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[From the U.S. Government Publishing Office]


114th Congress     }                                  {      Report
                        HOUSE OF REPRESENTATIVES
 2d Session        }                                  {       114-413
======================================================================



 
             COMMON SENSE NUTRITION DISCLOSURE ACT OF 2015

                                _______
                                

February 2, 2016.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

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

                              R E P O R T

                             together with

                            DISSENTING VIEWS

                        [To accompany H.R. 2017]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 2017) to amend the Federal Food, Drug, and 
Cosmetic Act to improve and clarify certain disclosure 
requirements for restaurants and similar retail food 
establishments, and to amend the authority to bring proceedings 
under section 403A, having considered the same, report 
favorably thereon with an amendment and recommend that the bill 
as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     3
Background and Need for Legislation..............................     4
Hearings.........................................................     4
Committee Consideration..........................................     5
Committee Votes..................................................     5
Committee Oversight Findings.....................................     7
Statement of General Performance Goals and Objectives............     7
New Budget Authority, Entitlement Authority, and Tax Expenditures     7
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     7
Committee Cost Estimate..........................................     7
Congressional Budget Office Estimate.............................     7
Federal Mandates Statement.......................................     9
Duplication of Federal Programs..................................     9
Disclosure of Directed Rule Makings..............................     9
Advisory Committee Statement.....................................     9
Applicability to Legislative Branch..............................     9
Section-by-Section Analysis of the Legislation...................    10
Changes in Existing Law Made by the Bill, as Reported............    10
Minority, Additional, or Dissenting Views........................    34

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

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Common Sense Nutrition Disclosure Act 
of 2015''.

SEC. 2. AMENDING CERTAIN DISCLOSURE REQUIREMENTS FOR RESTAURANTS AND 
                    SIMILAR RETAIL FOOD ESTABLISHMENTS.

  (a) In General.--Section 403(q)(5)(H) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343(q)(5)(H)) is amended--
          (1) in subclause (ii)--
                  (A) in item (I)(aa), by striking ``the number of 
                calories contained in the standard menu item, as 
                usually prepared and offered for sale'' and inserting 
                ``the number of calories contained in the whole 
                standard menu item, or the number of servings (as 
                reasonably determined by the restaurant or similar 
                retail food establishment) and number of calories per 
                serving, or the number of calories per the common unit 
                division of the standard menu item, such as for a 
                multiserving item that is typically divided before 
                presentation to the consumer'';
                  (B) in item (II)(aa), by striking ``the number of 
                calories contained in the standard menu item, as 
                usually prepared and offered for sale'' and inserting 
                ``the number of calories contained in the whole 
                standard menu item, or the number of servings (as 
                reasonably determined by the restaurant or similar 
                retail food establishment) and number of calories per 
                serving, or the number of calories per the common unit 
                division of the standard menu item, such as for a 
                multiserving item that is typically divided before 
                presentation to the consumer''; and
                  (C) by adding at the end the following flush text:
        ``In the case of restaurants or similar retail food 
        establishments where the majority of orders are placed by 
        customers who are off-premises at the time such order is 
        placed, the information required to be disclosed under items 
        (I) through (IV) may be provided by a remote-access menu (such 
        as a menu available on the Internet) as the sole method of 
        disclosure instead of on-premises writings.'';
          (2) in subclause (iii)--
                  (A) by inserting ``either'' after ``a restaurant or 
                similar retail food establishment shall''; and
                  (B) by inserting ``or comply with subclause (ii)'' 
                after ``per serving'';
          (3) in subclause (iv)--
                  (A) by striking ``For the purposes of this clause'' 
                and inserting the following:
                  ``(I) In general.--For the purposes of this clause'';
                  (B) by striking ``and other reasonable means''' and 
                inserting ``or other reasonable means'''; and
                  (C) by adding at the end the following:
                  ``(II) Reasonable basis defined.--For the purposes of 
                this subclause, with respect to a nutrient disclosure, 
                the term `reasonable basis'' means that the nutrient 
                disclosure is within acceptable allowances for 
                variation in nutrient content. Such acceptable 
                allowances shall include allowances for variation in 
                serving size, inadvertent human error in formulation or 
                preparation of menu items, and variations in 
                ingredients.'';
          (4) by amending subclause (v) to read as follows:
          ``(v) Menu variability and combination meals.--The Secretary 
        shall establish by regulation standards for determining and 
        disclosing the nutrient content for standard menu items that 
        come in different flavors, varieties, or combinations, but 
        which are listed as a single menu item, such as soft drinks, 
        ice cream, pizza, doughnuts, or children's combination meals. 
        Such standards shall allow a restaurant or similar retail food 
        establishment to choose whether to determine and disclose such 
        content for the whole standard menu item, for a serving or 
        common unit division thereof, or for a serving or common unit 
        division thereof accompanied by the number of servings or 
        common unit divisions in the whole standard menu item. Such 
        standards shall allow a restaurant or similar retail food 
        establishment to determine and disclose such content by using 
        any of the following methods: ranges, averages, individual 
        labeling of flavors or components, or labeling of one preset 
        standard build. In addition to such methods, the Secretary may 
        allow the use of other methods, to be determined by the 
        Secretary, for which there is a reasonable basis (as such term 
        is defined in subclause (iv)(II)).'';
          (5) in subclause (x)--
                  (A) by striking ``Not later than 1 year after the 
                date of enactment of this clause, the Secretary shall 
                promulgate proposed regulations to carry out this 
                clause.'' and inserting ``Not later than 1 year after 
                the date of enactment of the Common Sense Nutrition 
                Disclosure Act of 2015, the Secretary shall issue 
                proposed regulations to carry out this clause, as 
                amended by such Act. Any final regulations that are 
                promulgated pursuant to the Common Sense Nutrition 
                Disclosure Act of 2015, and any final regulations that 
                were promulgated pursuant to this clause before the 
                date of enactment of the Common Sense Nutrition 
                Disclosure Act of 2015, shall not take effect earlier 
                than 2 years after the promulgation of final 
                regulations pursuant to the Common Sense Nutrition 
                Disclosure Act of 2015.''; and
                  (B) by adding at the end the following:
                  ``(IV) Certifications.--Restaurants and similar 
                retail food establishments shall not be required to 
                provide certifications or similar signed statements 
                relating to compliance with the requirements of this 
                clause.'';
          (6) by amending subclause (xi) to read as follows:
          ``(xi) Definitions.--In this clause:
                  ``(I) Menu; menu board.--The term `menu' or `menu 
                board' means the one listing of items which the 
                restaurant or similar retail food establishment 
                reasonably believes to be, and designates as, the 
                primary listing from which customers make a selection 
                in placing an order. The ability to order from an 
                advertisement, coupon, flyer, window display, 
                packaging, social media, or other similar writing does 
                not make the writing a menu or menu board.
                  ``(II) Preset standard build.--The term `preset 
                standard build' means the finished version of a menu 
                item most commonly ordered by consumers.
                  ``(III) Standard menu item.--The term `standard menu 
                item' means a food item of the type described in 
                subclause (i) or (ii) of subparagraph (5)(A) with the 
                same recipe prepared in substantially the same way with 
                substantially the same food components that--
                          ``(aa) is routinely included on a menu or 
                        menu board or routinely offered as a self-
                        service food or food on display at 20 or more 
                        locations doing business under the same name; 
                        and
                          ``(bb) is not a food referenced in subclause 
                        (vii).''; and
          (7) by adding at the end the following:
          ``(xii) Opportunity to correct violations.--Any restaurant or 
        similar retail food establishment that the Secretary determines 
        is in violation of this clause shall have 90 days after 
        receiving notification of the violation to correct the 
        violation. The Secretary shall take no enforcement action, 
        including the issuance of any public letter, for violations 
        that are corrected within such 90-day period.''.
  (b) National Uniformity.--Section 403A(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 343 1(b)) is amended by striking ``may 
exempt from subsection (a)'' and inserting ``may exempt from subsection 
(a) (other than subsection (a)(4))''.

SEC. 3. LIMITATION ON LIABILITY FOR DAMAGES ARISING FROM NONCOMPLIANCE 
                    WITH NUTRITION LABELING REQUIREMENTS.

  Section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 343(q)(5)(H)), as amended by section 2, is further amended by 
adding at the end the following:
          ``(xiii) Limitation on liability.--A restaurant or similar 
        retail food establishment shall not be liable in any civil 
        action in Federal or State court (other than an action brought 
        by the United States or a State) for any claims arising out of 
        an alleged violation of--
                  ``(I) this clause; or
                  ``(II) any State law permitted under section 
                403A(a)(4).''.

                          Purpose and Summary

    H.R. 2017, the Common Sense Nutrition Disclosure Act of 
2015, addresses the Food and Drug Administration's (FDA) final 
menu labeling regulations that are burdensome and inappropriate 
for food establishments such as convenience stores, 
supermarkets, grocery stores and pizza restaurants. H.R. 2017 
would provide a flexible approach to calorie disclosures by 
allowing for food establishments to provide consumers with 
caloric information in the most helpful way, such as online or 
on a digital table rather than a traditional menu board. 
Additionally, H.R. 2017 eliminates the criminal penalties and 
allows restaurants and retailers to take corrective action, and 
preempts civil litigation for violations of the federal menu 
labeling law and any state laws that may exist. Employees would 
no longer be penalized for inadvertent human error while 
preparing foods.

                  Background and Need for Legislation

    H.R. 2017, authored by Rep. Cathy McMorris-Rodgers (R-WA), 
would amend section 4205 of the Patient Protection and 
Affordable Care Act, which requires calorie and other nutrition 
information to be provided to consumers in restaurants and 
other similar retail food establishments that have twenty or 
more locations.
    The FDA's final rule implementing section 4205 was issued 
on November 25, 2014, three and a half years after FDA 
published the proposed rule. The final rule, which will go into 
effect on December 1, 2015, requires restaurants and similar 
retail food establishments to provide calorie and other 
nutrition information to consumers. According to the final 
rule, similar retail establishments include:

        . . . bakeries, cafeterias, coffee shops, convenience 
        stores, delicatessens, food service facilities located 
        within entertainment venues (such as amusement parts, 
        bowling allies, and movie theaters), food service 
        vendors (e.g., ice cream shops and mall cookie 
        counters), food take out and/or delivery 
        establishments), grocery stores, retail confectionary 
        stores, superstores, quick service restaurants and 
        table service restaurants.\1\
---------------------------------------------------------------------------
    \1\https://www.federalregister.gov/articles/2014/12/01/2014-27833/
food-labeling-nutrition-labeling-of-standard-menu-items-in-restaurants-
and-similar-retail-food.

    The bill revises the federal menu labeling requirements to 
allow covered restaurants and retail food establishments to 
determine how calorie information should be displayed for menu 
items including serving size, change the definition of 
`reasonable basis' to allow for variation in nutrient content 
due to inadvertent human error in formulation or preparation of 
a menu item, permit nutrition information to be posted solely 
via remote-access menu, and require FDA to establish by 
regulation how nutrient content for variable menu items and 
combination meals should be determined and disclosed, among 
other modifications.

