[House Report 115-486]
[From the U.S. Government Publishing Office]


115th Congress }                                            { Report
                        HOUSE OF REPRESENTATIVES
 2d Session    }                                            { 115-486

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

 
             COMMON SENSE NUTRITION DISCLOSURE ACT OF 2017

                                _______
                                

January 8, 2018.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

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

                              R E P O R T

                             together with

                            DISSENTING VIEWS

                        [To accompany H.R. 772]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 772) 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
Committee Action.................................................     4
Committee Votes..................................................     4
Oversight Findings and Recommendations...........................     7
New Budget Authority, Entitlement Authority, and Tax Expenditures     7
Congressional Budget Office Estimate.............................     7
Federal Mandates Statement.......................................     9
Statement of General Performance Goals and Objectives............     9
Duplication of Federal Programs..................................     9
Committee Cost Estimate..........................................     9
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     9
Disclosure of Directed Rule Makings..............................     9
Advisory Committee Statement.....................................    10
Applicability to Legislative Branch..............................    10
Section-by-Section Analysis of the Legislation...................    10
Changes in Existing Law Made by the Bill, as Reported............    11
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 2017''.

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) Permissible variation.--If the restaurant or 
                similar food establishment uses such means as the basis 
                for its nutrient content disclosures, such disclosures 
                shall be treated as having a reasonable basis even if 
                such disclosures vary from actual nutrient content, 
                including but not limited to variations in serving 
                size, inadvertent human error in formulation or 
                preparation of menu items, variations in ingredients, 
                or other reasonable variations.'';
          (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 2017, the Secretary shall issue 
                proposed regulations to carry out this clause, as 
                amended by such Act. Final regulations to carry out 
                this clause, including any regulations promulgated 
                before the date of enactment of the Common Sense 
                Nutrition Disclosure Act of 2017, shall not take effect 
                until such compliance date as shall be specified by the 
                Secretary in the regulations promulgated pursuant to 
                the Common Sense Nutrition Disclosure Act of 2017.''; 
                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. 772, the Common Sense Nutrition Disclosure Act of 
2017, addresses the Food and Drug Administration's (FDA) final 
menu labeling regulations. H.R. 772 would provide a flexible 
approach to nutrition disclosures by allowing establishments to 
provide consumers with information in a workable and helpful 
format, such as online or on a digital table rather than a 
traditional menu board.
    Additionally, H.R. 772 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. 772, authored by Rep. McMorris-Rodgers (R-WA) and Rep. 
Cardenas (D-CA), would amend the Federal Food, Drug, and 
Cosmetics Act to revise information certain restaurants and 
retail food establishments must disclose about nutrition to 
consumers. The FDA's final rule implementing section 4205 of 
the Patient Protection and Affordable Care Act was issued on 
November 25, 2014, three and a half years after FDA published 
the proposed rule. The final rule 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\ Food Labeling; Nutrition Labeling of Standard Menu Items in 
Restaurants and Similar Retail Food Establishments, 79 Fed. Reg. 71155 
(Dec. 1, 2015) (codified at 21 C.F.R. 101; 21 C.F.R. 11).

    The bill revises the federal nutrition disclosure 
requirements to allow covered restaurants and retail food 
establishments to determine how nutrition 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.

                            Committee Action

    The Committee on Energy and Commerce has not held hearings 
on the legislation.
    On July 27, 2017, the full Committee on Energy and Commerce 
met in open markup session and ordered H.R. 772, as amended, 
favorably reported to the House by a record vote of 39 yeas and 
14 nays.

                            Committee Votes

    Clause 3(b) of rule XIII 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:


                 Oversight Findings and Recommendations

    Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of 
rule XIII, the Committee has not held hearings on this 
legislation.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to clause 3(c)(2) of rule XIII, the Committee 
finds that H.R. 772 would result in no new or increased budget 
authority, entitlement authority, or tax expenditures or 
revenues.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII, 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, September 20, 2017.
Hon. Greg Walden,
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. 772, the Common 
Sense Nutrition Disclosure Act of 2017.
    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,
                                                          Director.
    Enclosure.

