or under section 902, 903, 905, or 909 which is inconsistent 
with a requirement imposed on such tobacco product under 
section 907, section 910, section 911, or subsection (d) of 
this section shall not apply to such tobacco product.
  (b) Information on Public Access and Comment.--Each notice of 
proposed rulemaking or other notification under section 907, 
908, 909, 910, or 911 or under this section, any other notice 
which is published in the Federal Register with respect to any 
other action taken under any such section and which states the 
reasons for such action, and each publication of findings 
required to be made in connection with rulemaking under any 
such section shall set forth--
          (1) the manner in which interested persons may 
        examine data and other information on which the notice 
        or findings is based; and
          (2) the period within which interested persons may 
        present their comments on the notice or findings 
        (including the need therefore) orally or in writing, 
        which period shall be at least 60 days but may not 
        exceed 90 days unless the time is extended by the 
        Secretary by a notice published in the Federal Register 
        stating good cause therefore.
  (c) Limited Confidentiality of Information.--Any information 
reported to or otherwise obtained by the Secretary or the 
Secretary's representative under section 903, 904, 907, 908, 
909, 910, 911, or 704, or under subsection (e) or (f) of this 
section, which is exempt from disclosure under subsection (a) 
of section 552 of title 5, United States Code, by reason of 
subsection (b)(4) of that section shall be considered 
confidential and shall not be disclosed, except that the 
information may be disclosed to other officers or employees 
concerned with carrying out this chapter, or when relevant in 
any proceeding under this chapter.
  (d) Restrictions.--
          (1) In general.--The Secretary may by regulation 
        require restrictions on the sale and distribution of a 
        tobacco product, including restrictions on the access 
        to, and the advertising and promotion of, the tobacco 
        product, if the Secretary determines that such 
        regulation would be appropriate for the protection of 
        the public health. The Secretary may by regulation 
        impose restrictions on the advertising and promotion of 
        a tobacco product consistent with and to full extent 
        permitted by the first amendment to the Constitution. 
        The finding as to whether such regulation would be 
        appropriate for the protection of the public health 
        shall be determined with respect to the risks and 
        benefits to the population as a whole, including users 
        and nonusers of the tobacco product, and taking into 
        account--
                  (A) the increased or decreased likelihood 
                that existing users of tobacco products will 
                stop using such products; and
                  (B) the increased or decreased likelihood 
                that those who do not use tobacco products will 
                start using such products.
        No such regulation may require that the sale or 
        distribution of a tobacco product be limited to the 
        written or oral authorization of a practitioner 
        licensed by law to prescribe medical products.
          (2) Label statements.--The label of a tobacco product 
        shall bear such appropriate statements of the 
        restrictions required by a regulation under subsection 
        (a) as the Secretary may in such regulation prescribe.
          (3) Limitations.--
                  (A) In general.--No restrictions under 
                paragraph (1) may--
                          (i) prohibit the sale of any tobacco 
                        product in face-to-face transactions by 
                        a specific category of retail outlets; 
                        or
                          (ii) establish a minimum age of sale 
                        of tobacco products to any person older 
                        than 18 years of age.
                  (B) Matchbooks.--For purposes of any 
                regulations issued by the Secretary, matchbooks 
                of conventional size containing not more than 
                20 paper matches, and which are customarily 
                given away for free with the purchase of 
                tobacco products, shall be considered as adult-
                written publications which shall be permitted 
                to contain advertising. Notwithstanding the 
                preceding sentence, if the Secretary finds that 
                such treatment of matchbooks is not appropriate 
                for the protection of the public health, the 
                Secretary may determine by regulation that 
                matchbooks shall not be considered adult-
                written publications.
          (4) Remote sales.--
                  (A) In general.--The Secretary shall--
                          (i) within 18 months after the date 
                        of enactment of this chapter, 
                        promulgate regulations regarding the 
                        sale and distribution of tobacco 
                        products that occur through means other 
                        than a direct, face-to-face exchange 
                        between a retailer and a consumer in 
                        order to prevent the sale and 
                        distribution of tobacco products to 
                        individuals who have not attained the 
                        minimum age established by applicable 
                        law for the purchase of such products, 
                        including requirements for age 
                        verification; and
                          (ii) within 2 years after such date 
                        of enactment, issue regulations to 
                        address the promotion and marketing of 
                        tobacco products that are sold or 
                        distributed through means other than a 
                        direct, face-to-face exchange between a 
                        retailer and a consumer in order to 
                        protect individuals who have not 
                        attained the minimum age established by 
                        applicable law for the purchase of such 
                        products.
                  (B) Relation to other authority.--Nothing in 
                this paragraph limits the authority of the 
                Secretary to take additional actions under the 
                other paragraphs of this subsection.
  (e) Good Manufacturing Practice Requirements.--
          (1) Methods, facilities, and controls to conform.--
                  (A) In general.--In applying manufacturing 
                restrictions to tobacco, the Secretary shall, 
                in accordance with subparagraph (B), prescribe 
                regulations (which may differ based on the type 
                of tobacco product involved) requiring that the 
                methods used in, and the facilities and 
                controls used for, the manufacture, 
                preproduction design validation (including a 
                process to assess the performance of a tobacco 
                product), packing, and storage of a tobacco 
                product conform to current good manufacturing 
                practice, or hazard analysis and critical 
                control point methodology, as prescribed in 
                such regulations to assure that the public 
                health is protected and that the tobacco 
                product is in compliance with this chapter. 
                Such regulations may provide for the testing of 
                raw tobacco for pesticide chemical residues 
                regardless of whether a tolerance for such 
                chemical residues has been established.
                  (B) Requirements.--The Secretary shall--
                          (i) before promulgating any 
                        regulation under subparagraph (A), 
                        afford the Tobacco Products Scientific 
                        Advisory Committee an opportunity to 
                        submit recommendations with respect to 
                        the regulation proposed to be 
                        promulgated;
                          (ii) before promulgating any 
                        regulation under subparagraph (A), 
                        afford opportunity for an oral hearing;
                          (iii) provide the Tobacco Products 
                        Scientific Advisory Committee a 
                        reasonable time to make its 
                        recommendation with respect to proposed 
                        regulations under subparagraph (A);
                          (iv) in establishing the effective 
                        date of a regulation promulgated under 
                        this subsection, take into account the 
                        differences in the manner in which the 
                        different types of tobacco products 
                        have historically been produced, the 
                        financial resources of the different 
                        tobacco product manufacturers, and the 
                        state of their existing manufacturing 
                        facilities, and shall provide for a 
                        reasonable period of time for such 
                        manufacturers to conform to good 
                        manufacturing practices; and
                          (v) not require any small tobacco 
                        product manufacturer to comply with a 
                        regulation under subparagraph (A) for 
                        at least 4 years following the 
                        effective date established by the 
                        Secretary for such regulation.
          (2) Exemptions; variances.--
                  (A) Petition.--Any person subject to any 
                requirement prescribed under paragraph (1) may 
                petition the Secretary for a permanent or 
                temporary exemption or variance from such 
                requirement. Such a petition shall be submitted 
                to the Secretary in such form and manner as the 
                Secretary shall prescribe and shall--
                          (i) in the case of a petition for an 
                        exemption from a requirement, set forth 
                        the basis for the petitioner's 
                        determination that compliance with the 
                        requirement is not required to assure 
                        that the tobacco product will be in 
                        compliance with this chapter;
                          (ii) in the case of a petition for a 
                        variance from a requirement, set forth 
                        the methods proposed to be used in, and 
                        the facilities and controls proposed to 
                        be used for, the manufacture, packing, 
                        and storage of the tobacco product in 
                        lieu of the methods, facilities, and 
                        controls prescribed by the requirement; 
                        and
                          (iii) contain such other information 
                        as the Secretary shall prescribe.
                  (B) Referral to the tobacco products 
                scientific advisory committee.--The Secretary 
                may refer to the Tobacco Products Scientific 
                Advisory Committee any petition submitted under 
                subparagraph (A). The Tobacco Products 
                Scientific Advisory Committee shall report its 
                recommendations to the Secretary with respect 
                to a petition referred to it within 60 days 
                after the date of the petition's referral. 
                Within 60 days after--
                          (i) the date the petition was 
                        submitted to the Secretary under 
                        subparagraph (A); or
                          (ii) the day after the petition was 
                        referred to the Tobacco Products 
                        Scientific Advisory Committee,
                whichever occurs later, the Secretary shall by 
                order either deny the petition or approve it.
                  (C) Approval.--The Secretary may approve--
                          (i) a petition for an exemption for a 
                        tobacco product from a requirement if 
                        the Secretary determines that 
                        compliance with such requirement is not 
                        required to assure that the tobacco 
                        product will be in compliance with this 
                        chapter; and
                          (ii) a petition for a variance for a 
                        tobacco product from a requirement if 
                        the Secretary determines that the 
                        methods to be used in, and the 
                        facilities and controls to be used for, 
                        the manufacture, packing, and storage 
                        of the tobacco product in lieu of the 
                        methods, facilities, and controls 
                        prescribed by the requirement are 
                        sufficient to assure that the tobacco 
                        product will be in compliance with this 
                        chapter.
                  (D) Conditions.--An order of the Secretary 
                approving a petition for a variance shall 
                prescribe such conditions respecting the 
                methods used in, and the facilities and 
                controls used for, the manufacture, packing, 
                and storage of the tobacco product to be 
                granted the variance under the petition as may 
                be necessary to assure that the tobacco product 
                will be in compliance with this chapter.
                  (E) Hearing.--After the issuance of an order 
                under subparagraph (B) respecting a petition, 
                the petitioner shall have an opportunity for an 
                informal hearing on such order.
          (3) Compliance.--Compliance with requirements under 
        this subsection shall not be required before the end of 
        the 3-year period following the date of enactment of 
        the Family Smoking Prevention and Tobacco Control Act.
  (f) Research and Development.--The Secretary may enter into 
contracts for research, testing, and demonstrations respecting 
tobacco products and may obtain tobacco products for research, 
testing, and demonstration purposes.

SEC. 907. TOBACCO PRODUCT STANDARDS.

  (a) In General.--
          (1) Special rules.--
                  (A) Special rule for cigarettes.--Beginning 3 
                months after the date of enactment of the 
                Family Smoking Prevention and Tobacco Control 
                Act, a cigarette or any of its component parts 
                (including the tobacco, filter, or paper) shall 
                not contain, as a constituent (including a 
                smoke constituent) or additive, an artificial 
                or natural flavor (other than tobacco or 
                menthol) or an herb or spice, including 
                strawberry, grape, orange, clove, cinnamon, 
                pineapple, vanilla, coconut, licorice, cocoa, 
                chocolate, cherry, or coffee, that is a 
                characterizing flavor of the tobacco product or 
                tobacco smoke. Nothing in this subparagraph 
                shall be construed to limit the Secretary's 
                authority to take action under this section or 
                other sections of this Act applicable to 
                menthol or any artificial or natural flavor, 
                herb, or spice not specified in this 
                subparagraph. For purposes of this section, a 
                cigarette or any of its component parts has a 
                characterizing flavor if the cigarette, its 
                tobacco smoke, or the component part imparts a 
                distinguishable taste or aroma other than 
                tobacco or menthol either prior to consumption 
                or during consumption, or is advertised or 
                marketed as having or producing a flavor, 
                taste, or aroma other than tobacco or menthol.
                  (B) Additional special rule.--No tobacco 
                product manufactured in or imported into the 
                United States shall contain foreign-grown 
                tobacco that--
                          (i) contains a level of any pesticide 
                        chemical residue in excess of any 
                        maximum permissible residue level that 
                        is applicable to domestically grown 
                        tobacco; or
                          (ii) was grown or processed using any 
                        pesticide chemical not approved under 
                        Federal law for use in domestic tobacco 
                        farming or processing.
          (2) Revision of tobacco product standards.--The 
        Secretary may revise the tobacco product standards in 
        paragraph (1) in accordance with subsection (c).
          (3) Tobacco product standards.--
                  (A) In general.--The Secretary may adopt 
                tobacco product standards in addition to those 
                in paragraph (1) if the Secretary finds that a 
                tobacco product standard is appropriate for the 
                protection of the public health.
                  (B) Determinations.--
                          (i) Considerations.--In making a 
                        finding described in subparagraph (A), 
                        the Secretary shall consider scientific 
                        evidence concerning--
                                  (I) the risks and benefits to 
                                the population as a whole, 
                                including users and nonusers of 
                                tobacco products, of the 
                                proposed standard;
                                  (II) the increased or 
                                decreased likelihood that 
                                existing users of tobacco 
                                products will stop using such 
                                products; and
                                  (III) the increased or 
                                decreased likelihood that those 
                                who do not use tobacco products 
                                will start using such products.
                          (ii) Additional considerations.--In 
                        the event that the Secretary makes a 
                        determination, set forth in a proposed 
                        tobacco product standard in a proposed 
                        rule, that it is appropriate for the 
                        protection of public health to require 
                        the reduction or elimination of an 
                        additive, constituent (including a 
                        smoke constituent), or other component 
                        of a tobacco product because the 
                        Secretary has found that the additive, 
                        constituent, or other component is or 
                        may be harmful, any party objecting to 
                        the proposed standard on the ground 
                        that the proposed standard will not 
                        reduce or eliminate the risk of illness 
                        or injury may provide for the 
                        Secretary's consideration scientific 
                        evidence that demonstrates that the 
                        proposed standard will not reduce or 
                        eliminate the risk of illness or 
                        injury.
          (4) Content of tobacco product standards.--A tobacco 
        product standard established under this section for a 
        tobacco product--
                  (A) shall include provisions that are 
                appropriate for the protection of the public 
                health, including provisions, where 
                appropriate--
                          (i) for nicotine yields of the 
                        product;
                          (ii) for the reduction or elimination 
                        of other constituents, including smoke 
                        constituents, or harmful components of 
                        the product; or
                          (iii) relating to any other 
                        requirement under subparagraph (B);
                  (B) shall, where appropriate for the 
                protection of the public health, include--
                          (i) provisions respecting the 
                        construction, components, ingredients, 
                        additives, constituents, including 
                        smoke constituents, and properties of 
                        the tobacco product;
                          (ii) provisions for the testing (on a 
                        sample basis or, if necessary, on an 
                        individual basis) of the tobacco 
                        product;
                          (iii) provisions for the measurement 
                        of the tobacco product characteristics 
                        of the tobacco product;
                          (iv) provisions requiring that the 
                        results of each or of certain of the 
                        tests of the tobacco product required 
                        to be made under clause (ii) show that 
                        the tobacco product is in conformity 
                        with the portions of the standard for 
                        which the test or tests were required; 
                        and
                          (v) a provision requiring that the 
                        sale and distribution of the tobacco 
                        product be restricted but only to the 
                        extent that the sale and distribution 
                        of a tobacco product may be restricted 
                        under a regulation under section 
                        906(d);
                  (C) shall, where appropriate, require the use 
                and prescribe the form and content of labeling 
                for the proper use of the tobacco product; and
                  (D) shall require tobacco products containing 
                foreign-grown tobacco to meet the same 
                standards applicable to tobacco products 
                containing domestically grown tobacco.
          (5) Periodic reevaluation of tobacco product 
        standards.--The Secretary shall provide for periodic 
        evaluation of tobacco product standards established 
        under this section to determine whether such standards 
        should be changed to reflect new medical, scientific, 
        or other technological data. The Secretary may provide 
        for testing under paragraph (4)(B) by any person.
          (6) Involvement of other agencies; informed 
        persons.--In carrying out duties under this section, 
        the Secretary shall endeavor to--
                  (A) use personnel, facilities, and other 
                technical support available in other Federal 
                agencies;
                  (B) consult with other Federal agencies 
                concerned with standard setting and other 
                nationally or internationally recognized 
                standard-setting entities; and
                  (C) invite appropriate participation, through 
                joint or other conferences, workshops, or other 
                means, by informed persons representative of 
                scientific, professional, industry, 
                agricultural, or consumer organizations who in 
                the Secretary's judgment can make a significant 
                contribution.
  (b) Considerations by Secretary.--
          (1) Technical achievability.--The Secretary shall 
        consider information submitted in connection with a 
        proposed standard regarding the technical achievability 
        of compliance with such standard.
          (2) Other considerations.--The Secretary shall 
        consider all other information submitted in connection 
        with a proposed standard, including information 
        concerning the countervailing effects of the tobacco 
        product standard on the health of adolescent tobacco 
        users, adult tobacco users, or nontobacco users, such 
        as the creation of a significant demand for contraband 
        or other tobacco products that do not meet the 
        requirements of this chapter and the significance of 
        such demand.
  (c) Proposed Standards.--
          (1) In general.--The Secretary shall publish in the 
        Federal Register a notice of proposed rulemaking for 
        the establishment, amendment, or revocation of any 
        tobacco product standard.
          (2) Requirements of notice.--A notice of proposed 
        rulemaking for the establishment or amendment of a 
        tobacco product standard for a tobacco product shall--
                  (A) set forth a finding with supporting 
                justification that the tobacco product standard 
                is appropriate for the protection of the public 
                health;
                  (B) invite interested persons to submit a 
                draft or proposed tobacco product standard for 
                consideration by the Secretary;
                  (C) invite interested persons to submit 
                comments on structuring the standard so that it 
                does not advantage foreign-grown tobacco over 
                domestically grown tobacco; and
                  (D) invite the Secretary of Agriculture to 
                provide any information or analysis which the 
                Secretary of Agriculture believes is relevant 
                to the proposed tobacco product standard.
          (3) Finding.--A notice of proposed rulemaking for the 
        revocation of a tobacco product standard shall set 
        forth a finding with supporting justification that the 
        tobacco product standard is no longer appropriate for 
        the protection of the public health.
          (4) Comment.--The Secretary shall provide for a 
        comment period of not less than 60 days.
  (d) Promulgation.--
          (1) In general.--After the expiration of the period 
        for comment on a notice of proposed rulemaking 
        published under subsection (c) respecting a tobacco 
        product standard and after consideration of comments 
        submitted under subsections (b) and (c) and any report 
        from the Tobacco Products Scientific Advisory 
        Committee, if the Secretary determines that the 
        standard would be appropriate for the protection of the 
        public health, the Secretary shall--
                  (A) promulgate a regulation establishing a 
                tobacco product standard and publish in the 
                Federal Register findings on the matters 
                referred to in subsection (c); or
                  (B) publish a notice terminating the 
                proceeding for the development of the standard 
                together with the reasons for such termination.
          (2) Effective date.--A regulation establishing a 
        tobacco product standard shall set forth the date or 
        dates upon which the standard shall take effect, but no 
        such regulation may take effect before 1 year after the 
        date of its publication unless the Secretary determines 
        that an earlier effective date is necessary for the 
        protection of the public health. Such date or dates 
        shall be established so as to minimize, consistent with 
        the public health, economic loss to, and disruption or 
        dislocation of, domestic and international trade. In 
        establishing such effective date or dates, the 
        Secretary shall consider information submitted in 
        connection with a proposed product standard by 
        interested parties, including manufacturers and tobacco 
        growers, regarding the technical achievability of 
        compliance with the standard, and including information 
        concerning the existence of patents that make it 
        impossible to comply in the timeframe envisioned in the 
        proposed standard. If the Secretary determines, based 
        on the Secretary's evaluation of submitted comments, 
        that a product standard can be met only by 
        manufacturers requiring substantial changes to the 
        methods of farming the domestically grown tobacco used 
        by the manufacturer, the effective date of that product 
        standard shall be not less than 2 years after the date 
        of publication of the final regulation establishing the 
        standard.
          (3) Limitation on power granted to the food and drug 
        administration.--Because of the importance of a 
        decision of the Secretary to issue a regulation--
                  (A) banning all cigarettes, all smokeless 
                tobacco products, all little cigars, all cigars 
                other than little cigars, all pipe tobacco, or 
                all roll-your-own tobacco products; or
                  (B) requiring the reduction of nicotine 
                yields of a tobacco product to zero,
        the Secretary is prohibited from taking such actions 
        under this Act.
          (4) Amendment; revocation.--
                  (A) Authority.--The Secretary, upon the 
                Secretary's own initiative or upon petition of 
                an interested person, may by a regulation, 
                promulgated in accordance with the requirements 
                of subsection (c) and paragraph (2), amend or 
                revoke a tobacco product standard.
                  (B) Effective date.--The Secretary may 
                declare a proposed amendment of a tobacco 
                product standard to be effective on and after 
                its publication in the Federal Register and 
                until the effective date of any final action 
                taken on such amendment if the Secretary 
                determines that making it so effective is in 
                the public interest.
          (5) Referral to advisory committee.--
                  (A) In general.--The Secretary may refer a 
                proposed regulation for the establishment, 
                amendment, or revocation of a tobacco product 
                standard to the Tobacco Products Scientific 
                Advisory Committee for a report and 
                recommendation with respect to any matter 
                involved in the proposed regulation which 
                requires the exercise of scientific judgment.
                  (B) Initiation of referral.--The Secretary 
                may make a referral under this paragraph--
                          (i) on the Secretary's own 
                        initiative; or
                          (ii) upon the request of an 
                        interested person that--
                                  (I) demonstrates good cause 
                                for the referral; and
                                  (II) is made before the 
                                expiration of the period for 
                                submission of comments on the 
                                proposed regulation.
                  (C) Provision of data.--If a proposed 
                regulation is referred under this paragraph to 
                the Tobacco Products Scientific Advisory 
                Committee, the Secretary shall provide the 
                Advisory Committee with the data and 
                information on which such proposed regulation 
                is based.
                  (D) Report and recommendation.--The Tobacco 
                Products Scientific Advisory Committee shall, 
                within 60 days after the referral of a proposed 
                regulation under this paragraph and after 
                independent study of the data and information 
                furnished to it by the Secretary and other data 
                and information before it, submit to the 
                Secretary a report and recommendation 
                respecting such regulation, together with all 
                underlying data and information and a statement 
                of the reason or basis for the recommendation.
                  (E) Public availability.--The Secretary shall 
                make a copy of each report and recommendation 
                under subparagraph (D) publicly available.