                                Hearings

    The Subcommittee on Health held a hearing on H.R. 2017 on 
June 4, 2015. The Subcommittee received testimony from:
     Ms. Sonja Yates Hubbard, Chief Executive Officer, 
E-Z Mart Stores, Inc., on behalf of the National Association of 
Convenience Stores;
     Mr. Israel O'Quinn, Director of Strategic 
Initiatives, Food City, on behalf of the Food Marketing 
Institute and the National Grocer's Association;
     Ms. Lynn Liddle, Executive Vice President, 
Communications, Legislative Affairs and Investor Relations, 
Domino's, on behalf of the American Pizza Community;
     Ms. Karen Raskopf, Chief Communications Officer, 
Dunkin' Brands, Inc.;
     Ms. Margo G. Wootan, D.Sc., Director, Nutrition 
Policy, Center for Science in the Public Interest.

                        Committee Consideration

    On November 3 and 4, 2015, the Subcommittee on Health met 
in open markup session and forwarded H.R. 2017 to the full 
Committee, as amended, by a voice vote. On November 17 and 18, 
2015, the full Committee on Energy and Commerce met in open 
markup session and ordered H.R. 2017 reported to the House, as 
amended, by a record vote of 36 yeas, 12 nays, and 1 present.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. The 
following reflects the record votes taken during the Committee 
consideration:
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee held a hearing and made 
findings that are reflected in this report.

         Statement of General Performance Goals and Objectives

    The objective of H.R. 2017 is to amend the Federal menu 
labeling requirements that allow covered restaurants and retail 
food establishments to determine how nutrition information 
should be disclosed to consumer.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
2017 would result in no new or increased budget authority, 
entitlement authority, or tax expenditures or revenues.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    In compliance with clause 9(e), 9(f), and 9(g) of rule XXI 
of the Rules of the House of Representatives, the Committee 
finds that H.R. 2017 contains no earmarks, limited tax 
benefits, or limited tariff benefits.

                        Committee Cost Estimate

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

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                  Washington, DC, February 1, 2016.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 2017, the Common 
Sense Nutrition Disclosure Act of 2015.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Ellen Werble.
            Sincerely,
                                                        Keith Hall.
    Enclosure.

H.R. 2017--Common Sense Nutrition Disclosure Act of 2015

    Summary: H.R. 2017 would amend the Federal Food, Drug, and 
Cosmetics Act to revise the information certain restaurants and 
retail food establishments must disclose about nutrition to the 
consumer. CBO estimates that implementing H.R. 2017 would cost 
$9 million over the 2016-2021 period, assuming appropriation of 
the necessary amounts. Enacting H.R. 2017 would not affect 
direct spending or revenues; therefore, pay-as-you-go 
procedures do not apply.
    CBO estimates that enacting H.R. 2017 would not increase 
net direct spending or on-budget deficits in any of the four 
consecutive 10-year periods beginning in 2027.
    H.R. 2017 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act (UMRA).
    Estimated cost to the Federal Government: The estimated 
budgetary effect of H.R. 2017 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                            By fiscal year, in millions of dollars----
                                                ----------------------------------------------------------------
                                                   2016     2017     2018     2019     2020     2021   2016-2021
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION
 
Estimated Authorization Level..................        0        2        2        1        1        1         9
Estimated Outlays..............................        0        2        2        1        1        1         9
----------------------------------------------------------------------------------------------------------------
Note:Components may not sum to totals because of rounding.

    Basis of estimate: H.R. 2017 would modify the labeling 
requirements for nutrition information displayed by restaurants 
and other retail food establishments. The Food and Drug 
Administration (FDA) issued a final rule on such labeling in 
December 2014, and subsequently several guidances to implement 
those requirements. The legislation would require the Secretary 
of Health and Human Services to issue new proposed regulations 
within a year to modify the current requirements. Some of those 
modifications would include:
     Providing options for displaying the number of 
calories for menu items, such as displaying the number of 
servings and calories per serving for each item;
     Defining a reasonable basis to allow for 
acceptable variations, such as serving size and inadvertent 
human error in formulation or preparation of the menu item; and
     Allowing restaurants or similar retail food 
establishments where the majority of orders are placed by 
customers who are off-premises at the time to post nutrition 
information on a remote-access menu, such as the Internet, as 
the sole method of disclosure.
    CBO estimates those modifications would take several years 
to fully implement because they would significantly change the 
current regulation. CBO expects FDA would have to develop and 
publish a new regulation and additional guidance to comply with 
modifications. Based on information provided by FDA, historical 
spending on similar activities, and assuming appropriation of 
the necessary amounts, CBO estimates that those activities 
would cost FDA $9 million over the 2016-2021 period.
    Pay-As-You-Go considerations: None.
    Increase in long term direct spending and deficits: CBO 
estimates that enacting H.R. 2017 would not increase net direct 
spending or on-budget deficits in any of the four consecutive 
10-year periods beginning in 2027.
    Intergovernmental and private sector impact: H.R. 2017 
contains no intergovernmental or private-sector mandates as 
defined in UMRA and would not impose costs on state, local, or 
tribal governments. Section 2(b) of the bill would remove the 
ability of states to petition the FDA to enforce their own 
nutrition labeling requirements on food sold in some chain 
restaurants or similar retail food establishments. The ability 
of states to enforce such requirements without FDA approval is 
already preempted by federal law. Because existing law provides 
FDA with broad authority over state nutrition laws, the removal 
of the option for states to petition FDA for the ability to 
enforce their own laws is not considered a new mandate.
    Estimate prepared by: Federal Costs: Ellen Werble; Impact 
on State, Local, and Tribal Governments: J'nell Blanco Suchy; 
Impact on the Private Sector: Amy Petz.
    Estimate approved by: Holly Harvey, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

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

                    Duplication of Federal Programs

    No provision of H.R. 2017 establishes or reauthorizes a 
program of the Federal Government known to be duplicative of 
another Federal program, a program that was included in any 
report from the Government Accountability Office to Congress 
pursuant to section 21 of Public Law 111-139, or a program 
related to a program identified in the most recent Catalog of 
Federal Domestic Assistance.

                  Disclosure of Directed Rule Makings

    The Committee estimates that enacting H.R. 2017 
specifically directs to be completed one rule making within the 
meaning of 5 U.S.C. 551.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

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

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    This section provides the short title of ``Common Sense 
Nutrition Disclosure Act of 2015.''

Section 2. Amending certain disclosure requirements for restaurants and 
        similar retail food establishments

    Subsection (A) would allow covered restaurants and retail 
food establishments to determine how calorie information will 
be disclosed, including determining the serving size of a menu 
item. Subsection (B) would allow covered restaurants and retail 
food establishments to list calorie information for a whole 
standard menu item, serving amount as determined by the covered 
establishment, or common unit if a standard menu item on a menu 
board on a per item or serving amount. Subsection (C) would 
allow businesses to list the calorie information by remote 
access if the majority of customers were ordering from off the 
premises. Additionally, the section would define ``reasonable 
basis'' to ensure that there are allowances for variations in 
serving size, inadvertent human error in formulation or 
preparation of menu items, and variations in ingredients. The 
Secretary would also be required to issue a regulation 
regarding standards for disclosure of nutrition information for 
variable menu items and combination meals. Further, this 
section prohibits the FDA from requiring covered restaurants 
and retail food establishments to provide certifications or 
similar signed statements related to compliance with federal 
menu labeling requirements. This section also modifies the 
definitions of ``menu'' and ``menu board'' to allow covered 
establishments to designate the primary listing customers order 
from, establishes a definition of ``present standard build'' to 
include finished menu items commonly ordered by consumers, and 
amends the definition of ``standard menu item'' to limit the 
definition to items that are prepared in substantially the same 
way with substantially the same food components. This section 
also would provide restaurants and similar retail 
establishments 90 days to correct a violation before 
enforcement action is taken. Finally, this section would 
preempt the ability of States and localities to petition FDA to 
require menu labeling that is different from the federal 
labeling requirements for covered establishments.

Section 3. Limitation on liability for damages arising from 
        noncompliance with nutrition labeling requirements

    This section states that an establishment shall not be 
liable in any civil litigation in Federal or State court for 
claims arising out of an alleged violation of the federal menu 
labeling law or any State menu label law.