H.R. 772--Common Sense Nutrition Disclosure Act of 2017

    Summary: H.R. 772 would amend the Federal Food, Drug, and 
Cosmetics Act to revise information certain restaurants and 
retail food establishments must disclose about nutrition to the 
consumer. CBO estimates that implementing H.R. 772 would cost 
$8 million over the 2018-2022 period, assuming appropriation of 
the necessary amounts. Enacting H.R. 772 would not affect 
direct spending or revenues; therefore, pay-as-you-go 
procedures do not apply.
    CBO estimates that enacting H.R. 772 would not increase net 
direct spending or on-budget deficits in any of the four 
consecutive 10-year periods beginning in 2028.
    H.R. 772 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act (UMRA) 
and would not impose costs on state, local, or tribal 
governments.
    Estimated cost to the Federal Government: The estimated 
budgetary effect of H.R. 772 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

 
----------------------------------------------------------------------------------------------------------------
                                                                   By fiscal year, in millions of dollars--
                                                            ----------------------------------------------------
                                                              2017   2018   2019   2020   2021   2022  2017-2022
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Estimated Authorization Level..............................      0      2      2      1      1      1         8
Estimated Outlays..........................................      0      2      2      1      1      1         8
----------------------------------------------------------------------------------------------------------------
Note: Components may not sum to totals because of rounding.

    Basis of estimate: H.R. 772 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 guidance documents 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 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 platform, 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. Using information from FDA, CBO estimates the 
agency would need about nine additional employees in each of 
the first two years to develop and publish the regulations, and 
about five additional employees each year from 2020-2022 to 
implement the regulations including engaging with affected 
stakeholders. CBO estimates an average annual cost per employee 
of about $290,000 across the 2018-2022 window. (That estimate 
accounts for the effects of inflation.) On that basis, CBO 
estimates that implementing those activities would cost FDA $8 
million over the 2018-2022 period, assuming appropriation of 
the necessary amounts.
    Pay-As-You-Go considerations: None.
    Increase in long term direct spending and deficits: CBO 
estimates that enacting H.R. 772 would not increase net direct 
spending or on-budget deficits in any of the four consecutive 
10-year periods beginning in 2028,
    Estimated impact on state, local, and tribal governments: 
H.R. 772 contains no intergovernmental 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.
    Estimated impact on the private sector: This bill contains 
no private-sector mandates as defined in UMRA.
    Estimate prepared by: Federal costs: Ellen Werble; Impact 
on state, local, and tribal governments: Zachary Byrum; Impact 
on the private sector: Amy Petz.
    Estimate approved by: Theresa Gullo, 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.

         Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to 
establish workable standards for chain restaurants and similar 
retail food establishments in order to provide consumers with 
nutrition information for standard menu items and avoid a 
patchwork of state and local requirements.

                    Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 772 is known to be duplicative of another Federal program, 
including any program that was included in a report to Congress 
pursuant to section 21 of Public Law 111-139 or the most recent 
Catalog of Federal Domestic Assistance.

                        Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, 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.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 772 contains no earmarks, limited tax 
benefits, or limited tariff benefits.

                  Disclosure of Directed Rule Makings

    Pursuant to section 3(i) of H. Res. 5, the following 
directed rule makings are contained in H.R. 772:
           Section 2(a)(4): 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)).

                      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 2017.''

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 orders are placed 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 italic, 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) Permissible variation.--If the 
                restaurant or similar food establishment uses 
                such means as the basis for its nutrient 
                content disclosures, such disclosures shall be 
                treated as having a reasonable basis even if 
                such disclosures vary from actual nutrient 
                content, including but not limited to 
                variations in serving size, inadvertent human 
                error in formulation or preparation of menu 
                items, variations in ingredients, or other 
                reasonable variations.
          [(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 
                2017, the Secretary shall issue proposed 
                regulations to carry out this clause, as 
                amended by such Act. Final regulations to carry 
                out this clause, including any regulations 
                promulgated before the date of enactment of the 
                Common Sense Nutrition Disclosure Act of 2017, 
                shall not take effect until such compliance 
                date as shall be specified by the Secretary in 
                the regulations promulgated pursuant to the 
                Common Sense Nutrition Disclosure Act of 2017.
                  (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 passage of H.R. 772, the Common Sense Nutrition 
Disclosure Act of 2017, a bill that would amend the Federal 
Food, Drug, and Cosmetic Act (FFDCA) to revise how calorie and 
other nutritional information is displayed in restaurants and 
other retail food establishments. Disclosure of nutritional 
information in certain restaurants and other retail food 
establishments was established in the Affordable Care Act (ACA) 
nearly eight years ago as a consumer driven approach to prevent 
and combat obesity. We have significant concerns that H.R. 772 
would undermine the intent of the federal menu labeling 
requirements and interfere with the Food and Drug 
Administration's (FDA) ability to implement the law as Congress 
intended.

