Amendment Text: H.Amdt.71 — 111th Congress (2009-2010)

There is one version of the amendment.

Shown Here:
Amendment as Offered (04/01/2009)

This Amendment appears on page H4344-4365 in the following article from the Congressional Record.


[Pages H4318-H4368]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




           FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

  Mr. WAXMAN. Mr. Speaker, pursuant to House Resolution 307, I call up 
the bill (H.R. 1256) to protect the public health by providing the Food 
and Drug Administration with certain authority to regulate tobacco 
products, and ask for its immediate consideration.
  The Clerk read the title of the bill.
  The SPEAKER pro tempore. Pursuant to House Resolution 307, the 
amendment printed in part A of House Report 111-72 is adopted, and the 
bill, as amended, is considered read.
  The text of the bill, as amended, is as follows:

                               H.R. 1256

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     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. Enforcement action plan for advertising and promotion 
              restrictions.

 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.

[[Page H4319]]

       (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) 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).
       (48) 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).
       (49) 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

[[Page H4320]]

     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 shall 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 country.--The term `Indian country' has the 
     meaning given such term in section 1151 of title 18, United 
     States Code.
       ``(10) 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.
       ``(11) 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.
       ``(12) 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.
       ``(13) 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.
       ``(14) 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.
       ``(15) 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.
       ``(16) 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.
       ``(17) 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.
       ``(18) 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.
       ``(19) State; territory.--The terms `State' and `Territory' 
     shall have the meanings given to such terms in section 201.
       ``(20) 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.
       ``(21) Tobacco warehouse.--

[[Page H4321]]

       ``(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.
       ``(22) 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, roll-your-own 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 the Family Smoking Prevention 
     and Tobacco Control Act, 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

[[Page H4322]]

     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 the 
     Family Smoking Prevention and Tobacco Control 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 such date of enactment, 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 such date of enactment 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 enactment of the Family Smoking Prevention and 
     Tobacco Control 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

[[Page H4323]]

     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

[[Page H4324]]

     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 the 
     Family Smoking Prevention and Tobacco Control Act, 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.
       ``(B) Additional special rule.--Beginning 2 years after the 
     date of enactment of the Family Smoking Prevention and 
     Tobacco Control Act, a tobacco product manufacturer shall not 
     use tobacco, including foreign grown tobacco, that contains a 
     pesticide chemical residue that is at a level greater than is 
     specified by any tolerance applicable under Federal law to 
     domestically grown tobacco.
       ``(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

[[Page H4325]]

     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, the Secretary shall--
       ``(A) if the Secretary determines that the standard would 
     be appropriate for the protection of the public health, 
     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.

[[Page H4326]]

       ``(E) Public availability.--The Secretary shall make a copy 
     of each report and recommendation under subparagraph (D) 
     publicly available.
       ``(e) Menthol Cigarettes.--
       ``(1) Referral; considerations.--Immediately upon the 
     establishment of the Tobacco Products Scientific Advisory 
     Committee under section 917(a), the Secretary shall refer to 
     the Committee for report and recommendation, under section 
     917(c)(4), the issue of the impact of the use of menthol in 
     cigarettes on the public health, including such use among 
     children, African Americans, Hispanics, and other racial and 
     ethnic minorities. In its review, the Tobacco Products 
     Scientific Advisory Committee shall address the 
     considerations listed in subsections (a)(3)(B)(i) and (b).
       ``(2) Report and recommendation.--Not later than 1 year 
     after its establishment, the Tobacco Product Scientific 
     Advisory Committee shall submit to the Secretary the report 
     and recommendations required pursuant to paragraph (1).
       ``(3) Rule of construction.--Nothing in this subsection 
     shall be construed to limit the Secretary's authority to take 
     action under this section or other sections of this Act 
     applicable to menthol.

     ``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,

[[Page H4327]]

     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

[[Page H4328]]

     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, beginning 30 days after such effective date, a 
     manufacturer shall not introduce into the domestic commerce 
     of the United States any product, irrespective of the date of 
     manufacture, 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

[[Page H4329]]

     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

[[Page H4330]]

     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 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, 
     provided that, for purposes of the testing requirements of 
     this paragraph, tobacco products manufactured and sold by a 
     single tobacco product manufacturer that are identical in all 
     respects except the labels, packaging design, logo, trade 
     dress, trademark, brand name, or any combination thereof, 
     shall be considered as a single brand; 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

[[Page H4331]]

     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 6 months 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--

[[Page H4332]]

       ``(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 FEES.

       ``(a) Establishment of Quarterly Fee.--Beginning on the 
     date of enactment of the Family Smoking Prevention and 
     Tobacco Control Act, the Secretary shall in accordance with 
     this section assess user fees on, and collect such fees from, 
     each manufacturer and importer of tobacco products subject to 
     this chapter. The fees shall be assessed and collected with 
     respect to each quarter of each fiscal year, and the total 
     amount assessed and collected for a fiscal year shall be the 
     amount specified in subsection (b)(1) for such year, subject 
     to subsection (c).
       ``(b) Assessment of User Fee.--
       ``(1) Amount of assessment.--The total amount of user fees 
     authorized to be assessed and collected under subsection (a) 
     for a fiscal year is the following, as applicable to the 
     fiscal year involved:
       ``(A) For fiscal year 2009, $85,000,000 (subject to 
     subsection (e)).
       ``(B) For fiscal year 2010, $235,000,000.
       ``(C) For fiscal year 2011, $450,000,000.
       ``(D) For fiscal year 2012, $477,000,000.
       ``(E) For fiscal year 2013, $505,000,000.
       ``(F) For fiscal year 2014, $534,000,000.
       ``(G) For fiscal year 2015, $566,000,000.
       ``(H) For fiscal year 2016, $599,000,000.
       ``(I) For fiscal year 2017, $635,000,000.
       ``(J) For fiscal year 2018, $672,000,000.
       ``(K) For fiscal year 2019 and each subsequent fiscal year, 
     $712,000,000.
       ``(2) Allocations of assessment by class of tobacco 
     products.--
       ``(A) In general.--The total user fees assessed and 
     collected under subsection (a) 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 for the 
     fiscal year multiplied by the amount specified in paragraph 
     (1) for the 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 the 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 for 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.
       ``(6) Timing of 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 this 
     subsection for 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.
       ``(7) Memorandum of understanding.--
       ``(A) 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) 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.
       ``(B) 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 paragraph 
     (2) and the percentage shares described in paragraph (4). The 
     Secretary may carry out this subparagraph by entering into a 
     contract with the head of the Federal agency referred to in 
     subparagraph (A) to continue to provide the necessary 
     information.
       ``(c) Crediting and Availability of Fees.--
       ``(1) In general.--Fees authorized under subsection (a) 
     shall be collected and available for obligation only to the 
     extent and in the amount provided in advance in 
     appropriations Acts. Such fees are authorized to remain 
     available until expended. Such sums as may be necessary may 
     be transferred from the Food and Drug Administration salaries 
     and expenses appropriation account without fiscal year 
     limitation to such appropriation account for salaries and 
     expenses with such fiscal year limitation.
       ``(2) Availability.--
       ``(A) In general.--Fees appropriated under paragraph (3) 
     are available only for the purpose of paying 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 under subsection (a) may be used for any other 
     costs.
       ``(B) Prohibition against use of other funds.--
       ``(i) In general.--Except as provided in clause (ii), fees 
     collected under subsection (a) are the only funds authorized 
     to be made available for the purpose described in 
     subparagraph (A).
       ``(ii) Startup costs.--Clause (i) does not apply until the 
     date on which the Secretary has collected fees under 
     subsection (a) for 2 fiscal year quarters. Until such date, 
     other amounts available to the Food and Drug Administration 
     (excluding fees collected under subsection (a)) are 
     authorized to be made available to pay the costs described in 
     subparagraph (A), provided that such amounts are reimbursed 
     through fees collected under subsection (a).
       ``(3) Authorization of appropriations.--For fiscal year 
     2009 and each subsequent fiscal year, there is authorized to 
     be appropriated for fees under this section an amount equal 
     to the amount specified in subsection (b)(1) for the fiscal 
     year.
       ``(d) Collection of Unpaid Fees.--In any case where the 
     Secretary does not receive payment of a fee assessed under 
     subsection (a) within 30 days after it is due, such fee shall 
     be treated as a claim of the United States Government subject 
     to subchapter II of chapter 37 of title 31, United States 
     Code.
       ``(e) Applicability to Fiscal Year 2009.--If the date of 
     enactment of the Family Smoking Prevention and Tobacco 
     Control

[[Page H4333]]

     Act occurs during fiscal year 2009, the following applies, 
     subject to subsection (c):
       ``(1) The Secretary shall determine the fees that would 
     apply for a single quarter of such fiscal year according to 
     the application of subsection (b) to the amount specified in 
     paragraph (1)(A) of such subsection (referred to in this 
     subsection as the `quarterly fee amounts').
       ``(2) For the quarter in which such date of enactment 
     occurs, the amount of fees assessed shall be a pro rata 
     amount, determined according to the number of days remaining 
     in the quarter (including such date of enactment) and 
     according to the daily equivalent of the quarterly fee 
     amounts. Fees assessed under the preceding sentence shall not 
     be collected until the next quarter.
       ``(3) For the quarter following the quarter to which 
     paragraph (2) applies, the full quarterly fee amounts shall 
     be assessed and collected, in addition to collection of the 
     pro rata fees assessed under paragraph (2).''.

     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

[[Page H4334]]

       (B) by striking ``or 761 or the refusal to permit access 
     to'' and inserting ``761, 909, or 920 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 920(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 920; 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)(1) (U.S.C. 372(a)(1)) is 
     amended--
       (1) by striking ``(a)(1)'' and inserting ``(a)(1)(A)''; and
       (2) by adding at the end the following:
       ``(B)(i) 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.
       ``(ii) The Secretary shall not enter into any contract 
     under clause (i) with the government of any of the several 
     States to exercise enforcement authority under this Act on 
     Indian country without the express written consent of the 
     Indian tribe involved.''.
       (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 striking ``devices, or cosmetics'' each place it 
     appears and inserting ``devices, tobacco products, or 
     cosmetics'';
       (B) by striking ``or restricted devices'' each place it 
     appears and inserting ``restricted devices, or tobacco 
     products'';
       (C) by striking ``and devices and subject to'' and all that 
     follows through ``other drugs or devices'' and inserting 
     ``devices, and tobacco products and subject to reporting and 
     inspection under regulations lawfully issued pursuant to 
     section 505(i) or (k), section 519, section 520(g), or 
     chapter IX and data relating to other drugs, devices, or 
     tobacco products'';
       (2) in subsection (b), by inserting ``tobacco product,'' 
     after ``device,''; and
       (3) 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)--
       (A) by inserting ``tobacco product'' after ``drug, 
     device,''; and
       (B) by inserting ``, and a tobacco product intended for 
     export shall not be deemed to be in violation of section 
     906(e), 907, 911, or 920(a),'' before ``if it--'';
       (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.''.

[[Page H4335]]

       (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, beginning 30 days after such 
     effective date, a manufacturer shall not introduce into the 
     domestic commerce of the United States any product, 
     irrespective of the date of manufacture, 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 enactment of 
     this Act, submit a report to the Congress on the results of 
     such study.

     SEC. 105. ENFORCEMENT ACTION PLAN FOR ADVERTISING AND 
                   PROMOTION RESTRICTIONS.

       (a) Action Plan.--
       (1) Development.--Not later than 6 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (in this section referred to as the ``Secretary'') 
     shall develop and publish an action plan to enforce 
     restrictions adopted pursuant to section 906 of the Federal 
     Food, Drug, and Cosmetic Act, as added by section 101(b) of 
     this Act, or pursuant to section 102(a) of this Act, on 
     promotion and advertising of menthol and other cigarettes to 
     youth.
       (2) Consultation.--The action plan required by paragraph 
     (1) shall be developed in consultation with public health 
     organizations and other stakeholders with demonstrated 
     expertise and experience in serving minority communities.
       (3) Priority.--The action plan required by paragraph (1) 
     shall include provisions designed to ensure enforcement of 
     the restrictions described in paragraph (1) in minority 
     communities.
       (b) State and Local Activities.--
       (1) Information on authority.--Not later than 3 months 
     after the date of enactment of this Act, the Secretary shall 
     inform State, local, and tribal governments of the authority 
     provided to such entities under section 5(c) of the Federal 
     Cigarette Labeling and Advertising Act, as added by section 
     203 of this Act, or preserved by such entities under section 
     916 of the Federal Food, Drug, and Cosmetic Act, as added by 
     section 101(b) of this Act.
       (2) Community assistance.--At the request of communities 
     seeking assistance to prevent underage tobacco use, the 
     Secretary shall provide such assistance, including assistance 
     with strategies to address the prevention of underage tobacco 
     use in communities with a disproportionate use of menthol 
     cigarettes by minors.

 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.

[[Page H4336]]

       ``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 amendment made by subsection (a) 
     shall take effect 12 months after the date of enactment of 
     this Act. Such effective date shall be with respect to the 
     date of manufacture, provided that, in any case, beginning 30 
     days after such effective date, a manufacturer shall not 
     introduce into the domestic commerce of the United States any 
     product, irrespective of the date of manufacture, that is not 
     in conformance with section 4 of the Federal Cigarette 
     Labeling and Advertising Act (15 U.S.C. 1333), as amended by 
     subsection (a).

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

       (a) Preemption.--Section 5(a) of the Federal Cigarette 
     Labeling and Advertising Act (15 U.S.C. 1334(a)) is amended 
     by striking ``No'' and inserting ``Except to the extent the 
     Secretary requires additional or different statements on any 
     cigarette package by a regulation, by an order, by a 
     standard, by an authorization to market a product, or by a 
     condition of marketing a product, pursuant to the Family 
     Smoking Prevention and Tobacco Control Act (and the 
     amendments made by that Act), or as required under section 
     903(a)(2) or section 920(a) of the Federal Food, Drug, and 
     Cosmetic Act, no''.
       (b) Change in Required 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

[[Page H4337]]

       ``(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)(A) Each label statement required by subsection (a) in 
     smokeless tobacco advertising shall comply with the standards 
     set forth in this paragraph.
       ``(B) For press and poster advertisements, each such 
     statement and (where applicable) any required statement 
     relating to tar, nicotine, or other constituent yield shall 
     comprise at least 20 percent of the area of the 
     advertisement.
       ``(C) The word `WARNING' shall appear in capital letters, 
     and each label statement shall appear in conspicuous and 
     legible type.
       ``(D) 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).
       ``(E) 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.
       ``(F) 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.
       ``(G) The label statements shall be in English, except 
     that--
       ``(i) 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
       ``(ii) 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)(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 amendment made by subsection (a) 
     shall take effect 12 months after the date of enactment of 
     this Act. Such effective date shall be with respect to the 
     date of manufacture, provided that, in any case, beginning 30 
     days after such effective date, a manufacturer shall not 
     introduce into the domestic commerce of the United States any 
     product, irrespective of the date of manufacture, that is not 
     in conformance with section 3 of the Comprehensive Smokeless 
     Tobacco Health Education Act of 1986 (15 U.S.C. 4402), as 
     amended by subsection (a)

     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

[[Page H4338]]

     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.--
       ``(1) Requirement.--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'.
       ``(2) Effective date.--The effective date specified in 
     paragraph (1) shall be with respect to the date of 
     manufacture, provided that, in any case, beginning 30 days 
     after such effective date, a manufacturer shall not introduce 
     into the domestic commerce of the United States any product, 
     irrespective of the date of manufacture, that is not in 
     conformance with such paragraph.
       ``(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. The 
     Secretary shall not authorize an officer or employee of the 
     government of any of the several States to exercise authority 
     under the preceding sentence on Indian country without the 
     express written consent of the Indian tribe involved.
       ``(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.
       ``(e) Consultation.--In carrying out this section, the 
     Secretary shall consult with the Attorney General of the 
     United States and the Secretary of the Treasury, as 
     appropriate.''.

     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 
     such 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).

  The SPEAKER pro tempore. After 1 hour of debate on the bill, as 
amended, it shall be in order to consider the amendment in the nature 
of a substitute printed in part B of the report, if ordered by the 
gentleman from Indiana (Mr. Buyer) or his designee, which shall be in 
order without intervention of any point of order, shall be considered 
read, and shall be debatable for 30 minutes equally divided and 
controlled by the proponent and an opponent.
  The gentleman from California (Mr. Waxman) and the gentleman from 
Indiana (Mr. Buyer) each will control 30 minutes.
  The Chair recognizes the gentleman from California.
  Mr. WAXMAN. Mr. Speaker, I yield myself such time as I may consume in 
debating this legislation.
  Mr. Speaker, and my colleagues, we have come to what I hope will be 
an historic occasion, and that is finally doing something about the 
harm that tobacco does to thousands and thousands of Americans who die 
each year, and to stop the attempt to get our children to smoke. But it 
has taken us far too long to get to this point.
  In 1994, the tobacco executives stood up before my subcommittee, they 
raised their hand, and they said they were going to tell the truth. 
They swore under oath, though, that nicotine was not addictive. They 
also said cigarettes were not harmful. They also said they didn't 
manipulate nicotine. They also said that they would never target kids. 
And, it turned out, they were not telling us the truth.
  In 1996, the Food and Drug Administration tried to regulate tobacco 
products, but the Supreme Court told them that they needed Congress to 
give them specific legal authority. Now, 13 years later, here we are 
finally giving FDA that authority to regulate the leading preventable 
cause of death in America.
  Every one of us has seen the devastating effects of tobacco through 
losing someone we love, watching others grow sick, or even feeling the 
grip of addiction firsthand. Worst of all is watching our children and 
grandchildren be targeted as the next wave of casualties.
  Regulating tobacco is the single most important thing we can do right 
now to curb this deadly toll, and FDA is the only agency with the right 
combination of scientific expertise, regulatory experience, and public 
health mission to oversee these products effectively.
  This legislation will direct the Food and Drug Administration to end 
the marketing and sales of tobacco to kids; to prevent manufacturers 
from calling cigarettes ``light'' or ``less dangerous'' when in fact 
they are not; and to require changes to what is in cigarettes, like 
toxic ingredients such as formaldehyde, benzene, radioactive elements, 
and other deadly chemicals.

                              {time}  1930

  Some have objected that this bill is too big a challenge for an 
already overburdened FDA. But it is clear to me that FDA's recent 
struggles are primarily a result of years of chronic underfunding. This 
does not mean that FDA, with strong and committed leadership, cannot 
take on the critical role of protecting the country against the harms 
of tobacco. It simply means that when we give the agency this new 
responsibility, we also must give it the

[[Page H4339]]

resources necessary to do the job and to do it well.
  We have ensured that this will happen. The tobacco program will be 
fully funded through a new user fee paid for by the industry. That 
money will go exclusively to the new tobacco center and will be enough 
for FDA to handle this task well. Furthermore, by doing so, we will 
ensure that the new tobacco program will have no impact on other 
missions at the Food And Drug Administration.
  In short, we have everything we need to take this historic step: A 
comprehensive and flexible set of new authorities and full, certain 
funding. All we need now is the political will to do the right thing.
  The breadth of support for this bill, from the AARP to the American 
Academy of Pediatrics, from the Southern Baptist Convention to the 
Islamic Society of North America, shows just how critical this issue is 
to all Americans. It is also supported by the American Lung 
Association, the American Heart Association and the American Cancer 
Society, the groups that are best situated to understand the damage 
caused by tobacco.
  I also want to note that we have worked hard to accommodate specific 
concerns that we have heard about this bill. In committee consideration 
of the bill last year, we made changes to ensure fairness and 
flexibility for convenience stores, tobacco growers and small 
manufacturers, and we worked with the minority to incorporate their 
suggestions. We also worked with members of the Congressional Black 
Caucus to ensure that menthol cigarettes will be an early focus of the 
agency's attention and the agency has the authority to deal with these 
and other products.
  I want to thank my colleague, Todd Platts, for his strong leadership 
and dedication to working on this legislation, as well as John Dingell 
and Frank Pallone for their diligent work in moving this bill forward 
over the years. I also want to thank Ed Towns, Stephen Lynch and Ike 
Skelton, all of whom were critical in getting us to this point. Each of 
these individuals has made this possible and produced a great victory 
for all Americans, especially our children.
  I urge the passage of this legislation.
  I reserve the balance of my time.
  Mr. BUYER. I yield myself such time as I may consume.
  I would note that the gentleman read a list of individuals that 
supports his bill. But what he left off the list and the prior speaker 
under the rule, the gentleman from Colorado, was very critical of the 
tobacco companies. But Altria supports the Waxman bill. Now what is 
interesting about this is I would ask the gentleman from Colorado, he 
was so critical of tobacco, but obviously he didn't know that a tobacco 
company was supporting the Waxman bill.
  I truly believe in my heart, since I had written Altria, and they 
have sent me a letter here in response to the substitute, H.R. 1261, I 
truly believe that had they not endorsed the Waxman bill 8 years ago 
that they would be endorsing this bill. And the reason I say that, I 
just find it in my heart, they let me know in their bill dated to me by 
the chairman and chief executive of Altria, he says, ``We specifically 
support H.R. 1266 and supported its predecessor bills for more than 8 
years.'' That is the Waxman bill. But he goes on further in his letter, 
and he says, ``Your letter seeks our input on several aspects of 
tobacco regulation. You recently introduced H.R. 1261, including harm 
reduction, product design standards and the appropriate public health 
standard for tobacco regulation. Before addressing these topics more 
specifically,'' and they do that in the letter, he said, ``I want to 
commend your thoughtful leadership on the topic of comprehensive 
tobacco regulation. Your focus on H.R. 1261 on harm reduction 
strategies will, we believe, encourage further meaningful conversation 
about how Federal regulators should exercise authority over tobacco 
products. We especially appreciate the focus you are bringing in the 
public policy debate in an important principle that regulation should 
ensure and certainly not discourage adult consumers access to accurate, 
objective and non-misleading information about the relative risks of 
all tobacco products. We have consistently expressed our view that it 
would be wrong for the Federal regulatory framework to deny adult 
tobacco consumers access to information about potential benefits to 
products that could ultimately reduce the harm caused by smoking.''
  Now that is the harm-reduction strategy that we have incorporated in 
this bipartisan bill. And so I wanted to bring that to everyone's 
attention that this harm-reduction strategy is extremely important. We 
should not have this abstinence approach that is in the Waxman bill. 
Now this was an approach that was drafted many, many years ago, and a 
lot of things have taken place since Mr. Waxman drafted this bill. And 
he is not taking these things into account. I respect the gentleman. I 
respect his efforts. I respect his tenacity and his persistence. And 
hopefully we will have a meeting of the minds one day, and we can 
incorporate both of our dual-tracked efforts here to move people to 
stop smoking.
  The supporters of the Waxman bill, as I noted from some of the 
speakers, they claim that it is designed to protect children from the 
dangers of smoking. But H.R. 1256 does not include any provision that 
actually protects minors from tobacco use. The American Association of 
Public Health Physicians wrote on March 3, 2009, ``The current bill, 
the bill which is before us and being debated, referred to as the 
Waxman bill, H.R. 1256, in its current form would ensure current levels 
of tobacco-related deaths while doing nothing of significance to reduce 
the number of teens who would initiate tobacco use with no bill at 
all.''
  You see, those of whom are supporting the substitute, we support 
steps to require the States to use more of their Master Settlement 
Agreement funds to combat underage smoking and promote smoking 
cessation while also strengthening the Synar amendment which prevents 
the underage purchasing of cigarettes. Unfortunately, H.R. 1256 does 
not contain these important public health provisions.
  With that, I reserve the balance of my time.
  Mr. WAXMAN. Mr. Speaker, I yield to the gentleman from North Carolina 
(Mr. Etheridge).
  Mr. ETHERIDGE. I thank the gentleman. I would like to engage the 
chairman in a colloquy to address the issue of FDA and tobacco farmers.
  I represent one of the largest tobacco-producing districts in the 
Nation, so naturally I have a lot of farmers who are very concerned 
about how they might be affected by this legislation.
  Mr. Chairman, my question to you is, does this bill in any way 
authorize the FDA to regulate tobacco farms?
  Mr. WAXMAN. I thank you for the question, Mr. Etheridge. This is an 
important question, especially for those who represent tobacco-growing 
districts. There has been some confusion about this point, so let me be 
clear. It is not the intent of this bill to allow FDA on the farm. The 
bill gives FDA the authority to regulate tobacco products but not 
tobacco leaf.
  Mr. ETHERIDGE. I thank you for that.
  And does the bill specifically state that FDA's regulatory authority 
would only apply to manufactured tobacco products and not the 
traditional production and harvest methods on the farm?
  Mr. WAXMAN. The gentleman is correct.
  Mr. ETHERIDGE. I thank the chairman.
  Mr. Waxman, I thank you for that, and I thank you for the 
clarification that this is a bill intended to protect our children and 
not to regulate tobacco farmers. Tobacco is a critical crop in North 
Carolina's economy and has been for a long time. I look forward to 
continuing to working with you to help North Carolina farmers preserve 
their jobs and their livelihood.
  Mr. WAXMAN. I reserve the balance of my time.
  Mr. BUYER. I yield myself such time as I may consume.
  The gentleman just spoke about his concern with regard to product 
standards. It is one of the chief concerns in the Waxman bill. The 
provisions on product standards allow the FDA to impose any 
requirements or prohibitions it sees fit, except that it may not ban 
the product or reduce nicotine delivery to zero. FDA need not consider 
the cost or feasibility of imposing a standard. FDA does have to 
consider

[[Page H4340]]

the possibility of a black market, but can impose a standard even if it 
will lead to the creation or expansion of a black market. That should 
concern everyone with regard to illicit trade.
  The Waxman bill also prevents communication about significant 
differences among levels of risk presented by different types of 
tobacco products, and it clamps down on any effects to develop and 
market modified-risk tobacco products. Modified-risk tobacco products 
are defined as any existing or new product that bears a claim or where 
the manufacturer conveys to consumers through media or otherwise that: 
It presents a lower risk or is less harmful than other tobacco 
products; has a reduced level of substance or reduced exposure to a 
substance; is free of or does not contain a substance; or uses the 
descriptor ``light,'' ``mild'' or ``low'' or a similar descriptor.
  Approval of a modified-risk product requires under the Waxman bill 
that the product will significantly reduce harm and the risk of disease 
to the individual users and that approval benefits the health of the 
population as a whole. You see, this is a two-tier standard and is 
almost impossible or nearly impossible to satisfy. So I completely 
understand why the gentleman came to the floor concerned about product 
standards. So if you want to embrace a harm-reduction strategy to 
migrate people from smoking down the continuum of risk to eventually 
quitting, the Waxman bill does not permit that. We don't permit the 
innovation of science to drive people to lower-risk products. And that 
is what the substitute tries to do.
  With that, I will yield to the gentleman, the ranking Republican, 
Lamar Smith of Texas, such time as he may consume.
  Mr. SMITH of Texas. Mr. Speaker, I thank my colleague from Indiana 
for yielding me time.
  Mr. Speaker, H.R. 1256 directs the Secretary of HHS to promulgate an 
interim final rule that is identical to the FDA's 1996 rule, which 
legal experts from across the political spectrum have stated would 
violate the first amendment.
  While these experts' views should carry great weight, even more 
persuasive is the fact that the U.S. Supreme Court also has weighed in 
on various provisions of the rule, finding them unconstitutional. In 
Lorillard Tobacco v. Reilly, the U.S. Supreme Court struck down a 
Massachusetts statute that was similar in many ways to the FDA's 
proposed rule. The statute banned outdoor ads within 1,000 feet of 
schools, parks and playgrounds and also restricted point-of-sale 
advertising for tobacco products.
  The Court held that this regulation ran afoul of the test established 
in the Central Hudson case, which defines the protection afforded 
commercial speech under the first amendment, as it was not sufficiently 
narrowly tailored and would have disparate impacts from community to 
community.
  The Court then noted that since the Massachusetts statute was based 
on the FDA's rule, the FDA rule would have similar constitutional 
problems. As Justice Sandra Day O'Connor wrote for the court, ``The 
uniformly broad sweep of the geographical limitation demonstrates a 
lack of tailoring.''
  Additionally, the proposed rule in H.R. 1256 would require ads to use 
only black text on a white background. The U.S. Supreme Court found a 
similar provision unconstitutional in Zauderer v. Office of 
Disciplinary Counsel. In that case, dealing with advertising for legal 
services, the Court held that the use of colors and illustrations in 
ads is entitled to the same first amendment protections given verbal 
commercial speech.
  Justice Byron White, in his opinion for the Court, wrote that 
pictures and illustrations in ads cannot be banned ``simply on the 
strength of the general argument that the visual content of 
advertisements may, under some circumstances, be deceptive or 
manipulative.''
  So there are numerous speech restrictions in this legislation that 
raise serious first amendment concerns. This will create a swarm of 
lawsuits that will only divert us from trying to develop more effective 
approaches to tobacco use in the United States.
  To include speech restrictions that a broad range of legal experts 
have stated are almost certain to be unconstitutional fatally taints 
this bill.