SEC. 908. NOTIFICATION AND OTHER REMEDIES.

  (a) Notification.--If the Secretary determines that--
          (1) a tobacco product which is introduced or 
        delivered for introduction into interstate commerce for 
        commercial distribution presents an unreasonable risk 
        of substantial harm to the public health; and
          (2) notification under this subsection is necessary 
        to eliminate the unreasonable risk of such harm and no 
        more practicable means is available under the 
        provisions of this chapter (other than this section) to 
        eliminate such risk,
the Secretary may issue such order as may be necessary to 
assure that adequate notification is provided in an appropriate 
form, by the persons and means best suited under the 
circumstances involved, to all persons who should properly 
receive such notification in order to eliminate such risk. The 
Secretary may order notification by any appropriate means, 
including public service announcements. Before issuing an order 
under this subsection, the Secretary shall consult with the 
persons who are to give notice under the order.
  (b) No Exemption From Other Liability.--Compliance with an 
order issued under this section shall not relieve any person 
from liability under Federal or State law. In awarding damages 
for economic loss in an action brought for the enforcement of 
any such liability, the value to the plaintiff in such action 
of any remedy provided under such order shall be taken into 
account.
  (c) Recall Authority.--
          (1) In general.--If the Secretary finds that there is 
        a reasonable probability that a tobacco product 
        contains a manufacturing or other defect not ordinarily 
        contained in tobacco products on the market that would 
        cause serious, adverse health consequences or death, 
        the Secretary shall issue an order requiring the 
        appropriate person (including the manufacturers, 
        importers, distributors, or retailers of the tobacco 
        product) to immediately cease distribution of such 
        tobacco product. The order shall provide the person 
        subject to the order with an opportunity for an 
        informal hearing, to be held not later than 10 days 
        after the date of the issuance of the order, on the 
        actions required by the order and on whether the order 
        should be amended to require a recall of such tobacco 
        product. If, after providing an opportunity for such a 
        hearing, the Secretary determines that inadequate 
        grounds exist to support the actions required by the 
        order, the Secretary shall vacate the order.
          (2) Amendment of order to require recall.--
                  (A) In general.--If, after providing an 
                opportunity for an informal hearing under 
                paragraph (1), the Secretary determines that 
                the order should be amended to include a recall 
                of the tobacco product with respect to which 
                the order was issued, the Secretary shall, 
                except as provided in subparagraph (B), amend 
                the order to require a recall. The Secretary 
                shall specify a timetable in which the tobacco 
                product recall will occur and shall require 
                periodic reports to the Secretary describing 
                the progress of the recall.
                  (B) Notice.--An amended order under 
                subparagraph (A)--
                          (i) shall not include recall of a 
                        tobacco product from individuals; and
                          (ii) shall provide for notice to 
                        persons subject to the risks associated 
                        with the use of such tobacco product.
                In providing the notice required by clause 
                (ii), the Secretary may use the assistance of 
                retailers and other persons who distributed 
                such tobacco product. If a significant number 
                of such persons cannot be identified, the 
                Secretary shall notify such persons under 
                section 705(b).
          (3) Remedy not exclusive.--The remedy provided by 
        this subsection shall be in addition to remedies 
        provided by subsection (a).

SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS.

  (a) In General.--Every person who is a tobacco product 
manufacturer or importer of a tobacco product shall establish 
and maintain such records, make such reports, and provide such 
information, as the Secretary may by regulation reasonably 
require to assure that such tobacco product is not adulterated 
or misbranded and to otherwise protect public health. 
Regulations prescribed under the preceding sentence--
          (1) may require a tobacco product manufacturer or 
        importer to report to the Secretary whenever the 
        manufacturer or importer receives or otherwise becomes 
        aware of information that reasonably suggests that one 
        of its marketed tobacco products may have caused or 
        contributed to a serious unexpected adverse experience 
        associated with the use of the product or any 
        significant increase in the frequency of a serious, 
        expected adverse product experience;
          (2) shall require reporting of other significant 
        adverse tobacco product experiences as determined by 
        the Secretary to be necessary to be reported;
          (3) shall not impose requirements unduly burdensome 
        to a tobacco product manufacturer or importer, taking 
        into account the cost of complying with such 
        requirements and the need for the protection of the 
        public health and the implementation of this chapter;
          (4) when prescribing the procedure for making 
        requests for reports or information, shall require that 
        each request made under such regulations for submission 
        of a report or information to the Secretary state the 
        reason or purpose for such request and identify to the 
        fullest extent practicable such report or information;
          (5) when requiring submission of a report or 
        information to the Secretary, shall state the reason or 
        purpose for the submission of such report or 
        information and identify to the fullest extent 
        practicable such report or information; and
          (6) may not require that the identity of any patient 
        or user be disclosed in records, reports, or 
        information required under this subsection unless 
        required for the medical welfare of an individual, to 
        determine risks to public health of a tobacco product, 
        or to verify a record, report, or information submitted 
        under this chapter.
In prescribing regulations under this subsection, the Secretary 
shall have due regard for the professional ethics of the 
medical profession and the interests of patients. The 
prohibitions of paragraph (6) continue to apply to records, 
reports, and information concerning any individual who has been 
a patient, irrespective of whether or when he ceases to be a 
patient.
  (b) Reports of Removals and Corrections.--
          (1) In general.--Except as provided in paragraph (2), 
        the Secretary shall by regulation require a tobacco 
        product manufacturer or importer of a tobacco product 
        to report promptly to the Secretary any corrective 
        action taken or removal from the market of a tobacco 
        product undertaken by such manufacturer or importer if 
        the removal or correction was undertaken--
                  (A) to reduce a risk to health posed by the 
                tobacco product; or
                  (B) to remedy a violation of this chapter 
                caused by the tobacco product which may present 
                a risk to health.
        A tobacco product manufacturer or importer of a tobacco 
        product who undertakes a corrective action or removal 
        from the market of a tobacco product which is not 
        required to be reported under this subsection shall 
        keep a record of such correction or removal.
          (2) Exception.--No report of the corrective action or 
        removal of a tobacco product may be required under 
        paragraph (1) if a report of the corrective action or 
        removal is required and has been submitted under 
        subsection (a).

SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TOBACCO PRODUCTS.