      THE PUBLIC HEALTH NEED FOR NUTRITIONAL INFORMATION IS GREAT

    In recent years, obesity and diet related chronic diseases 
have become a prominent public health issue. More than two-
thirds of adults and one-third of children are considered to be 
overweight or obese.\1\ Additionally, on average, Americans 
consume roughly one-third of their calories, and nearly half of 
their total food spending, on food prepared outside the 
home.\2\ For this reason, access to nutritional information at 
the point of sale 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 & Obesity Statistics (August 2017) (https://
www.niddk.nih.gov/health-information/health-statistics/overweight-
obesity).
    \2\Jessica Erin Todd et al., The Impact of Food Away From Home on 
Adult Diet Quality, U.S. Dept. of Agriculture (Feb. 2010); U.S. Dept. 
of Agriculture, Food-Away-from-Home (Sept. 2017) (https://
www.ers.usda.gov/topics/food-choices-health/food-consumption-demand/
food-away-from-home.aspx).
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    In order to provide consumers with access to nutrition 
information when eating out, and to address concerns related to 
the variation in implementation of independent menu labeling 
laws in municipalities across the country, the ACA included a 
provision that mandated nutrition labeling for standard menu 
items in restaurants and retail food establishments with 20 or 
more locations.\3\
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    \3\The Affordable Care Act, Section 4205, Nutrition Labeling of 
Restaurant Menus and Food Sold in Vending Machines, Pub. L. No. 111-
148.
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    FDA ENGAGED IN A ROBUST STAKEHOLDER PROCESS TO IMPLEMENT THE LAW

    The ACA tasked FDA with establishing standards for 
determining and disclosing nutrition information for standard 
menu items and variable menu items, as well as other 
provisions. Since the passage of the law in 2010, FDA has 
continually engaged with stakeholders in the promulgation of 
the subsequent implementing regulations. In April 2011, FDA 
published a proposed menu labeling rule, which garnered over 
1,100 comments. Subsequently, the agency released the final 
menu labeling rule in December 2014, which included a number of 
changes to address concerns raised by stakeholders.\4\
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    \4\Food and Drug Administration (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 (Dec. 1, 2014) (Final Rule).
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    The agency also released menu labeling guidance in 
September 2015 intended to help covered restaurants and retail 
food establishments better understand the federal menu labeling 
requirements and assist in the implementation of these 
requirements.\5\ FDA announced in this draft guidance 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. 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 
published Level 1 guidance, or final guidance, on menu labeling 
requirements. On May 5, 2016, FDA announced the availability of 
Level 1 guidance and stated that enforcement of the final rule 
would commence on May 5, 2017.\6\ However, on May 1, 2017, mere 
days before the compliance deadline, FDA again extended the 
compliance date for menu labeling requirements from May 5, 2017 
to May 7, 2018.\7\ FDA contended that the compliance date for 
the final rule was extended once again in order to ``consider 
how we might further reduce the regulatory burden or increase 
flexibility while continuing to achieve our regulatory 
objectives'' and invited comments on these issues.\8\
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    \5\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).
    \6\FDA, 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 the Patient Protection 
Affordable Care Act of 2010), 81 FR 27067 (May 5, 2016).
    \7\FDA, Constituent Updates, FDA Extends Menu Labeling Compliance 
Date to 2018 (May 1, 2017) (https://www.fda.gov/Food/NewsEvents/
ConstituentUpdates/ucm554948.htm).
    \8\FDA, Food Labeling; Nutrition Labeling of Standard Menu Items in 
Restaurants and Similar Retail Food Establishments; Extension of 
Compliance Date; Request for Comments (May 4, 2017) (https://
www.federalregister.gov/documents/2017/05/04/2017-09029/food-labeling-
nutrition-labeling-of-standard-menu-items-in-restaurants-and-similar-
retail-food).
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    On August 25, 2017, FDA Commissioner Gottlieb announced 
that FDA would provide additional guidance on the menu labeling 
requirements by the end of the year in order to address ongoing 
concerns raised by stakeholders.\9\ Gottlieb noted that 
additional guidance should allow covered establishments to 
implement the requirements by next year's compliance date.\10\
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    \9\FDA, Statement from FDA Commissioner Scott Gottlieb, MD., on the 
FDA's role in ensuring Americans have access to clear and consistent 
calorie and nutrition information; forthcoming guidance will provide 
greater clarity and certainty (Aug. 25, 2017) (https://www.fda.gov/
NewsEvents/Newsroom/PressAnnouncements/ucm573277.htm).
    \10\Id.
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    Finally, on November 7, 2017, FDA released an additional 
draft guidance document entitled Menu Labeling: Supplemental 
Guidance for Industry that further clarifies the agency's 
interpretations of the menu labeling provisions and offers 
stakeholders additional information about compliance.\11\ FDA 
also noted that the agency is ``fully committed to keeping'' 
the May 7, 2018 deadline for compliance.\12\
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    \11\FDA, Menu Labeling: Supplemental Guidance for Industry (Nov. 
2017) (Draft Guidance) (https://www.fda.gov/downloads/Food/
GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/
UCM583492.pdf).
    \12\FDA, Constituent Updates, FDA Issues Menu Labeling Guidance, 
Utilizing Q&A Formant and Graphics to Address Concerns, Offer 
Solutions, and Provide Flexibility (Nov. 7, 2017) (https://www.fda.gov/
Food/NewsEvents/ConstituentUpdates/ucm583494.htm).
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  H.R. 772 DECREASES CONSUMER ACCESS TO ACCURATE NUTRITION INFOMRATION