                              {time}  1945

  I know the bill is well-intentioned, but I hope my colleagues will 
support the alternative offered by the gentleman from Indiana (Mr. 
Buyer).
  Mr. BUYER. I reserve the balance of my time.
  Mr. WAXMAN. I am including in the Record an exchange of letters on 
H.R. 1256 between the chairman of the Committee on the Judiciary and 
myself.

                                   Committee on the Judiciary,

                                   Washington, DC, March 24, 2009.
     Hon. Henry A. Waxman,
     Chairman, Committee on Energy and Commerce,
     House of Representatives, Washington, DC.
       Dear Chairman Waxman: This is to advise you that, as a 
     result of your having worked with us to appropriately craft 
     provisions in H.R. 1256, the ``Family Smoking Prevention and 
     Tobacco Control Act,'' that fall within the rule X 
     jurisdiction of the Committee on the Judiciary, we are able 
     to agree to discharging our committee from further 
     consideration of the bill in order that it may proceed 
     without delay to the House floor for consideration.
       The Judiciary Committee takes this action with the 
     understanding that by foregoing further consideration of H.R. 
     1256 at this time, we do not waive any jurisdiction over 
     subject matter contained in this or similar legislation. We 
     also reserve the right to seek appointment of an appropriate 
     number of conferees to any House-Senate conference involving 
     this important legislation, and request your support if such 
     a request is made.
       I would appreciate your including this letter in the 
     Congressional Record during consideration of the bill on the 
     House floor. Thank you for your attention to this request, 
     and for the cooperative relationship between our two 
     committees.
           Sincerely,
                                                John Conyers, Jr.,
     Chairman.
                                  ____



                                Congress of the United States,

                             Committee on Energy and Commerce,

                                   Washington, DC, March 25, 2009.
     Hon. John Conyers,
     Chairman, Committee on the Judiciary,
     Washington, DC.
       Dear Chairman Conyers: Thank you for your letter regarding 
     H.R. 1256, the ``Family Smoking Prevention and Tobacco 
     Control Act.'' The letter noted that certain provisions of 
     the bill are within the jurisdiction of the Committee on the 
     Judiciary under rule X of the Rules of the House.
       The Committee on Energy and Commerce recognizes the 
     jurisdictional interest of the Committee on the Judiciary in 
     these provisions. We further appreciate your agreement to 
     forgo action on the bill, and I concur that the agreement 
     does not in any way prejudice the Committee on the Judiciary 
     with respect to the appointment of conferees or its 
     jurisdictional prerogatives on this bill or similar 
     legislation in the future.
       I will include our letters in the Congressional Record 
     during consideration of the bill on the House floor. Again I 
     appreciate your cooperation regarding this important 
     legislation.
           Sincerely,
                                                   Henry A. Waxman

  I reserve the balance of my time.
  Mr. BUYER. I would yield now 3 minutes to Dr. Gingrey, the gentleman 
from Georgia.
  Mr. GINGREY of Georgia. Mr. Speaker, I thank the gentleman for 
yielding. And I certainly want to pay tribute to Chairman Waxman in 
regard to the work that he has done over these many years, 10, at 
least, in regard to trying to help our society rid themselves of, 
really, the scourge of smoking cigarettes and many health care problems 
that that leads to. I don't think that there's any question in 
anybody's mind about that. And certainly the Surgeon General's warning, 
very profound, clear warning on a package of cigarettes, should bring 
their attention to that every time they light up, whether we're talking 
about young adults or at any age group. And leading to lung cancer and 
chronic obstructive pulmonary disease, maybe better known as emphysema. 
So I commend Chairman Waxman very much. I think his heart is in the 
right place, and what he's trying to do is very credible.
  But I do feel that Representative Buyer, from Indiana, and his 
substitute amendment, will be presented shortly. I really feel, Mr. 
Speaker, that this is very likely a better way. And so I do rise in 
strong support of the Buyer amendment in the nature of a substitute.
  Despite decades of intense efforts to eradicate the practice, still 
more than 40 million American adults continue to smoke cigarettes, and 
that is likely to remain the case, unfortunately, for decades to come.
  All tobacco products are harmful, but the health risks associated 
with cigarettes are significantly greater than those associated with 
the use of smoke-

[[Page H4341]]

free tobacco and nicotine-only products.
  So, given these facts, an increasing number of public health experts 
advocate adopting a tobacco ``harm-reduction'' approach like that 
proposed in the Buyer amendment that will lower the health risks 
associated with using tobacco or nicotine.
  A growing body of science shows that smokers who switch to smokeless 
tobacco products can significantly decrease their risk of tobacco-
related illness and death.
  A World Health Organization Study Group wrote last year that: 
``Smokeless tobacco products do not cause the lung diseases causally 
associated with the use of combusted tobacco products such as 
cigarettes, pipes and cigars.''
  Scientific studies show that even the risk for cancers of the mouth 
and the throat are higher for smokers than for those who use tobacco 
products that do not burn. Year after year, this body has considered 
tobacco regulation that fails to recognize the significant progress 
that can be achieved by adding this harm-reduction component to 
tobacco-control efforts.
  An article last year, Mr. Speaker, in the Journal of Health Care Law 
and Policy correctly concluded that, and this is a quote, ``Ignoring 
harm reduction is simply not a viable option as there is no question 
that it is possible to provide massively less toxic alternative 
products.''
  The SPEAKER pro tempore. The time of the gentleman has expired.
  Mr. BUYER. I yield to the gentleman of Georgia an additional minute.
  Mr. GINGREY of Georgia. Mr. Speaker, a 2007 article in the 
International Journal of Drug Policy noted that ``A pragmatic, public 
health approach to tobacco control would recognize a continuum of risk 
and encourage nicotine users to move themselves down the risk spectrum 
by choosing safer alternatives to smoking, without demanding 
abstinence.''
  The Buyer amendment presents us with the opportunity to institute 
that type of pragmatic approach. It offers a stringent regime under 
which harm-reduction strategies can augment and leverage continued 
efforts to prevent tobacco use, and to encourage current smokers to 
quit.
  So, as a physician who deeply cares about the health and the welfare 
of our citizens, I urge you, my colleagues on both sides of the aisle, 
to adopt the amendment as our Nation's best option for fighting the 
disease and the death caused by tobacco in the 21st century.
  Mr. BUYER. I reserve my time.
  Mr. WAXMAN. Mr. Speaker, I have no further requests for time. 
Although some Members may join us shortly, I ask the gentleman how many 
other speakers he wishes to call on before we close the debate.
  Mr. BUYER. We have two speakers that I'm aware of that are on their 
way.
  Mr. WAXMAN. I'll reserve my time and let you go forward. I see there 
are some of your Members there if they're going to speak on the bill.
  Mr. BUYER. To the gentleman's question, you wanted to know how many 
more speakers do I have. I was not prepared that you would not have 
speakers in support of your bill, so I thought that we'd be going back 
and forth, so I have Members coming from their offices to the floor. 
But I would be more than happy to take some of my time.
  May I ask, Mr. Speaker--actually, we're on your time, I guess, at the 
moment. I guess, on your time. May I ask how much time both of us may 
have remaining?
  The SPEAKER pro tempore. The gentleman from Indiana has 16 minutes 
remaining. The gentleman from California has 23\1/2\ minutes remaining.
  Mr. WAXMAN. We're going to reserve the balance of our time.
  Mr. BUYER. I yield myself such time as I may consume.
  We've had a discussion here on the floor, Mr. Speaker, with regard to 
other concerns over the Food and Drug Administration and its ability to 
regulate tobacco products, products that will never qualify as safe and 
effective, and could have significant negative impacts on all 
Americans.
  Congress has spent a great deal of time investigating the ways in 
which the FDA has been unable to fulfill its core mission. Burdening 
the FDA with additional responsibilities outside 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.
  H.R. 1256 allows the FDA to divert resources from its core mission, 
including funds from food safety inspections and drugs and devices 
approvals to fund the startup costs of a newer tobacco center. At a 
time when FDA is struggling to perform many of its core functions, 
diversion of its limited resources will negatively impact the safety of 
the American public.
  Now, in a bipartisan manner, we share the concerns of many in the 
public health community that effectively giving FDA's stamp of approval 
on cigarettes will improperly lead people to believe that these 
products are safe, and they really aren't. So there actually could be 
this perception, when people see that the FDA has approved it, there 
could be this public perception that there's an FDA approval of a 
particular nicotine delivery device.
  Now, what we seek to do is to turn this over to a different agency, 
whereby we can learn about the different relative risks among that 
continuum of risk, so that people can make, then, informed decisions 
and choices relative to the use of tobacco products.
  Now, I agree with the American Association of Public Health 
Physicians, which wrote on March 3, 2009, in regard to H.R. 1256, ``The 
current bill, in its current form, would assure current levels of 
tobacco-related deaths, while doing nothing of significance to reduce 
the number of teens who would initiate tobacco use with no bill at 
all.''
  Now, I read that earlier, but it's so important I had to read it 
again. Now, Congressman McIntyre and I have authored this bipartisan 
alternative to establish the Tobacco Harm Reduction Center under the 
Department of Health and Human Services. The alternative is based on 
public health policies that acknowledge a continuum of risk among all 
tobacco products, and referenced scientific literature which shows that 
smokeless tobacco products are 90 to even 99 percent less hazardous 
than cigarettes in their risks of causing tobacco-related illnesses and 
death.
  Now, why wouldn't we embrace that as a form of public policy?
  Unlike H.R. 1256, the alternative substitute would have insured adult 
tobacco users are given complete, accurate and truthful information 
about the risks and relative risks of all tobacco products so that they 
can make informed health decisions, while providing incentives to 
develop reduced-risk tobacco products.
  See, that's really one of the chief concerns I have about Mr. 
Waxman's legislation is that when he creates a two-tier product 
standard with the implementation of new products, how can we ever 
migrate people to a lesser-harm nicotine delivery device in our efforts 
to get them to quit? That's why we have this position by Mr. Waxman, 
either you smoke or you die. And that's not what we should be 
embracing.
  The alternative substitute, which Members will have a chance to vote 
on, strengthens prevention against minors' tobacco use, ensures that 
States properly fund anti-tobacco education and smoking-cessation 
programs, and protects American jobs.
  Now, this alternative legislation will significantly improve the 
public health, while also protecting the already overburdened FDA from 
new responsibilities that take away from its ability to protect, once 
again, our Nation's food and drug supply.
  In 2001 the Institute of Medicine noted, ``The potential for 
reduction in morbidity and mortality that could result from the use of 
less toxic products by those who do not stop using tobacco, justifies 
the inclusion of harm reduction as a component in a broad program of 
tobacco control.'' That was my appeal to Chairman Waxman as to why the 
harm reduction strategy should be endorsed.
  You see, if enacted, H.R. 1256, Mr. Waxman's bill, significantly 
curtails, if not entirely eliminates, incentives for manufacturers to 
develop and market products that reduce exposure to tobacco toxic 
substances. In order to obtain approval of a modified risk product, an 
applicant must demonstrate that the marketing and the labeling of the 
product will not mislead consumers into believing that the product is 
or

[[Page H4342]]

has been demonstrated to be less harmful than current products.
  Further, it has to be demonstrated that the product reduces risk for 
both the individual and for the population as a whole. This is the two-
tiered standard I keep referring to. It is unlikely that such a 
standard could ever be proven. You see, that is what is so clever about 
Mr. Waxman's legislation. He puts in a standard that can never be 
achieved. And if you want to move people down a continuum of risk and 
improve public health, it cannot be done under Mr. Waxman's approach.
  Now, those of us that support the substitute are concerned that such 
disincentives will effectively freeze the current tobacco market and 
prevent innovation that could lead to significantly less harmful 
tobacco products and improve the Nation's health. That is the exact 
position that Altria took in their letter to me.
  Mr. Speaker, H.R. 1256 directs the Secretary of HHS to promulgate an 
interim final rule that is identical to the FDA's 1996 rule, which 
legal experts from across the political spectrum have stated would 
violate the First Amendment. While these experts' views should carry 
great weight, even more dispositive is the fact that the U.S. Supreme 
Court has also weighed in on various provisions of the rule, finding 
them unconstitutional.
  In Lorillard Tobacco Co. v. Reilly, the U.S. Supreme Court struck 
down a Massachusetts statute that was similar in many ways to the FDA's 
proposed rule. The statute banned outdoor ads within 1,000 feet of 
schools, parks and playgrounds and also restricted point-of-sale 
advertising for tobacco products. The Court held that this regulation 
ran afoul of the test established in the Central Hudson case, which 
defines the protection afforded commercial speech under the First 
Amendment, as it was not sufficiently narrowly tailored, and would have 
disparate impacts from community to community.
  The Court then noted that since the Massachusetts statute was based 
on the FDA's rule, the FDA rule would have similar unconstitutional 
effects on a nationwide basis. As Justice Sandra Day O'Connor wrote for 
the Court, ``the uniformly broad sweep of the geographical limitation 
demonstrates a lack of tailoring.''
  Additionally, the proposed rule in H.R. 1256 would require ads to use 
only black text on a white background. Again, the U.S. Supreme Court 
found a similar provision unconstitutional in Zauderer v. Office of 
Disciplinary Counsel. In that case, dealing with advertising for legal 
services, the Court held that the use of colors and illustrations in 
ads are entitled to the same First Amendment protections given verbal 
commercial speech. Justice Byron White, in his opinion for the Court, 
wrote that pictures and illustrations in ads cannot be banned ``simply 
on the strength of the general argument that the visual content of 
advertisements may, under some circumstances, be deceptive or 
manipulative.''
  There are numerous other speech restrictions in this legislation that 
raise serious First Amendment issues and will create a swarm of 
lawsuits that will only divert us from trying to develop more effective 
approaches to tobacco use in the United States. To put forward speech 
restrictions that a broad range of experts have stated are almost 
certain to be struck down would be highly counterproductive, and the 
only winners in this effort will be the litigants' constitutional 
lawyers rather than the American public.
  I reserve the balance of my time.

                              {time}  2000

  Mr. WAXMAN. Mr. Speaker, I am ready to move on to the Buyer 
substitute, and if the gentleman from Indiana is ready to yield back 
his time, I will yield back my time, and we can go to the substitute, 
itself.
  Mr. BUYER. You would not rob me of the opportunity to put my chart on 
display, would you, Mr. Chairman?
  Mr. WAXMAN. I wouldn't deny you any opportunity to make any points or 
to show any charts.
  Mr. BUYER. Thank you.
  Mr. WAXMAN. Is the gentleman ready to offer his amendment?
  Mr. BUYER. I am prepared to show a chart on my debate time.
  Mr. WAXMAN. Oh. Well then, I'll reserve the balance of my time.
  Mr. BUYER. I thank the gentleman.
  How much time do I have, Mr. Speaker?
  The SPEAKER pro tempore. The gentleman has 9\1/2\ minutes remaining.
  Mr. BUYER. I yield 3 minutes to the gentleman from Texas, Dr. 
Burgess.
  Mr. BURGESS. I thank the gentleman for yielding.
  This bill is certainly a misplaced priority. Mr. Speaker, I lost both 
parents to tobacco-related illness. I know of the seriousness of this 
illness. I saw it virtually every day in the 25 years I practiced 
medicine. Tobacco is a scourge upon our society.
  It is for Congress to meet then. In the bill in front of us this 
evening, the Food and Drug Administration, a Federal agency that right 
now is essentially a beleaguered agency that cannot do what we require 
it to do with regulating food and drugs, is now going to be given a 
completely new mission.
  The mission of the Food and Drug Administration is to ensure that we 
have drugs that are safe and effective. Tobacco, when used as directed, 
kills 400,000 people a year. Tobacco certainly could be regarded as 
effective when used as directed, but it could never be regarded as 
safe.
  Last night, in the Rules Committee, I attempted to offer an amendment 
which would have allowed the Food and Drug Administration to at least 
require that a cigarette be manufactured that contains zero milligrams 
of nicotine. In fact, there is explicit language in the bill that 
prohibits the Food and Drug Administration from requiring a zero-
milligram nicotine cigarette. Why is this important?
  Well, I told the Rules Committee last night that this was essentially 
the anti-hypocrisy amendment. If we were serious about what we were 
trying to do for public health, we would allow the Food and Drug 
Administration to eliminate nicotine in the cigarette because, after 
all, a tobacco cigarette is a drug-delivery device. Its sole purpose is 
to deliver nicotine to the user. In fact, if you do not have nicotine 
with its addictive powers, cigarette smoking is, itself, so unpleasant 
that no one would willingly smoke a cigarette. They do so to satisfy 
the addiction to nicotine.
  In some of Chairman Waxman's hearings that he did in the last decade, 
he had tobacco executives admit that they manipulated levels of 
nicotine. Why? Because the nicotine is required to addict a smoker so 
he will continue to smoke. Eliminate the nicotine, and you have 
eliminated the smoking as a habit. As a consequence, the enormous 
public health debt that we're piling up in treating smoking-related 
illnesses suddenly becomes a much more realistic figure.
  I, frankly, do not understand why we would have a bill on the floor 
to allow the Food and Drug Administration to regulate tobacco usage 
when we will not allow them to have the one tool that would actually do 
some good in this legislation, which is to allow the Food and Drug 
Administration to require a zero-milligram nicotine cigarette.
  In other words, we're going to allow nicotine to continue to be in 
cigarettes, allow the level to continue to be manipulated and continue 
to allow the youth of this country to be addicted to this pernicious 
habit. If we were really serious, if it weren't just the fact that 
we're addicted to tobacco money, we would allow the FDA the ability to 
exclude nicotine from cigarette products.
  Mr. WAXMAN. Mr. Speaker, we have put in this bill that the FDA has 
the power to lower the levels of nicotine to a level that would be 
appropriate for the protection of the public health. We did not allow 
the FDA, under the legislation, to eliminate nicotine from cigarettes 
because we're all aware that, if cigarettes were not permitted to 
contain nicotine at all, that would be tantamount to an outright ban on 
cigarettes. I would not like to see people smoking cigarettes at all, 
but I'm not for prohibition, and therefore, we did not give the FDA 
that power to ban cigarettes in effect.
  Now, it's odd to find that we're criticized for not doing enough and 
then are criticized for doing too much. You can't have it both ways. I 
think the FDA is in the position to regulate. We ought to give them 
that power, and that's why I would urge support for the legislation.
  At this time, I would like to yield 5 minutes to the gentleman from 
Pennsylvania (Mr. Platts), and if he needs more time, I'll yield more 
to him.
  Mr. PLATTS. Mr. Speaker, I rise in support of H.R. 1256, the Family 
Smoking Prevention and Tobacco Control Act. My good friend and former 
colleague, Congressman Tom Davis, helped to champion this effort with 
Chairman Waxman for many years. With Congressman Davis' retirement last 
year, I'm honored to have taken

[[Page H4343]]

his place as the lead Republican sponsor of this important legislation 
and to have the privilege of working with Chairman Waxman and his staff 
on this important effort.
  Mr. Speaker, tobacco is one of the deadliest consumer products on the 
market today. It kills over 400,000 Americans every year. Yet it is one 
of the least regulated of all consumer products. In other words, while 
the FDA has the authority to regulate seemingly harmless products such 
as lipstick, hair spray and shaving cream, to name just three, the FDA 
does not have the authority it needs to regulate one of the deadliest, 
if not the deadliest, products available for sale to our citizens. It 
is long past time when tobacco products should be subject to serious 
regulation to protect the public's health. This bill would finally 
accomplish this important goal.
  First, this legislation would ensure that tobacco products are not 
advertised to or sold to children. Addiction to tobacco begins almost 
universally in childhood and in adolescence. Every day, almost 4,000 
children try their first cigarette, and over 1,000 become daily 
smokers. Tobacco companies have long taken advantage of this 
vulnerability by promoting their products through such tactics as 
cartoon advertisements, free tobacco-themed merchandise that appeals to 
kids and through sponsorships of sports and entertainment events.
  With health care costs spiraling out of control every year, the cost 
of treating these smokers later in life is fast becoming prohibitively 
expensive. Prohibiting advertising to children would go a long way in 
preventing young people in America from starting to smoke, and it would 
save billions of dollars and countless lives in the years to come.
  Second, this legislation would require that tobacco products marketed 
as safer than other tobacco products are, in fact, demonstrated to be 
safer. The history of low-tar cigarettes illustrates the grave danger 
to public health caused by fooling consumers into believing 
unsubstantiated claims that one kind of cigarette is safer than 
another. Millions of Americans switched to low-tar cigarettes, 
believing they were reducing their risk of lung cancer. Many were 
convinced to switch instead of to quit. It was not until decades later 
that we learned through the deaths of those smoking low-tar cigarettes 
that low-tar cigarettes were just as dangerous as full-tar cigarettes. 
Under this legislation, we will not have to wait for the deaths of 
millions of more Americans to learn whether a so-called ``safer'' 
cigarette is what it claims to be.
  This bill does not ban tobacco products. H.R. 1256 would allow the 
FDA to scientifically evaluate the health benefits and risks posed by 
ingredients in cigarettes, and it would take steps to reduce the harm 
caused by tobacco products. This legislation preserves an adult's 
choice to smoke. Even though I don't believe we want anyone to, it 
preserves that choice, and we make sure that those tobacco products 
that are marketed as safe alternatives to cigarettes are, in fact, 
scientifically proven to be safer.
  Finally, I understand that some individuals have concerns with 
placing such authority under the FDA. I think it's important to note 
that the FDA already regulates products that people use to help quit 
smoking, such as nicotine gums and patches. In addition, this 
legislation does provide an entirely separate funding stream for the 
FDA's regulation of tobacco products to ensure that other important 
efforts carried out by this agency are not diminished.
  I hope my colleagues will join me in supporting the Family Smoking 
Prevention and Tobacco Control Act.
  For the record, I believe there was reference that the reason we're 
not completely banning it is because of the influence of tobacco funds 
in campaigns. If I understand that correctly, I want to be on the 
record as one who doesn't accept any political action committee funds, 
including tobacco funds, and I've not received any such funds. Never 
have. Never will. This is about doing right for American citizens. It's 
about the health of our citizens. It's especially about the health of 
our children.
  Vote ``yes'' and oppose this substitute. Support the underlying bill.
  Mr. BUYER. I want to thank both gentlemen--Mr. Platts and the 
chairman--for his bill. As I've said, I complimented you earlier about 
your persistence and about your tenacity, about your drive and your 
sincerity. I don't question it at all. I have a different approach on 
how we can improve public policy, and this has been a good debate. I 
want to thank the chairman for allowing this debate to occur. It was a 
healthy debate at the committee during the markup. I think it's a 
healthy debate for us to have.
  Over 100 countries around the world are struggling with how they 
answer these public health questions on how to deal with individuals 
who become addicted to nicotine. When you look at this approach of, 
``Well, let's just quit. Stop smoking and just quit,'' I just take a 
simple look at this. I say there are 45 million smokers, and then there 
are 2 million who are trying to stop smoking. Yet there's only a 7 
percent success rate. Something is not working. To me, that's a rate of 
failure.
  So that's why Mr. McIntyre and I came up with a different approach. 
We came up with a harm-reduction approach, and what we seek to do is to 
put our arms around everything. Not only are we trying to accomplish 
some of the similar goals of Mr. Waxman and Mr. Platts and of others 
who support Mr. Waxman's approach, but we wanted to include everything. 
We could include abstinence. We could include cessation programs and 
prevention and education. We seek to do that because we have a harm-
reduction strategy to do that, and we want to move people down a 
continuum of risk.
  When you look at the 45 million smokers, 85 percent of them are 
smoking light or ultralight cigarettes. Now, the reason they do that is 
they make a subconscious decision that somehow it's a healthier or a 
safer cigarette. The reality is it's not. It's not.
  So Mr. Platts is absolutely correct, but what we seek to do in the 
substitute is we want to regulate tobacco. That's what Mr. McIntyre and 
I seek to do. We want to regulate tobacco. We don't want to do it under 
the FDA. We want to do it in a harm-reduction center, and we want the 
tobacco companies to come forward. We'll regulate that tobacco, but we 
want to migrate smokers into other forms of products. I'm going to talk 
about that in greater detail on the substitute.
  At this point, Mr. Waxman, I don't have any other speakers, so we can 
proceed to the substitute.
  Mr. DINGELL. Mr. Speaker, I rise in strong support of H.R. 1256, the 
Family Smoking Prevention and Tobacco Control Act. This historic 
legislation will grant the Food and Drug Administration the authority 
to regulate tobacco products. Aside from a few technical changes, H.R. 
1256 is identical to the legislation Chairman Waxman and I worked hard 
together to pass in the House last year.
  This legislation is long overdue:
  In 1957, Surgeon General Leroy Burney declared the causal link 
between smoking and lung cancer.
  In 1964, Surgeon General Luther Terry's Report proclaimed that 
cigarette smoking is a health hazard of sufficient importance in the 
United States to warrant appropriate remedial action.
  Today, fifty-two years after the cancer link was established, forty-
five years after the call for remedial action, we are finally poised to 
regulate this lethal product.
  H.R. 1256 creates a fully-funded separate tobacco center at FDA to 
regulate tobacco products. The FDA is the appropriate scientific and 
regulatory agency to provide this oversight. Through a user fee on 
tobacco products, FDA will have the resources to implement this 
legislation and the legislation segregates the tobacco center and its 
funding from other FDA programs.
  The FDA needs more resources and greater authority to meet its other 
obligations with respect to food, drugs, devices and cosmetics. My 
colleagues, Mr. Pallone and Mr. Stupak, and I have introduced 
legislation to address this need. To my colleagues who are concerned 
with FDA's lack of resources, I invite you to join us in this effort.
  Each year, tobacco use kills more than 400,000 people. The American 
people need assurance that their food and medical products are safe. 
But they also need meaningful oversight of tobacco products. This 
Congress can deliver both.
  I urge my colleagues to vote in favor of H.R. 1256.
  Mr. VAN HOLLEN. Madam Speaker, as an original cosponsor, I rise in 
strong support of the bipartisan Family Smoking Prevention and Tobacco 
Control Act. I want to thank Chairman Waxman and so many others for 
their

[[Page H4344]]

leadership in bringing this legislation to the floor after so many 
years and so many battles. This is an important day for the American 
people.
  Granting the Food and Drug Administration authority to regulate 
tobacco products is long overdue and is a critical step in the 
protection of the public's health. As we know, the FDA has the power to 
regulate and oversee all sorts of products that are sold today. Many 
products that they regulate are not addictive. Yet we do not have the 
FDA's regulatory authority when it came to the very addictive products 
of tobacco and nicotine.
  Because of the lack of regulatory authority on tobacco products, the 
FDA has been sidelined and the result is that the big tobacco companies 
have taken advantage of that opportunity and exploited it by marketing 
their deadly products to young people. For far too long, the tobacco 
companies have been targeting our kids, deceiving all of us about the 
harmful effects of their products and manipulating the ingredients in 
their products--all to ensure that their profit levels remained high. 
In order for them to continue to make their profits, they had to 
continue getting one generation after another hooked on tobacco 
products.
  Let's make sure that future generations of young people do not get 
addicted. Addiction to tobacco products has had a huge cost to our 
society in terms of lives and money with over 400,000 American deaths 
every year. We have a chance today to put an end to that cycle.
  In my home State of Maryland, I am very proud of the steps we have 
taken to curb the effects of tobacco use. We increased the tobacco tax 
and youth smoking has declined. We also passed a comprehensive 
smokefree indoor air law in 2007. But we can't have every State 
fighting alone to have a successful national program to curb tobacco 
use. We need one entity that has this power to help protect the 
American people, especially the young people of our country, from the 
deadly effects of tobacco products.
  Mr. Speaker, this bill is a crucial step in protecting the health and 
well-being of our constituents from the deadly effects of tobacco use. 
It will save lives and money. I urge my colleagues to join me in a yes 
vote on this much-needed legislation.
  Mr. LUCAS. Mr. Speaker, I am appalled at the blatant disregard for 
the public policy process. What kind of trick is being played out on 
the American people when half of H.R. 1256--the half that pays for FDA 
legislation--comes on suspension of the rules and the other half, the 
part that burdens American companies with more taxes and regulation, 
comes under a closed rule?
  This bill gives FDA broad statutory authority to regulate the 
manufacturing, distribution, advertising, promotion, sale, and use of 
cigarettes and smokeless tobacco. And, it will ultimately result in FDA 
being on the farm micromanaging our farmers.
  FDA has clearly proven it is severely overburdened with its current 
authority. Just look to the recent examples of salmonella found in 
peanut and pistachio products. Why would we give a huge new expansion 
of authority to an agency that has proven it can't handle the load it 
has? Can you honestly tell the American people to have confidence in 
the FDA to protect them?
  How will this new authority be paid for? New taxes, of course. The 
bill taxes companies and importers to pay for the cost of regulation. 
The bill sets the amount of the assessments each year, which will 
increase to $712 million per year.
  Also, this bill calls for using funds from the Thrift Savings Plan. 
Do we really want to use the savings portion of the bill to pay for 
more Washington bureaucracy?
  Tobacco producers, small convenience stores, and tobacco 
warehouseman, which are the backbones of commerce across poor and rural 
districts, will be put out of business under this bill.
  And, farmers--beware--FDA will come directly on your farm and tell 
you how to operate. Producers will bear the brunt of this legislation. 
FDA will tell producers what type of seeds they can plant, the methods 
in which they cultivate those seeds, the records they must keep and on 
and on and on.
  I ask for a ``no'' vote on this classic tax and regulate bill.
  Mr. BUYER. I yield back the balance of my time.
  Mr. WAXMAN. Mr. Speaker, I also yield back my time.
  The SPEAKER pro tempore. All time for debate on the bill has expired.