  (a) In General.--
          (1) New tobacco product defined.--For purposes of 
        this section the term ``new tobacco product'' means--
                  (A) any tobacco product (including those 
                products in test markets) that was not 
                commercially marketed in the United States as 
                of February 15, 2007; or
                  (B) any modification (including a change in 
                design, any component, any part, or any 
                constituent, including a smoke constituent, or 
                in the content, delivery or form of nicotine, 
                or any other additive or ingredient) of a 
                tobacco product where the modified product was 
                commercially marketed in the United States 
                after February 15, 2007.
          (2) Premarket review required.--
                  (A) New products.--An order under subsection 
                (c)(1)(A)(i) for a new tobacco product is 
                required unless--
                          (i) the manufacturer has submitted a 
                        report under section 905(j); and the 
                        Secretary has issued an order that the 
                        tobacco product--
                                  (I) is substantially 
                                equivalent to a tobacco product 
                                commercially marketed (other 
                                than for test marketing) in the 
                                United States as of February 
                                15, 2007; and
                                  (II) is in compliance with 
                                the requirements of this Act; 
                                or
                          (ii) the tobacco product is exempt 
                        from the requirements of section 905(j) 
                        pursuant to a regulation issued under 
                        section 905(j)(3).
                  (B) Application to certain post-february 15, 
                2007, products.--Subparagraph (A) shall not 
                apply to a tobacco product--
                          (i) that was first introduced or 
                        delivered for introduction into 
                        interstate commerce for commercial 
                        distribution in the United States after 
                        February 15, 2007, and prior to the 
                        date that is 21 months after the date 
                        of enactment of the Family Smoking 
                        Prevention and Tobacco Control Act; and
                          (ii) for which a report was submitted 
                        under section 905(j) within such 21-
                        month period,
                except that subparagraph (A) shall apply to the 
                tobacco product if the Secretary issues an 
                order that the tobacco product is not 
                substantially equivalent.
          (3) Substantially equivalent defined.--
                  (A) In general.--In this section and section 
                905(j), the term ``substantially equivalent'' 
                or ``substantial equivalence'' means, with 
                respect to the tobacco product being compared 
                to the predicate tobacco product, that the 
                Secretary by order has found that the tobacco 
                product--
                          (i) has the same characteristics as 
                        the predicate tobacco product; or
                          (ii) has different characteristics 
                        and the information submitted contains 
                        information, including clinical data if 
                        deemed necessary by the Secretary, that 
                        demonstrates that it is not appropriate 
                        to regulate the product under this 
                        section because the product does not 
                        raise different questions of public 
                        health.
                  (B) Characteristics.--In subparagraph (A), 
                the term ``characteristics'' means the 
                materials, ingredients, design, composition, 
                heating source, or other features of a tobacco 
                product.
                  (C) Limitation.--A tobacco product may not be 
                found to be substantially equivalent to a 
                predicate tobacco product that has been removed 
                from the market at the initiative of the 
                Secretary or that has been determined by a 
                judicial order to be misbranded or adulterated.
          (4) Health information.--
                  (A) Summary.--As part of a submission under 
                section 905(j) respecting a tobacco product, 
                the person required to file a premarket 
                notification under such section shall provide 
                an adequate summary of any health information 
                related to the tobacco product or state that 
                such information will be made available upon 
                request by any person.
                  (B) Required information.--Any summary under 
                subparagraph (A) respecting a tobacco product 
                shall contain detailed information regarding 
                data concerning adverse health effects and 
                shall be made available to the public by the 
                Secretary within 30 days of the issuance of a 
                determination that such tobacco product is 
                substantially equivalent to another tobacco 
                product.
  (b) Application.--
          (1) Contents.--An application under this section 
        shall contain--
                  (A) full reports of all information, 
                published or known to, or which should 
                reasonably be known to, the applicant, 
                concerning investigations which have been made 
                to show the health risks of such tobacco 
                product and whether such tobacco product 
                presents less risk than other tobacco products;
                  (B) a full statement of the components, 
                ingredients, additives, and properties, and of 
                the principle or principles of operation, of 
                such tobacco product;
                  (C) a full description of the methods used 
                in, and the facilities and controls used for, 
                the manufacture, processing, and, when 
                relevant, packing and installation of, such 
                tobacco product;
                  (D) an identifying reference to any tobacco 
                product standard under section 907 which would 
                be applicable to any aspect of such tobacco 
                product, and either adequate information to 
                show that such aspect of such tobacco product 
                fully meets such tobacco product standard or 
                adequate information to justify any deviation 
                from such standard;
                  (E) such samples of such tobacco product and 
                of components thereof as the Secretary may 
                reasonably require;
                  (F) specimens of the labeling proposed to be 
                used for such tobacco product; and
                  (G) such other information relevant to the 
                subject matter of the application as the 
                Secretary may require.
          (2) Referral to tobacco products scientific advisory 
        committee.--Upon receipt of an application meeting the 
        requirements set forth in paragraph (1), the 
        Secretary--
                  (A) may, on the Secretary's own initiative; 
                or
                  (B) may, upon the request of an applicant,
        refer such application to the Tobacco Products 
        Scientific Advisory Committee for reference and for 
        submission (within such period as the Secretary may 
        establish) of a report and recommendation respecting 
        the application, together with all underlying data and 
        the reasons or basis for the recommendation.
  (c) Action on Application.--
          (1) Deadline.--
                  (A) In general.--As promptly as possible, but 
                in no event later than 180 days after the 
                receipt of an application under subsection (b), 
                the Secretary, after considering the report and 
                recommendation submitted under subsection 
                (b)(2), shall--
                          (i) issue an order that the new 
                        product may be introduced or delivered 
                        for introduction into interstate 
                        commerce if the Secretary finds that 
                        none of the grounds specified in 
                        paragraph (2) of this subsection 
                        applies; or
                          (ii) issue an order that the new 
                        product may not be introduced or 
                        delivered for introduction into 
                        interstate commerce if the Secretary 
                        finds (and sets forth the basis for 
                        such finding as part of or accompanying 
                        such denial) that 1 or more grounds for 
                        denial specified in paragraph (2) of 
                        this subsection apply.
                  (B) Restrictions on sale and distribution.--
                An order under subparagraph (A)(i) may require 
                that the sale and distribution of the tobacco 
                product be restricted but only to the extent 
                that the sale and distribution of a tobacco 
                product may be restricted under a regulation 
                under section 906(d).
          (2) Denial of application.--The Secretary shall deny 
        an application submitted under subsection (b) if, upon 
        the basis of the information submitted to the Secretary 
        as part of the application and any other information 
        before the Secretary with respect to such tobacco 
        product, the Secretary finds that--
                  (A) there is a lack of a showing that 
                permitting such tobacco product to be marketed 
                would be appropriate for the protection of the 
                public health;
                  (B) the methods used in, or the facilities or 
                controls used for, the manufacture, processing, 
                or packing of such tobacco product do not 
                conform to the requirements of section 906(e);
                  (C) based on a fair evaluation of all 
                material facts, the proposed labeling is false 
                or misleading in any particular; or
                  (D) such tobacco product is not shown to 
                conform in all respects to a tobacco product 
                standard in effect under section 907, and there 
                is a lack of adequate information to justify 
                the deviation from such standard.
          (3) Denial information.--Any denial of an application 
        shall, insofar as the Secretary determines to be 
        practicable, be accompanied by a statement informing 
        the applicant of the measures required to remove such 
        application from deniable form (which measures may 
        include further research by the applicant in accordance 
        with 1 or more protocols prescribed by the Secretary).
          (4) Basis for finding.--For purposes of this section, 
        the finding as to whether the marketing of a tobacco 
        product for which an application has been submitted is 
        appropriate for the protection of the public health 
        shall be determined with respect to the risks and 
        benefits to the population as a whole, including users 
        and nonusers of the tobacco product, and taking into 
        account--
                  (A) the increased or decreased likelihood 
                that existing users of tobacco products will 
                stop using such products; and
                  (B) the increased or decreased likelihood 
                that those who do not use tobacco products will 
                start using such products.
          (5) Basis for action.--
                  (A) Investigations.--For purposes of 
                paragraph (2)(A), whether permitting a tobacco 
                product to be marketed would be appropriate for 
                the protection of the public health shall, when 
                appropriate, be determined on the basis of 
                well-controlled investigations, which may 
                include 1 or more clinical investigations by 
                experts qualified by training and experience to 
                evaluate the tobacco product.
                  (B) Other evidence.--If the Secretary 
                determines that there exists valid scientific 
                evidence (other than evidence derived from 
                investigations described in subparagraph (A)) 
                which is sufficient to evaluate the tobacco 
                product, the Secretary may authorize that the 
                determination for purposes of paragraph (2)(A) 
                be made on the basis of such evidence.
  (d) Withdrawal and Temporary Suspension.--
          (1) In general.--The Secretary shall, upon obtaining, 
        where appropriate, advice on scientific matters from 
        the Tobacco Products Scientific Advisory Committee, and 
        after due notice and opportunity for informal hearing 
        for a tobacco product for which an order was issued 
        under subsection (c)(1)(A)(i), issue an order 
        withdrawing the order if the Secretary finds--
                  (A) that the continued marketing of such 
                tobacco product no longer is appropriate for 
                the protection of the public health;
                  (B) that the application contained or was 
                accompanied by an untrue statement of a 
                material fact;
                  (C) that the applicant--
                          (i) has failed to establish a system 
                        for maintaining records, or has 
                        repeatedly or deliberately failed to 
                        maintain records or to make reports, 
                        required by an applicable regulation 
                        under section 909;
                          (ii) has refused to permit access to, 
                        or copying or verification of, such 
                        records as required by section 704; or
                          (iii) has not complied with the 
                        requirements of section 905;
                  (D) on the basis of new information before 
                the Secretary with respect to such tobacco 
                product, evaluated together with the evidence 
                before the Secretary when the application was 
                reviewed, that the methods used in, or the 
                facilities and controls used for, the 
                manufacture, processing, packing, or 
                installation of such tobacco product do not 
                conform with the requirements of section 906(e) 
                and were not brought into conformity with such 
                requirements within a reasonable time after 
                receipt of written notice from the Secretary of 
                nonconformity;
                  (E) on the basis of new information before 
                the Secretary, evaluated together with the 
                evidence before the Secretary when the 
                application was reviewed, that the labeling of 
                such tobacco product, based on a fair 
                evaluation of all material facts, is false or 
                misleading in any particular and was not 
                corrected within a reasonable time after 
                receipt of written notice from the Secretary of 
                such fact; or
                  (F) on the basis of new information before 
                the Secretary, evaluated together with the 
                evidence before the Secretary when such order 
                was issued, that such tobacco product is not 
                shown to conform in all respects to a tobacco 
                product standard which is in effect under 
                section 907, compliance with which was a 
                condition to the issuance of an order relating 
                to the application, and that there is a lack of 
                adequate information to justify the deviation 
                from such standard.
          (2) Appeal.--The holder of an application subject to 
        an order issued under paragraph (1) withdrawing an 
        order issued pursuant to subsection (c)(1)(A)(i) may, 
        by petition filed on or before the 30th day after the 
        date upon which such holder receives notice of such 
        withdrawal, obtain review thereof in accordance with 
        section 912.
          (3) Temporary suspension.--If, after providing an 
        opportunity for an informal hearing, the Secretary 
        determines there is reasonable probability that the 
        continuation of distribution of a tobacco product under 
        an order would cause serious, adverse health 
        consequences or death, that is greater than ordinarily 
        caused by tobacco products on the market, the Secretary 
        shall by order temporarily suspend the authority of the 
        manufacturer to market the product. If the Secretary 
        issues such an order, the Secretary shall proceed 
        expeditiously under paragraph (1) to withdraw such 
        application.
  (e) Service of Order.--An order issued by the Secretary under 
this section shall be served--
          (1) in person by any officer or employee of the 
        department designated by the Secretary; or
          (2) by mailing the order by registered mail or 
        certified mail addressed to the applicant at the 
        applicant's last known address in the records of the 
        Secretary.
  (f) Records.--
          (1) Additional information.--In the case of any 
        tobacco product for which an order issued pursuant to 
        subsection (c)(1)(A)(i) for an application filed under 
        subsection (b) is in effect, the applicant shall 
        establish and maintain such records, and make such 
        reports to the Secretary, as the Secretary may by 
        regulation, or by order with respect to such 
        application, prescribe on the basis of a finding that 
        such records and reports are necessary in order to 
        enable the Secretary to determine, or facilitate a 
        determination of, whether there is or may be grounds 
        for withdrawing or temporarily suspending such order.
          (2) Access to records.--Each person required under 
        this section to maintain records, and each person in 
        charge of custody thereof, shall, upon request of an 
        officer or employee designated by the Secretary, permit 
        such officer or employee at all reasonable times to 
        have access to and copy and verify such records.
  (g) Investigational Tobacco Product Exemption for 
Investigational Use.--The Secretary may exempt tobacco products 
intended for investigational use from the provisions of this 
chapter under such conditions as the Secretary may by 
regulation prescribe.

SEC. 911. MODIFIED RISK TOBACCO PRODUCTS.