         Changes in Existing Law Made by the Bill, as Reported

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

                  FEDERAL FOOD, DRUG, AND COSMETIC ACT



           *       *       *       *       *       *       *
CHAPTER IV--FOOD

           *       *       *       *       *       *       *


                            misbranded food

  Sec. 403. A food shall be deemed to be misbranded--
  (a) If (1) its labeling is false or misleading in any 
particular, or (2) in the case of a food to which section 411 
applies, its advertising is false or misleading in a material 
respect or its labeling is in violation of section 411(b)(2).
  (b) If it is offered for sale under the name of another food.
  (c) If it is an imitation of another food, unless its label 
bears, in type of uniform size and prominence, the word 
``imitation'' and, immediately thereafter, the name of the food 
imitated.
  (d) If its container is so made, formed, or filled as to be 
misleading.
  (e) If in package form unless it bears a label containing (1) 
the name and place of business of the manufacturer, packer, or 
distributor; and (2) an accurate statement of the quantity of 
the contents in terms of weight, measure, or numerical count, 
except that under clause (2) of this paragraph reasonable 
variations shall be permitted, and exemptions as to small 
packages shall be established, by regulations prescribed by the 
Secretary.
  (f) If any word, statement, or other information required by 
or under authority of this Act to appear on the label or 
labeling is not prominently placed thereon with such 
conspicuousness (as compared with other words, statements, 
designs, or devices, 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.
  (g) If it purports to be or is represented as a food for 
which a definition and standard of identity has been prescribed 
by regulations as provided by section 401, unless (1) it 
conforms to such definition and standard, and (2) its label 
bears the name of the food specified in the definition and 
standard, and, insofar as may be required by such regulations, 
the common names of optional ingredients (other than spices, 
flavoring, and coloring) present in such food.
  (h) If it purports to be or is represented as--
          (1) a food for which a standard of quality has been 
        prescribed by regulations as provided by section 401, 
        and its quality falls below such standard, unless its 
        label bears, in such manner and form as such 
        regulations specify, a statement that it falls below 
        such standard;
          (2) a food for which a standard or standards of fill 
        of container have been prescribed by regulations as 
        provided by section 401, and it falls below the 
        standard of fill of container applicable thereto, 
        unless its label bears, in such manner and form as such 
        regulations specify, a statement that it falls below 
        such standard; or
          (3) a food that is pasteurized unless--
                  (A) such food has been subjected to a safe 
                process or treatment that is prescribed as 
                pasteurization for such food in a regulation 
                promulgated under this Act; or
                  (B)(i) such food has been subjected to a safe 
                process or treatment that--
                          (I) is reasonably certain to achieve 
                        destruction or elimination in the food 
                        of the most resistant microorganisms of 
                        public health significance that are 
                        likely to occur in the food;
                          (II) is at least as protective of the 
                        public health as a process or treatment 
                        described in subparagraph (A);
                          (III) is effective for a period that 
                        is at least as long as the shelf life 
                        of the food when stored under normal 
                        and moderate abuse conditions; and
                          (IV) is the subject of a notification 
                        to the Secretary, including 
                        effectiveness data regarding the 
                        process or treatment; and
                  (ii) at least 120 days have passed after the 
                date of receipt of such notification by the 
                Secretary without the Secretary making a 
                determination that the process or treatment 
                involved has not been shown to meet the 
                requirements of subclauses (I) through (III) of 
                clause (i).
For purposes of paragraph (3), a determination by the Secretary 
that a process or treatment has not been shown to meet the 
requirements of subclauses (I) through (III) of subparagraph 
(B)(i) shall constitute final agency action under such 
subclauses.
  (i) Unless its label bears (1) the common or usual name of 
the food, if any there be, and (2) in case it is fabricated 
from two or more ingredients, the common or usual name of each 
such ingredient and if the food purports to be a beverage 
containing vegetable or fruit juice, a statement with 
appropriate prominence on the information panel of the total 
percentage of such fruit or vegetable juice contained in the 
food; except that spices, flavorings, and colors not required 
to be certified under section 721(c) unless sold as spices, 
flavorings, or such colors, may be designated as spices, 
flavorings, and colorings without naming each. To the extent 
that compliance with the requirements of clause (2) of this 
paragraph is impracticable, or results in deception or unfair 
competition, exemptions shall be established by regulations 
promulgated by the Secretary.
  (j) If it purports to be or is represented for special 
dietary uses, unless its label bears such information 
concerning its vitamin, mineral, and other dietary properties 
as the Secretary determines to be, and by regulations 
prescribes as, necessary in order fully to inform purchasers as 
to its value for such uses.
  (k) If it bears or contains any artificial flavoring, 
artificial coloring, or chemical preservative, unless it bears 
labeling stating that fact, except that to the extent that 
compliance with the requirements of this paragraph is 
impracticable, exemptions shall be established by regulations 
promulgated by the Secretary. The provisions of this paragraph 
and paragraphs (g) and (i) with respect to artificial coloring 
shall not apply in the case of butter, cheese, or ice cream. 
The provisions of this paragraph with respect to chemical 
preservatives shall not apply to a pesticide chemical when used 
in or on a raw agricultural commodity which is the produce of 
the soil.
  (l) If it is a raw agricultural commodity which is the 
produce of the soil, bearing or containing a pesticide chemical 
applied after harvest, unless the shipping container of such 
commodity bears labeling which declares the presence of such 
chemical in or on such commodity and the common or usual name 
and the function of such chemical, except that no such 
declaration shall be required while such commodity, having been 
removed from the shipping container, is being held or displayed 
for sale at retail out of such container in accordance with the 
custom of the trade.
  (m) If it is a color additive, unless its packaging and 
labeling are in conformity with such packaging and labeling 
requirements, applicable to such color additive, as may be 
contained in regulations issued under section 721.
  (n) If its packaging or labeling is in violation of an 
applicable regulation issued pursuant to section 3 or 4 of the 
Poison Prevention Packaging Act of 1970.
  (q)(1) Except as provided in subparagraphs (3), (4), and (5), 
if it is a food intended for human consumption and is offered 
for sale, unless its label or labeling bears nutrition 
information that provides--
          (A)(i) the serving size which is an amount 
        customarily consumed and which is expressed in a common 
        household measure that is appropriate to the food, or
          (ii) if the use of the food is not typically 
        expressed in a serving size, the common household unit 
        of measure that expresses the serving size of the food,
          (B) the number of servings or other units of measure 
        per container,
          (C) the total number of calories--
                  (i) derived from any source, and
                  (ii) derived from the total fat,
        in each serving size or other unit of measure of the 
        food,
          (D) the amount of the following nutrients: Total fat, 
        saturated fat, cholesterol, sodium, total 
        carbohydrates, complex carbohydrates, sugars, dietary 
        fiber, and total protein contained in each serving size 
        or other unit of measure,
          (E) any vitamin, mineral, or other nutrient required 
        to be placed on the label and labeling of food under 
        this Act before October 1, 1990, if the Secretary 
        determines that such information will assist consumers 
        in maintaining healthy dietary practices.
The Secretary may by regulation require any information 
required to be placed on the label or labeling by this 
subparagraph or subparagraph (2)(A) to be highlighted on the 
label or labeling by larger type, bold type, or contrasting 
color if the Secretary determines that such highlighting will 
assist consumers in maintaining healthy dietary practices.
  (2)(A) If the Secretary determines that a nutrient other than 
a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) 
should be included in the label or labeling of food subject to 
subparagraph (1) for purposes of providing information 
regarding the nutritional value of such food that will assist 
consumers in maintaining healthy dietary practices, the 
Secretary may by regulation require that information relating 
to such additional nutrient be included in the label or 
labeling of such food.
  (B) If the Secretary determines that the information relating 
to a nutrient required by subparagraph (1)(C), (1)(D), or 
(1)(E) or clause (A) of this subparagraph to be included in the 
label or labeling of food is not necessary to assist consumers 
in maintaining healthy dietary practices, the Secretary may by 
regulation remove information relating to such nutrient from 
such requirement.
  (3) For food that is received in bulk containers at a retail 
establishment, the Secretary may, by regulation, provide that 
the nutrition information required by subparagraphs (1) and (2) 
be displayed at the location in the retail establishment at 
which the food is offered for sale.
  (4)(A) The Secretary shall provide for furnishing the 
nutrition information required by subparagraphs (1) and (2) 
with respect to raw agricultural commodities and raw fish by 
issuing voluntary nutrition guidelines, as provided by clause 
(B) or by issuing regulations that are mandatory as provided by 
clause (D).
  (B)(i) Upon the expiration of 12 months after the date of the 
enactment of the Nutrition Labeling and Education Act of 1990, 
the Secretary, after providing an opportunity for comment, 
shall issue guidelines for food retailers offering raw 
agricultural commodities or raw fish to provide nutrition 
information specified in subparagraphs (1) and (2). Such 
guidelines shall take into account the actions taken by food 
retailers during such 12-month period to provide to consumers 
nutrition information on raw agricultural commodities and raw 
fish. Such guidelines shall only apply--
          (I) in the case of raw agricultural commodities, to 
        the 20 varieties of vegetables most frequently consumed 
        during a year and the 20 varieties of fruit most 
        frequently consumed during a year, and
          (II) to the 20 varieties of raw fish most frequently 
        consumed during a year.
The vegetables, fruits, and raw fish to which such guidelines 
apply shall be determined by the Secretary by regulation and 
the Secretary may apply such guidelines regionally.
  (ii) Upon the expiration of 12 months after the date of the 
enactment of the Nutrition Labeling and Education Act of 1990, 
the Secretary shall issue a final regulation defining the 
circumstances that constitute substantial compliance by food 
retailers with the guidelines issued under subclause (i). The 
regulation shall provide that there is not substantial 
compliance if a significant number of retailers have failed to 
comply with the guidelines. The size of the retailers and the 
portion of the market served by retailers in compliance with 
the guidelines shall be considered in determining whether the 
substantial-compliance standard has been met.
  (C)(i) Upon the expiration of 30 months after the date of the 
enactment of the Nutrition Labeling and Education Act of 1990, 
the Secretary shall issue a report on actions taken by food 
retailers to provide consumers with nutrition information for 
raw agricultural commodities and raw fish under the guidelines 
issued under clause (A). Such report shall include a 
determination of whether there is substantial compliance with 
the guidelines.
  (ii) If the Secretary finds that there is substantial 
compliance with the guidelines, the Secretary shall issue a 
report and make a determination of the type required in 
subclause (i) every two years.
  (D)(i) If the Secretary determines that there is not 
substantial compliance with the guidelines issued under clause 
(A), the Secretary shall at the time such determination is made 
issue proposed regulations requiring that any person who offers 
raw agricultural commodities or raw fish to consumers provide, 
in a manner prescribed by regulations, the nutrition 
information required by subparagraphs (1) and (2). The 
Secretary shall issue final regulations imposing such 
requirements 6 months after issuing the proposed regulations. 
The final regulations shall become effective 6 months after the 
date of their promulgation.
  (ii) Regulations issued under subclause (i) may require that 
the nutrition information required by subparagraphs (1) and (2) 
be provided for more than 20 varieties of vegetables, 20 
varieties of fruit, and 20 varieties of fish most frequently 
consumed during a year if the Secretary finds that a larger 
number of such products are frequently consumed. Such 
regulations shall permit such information to be provided in a 
single location in each area in which raw agricultural 
commodities and raw fish are offered for sale. Such regulations 
may provide that information shall be expressed as an average 
or range per serving of the same type of raw agricultural 
commodity or raw fish. The Secretary shall develop and make 
available to the persons who offer such food to consumers the 
information required by subparagraphs (1) and (2).
  (iii) Regulations issued under subclause (i) shall permit the 
required information to be provided in each area of an 
establishment in which raw agricultural commodities and raw 
fish are offered for sale. The regulations shall permit food 
retailers to display the required information by supplying 
copies of the information provided by the Secretary, by making 
the information available in brochure, notebook or leaflet 
form, or by posting a sign disclosing the information. Such 
regulations shall also permit presentation of the required 
information to be supplemented by a video, live demonstration, 
or other media which the Secretary approves.
  (E) For purposes of this subparagraph, the term ``fish'' 
includes freshwater or marine fin fish, crustaceans, and 