                     Amendment Offered by Mr. Buyer

  Mr. BUYER. Mr. Speaker, I have an amendment at the desk.
  The SPEAKER pro tempore. The Clerk will designate the amendment.
  The text of the amendment is as follows:

       Amendment in the nature of a substitute printed in part B 
     of House Report 111-72 offered by Mr. Buyer:
       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 ``Youth 
     Prevention and Tobacco Harm Reduction 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.
Sec. 6. Effective date.

        TITLE I--AUTHORITY OF THE TOBACCO HARM REDUCTION CENTER

Sec. 100. Definitions.
Sec. 101. Center authority over tobacco products.
Sec. 102. Exclusion of other regulatory programs.
Sec. 103. Existing Federal statutes maintained.
Sec. 104. Proceedings in the name of the United States; subpoenas; 
              preemption of State and local law; no private right of 
              action.
Sec. 105. Illicit trade.
Sec. 106. Adulterated tobacco products.
Sec. 107. Misbranded tobacco products.
Sec. 108. Submission of health information to the Administrator.
Sec. 109. Registration and listing.
Sec. 110. General provisions respecting control of tobacco products.
Sec. 111. Smoking article standards.
Sec. 112. Notification and other remedies.
Sec. 113. Records and reports on tobacco products.
Sec. 114. Application for review of certain smoking articles.
Sec. 115. Modified risk tobacco products.
Sec. 116. Judicial review.
Sec. 117. Jurisdiction of and coordination with the Federal Trade 
              Commission.
Sec. 118. Regulation requirement.
Sec. 119. Preservation of State and local authority.
Sec. 120. Tobacco Products Scientific Advisory Committee.
Sec. 121. Drug products used to treat tobacco dependence.
Sec. 122. Advertising and marketing of tobacco products.

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

Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Smokeless tobacco labels and advertising warnings.

     TITLE III--PUBIC DISCLOSURES BY TOBACCO PRODUCTS MANUFACTURERS

Sec. 301. Disclosures on packages of tobacco products.
Sec. 302. Disclosures on packages of smokeless tobacco.
Sec. 303. Public disclosure of ingredients.

       TITLE IV--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS

Sec. 401. Study and report on illicit trade.
Sec. 402. Amendment to section 1926 of the Public Health Service Act.
Sec. 403. Establishment of rankings.

                    TITLE V--ENFORCEMENT PROVISIONS

Sec. 501. Prohibited acts.
Sec. 502. Injunction proceedings.
Sec. 503. Penalties.
Sec. 504. Seizure.
Sec. 505. Report of minor violations.
Sec. 506. Inspection.
Sec. 507. Effect of compliance.
Sec. 508. Imports.
Sec. 509. Tobacco products for export.

                   TITLE VI--MISCELLANEOUS PROVISIONS

Sec. 601. Use of payments under the master settlement agreement and 
              individual State settlement agreements.
Sec. 602. Preemption of State Laws Implementing Fire Safety Standard 
              for Cigarettes.
Sec. 603. Inspection by the alcohol and tobacco tax trade bureau of 
              records of certain cigarette and smokeless tobacco 
              sellers.
Sec. 604. Severability.

                  TITLE VII--TOBACCO GROWER PROTECTION

Sec. 701. Tobacco grower protection.

     SEC. 2. FINDINGS.

       The Congress finds the following:
       (1) Cigarette smoking is a leading cause of preventable 
     deaths in the United States. Cigarette smoking significantly 
     increases the risk of developing lung cancer, heart disease, 
     chronic bronchitis, emphysema and other serious diseases with 
     adverse health conditions.
       (2) The risk for serious diseases is significantly affected 
     by the type of tobacco product and the frequency, duration 
     and manner of use.
       (3) No tobacco product has been shown to be safe and 
     without risks. The health risks associated with cigarettes 
     are significantly greater than those associated with the use 
     of smoke-free tobacco and nicotine products.
       (4) Nicotine in tobacco products is addictive but is not 
     considered a significant threat to health.
       (5) It is the smoke inhaled from burning tobacco which 
     poses the most significant risk of serious diseases.
       (6) Quitting cigarette smoking significantly reduces the 
     risk for serious diseases.
       (7) Adult tobacco consumers have a right to be fully and 
     accurately informed about the risks of serious diseases, the 
     significant

[[Page H4345]]

     differences in the comparative risks of different tobacco and 
     nicotine-based products, and the benefits of quitting. This 
     information should be based on sound science.
       (8) Governments, public health officials, tobacco 
     manufacturers and others share a responsibility to provide 
     adult tobacco consumers with accurate information about the 
     various health risks and comparative risks associated with 
     the use of different tobacco and nicotine products.
       (9) Tobacco products should be regulated in a manner that 
     is designed to achieve significant and measurable reductions 
     in the morbidity and mortality associated with tobacco use. 
     Regulations should enhance the information available to adult 
     consumers to permit them to make informed choices, and 
     encourage the development of tobacco and nicotine products 
     with lower risks than cigarettes currently sold in the United 
     States.
       (10) The form of regulation should be based on the risks 
     and comparative risks of tobacco and nicotine products and 
     their respective product categories.
       (11) The regulation of marketing of tobacco products should 
     be consistent with constitutional protections and enhance an 
     adult consumer's ability to make an informed choice by 
     providing accurate information on the risks and comparative 
     risks of tobacco products.
       (12) Reducing the diseases and deaths associated with the 
     use of cigarettes serves public health goals and is in the 
     best interest of consumers and society. Harm reduction should 
     be the critical element of any comprehensive public policy 
     surrounding the health consequences of tobacco use.
       (13) Significant reductions in the harm associated with the 
     use of cigarettes can be achieved by providing accurate 
     information regarding the comparative risks of tobacco 
     products to adult tobacco consumers, thereby encouraging 
     smokers to migrate to the use of smoke-free tobacco and 
     nicotine products, and by developing new smoke-free tobacco 
     and nicotine products and other actions.
       (14) Governments, public health officials, manufacturers, 
     tobacco producers and consumers should support the 
     development, production, and commercial introduction of 
     tobacco leaf, and tobacco and nicotine-based products that 
     are scientifically shown to reduce the risks associated with 
     the use of existing tobacco products, particularly 
     cigarettes.
       (15) Adult tobacco consumers should have access to a range 
     of commercially viable tobacco and nicotine-based products.
       (16) There is substantial scientific evidence that selected 
     smokeless tobacco products can satisfy the nicotine addiction 
     of inveterate smokers while eliminating most, if not all, 
     risk of pulmonary and cardiovascular complications of smoking 
     and while reducing the risk of cancer by more than 95 
     percent.
       (17) Transitioning smokers to selected smokeless tobacco 
     products will eliminate environmental tobacco smoke and fire-
     related hazards.
       (18) Current ``abstain, quit, or die'' tobacco control 
     policies in the United States may have reached their maximum 
     possible public health benefit because of the large number of 
     cigarette smokers either unwilling or unable to discontinue 
     their addiction to nicotine.
       (19) There is evidence that harm reduction works and can be 
     accomplished in a way that will not increase initiation or 
     impede smoking cessation.
       (20) Health-related agencies and organizations, both within 
     the United States and abroad have already gone on record 
     endorsing Harm Reduction as an approach to further reducing 
     tobacco related illness and death.
       (21) Current Federal policy requires tobacco product 
     labeling that leaves the incorrect impression that all 
     tobacco product present equal risk.

     SEC. 3. PURPOSE.

       The purposes of this Act are--
       (1) to provide authority to the Tobacco Harm Reduction 
     Center by recognizing it as the primary Federal regulatory 
     authority with respect to tobacco products as provided for in 
     this Act;
       (2) to ensure that the Center 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 Center 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 Center with the authority to regulate the 
     levels of tar, nicotine, and other harmful components of 
     tobacco products;
       (6) to ensure that consumers are better informed regarding 
     the relative risks for death and disease between categories 
     of tobacco products;
       (7) to continue to allow 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 prevention, cessation, and harm reduction 
     policies and regulations to reduce disease risk and the 
     social costs associated with tobacco-related diseases;
       (10) to provide authority to the Department of Health and 
     Human Services to regulate tobacco products;
       (11) to establish national policies that effectively reduce 
     disease and death associated with cigarette smoking and other 
     tobacco use;
       (12) to establish national policies that encourage 
     prevention, cessation, and harm reduction measures regarding 
     the use of tobacco products;
       (13) to encourage current cigarette smokers who will not 
     quit to use noncombustible tobacco or nicotine products that 
     have significantly less risk than cigarettes;
       (14) to establish national policies that accurately and 
     consistently inform adult tobacco consumers of significant 
     differences in risk between respective tobacco products;
       (15) to establish national policies that encourage and 
     assist the development and awareness of noncombustible 
     tobacco and nicotine products;
       (16) to coordinate national and State prevention, 
     cessation, and harm reduction programs;
       (17) to impose measures to ensure tobacco products are not 
     sold or accessible to underage purchasers; and
       (18) to strengthen Federal and State legislation to prevent 
     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;
       (2) affect any action pending in Federal, State, or Tribal 
     court, or any agreement, consent decree, or contract of any 
     kind; or
       (3) be applicable to tobacco products or component parts 
     manufactured in the United States for export.
       (b) Agricultural Activities.--The provisions of this Act 
     (or an amendment made by this Act) which authorize the 
     Administrator 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 Administrator 
     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.

     SEC. 6. EFFECTIVE DATE.

       Except as otherwise specifically provided, the effective 
     date of this Act shall be the date of its enactment.

        TITLE I--AUTHORITY OF THE TOBACCO HARM REDUCTION CENTER

     SEC. 100. DEFINITIONS.

       In this Act:
       (1) The term ``Administrator'' means the chief executive of 
     the Tobacco Harm Reduction Center.
       (2) The term ``adult'' means any individual who has 
     attained the minimum age under applicable State law to be an 
     individual to whom tobacco products may lawfully be sold.
       (3) The term ``adult-only facility'' means a facility or 
     restricted area, whether open-air or enclosed, where the 
     operator ensures, or has a reasonable basis to believe, that 
     no youth is present. A facility or restricted area need not 
     be permanently restricted to adults in order to constitute an 
     adult-only facility, if the operator ensures, or has a 
     reasonable basis to believe, that no youth is present during 
     any period of operation as an adult-only facility.
       (4) The term ``affiliate'' means a person that directly or 
     indirectly owns or controls, is owned or controlled by, or is 
     under common ownership or control with, another person. The 
     terms ``owns,'' ``is owned'', and ``ownership'' refer to 
     ownership of an equity interest, or the equivalent thereof, 
     of 50 percent or more.
       (5) The term ``annual report'' means a tobacco product 
     manufacturer's annual report to the Center, which provides 
     ingredient information and nicotine yield ratings for each 
     brand style that tobacco product manufacturer manufactures 
     for commercial distribution domestically.
       (6) The term ``brand name'' means a brand name of a tobacco 
     product distributed or sold domestically, alone, or in 
     conjunction with any other word, trademark, logo, symbol, 
     motto, selling message, recognizable pattern of colors, or 
     any other indicium of product identification identical or 
     similar to, or identifiable with, those used for any domestic 
     brand of tobacco product. The term shall not include the 
     corporate name of any tobacco product manufacturer that does 
     not, after the effective date of this Act, sell a brand style 
     of tobacco product in the United States that includes such 
     corporate name.
       (7) The term ``brand style'' means a tobacco product having 
     a brand name, and distinguished by the selection of the 
     tobacco,

[[Page H4346]]

     ingredients, structural materials, format, configuration, 
     size, package, product descriptor, amount of tobacco, or 
     yield of ``tar'' or nicotine.
       (8) The term ``Center'' means the Tobacco Harm Reduction 
     Center.
       (9) The term ``cigar'' has the meaning assigned that term 
     by the Alcohol and Tobacco Tax and Trade Bureau in section 
     40.11 of title 27, Code of Federal Regulations.
       (10) The term ``cigarette'' means--
       (A) any roll of tobacco wrapped in paper or in any 
     substance not containing tobacco; or
       (B) any roll of tobacco wrapped in any substance containing 
     tobacco which, because of the appearance of the roll of 
     tobacco, the type of tobacco used in the filler, or its 
     package or labeling, is likely to be offered to, or purchased 
     by, consumers as a cigarette described in paragraph (1).
       (11) The term ``competent and reliable scientific 
     evidence'' means evidence based on tests, analyses, research, 
     or studies, conducted and evaluated in an objective manner by 
     individuals qualified to do so, using procedures generally 
     accepted in the relevant scientific disciplines to yield 
     accurate and reliable results.
       (12) The term ``distributor'' means any person who furthers 
     the distribution of tobacco products, whether domestic or 
     imported, at any point from the original place of manufacture 
     to the person who sells or distributes the tobacco product to 
     individuals for personal consumption. Common carriers, 
     retailers, and those engaged solely in advertising are not 
     considered distributors for purposes of this Act.
       (13) The terms ``domestic'' and ``domestically'' mean 
     within the United States, including activities within the 
     United States involving advertising, marketing, distribution, 
     or sale of tobacco products that are intended for consumption 
     within the United States.
       (14) The term ``illicit tobacco product'' means any tobacco 
     product intended for use by consumers in the United States--
       (A) as to which not all applicable duties or taxes have 
     been paid in full;
       (B) that has been stolen, smuggled, or is otherwise 
     contraband;
       (C) that is counterfeit; or
       (D) that has or had a label, labeling, or packaging 
     stating, or that stated, that the product is or was for 
     export only, or that it is or was at any time restricted by 
     section 5704 of title 26, United States Code.
       (15) The term ``illicit trade'' means any transfer, 
     distribution, or sale in interstate commerce of any illicit 
     tobacco product.
       (16) The term ``immediate container'' does not include 
     package liners.
       (17) The term ``Indian tribe'' has the meaning assigned 
     that term in section 4(e) of the Indian Self Determination 
     and Education Assistance Act.
       (18) The term ``ingredient'' means tobacco and any 
     substance added to tobacco to have an effect in the final 
     tobacco product or when the final tobacco product is used by 
     a consumer.
       (19) The term ``International Organization for 
     Standardization (ISO) testing regimen'' means the methods for 
     measuring cigarette smoke yields, as set forth in the most 
     recent version of ISO 3308, entitled ``Routine analytical 
     cigarette-smoking machine--Definition of standard 
     conditions''; ISO 4387, entitled ``Cigarettes--Determination 
     of total and nicotine-free dry particulate matter using a 
     routine analytical smoking machine''; ISO 10315, entitled 
     ``Cigarettes--Determination of nicotine in smoke 
     condensates--Gas-chromatographic method''; ISO 10362-1, 
     entitled ``Cigarettes--Determination of water in smoke 
     condensates--Part 1: Gas-chromatographic method''; and ISO 
     8454, entitled ``Cigarettes--Determination of carbon monoxide 
     in the vapour phase of cigarette smoke--NDIR method''. A 
     cigarette that does not burn down in accordance with the 
     testing regimen standards may be measured under the same puff 
     regimen using the number of puffs that such a cigarette 
     delivers before it extinguishes, plus an additional three 
     puffs, or with such other modifications as the Administrator 
     may approve.
       (20) The term ``interstate commerce'' means all trade, 
     traffic, or other commerce--
       (A) within the District of Columbia, or any territory or 
     possession of the United States;
       (B) between any point in a State and any point outside 
     thereof;
       (C) between points within the same State through any place 
     outside such State; or
       (D) over which the United States has jurisdiction.
       (21) The term ``label'' means a display of written, 
     printed, or graphic matter upon or applied securely to the 
     immediate container of a tobacco product.
       (22) The term ``labeling'' means all labels and other 
     written, printed, or graphic matter (1) upon or applied 
     securely to any tobacco product or any of its containers or 
     wrappers, or (2) accompanying a tobacco product.
       (23) The term ``little cigar'' has the meaning assigned 
     that term by the Alcohol and Tobacco Tax and Trade Bureau in 
     section 40.11 of title 27, Code of Federal Regulations.
       (24) The term ``loose tobacco'' means any form of tobacco, 
     alone or in combination with any other ingredient or 
     material, that, because of its appearance, form, type, 
     packaging, or labeling, is suitable for use and likely to be 
     offered to, or purchased by, consumers as tobacco for making 
     or assembling cigarettes, incorporation into pipes, or 
     otherwise used by consumers to make any tobacco product.
       (25) The term ``manufacture'' means to design, manufacture, 
     fabricate, assemble, process, package, or repackage, label, 
     or relabel, import, or hold or store in a commercial 
     quantity, but does not include--
       (A) the growing, curing, de-stemming, or aging of tobacco; 
     or
       (B) the holding, storing or transporting of a tobacco 
     product by a common carrier for hire, a public warehouse, a 
     testing laboratory, a distributor, or a retailer.
       (26) The term ``nicotine-containing product'' means a 
     product, other than a tobacco product, that contains added 
     nicotine, whether or not in the form of a salt or solvate, 
     that has been--
       (A) synthetically produced, or
       (B) obtained from tobacco or other source of nicotine.
       (27) The term ``package'' means a pack, box, carton, pouch, 
     or container of any kind in which a tobacco product or 
     tobacco products are offered for sale, sold, or otherwise 
     distributed to consumers. The term ``package'' does not 
     include an outer container used solely for shipping one or 
     more packages of a tobacco product or tobacco products.
       (28) The term ``person'' means any individual, partnership, 
     corporation, committee, association, organization or group of 
     persons, or other legal or business entity.
       (29) The term ``proof of age'' means a driver's license or 
     other form of identification that is issued by a governmental 
     authority and includes a photograph and a date of birth of 
     the individual.
       (30) The term ``raw tobacco'' means tobacco in a form that 
     is received by a tobacco product manufacturer as an 
     agricultural commodity, whether in a form that is natural, 
     stem, or leaf, cured or aged, or as parts or pieces, but not 
     in a reconstituted form, extracted pulp form, or extract 
     form.
       (31) The term ``reduced-exposure claim'' means a statement 
     in advertising or labeling intended for one or more consumers 
     of tobacco products, that a tobacco product provides a 
     reduced exposure of users of that tobacco product to one or 
     more toxicants, as compared to an appropriate reference 
     tobacco product or category of tobacco products. A statement 
     or representation that a tobacco product or the tobacco in a 
     tobacco product contains ``no additives'' or is ``natural'' 
     or that uses a substantially similar term is not a reduced-
     exposure claim if the advertising or labeling that contains 
     such statement or representation also contains the disclosure 
     required by section 108(h) of this Act.
       (32) The term ``reduced-risk claim'' means a statement in 
     advertising or labeling intended for one or more consumers of 
     smoking articles, that a smoking article provides to users of 
     that product a reduced risk of morbidity or mortality 
     resulting from one or more chronic diseases or serious 
     adverse health conditions associated with tobacco use, as 
     compared to an appropriate reference smoking article or 
     category of smoking articles, even if it is not stated, 
     represented, or implied that all health risks associated with 
     using that smoking article have been reduced or eliminated. A 
     statement or representation that a smoking article or the 
     tobacco in a smoking article contains ``no additives,'' or is 
     ``natural,'' or that uses a substantially similar term is not 
     a reduced-risk claim if the advertising or labeling that 
     contains such statement or representation also contains the 
     disclosure required by section 108(h).
       (33) The term ``retailer'' means any person that--
       (A) sells tobacco products to individuals for personal 
     consumption; or
       (B) operates a facility where the sale of tobacco products 
     to individuals for personal consumption is permitted.
       (34) The term ``small business'' means a tobacco product 
     manufacturer that--
       (A) has 150 or fewer employees; and
       (B) during the 3-year period prior to the current calendar 
     year, had an average annual gross revenue from tobacco 
     products that did not exceed $40,000,000.
       (35) The term ``smokeless tobacco product'' means any form 
     of finely cut, ground, powdered, reconstituted, processed or 
     shaped tobacco, leaf tobacco, or stem tobacco, whether or not 
     combined with any other ingredient, whether or not in extract 
     or extracted form, and whether or not incorporated within any 
     carrier or construct, that is intended to be placed in the 
     oral or nasal cavity, including dry snuff, moist snuff, and 
     chewing tobacco.
       (36) The term ``smoking article'' means any tobacco-
     containing article that is intended, when used by a consumer, 
     to be burned or otherwise to employ heat to produce a vapor, 
     aerosol or smoke that--
       (A) incorporates components of tobacco or derived from 
     tobacco; and
       (B) is intended to be inhaled by the user.
       (37) The term ``State'' means any State of the United 
     States and, except as otherwise specifically provided, 
     includes any Indian tribe or tribal organization, the 
     District of Columbia, the Commonwealth of Puerto Rico, Guam, 
     the Virgin Islands, American Samoa, Wake Island, Midway 
     Island, Kingman Reef, Johnston Atoll, the Northern Marianas, 
     and any other trust territory or possession of the United 
     States.
       (38) The term ``tar'' means nicotine-free dry particulate 
     matter as defined in ISO 4387, entitled ``Cigarettes--
     Determination of total and nicotine-free dry particulate 
     matter using a routine analytical smoking machine''.

[[Page H4347]]

       (39) The term ``tobacco'' means a tobacco plant or any part 
     of a harvested tobacco plant intended for use in the 
     production of a tobacco product, including leaf, lamina, 
     stem, or stalk, whether in green, cured, or aged form, 
     whether in raw, treated, or processed form, and whether or 
     not combined with other materials, including any by-product, 
     extract, extracted pulp material, or any other material 
     (other than purified nicotine) derived from a tobacco plant 
     or any component thereof, and including strip, filler, stem, 
     powder, and granulated, blended, or reconstituted forms of 
     tobacco.
       (40) The term ``tobacco product'' means--
       (A) the singular of ``tobacco products'' as defined in 
     section 5702(c) of the Internal Revenue Code of 1986;
       (B) any other product that contains tobacco as a principal 
     ingredient and that, because of its appearance, type, or the 
     tobacco used in the product, or its packaging and labeling, 
     is likely to be offered to, or purchased by, consumers as a 
     tobacco product as described in subparagraph (A); and
       (C) any form of tobacco or any construct incorporating 
     tobacco, intended for human consumption, whether by--
       (i) placement in the oral or nasal cavity;
       (ii) inhalation of vapor, aerosol, or smoke; or
       (iii) any other means.
       (41) The term ``tobacco product category'' means a type of 
     tobacco product characterized by its composition, components, 
     and intended use, and includes tobacco products classified as 
     cigarettes, loose tobacco for roll-your-own tobacco products, 
     little cigars, cigars, pipe tobacco, moist snuff, dry snuff, 
     chewing tobacco, and other forms of tobacco products (which 
     are treated in this Act collectively as a single category).
       (42) The term ``tobacco product communication'' means any 
     means, medium, or manner for providing information relating 
     to any tobacco product, including face-to-face interaction, 
     mailings by postal service or courier to an individual who is 
     an addressee, and electronic mail to an individual who is an 
     addressee.
       (43) The term ``tobacco product manufacturer'' means an 
     entity that directly--
       (A) manufactures anywhere a tobacco product that is 
     intended to be distributed commercially in the United States, 
     including a tobacco product intended to be distributed 
     commercially in the United States through an importer;
       (B) is the first purchaser for resale in the United States 
     of tobacco products manufactured outside the United States 
     for distribution commercially in the United States; or
       (C) is a successor or assign of any of the foregoing.
       (44) The term ``toxicant'' means a chemical or physical 
     agent that produces an adverse biological effect.
       (45) The term ``tribal organization'' has the meaning 
     assigned that term in section 4(1) of the Indian Self 
     Determination and Education Assistance Act.
       (46) The term ``United States'' means the several States, 
     as defined in this Act.
       (47) The term ``youth'' means any individual who in not an 
     adult.

     SEC. 101. CENTER 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 117, shall be regulated by the 
     Administrator under this Act.
       (b) Applicability.--This Act shall apply to all cigarettes, 
     cigarette tobacco, roll-your-own tobacco, and smokeless 
     tobacco and to any other tobacco products that the 
     Administrator by regulation deems to be subject to this Act.
       (c) Center.--The Secretary of Health and Human Services 
     shall establish within the Department of Health and Human 
     Services the Tobacco Harm Reduction Center. The head of the 
     Center shall be an Administrator, who shall assume the 
     statutory authority conferred by this Act, perform the 
     functions that relate to the subject matter of this Act, and 
     have the authority to promulgate regulations for the 
     efficient enforcement of this Act. In promulgating any 
     regulations under such authority, in whole or in part or any 
     regulation that is likely to have an annual effect on the 
     economy of $50,000,000 or more or have a material adverse 
     effect on adult users of tobacco products, tobacco product 
     manufacturers, distributors, or retailers, the Administrator 
     shall--
       (1) determine the technological and economic ability of 
     parties that would be required to comply with the regulation 
     to comply with it;
       (2) consider experience gained under any relevantly similar 
     regulations at the Federal or State level;
       (3) determine the reasonableness of the relationship 
     between the costs of complying with such regulation and the 
     public health benefits to be achieved by such regulation;
       (4) determine the reasonable likelihood of measurable and 
     substantial reductions in morbidity and mortality among 
     individual tobacco users;
       (5) determine the impact to United States tobacco producers 
     and farm operations;
       (6) determine the impact on the availability and use of 
     tobacco products by minors; and
       (7) determine the impact on illicit trade of tobacco 
     products.
       (d) Limitation of Authority.--
       (1) In general.--The provisions of this Act 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 Center have any authority to enter onto a farm owned by a 
     producer of tobacco leaf without the written consent of such 
     producer.
       (2) Exception.--Notwithstanding paragraph (1), 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 Act 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.
       (3) Rule of construction.--Nothing in this Act shall be 
     construed to grant the Administrator authority to promulgate 
     regulations on any matter that involves the production of 
     tobacco leaf or a producer thereof.
       (e) Rulemaking Procedures.--Each rulemaking under this Act 
     shall be in accordance with chapter 5 of title 5, United 
     States Code.
       (f) Consultation Prior to Rulemaking.--Prior to 
     promulgating rules under this Act, the Administrator shall 
     endeavor to consult with other Federal agencies as 
     appropriate.

     SEC. 102. EXCLUSION OF OTHER REGULATORY PROGRAMS.