  (a) In General.--No person may introduce or deliver for 
introduction into interstate commerce any modified risk tobacco 
product unless an order issued pursuant to subsection (g) is 
effective with respect to such product.
  (b) Definitions.--In this section:
          (1) Modified risk tobacco product.--The term 
        ``modified risk tobacco product'' means any tobacco 
        product that is sold or distributed for use to reduce 
        harm or the risk of tobacco-related disease associated 
        with commercially marketed tobacco products.
          (2) Sold or distributed.--
                  (A) In general.--With respect to a tobacco 
                product, the term ``sold or distributed for use 
                to reduce harm or the risk of tobacco-related 
                disease associated with commercially marketed 
                tobacco products'' means a tobacco product--
                          (i) the label, labeling, or 
                        advertising of which represents 
                        explicitly or implicitly that--
                                  (I) the tobacco product 
                                presents a lower risk of 
                                tobacco-related disease or is 
                                less harmful than one or more 
                                other commercially marketed 
                                tobacco products;
                                  (II) the tobacco product or 
                                its smoke contains a reduced 
                                level of a substance or 
                                presents a reduced exposure to 
                                a substance; or
                                  (III) the tobacco product or 
                                its smoke does not contain or 
                                is free of a substance;
                          (ii) the label, labeling, or 
                        advertising of which uses the 
                        descriptors ``light'', ``mild'', or 
                        ``low'' or similar descriptors; or
                          (iii) the tobacco product 
                        manufacturer of which has taken any 
                        action directed to consumers through 
                        the media or otherwise, other than by 
                        means of the tobacco product's label, 
                        labeling, or advertising, after the 
                        date of enactment of the Family Smoking 
                        Prevention and Tobacco Control Act, 
                        respecting the product that would be 
                        reasonably expected to result in 
                        consumers believing that the tobacco 
                        product or its smoke may present a 
                        lower risk of disease or is less 
                        harmful than one or more commercially 
                        marketed tobacco products, or presents 
                        a reduced exposure to, or does not 
                        contain or is free of, a substance or 
                        substances.
                  (B) Limitation.--No tobacco product shall be 
                considered to be ``sold or distributed for use 
                to reduce harm or the risk of tobacco-related 
                disease associated with commercially marketed 
                tobacco products'', except as described in 
                subparagraph (A).
                  (C) Smokeless tobacco product.--No smokeless 
                tobacco product shall be considered to be 
                ``sold or distributed for use to reduce harm or 
                the risk of tobacco-related disease associated 
                with commercially marketed tobacco products'' 
                solely because its label, labeling, or 
                advertising uses the following phrases to 
                describe such product and its use: ``smokeless 
                tobacco'', ``smokeless tobacco product'', ``not 
                consumed by smoking'', ``does not produce 
                smoke'', ``smokefree'', ``smoke-free'', 
                ``without smoke'', ``no smoke'', or ``not 
                smoke''.
          (3) Effective date.--The provisions of paragraph 
        (2)(A)(ii) shall take effect 12 months after the date 
        of enactment of the Family Smoking Prevention and 
        Tobacco Control Act for those products whose label, 
        labeling, or advertising contains the terms described 
        in such paragraph on such date of enactment. The 
        effective date shall be with respect to the date of 
        manufacture, provided that, in any case, 30 days after 
        such effective date, a manufacturer shall not introduce 
        into the domestic commerce of the United States any 
        product that is not in conformance with paragraph 
        (2)(A)(ii).
  (c) Tobacco Dependence Products.--A product that is intended 
to be used for the treatment of tobacco dependence, including 
smoking cessation, is not a modified risk tobacco product under 
this section if it has been approved as a drug or device by the 
Food and Drug Administration and is subject to the requirements 
of chapter V.
  (d) Filing.--Any person may file with the Secretary an 
application for a modified risk tobacco product. Such 
application shall include--
          (1) a description of the proposed product and any 
        proposed advertising and labeling;
          (2) the conditions for using the product;
          (3) the formulation of the product;
          (4) sample product labels and labeling;
          (5) all documents (including underlying scientific 
        information) relating to research findings conducted, 
        supported, or possessed by the tobacco product 
        manufacturer relating to the effect of the product on 
        tobacco-related diseases and health-related conditions, 
        including information both favorable and unfavorable to 
        the ability of the product to reduce risk or exposure 
        and relating to human health;
          (6) data and information on how consumers actually 
        use the tobacco product; and
          (7) such other information as the Secretary may 
        require.
  (e) Public Availability.--The Secretary shall make the 
application described in subsection (d) publicly available 
(except matters in the application which are trade secrets or 
otherwise confidential, commercial information) and shall 
request comments by interested persons on the information 
contained in the application and on the label, labeling, and 
advertising accompanying such application.
  (f) Advisory Committee.--
          (1) In general.--The Secretary shall refer to the 
        Tobacco Products Scientific Advisory Committee any 
        application submitted under this section.
          (2) Recommendations.--Not later than 60 days after 
        the date an application is referred to the Tobacco 
        Products Scientific Advisory Committee under paragraph 
        (1), the Advisory Committee shall report its 
        recommendations on the application to the Secretary.
  (g) Marketing.--
          (1) Modified risk products.--Except as provided in 
        paragraph (2), the Secretary shall, with respect to an 
        application submitted under this section, issue an 
        order that a modified risk product may be commercially 
        marketed only if the Secretary determines that the 
        applicant has demonstrated that such product, as it is 
        actually used by consumers, will--
                  (A) significantly reduce harm and the risk of 
                tobacco-related disease to individual tobacco 
                users; and
                  (B) benefit the health of the population as a 
                whole taking into account both users of tobacco 
                products and persons who do not currently use 
                tobacco products.
          (2) Special rule for certain products.--
                  (A) In general.--The Secretary may issue an 
                order that a tobacco product may be introduced 
                or delivered for introduction into interstate 
                commerce, pursuant to an application under this 
                section, with respect to a tobacco product that 
                may not be commercially marketed under 
                paragraph (1) if the Secretary makes the 
                findings required under this paragraph and 
                determines that the applicant has demonstrated 
                that--
                          (i) such order would be appropriate 
                        to promote the public health;
                          (ii) any aspect of the label, 
                        labeling, and advertising for such 
                        product that would cause the tobacco 
                        product to be a modified risk tobacco 
                        product under subsection (b) is limited 
                        to an explicit or implicit 
                        representation that such tobacco 
                        product or its smoke does not contain 
                        or is free of a substance or contains a 
                        reduced level of a substance, or 
                        presents a reduced exposure to a 
                        substance in tobacco smoke;
                          (iii) scientific evidence is not 
                        available and, using the best available 
                        scientific methods, cannot be made 
                        available without conducting long-term 
                        epidemiological studies for an 
                        application to meet the standards set 
                        forth in paragraph (1); and
                          (iv) the scientific evidence that is 
                        available without conducting long-term 
                        epidemiological studies demonstrates 
                        that a measurable and substantial 
                        reduction in morbidity or mortality 
                        among individual tobacco users is 
                        reasonably likely in subsequent 
                        studies.
                  (B) Additional findings required.--To issue 
                an order under subparagraph (A) the Secretary 
                must also find that the applicant has 
                demonstrated that--
                          (i) the magnitude of the overall 
                        reductions in exposure to the substance 
                        or substances which are the subject of 
                        the application is substantial, such 
                        substance or substances are harmful, 
                        and the product as actually used 
                        exposes consumers to the specified 
                        reduced level of the substance or 
                        substances;
                          (ii) the product as actually used by 
                        consumers will not expose them to 
                        higher levels of other harmful 
                        substances compared to the similar 
                        types of tobacco products then on the 
                        market unless such increases are 
                        minimal and the reasonably likely 
                        overall impact of use of the product 
                        remains a substantial and measurable 
                        reduction in overall morbidity and 
                        mortality among individual tobacco 
                        users;
                          (iii) testing of actual consumer 
                        perception shows that, as the applicant 
                        proposes to label and market the 
                        product, consumers will not be misled 
                        into believing that the product--
                                  (I) is or has been 
                                demonstrated to be less 
                                harmful; or
                                  (II) presents or has been 
                                demonstrated to present less of 
                                a risk of disease than 1 or 
                                more other commercially 
                                marketed tobacco products; and
                          (iv) issuance of an order with 
                        respect to the application is expected 
                        to benefit the health of the population 
                        as a whole taking into account both 
                        users of tobacco products and persons 
                        who do not currently use tobacco 
                        products.
                  (C) Conditions of marketing.--
                          (i) In general.--Applications subject 
                        to an order under this paragraph shall 
                        be limited to a term of not more than 5 
                        years, but may be renewed upon a 
                        finding by the Secretary that the 
                        requirements of this paragraph continue 
                        to be satisfied based on the filing of 
                        a new application.
                          (ii) Agreements by applicant.--An 
                        order under this paragraph shall be 
                        conditioned on the applicant's 
                        agreement to conduct postmarket 
                        surveillance and studies and to submit 
                        to the Secretary the results of such 
                        surveillance and studies to determine 
                        the impact of the order on consumer 
                        perception, behavior, and health and to 
                        enable the Secretary to review the 
                        accuracy of the determinations upon 
                        which the order was based in accordance 
                        with a protocol approved by the 
                        Secretary.
                          (iii) Annual submission.--The results 
                        of such postmarket surveillance and 
                        studies described in clause (ii) shall 
                        be submitted annually.
          (3) Basis.--The determinations under paragraphs (1) 
        and (2) shall be based on--
                  (A) the scientific evidence submitted by the 
                applicant; and
                  (B) scientific evidence and other information 
                that is made available to the Secretary.
          (4) Benefit to health of individuals and of 
        population as a whole.--In making the determinations 
        under paragraphs (1) and (2), the Secretary shall take 
        into account--
                  (A) the relative health risks to individuals 
                of the tobacco product that is the subject of 
                the application;
                  (B) the increased or decreased likelihood 
                that existing users of tobacco products who 
                would otherwise stop using such products will 
                switch to the tobacco product that is the 
                subject of the application;
                  (C) the increased or decreased likelihood 
                that persons who do not use tobacco products 
                will start using the tobacco product that is 
                the subject of the application;
                  (D) the risks and benefits to persons from 
                the use of the tobacco product that is the 
                subject of the application as compared to the 
                use of products for smoking cessation approved 
                under chapter V to treat nicotine dependence; 
                and
                  (E) comments, data, and information submitted 
                by interested persons.
  (h) Additional Conditions for Marketing.--
          (1) Modified risk products.--The Secretary shall 
        require for the marketing of a product under this 
        section that any advertising or labeling concerning 
        modified risk products enable the public to comprehend 
        the information concerning modified risk and to 
        understand the relative significance of such 
        information in the context of total health and in 
        relation to all of the diseases and health-related 
        conditions associated with the use of tobacco products.
          (2) Comparative claims.--
                  (A) In general.--The Secretary may require 
                for the marketing of a product under this 
                subsection that a claim comparing a tobacco 
                product to 1 or more other commercially 
                marketed tobacco products shall compare the 
                tobacco product to a commercially marketed 
                tobacco product that is representative of that 
                type of tobacco product on the market (for 
                example the average value of the top 3 brands 
                of an established regular tobacco product).
                  (B) Quantitative comparisons.--The Secretary 
                may also require, for purposes of subparagraph 
                (A), that the percent (or fraction) of change 
                and identity of the reference tobacco product 
                and a quantitative comparison of the amount of 
                the substance claimed to be reduced shall be 
                stated in immediate proximity to the most 
                prominent claim.
          (3) Label disclosure.--
                  (A) In general.--The Secretary may require 
                the disclosure on the label of other substances 
                in the tobacco product, or substances that may 
                be produced by the consumption of that tobacco 
                product, that may affect a disease or health-
                related condition or may increase the risk of 
                other diseases or health-related conditions 
                associated with the use of tobacco products.
                  (B) Conditions of use.--If the conditions of 
                use of the tobacco product may affect the risk 
                of the product to human health, the Secretary 
                may require the labeling of conditions of use.
          (4) Time.--An order issued under subsection (g)(1) 
        shall be effective for a specified period of time.
          (5) Advertising.--The Secretary may require, with 
        respect to a product for which an applicant obtained an 
        order under subsection (g)(1), that the product comply 
        with requirements relating to advertising and promotion 
        of the tobacco product.
  (i) Postmarket Surveillance and Studies.--
          (1) In general.--The Secretary shall require, with 
        respect to a product for which an applicant obtained an 
        order under subsection (g)(1), that the applicant 
        conduct postmarket surveillance and studies for such a 
        tobacco product to determine the impact of the order 
        issuance on consumer perception, behavior, and health, 
        to enable the Secretary to review the accuracy of the 
        determinations upon which the order was based, and to 
        provide information that the Secretary determines is 
        otherwise necessary regarding the use or health risks 
        involving the tobacco product. The results of 
        postmarket surveillance and studies shall be submitted 
        to the Secretary on an annual basis.
          (2) Surveillance protocol.--Each applicant required 
        to conduct a surveillance of a tobacco product under 
        paragraph (1) shall, within 30 days after receiving 
        notice that the applicant is required to conduct such 
        surveillance, submit, for the approval of the 
        Secretary, a protocol for the required surveillance. 
        The Secretary, within 60 days of the receipt of such 
        protocol, shall determine if the principal investigator 
        proposed to be used in the surveillance has sufficient 
        qualifications and experience to conduct such 
        surveillance and if such protocol will result in 
        collection of the data or other information designated 
        by the Secretary as necessary to protect the public 
        health.
  (j) Withdrawal of Authorization.--The Secretary, after an 
opportunity for an informal hearing, shall withdraw an order 
under subsection (g) if the Secretary determines that--
          (1) the applicant, based on new information, can no 
        longer make the demonstrations required under 
        subsection (g), or the Secretary can no longer make the 
        determinations required under subsection (g);
          (2) the application failed to include material 
        information or included any untrue statement of 
        material fact;
          (3) any explicit or implicit representation that the 
        product reduces risk or exposure is no longer valid, 
        including if--
                  (A) a tobacco product standard is established 
                pursuant to section 907;
                  (B) an action is taken that affects the risks 
                presented by other commercially marketed 
                tobacco products that were compared to the 
                product that is the subject of the application; 
                or
                  (C) any postmarket surveillance or studies 
                reveal that the order is no longer consistent 
                with the protection of the public health;
          (4) the applicant failed to conduct or submit the 
        postmarket surveillance and studies required under 
        subsection (g)(2)(C)(ii) or subsection (i); or
          (5) the applicant failed to meet a condition imposed 
        under subsection (h).
  (k) Chapter IV or V.--A product for which the Secretary has 
issued an order pursuant to subsection (g) shall not be subject 
to chapter IV or V.
  (l) Implementing Regulations or Guidance.--
          (1) Scientific evidence.--Not later than 2 years 
        after the date of enactment of the Family Smoking 
        Prevention and Tobacco Control Act, the Secretary shall 
        issue regulations or guidance (or any combination 
        thereof) on the scientific evidence required for 
        assessment and ongoing review of modified risk tobacco 
        products. Such regulations or guidance shall--
                  (A) to the extent that adequate scientific 
                evidence exists, establish minimum standards 
                for scientific studies needed prior to issuing 
                an order under subsection (g) to show that a 
                substantial reduction in morbidity or mortality 
                among individual tobacco users occurs for 
                products described in subsection (g)(1) or is 
                reasonably likely for products described in 
                subsection (g)(2);
                  (B) include validated biomarkers, 
                intermediate clinical endpoints, and other 
                feasible outcome measures, as appropriate;
                  (C) establish minimum standards for 
                postmarket studies, that shall include regular 
                and long-term assessments of health outcomes 
                and mortality, intermediate clinical endpoints, 
                consumer perception of harm reduction, and the 
                impact on quitting behavior and new use of 
                tobacco products, as appropriate;
                  (D) establish minimum standards for required 
                postmarket surveillance, including ongoing 
                assessments of consumer perception;
                  (E) require that data from the required 
                studies and surveillance be made available to 
                the Secretary prior to the decision on renewal 
                of a modified risk tobacco product; and
                  (F) establish a reasonable timetable for the 
                Secretary to review an application under this 
                section.
          (2) Consultation.--The regulations or guidance issued 
        under paragraph (1) shall be developed in consultation 
        with the Institute of Medicine, and with the input of 
        other appropriate scientific and medical experts, on 
        the design and conduct of such studies and 
        surveillance.
          (3) Revision.--The regulations or guidance under 
        paragraph (1) shall be revised on a regular basis as 
        new scientific information becomes available.
          (4) New tobacco products.--Not later than 2 years 
        after the date of enactment of the Family Smoking 
        Prevention and Tobacco Control Act, the Secretary shall 
        issue a regulation or guidance that permits the filing 
        of a single application for any tobacco product that is 
        a new tobacco product under section 910 and which the 
        applicant seeks to commercially market under this 
        section.
  (m) Distributors.--Except as provided in this section, no 
distributor may take any action, after the date of enactment of 
the Family Smoking Prevention and Tobacco Control Act, with 
respect to a tobacco product that would reasonably be expected 
to result in consumers believing that the tobacco product or 
its smoke may present a lower risk of disease or is less 
harmful than one or more commercially marketed tobacco 
products, or presents a reduced exposure to, or does not 
contain or is free of, a substance or substances.

SEC. 912. JUDICIAL REVIEW.

  (a) Right To Review.--
          (1) In general.--Not later than 30 days after--
                  (A) the promulgation of a regulation under 
                section 907 establishing, amending, or revoking 
                a tobacco product standard; or
                  (B) a denial of an application under section 
                910(c),
        any person adversely affected by such regulation or 
        denial may file a petition for judicial review of such 
        regulation or denial with the United States Court of 
        Appeals for the District of Columbia Circuit or for the 
        circuit in which such person resides or has their 
        principal place of business.
          (2) Requirements.--
                  (A) Copy of petition.--A copy of the petition 
                filed under paragraph (1) shall be transmitted 
                by the clerk of the court involved to the 
                Secretary.
                  (B) Record of proceedings.--On receipt of a 
                petition under subparagraph (A), the Secretary 
                shall file in the court in which such petition 
                was filed--
                          (i) the record of the proceedings on 
                        which the regulation or order was 
                        based; and
                          (ii) a statement of the reasons for 
                        the issuance of such a regulation or 
                        order.
                  (C) Definition of record.--In this section, 
                the term ``record'' means--
                          (i) all notices and other matter 
                        published in the Federal Register with 
                        respect to the regulation or order 
                        reviewed;
                          (ii) all information submitted to the 
                        Secretary with respect to such 
                        regulation or order;
                          (iii) proceedings of any panel or 
                        advisory committee with respect to such 
                        regulation or order;
                          (iv) any hearing held with respect to 
                        such regulation or order; and
                          (v) any other information identified 
                        by the Secretary, in the administrative 
                        proceeding held with respect to such 
                        regulation or order, as being relevant 
                        to such regulation or order.
  (b) Standard of Review.--Upon the filing of the petition 
under subsection (a) for judicial review of a regulation or 
order, the court shall have jurisdiction to review the 
regulation or order in accordance with chapter 7 of title 5, 
United States Code, and to grant appropriate relief, including 
interim relief, as provided for in such chapter. A regulation 
or denial described in subsection (a) shall be reviewed in 
accordance with section 706(2)(A) of title 5, United States 
Code.
  (c) Finality of Judgment.--The judgment of the court 
affirming or setting aside, in whole or in part, any regulation 
or order shall be final, subject to review by the Supreme Court 
of the United States upon certiorari or certification, as 
provided in section 1254 of title 28, United States Code.
  (d) Other Remedies.--The remedies provided for in this 
section shall be in addition to, and not in lieu of, any other 
remedies provided by law.
  (e) Regulations and Orders Must Recite Basis in Record.--To 
facilitate judicial review, a regulation or order issued under 
section 906, 907, 908, 909, 910, or 916 shall contain a 
statement of the reasons for the issuance of such regulation or 
order in the record of the proceedings held in connection with 
its issuance.

SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS.

  The Secretary shall issue regulations to require that retail 
establishments for which the predominant business is the sale 
of tobacco products comply with any advertising restrictions 
applicable to retail establishments accessible to individuals 
under the age of 18.

SEC. 914. JURISDICTION OF AND COORDINATION WITH THE FEDERAL TRADE 
                    COMMISSION.

  (a) Jurisdiction.--
          (1) In general.--Except where expressly provided in 
        this chapter, nothing in this chapter shall be 
        construed as limiting or diminishing the authority of 
        the Federal Trade Commission to enforce the laws under 
        its jurisdiction with respect to the advertising, sale, 
        or distribution of tobacco products.
          (2) Enforcement.--Any advertising that violates this 
        chapter or a provision of the regulations referred to 
        in section 102 of the Family Smoking Prevention and 
        Tobacco Control Act, is an unfair or deceptive act or 
        practice under section 5(a) of the Federal Trade 
        Commission Act and shall be considered a violation of a 
        rule promulgated under section 18 of that Act.
  (b) Coordination.--With respect to the requirements of 
section 4 of the Federal Cigarette Labeling and Advertising Act 
and section 3 of the Comprehensive Smokeless Tobacco Health 
Education Act of 1986--
          (1) the Chairman of the Federal Trade Commission 
        shall coordinate with the Secretary concerning the 
        enforcement of such Act as such enforcement relates to 
        unfair or deceptive acts or practices in the 
        advertising of cigarettes or smokeless tobacco; and
          (2) the Secretary shall consult with the Chairman of 
        such Commission in revising the label statements and 
        requirements under such sections.

SEC. 915. REGULATION REQUIREMENT.