mollusks, including shellfish, amphibians, and other forms of 
aquatic animal life.
  (F) No person who offers raw agricultural commodities or raw 
fish to consumers may be prosecuted for minor violations of 
this subparagraph if there has been substantial compliance with 
the requirements of this paragraph.
  (5)(A) Subparagraphs (1), (2), (3), and (4) shall not apply 
to food--
          (i) except as provided in clause (H)(ii)(III), which 
        is served in restaurants or other establishments in 
        which food is served for immediate human consumption or 
        which is sold for sale or use in such establishments,
          (ii) except as provided in clause (H)(ii)(III), which 
        is processed and prepared primarily in a retail 
        establishment, which is ready for human consumption, 
        which is of the type described in subclause (i), and 
        which is offered for sale to consumers but not for 
        immediate human consumption in such establishment and 
        which is not offered for sale outside such 
        establishment,
          (iii) which is an infant formula subject to section 
        412,
          (iv) which is a medical food as defined in section 
        5(b) of the Orphan Drug Act (21 U.S.C. 360ee(b)), or
          (v) which is described in section 405(2).
  (B) Subparagraphs (1) and (2) shall not apply to the label of 
a food if the Secretary determines by regulations that 
compliance with such subparagraphs is impracticable because the 
package of such food is too small to comply with the 
requirements of such subparagraphs and if the label of such 
food does not contain any nutrition information.
  (C) If a food contains insignificant amounts, as determined 
by the Secretary, of all the nutrients required by 
subparagraphs (1) and (2) to be listed in the label or labeling 
of food, the requirements of such subparagraphs shall not apply 
to such food if the label, labeling, or advertising of such 
food does not make any claim with respect to the nutritional 
value of such food. If a food contains insignificant amounts, 
as determined by the Secretary, of more than one-half the 
nutrients required by subparagraphs (1) and (2) to be in the 
label or labeling of the food, the Secretary shall require the 
amounts of such nutrients to be stated in a simplified form 
prescribed by the Secretary.
  (D) If a person offers food for sale and has annual gross 
sales made or business done in sales to consumers which is not 
more than $500,000 or has annual gross sales made or business 
done in sales of food to consumers which is not more than 
$50,000, the requirements of subparagraphs (1), (2), (3), and 
(4) shall not apply with respect to food sold by such person to 
consumers unless the label or labeling of food offered by such 
person provides nutrition information or makes a nutrition 
claim.
  (E)(i) During the 12-month period for which an exemption from 
subparagraphs (1) and (2) is claimed pursuant to this 
subclause, the requirements of such subparagraphs shall not 
apply to any food product if--
          (I) the labeling for such product does not provide 
        nutrition information or make a claim subject to 
        paragraph (r),
          (II) the person who claims for such product an 
        exemption from such subparagraphs employed fewer than 
        an average of 100 full-time equivalent employees,
          (III) such person provided the notice described in 
        subclause (iii), and
          (IV) in the case of a food product which was sold in 
        the 12-month period preceding the period for which an 
        exemption was claimed, fewer than 100,000 units of such 
        product were sold in the United States during such 
        preceding period, or in the case of a food product 
        which was not sold in the 12-month period preceding the 
        period for which such exemption is claimed, fewer than 
        100,000 units of such product are reasonably 
        anticipated to be sold in the United States during the 
        period for which such exemption is claimed.
  (ii) During the 12-month period after the applicable date 
referred to in this sentence, the requirements of subparagraphs 
(1) and (2) shall not apply to any food product which was first 
introduced into interstate commerce before May 8, 1994, if the 
labeling for such product does not provide nutrition 
information or make a claim subject to paragraph (r), if such 
person provided the notice described in subclause (iii), and 
if--
          (I) during the 12-month period preceding May 8, 1994, 
        the person who claims for such product an exemption 
        from such subparagraphs employed fewer than an average 
        of 300 full-time equivalent employees and fewer than 
        600,000 units of such product were sold in the United 
        States,
          (II) during the 12-month period preceding May 8, 
        1995, the person who claims for such product an 
        exemption from such subparagraphs employed fewer than 
        an average of 300 full-time equivalent employees and 
        fewer than 400,000 units of such product were sold in 
        the United States, or
          (III) during the 12-month period preceding May 8, 
        1996, the person who claims for such product an 
        exemption from such subparagraphs employed fewer than 
        an average of 200 full-time equivalent employees and 
        fewer than 200,000 units of such product were sold in 
        the United States.
  (iii) The notice referred to in subclauses (i) and (ii) shall 
be given to the Secretary prior to the beginning of the period 
during which the exemption under subclause (i) or (ii) is to be 
in effect, shall state that the person claiming such exemption 
for a food product has complied with the applicable 
requirements of subclause (i) or (ii), and shall--
          (I) state the average number of full-time equivalent 
        employees such person employed during the 12 months 
        preceding the date such person claims such exemption,
          (II) state the approximate number of units the person 
        claiming the exemption sold in the United States,
          (III) if the exemption is claimed for a food product 
        which was sold in the 12-month period preceding the 
        period for which the exemption was claimed, state the 
        approximate number of units of such product which were 
        sold in the United States during such preceding period, 
        and, if the exemption is claimed for a food product 
        which was not sold in such preceding period, state the 
        number of units of such product which such person 
        reasonably anticipates will be sold in the United 
        States during the period for which the exemption was 
        claimed, and
          (IV) contain such information as the Secretary may 
        require to verify the information required by the 
        preceding provisions of this subclause if the Secretary 
        has questioned the validity of such information.
If a person is not an importer, has fewer than 10 full-time 
equivalent employees, and sells fewer than 10,000 units of any 
food product in any year, such person is not required to file a 
notice for such product under this subclause for such year.
  (iv) In the case of a person who claimed an exemption under 
subclause (i) or (ii), if, during the period of such exemption, 
the number of full-time equivalent employees of such person 
exceeds the number in such subclause or if the number of food 
products sold in the United States exceeds the number in such 
subclause, such exemption shall extend to the expiration of 18 
months after the date the number of full-time equivalent 
employees or food products sold exceeded the applicable number.
  (v) For any food product first introduced into interstate 
commerce after May 8, 2002, the Secretary may by regulation 
lower the employee or units of food products requirement of 
subclause (i) if the Secretary determines that the cost of 
compliance with such lower requirement will not place an undue 
burden on persons subject to such lower requirement.
  (vi) For purposes of subclauses (i), (ii), (iii), (iv), and 
(v)--
          (I) the term ``unit'' means the packaging or, if 
        there is no packaging, the form in which a food product 
        is offered for sale to consumers,
          (II) the term ``food product'' means food in any 
        sized package which is manufactured by a single 
        manufacturer or which bears the same brand name, which 
        bears the same statement of identity, and which has 
        similar preparation methods, and
          (III) the term ``person'' in the case of a 
        corporation includes all domestic and foreign 
        affiliates of the corporation.
  (F) A dietary supplement product (including a food to which 
section 411 applies) shall comply with the requirements of 
subparagraphs (1) and (2) in a manner which is appropriate for 
the product and which is specified in regulations of the 
Secretary which shall provide that--
          (i) nutrition information shall first list those 
        dietary ingredients that are present in the product in 
        a significant amount and for which a recommendation for 
        daily consumption has been established by the 
        Secretary, except that a dietary ingredient shall not 
        be required to be listed if it is not present in a 
        significant amount, and shall list any other dietary 
        ingredient present and identified as having no such 
        recommendation;
          (ii) the listing of dietary ingredients shall include 
        the quantity of each such ingredient (or of a 
        proprietary blend of such ingredients) per serving;
          (iii) the listing of dietary ingredients may include 
        the source of a dietary ingredient; and
          (iv) the nutrition information shall immediately 
        precede the ingredient information required under 
        subclause (i), except that no ingredient identified 
        pursuant to subclause (i) shall be required to be 
        identified a second time.
  (G) Subparagraphs (1), (2), (3), and (4) shall not apply to 
food which is sold by a food distributor if the food 
distributor principally sells food to restaurants or other 
establishments in which food is served for immediate human 
consumption and does not manufacture, process, or repackage the 
food it sells.
  (H) Restaurants, Retail Food Establishments, and Vending 
Machines.--
          (i) General requirements for restaurants and similar 
        retail food establishments.--Except for food described 
        in subclause (vii), in the case of food that is a 
        standard menu item that is offered for sale in a 
        restaurant or similar retail food establishment that is 
        part of a chain with 20 or more locations doing 
        business under the same name (regardless of the type of 
        ownership of the locations) and offering for sale 
        substantially the same menu items, the restaurant or 
        similar retail food establishment shall disclose the 
        information described in subclauses (ii) and (iii).
          (ii) Information required to be disclosed by 
        restaurants and retail food establishments.--Except as 
        provided in subclause (vii), the restaurant or similar 
        retail food establishment shall disclose in a clear and 
        conspicuous manner--
                  (I)(aa) in a nutrient content disclosure 
                statement adjacent to the name of the standard 
                menu item, so as to be clearly associated with 
                the standard menu item, on the menu listing the 
                item for sale, [the number of calories 
                contained in the standard menu item, as usually 
                prepared and offered for sale] the number of 
                calories contained in the whole standard menu 
                item, or the number of servings (as reasonably 
                determined by the restaurant or similar retail 
                food establishment) and number of calories per 
                serving, or the number of calories per the 
                common unit division of the standard menu item, 
                such as for a multiserving item that is 
                typically divided before presentation to the 
                consumer; and
                  (bb) a succinct statement concerning 
                suggested daily caloric intake, as specified by 
                the Secretary by regulation and posted 
                prominently on the menu and designed to enable 
                the public to understand, in the context of a 
                total daily diet, the significance of the 
                caloric information that is provided on the 
                menu;
                  (II)(aa) in a nutrient content disclosure 
                statement adjacent to the name of the standard 
                menu item, so as to be clearly associated with 
                the standard menu item, on the menu board, 
                including a drive-through menu board, [the 
                number of calories contained in the standard 
                menu item, as usually prepared and offered for 
                sale] the number of calories contained in the 
                whole standard menu item, or the number of 
                servings (as reasonably determined by the 
                restaurant or similar retail food 
                establishment) and number of calories per 
                serving, or the number of calories per the 
                common unit division of the standard menu item, 
                such as for a multiserving item that is 
                typically divided before presentation to the 
                consumer; and
                  (bb) a succinct statement concerning 
                suggested daily caloric intake, as specified by 
                the Secretary by regulation and posted 
                prominently on the menu board, designed to 
                enable the public to understand, in the context 
                of a total daily diet, the significance of the 
                nutrition information that is provided on the 
                menu board;
                  (III) in a written form, available on the 
                premises of the restaurant or similar retail 
                establishment and to the consumer upon request, 
                the nutrition information required under 
                clauses (C) and (D) of subparagraph (1); and
                  (IV) on the menu or menu board, a prominent, 
                clear, and conspicuous statement regarding the 
                availability of the information described in 
                item (III).
        In the case of restaurants or similar retail food 
        establishments where the majority of orders are placed 
        by customers who are off-premises at the time such 
        order is placed, the information required to be 
        disclosed under items (I) through (IV) may be provided 
        by a remote-access menu (such as a menu available on 
        the Internet) as the sole method of disclosure instead 
        of on-premises writings.
          (iii) Self-service food and food on display.--Except 
        as provided in subclause (vii), in the case of food 
        sold at a salad bar, buffet line, cafeteria line, or 
        similar self-service facility, and for self-service 
        beverages or food that is on display and that is 
        visible to customers, a restaurant or similar retail 
        food establishment shall either place adjacent to each 
        food offered a sign that lists calories per displayed 