       (a) Exclusion of Tobacco Products and Nicotine-Containing 
     Products From the Federal Food, Drug, and Cosmetic Act.--No 
     tobacco product and no nicotine-containing product shall be 
     regulated as a food, drug, or device in accordance with 
     section 201 (f), (g) or (h) or Chapter IV or V of the Federal 
     Food, Drug, and Cosmetic Act, except that any tobacco product 
     commercially distributed domestically and any nicotine-
     containing product commercially distributed domestically 
     shall be subject to Chapter V of the Federal Food, Drug, and 
     Cosmetic Act if the manufacturer or a distributor of such 
     product markets it with an explicit claim that the product is 
     intended for use in the cure, mitigation, treatment, or 
     prevention of disease in man or other animals, within the 
     meaning of section 201(g)(1)(C) or section 201(h)(2) of that 
     Act.
       (b) Limitation on Effect of This Act.--Nothing in 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 any Federal, State, or 
     Tribal court, or any agreement, consent decree, or contract 
     of any kind.
       (c) Exclusions From Authority of Administrator.--The 
     authority granted to the Administrator under this Act shall 
     not apply to--
       (1) raw tobacco that is not in the possession or control of 
     a tobacco product manufacturer;
       (2) raw tobacco that is grown for a tobacco product 
     manufacturer by a grower, and that is in the possession of 
     that grower or of a person that is not a tobacco product 
     manufacturer and is within the scope of subparagraphs (A) 
     through(F) of paragraph (3); or
       (3) the activities, materials, facilities, or practices of 
     persons that are not tobacco product manufacturers and that 
     are--
       (A) producers of raw tobacco, including tobacco growers;
       (B) tobacco warehouses, and other persons that receive raw 
     tobacco from growers;
       (C) tobacco grower cooperatives;
       (D) persons that cure raw tobacco;
       (E) persons that process raw tobacco; and
       (F) persons that store raw tobacco for aging.
     If a producer of raw tobacco is also a tobacco product 
     manufacturer, an affiliate of a tobacco product manufacturer, 
     or a person producing raw tobacco for a tobacco product 
     manufacturer, then that producer shall be subject to this Act 
     only to the extent of that producer's capacity as a tobacco 
     product manufacturer.

     SEC. 103. EXISTING FEDERAL STATUTES MAINTAINED.

       Except as amended or repealed by this Act, all Federal 
     statutes in effect as of the effective date of this Act that 
     regulate tobacco, tobacco products, or tobacco product 
     manufacturers shall remain in full force and effect. Such 
     statutes include, without limitation--
       (1) the Federal Cigarette Labeling and Advertising Act, 
     sections 1331-1340 of title 15, United States Code, except 
     that section 1335 of title 15, United States Code, is 
     repealed;
       (2) the Comprehensive Smokeless Tobacco Health Education 
     Act of 1986, sections 4401-4408 of title 15, United States 
     Code, except that section 4402(f) of title 15, United States 
     Code, is repealed;
       (3) section 300x-26 of title 42, United States Code; and
       (4) those statutes authorizing regulation of tobacco, 
     tobacco products, or tobacco product manufacturers by the 
     Federal Trade Commission, the Department of Agriculture, the 
     Environmental Protection Agency, the Internal Revenue 
     Service, and the Alcohol and Tobacco Tax and Trade Bureau of 
     the Department of the Treasury.

     SEC. 104. PROCEEDINGS IN THE NAME OF THE UNITED STATES; 
                   SUBPOENAS; PREEMPTION OF STATE AND LOCAL LAW; 
                   NO PRIVATE RIGHT OF ACTION.

       In furtherance of this Act:
       (1) All proceedings for the enforcement, or to restrain 
     violations, of this Act shall be by

[[Page H4348]]

     and in the name of the United States. Subpoenas for witnesses 
     who are required to attend a court of the United States, in 
     any district, may run into any other district in any 
     proceeding under this section. No State, or political 
     subdivision thereof, may proceed or intervene in any Federal 
     or State court under this Act or under any regulation 
     promulgated under it, or allege any violation thereof except 
     a violation by the Administrator. Nothing in this Act shall 
     be construed to create a right of action by any private 
     person for any violation of any provision of this Act or of 
     any regulation promulgated under it.
       (2) With respect to any subject matter addressed by this 
     Act or by any regulation promulgated under it, no requirement 
     or prohibition shall be imposed under State or local law upon 
     any tobacco product manufacturer or distributor.
       (3) Paragraph (2) shall not apply to any requirement or 
     prohibition imposed under State or local law before the date 
     of introduction of the bill that was enacted as this Act.

     SEC. 105. ILLICIT TRADE.

       The Administrator shall not promulgate any regulation or 
     take any other action that has the effect of--
       (1) increasing illicit trade involving tobacco or any 
     tobacco product, or
       (2) making affected tobacco products unacceptable to a 
     substantial number of then current users of such products, 
     thereby creating a substantial risk that such users will 
     resort to illicit tobacco products, or tobacco products that 
     are otherwise noncompliant or unlawful.

     SEC. 106. ADULTERATED TOBACCO PRODUCTS.

       A tobacco product shall be deemed to be adulterated--
       (1) if it bears or contains any poisonous or deleterious 
     substance other than--
       (A) tobacco;
       (B) a substance naturally present in tobacco;
       (C) a pesticide or fungicide chemical residue in or on 
     tobacco if such pesticide or fungicide chemical is registered 
     by the Environmental Protection Agency for use on tobacco in 
     the United States; or
       (D) in the case of imported tobacco, a residue of a 
     pesticide or fungicide chemical that--
       (i) is approved for use in the country of origin of the 
     tobacco; and
       (ii) has not been banned, and the registration of which has 
     not been canceled, by the Environmental Protection Agency for 
     use on tobacco in the United States) that may render it 
     injurious to health; but, in case the substance is not an 
     added substance, such tobacco product shall not be considered 
     adulterated under this subsection if the quantity of such 
     substance in such tobacco product does not ordinarily render 
     it injurious to health;
       (2) if there is significant scientific agreement that, as a 
     result of the tobacco it contains, the tobacco product 
     presents a risk to human health that is materially higher 
     than the risk presented by--
       (A) such product on the effective date of this Act; or
       (B) if such product was not distributed commercially 
     domestically on that date, by comparable tobacco products of 
     the same style and within the same category that were 
     commercially distributed domestically on that date;
       (3) if it has been prepared, packed, or held under 
     unsanitary conditions whereby it may have become contaminated 
     with filth;
       (4) if its package is composed, in whole or in part, of any 
     poisonous or deleterious substance that may render the 
     contents injurious to health; or
       (5) if its ``tar'' yield is in violation of section 111.

     SEC. 107. MISBRANDED TOBACCO PRODUCTS.

       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) an identification of the type of product it is, by the 
     common or usual name of such type of product;
       (B) an accurate statement of the quantity of the contents 
     in the package in terms of weight, measure, or numerical 
     count, except that reasonable variations shall be permitted, 
     and exemptions as to small packages shall be established by 
     regulations promulgated by the Administrator;
       (C) the name and place of business of the tobacco product 
     manufacturer, packer, or distributor; and
       (D) the information required by section 201(c) and (e) or 
     section 202(c) and (e), as applicable;
       (3) if any word, statement, or other information required 
     by or under authority of this Act to appear on the label, 
     labeling, or advertising is not prominently placed thereon 
     with such conspicuousness (as compared with other words, 
     statements, or designs on the label, labeling, or 
     advertising, as applicable) and in such terms as to render it 
     reasonably likely to be read and understood by the ordinary 
     individual under customary conditions of purchase and use;
       (4) if any word, statement, or other information is 
     required by or under this Act to appear on the label, unless 
     such word, statement, or other information also appears on 
     the outside container or wrapper, if any, of the retail 
     package of such tobacco product, or is easily legible through 
     the outside container or wrapper;
       (5) if it was manufactured, prepared, or processed in an 
     establishment not duly registered under section 109, if it 
     was not included in a list required by section 109, or if a 
     notice or other information respecting it was not provided as 
     required by section 109;
       (6) if its packaging, labeling, or advertising is in 
     violation of this Act or of an applicable regulation 
     promulgated in accordance with this Act;
       (7) if it contains tobacco or another ingredient as to 
     which a required disclosure under this Act was not made;
       (8) if it is labeled or advertised, or the tobacco 
     contained in it is advertised, as--
       (A) containing ``no additives,'' or any substantially 
     similar term, unless the labeling or advertising, as 
     applicable, also contains, clearly and prominently, the 
     following disclosure: ``No additives in our tobacco does NOT 
     mean safer.''; or
       (B) being ``natural,'' or any substantially similar term, 
     unless the labeling or advertising, as applicable, also 
     contains, clearly and prominently, the following disclosure: 
     ``Natural does NOT mean safer.'';
       (9) if in its labeling or advertising a term descriptive of 
     the tobacco in the tobacco product is used otherwise than in 
     accordance with a sanction or approval granted by a Federal 
     agency;
       (10) if with respect to such tobacco product a disclosure 
     required by section 603 was not made;
       (11) if with respect to such tobacco product a 
     certification required by section 803 was not submitted or is 
     materially false or misleading; or
       (12) if its manufacturer or distributor made with respect 
     to it a claim prohibited by section 115.

     SEC. 108. SUBMISSION OF HEALTH INFORMATION TO THE 
                   ADMINISTRATOR.

       (a) Requirement.--Each tobacco product manufacturer or 
     importer, or agents thereof, shall submit to the 
     Administrator the following information:
       (1) Not later than 18 months after the date of enactment of 
     the 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 brand style.
       (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 
     Administrator in accordance with section 4(e) of the Federal 
     Cigarette Labeling and Advertising Act.
       (3) Beginning 4 years after the date of enactment of this 
     Act, a listing of all constituents, including smoke 
     constituents as applicable, identified by the Administrator 
     as 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.
       (b) Data Submission.--At the request of the Administrator, 
     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, 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 significant reduction in risk to health from 
     tobacco products can occur upon the employment of technology 
     available to the manufacturer.
     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) Data List.--
       (1) In general.--Not later than 4 years after the date of 
     enactment of the Act, and annually thereafter, the 
     Administrator 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 
     Administrator) the list established under subsection (d).
       (2) Consumer research.--The Administrator 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 Act, 
     the Administrator 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.
       (d) Data Collection.--Not later than 36 months after the 
     date of enactment of this Act, the Administrator shall 
     establish, and periodically revise as appropriate, a list of 
     harmful constituents, including smoke constituents, to health 
     in each tobacco product by brand and by quantity in each 
     brand and subbrand.

     SEC. 109. REGISTRATION AND LISTING.

       (a) Definitions.--As used in this section:
       (1) The term ``manufacture, preparation, or processing'' 
     shall include repackaging or

[[Page H4349]]

     otherwise changing the container, wrapper, or label of any 
     tobacco product package other than the carton in furtherance 
     of the distribution of the tobacco product from the original 
     place of manufacture to the person that makes final delivery 
     or sale to the ultimate consumer or user, but shall not 
     include the addition of a tax marking or other marking 
     required by law to an already packaged tobacco product.
       (2) The term ``name'' shall include in the case of a 
     partnership the name of the general partner and, in the case 
     of a privately held corporation, the name of the chief 
     executive officer of the corporation and the State of 
     incorporation.
       (b) Annual Registration.--Commencing one year after 
     enactment, on or before December 31 of each year, every 
     person that owns or operates any establishment in any State 
     engaged in the manufacture, preparation, or processing of a 
     tobacco product or products for commercial distribution 
     domestically shall register with the Administrator its name, 
     places of business, and all such establishments.
       (c) New Producers.--Every person upon first engaging, for 
     commercial distribution domestically, in the manufacture, 
     preparation, or processing of a tobacco product or products 
     in any establishment that it owns or operates in any State 
     shall immediately register with the Administrator its name, 
     places of business, and such establishment.
       (d) Registration of Foreign Establishments.--
       (1) Commencing one year after enactment of this Act, on or 
     before December 31 of each year, the person that, within any 
     foreign country, owns or operates any establishment engaged 
     in the manufacture, preparation, or processing of a tobacco 
     product that is imported or offered for import into the 
     United States shall, through electronic means or other means 
     permitted by the Administrator, register with the 
     Administrator the name and place of business of each such 
     establishment, the name of the United States agent for the 
     establishment, and the name of each importer of such tobacco 
     product in the United States that is known to such person.
       (2) Such person also shall provide the information required 
     by subsection (j), including sales made by mail, or through 
     the Internet, or other electronic means.
       (3) The Administrator is authorized to enter into 
     cooperative arrangements with officials of foreign countries 
     to ensure that adequate and effective means are available for 
     purposes of determining, from time to time, whether tobacco 
     products manufactured, prepared, or processed by an 
     establishment described in paragraph (1), if imported or 
     offered for import into the United States, shall be refused 
     admission on any of the grounds set forth in section 708.
       (e) Additional Establishments.--Every person duly 
     registered in accordance with the foregoing subsections of 
     this section shall immediately register with the 
     Administrator any additional establishment that it owns or 
     operates and in which it begins the manufacture, preparation, 
     or processing of a tobacco product or products for commercial 
     distribution domestically or for import into the United 
     States.
       (f) Exclusions From Application of This Section.--The 
     foregoing subsections of this section shall not apply to--
       (1) persons that manufacture, prepare, or process tobacco 
     products solely for use in research, teaching, chemical or 
     biological analysis, or export; or
       (2) such other classes of persons as the Administrator may 
     by regulation exempt from the application of this section 
     upon a finding that registration by such classes of persons 
     in accordance with this section is not necessary for the 
     protection of the public health.
       (g) Inspection of Premises.--Every establishment registered 
     with the Administrator pursuant to this section shall be 
     subject to inspection pursuant to section 706; and every such 
     establishment engaged in the manufacture, preparation, or 
     processing of a tobacco product or products shall be so 
     inspected by one or more officers or employees duly 
     designated by the Administrator at least once in the two-year 
     period beginning with the date of registration of such 
     establishment pursuant to this section and at least once in 
     every successive two-year period thereafter, except that 
     inspection of establishments outside the United States may be 
     conducted by other personnel pursuant to a cooperative 
     arrangement under subsection (d)(3).
       (h) Filing of Lists of Tobacco Products Manufactured, 
     Prepared, or Processed by Registrants; Statements; 
     Accompanying Disclosures.--
       (1) Every person that registers with the Administrator 
     under subsection (b), (c), (d), or (e) shall, at the time of 
     registration under any such subsection, file with the 
     Administrator a list of all brand styles (with each brand 
     style in each list listed by the common or usual name of the 
     tobacco product category to which it belongs and by any 
     proprietary name) that are being manufactured, prepared, or 
     processed by such person for commercial distribution 
     domestically or for import into the United States, and that 
     such person has not included in any list of tobacco products 
     filed by such person with the Administrator under this 
     paragraph or paragraph (2) before such time of registration. 
     Such list shall be prepared in such form and manner as the 
     Administrator may prescribe, and shall be accompanied by the 
     label for each such brand style and a representative sampling 
     of any other labeling and advertising for each;
       (2) Each person that registers with the Administrator under 
     this section shall report to the Administrator each August 
     for the preceding six-month period from January through June, 
     and each February for the preceding six-month period form 
     July through December, following information:
       (A) A list of each brand style introduced by the registrant 
     for commercial distribution domestically or for import into 
     the United States that has not been included in any list 
     previously filed by such registrant with the Administrator 
     under this subparagraph or paragraph (1). A list under this 
     subparagraph shall list a brand style by the common or usual 
     name of the tobacco product category to which it belongs and 
     by any proprietary 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 (or if such registrant has not 
     previously made a report under this paragraph, since the 
     effective date of this Act) such registrant has discontinued 
     the manufacture, preparation, or processing for commercial 
     distribution domestically or for import into the United 
     States of a brand style included in a list filed by such 
     registrant under subparagraph (A) or paragraph (1), notice of 
     such discontinuance, the date of such discontinuance, and the 
     identity (by the common or usual name of the tobacco product 
     category to which it belongs and by any proprietary name) of 
     such tobacco product.
       (C) If, since the date the registrant reported pursuant to 
     subparagraph (B) a notice of discontinuance of a tobacco 
     product, the registrant has resumed the manufacture, 
     preparation, or processing for commercial distribution 
     domestically or for import into the United States of that 
     brand style, notice of such resumption, the date of such 
     resumption, the identity of such brand style (by the common 
     or usual name of the tobacco product category to which it 
     belongs and by any proprietary name), and the other 
     information required by paragraph (1), unless the registrant 
     has previously reported such resumption to the Administrator 
     pursuant to this subparagraph.
       (D) Any material change in any information previously 
     submitted pursuant to this paragraph (2) or paragraph (1).
       (i) Electronic Registration.--Registrations under 
     subsections (b), (c), (d), and (e) (including the submission 
     of updated information) shall be submitted to the 
     Administrator by electronic means, unless the Administrator 
     grants a request for waiver of such requirement because use 
     of electronic means is not reasonable for the person 
     requesting such waiver.

     SEC. 110. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO 
                   PRODUCTS.

       (a) In General.--Any requirement established by or under 
     section 106, 107, or 113 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 111, section 114, section 115, or 
     subsection (d) of this section, and any requirement 
     established by or under section 106, 107, or 113 which is 
     inconsistent with a requirement imposed on such tobacco 
     product under section 111, section 114, section 115, 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 
     111, 112, 113, 114, or 115 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 Administrator 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 
     Administrator or the Administrator's representative under 
     section 107, 108, 111, 112, 113, 114, 115, or 504, 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 
     Act, or when relevant in any proceeding under this Act.
       (d) Restrictions.--
       (1) In general.--The Administrator may issue regulations, 
     consistent with this Act, regarding tobacco products if the 
     Administrator determines that such regulation would be 
     appropriate for the protection of the public health. 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 users of the 
     tobacco product, and taking into account that the standard is 
     reasonably likely to result in measurable and substantial 
     reductions in morbidly and mortality among individual tobacco 
     users.

[[Page H4350]]

       (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 Administrator may 
     in such regulation prescribe.
       (e) Good Manufacturing Practice Requirements.--
       (1) Methods, facilities, and controls to conform.--
       (A) In general.--In applying manufacturing restrictions to 
     tobacco, the Administrator 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 Act. Such 
     regulations may provide for the testing of raw tobacco for 
     pesticide chemical residues after a tolerance for such 
     chemical residues has been established.
       (B) Requirements.--The Administrator 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); and
       (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 but no earlier than four years from date of 
     enactment.
       (C) Additional special rule.--A tobacco product 
     manufactured in or imported into the United States shall not 
     contain foreign-grown flue-cured or burley tobacco that--
       (i) was knowingly grown or processed using a pesticide 
     chemical that is not approved under applicable Federal law 
     for use in domestic tobacco farming and processing; or
       (ii) in the case of a pesticide chemical that is so 
     approved, was grown or processed using the pesticide chemical 
     in a manner inconsistent with the approved labeling for use 
     of the pesticide chemical in domestic tobacco farming and 
     processing.
       (D) Exclusion.--Subparagraph (C)(ii) shall not apply to 
     tobacco products manufactured with foreign-grown flue-cured 
     or burley tobacco so long as that foreign grown tobacco was 
     either--
       (i) in the inventory of a manufacturer prior to the 
     effective date, or
       (ii) planted by the farmer prior to the effective date of 
     this Act and utilized by the manufacturer no later than 3 
     years after the effective date.
       (E) Setting of maximum residue limits.--The Administrator 
     shall adopt the following pesticide residue standards:
       Pesticide residue standards
       The maximum concentration of residues of the following 
     pesticides allowed in flue-cured or burley tobacco, expressed 
     as parts by weight of the residue per one million parts by 
     weight of the tobacco (PPM) are:
       CHLORDANE.....3.0
       DIBROMOCHLOROPROPANE (DBCP).....1.0
       DICAMBA (Temporary).... 5.0
       ENDRIN....0.1
       ETHYLENE DIBROMIDE (EDB)....0.1
       FORMOTHION.....0.5
       HEXACHLOROBENZENE (HCB)....0.1
       METHOXYCHLOR.....0.1
       TOXAPHENE.....0.3
       2,4-D (Temporary).....5.0
       2,4,5-T.....0.1
       Sum of ALDRIN and DIELDRIN.....0.1
       Sum of CYPERMETHRIN and PERMETHRIN (Temporary).....3.0
       Sum of DDT, TDE (DDD), and DDE .....0.4
       Sum of HEPTACHLOR and HEPTACHLOR EPOXIDE.....0.1
       (F) Maximum residue limits.--The Administrator shall adopt 
     regulations within one year of the effective date of this Act 
     to establish maximum residue limits for pesticides identified 
     under subparagraph (E) but not included in the table of such 
     subparagraph to account for the fact that weather and 
     agronomic conditions will cause pesticides identified in 
     subparagraph (E) to be detected in foreign-grown tobacco even 
     where the farmer has not knowingly added such pesticide.
       (2) Exemptions; variances.--
       (A) Petition.--Any person subject to any requirement 
     prescribed under paragraph (1) may petition the Administrator 
     for a permanent or temporary exemption or variance from such 
     requirement. Such a petition shall be submitted to the 
     Administrator in such form and manner as the Administrator 
     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 Act;
       (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 Administrator 
     shall prescribe.
       (B) Referral to the tobacco products scientific advisory 
     committee.--The Administrator 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 
     Administrator 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 
     Administrator under subparagraph (A); or
       (ii) the day after the petition was referred to the Tobacco 
     Products Scientific Advisory Committee,
     whichever occurs later, the Administrator shall by order 
     either deny the petition or approve it.
       (C) Approval.--The Administrator may approve--
       (i) a petition for an exemption for a tobacco product from 
     a requirement if the Administrator determines that compliance 
     with such requirement is not required to assure that the 
     tobacco product will be in compliance with this Act; and
       (ii) a petition for a variance for a tobacco product from a 
     requirement if the Administrator 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 Act.
       (D) Conditions.--An order of the Administrator 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 Act.
       (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 this Act.
       (f) Research and Development.--The Administrator may enter 
     into contracts for research, testing, and demonstrations 
     respecting tobacco products and may obtain tobacco products 
     for research, testing, and demonstration purposes.

     SEC. 111. SMOKING ARTICLE STANDARDS.

       (a) In General.--
       (1) Restrictions on descriptors used in marketing of 
     cigarettes.--
       (A) In general.--Except as provided in subparagraph (B), no 
     person shall use, with respect to any cigarette brand style 
     commercially distributed domestically, on the portion of the 
     package of such cigarette brand style that customarily is 
     visible to consumers before purchase, or in advertising of 
     such cigarette brand style any of the following as a 
     descriptor of any cigarette brand style--
       (i) the name of any candy or fruit;
       (ii) the word ``candy,'' ``citrus,'' ``cream,'' ``fruit,'' 
     ``sugar,'' ``sweet,'' ``tangy,'' or ``tart,''; or
       (iii) any extension or variation of any of the words 
     ``candy,'' ``citrus,'' ``cream,'' ``fruit,'' ``sugar,'' 
     ``sweet,'' ``tangy,'' or ``tart,'' including but not limited 
     to ``creamy,'' or ``fruity.''
       (B) Limitation.--Subparagraph (A) shall not apply to the 
     use of the following words or to any extension or variation 
     of any of them: ``coffee,'' ``mint,'' and ``menthol''.
       (C) Scented materials.--No person shall use, in the 
     advertising or labeling of any cigarette commercially 
     distributed domestically, any scented materials, except in an 
     adult-only facility.
       (D) Definitions.--In this section:
       (i) The term ``candy'' means a confection made from sugar 
     or sugar substitute, including any confection identified 
     generically or by brand, and shall include the words 
     ``cacao,'' ``chocolate,'' ``cinnamon,'' ``cocoa,'' ``honey,'' 
     ``licorice,'' ``maple,'' ``mocha,'' and ``vanilla.''
       (ii) The term ``fruit'' means any fruit identified by 
     generic name, type, or variety, including but not limited to 
     ``apple,'' ``banana,'' ``cherry,'' and ``orange.'' The term 
     ``fruit'' does not include words that identify seeds, nuts or 
     peppers, or types or varieties thereof or words that are 
     extensions or variations of such words.
       (2) Smoking article standards.--
       (A) In general.--The Administrator may adopt smoking 
     article standards in addition to those in paragraph (1) if 
     the Administrator finds that a smoking article standard is 
     appropriate for the protection of the public health.

[[Page H4351]]

       (B) Determinations.--
       (i) Considerations.--In making a finding described in 
     subparagraph (A), the Administrator shall consider scientific 
     evidence concerning--

       (I) the risks and benefits to the users of smoking articles 
     of the proposed standard; and
       (II) that the standard is reasonably likely to result in 
     measurable and substantial reductions in morbidity and 
     mortality among individual tobacco users.

       (ii) Additional considerations.--In the event that the 
     Administrator makes a determination, set forth in a proposed 
     smoking article 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 
     smoking article because the Administrator has found that the 
     additive, constituent, or other component is 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 Administrator's 
     consideration scientific evidence that demonstrates that the 
     proposed standard will not reduce or eliminate the risk of 
     illness or injury.
       (3) Content of smoking article standards.--A smoking 
     article standard established under this section for a smoking 
     article--
       (A) may include provisions that are appropriate for the 
     protection of the public health, including provisions, where 
     appropriate--
       (i) for ``tar'' and nicotine yields of the product;
       (ii) for the reduction of other constituents, including 
     smoke constituents, or harmful components of the product; or
       (iii) relating to any other requirement under subparagraph 
     (B); and
       (B) may, 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 smoking article;
       (ii) provisions for the testing (on a sample basis or, if 
     necessary, on an individual basis) of the smoking article;
       (iii) provisions for the measurement of the smoking article 
     characteristics of the smoking article; and
       (iv) provisions requiring that the results of each or of 
     certain of the tests of the smoking article required to be 
     made under clause (ii) show that the smoking article is in 
     conformity with the portions of the standard for which the 
     test or tests were required.
       (4) Periodic reevaluation of smoking article standards.--
     The Administrator may provide for periodic evaluation of 
     smoking article standards established under this section to 
     determine whether such standards should be changed to reflect 
     new medical, scientific, or other technological data.
       (5) Cigarette ``tar'' limits.--
       (A) No increase in ``tar'' yields.--No cigarette 
     manufacturer shall distribute for sale domestically a brand 
     style of cigarettes that generates a ``tar'' yield greater 
     than the ``tar'' yield of that brand style of cigarettes on 
     the date of introduction of this Act, as determined by the 
     ISO smoking regimen and its associated tolerances. The 
     ``tar'' tolerances for cigarettes with ISO ``tar'' yields in 
     the range of 1 to 20 milligrams per cigarette, based on 
     variations arising from sampling procedure, test method, and 
     sampled product, itself, are the greater of plus or minus--
       (i) 15 percent; or
       (ii) 1 milligram per cigarette.
       (B) Limit on new cigarettes.--After the effective date of 
     this Act, no cigarette manufacturer shall manufacture for 
     commercial distribution domestically a brand style of 
     cigarettes that both--
       (i) was not in commercial distribution domestically on the 
     effective date of this Act, and
       (ii) generates a ``tar'' yield of greater than 20 
     milligrams per cigarette as determined by the ISO smoking 
     regimen and its associated tolerances.
       (C) Limit on all cigarettes.--After December 31, 2010, no 
     cigarette manufacturer shall manufacture for commercial 
     distribution domestically a brand style of cigarettes that 
     generates a ``tar'' yield greater than 20 milligrams per 
     cigarette as determined by the ISO smoking regimen and its 
     associated tolerances.
       (D) Review by administrator.--After the effective date of 
     this Act, the Administrator shall evaluate the available 
     scientific evidence addressing the potential relationship 
     between historical ``tar'' yield values and risk of harm to 
     smokers. If upon a review of that evidence, and after 
     consultation with technical experts of the Tobacco Harm 
     Reduction Center and the Centers for Disease Control and 
     Prevention and notice and an opportunity for public comment, 
     the Administrator determines, that a reduction in ``tar'' 
     yield may reasonably be expected to provide a meaningful 
     reduction of the risk or risks of harm to smokers, the 
     Administrator shall issue an order that--
       (i) provides that no cigarette manufacturer shall 
     manufacture for commercial distribution domestically a 
     cigarette that generates a ``tar'' yield that exceeds 14 
     milligrams as determined by the ISO smoking regimen and its 
     associated tolerances; and
       (ii) provides a reasonable time for manufacturers to come 
     into compliance with such prohibition.
       (6) Involvement of other agencies; informed persons.--In 
     carrying out duties under this section, the Administrator 
     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 
     Administrator's judgment can make a significant contribution.
       (b) Considerations by Administrator.--
       (1) Technical achievability.--The Administrator shall 
     consider information submitted in connection with a proposed 
     standard regarding the technical achievability of compliance 
     with such standard.
       (2) Other considerations.--The Administrator shall consider 
     all other information submitted in connection with a proposed 
     standard, such as the creation of a significant demand for 
     contraband or other tobacco products that do not meet the 
     requirements of this Act and the significance of such demand.
       (c) Proposed Standards.--
       (1) In general.--The Administrator shall publish in the 
     Federal Register a notice of proposed rulemaking for the 
     establishment, amendment, or revocation of any smoking 
     article standard.
       (2) Requirements of notice.--A notice of proposed 
     rulemaking for the establishment or amendment of a smoking 
     article standard shall--
       (A) set forth a finding with supporting justification that 
     the smoking article standard is appropriate for the 
     protection of the public health;
       (B) invite interested persons to submit a draft or proposed 
     smoking article standard for consideration by the 
     Administrator;
       (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 smoking article 
     standard.
       (3) Finding.--A notice of proposed rulemaking for the 
     revocation of a smoking article standard shall set forth a 
     finding with supporting justification that the smoking 
     article standard is no longer appropriate for the protection 
     of the public health.
       (4) Comment.--The Administrator shall provide for a comment 
     period of not less than 90 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 standard and after consideration 
     of comments submitted under subsections (b) and (c) and any 
     report from the Tobacco Products Scientific Advisory 
     Committee, if the Administrator determines that the standard 
     would be appropriate for the protection of the public health, 
     the Administrator shall--
       (A) promulgate a regulation establishing a smoking article 
     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 smoking 
     article 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 Administrator 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 
     Administrator 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.
       (3) Limitation on power granted.--Because of the importance 
     of a decision of the Administrator to issue a regulation--
       (A) banning cigarettes, smokeless smoking articles, little 
     cigars, cigars other than little cigars, pipe tobacco, or 
     roll-your-own smoking articles;
       (B) requiring the reduction of ``tar'' or nicotine yields 
     of a smoking article to zero;
       (C) prohibiting the sale of any smoking article in face-to-
     face transactions by a specific category of retail outlets;
       (D) establishing a minimum age of sale of smoking articles 
     to any person older than 18 years of age; or
       (E) requiring that the sale or distribution of a smoking 
     article be limited to the written or oral authorization of a 
     practitioner licensed by law to prescribe medical products,
     the Administrator is prohibited from taking such actions 
     under this Act.