  (a) Testing, Reporting, and Disclosure.--Not later than 36 
months after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act, the Secretary shall 
promulgate regulations under this Act that meet the 
requirements of subsection (b).
  (b) Contents of Rules.--The regulations promulgated under 
subsection (a)--
          (1) shall require testing and reporting of tobacco 
        product constituents, ingredients, and additives, 
        including smoke constituents, by brand and subbrand 
        that the Secretary determines should be tested to 
        protect the public health; and
          (2) may require that tobacco product manufacturers, 
        packagers, or importers make disclosures relating to 
        the results of the testing of tar and nicotine through 
        labels or advertising or other appropriate means, and 
        make disclosures regarding the results of the testing 
        of other constituents, including smoke constituents, 
        ingredients, or additives, that the Secretary 
        determines should be disclosed to the public to protect 
        the public health and will not mislead consumers about 
        the risk of tobacco-related disease.
  (c) Authority.--The Secretary shall have the authority under 
this chapter to conduct or to require the testing, reporting, 
or disclosure of tobacco product constituents, including smoke 
constituents.
  (d) Small Tobacco Product Manufacturers.--
          (1) First compliance date.--The initial regulations 
        promulgated under subsection (a) shall not impose 
        requirements on small tobacco product manufacturers 
        before the later of--
                  (A) the end of the 2-year period following 
                the final promulgation of such regulations; and
                  (B) the initial date set by the Secretary for 
                compliance with such regulations by 
                manufacturers that are not small tobacco 
                product manufacturers.
          (2) Testing and reporting initial compliance 
        period.--
                  (A) 4-year period.--The initial regulations 
                promulgated under subsection (a) shall give 
                each small tobacco product manufacturer a 4-
                year period over which to conduct testing and 
                reporting for all of its tobacco products. 
                Subject to paragraph (1), the end of the first 
                year of such 4-year period shall coincide with 
                the initial date of compliance under this 
                section set by the Secretary with respect to 
                manufacturers that are not small tobacco 
                product manufacturers or the end of the 2-year 
                period following the final promulgation of such 
                regulations, as described in paragraph (1)(A). 
                A small tobacco product manufacturer shall be 
                required--
                          (i) to conduct such testing and 
                        reporting for 25 percent of its tobacco 
                        products during each year of such 4-
                        year period; and
                          (ii) to conduct such testing and 
                        reporting for its largest-selling 
                        tobacco products (as determined by the 
                        Secretary) before its other tobacco 
                        products, or in such other order of 
                        priority as determined by the 
                        Secretary.
                  (B) Case-by-case delay.--Notwithstanding 
                subparagraph (A), the Secretary may, on a case-
                by-case basis, delay the date by which an 
                individual small tobacco product manufacturer 
                must conduct testing and reporting for its 
                tobacco products under this section based upon 
                a showing of undue hardship to such 
                manufacturer. Notwithstanding the preceding 
                sentence, the Secretary shall not extend the 
                deadline for a small tobacco product 
                manufacturer to conduct testing and reporting 
                for all of its tobacco products beyond a total 
                of 5 years after the initial date of compliance 
                under this section set by the Secretary with 
                respect to manufacturers that are not small 
                tobacco product manufacturers.
          (3) Subsequent and additional testing and 
        reporting.--The regulations promulgated under 
        subsection (a) shall provide that, with respect to any 
        subsequent or additional testing and reporting of 
        tobacco products required under this section, such 
        testing and reporting by a small tobacco product 
        manufacturer shall be conducted in accordance with the 
        timeframes described in paragraph (2)(A), except that, 
        in the case of a new product, or if there has been a 
        modification described in section 910(a)(1)(B) of any 
        product of a small tobacco product manufacturer since 
        the last testing and reporting required under this 
        section, the Secretary shall require that any 
        subsequent or additional testing and reporting be 
        conducted in accordance with the same timeframe 
        applicable to manufacturers that are not small tobacco 
        product manufacturers.
          (4) Joint laboratory testing services.--The Secretary 
        shall allow any 2 or more small tobacco product 
        manufacturers to join together to purchase laboratory 
        testing services required by this section on a group 
        basis in order to ensure that such manufacturers 
        receive access to, and fair pricing of, such testing 
        services.
  (e) Extensions for Limited Laboratory Capacity.--
          (1) In general.--The regulations promulgated under 
        subsection (a) shall provide that a small tobacco 
        product manufacturer shall not be considered to be in 
        violation of this section before the deadline 
        applicable under paragraphs (3) and (4), if--
                  (A) the tobacco products of such manufacturer 
                are in compliance with all other requirements 
                of this chapter; and
                  (B) the conditions described in paragraph (2) 
                are met.
          (2) Conditions.--Notwithstanding the requirements of 
        this section, the Secretary may delay the date by which 
        a small tobacco product manufacturer must be in 
        compliance with the testing and reporting required by 
        this section until such time as the testing is reported 
        if, not later than 90 days before the deadline for 
        reporting in accordance with this section, a small 
        tobacco product manufacturer provides evidence to the 
        Secretary demonstrating that--
                  (A) the manufacturer has submitted the 
                required products for testing to a laboratory 
                and has done so sufficiently in advance of the 
                deadline to create a reasonable expectation of 
                completion by the deadline;
                  (B) the products currently are awaiting 
                testing by the laboratory; and
                  (C) neither that laboratory nor any other 
                laboratory is able to complete testing by the 
                deadline at customary, nonexpedited testing 
                fees.
          (3) Extension.--The Secretary, taking into account 
        the laboratory testing capacity that is available to 
        tobacco product manufacturers, shall review and verify 
        the evidence submitted by a small tobacco product 
        manufacturer in accordance with paragraph (2). If the 
        Secretary finds that the conditions described in such 
        paragraph are met, the Secretary shall notify the small 
        tobacco product manufacturer that the manufacturer 
        shall not be considered to be in violation of the 
        testing and reporting requirements of this section 
        until the testing is reported or until 1 year after the 
        reporting deadline has passed, whichever occurs sooner. 
        If, however, the Secretary has not made a finding 
        before the reporting deadline, the manufacturer shall 
        not be considered to be in violation of such 
        requirements until the Secretary finds that the 
        conditions described in paragraph (2) have not been 
        met, or until 1 year after the reporting deadline, 
        whichever occurs sooner.
          (4) Additional extension.--In addition to the time 
        that may be provided under paragraph (3), the Secretary 
        may provide further extensions of time, in increments 
        of no more than 1 year, for required testing and 
        reporting to occur if the Secretary determines, based 
        on evidence properly and timely submitted by a small 
        tobacco product manufacturer in accordance with 
        paragraph (2), that a lack of available laboratory 
        capacity prevents the manufacturer from completing the 
        required testing during the period described in 
        paragraph (3).
  (f) Rule of Construction.--Nothing in subsection (d) or (e) 
shall be construed to authorize the extension of any deadline, 
or to otherwise affect any timeframe, under any provision of 
this Act or the Family Smoking Prevention and Tobacco Control 
Act other than this section.

SEC. 916. PRESERVATION OF STATE AND LOCAL AUTHORITY.

  (a) In General.--
          (1) Preservation.--Except as provided in paragraph 
        (2)(A), nothing in this chapter, or rules promulgated 
        under this chapter, shall be construed to limit the 
        authority of a Federal agency (including the Armed 
        Forces), a State or political subdivision of a State, 
        or the government of an Indian tribe to enact, adopt, 
        promulgate, and enforce any law, rule, regulation, or 
        other measure with respect to tobacco products that is 
        in addition to, or more stringent than, requirements 
        established under this chapter, including a law, rule, 
        regulation, or other measure relating to or prohibiting 
        the sale, distribution, possession, exposure to, access 
        to, advertising and promotion of, or use of tobacco 
        products by individuals of any age, information 
        reporting to the State, or measures relating to fire 
        safety standards for tobacco products. No provision of 
        this chapter shall limit or otherwise affect any State, 
        Tribal, or local taxation of tobacco products.
          (2) Preemption of certain state and local 
        requirements.--
                  (A) In general.--No State or political 
                subdivision of a State may establish or 
                continue in effect with respect to a tobacco 
                product any requirement which is different 
                from, or in addition to, any requirement under 
                the provisions of this chapter relating to 
                tobacco product standards, premarket review, 
                adulteration, misbranding, labeling, 
                registration, good manufacturing standards, or 
                modified risk tobacco products.
                  (B) Exception.--Subparagraph (A) does not 
                apply to requirements relating to the sale, 
                distribution, possession, information reporting 
                to the State, exposure to, access to, the 
                advertising and promotion of, or use of, 
                tobacco products by individuals of any age, or 
                relating to fire safety standards for tobacco 
                products. Information disclosed to a State 
                under subparagraph (A) that is exempt from 
                disclosure under section 552(b)(4) of title 5, 
                United States Code, shall be treated as a trade 
                secret and confidential information by the 
                State.
  (b) Rule of Construction Regarding Product Liability.--No 
provision of this chapter relating to a tobacco product shall 
be construed to modify or otherwise affect any action or the 
liability of any person under the product liability law of any 
State.

SEC. 917. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.

  (a) Establishment.--Not later than 1 year after the date of 
enactment of the Family Smoking Prevention and Tobacco Control 
Act, the Secretary shall establish a 12-member advisory 
committee, to be known as the Tobacco Products Scientific 
Advisory Committee (in this section referred to as the 
``Advisory Committee'').
  (b) Membership.--
          (1) In general.--
                  (A) Members.--The Secretary shall appoint as 
                members of the Tobacco Products Scientific 
                Advisory Committee individuals who are 
                technically qualified by training and 
                experience in medicine, medical ethics, 
                science, or technology involving the 
                manufacture, evaluation, or use of tobacco 
                products, who are of appropriately diversified 
                professional backgrounds. The committee shall 
                be composed of--
                          (i) 7 individuals who are physicians, 
                        dentists, scientists, or health care 
                        professionals practicing in the area of 
                        oncology, pulmonology, cardiology, 
                        toxicology, pharmacology, addiction, or 
                        any other relevant specialty;
                          (ii) 1 individual who is an officer 
                        or employee of a State or local 
                        government or of the Federal 
                        Government;
                          (iii) 1 individual as a 
                        representative of the general public;
                          (iv) 1 individual as a representative 
                        of the interests of the tobacco 
                        manufacturing industry;
                          (v) 1 individual as a representative 
                        of the interests of the small business 
                        tobacco manufacturing industry, which 
                        position may be filled on a rotating, 
                        sequential basis by representatives of 
                        different small business tobacco 
                        manufacturers based on areas of 
                        expertise relevant to the topics being 
                        considered by the Advisory Committee; 
                        and
                          (vi) 1 individual as a representative 
                        of the interests of the tobacco 
                        growers.
                  (B) Nonvoting members.--The members of the 
                committee appointed under clauses (iv), (v), 
                and (vi) of subparagraph (A) shall serve as 
                consultants to those described in clauses (i) 
                through (iii) of subparagraph (A) and shall be 
                nonvoting representatives.
                  (C) Conflicts of interest.--No members of the 
                committee, other than members appointed 
                pursuant to clauses (iv), (v), and (vi) of 
                subparagraph (A) shall, during the member's 
                tenure on the committee or for the 18-month 
                period prior to becoming such a member, receive 
                any salary, grants, or other payments or 
                support from any business that manufactures, 
                distributes, markets, or sells cigarettes or 
                other tobacco products.
          (2) Limitation.--The Secretary may not appoint to the 
        Advisory Committee any individual who is in the regular 
        full-time employ of the Food and Drug Administration or 
        any agency responsible for the enforcement of this Act. 
        The Secretary may appoint Federal officials as ex 
        officio members.
          (3) Chairperson.--The Secretary shall designate 1 of 
        the members appointed under clauses (i), (ii), and 
        (iii) of paragraph (1)(A) to serve as chairperson.
  (c) Duties.--The Tobacco Products Scientific Advisory 
Committee shall provide advice, information, and 
recommendations to the Secretary--
          (1) as provided in this chapter;
          (2) on the effects of the alteration of the nicotine 
        yields from tobacco products;
          (3) on whether there is a threshold level below which 
        nicotine yields do not produce dependence on the 
        tobacco product involved; and
          (4) on its review of other safety, dependence, or 
        health issues relating to tobacco products as requested 
        by the Secretary.
  (d) Compensation; Support; FACA.--
          (1) Compensation and travel.--Members of the Advisory 
        Committee who are not officers or employees of the 
        United States, while attending conferences or meetings 
        of the committee or otherwise engaged in its business, 
        shall be entitled to receive compensation at rates to 
        be fixed by the Secretary, which may not exceed the 
        daily equivalent of the rate in effect under the Senior 
        Executive Schedule under section 5382 of title 5, 
        United States Code, for each day (including travel 
        time) they are so engaged; and while so serving away 
        from their homes or regular places of business each 
        member may be allowed travel expenses, including per 
        diem in lieu of subsistence, as authorized by section 
        5703 of title 5, United States Code, for persons in the 
        Government service employed intermittently.
          (2) Administrative support.--The Secretary shall 
        furnish the Advisory Committee clerical and other 
        assistance.
          (3) Nonapplication of faca.--Section 14 of the 
        Federal Advisory Committee Act does not apply to the 
        Advisory Committee.
  (e) Proceedings of Advisory Panels and Committees.--The 
Advisory Committee shall make and maintain a transcript of any 
proceeding of the panel or committee. Each such panel and 
committee shall delete from any transcript made under this 
subsection information which is exempt from disclosure under 
section 552(b) of title 5, United States Code.

SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.

  (a) In General.--The Secretary shall--
          (1) at the request of the applicant, consider 
        designating products for smoking cessation, including 
        nicotine replacement products as fast track research 
        and approval products within the meaning of section 
        506;
          (2) consider approving the extended use of nicotine 
        replacement products (such as nicotine patches, 
        nicotine gum, and nicotine lozenges) for the treatment 
        of tobacco dependence; and
          (3) review and consider the evidence for additional 
        indications for nicotine replacement products, such as 
        for craving relief or relapse prevention.
  (b) Report on Innovative Products.--
          (1) In general.--Not later than 3 years after the 
        date of enactment of the Family Smoking Prevention and 
        Tobacco Control Act, the Secretary, after consultation 
        with recognized scientific, medical, and public health 
        experts (including both Federal agencies and 
        nongovernmental entities, the Institute of Medicine of 
        the National Academy of Sciences, and the Society for 
        Research on Nicotine and Tobacco), shall submit to the 
        Congress a report that examines how best to regulate, 
        promote, and encourage the development of innovative 
        products and treatments (including nicotine-based and 
        non-nicotine-based products and treatments) to better 
        achieve, in a manner that best protects and promotes 
        the public health--
                  (A) total abstinence from tobacco use;
                  (B) reductions in consumption of tobacco; and
                  (C) reductions in the harm associated with 
                continued tobacco use.
          (2) Recommendations.--The report under paragraph (1) 
        shall include the recommendations of the Secretary on 
        how the Food and Drug Administration should coordinate 
        and facilitate the exchange of information on such 
        innovative products and treatments among relevant 
        offices and centers within the Administration and 
        within the National Institutes of Health, the Centers 
        for Disease Control and Prevention, and other relevant 
        agencies.

SEC. 919. USER FEE.