        food item or per serving or comply with subclause (ii)
          (iv) Reasonable basis.--[For the purposes of this 
        clause]
                  (I) In general._For the purposes of this 
                clause, a restaurant or similar retail food 
                establishment shall have a reasonable basis for 
                its nutrient content disclosures, including 
                nutrient databases, cookbooks, laboratory 
                analyses, [and other reasonable means] or other 
                reasonable means, as described in section 
                101.10 of title 21, Code of Federal Regulations 
                (or any successor regulation) or in a related 
                guidance of the Food and Drug Administration.
                  (II) Reasonable basis defined.--For the 
                purposes of this subclause, with respect to a 
                nutrient disclosure, the term ``reasonable 
                basis''' means that the nutrient disclosure is 
                within acceptable allowances for variation in 
                nutrient content. Such acceptable allowances 
                shall include allowances for variation in 
                serving size, inadvertent human error in 
                formulation or preparation of menu items, and 
                variations in ingredients.
          [(v) Menu variability and combination meals.--The 
        Secretary shall establish by regulation standards for 
        determining and disclosing the nutrient content for 
        standard menu items that come in different flavors, 
        varieties, or combinations, but which are listed as a 
        single menu item, such as soft drinks, ice cream, 
        pizza, doughnuts, or children's combination meals, 
        through means determined by the Secretary, including 
        ranges, averages, or other methods.]
          (v) Menu variability and combination meals.--The 
        Secretary shall establish by regulation standards for 
        determining and disclosing the nutrient content for 
        standard menu items that come in different flavors, 
        varieties, or combinations, but which are listed as a 
        single menu item, such as soft drinks, ice cream, 
        pizza, doughnuts, or children's combination meals. Such 
        standards shall allow a restaurant or similar retail 
        food establishment to choose whether to determine and 
        disclose such content for the whole standard menu item, 
        for a serving or common unit division thereof, or for a 
        serving or common unit division thereof accompanied by 
        the number of servings or common unit divisions in the 
        whole standard menu item. Such standards shall allow a 
        restaurant or similar retail food establishment to 
        determine and disclose such content by using any of the 
        following methods: ranges, averages, individual 
        labeling of flavors or components, or labeling of one 
        preset standard build. In addition to such methods, the 
        Secretary may allow the use of other methods, to be 
        determined by the Secretary, for which there is a 
        reasonable basis (as such term is defined in subclause 
        (iv)(II)).
          (vi) Additional information.--If the Secretary 
        determines that a nutrient, other than a nutrient 
        required under subclause (ii)(III), should be disclosed 
        for the purpose of providing information to assist 
        consumers in maintaining healthy dietary practices, the 
        Secretary may require, by regulation, disclosure of 
        such nutrient in the written form required under 
        subclause (ii)(III).
          (vii) Nonapplicability to certain food.--
                  (I) In general.--Subclauses (i) through (vi) 
                do not apply to--
                          (aa) items that are not listed on a 
                        menu or menu board (such as condiments 
                        and other items placed on the table or 
                        counter for general use);
                          (bb) daily specials, temporary menu 
                        items appearing on the menu for less 
                        than 60 days per calendar year, or 
                        custom orders; or
                          (cc) such other food that is part of 
                        a customary market test appearing on 
                        the menu for less than 90 days, under 
                        terms and conditions established by the 
                        Secretary.
                  (II) Written forms.--Subparagraph (5)(C) 
                shall apply to any regulations promulgated 
                under subclauses (ii)(III) and (vi).
          (viii) Vending machines.--
                  (I) In general.--In the case of an article of 
                food sold from a vending machine that--
                          (aa) does not permit a prospective 
                        purchaser to examine the Nutrition 
                        Facts Panel before purchasing the 
                        article or does not otherwise provide 
                        visible nutrition information at the 
                        point of purchase; and
                          (bb) is operated by a person who is 
                        engaged in the business of owning or 
                        operating 20 or more vending machines,
                the vending machine operator shall provide a 
                sign in close proximity to each article of food 
                or the selection button that includes a clear 
                and conspicuous statement disclosing the number 
                of calories contained in the article.
          (ix) Voluntary provision of nutrition information.--
                  (I) In general.--An authorized official of 
                any restaurant or similar retail food 
                establishment or vending machine operator not 
                subject to the requirements of this clause may 
                elect to be subject to the requirements of such 
                clause, by registering biannually the name and 
                address of such restaurant or similar retail 
                food establishment or vending machine operator 
                with the Secretary, as specified by the 
                Secretary by regulation.
                  (II) Registration.--Within 120 days of 
                enactment of this clause, the Secretary shall 
                publish a notice in the Federal Register 
                specifying the terms and conditions for 
                implementation of item (I), pending 
                promulgation of regulations.
                  (III) Rule of construction.--Nothing in this 
                subclause shall be construed to authorize the 
                Secretary to require an application, review, or 
                licensing process for any entity to register 
                with the Secretary, as described in such item.
          (x) Regulations.--
                  (I) Proposed regulation.--[Not later than 1 
                year after the date of enactment of this 
                clause, the Secretary shall promulgate proposed 
                regulations to carry out this clause.] Not 
                later than 1 year after the date of enactment 
                of the Common Sense Nutrition Disclosure Act of 
                2015, the Secretary shall issue proposed 
                regulations to carry out this clause, as 
                amended by such Act. Any final regulations that 
                are promulgated pursuant to the Common Sense 
                Nutrition Disclosure Act of 2015, and any final 
                regulations that were promulgated pursuant to 
                this clause before the date of enactment of the 
                Common Sense Nutrition Disclosure Act of 2015, 
                shall not take effect earlier than 2 years 
                after the promulgation of final regulations 
                pursuant to the Common Sense Nutrition 
                Disclosure Act of 2015.
                  (II) Contents.--In promulgating regulations, 
                the Secretary shall--
                          (aa) consider standardization of 
                        recipes and methods of preparation, 
                        reasonable variation in serving size 
                        and formulation of menu items, space on 
                        menus and menu boards, inadvertent 
                        human error, training of food service 
                        workers, variations in ingredients, and 
                        other factors, as the Secretary 
                        determines; and
                          (bb) specify the format and manner of 
                        the nutrient content disclosure 
                        requirements under this subclause.
                  (III) Reporting.--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 quarterly report that 
                describes the Secretary's progress toward 
                promulgating final regulations under this 
                subparagraph.
                  (IV) Certifications.--Restaurants and similar 
                retail food establishments shall not be 
                required to provide certifications or similar 
                signed statements relating to compliance with 
                the requirements of this clause.
          [(xi) Definition.--In this clause, the term ``menu'' 
        or ``menu board'' means the primary writing of the 
        restaurant or other similar retail food establishment 
        from which a consumer makes an order selection.]
          (xi) Definitions.--In this clause:
                  (I) Menu; menu board.--The term ``menu'' or 
                ``menu board'' means the one listing of items 
                which the restaurant or similar retail food 
                establishment reasonably believes to be, and 
                designates as, the primary listing from which 
                customers make a selection in placing an order. 
                The ability to order from an advertisement, 
                coupon, flyer, window display, packaging, 
                social media, or other similar writing does not 
                make the writing a menu or menu board.
                  (II) Preset standard build.--The term 
                ``preset standard build'' means the finished 
                version of a menu item most commonly ordered by 
                consumers.
                  (III) Standard menu item.--The term 
                ``standard menu item'' means a food item of the 
                type described in subclause (i) or (ii) of 
                subparagraph (5)(A) with the same recipe 
                prepared in substantially the same way with 
                substantially the same food components that--
                          (aa) is routinely included on a menu 
                        or menu board or routinely offered as a 
                        self-service food or food on display at 
                        20 or more locations doing business 
                        under the same name; and
                          (bb) is not a food referenced in 
                        subclause (vii).
          (xii) Opportunity to correct violations.--Any 
        restaurant or similar retail food establishment that 
        the Secretary determines is in violation of this clause 
        shall have 90 days after receiving notification of the 
        violation to correct the violation. The Secretary shall 
        take no enforcement action, including the issuance of 
        any public letter, for violations that are corrected 
        within such 90-day period.
          (xiii) Limitation on liability.--A restaurant or 
        similar retail food establishment shall not be liable 
        in any civil action in Federal or State court (other 
        than an action brought by the United States or a State) 
        for any claims arising out of an alleged violation of--
                  (I) this clause; or
                  (II) any State law permitted under section 
                403A(a)(4).
  (r)(1) Except as provided in clauses (A) through (C) of 
subparagraph (5), if it is a food intended for human 
consumption which is offered for sale and for which a claim is 
made in the label or labeling of the food which expressly or by 
implication--
          (A) characterizes the level of any nutrient which is 
        of the type required by paragraph (q)(1) or (q)(2) to 
        be in the label or labeling of the food unless the 
        claim is made in accordance with subparagraph (2), or
          (B) characterizes the relationship of any nutrient 
        which is of the type required by paragraph (q)(1) or 
        (q)(2) to be in the label or labeling of the food to a 
        disease or a health-related condition unless the claim 
        is made in accordance with subparagraph (3) or (5)(D).
A statement of the type required by paragraph (q) that appears 
as part of the nutrition information required or permitted by 
such paragraph is not a claim which is subject to this 
paragraph and a claim subject to clause (A) is not subject to 
clause (B).
  (2)(A) Except as provided in subparagraphs (4)(A)(ii) and 
(4)(A)(iii) and clauses (A) through (C) of subparagraph (5), a 
claim described in subparagraph (1)(A)--
          (i) may be made only if the characterization of the 
        level made in the claim uses terms which are defined in 
        regulations of the Secretary,
          (ii) may not state the absence of a nutrient unless--
                  (I) the nutrient is usually present in the 
                food or in a food which substitutes for the 
                food as defined by the Secretary by regulation, 
                or
                  (II) the Secretary by regulation permits such 
                a statement on the basis of a finding that such 
                a statement would assist consumers in 
                maintaining healthy dietary practices and the 
                statement discloses that the nutrient is not 
                usually present in the food,
          (iii) may not be made with respect to the level of 
        cholesterol in the food if the food contains, as 
        determined by the Secretary by regulation, fat or 
        saturated fat in an amount which increases to persons 
        in the general population the risk of disease or a 
        health related condition which is diet related unless--
                  (I) the Secretary finds by regulation that 
                the level of cholesterol is substantially less 
                than the level usually present in the food or 
                in a food which substitutes for the food and 
                which has a significant market share, or the 
                Secretary by regulation permits a statement 
                regarding the absence of cholesterol on the 
                basis of a finding that cholesterol is not 
                usually present in the food and that such a 
                statement would assist consumers in maintaining 
                healthy dietary practices and a requirement 
                that the statement disclose that cholesterol is 
                not usually present in the food, and
                  (II) the label or labeling of the food 
                discloses the level of such fat or saturated 
                fat in immediate proximity to such claim and 
                with appropriate prominence which shall be no 