[[Page H4352]]

       (4) Matchbooks.--For purposes of any regulations issued by 
     the Administrator under this Act, matchbooks of conventional 
     size containing not more than 20 paper matches, and which are 
     customarily given away for free with the purchase of smoking 
     articles, shall be considered as adult-written publications 
     which shall be permitted to contain advertising.
       (5) Amendment; revocation.--
       (A) Authority.--The Administrator, upon the Administrator'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 smoking article standard.
       (B) Effective date.--The Administrator may declare a 
     proposed amendment of a smoking article 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 Administrator determines that 
     making it so effective is in the public interest.
       (6) Referral to advisory committee.--
       (A) In general.--The Administrator shall refer a proposed 
     regulation for the establishment, amendment, or revocation of 
     a smoking article 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 Administrator shall make a 
     referral under this paragraph--
       (i) on the Administrator'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 Administrator 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 90 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 Administrator and other data and information 
     before it, submit to the Administrator 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 Administrator shall make a 
     copy of each report and recommendation under subparagraph (D) 
     publicly available.

     SEC. 112. NOTIFICATION AND OTHER REMEDIES.

       (a) Notification.--If the Administrator 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 materially above the risk for death and disease of 
     tobacco products currently in interstate commerce, 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 
     Act (other than this section) to eliminate such risk,
     the Administrator 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 Administrator may order notification by any 
     appropriate means, including public service announcements. 
     Before issuing an order under this subsection, the 
     Administrator 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 Administrator 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, 
     acute adverse health consequences or death, the Administrator 
     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 Administrator 
     determines that inadequate grounds exist to support the 
     actions required by the order, the Administrator 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 Administrator 
     determines that the order should be amended to include a 
     recall of the tobacco product with respect to which the order 
     was issued, the Administrator shall, except as provided in 
     subparagraph (B), amend the order to require a recall. The 
     Administrator shall specify a timetable in which the tobacco 
     product recall will occur and shall require periodic reports 
     to the Administrator 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 
     Administrator 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 
     Administrator 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. 113. RECORDS AND REPORTS ON TOBACCO PRODUCTS.

       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 Administrator may by regulation 
     reasonably require to assure that such tobacco product is not 
     adulterated or misbranded.

     SEC. 114. APPLICATION FOR REVIEW OF CERTAIN SMOKING ARTICLES.

       (a) In General.--
       (1) New smoking article defined.--For purposes of this 
     section the term ``new smoking article'' means--
       (A) any smoking article that was not commercially marketed 
     in the United States as of the date of enactment of this Act; 
     and
       (B) any smoking article that incorporates a significant 
     modification (including changes in design, component, part, 
     or constituent, including a smoke constituent, or in the 
     content, delivery or form of nicotine, or other additive or 
     ingredient) of a smoking article where the modified product 
     was commercially marketed in the United States after the date 
     of enactment of this Act.
       (2) Premarket review required.--
       (A) New products.--An order under subsection (c)(1)(A) for 
     a new smoking article is required unless the product--
       (i) is substantially equivalent to a smoking article 
     commercially marketed in the United States as of date of 
     enactment of this Act; and
       (ii) is in compliance with the requirements of this Act.
       (B) Consumer testing.--This section shall not apply to 
     smoking articles that are provided to adult tobacco consumers 
     for purposes of consumer testing. For purposes of this 
     section, the term ``consumer testing'' means an assessment of 
     smoking articles that is conducted by or under the control 
     and direction of a manufacturer for the purpose of evaluating 
     consumer acceptance of such smoking articles, utilizing only 
     the quantity of cigarettes that is reasonably necessary for 
     such assessment
       (3) Substantially equivalent defined.--
       (A) In general.--In this section, the term ``substantially 
     equivalent'' or ``substantial equivalence'' means, with 
     respect to the smoking article being compared to the 
     predicate smoking article, that the Administrator by order 
     has found that the smoking article--
       (i) has the same general characteristics as the predicate 
     smoking article; or
       (ii) has different characteristics and the information 
     submitted contains information, including clinical data if 
     deemed necessary by the Administrator, 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 for the consumer of the product.
       (B) Characteristics.--In subparagraph (A), the term 
     ``characteristics'' means the materials, ingredients, design, 
     composition, heating source, or other features of a smoking 
     article.
       (C) Limitation.--A smoking article may not be found to be 
     substantially equivalent to a predicate smoking article that 
     has been removed from the market at the initiative of the 
     Administrator or that has been determined by a judicial order 
     to be misbranded or adulterated.
       (4) Health information.--As part of a submission respecting 
     a smoking article, the person required to file a premarket 
     notification shall provide an adequate summary of any health 
     information related to the smoking article or state that such 
     information will be made available upon request by any 
     person.
       (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 smoking article and whether such smoking 
     article presents less risk than other smoking articles;

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       (B) a full statement of the components, ingredients, 
     additives, and properties, and of the principle or principles 
     of operation, of such smoking article;
       (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 smoking article;
       (D) an identifying reference to any smoking article 
     standard under section 111 which would be applicable to any 
     aspect of such smoking article, and either adequate 
     information to show that such aspect of such smoking article 
     fully meets such smoking article standard or adequate 
     information to justify any deviation from such standard;
       (E) such samples of such smoking article and of components 
     thereof as the Administrator may reasonably require;
       (F) specimens of the labeling proposed to be used for such 
     smoking article; and
       (G) such other information relevant to the subject matter 
     of the application as the Administrator may require.
       (2) Referral to tobacco products scientific advisory 
     committee.--Upon receipt of an application meeting the 
     requirements set forth in paragraph (1), the Administrator--
       (A) may, on the Administrator'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 Administrator 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.--As promptly as possible, but in no event 
     later than 90 days after the receipt of an application under 
     subsection (b), the Administrator, after considering the 
     report and recommendation submitted under subsection (b)(2), 
     shall--
       (A) issue an order that the new product may be introduced 
     or delivered for introduction into interstate commerce if the 
     Administrator finds that none of the grounds specified in 
     paragraph (2) of this subsection applies; or
       (B) issue an order that the new product may not be 
     introduced or delivered for introduction into interstate 
     commerce if the Administrator 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.
       (2) Denial of application.--The Administrator shall deny an 
     application submitted under subsection (b) if, upon the basis 
     of the information submitted to the Administrator as part of 
     the application and any other information before the 
     Administrator with respect to such smoking article, the 
     Administrator finds that--
       (A) there is a lack of a showing that permitting such 
     smoking article 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 smoking 
     article do not conform to the requirements of section 110(e);
       (C) based on a fair evaluation of all material facts, the 
     proposed labeling is false or misleading in any particular; 
     or
       (D) such smoking article is not shown to conform to a 
     smoking article standard in effect under section 111, 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 Administrator 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 Administrator).
       (4) Basis for finding.--For purposes of this section, the 
     finding as to whether the commercial introduction of a 
     smoking article 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 
     users of the smoking article, and taking into account whether 
     such commercial introduction is reasonably likely to increase 
     the morbidly and mortality among individual tobacco users.
       (d) Withdrawal and Temporary Suspension.--
       (1) In general.--The Administrator 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 smoking 
     article for which an order was issued under subsection 
     (c)(1)(A), issue an order withdrawing the order if the 
     Administrator finds--
       (A) that the continued marketing of such smoking article 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 113; or
       (ii) has refused to permit access to, or copying or 
     verification of, such records as required by section 110; or
       (D) on the basis of new information before the 
     Administrator with respect to such smoking article, evaluated 
     together with the evidence before the Administrator 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 smoking article 
     do not conform with the requirements of section 110(e) and 
     were not brought into conformity with such requirements 
     within a reasonable time after receipt of written notice from 
     the Administrator of nonconformity;
       (E) on the basis of new information before the 
     Administrator, evaluated together with the evidence before 
     the Administrator when the application was reviewed, that the 
     labeling of such smoking article, 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 Administrator of 
     such fact; or
       (F) on the basis of new information before the 
     Administrator, evaluated together with the evidence before 
     the Administrator when such order was issued, that such 
     smoking article is not shown to conform in all respects to a 
     smoking article standard which is in effect under section 
     111, 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) 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 116.
       (3) Temporary suspension.--If, after providing an 
     opportunity for an informal hearing, the Administrator 
     determines there is reasonable probability that the 
     continuation of distribution of a smoking article under an 
     order would cause serious, adverse health consequences or 
     death, that is greater than ordinarily caused by smoking 
     articles on the market, the Administrator shall by order 
     temporarily suspend the authority of the manufacturer to 
     market the product. If the Administrator issues such an 
     order, the Administrator shall proceed expeditiously under 
     paragraph (1) to withdraw such application.
       (e) Service of Order.--An order issued by the Administrator 
     under this section shall be served--
       (1) in person by any officer or employee of the department 
     designated by the Administrator; 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 Administrator.
       (f) Records.--
       (1) Additional information.--In the case of any smoking 
     article for which an order issued pursuant to subsection 
     (c)(1)(A) for an application filed under subsection (b) is in 
     effect, the applicant shall establish and maintain such 
     records, and make such reports to the Administrator, as the 
     Administrator 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 
     Administrator 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 Administrator, permit such officer 
     or employee at all reasonable times to have access to and 
     copy and verify such records.
       (g) Investigational Smoking Article Exemption for 
     Investigational Use.--The Administrator may exempt smoking 
     articles intended for investigational use from the provisions 
     of this Act under such conditions as the Administrator may by 
     regulation prescribe.

     SEC. 115. 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;

[[Page H4354]]

       (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'', ``low'', ``medium'', ``ultra 
     light'', ``low tar'' or ``ultra low tar''; 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 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''.
       (3) Effective date.--The provisions of paragraph (2)(A)(ii) 
     shall take effect 12 months after the date of enactment of 
     the Act.
       (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 Center and is subject to the requirements of 
     chapter V.
       (d) Filing.--Any person may file with the Administrator 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 Administrator may 
     require.
       (e) Public Availability.--The Administrator 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 Administrator 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 Administrator.
       (g) Marketing.--
       (1) Modified risk products.--Except as provided in 
     paragraph (2), the Administrator 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 Administrator 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) is reasonably likely to result in measurable and 
     substantial reductions in morbidity and mortality among 
     individual tobacco users.
       (2) Special rule for certain products.--
       (A) In general.--The Administrator 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 Administrator 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 significantly less 
     harmful; or
       (II) presents or has been demonstrated to present 
     significant less of a risk of disease than other commercially 
     marketed tobacco products; and

       (iv) issuance of an order with respect to the application 
     is expected to benefit the health of users of tobacco 
     products.
       (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 Administrator.
       (h) Additional Conditions for Marketing.--
       (1) Modified risk products.--The Administrator 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 Administrator may require for the 
     marketing of a product under this subsection that a claim 
     comparing a tobacco product to 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 Administrator 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.
       (i) Postmarket Surveillance and Studies.--
       (1) In general.--The Administrator 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 
     Administrator to review the accuracy of the determinations 
     upon which the order was based, and to provide information 
     that the Administrator 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 Administrator 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 Administrator, a protocol for the 
     required surveillance. The Administrator, within 30 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 
     Administrator as necessary to protect the public health.
       (j) Withdrawal of Authorization.--The Administrator, after 
     an opportunity for an informal hearing, shall withdraw an 
     order under subsection (g) if the Administrator determines 
     that--
       (1) the applicant, based on new information, can no longer 
     make the demonstrations required under subsection (g), or the 
     Administrator can no longer make the determinations required 
     under subsection (g);

[[Page H4355]]

       (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 111;
       (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 Administrator 
     has issued an order pursuant to subsection (g) shall not be 
     subject to chapter IV or V of the Federal Food, Drug, and 
     Cosmetic Act.
       (l) Implementing Regulations or Guidance.--
       (1) Scientific evidence.--Not later than 2 years after the 
     date of enactment of the Act, the Administrator 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 a 
     reasonable likelihood 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; and
       (E) establish a reasonable timetable for the Administrator 
     to review an application under this section.
       (2) Consultation.--The regulations or guidance issued under 
     paragraph (1) may 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 Act, the Administrator 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 114 and which the applicant seeks to 
     commercially market under this section.

     SEC. 116. JUDICIAL REVIEW.

       (a) Right To Review.--
       (1) In general.--Not later than 60 days after--
       (A) the promulgation of a regulation under section 111 
     establishing, amending, or revoking a tobacco product 
     standard; or
       (B) a denial of an application under section 114(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 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 Administrator.
       (B) Record of proceedings.--On receipt of a petition under 
     subparagraph (A), the Administrator 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 Administrator 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 Administrator, 
     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 110, 111, 112, 113, 114, or 119 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. 117. JURISDICTION OF AND COORDINATION WITH THE FEDERAL 
                   TRADE COMMISSION.

       Except where expressly provided in this Act, nothing in 
     this Act 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.

     SEC. 118. REGULATION REQUIREMENT.

       (a) Testing, Reporting, and Disclosure.--Not later than 36 
     months after the date of enactment of the Act, the 
     Administrator 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 annual testing and reporting of tobacco 
     product constituents, ingredients, and additives, including 
     smoke constituents, by brand style that the Administrator 
     determines should be tested to protect the public health, 
     provided that, for purposes of the testing requirements of 
     this paragraph, tobacco products manufactured and sold by a 
     single tobacco product manufacturer that are identical in all 
     respects except the labels, packaging design, logo, trade 
     dress, trademark, brand name, or any combination thereof, 
     shall be considered as a single brand style; 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.
       (c) Authority.--The Administrator shall have the authority 
     under this Act to conduct or to require the testing, 
     reporting, or disclosure of tobacco product constituents, 
     including smoke constituents.
       (d) Joint Laboratory Testing Services.--The Administrator 
     shall allow any 2 or more 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 tobacco product 
     manufacturer shall not be considered to be in violation of 
     this section before the applicable deadline, if--
       (A) the tobacco products of such manufacturer are in 
     compliance with all other requirements of this Act; and
       (B) the conditions described in paragraph (2) are met.
       (2) Conditions.--Notwithstanding the requirements of this 
     section, the Administrator may delay the date by which a 
     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 tobacco product manufacturer provides evidence to 
     the Administrator 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 Administrator, taking into account the 
     laboratory testing capacity that is available to tobacco 
     product manufacturers, shall review and verify the evidence 
     submitted by a tobacco product manufacturer in accordance 
     with paragraph (2). If the Administrator finds that the 
     conditions described in such paragraph are met, the 
     Administrator shall notify the 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,

[[Page H4356]]

     the Administrator has not made a finding before the reporting 
     deadline, the manufacturer shall not be considered to be in 
     violation of such requirements until the Administrator 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 Administrator may 
     provide further extensions of time, in increments of no more 
     than 1 year, for required testing and reporting to occur if 
     the Administrator determines, based on evidence properly and 
     timely submitted by a 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 other than this section.

     SEC. 119. PRESERVATION OF STATE AND LOCAL AUTHORITY.

       (a) In General.--
       (1) Preservation.--Except as provided in paragraph (2)(A), 
     nothing in this Act, or rules promulgated under this Act, 
     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 requirements established under this 
     Act, including a law, rule, regulation, or other measure 
     relating to or prohibiting the sale, distribution, 
     possession, or use of tobacco products by individuals of any 
     age, information reporting to the State. No provision of this 
     Act 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 
     Act 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, use of, tobacco product 
     by individuals of any age. 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 Act 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. 120. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.

       (a) Establishment.--Not later than 6 months after the date 
     of enactment of this Act, the Administrator shall establish a 
     16-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 Administrator shall appoint as members of 
     the Tobacco Harm Reduction 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) 6 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) 2 individuals who are an officer or employee of a 
     State or local government or of the Federal Government;
       (iii) 2 representatives of the general public;
       (iv) 2 representatives of the interests of the tobacco 
     manufacturing industry;
       (v) 1 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;
       (vi) 1 individual as a representative of the interests of 
     the tobacco growers; and
       (vii) 1 individual who is an expert in illicit trade of 
     tobacco products.
       (B) 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 or government agency with any form of jurisdiction 
     over tobacco products.
       (2) Limitation.--The Administrator may not appoint to the 
     Advisory Committee any individual who is in the regular full-
     time employ of the Tobacco Harm Reduction Center or any 
     agency responsible for the enforcement of this Act. The 
     Administrator may appoint Federal officials as ex officio 
     members.
       (3) Chairperson.--The Administrator 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 Administrator--
       (1) as provided in this Act;
       (2) on the implementation of prevention, cessation, and 
     harm reduction policies;
       (3) on implementation of policies and programs to fully 
     inform consumers of the respective risks of tobacco products; 
     and
       (4) on its review of other safety, dependence, or health 
     issues relating to tobacco products as requested by the 
     Administrator.
       (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 
     Administrator, 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 Administrator 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. 121. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.

       (a) Report on Innovative Products.--
       (1) In general.--Not later than 3 years after the date of 
     enactment of this Act, the Administrator, 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 promote, and encourage the development and use by 
     current tobacco users of innovative tobacco and nicotine 
     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 by moving current users to noncombustible tobacco 
     products.
       (2) Recommendations.--The report under paragraph (1) shall 
     include the recommendations of the Administrator on how the 
     Tobacco Harm and Reduction Center should coordinate and 
     facilitate the exchange of information on such innovative 
     products and treatments among relevant offices and centers 
     within the Center and within the National Institutes of 
     Health, the Centers for Disease Control and Prevention, and 
     other relevant Federal and State agencies.

     SEC. 122. ADVERTISING AND MARKETING OF TOBACCO PRODUCTS.

       (a) Within 18 months of enactment of the Act, the 
     Administrator shall report to Congress on the benefits to 
     public health of imposing restrictions or prohibitions on the 
     advertising and marketing, consistent with or in addition to 
     such restrictions or prohibitions contained in the Master 
     Settlement Agreement, on tobacco products.
       (b) The Administrator shall specify in the report 
     constitutional free speech implications for each recommended 
     restriction or prohibition.
       (c) The Administrator shall also specify the class of 
     tobacco products to which the prohibition or restriction 
     would be applicable and the impact of such actions on harm 
     reduction policies, practices, and accurate information 
     available to tobacco users.
       (d) The Administrator shall establish and consult with an 
     advisory committee consisting of experts in constitutional 
     law, harm reduction policies, marketing practices, and 
     consumer behavior in preparing this report.

[[Page H4357]]

TITLE II--TOBACCO PRODUCTS 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 lower 
     portion of the front panel of the package, directly on the 
     package underneath the cellophane or other clear wrapping. 
     Each label statement shall comprise at least the bottom 25 
     percent of the front panel 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 smoking article 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 bottom of each advertisement within the trim 
     area. 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 smokeless tobacco 
     products, each label statement required by subsection (a) may 
     be printed on the inside cover of the matchbook.
       ``(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 smokeless 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 smokeless 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 smokeless 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 amendment made by subsection (a) 
     shall take effect 24 months after the date of enactment of 
     this Act. Such effective date shall be with respect to the 
     date of manufacture, provided that, in any case, beginning 30 
     days after such effective date, a manufacturer shall not 
     introduce into the domestic commerce of the United States any 
     product, irrespective of the date of manufacture, that is not 
     in conformance with section 4 of the Federal Cigarette 
     Labeling and Advertising Act (15 U.S.C. 1333), as amended by 
     subsection (a).

     SEC. 202. 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 has significantly lower risks for 
     diseases associated with cigarettes.
       ``WARNING: Smokeless tobacco is addictive.
       ``(2) The label statements required by paragraph (1) shall 
     be introduced by each smokeless tobacco product manufacturer, 
     packager, importer, distributor, or retailer of smokeless 
     tobacco products concurrently into the distribution chain of 
     such products.
       ``(3) The provisions of this subsection do not apply to a 
     smokeless 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.
       ``(4) 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 smokeless 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 smokeless 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)(A) Each label statement required by subsection (a) in 
     smokeless tobacco advertising shall comply with the standards 
     set forth in this paragraph.
       ``(B) For press and poster advertisements, each such 
     statement and (where applicable) any required statement 
     relating to nicotine, or other constituent yield shall 
     comprise at least 20 percent of the area of the 
     advertisement.

[[Page H4358]]

       ``(C) The word `WARNING' shall appear in capital letters, 
     and each label statement shall appear in conspicuous and 
     legible type.
       ``(D) 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).
       ``(E) 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.
       ``(F) 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.
       ``(G) The label statements shall be in English, except 
     that--
       ``(i) 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
       ``(ii) 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)(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 smokeless 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 smokeless 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 smokeless 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.
       ``(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 amendment made by subsection (a) 
     shall take effect 24 months after the date of enactment of 
     this Act. Such effective date shall be with respect to the 
     date of manufacture, provided that, in any case, beginning 30 
     days after such effective date, a manufacturer shall not 
     introduce into the domestic commerce of the United States any 
     product, irrespective of the date of manufacture, that is not 
     in conformance with section 3 of the Comprehensive Smokeless 
     Tobacco Health Education Act of 1986 (15 U.S.C. 4402), as 
     amended by subsection (a).

     TITLE III--PUBIC DISCLOSURES BY TOBACCO PRODUCTS MANUFACTURERS

     SEC. 301. DISCLOSURES ON PACKAGES OF TOBACCO PRODUCTS.

       (a) Back Face for Required Disclosures.--For purposes of 
     this section--
       (1) the principal face of a package of a tobacco product is 
     the face that has the largest surface area or, for faces with 
     identical surface areas, any of the faces that have the 
     largest surface area; a package shall not be characterized as 
     having more than 2 principal faces;
       (2) the front face shall be the principal face of the 
     package;
       (3) if the front and back faces are of different sizes in 
     terms of area, then the larger face shall be the front face;
       (4) the back face shall be the principal face of a package 
     that is opposite the front face of the package;
       (5) the bottom 50 percent of the back face of the package 
     shall be allocated for required package disclosures in 
     accordance with this section; and
       (6) if a package of a tobacco product is cylindrical, a 
     contiguous area constituting 30 percent of the total surface 
     area of the cylinder shall be deemed the back face.
       (b) Required Information on Back Face.--Not later than 24 
     months after the effective date of this Act, the bottom 50 
     percent of the back face of a package of a tobacco product 
     shall be available solely for disclosures required by or 
     under this Act, the Federal Cigarette Labeling and 
     Advertising Act, sections 1331-1340 of title 15, United 
     States Code, and any other Federal statute. Such disclosures 
     shall include--
       (1) the printed name and address of the manufacturer, 
     packer, or distributor, and any other identification 
     associated with the manufacturer, packer, or distributor or 
     with the tobacco product that the Administrator may require;
       (2) a list of ingredients as required by subsection (e); 
     and
       (3) the appropriate tax registration number.
       (c) Package Disclosure of Ingredients.--Not later than 24 
     months after the effective date of this Act, the package of a 
     tobacco product shall bear a list of the common or usual 
     names of the ingredients present in the tobacco product in an 
     amount greater than 0.1 percent of the total dry weight of 
     the tobacco (including all ingredients), that shall comply 
     with the following:
       (1) Such listing of ingredients shall appear under, or be 
     conspicuously accompanied by, the heading ``Tobacco and 
     principal tobacco ingredients''.
       (2) Tobacco may be listed as ``tobacco,'' and shall be the 
     first listed ingredient.
       (3) After tobacco, the ingredients shall be listed in 
     descending order of predominance, by weight.
       (4) Spices and natural and artificial flavors may be 
     listed, respectively, as ``spices'' and ``natural and 
     artificial flavors'' without naming each.
       (5) Preservatives may be listed as ``preservatives'' 
     without naming each.
       (6) The disclosure of any ingredient in accordance with 
     this section may, at the option of the tobacco product 
     manufacturer, designate the functionality or purpose of that 
     ingredient.
       (7) The package say state ``Not for sale to minors''.
       (8) In the case of a package of cigarettes, the package 
     shall state that smokeless tobacco has significantly lower 
     risks for disease and death than cigarettes.

     SEC. 302. DISCLOSURES ON PACKAGES OF SMOKELESS TOBACCO.

       (a) Back Face for Required Disclosures.--For purposes of 
     this section--
       (1) the principal face of a package of smokeless tobacco is 
     the face that has the largest surface area or, for faces with 
     identical surface areas, any of the faces that have the 
     largest surface area; a package shall not be characterized as 
     having more than two principal faces;
       (2) the front or top face shall be the principal face of 
     the package;
       (3) if the front or top and back or bottom faces are of 
     different sizes in terms of area, then the larger face shall 
     be the front or top face;
       (4) the back or bottom face of the package shall be the 
     principal face of a package that is opposite the front or top 
     face of the package;
       (5) beginning 24 months after the effective date of this 
     Act, 50 percent of the back or bottom face of the package 
     shall be allocated for required package disclosures in 
     accordance with this section; and
       (6) if the package is cylindrical, a contiguous area 
     constituting 30 percent of the total surface area of the 
     cylinder shall be deemed the back face.
       (b) Required Information on Back or Bottom Face.--50 
     percent of the back or bottom face of a package of smokeless 
     tobacco shall be available solely for disclosures required by 
     or under this Act, the Comprehensive Smokeless Tobacco Health 
     Education Act of 1986, sections 4401-4408 of title 15, United 
     States Code, and any other Federal statute. Such disclosures 
     shall include a list of ingredients as required by subsection 
     (e).
       (c) Package Disclosure of Ingredients.--Commencing 24 
     months after the effective date of this Act, a package of 
     smokeless tobacco shall bear a list of the common or usual 
     names of the ingredients present in the smokeless tobacco in 
     an amount greater than 0.1 percent of the total dry weight of 
     the tobacco (including all ingredients).
       (1) Such listing of ingredients shall appears under, or be 
     conspicuously accompanied by, the heading ``Tobacco and 
     principal tobacco ingredients''.
       (2) Tobacco may be listed as ``tobacco,'' and shall be the 
     first listed ingredient.
       (3) After tobacco, the ingredients shall be listed in 
     descending order of predominance, by weight.
       (4) Spices and natural and artificial flavors may be 
     listed, respectively, as ``spices'' and ``natural and 
     artificial flavors'' without naming each.
       (5) Preservatives may be listed as ``preservatives'' 
     without naming each.
       (6) The disclosure of any ingredient in accordance with 
     this section may, at the option of the tobacco product 
     manufacturer, designate the functionality or purpose of that 
     ingredient.
       (7) Not for sale to minors.