  (a) Establishment of Quarterly User Fee.--The Secretary shall 
assess a quarterly user fee with respect to every quarter of 
each fiscal year commencing fiscal year 2008, calculated in 
accordance with this section, upon each manufacturer and 
importer of tobacco products subject to this chapter.
  (b) Funding of FDA Regulation of Tobacco Products.--
          (1) In general.--The Secretary shall make user fees 
        collected pursuant to subsection (c)(1) available to 
        pay, in each fiscal year beginning with fiscal year 
        2008, for the costs of the activities of the Food and 
        Drug Administration related to the regulation of 
        tobacco products under this chapter and the Family 
        Smoking Prevention and Tobacco Control Act. No fees 
        collected pursuant to subsection (c)(1) may be used by 
        the Secretary for any other costs.
          (2) Availability.--Subject to paragraph (1), fees 
        collected pursuant to subsection (c)(1) shall be 
        available to the Secretary without further 
        appropriation in the following amounts:
                  (A) For fiscal year 2008, $85,000,000.
                  (B) For fiscal year 2009, $235,000,000.
                  (C) For fiscal year 2010, $450,000,000.
                  (D) For fiscal year 2011, $477,000,000.
                  (E) For fiscal year 2012, $505,000,000.
                  (F) For fiscal year 2013, $534,000,000.
                  (G) For fiscal year 2014, $566,000,000.
                  (H) For fiscal year 2015, $599,000,000.
                  (I) For fiscal year 2016, $635,000,000.
                  (J) For fiscal year 2017, $672,000,000.
                  (K) For fiscal year 2018 and each subsequent 
                fiscal year, $712,000,000.
        Fees made available to the Secretary under this 
        paragraph shall remain available until expended.
          (3) Offsetting receipts.--Fees collected pursuant to 
        subsection (c)(1) shall be recorded as offsetting 
        receipts.
          (4) Prohibition against use of other funds.--
                  (A) In general.--Except as provided in 
                subparagraph (B), fees collected pursuant to 
                this section shall be the only funds used to 
                pay the costs of the activities of the Food and 
                Drug Administration related to the regulation 
                of tobacco products under this chapter and the 
                Family Smoking Prevention and Tobacco Control 
                Act.
                  (B) Startup costs.--Subparagraph (A) shall 
                not apply until the date on which the Secretary 
                has collected fees pursuant to this section for 
                2 fiscal year quarters. Until such date, 
                amounts available to the Food and Drug 
                Administration (other than fees collected 
                pursuant to this section) may be used to pay 
                the costs described in subparagraph (A), 
                provided that such amounts are reimbursed 
                through such fees.
  (c) Assessment of User Fee.--
          (1) Amount of assessment.--The assessment under this 
        section for--
                  (A) fiscal year 2008 shall be $90,100,000;
                  (B) fiscal year 2009 shall be $249,100,000;
                  (C) fiscal year 2010 shall be $477,000,000;
                  (D) fiscal year 2011 shall be $505,620,000;
                  (E) fiscal year 2012 shall be $535,300,000;
                  (F) fiscal year 2013 shall be $566,040,000;
                  (G) fiscal year 2014 shall be $599,960,000;
                  (H) fiscal year 2015 shall be $634,940,000;
                  (I) fiscal year 2016 shall be $673,100,000;
                  (J) fiscal year 2017 shall be $712,320,000; 
                and
                  (K) fiscal year 2018 and each subsequent 
                fiscal year shall be $754,720,000.
          (2) Allocations of assessment by class of tobacco 
        products.--
                  (A) In general.--The total user fees assessed 
                each fiscal year with respect to each class of 
                tobacco products shall be an amount that is 
                equal to the applicable percentage of each 
                class multiplied by the amount specified in 
                paragraph (1) for each fiscal year.
                  (B) Applicable percentage.--
                          (i) In general.--For purposes of 
                        subparagraph (A), the applicable 
                        percentage for a fiscal year for each 
                        of the following classes of tobacco 
                        products shall be determined in 
                        accordance with clause (ii):
                                  (I) Cigarettes.
                                  (II) Cigars, including small 
                                cigars and cigars other than 
                                small cigars.
                                  (III) Snuff.
                                  (IV) Chewing tobacco.
                                  (V) Pipe tobacco.
                                  (VI) Roll-your-own tobacco.
                          (ii) Allocations.--The applicable 
                        percentage of each class of tobacco 
                        product described in clause (i) for a 
                        fiscal year shall be the percentage 
                        determined under section 625(c) of 
                        Public Law 108-357 for each such class 
                        of product for such fiscal year.
                          (iii) Requirement of regulations.--
                        Notwithstanding clause (ii), no user 
                        fees shall be assessed on a class of 
                        tobacco products unless such class of 
                        tobacco products is listed in section 
                        901(b) or is deemed by the Secretary in 
                        a regulation under section 901(b) to be 
                        subject to this chapter.
                          (iv) Reallocations.--In the case of a 
                        class of tobacco products that is not 
                        listed in section 901(b) or deemed by 
                        the Secretary in a regulation under 
                        section 901(b) to be subject to this 
                        chapter, the amount of user fees that 
                        would otherwise be assessed to such 
                        class of tobacco products shall be 
                        reallocated to such other classes of 
                        tobacco products that are subject to 
                        this chapter in the same manner and 
                        based on the same relative percentages 
                        otherwise determined under clause (ii).
          (3) Determination of user fee by company.--
                  (A) In general.--The total user fee to be 
                paid by each manufacturer or importer of a 
                particular class of tobacco products shall be 
                determined in each quarter by multiplying--
                          (i) such manufacturer's or importer's 
                        percentage share as determined under 
                        paragraph (4); by
                          (ii) the portion of the user fee 
                        amount for the current quarter to be 
                        assessed on all manufacturers and 
                        importers of such class of tobacco 
                        products as determined under paragraph 
                        (2).
                  (B) No fee in excess of percentage share.--No 
                manufacturer or importer of tobacco products 
                shall be required to pay a user fee in excess 
                of the percentage share of such manufacturer or 
                importer.
          (4) Allocation of assessment within each class of 
        tobacco product.--The percentage share of each 
        manufacturer or importer of a particular class of 
        tobacco products of the total user fee to be paid by 
        all manufacturers or importers of that class of tobacco 
        products shall be the percentage determined for 
        purposes of allocations under subsections (e) through 
        (h) of section 625 of Public Law 108-357.
          (5) Allocation for cigars.--Notwithstanding paragraph 
        (4), if a user fee assessment is imposed on cigars, the 
        percentage share of each manufacturer or importer of 
        cigars shall be based on the excise taxes paid by such 
        manufacturer or importer during the prior fiscal year.
  (d) Timing of User Fee Assessment.--The Secretary shall 
notify each manufacturer and importer of tobacco products 
subject to this section of the amount of the quarterly 
assessment imposed on such manufacturer or importer under 
subsection (c) during each quarter of each fiscal year. Such 
notifications shall occur not later than 30 days prior to the 
end of the quarter for which such assessment is made, and 
payments of all assessments shall be made by the last day of 
the quarter involved.
  (e) Memorandum of Understanding.--
          (1) In general.--The Secretary shall request the 
        appropriate Federal agency to enter into a memorandum 
        of understanding that provides for the regular and 
        timely transfer from the head of such agency to the 
        Secretary of the information described in paragraphs 
        (2)(B)(ii) and (4) of subsection (c) and all necessary 
        information regarding all tobacco product manufacturers 
        and importers required to pay user fees. The Secretary 
        shall maintain all disclosure restrictions established 
        by the head of such agency regarding the information 
        provided under the memorandum of understanding.
          (2) Assurances.--Beginning not later than fiscal year 
        2015, and for each subsequent fiscal year, the 
        Secretary shall ensure that the Food and Drug 
        Administration is able to determine the applicable 
        percentages described in subsection (c)(2) and the 
        percentage shares described in subsection (c)(4). The 
        Secretary may carry out this paragraph by entering into 
        a contract with the head of the Federal agency referred 
        to in paragraph (1) to continue to provide the 
        necessary information.
  (f) Effective Date.--
          (1) In general.--The user fees prescribed by this 
        section shall be assessed in fiscal year 2008, and 
        shall be assessed in each fiscal year thereafter.
          (2) Special rule.--If the date of enactment of the 
        Family Smoking Prevention and Tobacco Control Act 
        occurs during a quarter of fiscal year 2008, the user 
        fees for the portion of the quarter that occurs after 
        such date of enactment shall be assessed during the 
        next full quarter.
  (g) Study by GAO.--
          (1) In general.--The Comptroller General of the 
        United States shall conduct a study on--
                  (A) the prevalence of youth tobacco use and 
                the brands and subbrands that individuals under 
                the age of 18 consume;
                  (B) the feasibility of structuring the user 
                fees or a portion of the user fees collected 
                under this section on the youth market share of 
                a manufacturer or year to year changes in a 
                manufacturer's share of youth market; and
                  (C) the potential effects of tobacco 
                marketing to youth audiences if user fees were 
                calculated in whole or in part on youth market 
                share.
          (2) Report.--The Comptroller General shall submit to 
        the Energy and Commerce Committee of the House of 
        Representatives and the Health, Education, Labor, and 
        Pensions Committee of the Senate a report on the study 
        conducted under paragraph (1) by not later than 3 years 
        after the date of enactment of the Family Smoking 
        Prevention and Tobacco Control Act.

SEC. 920. LABELING, RECORDKEEPING, RECORDS INSPECTION.

  (a) Origin Labeling.--Beginning 1 year after the date of 
enactment of the Family Smoking Prevention and Tobacco Control 
Act, the label, packaging, and shipping containers of tobacco 
products for introduction or delivery for introduction into 
interstate commerce in the United States shall bear the 
statement ``sale only allowed in the United States''.
  (b) Regulations Concerning Recordkeeping for Tracking and 
Tracing.--
          (1) In general.--The Secretary shall promulgate 
        regulations regarding the establishment and maintenance 
        of records by any person who manufactures, processes, 
        transports, distributes, receives, packages, holds, 
        exports, or imports tobacco products.
          (2) Inspection.--In promulgating the regulations 
        described in paragraph (1), the Secretary shall 
        consider which records are needed for inspection to 
        monitor the movement of tobacco products from the point 
        of manufacture through distribution to retail outlets 
        to assist in investigating potential illicit trade, 
        smuggling, or counterfeiting of tobacco products.
          (3) Codes.--The Secretary may require codes on the 
        labels of tobacco products or other designs or devices 
        for the purpose of tracking or tracing the tobacco 
        product through the distribution system.
          (4) Size of business.--The Secretary shall take into 
        account the size of a business in promulgating 
        regulations under this section.
          (5) Recordkeeping by retailers.--The Secretary shall 
        not require any retailer to maintain records relating 
        to individual purchasers of tobacco products for 
        personal consumption.
  (c) Records Inspection.--If the Secretary has a reasonable 
belief that a tobacco product is part of an illicit trade or 
smuggling or is a counterfeit product, each person who 
manufactures, processes, transports, distributes, receives, 
holds, packages, exports, or imports tobacco products shall, at 
the request of an officer or employee duly designated by the 
Secretary, permit such officer or employee, at reasonable times 
and within reasonable limits and in a reasonable manner, upon 
the presentation of appropriate credentials and a written 
notice to such person, to have access to and copy all records 
(including financial records) relating to such article that are 
needed to assist the Secretary in investigating potential 
illicit trade, smuggling, or counterfeiting of tobacco 
products.
  (d) Knowledge of Illegal Transaction.--
          (1) Notification.--If the manufacturer or distributor 
        of a tobacco product has knowledge which reasonably 
        supports the conclusion that a tobacco product 
        manufactured or distributed by such manufacturer or 
        distributor that has left the control of such person 
        may be or has been--
                  (A) imported, exported, distributed, or 
                offered for sale in interstate commerce by a 
                person without paying duties or taxes required 
                by law; or
                  (B) imported, exported, distributed, or 
                diverted for possible illicit marketing,
        the manufacturer or distributor shall promptly notify 
        the Attorney General and the Secretary of the Treasury 
        of such knowledge.
          (2) Knowledge defined.--For purposes of this 
        subsection, the term ``knowledge'' as applied to a 
        manufacturer or distributor means--
                  (A) the actual knowledge that the 
                manufacturer or distributor had; or
                  (B) the knowledge which a reasonable person 
                would have had under like circumstances or 
                which would have been obtained upon the 
                exercise of due care.

                     CHAPTER [IX] X--MISCELLANEOUS

                          SEPARABILITY CLAUSE

  Sec. [901.] 1001. If any provision of this Act is declared 
unconstitutional, or the applicability thereof to any person or 
circumstances is held invalid, the constitutionality of the 
remainder of the Act and the applicability thereof to other 
persons and circumstances shall not be affected thereby.

           *       *       *       *       *       *       *


                       EFFECTIVE DATE AND REPEALS

  Sec. [902.] 1002. (a) * * *

           *       *       *       *       *       *       *


SEC. [903.] 1003. FOOD AND DRUG ADMINISTRATION.

  (a) * * *

           *       *       *       *       *       *       *

  (d) Commissioner.--
          (1) * * *

           *       *       *       *       *       *       *

          (2) General powers.--The Secretary, through the 
        Commissioner, shall be responsible for executing this 
        Act and for--
                  (A) * * *

           *       *       *       *       *       *       *

                  (C) research relating to foods, drugs, 
                cosmetics, [and] devices, and tobacco products 
                in carrying out this Act;

           *       *       *       *       *       *       *


SEC. [904.] 1004. SCIENTIFIC REVIEW GROUPS.

  Without regard to the provisions of title 5, United States 
Code, governing appointments in the competitive service and 
without regard to the provisions of chapter 51 and subchapter 
III of chapter 53 of such title relating to classification and 
General Schedule pay rates, the Commissioner of Food and Drugs 
may--
          (1) * * *

           *       *       *       *       *       *       *


SEC. [905.] 1005. LOAN REPAYMENT PROGRAM.

  (a) * * *

           *       *       *       *       *       *       *


SEC. [906.] 1006. PRACTICE OF MEDICINE.

  Nothing in this Act shall be construed to limit or interfere 
with the authority of a health care practitioner to prescribe 
or administer any legally marketed device to a patient for any 
condition or disease within a legitimate health care 
practitioner-patient relationship. This section shall not limit 
any existing authority of the Secretary to establish and 
enforce restrictions on the sale or distribution, or in the 
labeling, of a device that are part of a determination of 
substantial equivalence, established as a condition of 
approval, or promulgated through regulations. Further, this 
section shall not change any existing prohibition on the 
promotion of unapproved uses of legally marketed devices.

           *       *       *       *       *       *       *


SEC. [907.] 1007. CONTRACTS FOR EXPERT REVIEW.

  (a) * * *

           *       *       *       *       *       *       *


SEC. [908.] 1008. NOTICES TO STATES REGARDING IMPORTED FOOD.

  (a) * * *

           *       *       *       *       *       *       *


SEC. [909.] 1009. GRANTS TO STATES FOR INSPECTIONS.

  (a) * * *
  (b) Notices Regarding Adulterated Imported Food.--The 
Secretary may make grants to the States for the purpose of 
assisting the States with the costs of taking appropriate 
action to protect the public health in response to notification 
under [section 908] section 1008, including planning and 
otherwise preparing to take such action.

           *       *       *       *       *       *       *


SEC. [910.] 1010. OFFICE OF THE CHIEF SCIENTIST.

  (a) * * *

           *       *       *       *       *       *       *

                              ----------                              


                      FEDERAL MEAT INSPECTION ACT



           *       *       *       *       *       *       *
TITLE IV--AUXILIARY PROVISIONS

           *       *       *       *       *       *       *


  Sec. 409.(a) Notwithstanding any other provisions of law, 
including [section 902(b)] section 1002(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 392(a)), the provisions of 
this Act shall not derogate from any authority conferred by the 
Federal Food, Drug, and Cosmetic Act prior to enactment of the 
Wholesome Meat Act.

           *       *       *       *       *       *       *

                              ----------                              


             FEDERAL CIGARETTE LABELING AND ADVERTISING ACT



           *       *       *       *       *       *       *
                               [LABELING

  [Sec. 4. (a)(1) It shall be unlawful for any person to 
manufacture, package, or import for sale or distribution within 
the United States any cigarettes the package of which fails to 
bear, in accordance with the requirements of this section, one 
of the following labels:
          [SURGEON GENERAL'S WARNING: Smoking Causes Lung 
        Cancer, Heart Disease, Emphysema, And May Complicate 
        Pregnancy
          [SURGEON GENERAL'S WARNING: Quitting Smoking Now 
        Greatly Reduces Serious Risks to Your Health.
          [SURGEON GENERAL'S WARNING: Smoking by Pregnant Women 
        May Result in Fetal Injury, Premature Birth, And Low 
        Birth Weight.
          [SURGEON GENERAL'S WARNING: Cigarette Smoke Contains 
        Carbon Monoxide.
  [(2) It shall be unlawful for any manufacturer or importer of 
cigarettes to advertise or cause to be advertised (other than 
through the use of outdoor billboards) within the United States 
any cigarette unless the advertising bears, in accordance with 
the requirements of this section, one of the following labels:
          [SURGEON GENERAL'S WARNING: Smoking Causes Lung 
        Cancer, Heart Disease, Emphysema, And May Complicate 
        Pregnancy.
          [SURGEON GENERAL'S WARNING: Quitting Smoking Now 
        Greatly Reduces Serious Risks to Your Health.
          [SURGEON GENERAL'S WARNING: Smoking by Pregnant Women 
        May Result in Fetal Injury, Premature Birth, And Low 
        Birth Weight.
          [SURGEON GENERAL'S WARNING: Cigarette Smoke Contains 
        Carbon Monoxide.
  [(3) It shall be unlawful for any manufacturer or importer of 
cigarettes to advertise or cause to be advertised within the 
United States through the use of outdoor billboards any 
cigarette unless the advertising bears, in accordance with the 
requirements of this section, one of the following labels:
          [SURGEON GENERAL'S WARNING: Smoking Causes Lung 
        Cancer, Heart Disease, And Emphysema
          [SURGEON GENERAL'S WARNING: Quitting Smoking Now 
        Greatly Reduces Serious Health Risks.
          [SURGEON GENERAL'S WARNING: Pregnant Women Who Smoke 
        Risk Fetal Injury, And Premature Birth.
          [SURGEON GENERAL'S WARNING: Cigarette Smoke Contains 
        Carbon Monoxide.
  [(b)(1) Each label statement required by paragraph (1) of 
subsection (a) shall be located in the place label statements 
were placed on cigarete packages as of the date of the 
enactment of this subsection. The phrase ``Surgeon General's 
Warning'' shall appear in capital letters and the size of all 
other lettes in the label shall be the same as the size of such 
letters as of such date of enactment. All the letters in the 
label shall appear in conspicuous and legible type in contrast 
by typography, layout, or color with all other printed material 
on the package.
  [(2) The format of each label statement required by paragaph 
(2) of subsection (a) shall be the format required for label 
statements in cigarette advertising as of the date of the 
enactment of this subsection, except that the phrase ``Surgeon 
General's Warning'' shall appear in capital letters, the area 
of the rectangle enclosing the label shall be 50 per centum 
larger in size with a corresponding increase in the size of the 
type in the label, the width of the rule forming the border 
around the label shall be twice that in effect on such date, 
and the label may be placed at a distance from the other edge 
of the advertisement which is one-half the distance permitted 
on such date. Each label statement shall appear in conspicuous 
and legible type in contrast by typography, layout, or color 
with all other printed material in the advertisement.
  [(3) The format and type style of each label statement 
required by paragraph (3) of subsection (a) shall be the format 
and type style required in outdoor billboard advertising as of 
the date of the enactment of this subsection. Each such label 
statement shall be printed in capital letters of the height of 
the tallest letter in a label statement on outdoor advertising 
of the same dimension on such date of enactment. Each such 
label statement shall be enclosed by a black border which is 
located within the perimeter of the format required in outdoor 
billboard advertising of the same dimension on such date of 
enactment and the width of which is twice the width of the 
vertical element of any letter in the label statement within 
the border.
  [(c)(1) Except as provided in paragraph (2), the label 
statements specified in paragraphs (1), (2), and (3) of 
subsection (a) shall be rotated by each manufacturer or 
importer of cigarettes quarterly in alternating sequence on 
packages of each brand of cigarettes manufactured by the 
manufacturer or importer and in the advertisements for each 
such brand of cigarettes in accordance with a plan submitted by 
the manufacturer or importer and approved by the Federal Trade 
Commission. The Federal Trade Commission shall approve a plan 
submitted by a manufacturer or importer of cigarettes which 
will provide the rotation required by this subsection and which 
assures that all of the labels required by paragraphs (1), (2), 
and (3) will be displayed by the manufacturer or importer at 
the same time.
  [(2)(A) A manufacturer or importer of cigarettes may apply to 
the Federal Trade Commission to have the label rotation 
described in subparagraph (C) apply with respect to a brand 
style of cigarettes manufactured or imported by such 
manufacturer or importer if--
  [(i) the number of cigarettes of such brand style sold in the 
fiscal year of the manufacturer or importer preceding the 
submission of the application is less than one-fourth of 1 
percent of all the cigarettes sold in the United States in such 
year, and
  [(ii) more than one-half of the cigarettes manufactured or 
imported by such manufacturer or importer for sale in the 
United States are packaged into brand styles which meet the 
requirements of clause (i).
        If an application is approved by the Commission, the 
        label rotation described in subparagraph (C) shall 
        apply with respect to the applicant during the one-year 
        period beginning on the date of the application 
        approval.
  [(B) An applicant under subparagraph (A) shall include in its 
application a plan under which the label statements specified 
in paragraph (1) of subsection (a) will be rotated by the 
applicant manufacturer or importer in accordance with the label 
rotation described in subparagraph (C).
  [(C) Under the label rotation which the manufacturer or 
importer with an approved application may put into effect each 
of the labels specified in paragraph (1) of subsection (a) 
shall appear on the packages of each brand style of cigarettes 
with respect to which the application was approved an equal 
number of times within the twelve-month period beginning on the 
date of the approval by the Commission of the application.
  [(d) Subsection (a) does not apply to a distributor a 
retailer of cigarettes who does not manufacture, package, or 
import cigarettes for sale or distribution within the United 
States.]