                less than one-half the size of the claim with 
                respect to the level of cholesterol,
          (iv) may not be made with respect to the level of 
        saturated fat in the food if the food contains 
        cholesterol unless the label or labeling of the food 
        discloses the level of cholesterol in the food in 
        immediate proximity to such claim and with appropriate 
        prominence which shall be no less than one-half the 
        size of the claim with respect to the level of 
        saturated fat,
          (v) may not state that a food is high in dietary 
        fiber unless the food is low in total fat as defined by 
        the Secretary or the label or labeling discloses the 
        level of total fat in the food in immediate proximity 
        to such statement and with appropriate prominence which 
        shall be no less than one-half the size of the claim 
        with respect to the level of dietary fiber, and
          (vi) may not be made if the Secretary by regulation 
        prohibits the claim because the claim is misleading in 
        light of the level of another nutrient in the food.
  (B) If a claim described in subparagraph (1)(A) is made with 
respect to a nutrient in a food and the Secretary makes a 
determination that the food contains a nutrient at a level that 
increases to persons in the general population the risk of a 
disease or health-related condition that is diet related, the 
label or labeling of such food shall contain, prominently and 
in immediate proximity to such claim, the following statement: 
``See nutrition information for __ content.'' The blank shall 
identify the nutrient associated with the increased disease or 
health-related condition risk. In making the determination 
described in this clause, the Secretary shall take into account 
the significance of the food in the total daily diet.
  (C) Subparagraph (2)(A) does not apply to a claim described 
in subparagraph (1)(A) and contained in the label or labeling 
of a food if such claim is contained in the brand name of such 
food and such brand name was in use on such food before October 
25, 1989, unless the brand name contains a term defined by the 
Secretary under subparagraph (2)(A)(i). Such a claim is subject 
to paragraph (a).
  (D) Subparagraph (2) does not apply to a claim described in 
subparagraph (1)(A) which uses the term ``diet'' and is 
contained in the label or labeling of a soft drink if (i) such 
claim is contained in the brand name of such soft drink, (ii) 
such brand name was in use on such soft drink before October 
25, 1989, and (iii) the use of the term ``diet'' was in 
conformity with section 105.66 of title 21 of the Code of 
Federal Regulations. Such a claim is subject to paragraph (a).
  (E) Subclauses (i) through (v) of subparagraph (2)(A) do not 
apply to a statement in the label or labeling of food which 
describes the percentage of vitamins and minerals in the food 
in relation to the amount of such vitamins and minerals 
recommended for daily consumption by the Secretary.
  (F) Subclause (i) clause (A) does not apply to a statement in 
the labeling of a dietary supplement that characterizes the 
percentage level of a dietary ingredient for which the 
Secretary has not established a reference daily intake, daily 
recommended value, or other recommendation for daily 
consumption.
  (G) A claim of the type described in subparagraph (1)(A) for 
a nutrient, for which the Secretary has not promulgated a 
regulation under clause (A)(i), shall be authorized and may be 
made with respect to a food if--
          (i) a scientific body of the United States Government 
        with official responsibility for public health 
        protection or research directly relating to human 
        nutrition (such as the National Institutes of Health or 
        the Centers for Disease Control and Prevention) or the 
        National Academy of Sciences or any of its subdivisions 
        has published an authoritative statement, which is 
        currently in effect, which identifies the nutrient 
        level to which the claim refers;
          (ii) a person has submitted to the Secretary, at 
        least 120 days (during which the Secretary may notify 
        any person who is making a claim as authorized by 
        clause (C) that such person has not submitted all the 
        information required by such clause) before the first 
        introduction into interstate commerce of the food with 
        a label containing the claim, (I) a notice of the 
        claim, which shall include the exact words used in the 
        claim and shall include a concise description of the 
        basis upon which such person relied for determining 
        that the requirements of subclause (i) have been 
        satisfied, (II) a copy of the statement referred to in 
        subclause (i) upon which such person relied in making 
        the claim, and (III) a balanced representation of the 
        scientific literature relating to the nutrient level to 
        which the claim refers;
          (iii) the claim and the food for which the claim is 
        made are in compliance with clauses (A) and (B), and 
        are otherwise in compliance with paragraph (a) and 
        section 201(n); and
          (iv) the claim is stated in a manner so that the 
        claim is an accurate representation of the 
        authoritative statement referred to in subclause (i) 
        and so that the claim enables the public to comprehend 
        the information provided in the claim and to understand 
        the relative significance of such information in the 
        context of a total daily diet.
For purposes of this clause, a statement shall be regarded as 
an authoritative statement of a scientific body described in 
subclause (i) only if the statement is published by the 
scientific body and shall not include a statement of an 
employee of the scientific body made in the individual capacity 
of the employee.
  (H) A claim submitted under the requirements of clause (G) 
may be made until--
          (i) such time as the Secretary issues a regulation--
                  (I) prohibiting or modifying the claim and 
                the regulation has become effective, or
                  (II) finding that the requirements of clause 
                (G) have not been met, including finding that 
                the petitioner had not submitted all the 
                information required by such clause; or
          (ii) a district court of the United States in an 
        enforcement proceeding under chapter III has determined 
        that the requirements of clause (G) have not been met.
  (3)(A) Except as provided in subparagraph (5), a claim 
described in subparagraph (1)(B) may only be made--
          (i) if the claim meets the requirements of the 
        regulations of the Secretary promulgated under clause 
        (B), and
          (ii) if the food for which the claim is made does not 
        contain, as determined by the Secretary by regulation, 
        any nutrient in an amount which increases to persons in 
        the general population the risk of a disease or health-
        related condition which is diet related, taking into 
        account the significance of the food in the total daily 
        diet, except that the Secretary may by regulation 
        permit such a claim based on a finding that such a 
        claim would assist consumers in maintaining healthy 
        dietary practices and based on a requirement that the 
        label contain a disclosure of the type required by 
        subparagraph (2)(B).
  (B)(i) The Secretary shall promulgate regulations authorizing 
claims of the type described in subparagraph (1)(B) only if the 
Secretary determines, based on the totality of publicly 
available scientific evidence (including evidence from well-
designed studies conducted in a manner which is consistent with 
generally recognized scientific procedures and principles), 
that there is significant scientific agreement, among experts 
qualified by scientific training and experience to evaluate 
such claims, that the claim is supported by such evidence.
  (ii) A regulation described in subclause (i) shall describe--
          (I) the relationship between a nutrient of the type 
        required in the label or labeling of food by paragraph 
        (q)(1) or (q)(2) and a disease or health-related 
        condition, and
          (II) the significance of each such nutrient in 
        affecting such disease or health-related condition.
  (iii) A regulation described in subclause (i) shall require 
such claim to be stated in a manner so that the claim is an 
accurate representation of the matters set out in subclause 
(ii) and so that the claim enables the public to comprehend the 
information provided in the claim and to understand the 
relative significance of such information in the context of a 
total daily diet.
  (C) Notwithstanding the provisions of clauses (A)(i) and (B), 
a claim of the type described in subparagraph (1)(B) which is 
not authorized by the Secretary in a regulation promulgated in 
accordance with clause (B) shall be authorized and may be made 
with respect to a food if--
          (i) a scientific body of the United States Government 
        with official responsibility for public health 
        protection or research directly relating to human 
        nutrition (such as the National Institutes of Health or 
        the Centers for Disease Control and Prevention) or the 
        National Academy of Sciences or any of its subdivisions 
        has published an authoritative statement, which is 
        currently in effect, about the relationship between a 
        nutrient and a disease or health-related condition to 
        which the claim refers;
          (ii) a person has submitted to the Secretary, at 
        least 120 days (during which the Secretary may notify 
        any person who is making a claim as authorized by 
        clause (C) that such person has not submitted all the 
        information required by such clause) before the first 
        introduction into interstate commerce of the food with 
        a label containing the claim, (I) a notice of the 
        claim, which shall include the exact words used in the 
        claim and shall include a concise description of the 
        basis upon which such person relied for determining 
        that the requirements of subclause (i) have been 
        satisfied, (II) a copy of the statement referred to in 
        subclause (i) upon which such person relied in making 
        the claim, and (III) a balanced representation of the 
        scientific literature relating to the relationship 
        between a nutrient and a disease or health-related 
        condition to which the claim refers;
          (iii) the claim and the food for which the claim is 
        made are in compliance with clause (A)(ii) and are 
        otherwise in compliance with paragraph (a) and section 
        201(n); and
          (iv) the claim is stated in a manner so that the 
        claim is an accurate representation of the 
        authoritative statement referred to in subclause (i) 
        and so that the claim enables the public to comprehend 
        the information provided in the claim and to understand 
        the relative significance of such information in the 
        context of a total daily diet.
For purposes of this clause, a statement shall be regarded as 
an authoritative statement of a scientific body described in 
subclause (i) only if the statement is published by the 
scientific body and shall not include a statement of an 
employee of the scientific body made in the individual capacity 
of the employee.
  (D) A claim submitted under the requirements of clause (C) 
may be made until--
          (i) such time as the Secretary issues a regulation 
        under the standard in clause (B)(i)--
                  (I) prohibiting or modifying the claim and 
                the regulation has become effective, or
                  (II) finding that the requirements of clause 
                (C) have not been met, including finding that 
                the petitioner has not submitted all the 
                information required by such clause; or
          (ii) a district court of the United States in an 
        enforcement proceeding under chapter III has determined 
        that the requirements of clause (C) have not been met.
  (4)(A)(i) Any person may petition the Secretary to issue a 
regulation under subparagraph (2)(A)(i) or (3)(B) relating to a 
claim described in subparagraph (1)(A) or (1)(B). Not later 
than 100 days after the petition is received by the Secretary, 
the Secretary shall issue a final decision denying the petition 
or file the petition for further action by the Secretary. If 
the Secretary does not act within such 100 days, the petition 
shall be deemed to be denied unless an extension is mutually 
agreed upon by the Secretary and the petitioner. If the 
Secretary denies the petition or the petition is deemed to be 
denied, the petition shall not be made available to the public. 
If the Secretary files the petition, the Secretary shall deny 
the petition or issue a proposed regulation to take the action 
requested in the petition not later than 90 days after the date 
of such decision. If the Secretary does not act within such 90 
days, the petition shall be deemed to be denied unless an 
extension is mutually agreed upon by the Secretary and the 
petitioner. If the Secretary issues a proposed regulation, the 
rulemaking shall be completed within 540 days of the date the 
petition is received by the Secretary. If the Secretary does 
not issue a regulation within such 540 days, the Secretary 
shall provide the Committee on Commerce of the House of 
Representatives and the Committee on Labor and Human Resources 
of the Senate the reasons action on the regulation did not 
occur within such 540 days.
  (ii) Any person may petition the Secretary for permission to 
use in a claim described in subparagraph (1)(A) terms that are 
consistent with the terms defined by the Secretary under 
subparagraph (2)(A)(i). Within 90 days of the submission of 
such a petition, the Secretary shall issue a final decision 
denying the petition or granting such permission.
  (iii) Any person may petition the Secretary for permission to 
use an implied claim described in subparagraph (1)(A) in a 
brand name. After publishing notice of an opportunity to 
comment on the petition in the Federal Register and making the 
petition available to the public, the Secretary shall grant the 
petition if the Secretary finds that such claim is not 
misleading and is consistent with terms defined by the 
Secretary under subparagraph (2)(A)(i). The Secretary shall 
grant or deny the petition within 100 days of the date it is 
submitted to the Secretary and the petition shall be considered 
granted if the Secretary does not act on it within such 100 
days.
  (B) A petition under clause (A)(i) respecting a claim 
described in subparagraph (1)(A) or (1)(B) shall include an 
explanation of the reasons why the claim meets the requirements 
of this paragraph and a summary of the scientific data which 
supports such reasons.
  (C) If a petition for a regulation under subparagraph (3)(B) 
relies on a report from an authoritative scientific body of the 
United States, the Secretary shall consider such report and 
shall justify any decision rejecting the conclusions of such 
report.
  (5)(A) This paragraph does not apply to infant formulas 
subject to section 412(h) and medical foods as defined in 
section 5(b) of the Orphan Drug Act.
  (B) Subclauses (iii) through (v) of subparagraph (2)(A) and 