     SEC. 303. PUBLIC DISCLOSURE OF INGREDIENTS.

       (a) Regulations.--Not later than 24 months after the 
     effective date of this Act, the Administrator shall, by 
     regulation, establish standards under which each tobacco 
     product manufacturer shall disclose publicly, and update at 
     least annually--
       (1) a list of the ingredients it uses in each brand style 
     it manufactures for commercial distribution domestically, as 
     provided in subsection (b); and

[[Page H4359]]

       (2) a composite list of all the ingredients it uses in any 
     of the brand styles it manufactures for commercial 
     distribution domestically, as provided in subsection (c).
       (b) Ingredients To Be Disclosed as to Each Brand Style.--
       (1) In general.--With respect to the public disclosure 
     required by subsection (a)(1), as to each brand style, the 
     tobacco product manufacture shall disclose the common or 
     usual name of each ingredient present in the brand style in 
     an amount greater than 0.1 percent of the total dry weight of 
     the tobacco (including all ingredients).
       (2) Requirements.--Disclosure under paragraph (1) shall 
     comply with the following:
       (A) Tobacco may be listed as ``tobacco,'' and shall be the 
     first listed ingredient.
       (B) After tobacco, the ingredients shall be listed in 
     descending order of predominance, by weight.
       (C) Spices and natural and artificial flavors may be 
     listed, respectively, as ``spices'' and ``natural and 
     artificial flavors'' without naming each.
       (D) Preservatives may be listed as ``preservatives'' 
     without naming each.
       (E) The disclosure of any ingredient in accordance with 
     this section may, at the option of the tobacco product 
     manufacturer, designate the functionality or purpose of that 
     ingredient.
       (c) Aggregate Disclosure of Ingredients.--
       (1) In general.--The public disclosure required of a 
     tobacco product manufacturer by subsection (a)(2) shall 
     consist of a single list of all ingredients used in any brand 
     style a tobacco product manufacturer manufactures for 
     commercial distribution domestically, without regard to the 
     quantity used, and including, separately, each spice, each 
     natural or artificial flavoring, and each preservative.
       (2) Listing.--The ingredients shall be listed by their 
     respective common or usual names in descending order of 
     predominance by the total weight used annually by the tobacco 
     product manufacturer in manufacturing tobacco products for 
     commercial distribution domestically.
       (d) No Required Disclosure of Quantities.--The 
     Administrator shall not require any public disclosure of 
     quantitative information about any ingredient in a tobacco 
     product.
       (e) Disclosure on Website.--The public disclosures required 
     by subsection (a) of this section may be by posting on an 
     Internet-accessible website, or other location electronically 
     accessible to the public, which is identified on all packages 
     of a tobacco product manufacturer's tobacco products.
       (f) Timing of Initial Required Disclosures.--No disclosure 
     pursuant to this section shall be required to commence until 
     the regulations under subsection (a) have been in effect for 
     not less than 1 year.

       TITLE IV--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS

     SEC. 401. STUDY AND REPORT ON ILLICIT TRADE.

       (a) The Administrator shall, after consultation with other 
     relevant agencies including Customs and Tobacco Tax Bureau, 
     conduct a study of trade in tobacco products that involves 
     passage of tobacco products either between the States or from 
     or to any other country across any border of the United 
     States to--
       (1) collect data on such trade in tobacco products, 
     including illicit trade involving tobacco products, and make 
     recommendations on the monitoring and enforcement of such 
     trade;
       (2) collect data on any advertising intended to be 
     broadcast, transmitted, or distributed from or to the United 
     States from or to another country and make recommendations on 
     how to prevent or eliminate, and what technologies could help 
     facilitate the elimination of, such advertising; and
       (3) collect data on such trade in tobacco products by 
     person that is not--
       (A) a participating manufacturer (as that term is defined 
     in section II(jj) of the Master Settlement Agreement of 
     November 23, 1998, between certain of the States and certain 
     tobacco product manufacturers); or
       (B) an affiliate or subsidiary of a participating 
     manufacturer.
       (b) Not later than 18 months after the effective date of 
     this Act, the Administrator shall submit to the Secretary, 
     and committees of relevant jurisdiction in Congress, a report 
     the recommendations of the study conducted under subsection 
     (a).

     SEC. 402. AMENDMENT TO SECTION 1926 OF THE PUBLIC HEALTH 
                   SERVICE ACT.

       Section 1926 of the Public Health Service Act (42 U.S.C. 
     Sec.  300x-26) is amended by adding at the end thereof the 
     following:
       ``(e)(1) Subject to paragraphs (2) and (3), for the first 
     fiscal year after enactment and each subsequent fiscal year, 
     the Secretary shall reduce, as provided in subsection (h), 
     the amount of any grant under section 300x-21 of this title 
     for any State that does not have in effect a statute with 
     substantially the following provisions:

     `` `SEC. 1. DISTRIBUTION TO MINORS.

       `` `(a) No person shall distribute a tobacco product to an 
     individual under 18 years of age or a different minimum age 
     established under State law. A person who violates this 
     subsection is liable for a civil money penalty of not less 
     than $25 nor more than $125 for each violation of this 
     subsection;
       `` `(b) The employer of an employee who has violated 
     subsection (a) twice while in the employ of such employer is 
     liable for a civil money penalty of $125 for each subsequent 
     violation by such employee.
       `` `(c) It shall be a defense to a charge brought under 
     subsection (a) that--
       `` `(1) the defendant--
       `` `(A) relied upon proof of age that appeared on its face 
     to be valid in accordance with the Federal Tobacco Act of 
     2007;
       `` `(B) had complied with the requirements of section 5 
     and, if applicable, section 7; or
       `` `(C) relied upon a commercially available electronic age 
     verification service to confirm that the person was an age-
     verified adult; or
       `` `(2) the individual to whom the tobacco product was 
     distributed was at the time of the distribution used in 
     violation of subsection 8(b).

     `` `SEC. 2. PURCHASE, RECEIPT, OR POSSESSION BY MINORS 
                   PROHIBITED.

       `` `(a) An individual under 18 years of age or a different 
     minimum age established under State law shall not purchase or 
     attempt to purchase, receive or attempt to receive, possess 
     or attempt to possess, a tobacco product. An individual who 
     violates this subsection is liable for a civil money penalty 
     of not less than $25 nor more than $125 for each such 
     violation, and shall be required to perform not less than 
     four hours nor more than ten hours of community service. Upon 
     the second or each subsequent violation of this subsection, 
     such individual shall be required to perform not less than 
     eight hours nor more than twenty hours of community service.
       `` `(b) A law enforcement agency, upon determining that an 
     individual under 18 years of age or a different minimum age 
     established under State law allegedly purchased, received, 
     possessed, or attempted to purchase, receive, or possess, a 
     tobacco product in violation of subsection (a) shall notify 
     the individual's parent or parents, custodian, or guardian as 
     to the nature of the alleged violation if the name and 
     address of a parent or parents, guardian, or custodian is 
     reasonably ascertainable by the law enforcement agency. The 
     notice required by this subsection shall be made not later 
     than 48 hours after the individual who allegedly violated 
     subsection (a) is cited by such agency for the violation. The 
     notice may be made by any means reasonably calculated to give 
     prompt actual notice, including notice in person, by 
     telephone, or by first-class mail.
       `` `(c) Subsection (a) does not prohibit an individual 
     under 18 years of age or a different minimum age established 
     under State law from possessing a tobacco product during 
     regular working hours and in the course of such individual's 
     employment if the tobacco product is not possessed for such 
     individual's consumption.

     `` `SEC. 3. OUT-OF-PACKAGE DISTRIBUTION.

       `` `It shall be unlawful for any person to distribute 
     cigarettes or a smokeless tobacco product other than in an 
     unopened package that complies in full with section 108 of 
     the Federal Tobacco Act of 2007. A person who distributes a 
     cigarette or a smokeless tobacco product in violation of this 
     section is liable for a civil money penalty of not less than 
     $25 nor more than $125 for each such violation.

     `` `SEC. 4. SIGNAGE.

       `` `It shall be unlawful for any person who sells tobacco 
     products over-the-counter to fail to post conspicuously on 
     the premises where such person sells tobacco products over-
     the-counter a sign communicating that--
       `` `(1) the sale of tobacco products to individuals under 
     18 years of age or a different minimum age established under 
     State law is prohibited by law;
       `` `(2) the purchase of tobacco products by individuals 
     under 18 years of age or a different minimum age established 
     under State law is prohibited by law; and
       `` `(3) proof of age may be demanded before tobacco 
     products are sold.
     A person who fails to post a sign that complies fully with 
     this section is liable for a civil money penalty of not less 
     than $25 nor more than $125.

     `` `SEC. 5. NOTIFICATION OF EMPLOYEES.

       `` `(a) Within 180 days of the effective date of the Youth 
     Prevention and Tobacco Harm Reduction Act, every person 
     engaged in the business of selling tobacco products at retail 
     shall implement a program to notify each employee employed by 
     that person who sells tobacco products at retail that--
       `` `(1) the sale or other distribution of tobacco products 
     to any individual under 18 years of age or a different 
     minimum age established under State law, and the purchase, 
     receipt, or possession of tobacco products in a place open to 
     the public by any individual under 18 years of age or a 
     different minimum age established under State law, is 
     prohibited; and
       `` `(2) out-of-package distribution of cigarettes and 
     smokeless tobacco products is prohibited.
     Any employer failing to provide the required notice to any 
     employee shall be liable for a civil money penalty of not 
     less than $25 nor more than $125 for each such violation.
       `` `(b) It shall be a defense to a charge that an employer 
     violated subsection (a) of this section that the employee 
     acknowledged receipt, either in writing or by electronic 
     means, prior to the alleged violation, of a statement in 
     substantially the following form:
       ``I understand that State law prohibits the distribution of 
     tobacco products to individuals under 18 years of age or a 
     different minimum age established under State law and out-of-
     package distribution of cigarettes and smokeless tobacco 
     products, and permits a

[[Page H4360]]

     defense based on evidence that a prospective purchaser's 
     proof of age was reasonably relied upon and appeared on its 
     face to be valid. I understand that if I sell, give, or 
     voluntarily provide a tobacco product to an individual under 
     18 years of age or a different minimum age established under 
     State law, I may be found responsible for a civil money 
     penalty of not less than $25 nor more than $125 for each 
     violation. I promise to comply with this law.' '''
       `` `(c) If an employer is charged with a violation of 
     subsection (a) and the employer uses as a defense to such 
     charge the defense provided by subsection (b), the employer 
     shall be deemed to be liable for such violation if such 
     employer pays the penalty imposed on the employee involved in 
     such violation or in any way reimburses the employee for such 
     penalty.

     `` `SEC. 6. SELF-SERVICE DISPLAYS.

       `` `(a) It shall be unlawful for any person who sells 
     tobacco products over-the-counter at retail to maintain 
     packages of such products in any location accessible to 
     customers that is not under the control of a cashier or other 
     employee during regular business hours. This subsection does 
     not apply to any adult-only facility.
       `` `(b) Any person who violates subsection (a) is liable 
     for a civil money penalty of not less than $25 nor more than 
     $125 for each such violation, except that no person shall be 
     responsible for more than one violation per day at any one 
     retail store.

     `` `SEC. 7. DISTRIBUTION BY MAIL OR COURIER.

       `` `(a) It shall be unlawful to distribute or sell tobacco 
     products directly to consumers by mail or courier, unless the 
     person receiving purchase requests for tobacco products takes 
     reasonable action to prevent delivery to individuals who are 
     not adults by--
       `` `(1) requiring that addressees of the tobacco products 
     be age-verified adults;
       `` `(2) making good faith efforts to verify that such 
     addressees have attained the minimum age for purchase of 
     tobacco products established by the respective States wherein 
     the addresses of the addressees are located; and
       `` `(3) addressing the tobacco products delivered by mail 
     or courier to a physical addresses and not to post office 
     boxes.
       `` `(b) Any person who violates subsection (a) is liable 
     for a civil money penalty of not less than $25 nor more than 
     $125 for each such violation.

     `` `SEC. 8. RANDOM UNANNOUNCED INSPECTIONS; REPORTING; AND 
                   COMPLIANCE.

       `` `(a) The State Police, or a local law enforcement 
     authority duly designated by the State Police, shall enforce 
     this Act in a manner that can reasonably be expected to 
     reduce the extent to which tobacco products are distributed 
     to individuals under 18 years of age or a different minimum 
     age established under State law and shall conduct random, 
     unannounced inspections in accordance with the procedures set 
     forth in this Act and in regulations issued under section 
     1926 of the Federal Public Health Service Act (42 U.S.C. 
     Sec.  300x-26).
       `` `(b) The State may engage an individual under 18 years 
     of age or a different minimum age established under State law 
     to test compliance with this Act, except that such an 
     individual may be used to test compliance with this Act only 
     if the testing is conducted under the following conditions:
       `` `(1) Prior to use of any individual under 18 years of 
     age or a different minimum age established under State law in 
     a random, unannounced inspection, written consent shall be 
     obtained from a parent, custodian, or guardian of such 
     individual;
       `` `(2) An individual under 18 years of age or a different 
     minimum age established under State law shall act solely 
     under the supervision and direction of the State Police or a 
     local law enforcement authority duly designated by the State 
     Police during a random, unannounced inspection;
       `` `(3) An individual under 18 years of age or a different 
     minimum age established under State law used in random, 
     unannounced inspections shall not be used in any such 
     inspection at a store in which such individual is a regular 
     customer; and
       `` `(4) If an individual under 18 years of age or a 
     different minimum age established under State law 
     participating in random, unannounced inspections is 
     questioned during such an inspection about such individual's 
     age, such individual shall state his or her actual age and 
     shall present a true and correct proof of age if requested at 
     any time during the inspection to present it.
       `` `(c) Any person who uses any individual under 18 years 
     of age or a different minimum age established under State 
     law, other than as permitted by subsection (b), to test 
     compliance with this Act, is liable for a civil money penalty 
     of not less than $25 nor more than $125 for each such 
     violation.
       `` `(d) Civil money penalties collected for violations of 
     this Act and fees collected under section 9 shall be used 
     only to defray the costs of administration and enforcement of 
     this Act.

     `` `SEC. 9. LICENSURE.

       `` `(a) Each person engaged in the over-the-counter 
     distribution at retail of tobacco products shall hold a 
     license issued under this section. A separate license shall 
     be required for each place of business where tobacco products 
     are distributed at retail. A license issued under this 
     section is not assignable and is valid only for the person in 
     whose name it is issued and for the place of business 
     designated in the license.
       `` `(b) The annual license fee is $25 for each place of 
     business where tobacco products are distributed at retail.
       `` `(c) Every application for a license, including renewal 
     of a license, under this section shall be made upon a form 
     provided by the appropriate State agency or department, and 
     shall set forth the name under which the applicant transacts 
     or intends to transact business, the location of the place of 
     business for which the license is to be issued, the street 
     address to which all notices relevant to the license are to 
     be sent (in this Act referred to as ``notice address''), and 
     any other identifying information that the appropriate State 
     agency or department may require.
       `` `(d) The appropriate State agency or department shall 
     issue or renew a license or deny an application for a license 
     or the renewal of a license within 30 days of receiving a 
     properly completed application and the license fee. The 
     appropriate State agency or department shall provide notice 
     to an applicant of action on an application denying the 
     issuance of a license or refusing to renew a license.
       `` `(e) Every license issued by the appropriate State 
     agency or department pursuant to this section shall be valid 
     for 1 year from the date of issuance and shall be renewed 
     upon application except as otherwise provided in this Act.
       `` `(f) Upon notification of a change of address for a 
     place of business for which a license has been issued, a 
     license shall be reissued for the new address without the 
     filing of a new application.
       `` `(g) The appropriate State agency or department shall 
     notify every person in the State who is engaged in the 
     distribution at retail of tobacco products of the license 
     requirements of this section and of the date by which such 
     person should have obtained a license.
       `` `(h)(1) Except as provided in paragraph (2), any person 
     who engages in the distribution at retail of tobacco products 
     without a license required by this section is liable for a 
     civil money penalty in an amount equal to (i) two times the 
     applicable license fee, and (ii) $50 for each day that such 
     distribution continues without a license.
       `` `(2) Any person who engages in the distribution at 
     retail of tobacco products after a license issued under this 
     section has been suspended or revoked is liable for a civil 
     money penalty of $100 per day for each day on which such 
     distribution continues after the date such person received 
     notice of such suspension or revocation.
       `` `(i) No person shall engage in the distribution at 
     retail of tobacco products on or after 180 days after the 
     date of enactment this Act unless such person is authorized 
     to do so by a license issued pursuant to this section or is 
     an employee or agent of a person that has been issued such a 
     license.

     `` `SEC. 10. SUSPENSION, REVOCATION, DENIAL, AND NONRENEWAL 
                   OF LICENSES.

       `` `(a) Upon a finding that a licensee has been determined 
     by a court of competent jurisdiction to have violated this 
     Act during the license term, the State shall notify the 
     licensee in writing, served personally or by registered mail 
     at the notice address, that any subsequent violation of this 
     Act at the same place of business may result in an 
     administrative action to suspend the license for a period 
     determined by the specify the appropriate State agency or 
     department.
       `` `(b) Upon finding that a further violation by this Act 
     has occurred involving the same place of business for which 
     the license was issued and the licensee has been served 
     notice once under subsection (a), the appropriate State 
     agency or department may initiate an administrative action to 
     suspend the license for a period to be determined by the 
     appropriate State agency or department but not to exceed six 
     months. If an administrative action to suspend a license is 
     initiated, the appropriate State agency or department shall 
     immediately notify the licensee in writing at the notice 
     address of the initiation of the action and the reasons 
     therefor and permit the licensee an opportunity, at least 30 
     days after written notice is served personally or by 
     registered mail upon the licensee, to show why suspension of 
     the license would be unwarranted or unjust.
       `` `(c) The appropriate State agency or department may 
     initiate an administrative action to revoke a license that 
     previously has been suspended under subsection (b) if, after 
     the suspension and during the one-year period for which the 
     license was issued, the licensee committed a further 
     violation of this Act, at the same place of business for 
     which the license was issued. If an administrative action to 
     revoke a license is initiated, the appropriate State agency 
     or department shall immediately notify the licensee in 
     writing at the notice address of the initiation of the action 
     and the reasons therefor and permit the licensee an 
     opportunity, at least 30 days after written notice is served 
     personally or by registered mail upon the licensee, to show 
     why revocation of the license would be unwarranted or unjust.
       `` `(d) A person whose license has been suspended or 
     revoked with respect to a place of business pursuant to this 
     section shall pay a fee of $50 for the renewal or reissuance 
     of the license at that same place of business, in addition to 
     any applicable annual license fees.
       `` `(e) Revocation of a license under subsection (c) with 
     respect to a place of business shall not be grounds to deny 
     an application by any person for a new license with respect 
     to such place of business for more than 12 months subsequent 
     to the date of such revocation. Revocation or suspension of a 
     license with respect to a particular place of

[[Page H4361]]

     business shall not be grounds to deny an application for a 
     new license, to refuse to renew a license, or to revoke or 
     suspend an existing license at any other place of business.
       `` `(f) A licensee may seek judicial review of an action of 
     the appropriate State agency or department suspending, 
     revoking, denying, or refusing to renew a license under this 
     section by filing a complaint in a court of competent 
     jurisdiction. Any such complaint shall be filed within 30 
     days after the date on which notice of the action is received 
     by the licensee. The court shall review the evidence de novo.
       `` `(g) The State shall not report any action suspending, 
     revoking, denying, or refusing to renew a license under this 
     section to the Federal Secretary of Health and Human 
     Services, unless the opportunity for judicial review of the 
     action pursuant to subsection (f), if any, has been exhausted 
     or the time for seeking such judicial review has expired.

     `` `SEC. 11. NO PRIVATE RIGHT OF ACTION.

       `` `Nothing in this Act shall be construed to create a 
     right of action by any private person for any violation of 
     any provision of this Act.

     `` `SEC. 12. JURISDICTION AND VENUE.

       `` `Any action alleging a violation of this Act may be 
     brought only in a court of general jurisdiction in the city 
     or county where the violation is alleged to have occurred.

     `` `SEC. 13. REPORT.

       `` `The appropriate State agency or department shall 
     prepare for submission annually to the Federal Secretary of 
     Health and Human Services the report required by section 1926 
     of the Federal Public Health Service Act (42 U.S.C. 300x-
     26).' ''.
       ``(2) In the case of a State whose legislature does not 
     convene a regular session in fiscal year 2007, and in the 
     case of a State whose legislature does not convene a regular 
     session in fiscal year 2008, the requirement described in 
     subsection (e)(1) as a condition of a receipt of a grant 
     under section 300x-21 of this title shall apply only for 
     fiscal year 2009 and subsequent fiscal years.
       ``(3) Subsection (e)(1) shall not affect any State or local 
     law that (A) was in effect on the date of introduction of the 
     Federal Tobacco Act of 2007, and (B) covers the same subject 
     matter as the law described in subsection (e)(1). Any State 
     law that meets the conditions of this paragraph shall also be 
     deemed to meet the requirement described in subsection (e)(1) 
     as a condition of a receipt of a grant under section 300x-21 
     of this title, if such State law is at least as stringent as 
     the law described in subsection (e)(1).
       ``(f)(1) For the first applicable fiscal year and for each 
     subsequent fiscal year, a funding agreement for a grant under 
     section 300x-21 of this title is a funding agreement under 
     which the State involved will enforce the law described in 
     subsection (e)(1) of this section in a manner that can 
     reasonably be expected to reduce the extent to which tobacco 
     products are available to individuals under the age of 18 or 
     a different minimum age established under State law for the 
     purchase of tobacco products.
       ``(2) For the first applicable fiscal year and for each 
     subsequent fiscal year, a funding agreement for a grant under 
     section 300x-21 of this title is a funding agreement under 
     which the State involved will--
       ``(A) conduct random, unannounced inspections to ensure 
     compliance with the law described in subsection (e)(1); and
       ``(B) annually submit to the Secretary a report 
     describing--
       ``(i) the activities carried out by the State to enforce 
     such law during the fiscal year preceding the fiscal year for 
     which the State is seeking the grant;
       ``(ii) the extent of success the State has achieved in 
     reducing the availability of tobacco products to individuals 
     under 18 years of age or a different minimum age established 
     under State law, including the results of the inspections 
     conducted under subparagraph (A); and
       ``(iii) the strategies to be utilized by the State for 
     enforcing such law during the fiscal year for which the grant 
     is sought.
       ``(g) The law specified in subsection (e)(1) may be 
     administered and enforced by a State using--
       ``(1) any amounts made available to the State through a 
     grant under section 300x-21 of this title;
       ``(2) any amounts made available to the State under section 
     300w of this title;
       ``(3) any fees collected for licenses issued pursuant to 
     the law described in subsection (e)(1);
       ``(4) any fines or penalties assessed for violations of the 
     law specified in subsection (e)(1); or
       ``(5) any other funding source that the legislature of the 
     State may prescribe by statute.
       ``(h) Before making a grant under section 300x-21 of this 
     title to a State for the first applicable fiscal year or any 
     subsequent fiscal year, the Secretary shall make a 
     determination of whether the State has maintained compliance 
     with subsections (e) and (f) of this section. If, after 
     notice to the State and an opportunity for a hearing, the 
     Secretary determines that the State is not in compliance with 
     such subsections, the Secretary shall reduce the amount of 
     the allotment under section 300x-21 of this title for the 
     State for the fiscal year involved by an amount equal to--
       ``(1) In the case of the first applicable fiscal year, 10 
     percent of the amount determined under section 300x-33 for 
     the State for the fiscal year;
       ``(2) In the case of the first fiscal year following such 
     applicable fiscal year, 20 percent of the amount determined 
     under section 300x-33 for the State for the fiscal year;
       ``(3) In the case of the second such fiscal year, 30 
     percent of the amount determined under section 300x-33 for 
     the State for the fiscal year; and
       ``(4) In the case of the third such fiscal year or any 
     subsequent fiscal year, 40 percent of the amount determined 
     under section 300x-33 for the State for the fiscal year.
     The Secretary shall not have authority or discretion to grant 
     to any State a waiver of the terms and requirements of this 
     subsection or subsection (e) or (f).
       ``(i) For the purposes of subsections (e) through (h) of 
     this section the term `first applicable fiscal year' means--
       ``(1) fiscal year 2009, in the case of any State described 
     in subsection (e)(2) of this section; and
       ``(2) fiscal year 2008, in the case of any other State.
       ``(j) For purposes of subsections (e) through (h) of this 
     section, references to section 300x-21 shall include any 
     successor grant programs.`'
       ``(k) As required by paragraph (1), and subject to 
     paragraph (4), an Indian tribe shall satisfy the requirements 
     of subsection (e)(1) of this section by enacting a law or 
     ordinance with substantially the same provisions as the law 
     described in subsection (e)(1).
       ``(1) An Indian tribe shall comply with subsection (e)(1) 
     of this section within 180 days after the Administrator 
     finds, in accordance with this paragraph, that--
       ``(A) the Indian tribe has a governing body carrying out 
     substantial governmental powers and duties;
       ``(B) the functions to be exercised by the Indian tribe 
     under this Act pertain to activities on trust land within the 
     jurisdiction of the tribe; and
       ``(C) the Indian tribe is reasonably expected to be capable 
     of carrying out the functions required under this section.
     Within 2 years of the date of enactment of the Federal 
     Tobacco Act of 2007, as to each Indian tribe in the United 
     States, the Administrator shall make the findings 
     contemplated by this paragraph or determine that such 
     findings cannot be made, in accordance with the procedures 
     specified in paragraph (4).
       ``(2) As to Indian tribes subject to subsection (e)(1) of 
     this section, the Administrator shall promulgate regulations 
     that--
       ``(A) provide whether and to what extent, if any, the law 
     described in subsection (e)(1) may be modified as adopted by 
     Indian tribes; and
       ``(B) ensure, to the extent possible, that each Indian 
     tribe's retailer licensing program under subsection (e)(1) is 
     no less stringent than the program of the State or States in 
     which the Indian tribe is located.
       ``(3) If with respect to any Indian tribe the Administrator 
     determines that compliance with the requirements of 
     subsection (e)(1) is inappropriate or administratively 
     infeasible, the Administrator shall specify other means for 
     the Indian tribe to achieve the purposes of the law described 
     in subsection (e)(1) with respect to persons who engage in 
     the distribution at retail of tobacco products on tribal 
     lands.
       ``(4) The findings and regulations promulgated under 
     paragraphs (1) and (2) shall be promulgated in conformance 
     with section 553 of title 5, United States Code, and shall 
     comply with the following provisions:
       ``(A) In making findings as provided in paragraph (1), and 
     in drafting and promulgating regulations as provided in 
     paragraph (2) (including drafting and promulgating any 
     revised regulations), the Administrator shall confer with, 
     and allow for active participation by, representatives and 
     members of Indian tribes, and tribal organizations.
       ``(B) In carrying out rulemaking processes under this 
     subsection, the Administrator shall follow the guidance of 
     subchapter III of chapter 5 of title 5, United States Code, 
     commonly known as the `Negotiated Rulemaking Act of 1990.'
       ``(C) The tribal participants in the negotiation process 
     referred to in subparagraph (B) shall be nominated by and 
     shall represent the groups described in this subsection and 
     shall include tribal representatives from all geographic 
     regions.
       ``(D) The negotiations conducted under this paragraph (4) 
     shall be conducted in a timely manner.
       ``(E) If the Administrator determines that an extension of 
     the deadlines under subsection (k)(1) of this section is 
     appropriate, the Secretary may submit proposed legislation to 
     Congress for the extension of such deadlines.
       ``(5) This subsection shall not affect any law or ordinance 
     that (A) was in effect on tribal lands on the date of 
     introduction of the Youth Prevention and Tobacco Harm 
     Reduction Act, and (B) covers the same subject matter as the 
     law described in subsection (e)(1). Any law or ordinance that 
     meets the conditions of this paragraph shall also be deemed 
     to meet the requirement described in subsection (k)(1), if 
     such law or ordinance is at least as stringent as the law 
     described in subsection (e)(1).
       ``(6) For purposes of this subsection--
       ``(A) `Administrator' means the Administrator of the 
     Tobacco Harm Reduction Center.
       ``(B) `Indian tribe' has the meaning assigned that term in 
     section 4(e) of the Indian

[[Page H4362]]

     Self Determination and Education Assistance Act, section 
     450b(e) of title 25, United States Code.
       ``(C) `Tribal lands' means all lands within the exterior 
     boundaries of any Indian reservation, all lands the title to 
     which is held by the United States in trust for an Indian 
     tribe, or lands the title to which is held by an Indian tribe 
     subject to a restriction by the United States against 
     alienation, and all dependent Indian communities.
       ``(D) `tribal organization' has the meaning assigned that 
     term in section 4(l) of the Indian Self Determination and 
     Education Assistance Act, section 450b(l) of title 25, United 
     States Code.''.

