[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\
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\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.