subparagraph (2)(B) do not apply to food which is served in 
restaurants or other establishments in which food is served for 
immediate human consumption or which is sold for sale or use in 
such establishments.
  (C) A subparagraph (1)(A) claim made with respect to a food 
which claim is required by a standard of identity issued under 
section 401 shall not be subject to subparagraph (2)(A)(i) or 
(2)(B).
  (D) A subparagraph (1)(B) claim made with respect to a 
dietary supplement of vitamins, minerals, herbs, or other 
similar nutritional substances shall not be subject to 
subparagraph (3) but shall be subject to a procedure and 
standard, respecting the validity of such claim, established by 
regulation of the Secretary.
  (6) For purposes of paragraph (r)(1)(B), a statement for a 
dietary supplement may be made if--
          (A) the statement claims a benefit related to a 
        classical nutrient deficiency disease and discloses the 
        prevalence of such disease in the United States, 
        describes the role of a nutrient or dietary ingredient 
        intended to affect the structure or function in humans, 
        characterizes the documented mechanism by which a 
        nutrient or dietary ingredient acts to maintain such 
        structure or function, or describes general well-being 
        from consumption of a nutrient or dietary ingredient,
          (B) the manufacturer of the dietary supplement has 
        substantiation that such statement is truthful and not 
        misleading, and
          (C) the statement contains, prominently displayed and 
        in boldface type, the following: ``This statement has 
        not been evaluated by the Food and Drug Administration. 
        This product is not intended to diagnose, treat, cure, 
        or prevent any disease.''.
A statement under this subparagraph may not claim to diagnose, 
mitigate, treat, cure, or prevent a specific disease or class 
of diseases. If the manufacturer of a dietary supplement 
proposes to make a statement described in the first sentence of 
this subparagraph in the labeling of the dietary supplement, 
the manufacturer shall notify the Secretary no later than 30 
days after the first marketing of the dietary supplement with 
such statement that such a statement is being made.
  (7) The Secretary may make proposed regulations issued under 
this paragraph effective upon publication pending consideration 
of public comment and publication of a final regulation if the 
Secretary determines that such action is necessary--
          (A) to enable the Secretary to review and act 
        promptly on petitions the Secretary determines provide 
        for information necessary to--
                  (i) enable consumers to develop and maintain 
                healthy dietary practices;
                  (ii) enable consumers to be informed promptly 
                and effectively of important new knowledge 
                regarding nutritional and health benefits of 
                food; or
                  (iii) ensure that scientifically sound 
                nutritional and health information is provided 
                to consumers as soon as possible; or
          (B) to enable the Secretary to act promptly to ban or 
        modify a claim under this paragraph.
Such proposed regulations shall be deemed final agency action 
for purposes of judicial review.
  (s) If--
          (1) it is a dietary supplement; and
          (2)(A) the label or labeling of the supplement fails 
        to list--
                  (i) the name of each ingredient of the 
                supplement that is described in section 
                201(ff); and
                  (ii)(I) the quantity of each such ingredient; 
                or
                  (II) with respect to a proprietary blend of 
                such ingredients, the total quantity of all 
                ingredients in the blend;
          (B) the label or labeling of the dietary supplement 
        fails to identify the product by using the term 
        ``dietary supplement'', which term may be modified with 
        the name of such an ingredient;
          (C) the supplement contains an ingredient described 
        in section 201(ff)(1)(C), and the label or labeling of 
        the supplement fails to identify any part of the plant 
        from which the ingredient is derived;
          (D) the supplement--
                  (i) is covered by the specifications of an 
                official compendium;
                  (ii) is represented as conforming to the 
                specifications of an official compendium; and
                  (iii) fails to so conform; or
          (E) the supplement--
                  (i) is not covered by the specifications of 
                an official compendium; and
                  (ii)(I) fails to have the identity and 
                strength that the supplement is represented to 
                have; or
                  (II) fails to meet the quality (including 
                tablet or capsule disintegration), purity, or 
                compositional specifications, based on 
                validated assay or other appropriate methods, 
                that the supplement is represented to meet.
A dietary supplement shall not be deemed misbranded solely 
because its label or labeling contains directions or conditions 
of use or warnings.
  (t) If it purports to be or is represented as catfish, unless 
it is fish classified within the family Ictaluridae.
  (u) If it purports to be or is represented as ginseng, unless 
it is an herb or herbal ingredient derived from a plant 
classified within the genus Panax.
  (v) If--
          (1) it fails to bear a label required by the 
        Secretary under section 801(n)(1) (relating to food 
        refused admission into the United States);
          (2) the Secretary finds that the food presents a 
        threat of serious adverse health consequences or death 
        to humans or animals; and
          (3) upon or after notifying the owner or consignee 
        involved that the label is required under section 801, 
        the Secretary informs the owner or consignee that the 
        food presents such a threat.
  (w)(1) If it is not a raw agricultural commodity and it is, 
or it contains an ingredient that bears or contains, a major 
food allergen, unless either--
          (A) the word ``Contains''', followed by the name of 
        the food source from which the major food allergen is 
        derived, is printed immediately after or is adjacent to 
        the list of ingredients (in a type size no smaller than 
        the type size used in the list of ingredients) required 
        under subsections (g) and (i); or
          (B) the common or usual name of the major food 
        allergen in the list of ingredients required under 
        subsections (g) and (i) is followed in parentheses by 
        the name of the food source from which the major food 
        allergen is derived, except that the name of the food 
        source is not required when--
                  (i) the common or usual name of the 
                ingredient uses the name of the food source 
                from which the major food allergen is derived; 
                or
                  (ii) the name of the food source from which 
                the major food allergen is derived appears 
                elsewhere in the ingredient list, unless the 
                name of the food source that appears elsewhere 
                in the ingredient list appears as part of the 
                name of a food ingredient that is not a major 
                food allergen under section 201(qq)(2)(A) or 
                (B).
  (2) As used in this subsection, the term ``name of the food 
source from which the major food allergen is derived'' means 
the name described in section 201(qq)(1); provided that in the 
case of a tree nut, fish, or Crustacean shellfish, the term 
``name of the food source from which the major food allergen is 
derived'' means the name of the specific type of nut or species 
of fish or Crustacean shellfish.
  (3) The information required under this subsection may appear 
in labeling in lieu of appearing on the label only if the 
Secretary finds that such other labeling is sufficient to 
protect the public health. A finding by the Secretary under 
this paragraph (including any change in an earlier finding 
under this paragraph) is effective upon publication in the 
Federal Register as a notice.
  (4) Notwithstanding subsection (g), (i), or (k), or any other 
law, a flavoring, coloring, or incidental additive that is, or 
that bears or contains, a major food allergen shall be subject 
to the labeling requirements of this subsection.
  (5) The Secretary may by regulation modify the requirements 
of subparagraph (A) or (B) of paragraph (1), or eliminate 
either the requirement of subparagraph (A) or the requirements 
of subparagraph (B) of paragraph (1), if the Secretary 
determines that the modification or elimination of the 
requirement of subparagraph (A) or the requirements of 
subparagraph (B) is necessary to protect the public health.
  (6)(A) Any person may petition the Secretary to exempt a food 
ingredient described in section 201(qq)(2) from the allergen 
labeling requirements of this subsection.
  (B) The Secretary shall approve or deny such petition within 
180 days of receipt of the petition or the petition shall be 
deemed denied, unless an extension of time is mutually agreed 
upon by the Secretary and the petitioner.
  (C) The burden shall be on the petitioner to provide 
scientific evidence (including the analytical method used to 
produce the evidence) that demonstrates that such food 
ingredient, as derived by the method specified in the petition, 
does not cause an allergic response that poses a risk to human 
health.
  (D) A determination regarding a petition under this paragraph 
shall constitute final agency action.
  (E) The Secretary shall promptly post to a public site all 
petitions received under this paragraph within 14 days of 
receipt and the Secretary shall promptly post the Secretary's 
response to each.
  (7)(A) A person need not file a petition under paragraph (6) 
to exempt a food ingredient described in section 201(qq)(2) 
from the allergen labeling requirements of this subsection, if 
the person files with the Secretary a notification containing--
          (i) scientific evidence (including the analytical 
        method used) that demonstrates that the food ingredient 
        (as derived by the method specified in the 
        notification, where applicable) does not contain 
        allergenic protein; or
          (ii) a determination by the Secretary that the 
        ingredient does not cause an allergic response that 
        poses a risk to human health under a premarket approval 
        or notification program under section 409.
  (B) The food ingredient may be introduced or delivered for 
introduction into interstate commerce as a food ingredient that 
is not a major food allergen 90 days after the date of receipt 
of the notification by the Secretary, unless the Secretary 
determines within the 90-day period that the notification does 
not meet the requirements of this paragraph, or there is 
insufficient scientific evidence to determine that the food 
ingredient does not contain allergenic protein or does not 
cause an allergenic response that poses a risk to human health.
  (C) The Secretary shall promptly post to a public site all 
notifications received under this subparagraph within 14 days 
of receipt and promptly post any objections thereto by the 
Secretary.
  (x) Notwithstanding subsection (g), (i), or (k), or any other 
law, a spice, flavoring, coloring, or incidental additive that 
is, or that bears or contains, a food allergen (other than a 
major food allergen), as determined by the Secretary by 
regulation, shall be disclosed in a manner specified by the 
Secretary by regulation.
  (y) If it is a dietary supplement that is marketed in the 
United States, unless the label of such dietary supplement 
includes a domestic address or domestic phone number through 
which the responsible person (as described in section 761) may 
receive a report of a serious adverse event with such dietary 
supplement.
  Sec. 403A. (a) Except as provided in subsection (b), no State 
or political subdivision of a State may directly or indirectly 
establish under any authority or continue in effect as to any 
food in interstate commerce--
          (1) any requirement for a food which is the subject 
        of a standard of identity established under section 401 
        that is not identical to such standard of identity or 
        that is not identical to the requirement of section 
        403(g), except that this paragraph does not apply to a 
        standard of identity of a State or political 
        subdivision of a State for maple syrup that is of the 
        type required by sections 401 and 403(g),
          (2) any requirement for the labeling of food of the 
        type required by section 403(c), 403(e), 403(i)(2), 
        403(w), or 403(x) that is not identical to the 
        requirement of such section, except that this paragraph 
        does not apply to a requirement of a State or political 
        subdivision of a State that is of the type required by 
        section 403(c) and that is applicable to maple syrup,
          (3) any requirement for the labeling of food of the 
        type required by section 403(b), 403(d), 403(f), 
        403(h), 403(i)(1), or 403(k) that is not identical to 
        the requirement of such section, except that this 
        paragraph does not apply to a requirement of a State or 
        political subdivision of a State that is of the type 
        required by section 403(h)(1) and that is applicable to 
        maple syrup,
          (4) any requirement for nutrition labeling of food 
        that is not identical to the requirement of section 
        403(q), except that this paragraph does not apply to 
        food that is offered for sale in a restaurant or 
        similar retail food establishment that is not part of a 
        chain with 20 or more locations doing business under 
        the same name (regardless of the type of ownership of 
        the locations) and offering for sale substantially the 
        same menu items unless such restaurant or similar 
        retail food establishment complies with the voluntary 
        provision of nutrition information requirements under 
        section 403(q)(5)(H)(ix), or
          (5) any requirement respecting any claim of the type 
        described in section 403(r)(1) made in the label or 
        labeling of food that is not identical to the 
        requirement of section 403(r), except a requirement 
        respecting a claim made in the label or labeling of 
        food which is exempt under section 403(r)(5)(B).
Paragraph (3) shall take effect in accordance with section 6(b) 
of the Nutrition Labeling and Education Act of 1990.
  (b) Upon petition of a State or a political subdivision of a 
State, the Secretary [may exempt from subsection (a)] may 
exempt from subsection (a) (other than subsection (a)(4)), 
under such conditions as may be prescribed by regulation, any 
State or local requirement that--
          (1) would not cause any food to be in violation of 
        any applicable requirement under Federal law,
          (2) would not unduly burden interstate commerce, and
          (3) is designed to address a particular need for 
        information which need is not met by the requirements 
        of the sections referred to in subsection (a).