    H.R. 772 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--
be displayed. The bill 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 the number of calories per serving, or the 
number of calories per the common unit of division of the 
standard menu item. Effectively, this could allow 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.
    The bill also weakens requirements for locations where 
consumers can access nutritional information. It is our belief 
that consumers should be able to access nutritional information 
regardless of the location where they purchase food, whether it 
is in-store or online. However, H.R. 772 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. Therefore, 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 and create an 
uneven playing field.

                H.R. 772 DECREASES CONSUMER PROTECTIONS

    H.R. 772 includes several provisions that decrease the 
likelihood of industry compliance with the menu labeling 
requirements and remove consumer protections in the event of 
industry noncompliance. Under current law, covered restaurants 
and retail food establishments are required to provide FDA with 
a certification or signed statement that the establishment is 
in compliance with menu labeling requirements upon request. 
However, the bill removes this important mechanism which 
ensures that someone at each establishment is responsible for 
complying with the menu labeling requirements.
    In addition, the bill blocks covered establishments from 
any civil lawsuits (except those brought by federal or state 
governments) for not complying with federal menu labeling 
requirements. H.R. 772 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. These limits on liability remove a 
critical tool for communities and consumers to ensure that the 
establishments in their communities are compliant with the law.
    Further, H.R. 772 would also preempt states and localities 
from petitioning FDA to require menu labeling for food sold in 
covered establishments that differ from the federal menu 
labeling requirements. In effect, this provision would prevent 
states and localities from requiring and implementing menu 
labeling requirements that go farther than the federal 
requirements--inhibiting their ability to offer consumers 
greater access to nutrition and calorie information for foods 
purchased outside the home.

                   LEGISLATION IS THE WRONG APPROACH

    Finally, H.R. 772 is the wrong approach, as the bill is 
overly prescriptive, and unnecessary. FDA has engaged in 
considerable dialogue with stakeholders from all backgrounds 
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. Even as recently as November 2017 in its supplemental 
draft guidance, FDA has continued to work with stakeholders to 
ease compliance concerns and address outstanding questions. 
This bill would only upend the significant work done by the FDA 
and the progress made towards compliance.
    Although a small subset of the food industry continues to 
seek additional changes to the menu labeling requirements, 
additional legislation is not only unnecessary, but would be 
counterproductive to FDA's ongoing regulatory efforts. 
Undoubtedly, certain stakeholders face more complicated 
decisions in order to deliver accurate, understandable 
nutrition information to consumers. However, these issues and 
questions are better addressed under current law through the 
regulatory process.
    The implementation of H.R. 772 would also lead to 
significant delays. The final menu labeling requirements have 
been repeatedly delayed, most recently in May 2017, just days 
before the final compliance date. Covered restaurants and 
retail food establishments should have been prepared for 
compliance at that point. This bill would require FDA to 
promulgate new proposed and final regulations, leading to 
infinite delays and preventing consumers from accessing needed 
nutritional information for the foreseeable future.
    H.R. 772 would only create greater industry and consumer 
confusion, and could detrimentally impact the good industry 
actors that have chosen to move forward with compliance as 
currently required. Instead of further delaying and limiting 
access, we should be working to improve transparency and 
provide consumers with needed nutritional information. 
Unfortunately, H.R. 772 does the opposite.
                                   Frank Pallone, Jr.,
                                           Ranking Member.
                                   Gene Green,
                                           Ranking Member, Subcommittee 
                                               on Health.