SEC. 4. LABELING.

  (a) Label Requirements.--
          (1) In general.--It shall be unlawful for any person 
        to manufacture, package, sell, offer to sell, 
        distribute, or import for sale or distribution within 
        the United States any cigarettes the package of which 
        fails to bear, in accordance with the requirements of 
        this section, one of the following labels:
          WARNING: Cigarettes are addictive.
          WARNING: Tobacco smoke can harm your children.
          WARNING: Cigarettes cause fatal lung disease.
          WARNING: Cigarettes cause cancer.
          WARNING: Cigarettes cause strokes and heart disease.
          WARNING: Smoking during pregnancy can harm your baby.
          WARNING: Smoking can kill you.
          WARNING: Tobacco smoke causes fatal lung disease in 
        nonsmokers.
          WARNING: Quitting smoking now greatly reduces serious 
        risks to your health.
          (2) Placement; typography; etc.--Each label statement 
        required by paragraph (1) shall be located in the upper 
        portion of the front and rear panels of the package, 
        directly on the package underneath the cellophane or 
        other clear wrapping. Each label statement shall 
        comprise at least the top 30 percent of the front and 
        rear panels of the package. The word ``WARNING'' shall 
        appear in capital letters and all text shall be in 
        conspicuous and legible 17-point type, unless the text 
        of the label statement would occupy more than 70 
        percent of such area, in which case the text may be in 
        a smaller conspicuous and legible type size, provided 
        that at least 60 percent of such area is occupied by 
        required text. The text shall be black on a white 
        background, or white on a black background, in a manner 
        that contrasts, by typography, layout, or color, with 
        all other printed material on the package, in an 
        alternating fashion under the plan submitted under 
        subsection (c).
          (3) Does not apply to foreign distribution.--The 
        provisions of this subsection do not apply to a tobacco 
        product manufacturer or distributor of cigarettes which 
        does not manufacture, package, or import cigarettes for 
        sale or distribution within the United States.
          (4) Applicability to retailers.--A retailer of 
        cigarettes shall not be in violation of this subsection 
        for packaging that--
                  (A) contains a warning label;
                  (B) is supplied to the retailer by a license- 
                or permit-holding tobacco product manufacturer, 
                importer, or distributor; and
                  (C) is not altered by the retailer in a way 
                that is material to the requirements of this 
                subsection.
  (b) Advertising Requirements.--
          (1) In general.--It shall be unlawful for any tobacco 
        product manufacturer, importer, distributor, or 
        retailer of cigarettes to advertise or cause to be 
        advertised within the United States any cigarette 
        unless its advertising bears, in accordance with the 
        requirements of this section, one of the labels 
        specified in subsection (a).
          (2) Typography, etc.--Each label statement required 
        by subsection (a) in cigarette advertising shall comply 
        with the standards set forth in this paragraph. For 
        press and poster advertisements, each such statement 
        and (where applicable) any required statement relating 
        to tar, nicotine, or other constituent (including a 
        smoke constituent) yield shall comprise at least 20 
        percent of the area of the advertisement and shall 
        appear in a conspicuous and prominent format and 
        location at the top of each advertisement within the 
        trim area. The Secretary may revise the required type 
        sizes in such area in such manner as the Secretary 
        determines appropriate. The word ``WARNING'' shall 
        appear in capital letters, and each label statement 
        shall appear in conspicuous and legible type. The text 
        of the label statement shall be black if the background 
        is white and white if the background is black, under 
        the plan submitted under subsection (c). The label 
        statements shall be enclosed by a rectangular border 
        that is the same color as the letters of the statements 
        and that is the width of the first downstroke of the 
        capital ``W'' of the word ``WARNING'' in the label 
        statements. The text of such label statements shall be 
        in a typeface pro rata to the following requirements: 
        45-point type for a whole-page broadsheet newspaper 
        advertisement; 39-point type for a half-page broadsheet 
        newspaper advertisement; 39-point type for a whole-page 
        tabloid newspaper advertisement; 27-point type for a 
        half-page tabloid newspaper advertisement; 31.5-point 
        type for a double page spread magazine or whole-page 
        magazine advertisement; 22.5-point type for a 28 
        centimeter by 3 column advertisement; and 15-point type 
        for a 20 centimeter by 2 column advertisement. The 
        label statements shall be in English, except that--
                  (A) in the case of an advertisement that 
                appears in a newspaper, magazine, periodical, 
                or other publication that is not in English, 
                the statements shall appear in the predominant 
                language of the publication; and
                  (B) in the case of any other advertisement 
                that is not in English, the statements shall 
                appear in the same language as that principally 
                used in the advertisement.
          (3) Matchbooks.--Notwithstanding paragraph (2), for 
        matchbooks (defined as containing not more than 20 
        matches) customarily given away with the purchase of 
        tobacco products, each label statement required by 
        subsection (a) may be printed on the inside cover of 
        the matchbook.
          (4) Adjustment by secretary.--The Secretary may, 
        through a rulemaking under section 553 of title 5, 
        United States Code, adjust the format and type sizes 
        for the label statements required by this section; the 
        text, format, and type sizes of any required tar, 
        nicotine yield, or other constituent (including smoke 
        constituent) disclosures; or the text, format, and type 
        sizes for any other disclosures required under the 
        Federal Food, Drug, and Cosmetic Act. The text of any 
        such label statements or disclosures shall be required 
        to appear only within the 20 percent area of cigarette 
        advertisements provided by paragraph (2). The Secretary 
        shall promulgate regulations which provide for 
        adjustments in the format and type sizes of any text 
        required to appear in such area to ensure that the 
        total text required to appear by law will fit within 
        such area.
  (c) Marketing Requirements.--
          (1) Random display.--The label statements specified 
        in subsection (a)(1) shall be randomly displayed in 
        each 12-month period, in as equal a number of times as 
        is possible on each brand of the product and be 
        randomly distributed in all areas of the United States 
        in which the product is marketed in accordance with a 
        plan submitted by the tobacco product manufacturer, 
        importer, distributor, or retailer and approved by the 
        Secretary.
          (2) Rotation.--The label statements specified in 
        subsection (a)(1) shall be rotated quarterly in 
        alternating sequence in advertisements for each brand 
        of cigarettes in accordance with a plan submitted by 
        the tobacco product manufacturer, importer, 
        distributor, or retailer to, and approved by, the 
        Secretary.
          (3) Review.--The Secretary shall review each plan 
        submitted under paragraph (2) and approve it if the 
        plan--
                  (A) will provide for the equal distribution 
                and display on packaging and the rotation 
                required in advertising under this subsection; 
                and
                  (B) assures that all of the labels required 
                under this section will be displayed by the 
                tobacco product manufacturer, importer, 
                distributor, or retailer at the same time.
          (4) Applicability to retailers.--This subsection and 
        subsection (b) apply to a retailer only if that 
        retailer is responsible for or directs the label 
        statements required under this section except that this 
        paragraph shall not relieve a retailer of liability if 
        the retailer displays, in a location open to the 
        public, an advertisement that does not contain a 
        warning label or has been altered by the retailer in a 
        way that is material to the requirements of this 
        subsection and subsection (b).
  (d) Change in Required Statements.--The Secretary may, by a 
rulemaking conducted under section 553 of title 5, United 
States Code, adjust the format, type size, and text of any of 
the label requirements, require color graphics to accompany the 
text, increase the required label area from 30 percent up to 50 
percent of the front and rear panels of the package, or 
establish the format, type size, and text of any other 
disclosures required under the Federal Food, Drug, and Cosmetic 
Act, if the Secretary finds that such a change would promote 
greater public understanding of the risks associated with the 
use of tobacco products.
  (e) Tar, Nicotine, and Other Smoke Constituent Disclosure.--
          (1) In general.--The Secretary shall, by a rulemaking 
        conducted under section 553 of title 5, United States 
        Code, determine (in the Secretary's sole discretion) 
        whether cigarette and other tobacco product 
        manufacturers shall be required to include in the area 
        of each cigarette advertisement specified by subsection 
        (b) of this section, or on the package label, or both, 
        the tar and nicotine yields of the advertised or 
        packaged brand. Any such disclosure shall be in 
        accordance with the methodology established under such 
        regulations, shall conform to the type size 
        requirements of subsection (b) of this section, and 
        shall appear within the area specified in subsection 
        (b) of this section.
          (2) Resolution of differences.--Any differences 
        between the requirements established by the Secretary 
        under paragraph (1) and tar and nicotine yield 
        reporting requirements established by the Federal Trade 
        Commission shall be resolved by a memorandum of 
        understanding between the Secretary and the Federal 
        Trade Commission.
          (3) Cigarette and other tobacco product 
        constituents.--In addition to the disclosures required 
        by paragraph (1), the Secretary may, under a rulemaking 
        conducted under section 553 of title 5, United States 
        Code, prescribe disclosure requirements regarding the 
        level of any cigarette or other tobacco product 
        constituent including any smoke constituent. Any such 
        disclosure may be required if the Secretary determines 
        that disclosure would be of benefit to the public 
        health, or otherwise would increase consumer awareness 
        of the health consequences of the use of tobacco 
        products, except that no such prescribed disclosure 
        shall be required on the face of any cigarette package 
        or advertisement. Nothing in this section shall 
        prohibit the Secretary from requiring such prescribed 
        disclosure through a cigarette or other tobacco product 
        package or advertisement insert, or by any other means 
        under the Federal Food, Drug, and Cosmetic Act.
          (4) Retailers.--This subsection applies to a retailer 
        only if that retailer is responsible for or directs the 
        label statements required under this section.

                               PREEMPTION

  Sec. 5. (a) * * *

           *       *       *       *       *       *       *

  (c) Exception.--Notwithstanding subsection (b), a State or 
locality may enact statutes and promulgate regulations, based 
on smoking and health, that take effect after the effective 
date of the Family Smoking Prevention and Tobacco Control Act, 
imposing specific bans or restrictions on the time, place, and 
manner, but not content, of the advertising or promotion of any 
cigarettes.

           *       *       *       *       *       *       *

                              ----------                              


      COMPREHENSIVE SMOKELESS TOBACCO HEALTH EDUCATION ACT OF 1986

-

           *       *       *       *       *       *       *
[SEC. 3. SMOKELESS TOBACCO WARNING.

  [(a) General Rule.--
          [(1) It shall be unlawful for any person to 
        manufacture, package, or import for sale or 
        distribution within the United States any smokeless 
        tobacco product unless the product package bears, in 
        accordance with the requirements of this Act, one of 
        the following labels:
          [``WARNING: THIS PRODUCT MAY CAUSE MOUTH CANCER''
          [`` WARNING: THIS PRODUCT MAY CAUSE GUM DISEASE AND 
        TOOTH LOSS''
          [``WARNING: THIS PRODUCT IS NOT A SAFE ALTERNATIVE TO 
        CIGARETTES''.
          [(2) It shall be unlawful for any manufacturer, 
        packager, or importer of smokeless tobacco products to 
        advertise or cause to be advertised (other than through 
        the use of outdoor billboard advertising) within the 
        United States any smokeless tobacco product unless the 
        advertising bears, in accordance with the requirements 
        of this Act, one of the labels required by paragraph 
        (1).
  [(b) Label Format.--The Federal Trade Commission shall issue 
regulations requiring the label statement required by 
subsection (a) to appear--
          [(1) in the case of the smokeless tobacco product 
        package--
                  [(A) in a conspicuous and prominent place on 
                the package, and
                  [(B) in a conspicuous format and in 
                conspicuous and legible type in contrast with 
                all other printed material on the package, and
          [(2) in the case of advertising subject to subsection 
        (a)(2)--
                  [(A) in a conspicuous and prominent location 
                in the advertisement and in conspicuous and 
                legible type in contrast with all other printed 
                material in the advertisement,
                  [(B) in the following format:
                  [(C) the label statement shall appear in 
                capital letters and the area of the circle and 
                arrow shall be determined by the Federal Trade 
                Commission.
  [(c) Label Display.--The Federal Trade Commission shall issue 
regulations requiring each label statement required by 
subsection (a) to--
          [(1) in the case of a smokeless tobacco product 
        package, be randomly displayed by each manufacturer, 
        packager, or importer of a smokeless tobacco product in 
        each 12-month period in as equal a number of times as 
        is possible on each brand of the product and be 
        randomly distributed in all parts of the United States 
        in which such product is marketed, and
          [(2) in the case of any advertisement of a smokeless 
        tobacco product, be rotated every 4 months by each 
        manufacturer, packager, or importer of a smokeless 
        tobacco product in an alternating sequence in the 
        advertisement for each brand of the product.
  [(d) Plan.--(1) Each manufacturer, packager, or importer of a 
smokeless tobacco product shall submit a plan to the Federal 
Trade Commission which specifies the method such manufacturer, 
packager, or importer will use to rotate, display, and 
distribute the statements required by subsection (a) in 
accordance with the requirements of subsections (b) and (c).
  [(2) The Federal Trade Commission shall approve a plan 
submitted by a manufacturer, packager, or importer of a 
smokeless tobacco product under paragraph (1) if such plan 
provides for the rotation, display, and distribution on 
smokeless tobacco product packages and advertisements of the 
statements required by subsection (a) in a manner which 
complies with this section and the regulations promulgated 
pursuant to this section.
  [(e) Application.--This section does not apply to a 
distributor or a retailer of any smokeless tobacco product 
which does not manufacture, package, or import smokeless 
tobacco products for sale or distribution within the United 
States.
  [(f) Television and Radio Advertising.--Effective 6 months 
after the date of the enactment of this Act, it shall be 
unlawful to advertise smokeless tobacco on any medium of 
electronic communications subject to the jurisdiction of the 
Federal Communications Commission.]