           *       *       *       *       *       *       *


                            DISSENTING VIEWS

    We oppose the passage of H.R. 2017, the Common Sense 
Nutrition Disclosure Act of 2015, a bill that would amend the 
Federal Food, Drug, and Cosmetic Act to revise how calorie and 
other nutritional information is displayed in restaurants and 
other retail food establishments. Disclosure of this type of 
nutritional information was initially placed into law by the 
Affordable Care Act over six years ago. We have significant 
concern that this legislation would undermine the intent of 
federal menu labeling requirements to provide consumers with 
transparency regarding the calorie information for menu items 
in restaurants and retail food establishments as well as 
interfere with the Food and Drug Administration's ability to 
implement this law as Congress intended.

                             I. BACKGROUND

    In recent years, obesity and diet related chronic diseases 
have risen to become a prominent public health issue. 
Presently, more than two-thirds of adults and one-third of 
children are considered to be overweight or obese.\1\ The 
primary driver of this epidemic, most experts believe, is an 
increase in caloric intake. Importantly, research shows that 
Americans spend nearly half of their food dollars on foods 
prepared outside the home, and most consumers either do not 
know or underestimate the calorie counts of their meals.\2\ 
Therefore, access to nutritional information at the point of 
purchase is an important tool for consumers to make informed 
nutrition choices.
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    \1\National Institute of Diabetes and Digestive and Kidney 
Diseases, Overweight and Obesity Statistics (online at http://
www.niddk.nih.gov/health-information/health-statistics/Pages/
overweight-obesity-statistics.aspx).
    \2\Jason P. Block et al., Consumer's Estimation of Calorie Content 
at Fast Food Restaurants: Cross Sectional Observational Study, British 
Medical Journal 346, (2013):f2907
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    As a result of increasing awareness of the role diet plays 
in the obesity epidemic, states and localities began 
independently implementing menu labeling requirements. Since 
2006, five states and dozens of major cities and counties have 
adopted menu labeling laws. Included in these municipalities 
are some of the nation's most populous, including Philadelphia 
and New York City.\3\ These measures held broad support amongst 
public health, health professional and industry groups such as 
the American Heart Association, the American Medical 
Association and National Association of County and City Health 
Officials.
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    \3\Center for Science and the Public Interest, State and Local Menu 
Labeling Policies (April 2011) (online at http://cspinet.org/new/pdf/
ml_map.pdf).
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    One concern with the rapid spread of independent menu 
labeling laws was the broad variation in local laws. Chain 
restaurants found it difficult to comply and sought uniform 
standards. As a result, the National Restaurant Association has 
supported uniform menu-labeling requirements. To address these 
concerns and to improve consumer access to menu labeling 
provisions, the Affordable Care Act (ACA) included a provision 
that mandated nutrition labeling for standard menu items in 
restaurants and retail food establishments with 20 or more 
locations.\4\
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    \4\The Affordable Care Act, Section 4205, Nutrition Labeling of 
Restaurant Menus and Food Sold in Vending Machines, (online at http://
www.gpo.gov/fdsys/pkg/PLAW-111publ148/pdf/PLAW 111publ148.pdf).
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          II. IMPLEMENTATION OF ACA MENU LABELING REQUIREMENTS

    Since passage of the ACA in 2010, FDA has engaged in robust 
stakeholder engagement in the promulgation of the subsequent 
regulations. Per the ACA, the agency was tasked with 
establishing standards for determining and disclosing nutrition 
information for standard menu items and variable menu items as 
well as other provisions. Thus, in April 2011, FDA published a 
proposed menu labeling rule, which garnered over 1,100 
comments. Subsequently, the agency included a number of changes 
to address stakeholder concerns, and released the final rule in 
December 2014.\5\ FDA allowed restaurants and food 
establishments one year to become compliant with menu labeling 
requirements, establishing an effective date of December 1, 
2015.
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    \5\FDA, Food Labeling; Nutrition Labeling of Standard Menu Items in 
Restaurants and Similar Retail Food Establishments; Calorie Labeling of 
Articles of Food in Vending Machines; Final Rule, (Dec 1, 2014) (online 
at https://www.federalregister.gov/articles/2014/12/01/2014-27833/food-
labeling-nutrition-labeling-of-standard-menu-items-in-restaurants-and-
similar-retail-food).
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    The agency also released menu labeling guidance in 
September 2015 intended to help covered restaurants and retail 
food establishments to better understand the federal menu 
labeling requirements and assist in the implementation of these 
requirements.\6\ With the release of this draft guidance, FDA 
announced that it would provide covered establishments with an 
additional year to comply with the federal menu labeling 
requirements setting an effective date of December 1, 2016.\7\ 
Section 747 of the Consolidated Appropriations Act of 2016 
further delayed the effective date of the federal menu labeling 
requirements until the later of December 1, 2016, or until one 
year after FDA publishes Level 1 guidance, or final guidance, 
on menu labeling requirements.\8\
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    \6\FDA, Draft Guidance for Industry: A Labeling Guide for 
Restaurants and Retail Food Establishments Selling Away-From-Home 
Foods--Part II (Menu Labeling Requirements in Accordance with 21 CFR 
101.11, (Sept 2015) (online at http://www.fda.gov/downloads/Food/
GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/
UCM461963.pdf).
    \7\FDA, Statement on Release of Menu Labeling Guidance, (September 
11, 2-15) (online at http://www.fda.gov/Food/
IngredientsPackagingLabeling/LabelingNutrition/ucm217762.htm).
    \8\P.L. 114-113
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   III. H.R. 2017 DECREASES CONSUMER ACCESS TO ACCURATE NUTRITIONAL 
                              INFORMATION

    H.R. 2017 contains numerous provisions that both decrease 
consumer access to nutritional information and increase the 
likelihood of inconsistent or confusing menu labels. Current 
law requires that the number of calories contained in the 
standard menu item, as usually prepared and offered for sale, 
to be displayed. The bill as amended would change this 
requirement to allow restaurants and retail food establishments 
to choose how the calorie information is displayed--either in 
the whole standard menu item, or the number of servings as 
determined by the establishment and number of calories per 
serving, or the number of calories per the common unit of 
division of the standard menu item. Practically speaking, this 
allows businesses to create deceptive serving sizes. For 
example, a business could list the calories for a serving size 
of a portion of a sandwich, when the average consumer may 
mistakenly assume the calorie count is for the entire sandwich. 
It may also result in covered establishments setting serving 
sizes that are different between restaurants and retail food 
establishments and between similar menu items. These provisions 
could also create an uneven playing field amongst covered 
restaurants and retail food industries in how menu labeling 
applies within the industry.
    Beyond the allowance of unintuitive serving sizes, the bill 
also weakens requirements for locations where consumers can 
access nutritional information. It is my belief that consumers 
should be able to access nutritional information regardless of 
the location where they purchase the food, whether it is in-
store or online. The authors of the ACA menu labeling provision 
agree with this intent in the original legislation.\9\ However, 
as amended, H.R. 2017 would allow restaurants and retail food 
establishments to limit disclosure of calorie information to 
one menu or menu board designated by the establishment as the 
primary listing from which customers order. Further, the bill 
would allow covered establishments to disclose calorie 
information in the location in which the majority of food 
orders are placed. Hence, if a business receives 51 percent of 
its orders online, no calorie information would be required on 
menu boards for customers who make an in-store purchase and 
would instead only be available remotely. Both of these 
provisions would deny customers access to calorie information 
at the point of order.
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    \9\Letter from Representative Rosa DeLauro and former Senator Tom 
Harkin to The Honorable Shaun Donovan, Director of the Office of 
Management and Budget (August 15, 2014) (online at http://
www.help.senate.gov/ranking/newsroom/press/harkin-delauro-call-on-
administration-to-issue-strong-menu-labeling-rule).
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    Additionally, the bill contains technical provisions that 
create a potential loophole that may allow establishments to 
avoid menu labeling all together. Under the current FDA rule, 
all items that routinely appear on the menu are subject to menu 
labeling requirements. However, under H.R. 2017, this 
definition is changed to include only menu items that are 
routinely offered in at least 20 locations with the same 
recipe. Although on its face, this provision sounds innocuous, 
in practice it creates a potential loophole to avoid menu 
labeling. Given the nature of cooking, the seasonal nature of 
various ingredients and other factors, under this definition, 
companies could either intentionally or unintentionally escape 
menu labeling requirements due to minor alterations in recipes. 
Additionally, this change in definition is unnecessary, given 
that current FDA rules exclude restaurant ``specials'' or menu 
items that appear fewer than 60 days per calendar year.

              IV. H.R. 2017 DECREASES CONSUMER PROTECTIONS

    H.R. 2017 includes several provisions which decrease the 
likelihood of business compliance with the menu labeling and 
remove consumer protections in the event that a business does 
not comply with the requirements. Under current law, covered 
restaurants and retail food establishments are required to 
provide the FDA with a certification or signed statement that 
they are in compliance with menu labeling requirements upon 
request. However, the bill as amended removes this important 
mechanism that allows the FDA to ensure that someone at each 
establishment is responsible for complying with the menu 
labeling requirements.
    In addition, the bill also shields covered establishments 
from any civil lawsuits (except those brought by federal or 
state governments) for not complying with federal menu labeling 
requirements. It also shields establishments not subject to the 
menu labeling requirements (e.g., because they are not part of 
a chain with 20 or more locations) from civil lawsuits for not 
complying with state menu labeling requirements to which they 
are subject. This removes a critical tool for communities and 
consumers to ensure that the establishments in their 
communities are compliant with the law.
    Further, H.R. 2017 would also preempt States and Localities 
from petitioning FDA to require menu labeling for food sold in 
covered establishments that is different than the federal menu 
labeling requirements. In effect, this provision would prevent 
States and Localities from requiring and implementing menu 
labeling requirements that goes farther than the federal 
requirements inhibiting their ability to offer consumers 
greater access to nutrition and calorie information for foods 
purchased out of the home.

                V. LEGISLATION IS THE INCORRECT APPROACH

    Finally, H.R. 2017 is an overly prescriptive, permanent 
legislative approach that is unnecessary at this time. FDA has 
engaged in considerable dialogue with stakeholders from all 
perspectives including consumers, industry, and public health 
professionals. After its initial comment period, the agency 
made substantial changes to accommodate industry concerns on a 
variety of topics. Overall, the regulatory process has worked 
well. For this reason, over 100 nutrition and health 
professional individuals and organizations oppose H.R. 2017. 
Additionally, the National Restaurant Association concurs and 
also opposes H.R. 2017 as passed out of Committee.
    Although a small subset of the food industry seeks 
additional changes to menu labeling requirements, additional 
legislation is not only unnecessary, but would be 
counterproductive to current efforts. Undoubtedly, producers of 
craft foods with unique and varying recipes, such as pizza 
parlors, will experience more complicated decisions to deliver 
accurate, understandable nutrition information to consumers. 
However, these issues are easily addressed under current law 
through the rule-making process.
    It also is counter to what the majority of consumers want--
the inclusion of nutrition information on restaurant menus. 
Nearly 70 percent of consumers support the government requiring 
restaurants to post calorie information at the point of 
purchase.\10\ Six years have passed since the enactment of 
federal menu labeling requirements as a part of the ACA. Yet, 
this bill would extend these requirements an additional two 
years after the promulgation of final regulations pursuant to 
the Common Sense Nutrition Disclosure Act of 2015, further 
delaying consumer access to important nutrition information. 
Businesses are already prepared to enact menu labeling 
requirements and a last-minute change is simply unnecessary. 
The American people stand ready to improve the public health. 
Unfortunately H.R. 2017 acts as an unnecessary, misguided 
approach that would interfere with the FDA's well-executed 
implementation of existing law and delay consumer access to 
critical nutritional information. Instead of passing H.R. 2017, 
Congress should be further facilitate guidance and education to 
covered establishments in how nutrition information can be made 
available to consumers in a transparent manner.
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    \10\Sara N. Bleich and Keshia M. Pollack, The Public's 
Understanding of Daily Caloric Recommendations and Their Perspective of 
Calorie Posting in Chain restaurants, (2010), BMC Public Health (10) 
121.

                                   Frank Pallone, Jr.
                                   Gene Green.

                                  [all]