     SEC. 403. ESTABLISHMENT OF RANKINGS.

       (a) Standards and Procedures for Rankings.--Within 24 
     months after the effective date of this Act, the 
     Administrator shall, by regulation, after consultation with 
     an Advisory Committee established for such purpose, establish 
     the standards and procedures for promulgating rankings, 
     comprehensible to consumers of tobacco products, of the 
     following categories of tobacco products and also nicotine-
     containing products on the basis of the relative risks of 
     serious or chronic tobacco-related diseases and adverse 
     health conditions those categories of tobacco products and 
     also nicotine-containing products respectively present--
       (1) cigarettes;
       (2) loose tobacco for roll-your-own tobacco products;
       (3) little cigars;
       (4) cigars;
       (5) pipe tobacco;
       (6) moist snuff;
       (7) dry snuff;
       (8) chewing tobacco;
       (9) other forms of tobacco products, including pelletized 
     tobacco and compressed tobacco, treated collectively as a 
     single category; and
       (10) other nicotine-containing products, treated 
     collectively as a single category.
     The Administrator shall not have authority or discretion to 
     establish a relative-risk ranking of any category or 
     subcategory of tobacco products or any category or 
     subcategory of nicotine-containing products other than the 
     ten categories specified in this subsection.
       (b) Considerations in Promulgating Regulations.--In 
     promulgating regulations under this section, the 
     Administrator--
       (1) shall take into account relevant epidemiologic studies 
     and other relevant competent and reliable scientific 
     evidence; and
       (2) in assessing the risks of serious or chronic tobacco-
     related diseases and adverse health conditions presented by a 
     particular category, shall consider the range of tobacco 
     products or nicotine-containing products within the category, 
     and shall give appropriate weight to the market shares of the 
     respective products in the category.
       (c) Promulgation of Rankings of Categories.--Once the 
     initial regulations required by subsection (a) are in effect, 
     the Administrator shall promptly, by order, after notice and 
     an opportunity for comment, promulgate to the general public 
     rankings of the categories of tobacco products and nicotine-
     containing products in accordance with those regulations. The 
     Administrator shall promulgate the initial rankings of those 
     categories of tobacco products and nicotine-containing 
     products to the general public not later than January 1, 
     2010. Thereafter, on an annual basis, the Administrator 
     shall, by order, promulgate to the general public updated 
     rankings that are (1) in accordance with those regulations, 
     and (2) reflect the scientific evidence available at the time 
     of promulgation. The Administrator shall open and maintain an 
     ongoing public docket for receipt of data and other 
     information submitted by any person with respect to such 
     annual promulgation of rankings.

                    TITLE V--ENFORCEMENT PROVISIONS

     SEC. 501. PROHIBITED ACTS.

       The following acts and the causing thereof are hereby 
     prohibited--
       (1) the introduction or delivery for introduction into 
     interstate commerce of any tobacco product that is 
     adulterated or misbranded;
       (2) the adulteration or misbranding of any tobacco product 
     in interstate commerce;
       (3) the receipt in interstate commerce of any tobacco 
     product that is known to be adulterated or misbranded, and 
     the delivery or proffered delivery thereof for pay or 
     otherwise;
       (4) the failure to establish or maintain any record, or 
     make any report or other submission, or to provide any notice 
     required by or under this Act; or the refusal to permit 
     access to, verification of, or copying of any record as 
     required by this Act;
       (5) the refusal to permit entry or inspection as authorized 
     by this Act;
       (6) the making to the Administrator of a statement, report, 
     certification or other submission required by this Act, with 
     knowledge that such statement, report, certification, or 
     other submission is false in a material aspect;
       (7) the manufacturing, shipping, receiving, storing, 
     selling, distributing, possession, or use of any tobacco 
     product with knowledge that it is an illicit tobacco product;
       (8) the forging, simulating without proper permission, 
     falsely representing, or without proper authority using any 
     brand name;
       (9) the using by any person to his or her own advantage, or 
     revealing, other than to the Administrator or officers or 
     employees of the Agency, or to the courts when relevant in 
     any judicial proceeding under this Act, any information 
     acquired under authority of this Act concerning any item 
     which as a trade secret is entitled to protection; except 
     that the foregoing 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;
       (10) 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 tobacco 
     product, if such act is done while such tobacco product is 
     held for sale (whether or not the first sale) after shipment 
     in interstate commerce, and results in such tobacco product 
     being adulterated or misbranded;
       (11) the importation of any tobacco product that is 
     adulterated, misbranded, or otherwise not in compliance with 
     this Act; and
       (12) the commission of any act prohibited by section 201 of 
     this Act.

     SEC. 502. INJUNCTION PROCEEDINGS.

       (a) The district courts of the United States shall have 
     jurisdiction, for cause shown, to restrain violations of this 
     Act, except for violations of section 701(k).
       (b) In case of an alleged violation of an injunction or 
     restraining order issued under this section, which also 
     constitutes a violation of this Act, trial shall be by the 
     court, or upon demand of the defendant, by a jury.

     SEC. 503. PENALTIES.

       (a) Criminal Penalties.--Any person who willfully violates 
     a provision of section 501 of this Act shall be imprisoned 
     for not more than one year or fined not more than $25,000, or 
     both.
       (b) Civil Penalties for Violation of Section 803.--
       (1) Any person who knowingly distributes or sells, other 
     than through retail sale or retail offer for sale, any 
     cigarette brand style in violation of section 803(a)--
       (A) for a first offense shall be liable for a civil penalty 
     not to exceed $10,000 for each distribution or sale, or
       (B) for a second offense shall be liable for a civil 
     penalty not to exceed $25,000 for each distribution or sale,
     except that the penalty imposed against any person with 
     respect to violations during any 30-day period shall not 
     exceed $100,000.
       (2) Any retailer who knowingly distributes, sells or offers 
     for sale any cigarette brand style in violation of section 
     803(a) shall--
       (A) for a first offense for each sale or offer for sale of 
     cigarettes, if the total number of packages of cigarettes 
     sold or offered for sale--
       (i) does not exceed 50 packages of cigarettes, be liable 
     for a civil penalty not to exceed $500 for each sale or offer 
     for sale, and
       (ii) exceeds 50 packages of cigarettes, be liable for a 
     civil penalty not to exceed $1,000 for each sale or offer for 
     sale;
       (B) for each subsequent offense for each sale or offer for 
     sale of cigarettes, if the total number of cigarettes sold or 
     offered for sale--
       (i) does not exceed 50 packages of cigarettes, be liable 
     for a civil penalty not to exceed $2,000 for each sale or 
     offer for sale, and
       (ii) exceeds 50 packages of cigarettes, be liable for a 
     civil penalty not to exceed $5,000 for each sale or offer for 
     sale;
     except that the penalty imposed against any person during any 
     30-day period shall not exceed $25,000.

     SEC. 504. SEIZURE.

       (a) Articles Subject to Seizure.--
       (1) Any tobacco product that is adulterated or misbranded 
     when introduced into or while in interstate commerce or while 
     held for sale (whether or not the first sale) after shipment 
     in interstate commerce, or which may not, under the 
     provisions of this Act, be introduced into interstate 
     commerce, shall be liable to be proceeded against while in 
     interstate commerce, or at any time thereafter, on libel of 
     information and condemned in any district court of the United 
     States within the jurisdiction of which the tobacco product 
     is found. No libel for condemnation shall be instituted under 
     this Act for any alleged misbranding if there is pending in 
     any court a libel for condemnation proceeding under this Act 
     based upon the same alleged misbranding, and not more than 
     one such proceeding shall be instituted if no such proceeding 
     is so pending, except that such limitations shall not apply--
       (A) when such misbranding has been the basis of a prior 
     judgment in favor of the United States, in a criminal, 
     injunction, or libel for condemnation proceeding under this 
     Act, or
       (B) when the Administrator has probable cause to believe 
     from facts found, without hearing, by the Administrator or 
     any officer or employee of the Agency that the misbranded 
     tobacco product is dangerous to health beyond the inherent 
     danger to health posed by tobacco, or that the labeling of 
     the misbranded tobacco product is fraudulent, or would be in 
     a material respect misleading to the injury or damage of the 
     purchaser or consumer. In any case where the number of libel 
     for condemnation proceedings is limited as above provided, 
     the proceeding pending or instituted shall, on application of 
     the claimant, seasonably made, be removed for trial to any 
     district agreed upon by stipulation between the parties, or, 
     in case of failure to so stipulate within a reasonable time, 
     the claimant may apply to the court of the district in which 
     the seizure has been made, and

[[Page H4363]]

     such court (after giving the United States attorney for such 
     district reasonable notice and opportunity to be heard) shall 
     by order, unless good cause to the contrary is shown, specify 
     a district of reasonable proximity to the claimant's 
     principal place of business, to which the case shall be 
     removed for trial.
       (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 within the jurisdiction 
     of which they are found--
       (A) any tobacco product that is an illicit tobacco product;
       (B) any container of an illicit tobacco product;
       (C) any equipment or thing used in making an illicit 
     tobacco product; and
       (D) any adulterated or misbranded tobacco product.
       (3)(A) Except as provided in subparagraph (B), no libel for 
     condemnation may be instituted under paragraph (1) or (2) 
     against any tobacco product which--
       (i) is misbranded under this Act because of its 
     advertising, and
       (ii) is being held for sale to the ultimate consumer in an 
     establishment other than an establishment owned or operated 
     by a manufacturer, packer, or distributor of the tobacco 
     product.
       (B) A libel for condemnation may be instituted under 
     paragraph (1) or (2) against a tobacco product described in 
     subparagraph (A) if the tobacco product's advertising which 
     resulted in the tobacco product being misbranded was 
     disseminated in the establishment in which the tobacco 
     product is being held for sale to the ultimate consumer--
       (i) such advertising was disseminated by, or under the 
     direction of, the owner or operator of such establishment, or
       (ii) all or part of the cost of such advertising was paid 
     by such owner or operator.
       (b) Procedures.--The tobacco product, equipment, or other 
     thing proceeded against shall be liable to seizure by process 
     pursuant to the libel, and the procedure in cases under this 
     section shall conform, as nearly as may be, to the procedure 
     in admiralty; except that on demand of either party any issue 
     of fact joined in any such case shall be tried by jury. When 
     libel for condemnation proceedings under this section, 
     involving the same claimant and the same issues of 
     adulteration or misbranding, are pending in two or more 
     jurisdictions, such pending proceedings, upon application of 
     the claimant seasonably made to the court of one such 
     jurisdiction, shall be consolidated for trial by order of 
     such court, and tried in (1) any district selected by the 
     claimant where one of such proceedings is pending; or (2) a 
     district agreed upon by stipulation between the parties. If 
     no order for consolidation is so made within a reasonable 
     time, the claimant may apply to the court of one such 
     jurisdiction and such court (after giving the United States 
     attorney for such district reasonable notice and opportunity 
     to be heard) shall by order, unless good cause to the 
     contrary is shown, specify a district of reasonable proximity 
     to the claimant's principal place of business, in which all 
     such pending proceedings shall be consolidated for trial and 
     tried. Such order of consolidation shall not apply so as to 
     require the removal of any case the date for trial of which 
     has been fixed. The court granting such order shall give 
     prompt notification thereof to the other courts having 
     jurisdiction of the cases covered thereby.
       (c) Samples and Analyses.--The court at any time after 
     seizure up to a reasonable time before trial shall by order 
     allow any party to a condemnation proceeding, the party's 
     attorney or agent, to obtain a representative sample of the 
     article seized and a true copy of the analysis, if any, on 
     which the proceeding is based and the identifying marks or 
     numbers, if any, of the packages from which the samples 
     analyzed were obtained.
       (d) Disposition of Condemned Tobacco Products.--(1) Any 
     tobacco product 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 tobacco product 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 in which sold, the court may by order direct that such 
     tobacco product 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 Administrator; and the expenses of 
     such supervision shall be paid by the person obtaining 
     release of the tobacco product under bond. If the tobacco 
     product 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 tobacco 
     product was imported, and (B) that the person seeking the 
     release of the tobacco product 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 tobacco product to be delivered to the owner for 
     exportation under section 709 in lieu of destruction upon a 
     showing by the owner that there is a reasonable certainty 
     that the tobacco product will not be re-imported into the 
     United States.
       (2) The provisions of paragraph (1) of this subsection 
     shall, to the extent deemed appropriate by the court, apply 
     to any equipment or other thing which is not otherwise within 
     the scope of such paragraph and which is referred to in 
     paragraph (2) of subsection (a).
       (3) Whenever in any proceeding under this section, 
     involving paragraph (2) of subsection (a), the condemnation 
     of any equipment or thing (other than a tobacco product) is 
     decreed, the court shall allow the claim of any claimant, to 
     the extent of such claimant's interest, for remission or 
     mitigation of such forfeiture if such claimant proves to the 
     satisfaction of the court (A) that such claimant has not 
     caused the equipment or thing to be within one of the 
     categories referred to in such paragraph (2) and has no 
     interest in any tobacco product referred to therein, (B) that 
     such claimant has an interest in such equipment or other 
     thing as owner or lienor or otherwise, acquired by such 
     claimant in good faith, and (C) that such claimant at no time 
     had any knowledge or reason to believe that such equipment or 
     other thing was being or would be used in, or to facilitate, 
     the violation of laws of the United States relating to any 
     illicit tobacco product.
       (e) Costs and Fees.--When a decree of condemnation is 
     entered against the tobacco product or other article, court 
     costs and fees, and storage and other proper expenses shall 
     be awarded against the person, if any, intervening as 
     claimant of the tobacco product or other article.
       (f) Removal for Trial.--In the case of removal for trial of 
     any case as provided by subsection (a) or (b)--
       (1) The clerk of the court from which removal is made shall 
     promptly transmit to the court in which the case is to be 
     tried all records in the case necessary in order that such 
     court may exercise jurisdiction.
       (2) The court to which such case was removed shall have the 
     powers and be subject to the duties, for purposes of such 
     case, which the court from which removal was made would have 
     had, or to which such court would have been subject, if such 
     case had not been removed.
       (g) Administrative Detention of Tobacco Products.--
       (1) Detention authority.--
       (A) In general.--An officer or qualified employee of the 
     Agency may order the detention, in accordance with this 
     subsection, of any tobacco product that is found during an 
     inspection, examination, or investigation under this Act 
     conducted by such officer or qualified employee, if the 
     officer or qualified employee has credible evidence or 
     information indicating that such article presents a threat of 
     serious adverse health consequences beyond those normally 
     inherent in the use of tobacco products.
       (B) Administrator's approval.--A tobacco product or 
     component thereof may be ordered detained under subparagraph 
     (A) if, but only if, the Administrator or an official 
     designated by the Administrator approves the order. An 
     official may not be so designated unless the official is an 
     officer with supervisory responsibility for the inspection, 
     examination, or investigation that led to the order.
       (2) Period of detention.--A tobacco product may be detained 
     under paragraph (1) for a reasonable period, not to exceed 20 
     days, unless a greater period, not to exceed 30 days, is 
     necessary, to institute an action under subsection (a) or 
     section 702.
       (3) Security of detained tobacco product.--An order under 
     paragraph (1) may require that the tobacco product to be 
     detained be labeled or marked as detained, and shall require 
     that the tobacco product be maintained in or removed to a 
     secure facility, as appropriate. A tobacco product subject to 
     such an order shall not be transferred by any person from the 
     place at which the tobacco product is ordered detained, or 
     from the place to which the tobacco product is so removed, as 
     the case may be, until released by the Administrator or until 
     the expiration of the detention period applicable under such 
     order, whichever occurs first. This subsection may not be 
     construed as authorizing the delivery of the tobacco product 
     pursuant to the execution of a bond while the tobacco product 
     is subject to the order, and section 709 does not authorize 
     the delivery of the tobacco product pursuant to the execution 
     of a bond while the article is subject to the order.
       (4) Appeal of detention order.--
       (A) In general.--With respect to a tobacco product ordered 
     detained under paragraph (1), any person who would be 
     entitled to be a claimant of such tobacco product if the 
     tobacco product were seized under subsection (a) may appeal 
     the order to the Administrator. Within five days after such 
     an appeal is filed, the Administrator, after providing 
     opportunity for an informal hearing, shall confirm or 
     terminate the order involved, and such confirmation by the 
     Administrator shall be considered a final agency action for 
     purposes of section 702 of title 5, United States Code. If 
     during such five-day period the Administrator fails to 
     provide such an opportunity, or to confirm or terminate such 
     order, the order is deemed to be terminated.
       (B) Effect of instituting court action.--The process under 
     subparagraph (A) for the appeal of an order under paragraph 
     (1) terminates if the Administrator institutes an action 
     under subsection (a) or section 702 regarding the tobacco 
     product involved.

[[Page H4364]]

     SEC. 505. REPORT OF MINOR VIOLATIONS.

       Nothing in this Act shall be construed as requiring the 
     Administrator to report for prosecution, or for institution 
     of libel or injunction proceedings, minor violations of this 
     Act whenever the Administrator believes that the public 
     interest will be adequately served by a suitable written 
     notice or warning.

     SEC. 506. INSPECTION.

       (a) Authority To Inspect.--The Administrator shall have the 
     power to inspect the premises of a tobacco product 
     manufacturer for purposes of determining compliance with this 
     Act, or the regulations promulgated under it. Officers of the 
     Agency designated by the Administrator, upon presenting 
     appropriate credentials and a written notice to the person in 
     charge of the premises, are authorized to enter, at 
     reasonable times, without a search warrant, any factory, 
     warehouse, or other establishment in which tobacco products 
     are manufactured, processed, packaged, or held for domestic 
     distribution. Any such inspection shall be conducted within 
     reasonable limits and in a reasonable manner, and shall be 
     limited to examining only those things, including but not 
     limited to records, relevant to determining whether 
     violations of this Act, or regulations under it, have 
     occurred. No inspection authorized by this section 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), or research data. 
     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) Report of Observations.--Before leaving the premises, 
     the officer of the Agency who has supervised or conducted the 
     inspection shall give to the person in charge of the premises 
     a report in writing setting forth any conditions or practices 
     that appear to manifest a violation of this Act, or the 
     regulations under it.
       (c) Samples.--If the officer has obtained any sample in the 
     course of inspection, prior to leaving the premises that 
     officer shall give to the person in charge of the premises a 
     receipt describing the samples obtained. As to each sample 
     obtained, the officer shall furnish promptly to the person in 
     charge of the premises a copy of the sample and of any 
     analysis made upon the sample.

     SEC. 507. EFFECT OF COMPLIANCE.

       Compliance with the provisions of this Act and the 
     regulations promulgated under it shall constitute a complete 
     defense to any civil action, including but not limited to any 
     products liability action, that seeks to recover damages, 
     whether compensatory or punitive, based upon an alleged 
     defect in the labeling or advertising of any tobacco product 
     distributed for sale domestically.

     SEC. 508. IMPORTS.

       (a) Imports; List of Registered Foreign Establishments; 
     Samples From Unregistered Foreign Establishments; Examination 
     and Refusal of Admission.--The Secretary of Homeland Security 
     shall deliver to the Administrator, upon request by the 
     Administrator, samples of tobacco products that are being 
     imported or offered for import into the United States, giving 
     notice thereof to the owner or consignee, who may appear 
     before the Administrator and have the right to introduce 
     testimony. The Administrator shall furnish to the Secretary 
     of Homeland Security a list of establishments registered 
     pursuant to subsection (d) of section 109 of this Act, and 
     shall request that, if any tobacco products manufactured, 
     prepared, or processed in an establishment not so registered 
     are imported or offered for import into the United States, 
     samples of such tobacco products be delivered to the 
     Administrator, with notice of such delivery to the owner or 
     consignee, who may appear before the Administrator and have 
     the right to introduce testimony. If it appears from the 
     examination of such samples or otherwise that (1) such 
     tobacco product is forbidden or restricted in sale in the 
     country in which it was produced or from which it was 
     exported, or (2) such tobacco product is adulterated, 
     misbranded, or otherwise in violation of this Act, then such 
     tobacco product shall be refused admission, except as 
     provided in subsection (b) of this section. The Secretary of 
     Homeland Security shall cause the destruction of any such 
     tobacco product refused admission unless such tobacco product 
     is exported, under regulations prescribed by the Secretary of 
     Homeland Security, within ninety days of the date of notice 
     of such refusal or within such additional time as may be 
     permitted pursuant to such regulations.
       (b) Disposition of Refused Tobacco Products.--Pending 
     decision as to the admission of a tobacco product being 
     imported or offered for import, the Secretary of Homeland 
     Security may authorize delivery of such tobacco product to 
     the owner or consignee upon the execution by such consignee 
     of a good and sufficient bond providing for the payment of 
     such liquidated damages in the event of default as may be 
     required pursuant to regulations of the Secretary of Homeland 
     Security. If it appears to the Administrator that a tobacco 
     product included within the provisions of clause (3) of 
     subsection (a) of this section can, by relabeling or other 
     action, be brought into compliance with this Act or rendered 
     other than a tobacco product, final determination as to 
     admission of such tobacco product may be deferred and, upon 
     filing of timely written application by the owner or 
     consignee and the execution by such consignee of a bond as 
     provided in the preceding provisions of this subsection, the 
     Administrator may, in accordance with regulations, authorize 
     the applicant to perform such relabeling or other action 
     specified in such authorization (including destruction or 
     export of rejected tobacco products or portions thereof, as 
     may be specified in the Administrator's authorization). All 
     such relabeling or other action pursuant to such 
     authorization shall in accordance with regulations be under 
     the supervision of an officer or employee of the Agency 
     designated by the Administrator, or an officer or employee of 
     the Department of Homeland Security designated by the 
     Secretary of Homeland Security.
       (c) Charges Concerning Refused Tobacco Products.--All 
     expenses (including travel, per diem or subsistence, and 
     salaries of officers or employees of the United States) in 
     connection with the destruction provided for in subsection 
     (a) of this section and the supervision of the relabeling or 
     other action authorized under the provisions of subsection 
     (b) of this section, the amount of such expenses to be 
     determined in accordance with regulations, and all expenses 
     in connection with the storage, cartage, or labor with 
     respect to any tobacco product refused admission under 
     subsection (a) of this section, shall be paid by the owner or 
     consignee and, in default of such payment, shall constitute a 
     lien against any future importations made by such owner or 
     consignee.

     SEC. 509. TOBACCO PRODUCTS FOR EXPORT.

       (a) Exemption for Tobacco Products Exported.--Except as 
     provided in subsection (b), a tobacco product intended for 
     export shall be exempt from this Act if--
       (1) it is not in conflict with the laws of the country to 
     which it is intended fore export, as shown by either (A) a 
     document issued by the government of that country or (B) a 
     document provided by a person knowledgeable with respect to 
     the relevant laws of that country and qualified by training 
     and experience to opine on whether the tobacco product is or 
     is not in conflict with such laws;
       (2) it is labeled on the outside of the shipping package 
     that it is intended for export; and
       (3) the particular units of tobacco product intended for 
     export have not been sold or offered for sale in domestic 
     commerce.
       (b) Products for U.S. Armed Forces Overseas.--A tobacco 
     product intended for export shall not be exempt from this Act 
     if it is intended for sale or distribution to members or 
     units of the Armed Forces of the United States located 
     outside of the United States.
       (c) This Act shall not apply to a person that manufactures 
     and/or distributes tobacco products solely for export under 
     subsection (a), except to the extent such tobacco products 
     are subject to subsection (b).

                   TITLE VI--MISCELLANEOUS PROVISIONS

     SEC. 601. USE OF PAYMENTS UNDER THE MASTER SETTLEMENT 
                   AGREEMENT AND INDIVIDUAL STATE SETTLEMENT 
                   AGREEMENTS.

       (a) Reduction of Grant Amounts.--(1) For fiscal year 2010 
     and each subsequent fiscal year, the Secretary shall reduce, 
     as provided in subsection (b), the amount of any grant under 
     section 1921 of the Public Health Service Act (42 U.S.C. 
     Sec.  300x-21) for any State that spends on tobacco control 
     programs from the funds received by such State pursuant to 
     the Master Settlement Agreement, the Florida Settlement 
     Agreement, the Minnesota Settlement Agreement, the 
     Mississippi Memorandum of Understanding, or the Texas 
     Settlement Agreement, as applicable, less than 20 percent of 
     the amounts received by that State from settlement payments.
       (2) In the case of a State whose legislature does not 
     convene a regular session in fiscal year 2009 or 2010, and in 
     the case of a State whose legislature does not convene a 
     regular session in fiscal year 2010, the requirement 
     described in subsection (a)(1) as a condition of receipt of a 
     grant under section 1921 of the Public Health Service Act 
     shall apply only for fiscal year 2009 and subsequent fiscal 
     years.
       (b) Determination of State Spending.--Before making a grant 
     under section 1921 of the Public Health Service Act, section 
     300x-21 of title 42, United States Code, to a State for the 
     first applicable fiscal year or any subsequent fiscal year, 
     the Secretary shall make a determination of whether, during 
     the immediately preceding fiscal year, the State has spent on 
     tobacco control programs, from the funds received by such 
     State pursuant to the Master Settlement Agreement, the 
     Florida Settlement Agreement, the Minnesota Settlement 
     Agreement, the Mississippi Memorandum of Understanding, or 
     the Texas Settlement Agreement, as applicable, at least the 
     amount referenced in (a)(1). If, after notice to the State 
     and an opportunity for a hearing, the Secretary determines 
     that the State has spent less than such amount, the Secretary 
     shall reduce the amount of the allotment under section 300x-
     21 of title 42, United States Code, for the State for the 
     fiscal year involved by an amount equal to--
       (1) in the case of the first applicable fiscal year, 10 
     percent of the amount determined under section 300x-33 of 
     title 42, United States Code, for the State for the fiscal 
     year;
       (2) in the case of the first fiscal year following such 
     applicable fiscal year, 20 percent

[[Page H4365]]

     of the amount determined under section 300x-33 of title 42, 
     United States Code, for the State for the fiscal year;
       (3) in the case of the second such fiscal year, 30 percent 
     of the amount determined under section 300x-33 of title 42, 
     United States Code, for the State for the fiscal year; and
       (4) in the case of the third such fiscal year or any 
     subsequent fiscal year, 40 percent of the amount determined 
     under section 300x-33 of title 42, United States Code, for 
     the State for the fiscal year.
     The Secretary shall not have authority or discretion to grant 
     to any State a waiver of the terms and requirements of this 
     subsection or subsection (a).
       (c) Definitions.--For the purposes of this section--
       (1) The term ``first applicable fiscal year'' means--
       (A) fiscal year 2011, in the case of any State described in 
     subsection (a)(2) of this section; and
       (B) fiscal year 2010, in the case of any other State.
       (2) The term ``Florida Settlement Agreement'' means the 
     Settlement Agreement, together with the exhibits thereto, 
     entered into on August 25, 1997, between the State of Florida 
     and signatory tobacco product manufacturers, as specified 
     therein.
       (3) The term ``Master Settlement Agreement'' means the 
     Master Settlement Agreement, together with the exhibits 
     thereto, entered into on November 23, 1998, between the 
     signatory States and signatory tobacco product manufacturers, 
     as specified therein.
       (4) The term ``Minnesota Settlement Agreement'' means the 
     Settlement Agreement, together with the exhibits thereto, 
     entered into on May 8, 1998, between the State of Minnesota 
     and signatory tobacco product manufacturers, as specified 
     therein.
       (5) The term ``Mississippi Memorandum of Understanding'' 
     means the Memorandum of Understanding, together with the 
     exhibits thereto and Settlement Agreement contemplated 
     therein, entered into on July 2, 1997, between the State of 
     Mississippi and signatory tobacco product manufacturers, as 
     specified therein.
       (6) The term ``Secretary'' means the Secretary of Health 
     and Human Services.
       (7) The term ``Texas Settlement Agreement'' means the 
     Settlement Agreement, together with the exhibits thereto, 
     entered into on January 16, 1998, between the State of Texas 
     and signatory tobacco product manufacturers, as specified 
     therein.