SEC. 3. SMOKELESS TOBACCO WARNING.

  (a) General Rule.--
          (1) It shall be unlawful for any person to 
        manufacture, package, sell, offer to sell, distribute, 
        or import for sale or distribution within the United 
        States any smokeless tobacco product unless the product 
        package bears, in accordance with the requirements of 
        this Act, one of the following labels:
          WARNING: This product can cause mouth cancer.
          WARNING: This product can cause gum disease and tooth 
        loss.
          WARNING: This product is not a safe alternative to 
        cigarettes.
          WARNING: Smokeless tobacco is addictive.
          (2) Each label statement required by paragraph (1) 
        shall be--
                  (A) located on the 2 principal display panels 
                of the package, and each label statement shall 
                comprise at least 30 percent of each such 
                display panel; and
                  (B) in 17-point conspicuous and legible type 
                and in black text on a white background, or 
                white text on a black background, in a manner 
                that contrasts by typography, layout, or color, 
                with all other printed material on the package, 
                in an alternating fashion under the plan 
                submitted under subsection (b)(3), except that 
                if the text of a label statement would occupy 
                more than 70 percent of the area specified by 
                subparagraph (A), such text may appear in a 
                smaller type size, so long as at least 60 
                percent of such warning area is occupied by the 
                label statement.
          (3) The label statements required by paragraph (1) 
        shall be introduced by each tobacco product 
        manufacturer, packager, importer, distributor, or 
        retailer of smokeless tobacco products concurrently 
        into the distribution chain of such products.
          (4) The provisions of this subsection do not apply to 
        a tobacco product manufacturer or distributor of any 
        smokeless tobacco product that does not manufacture, 
        package, or import smokeless tobacco products for sale 
        or distribution within the United States.
          (5) A retailer of smokeless tobacco products shall 
        not be in violation of this subsection for packaging 
        that--
                  (A) contains a warning label;
                  (B) is supplied to the retailer by a license- 
                or permit-holding tobacco product manufacturer, 
                importer, or distributor; and
                  (C) is not altered by the retailer in a way 
                that is material to the requirements of this 
                subsection.
  (b) Required Labels.--
          (1) It shall be unlawful for any tobacco product 
        manufacturer, packager, importer, distributor, or 
        retailer of smokeless tobacco products to advertise or 
        cause to be advertised within the United States any 
        smokeless tobacco product unless its advertising bears, 
        in accordance with the requirements of this section, 
        one of the labels specified in subsection (a).
          (2) Each label statement required by subsection (a) 
        in smokeless tobacco advertising shall comply with the 
        standards set forth in this paragraph. For press and 
        poster advertisements, each such statement and (where 
        applicable) any required statement relating to tar, 
        nicotine, or other constituent yield shall--
                  (A) comprise at least 20 percent of the area 
                of the advertisement, and the warning area 
                shall be delineated by a dividing line of 
                contrasting color from the advertisement; and
                  (B) the word ``WARNING'' shall appear in 
                capital letters and each label statement shall 
                appear in conspicuous and legible type. The 
                text of the label statement shall be black on a 
                white background, or white on a black 
                background, in an alternating fashion under the 
                plan submitted under paragraph (3).
          (3)(A) The label statements specified in subsection 
        (a)(1) shall be randomly displayed in each 12-month 
        period, in as equal a number of times as is possible on 
        each brand of the product and be randomly distributed 
        in all areas of the United States in which the product 
        is marketed in accordance with a plan submitted by the 
        tobacco product manufacturer, importer, distributor, or 
        retailer and approved by the Secretary.
          (B) The label statements specified in subsection 
        (a)(1) shall be rotated quarterly in alternating 
        sequence in advertisements for each brand of smokeless 
        tobacco product in accordance with a plan submitted by 
        the tobacco product manufacturer, importer, 
        distributor, or retailer to, and approved by, the 
        Secretary.
          (C) The Secretary shall review each plan submitted 
        under subparagraphs (A) and (B) and approve it if the 
        plan--
                  (i) will provide for the equal distribution 
                and display on packaging and the rotation 
                required in advertising under this subsection; 
                and
                  (ii) assures that all of the labels required 
                under this section will be displayed by the 
                tobacco product manufacturer, importer, 
                distributor, or retailer at the same time.
          (D) This paragraph applies to a retailer only if that 
        retailer is responsible for or directs the label 
        statements under this section, unless the retailer 
        displays, in a location open to the public, an 
        advertisement that does not contain a warning label or 
        has been altered by the retailer in a way that is 
        material to the requirements of this subsection.
          (4) The Secretary may, through a rulemaking under 
        section 553 of title 5, United States Code, adjust the 
        format and type sizes for the label statements required 
        by this section; the text, format, and type sizes of 
        any required tar, nicotine yield, or other constituent 
        disclosures; or the text, format, and type sizes for 
        any other disclosures required under the Federal Food, 
        Drug, and Cosmetic Act. The text of any such label 
        statements or disclosures shall be required to appear 
        only within the 20 percent area of advertisements 
        provided by paragraph (2). The Secretary shall 
        promulgate regulations which provide for adjustments in 
        the format and type sizes of any text required to 
        appear in such area to ensure that the total text 
        required to appear by law will fit within such area.
  (c) Television and Radio Advertising.--It is unlawful to 
advertise smokeless tobacco on any medium of electronic 
communications subject to the jurisdiction of the Federal 
Communications Commission.
  (d) Authority To Revise Warning Label Statements.--The 
Secretary may, by a rulemaking conducted under section 553 of 
title 5, United States Code, adjust the format, type size, and 
text of any of the label requirements, require color graphics 
to accompany the text, increase the required label area from 30 
percent up to 50 percent of the front and rear panels of the 
package, or establish the format, type size, and text of any 
other disclosures required under the Federal Food, Drug, and 
Cosmetic Act, if the Secretary finds that such a change would 
promote greater public understanding of the risks associated 
with the use of smokeless tobacco products.

           *       *       *       *       *       *       *


SEC. 7. PREEMPTION.

  (a) Federal Action.--[No] Except as provided in the Family 
Smoking Prevention and Tobacco Control Act (and the amendments 
made by that Act), no statement relating to the use of 
smokeless tobacco products and health, other than the 
statements required by section 3, shall be required by any 
Federal agency to appear on any package or in any advertisement 
(unless the advertisement is an outdoor billboard 
advertisement) of a smokeless tobacco product.

           *       *       *       *       *       *       *


                            DISSENTING VIEWS

    Forcing the Food and Drug Administration (FDA) to regulate 
tobacco products--products that will never qualify as ``safe 
and effective''--could have significant negative impacts on all 
Americans. This Congress, and specifically this Committee, has 
spent a great deal of time investigating the ways in which the 
FDA has been unable to fulfill its core mission. Therefore, we 
are concerned that burdening the FDA with added 
responsibilities outside of the agency's expertise and core 
missions at this time will have dire consequences for the 
American people and the FDA's ability to ensure the safety and 
efficacy of our nation's food, drugs, and medical devices.
    If enacted, this legislation significantly curtails, if not 
entirely eliminates, incentives to develop and market products 
that reduce exposure to tobacco toxicants. In order to obtain 
approval of a modified-risk product, an applicant must 
demonstrate that the marketing and labeling of the product will 
not mislead consumers into believing that the product is or has 
been demonstrated to be less harmful. Further, it has to be 
demonstrated that the product reduces risk for both the 
individual and for the population as a whole. It is unlikely 
that such a standard could ever be proven. The legislation 
provides no incentives to manufacturers to research and develop 
reduced-risk products, and the requirement forcing companies to 
turn over all research to the FDA--whether used in reduced-risk 
product development or not--is a significant hindrance to the 
development of modified-risk products.
    The standard for approval of modified-risk products is 
unclear in H.R. 1108, which will create, at best, ambiguities 
for applicants in the standards that must be met or, at worst, 
product standards that can never be achieved, thus eliminating 
modified-risk products coming to market.
    We are also opposed to the annual tax assessments placed on 
the manufacturers added to this bill during the markup. 
Manufacturers will be assessed $754.72 million by 2018, yet FDA 
will only be allowed to spend $712 million directly on tobacco 
regulation. Claiming that a tax is a user fee does not change 
the fact that it is a tax. The remaining $42.72 million is 
required to eliminate the ``pay-go'' problem that will result 
from lower tax collections in other areas once this bill is 
enacted.
    On April 17, 1997, Chairman Bill Archer succinctly 
explained the various factors that determine whether an 
assessment should be considered a tax or fee based on well-
established precedent in the House of Representatives. In his 
statement, Chairman Archer explained the four criteria 
generally used: (i) The fees are assessed and collected solely 
to cover the costs of specified regulatory activities; (ii) The 
fees are assessed and collected only in such manner as may 
reasonably be expected to result in an aggregate amount 
collected during any fiscal year which does not exceed the 
aggregate amount of the regulatory costs referred to in (i) 
above; (iii) The only persons subject to the fees are those who 
directly avail themselves of, or are directly subject to, the 
regulatory activities referred to in (i) above; and (iv) The 
amounts of the fees (a) are structured such that any person's 
liability for such fees is reasonably based on the proportion 
of the regulatory activities which relate to such person, and 
(b) are nondiscriminatory between foreign and domestic 
entities.
    Clearly the assessments created under H.R. 1108 are taxes 
and not fees. The second prong of the test is clearly violated 
because the legislation does envision that the aggregate amount 
of fees collected during any fiscal year will exceed the 
aggregate amount of the regulatory costs.
    H.R. 1108 will limit competition, and provide essentially a 
monopoly to the largest companies operating today. In doing so, 
smaller companies will be denied competitive opportunities 
within the market, because the barriers to entry are just too 
high. This legislation provides the unintended consequence of 
creating monopolies within the market. Section 906 could allow 
the FDA to create a virtual monopoly in the tobacco market by 
creating tobacco product standards that only a few of the well-
capitalized companies have the resources to achieve. The 
regressive nature of excise taxes, as well as the price 
increases that accompany monopolistic behavior, will impact 
low-income Americans the hardest.
    If the FDA is forced to regulate tobacco products, this 
legislation calls for the immediate codification of regulations 
that were drafted over twelve years ago. The regulations issued 
in 1996 were promulgated under the premise that cigarettes were 
medical devices. This legislation would not regulate cigarettes 
as medical devices but rather creates a new category of tobacco 
products with separate regulatory requirements. Since 1996, the 
Master Settlement Agreement has been executed and various other 
State regulations have been enacted with respect to marketing, 
advertising, and tobacco use. We believe that it is poor public 
policy to not revisit the regulations and take the time to 
better understand how the current regulations those 
manufacturers are operating under and then update the language 
as necessary.
    We also believe that the marketing provisions of H.R. 1108 
are violative of the First Amendment. Section 102 of the bill 
directs the Secretary of Health and Human Services to publish 
an interim final rule that is ``identical in its provisions'' 
to the proposed rule promulgated by the FDA in 1996. Numerous 
legal experts have stated that the broad restrictions in that 
proposal are in effect a de facto ban on tobacco advertising, 
and violate the First Amendment. In fact, the U.S. Supreme 
Court held in Lorillard Tobacco Co. v. Thomas Reilly, Attorney 
General of Massachusetts, 533 U.S. 525 (2001) that a 
Massachusetts tobacco regulation that was virtually identical 
to one part of the FDA 1996 proposal was unconstitutional.
    The effect of the various proposals in H.R. 1108 is a 
suspension of the ability to advertise tobacco products to 
adults, violating the First Amendment protections for 
commercial speech. The U.S. Supreme Court has emphasized 
repeatedly, including the landmark Central Hudson case, Central 
Hudson Gas & Electric v. Public Service Commission, 447 U.S. 
557 (1980) that truthful, nondeceptive commercial speech cannot 
be banned or restricted unless the restriction ``directly and 
materially advances'' a ``substantial governmental interest'' 
and is ``narrowly tailored'' to ``reasonably fit'' that 
interest.
    Finding 30 in the legislation states that the final 
regulations issued on August 20, 1996 are consistent with the 
First Amendment. Finding 31 states the regulations described in 
Finding 30 ``will directly and materially advance the federal 
government's substantial interest in reducing the number of 
children and adolescences who use cigarettes and smokeless 
tobacco and in preventing the life-threatening health 
consequences associated with tobacco use.''
    These findings attempt to address the Constitutional test 
the Supreme Court developed in the Central Hudson case for 
determining if restrictions on commercial speech violate the 
First Amendment. One prong of the test is the restriction must 
be to advance a compelling government interest. The Central 
Hudson test also has a prong that states the restrictions be 
``narrowly tailored'' to ``reasonably fit'' that interest. 
Finding 31 states that ``less restricting and less 
comprehensive approaches have not and will not be effective in 
reducing the problems addressed by such regulations.'' Again, 
the authors of the bill try to preempt Constitutional questions 
of the legislation by reciting findings designed to answer the 
Constitutional test of Central Hudson. However, Finding 31 is 
not based in fact and clearly ignores the fact that youth 
smoking has declined dramatically since the Master Settlement 
Agreement. A 2006 University of Michigan study has shown youth 
smoking rates have declined from over 28% in 1997 to less than 
15% in 2006. Additionally, the rate of youths being able to 
purchase cigarettes in stores has dropped dramatically since 
the imposition of the Synar Amendment in 1996.
    Many members of the Committee would have supported further 
steps to require states to use more of their Master Settlement 
Agreement funds to combat underage smoking and promote smoking 
cessation while also strengthening the Synar Amendment on the 
underage purchasing of cigarettes. Such steps would have been 
narrowly tailored to achieve the government interest without 
imposing clearly unconstitutional restrictions of the First 
Amendment. Unfortunately, H.R. 1108 was drafted in a manner 
that would have made such amendments non-germane during 
Committee consideration of the legislation.
    The Majority understands the violative nature of many of 
the provisions in the legislation and thus included a 
severability clause to allow some parts of the bill to stand 
with the presumption that others would be struck down by the 
courts. In fact, in the Lorillard case, the Supreme Court 
struck down a regulation promulgated by the Attorney General of 
Massachusetts that was similar in many respects to the FDA's 
proposed rule. The Massachusetts regulation banned outdoor ads 
within 1,000-feet of schools, parks and playgrounds and also 
restricted point-of-sale advertising for tobacco products.
    In finding that the Massachusetts regulation was not 
narrowly tailored, Justice Sandra Day O'Connor actually noted a 
similar problem with the FDA regulation:

          First, the Attorney General did not seem to consider 
        the impact of the 1,000-foot restriction on commercial 
        speech in major metropolitan areas. The Attorney 
        General apparently selected the 1,000-foot distance 
        based on the FDA's decision to impose an identical 
        1,000-foot restriction when it attempted to regulate 
        cigarette and smokeless tobacco advertising. The FDA's 
        regulations would have had widely disparate effects 
        nationwide. Even in Massachusetts, the effect of the 
        Attorney General's speech regulations will vary based 
        on whether a locale is rural, suburban, or urban. The 
        uniformly broad sweep of the geographical limitation 
        demonstrates a lack of tailoring.

    In more recent commercial speech cases, the Supreme Court 
has substantially raised the bar government regulators need to 
hurdle to impose restrictions on advertising. Justice O'Connor, 
speaking for the majority of the court, for example, in 
Thompson v. Western States Medical Center, 535 U.S. 357 (2002), 
stated, ``If the First Amendment means anything, it means that 
regulating speech must be a last--not first--resort.''
    The government has a legitimate interest in protecting 
minors from the use of tobacco products. The proposed 
advertising regulations in H.R. 1108, however, are over broad 
and impermissibly restrictive. They are clearly 
unconstitutional.

                                   Joe Barton.
                                   Steve Buyer.
                                   Joseph R. Pitts.
                                   Marsha Blackburn.
                                   Nathan Deal.
                                   George Radanovich.
                                   John Sullivan.