     SEC. 602. PREEMPTION OF STATE LAWS IMPLEMENTING FIRE SAFETY 
                   STANDARD FOR CIGARETTES.

       (a) In General.--With respect to fire safety standards for 
     cigarettes, no State or political subdivision shall--
       (1) require testing of cigarettes that would be in addition 
     to, or different from, the testing prescribed in subsection 
     (b); or
       (2) require a performance standard that is in addition to, 
     or different from, the performance standard set forth in 
     subsection (b).
       (b) Test Method and Performance Standard.--
       (1) To the extent a State or political subdivision enacts 
     or has enacted legislation or a regulation setting a fire 
     safety standard for cigarettes, the test method employed 
     shall be--
       (A) the American Society of Testing and Materials 
     (``ASTM'') standard E2187-4, entitled ``Standard Test Method 
     for Measuring the Ignition Strength of Cigarettes'';
       (B) for each cigarette on 10 layers of filter paper;
       (C) so that a replicate test of 40 cigarettes for each 
     brand style of cigarettes comprises a complete test trial for 
     that brand style; and
       (D) in a laboratory that has been accredited in accordance 
     with ISO/IEC 17205 of the International Organization for 
     Standardization (``ISO'') and that has an implemented quality 
     control and quality assurance program that includes a 
     procedure capable of determining the repeatability of the 
     testing results to a repeatability value that is no greater 
     than 0.19.
       (2) To the extent a State or political subdivision enacts 
     or has enacted legislation or a regulation setting a fire 
     safety standard for cigarettes, the performance standard 
     employed shall be that no more than 25 percent of the 
     cigarettes of that brand style tested in a complete test in 
     accordance with paragraph (1) exhibit full-length burns.
       (c) Exception to Subsection (b).--In the event that a 
     manufacturer of a cigarette that a State or political 
     subdivision or its respective delegated agency determines 
     cannot be tested in accordance with the test method 
     prescribed in subsection (b)(1)(A), the manufacturer shall 
     propose a test method and performance standard for the 
     cigarette to the State or political subdivision. Upon 
     approval of the proposed test method and a determination by 
     the State or political division that the performance standard 
     proposed by the manufacturer is equivalent to the performance 
     standard prescribed in subsection (b)(2), the manufacturer 
     may employ such test method and performance standard to 
     certify such cigarette pursuant to this subsection 
     notwithstanding subsection (b).

     SEC. 603. INSPECTION BY THE ALCOHOL AND TOBACCO TAX TRADE 
                   BUREAU OF RECORDS OF CERTAIN CIGARETTE AND 
                   SMOKELESS TOBACCO SELLERS.

       (a) In General.--Any officer of the Bureau of the Alcohol 
     and Tobacco Tax Trade Bureau may, during normal business 
     hours, enter the premises of any person described in 
     subsection (b) for the purposes of inspecting--
       (1) any records or information required to be maintained by 
     such person under the provisions of law referred to in 
     subsection (d); or
       (2) any cigarettes or smokeless tobacco kept or stored by 
     such person at such premises.
       (b) Covered Persons.--Subsection (a) applies to any person 
     who engages in a delivery sale, and who ships, sells, 
     distributes, or receives any quantity in excess of 10,000 
     cigarettes, or any quantity in excess of 500 single-unit 
     consumer-sized cans or packages of smokeless tobacco, within 
     a single month.
       (c) Relief.--
       (1) In general.--The district courts of the United States 
     shall have the authority in a civil action under this 
     subsection to compel inspections authorized by subsection 
     (a).
       (2) Violations.--Whoever violates subsection (a) or an 
     order issued pursuant to paragraph (1) shall be subject to a 
     civil penalty in an amount not to exceed $10,000 for each 
     violation.
       (d) Covered Provisions of Law.--The provisions of law 
     referred to in this subsection are--
       (1) the Act of October 19, 1949 (15 U.S.C. 375; commonly 
     referred to as the ``Jenkins Act'');
       (2) chapter 114 of title 18, United States Code; and
       (3) this Act.
       (e) Delivery Sale Defined.--In this section, the term 
     ``delivery sale'' has the meaning given that term in 2343(e) 
     of title 18, United States Code, as amended by this Act.

     SEC. 604. 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 VII--TOBACCO GROWER PROTECTION

     SEC. 701. TOBACCO GROWER PROTECTION.

       No provision in this Act shall allow the Administrator or 
     any other person to require changes to traditional farming 
     practices, including standard cultivation practices, curing 
     processes, seed composition, tobacco type, fertilization, 
     soil, record keeping, or any other requirement affecting 
     farming practices.
       Amend the title so as to read: ``A bill to protect the 
     public health by establishing the Tobacco Harm Reduction 
     Center within the Department of Health and Human Services 
     with certain authority to regulate tobacco products, and for 
     other purposes.''.

  The SPEAKER pro tempore. Pursuant to House Resolution 307, the 
gentleman from Indiana (Mr. Buyer) and a Member opposed each will 
control 15 minutes.
  The Chair recognizes the gentleman from Indiana.
  Mr. BUYER. Thank you.
  Mr. Speaker, I have a parliamentary inquiry: Because this is my 
substitute, do I speak last on the substitute?
  The SPEAKER pro tempore. A manager in opposition will have the right 
to close.
  Mr. BUYER. Thank you.
  With that, I will yield to the cosponsor of this bipartisan 
substitute, Mr. McIntyre of North Carolina.
  Mr. McINTYRE. Mr. Speaker, I rise this evening in support of the 
Youth Prevention and Harm Reduction Act, which is embodied in the 
substitute that Mr. Buyer is describing and offering and on which he 
and I have worked together, which is a bipartisan bill.
  I have worked with Mr. Buyer to craft a practical approach to 
government regulation of tobacco that protects health while preserving 
a vital economic engine for many communities, not only throughout my 
district in southeastern North Carolina and across the great Tar Heel 
State, but also across the country.
  The underlying bill will grant the Food and Drug Administration wide 
authority to dictate to manufacturers and growers dramatic changes in 
product design and leaf cultivation, a concern that has been raised 
repeatedly by the tobacco growers in my district and tobacco growers 
throughout the States that are affected. The last thing we want, of 
course, is to have any government bureaucrat coming on the farm or 
dictating to farmers about how they grow their crops. This is the part 
that we want to be abundantly clear about.

                              {time}  2015

  The tobacco industry contributes over $36 billion to the U.S. economy 
each year employing over 19,000 individuals nationwide. In my home 
State of North Carolina, over 8,600 people are employed by the industry 
with a Statewide economic impact of nearly $24 billion. The 
manufacturing provisions and

[[Page H4366]]

the concern about the FDA and its involvement on the farm in the 
underlying bill would put many companies and growers out of business. 
And in this time of economic uncertainty, the last thing that any of us 
can afford is to lose more jobs. Our substitute specifically protects 
growers by preventing any government agency from requiring changes to 
traditional farming practices, including standard cultivization 
practices, curing processes, seed composition, tobacco-type 
fertilization, soil, record keeping or any other requirement affecting 
farming practices.
  In addition, this bill is about public health and prevents minors 
from smoking. Our substitute considers cutting-edge scientific 
research, as Mr. Buyer has indicated a little while ago, which would 
promote a harm-reduction strategy to move smokers to less harmful 
tobacco products.
  So we're talking about here about protecting public health, 
definitely protecting minors, and making sure that our growers and 
farmers are not put out of business.
  According to applied economics, the use of these reduced tobacco 
products increases the average probability of smoking cessation by over 
10 percent. The Buyer-McIntyre substitute specifically addresses youth 
tobacco by encouraging States to penalize minors for purchasing and 
possessing tobacco products. Under current law, retailers are 
prohibited from selling tobacco products to minors, but unlike with the 
purchase of alcohol, minors are not penalized for underage purchase and 
possession of tobacco products.
  This also calls upon the States to increase their percentage of the 
Master Settlement Agreement dollars to fund tobacco cessation and 
public health programs. In the past 10 years, States have spent just 
3.2 percent of their total tobacco-generated revenue on tobacco 
prevention and cessation programs.
  We take this concern about our youth seriously. I had a son. Back 
when he was in high school he was part of the Tobacco Free Kids Program 
and we understand, appreciate, and respect that; and, in fact, our bill 
has even stronger provisions dealing with that.
  The Buyer-McIntyre substitute is a commonsense way to help protect 
public health and protect our vital tobacco economy and the jobs that 
we cannot afford to lose, especially in this time of economic crisis in 
our country.
  I urge my colleagues to vote ``yes'' on the Buyer-McIntyre 
substitute, a bipartisan support, which provides a reasonable and 
pragmatic way to deal with tobacco regulation and help protect our 
minors from the harms of tobacco.
  I reserve my time.
  Mr. WAXMAN. Mr. Speaker, at this time, I rise to claim the time in 
opposition to the amendment.
  The SPEAKER pro tempore. The gentleman from California is recognized.
  Mr. WAXMAN. Mr. Speaker, I am pleased at this time to yield 3 minutes 
to a very important member of the Energy and Commerce Committee and its 
Subcommittee on Health, the gentlelady from California (Mrs. Capps).
  Mrs. CAPPS. Mr. Speaker, I thank my colleague and chairman of our 
committee and a real pioneer and hero in this area.
  I rise to give strong opposition to the Buyer amendment.
  The Buyer amendment would undermine the precise goals of this 
underlying bill, that is to prevent kids from smoking. There is nothing 
in the Buyer amendment that would restrict tobacco marketing to youth, 
yet we know that marketing to our kids is a persistent tobacco company 
tactic. They do it to draw in new smokers at a very early age to 
replace their dwindling client base because of people finally being 
able to quit or, unfortunately, dying as a complication of smoking.
  As a grandmother, I am horrified that my teenage granddaughters are 
the target of disgusting adds like this very one. Dressed to the Nines, 
this title was featured repeatedly in many magazines read frequently by 
young women and girls. The add highlights the latest fashion trends. It 
tells kids how to ``update your closet,'' and it directs them, of all 
things, to the Camel cigarettes Web site.
  Under the Waxman-Platts bill, however, we specifically eliminate this 
kind of marketing to kids that depict smoking as cool or glamorous. And 
that's because it is not. Smoking is not cool. It isn't glamorous. It's 
an expensive ticket to an early death, and the tobacco companies and 
the magazines that run these adds, they know it, and they should be 
ashamed of themselves. But these days, corporate shame is in short 
supply, and we cannot rely on it to protect our kids.
  In addition, this bill gives the FDA the authority to respond to the 
inevitable attempts by tobacco companies to circumvent new 
restrictions.
  So I urge my colleagues to reject this Buyer substitute amendment 
because it lacks critical provisions that are so important to prevent 
children, our youth, from smoking.
  I urge everyone to support the Waxman-Platts bill.
  Mr. BUYER. I would say to the gentlelady who just spoke in the well 
that Mr. Waxman's bill was drafted years ago, and it was drafted prior 
to the Master Settlement Agreement. And it is the Master Settlement 
Agreement itself that has great restrictions upon advertisers. So there 
is a reason that I don't have it--I say to the gentlelady, there is a 
reason I don't have that part in the bill because the Master Settlement 
Agreement that is now administered by the attorneys general in 46 
States, including the District of Columbia, who work in concert not 
only with the FDA but also with the Federal Trade Commission. These 
tobacco companies are not even advertising today in these types of 
magazines.
  But one of the reasons I didn't go further in advertising is that 
when we work in concert with the Harm Reduction Center under Health and 
Human Services, what we seek to do is to inform the public with regard 
to the relative risks among different types of tobacco product, and 
that's what we seek to do. We seek to migrate people from the smoking 
to other types of products.
  If I could, I would like to show exactly what I am about to share.
  What I would like to share here with you is a chart, and what is 
important about this chart is about the continuum of risk and about all 
of the different types of products that are available in the 
marketplace today.
  So when you think about this and you think about the continuum of 
risk, what I did is I sought to say, All right. Let's think about the 
products that are presently available out there.
  So when you think about that, we have non-filtered cigarettes. That's 
the worse. I mean, you get those toxins. You get them right into your 
body and substance, and that's really bad. Non-filtered cigarettes.
  Then you've got filtered cigarettes. We know that's a little bit 
better--all of these tobacco products are harmful. So we go from non-
filtered cigarettes to a filtered cigarette.
  Then I have a vented filtered cigarette, but those are really bad, 
too, because people try to gain access to that nicotine so they suck a 
little harder on that cigarette and they draw it deeper into their 
lungs. That's not a good thing.
  Then we have tobacco-heated cigarettes like the Accord. Now, we know 
that that reduces a lot of the toxic substances, but we're really not 
sure where on the continuum of risk does it lie along with the 
electronic cigarette because there isn't sufficient science yet to back 
that up.
  And these are products that--innovation that is coming out in the 
marketplace because people every day are making conscious decisions 
about what we eat, what we drink on a risk assessment, and that's what 
we are trying to do here in the statute.
  So after electronic cigarettes, we have smokeless tobacco products. 
Now, when I think about this, we can go from a non-filtered cigarette 
and go all the way down 90 percent down the health risk chart, 90 
percent, to get to a U.S. smokeless product.
  Let's talk about the difference between a U.S. smokeless product and 
a Swedish Snus. The U.S. smokeless tobacco product is fermented. So 
through that fermentation and the natural processing of tobacco and the 
nitrosamines, you still have some serious carcinogens and some toxic 
substances. But it is still scientifically shown to be a much better 
and safer tobacco product than that of smoking.
  You see, it is not the nicotine that is killing people. It's the 
smoke. It's the

[[Page H4367]]

smoke. It's the smoke. That's killing people.
  So to get away from that--I heard somebody coughing. It was the 
smoke, I am telling you.
  If we can pull them away from the smoke and move them down the 
continuum of risk chart--actually if we could get them into a Swedish 
snus, get them into a pasteurized product, we take away 98 percent of 
the health risk. And then if we can get them to--actually they are now 
called dissolvable tobacco products. These are orbs or strips that you 
can lay on your tongue or a stick that's a little like an oversized 
toothpick that you can stick in your mouth. These are tobacco products 
that contain no nitrosamines, and you can eliminate 99 percent of the 
health risk, but an individual can still gain their access to nicotine 
if they like.
  And what we're trying to do, though, is move then down the continuum 
of risk, make informed decisions in order for them to be healthier but 
still gain access to their nicotine.
  Then you have therapeutic nicotine devices, which are your gum, your 
patches, your lozenges.
  And then we have pharmaceuticals. We want people to quit smoking. But 
in order to do this, what we've done--not only Mr. McIntyre but Mr. 
Shuler and others here in a bipartisan effort--is to create a harm-
reduction strategy. And we embrace--so not only the goals of Mr. Waxman 
on abstinence, but we also embrace the goals of education, prevention 
and cessation activities as we try to move people and make informed 
choices along this continuum of risk.
  Now, what is so, to me, unconscionable is that if, in fact, Mr. 
Waxman's bills were to pass, is that these new innovative types of 
nicotine delivery devices could not make their access to the market. 
Now as I said--I will say it for the umpteenth time--I respect Mr. 
Waxman and his desire to try to get people to eliminate smoking. We 
just recognized that today only 7 percent success rate with regard to 
these type of nicotine replacement therapies, and that's a failure 
rate, and we shouldn't do that.
  I reserve the balance of my time.
  Mr. WAXMAN. Mr. Speaker, may I inquire how much time each side has 
remaining?
  The SPEAKER pro tempore. The gentleman from California has 13 minutes 
remaining. The gentleman from Indiana has 7\1/2\ minutes remaining.
  Mr. WAXMAN. Well, I plan to close the debate, and I know that Mr. 
Buyer has another speaker on his side, so I want to reserve the balance 
of my time.
  Mr. BUYER. Mr. Speaker, I would yield to one of the cosponsors of 
this substitute, Mr. Shuler of North Carolina, for as much time as he 
might consume.
  Mr. SHULER. Mr. Chairman, I want to commend you for your hard work, 
and although we may disagree on legislation, I want to commend you for 
your hard work in the prevention of smoking and trying to get children 
off smoking as well.
  So, Mr. Speaker, I strongly support the commonsense amendment 
proposed by the gentleman from Indiana. And I strongly oppose the 
underlying bill.
  Putting a dangerous, overworked FDA in charge of tobacco is a threat 
to public safety. Last year, the FDA commissioner testified that he had 
serious concerns that this bill could undermine the public health role 
of the FDA. And the FDA Science Board said the FDA's inability to keep 
up with scientific advancements means that Americans' lives will be at 
risk.
  What are these risks? Well, let me talk about three areas that just 
happened last year.
  Last summer, 1,400 people were sickened by peppers from Mexico, but 
we shut down the entire tomato industry. Just last month, more than 100 
people become sick because of salmonella and alfalfa sprouts. And in 
January, more than 500 people became sick because of salmonella from 
Peanut Corporation of America. Amazingly enough, this plant had never 
been inspected even after Canada rejected a shipment of peanuts. That's 
right. The FDA is overworked. We have to rely on the Canadians to 
inspect our food now.
  Instead of putting our food and drug supply at greater risk, let's 
deal with the underage smoking head on. This amendment does that by 
putting more resources into prevention and harm-reduction programs that 
have helped reduce youth smoking by over 50 percent for the last 10 
years.
  Let's pass this amendment so that we can keep our kids safe from 
cigarettes and keep our children safe with the food that they eat.

                              {time}  2030

  I ask my colleagues to support the passage of the Buyer amendment.
  Mr. WAXMAN. Mr. Speaker, I am going to reserve my time to close the 
debate, so I will allow the gentleman from Indiana (Mr. Buyer) to 
continue.
  Mr. BUYER. Mr. Speaker, I yield 3 minutes to the gentlewoman from 
Tennessee (Mrs. Blackburn).
  Mrs. BLACKBURN. Mr. Speaker, I thank the gentleman from Indiana for 
the excellent work that he has done on a substitute, for addressing 
this issue the way it should be addressed.
  We are all concerned about cigarette smoke and the effects of tobacco 
on our health, and I don't think that is the debate that is here. But 
one of the things that concerns me in this debate is that there are 
some pieces that have kind of been left out, that are not being 
addressed.
  Well, we all are concerned about what has happened with teen smoking, 
with the effects of tobacco on an individual's health. One of the 
things that has happened is the Synar amendment and the good work that 
the Synar language has done in reducing teen smoking has been left out, 
and what we are having brought forward is this bill that will actually 
give the FDA stamp of approval to some tobacco processes and uses. And 
for someone as a wife, a mother, a grandmother, a community volunteer 
that has actually worked to address school health curriculums, to 
address smoking, to fight and work with smoking cessation programs, I 
know that that is a dangerous step to give the FDA stamp of approval to 
tobacco usage.
  In addition to that, this is legislation that is going to build a 
bureaucracy. It is going to pull the government into our farms, into 
our manufacturers, into our retailers further and further.
  But, Mr. Speaker, I think that actually that's a lot of what is going 
on in this entire Congress, growing the bureaucracy. We're hearing it's 
going to take 250,000 new Federal employees to implement the stimulus 
and this massive budget that is before us; new Federal employees, 
250,000 new Federal employees. It is building bureaucracies, taking 
power away from individuals, taking power away from the House and 
handing it over to a bureaucracy that continues to grow every single 
day.
  And the steps that are being taken with moving tobacco to the FDA is 
another part of that. We know the FDA can't do the job in front of them 
now when it comes to dealing with policing drugs, looking at 
contaminated food, addressing the issues that we have had with 
everything from peanut butter to pistachios. They are not getting the 
job done, and now we want to pull them on to our farms and into our 
manufacturing facilities addressing tobacco, and we have processes that 
already work. But it's not about funding and keeping attention on 
processes that work.
  What we know is this is all about growing a bureaucracy. I encourage 
my colleagues to vote against this bill.
  Mr. BUYER. I yield myself such time as I may consume.
  According to the Journal of Health Care Law and Policy, dated 2008, 
``There is a very strong basis in science for believing that the harm 
caused by current cigarettes can be massively reduced by alternative 
nicotine delivery systems. Anti-tobacco campaigners who refuse to 
discuss harm reduction will merely be ensuring that they are not part 
of the ongoing dialogue that will shape this key area of policy.''
  I also would like to cite Britton and Edwards in The Lancet, 2007. 
``The risk of adverse effects associated with Snus use is lower than 
that associated with smoking, overall by an estimated 90 percent. 
Whatever the true overall hazard, use of low nitrosamine smokeless 
products is clearly substantially less harmful than tobacco smoking.''
  Also citing the Scientific Committee on Emerging and Newly Identified

[[Page H4368]]

Health Risks, dated 2007, ``The magnitude of the overall reduction in 
hazard,'' meaning switching from cigarettes to smokeless, ``is 
difficult to estimate.'' But as outlined in their paper, for 
cardiovascular disease, it is at least a 50 percent reduction; for 
pancreatic cancer, it is at least 30 percent; for oral and other GI 
cancer, it is at least 50 percent reduction and probably more; and for 
lung cancer and chronic obstructive pulmonary disease, it's possibly 
even 100 percent.
  Now, what I'm hopeful is that at some point, I'm going to make this 
quest that Mr. Waxman and I can somehow come together, because 
according to CBO the reduction in the rates of smoking in the Waxman 
bill is two-tenths of 1 percent per year. So we're going to take over 
$6 billion to reduce smoking rates under Mr. Waxman's approach by two-
tenths of 1 percent per year. Which means over a 10-year time frame, 
the total that we're going to reduce for smoking in the entire country 
is 2 percent. We are going to reduce smoking rates in the country under 
Mr. Waxman by 2 percent.
  We can do much better than that, and that's why we have this 
substitute is that we want to move people from smoking down the 
continuum of risk to eventually quitting, and I think that's exactly 
what the chairman embraces.
  Please support the substitute.
  The SPEAKER pro tempore. The gentleman's time has expired.
  Mr. WAXMAN. Mr. Speaker, I strongly oppose this substitute amendment 
offered by Mr. Buyer.
  The bill before us, the Waxman-Platts bill, has been carefully 
crafted over more than a decade, in close consultation with the public 
health community. It's been endorsed by over 1,000 different public 
health, scientific, medical, faith, and community organizations. It is 
also supported by a prestigious and bipartisan group of former public 
health officials, including former Secretaries of Health and Human 
Services, Tommy Thompson and Donna Shalala; former Surgeons General, 
David Satcher and Richard Carmona; former CDC Director, Julie 
Gerberding; and former FDA Commissioner, David Kessler. It reflects a 
strong, reasonable, and comprehensive approach to addressing the 
tobacco epidemic.
  Now, this Buyer substitute is deeply flawed. It represents an 
inadequate response for the greatest preventable cause of death and 
disease in the United States.
  One of the biggest problems in this substitute is that it places 
oversight of tobacco under a totally new, untested agency. They create 
a new government agency that lacks any experience in protecting the 
public health. FDA is our Nation's primary protector of the public 
health, and it has both the regulatory and scientific expertise to 
handle the complex task of regulating tobacco. The agency devoted 10 
years to investigating tobacco in the 1990s. It has over 100 years of 
experience in setting science-based standards to protect and promote 
the public health.
  Mr. Buyer's substitute would ignore all of this expertise, would 
ignore the whole record of all of the public health organizations, and 
set up a new agency. And the premise of his new agency would be tobacco 
harm reduction, and he showed us a chart. That chart in effect said 
that what we should do is try to encourage people to reduce the harm 
from tobacco by using other tobacco products.
  There's no evidence to support his approach. He is basing his 
assumption that current smokers will use smokeless tobacco to quit, but 
there's no evidence to support this assumption. In fact, the U.S. 
Public Health Service's clinical practice guidelines finds no evidence 
to suggest that smokeless tobacco is effective in helping smokers quit. 
Rather than have smokers quit, it's just as likely that smokeless 
tobacco can be used to introduce youth to tobacco use and to discourage 
smokers from quitting. I would submit that what his proposal would do 
would be to do everything but get smokers to quit, and it does not 
focus on getting people not to start smoking in the first place. The 
only evidence one can cite for using smokeless tobacco to quit is 
inadequate. It's not based on science, and I'm sure it will be a 
tremendous boon to the smokeless tobacco industry.
  A second major problem with the substitute is that it fails to 
provide any dedicated funding for tobacco regulation. Instead, it 
relies on a future appropriation that may or may not ever come along, 
and then this new agency is supposed to do something to reduce smoking 
in this country.
  It fails to create effective Federal enforcement to prevent tobacco 
sales to minors. The Buyer amendment would not punish individual retail 
clerks. Instead, it would fine kids for possession rather than making 
sure that they don't have access to cigarettes in the first place. The 
Waxman-Platts bill would instead create a strong Federal enforcement 
system to ensure that retailers do not sell to minors, while providing 
adequate procedural protections for retailers.
  Another flaw, it allows tobacco companies to keep targeting the kids. 
One of the most critical goals of our bill is to stop tobacco industry 
targeting of our children. This bill that's being offered as a 
substitute does nothing to address the problem. It leaves companies 
free to continue pushing their products on kids and teenagers, and I 
would submit that that is not a good substitute for the bill that is 
before us.
  I'm also extremely concerned that it effectively exempts smokeless 
tobacco products such as chewing tobacco from any oversight. It assumes 
that those products are safe. Well, there's no evidence for that. It 
ignores the range of harm-reduction options that pose far less risk 
such as nicotine replacement therapies, which, by the way, are already 
being approved as safe by the FDA, and instead, he wants to substitute 
smokeless tobacco for smoking cigarettes.
  The substitute fails to protect consumers from false and misleading 
claims about reduced harm. It would allow tobacco companies to market 
products as safer or posing less risk without providing scientific 
evidence that those claims are actually true. This means that consumers 
would still be vulnerable to false and misleading claims, and we know 
those claims: cigarettes are light, cigarettes are low tar. Those are 
the claims we've heard over the years, and they're wrong, they're 
dangerous, they're misleading, and nothing would be done to stop those 
kinds of claims under this substitute. Our bill would allow products to 
be marketed as less hazardous only when those claims are based on sound 
science and only when the health of the entire population is 
considered.
  And finally, the substitute gives the tobacco industry a vote in 
advising the agency on scientific decisions. This flies in the face of 
everything we know about the industry. Big Tobacco has shown repeatedly 
that it will distort and discard scientific evidence in service of its 
business objectives without regard to the public health. We don't give 
drug or device manufacturers a vote in advising the FDA, and we 
shouldn't do that here. Giving the tobacco industry voting 
representation on a scientific advisory committee has no precedent.
  I would submit you can choose between a substitute that's just been 
offered only in the last month or so or you can vote for a bill that 
has been reviewed by and approved by the Heart Association, the Lung 
Association, the Cancer Society, the Campaign for Tobacco-Free Kids, 
the American Public Health Association, the American Academy of 
Pediatrics, the New England Journal of Medicine, and the AARP, just to 
mention a few of the thousand groups that oppose the Buyer amendment 
and support the underlying bill.
  This tobacco harm-reduction act proposal is no substitute. In fact, 
it seems to me that the only harm it reduces is harm to the tobacco 
industry.
  I urge a ``no'' vote on the Buyer substitute.
  I yield back the balance of my time.
  The SPEAKER pro tempore. All time for debate has expired.
  Pursuant to clause 1(c) of rule XIX, further proceedings on this 
measure are postponed.

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