I 
115TH CONGRESS 
2D SESSION 
H. R. 5425 
To amend the Federal Food, Drug, and Cosmetic Act to strengthen require-
ments related to nutrient information on food labels, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 2, 2018 
Mr. PALLONE (for himself and Ms. DELAURO) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
strengthen requirements related to nutrient information 
on food labels, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Food Labeling Modernization Act of 2018’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Additional requirements for front-of-packaging (FOP) labeling for proc-
essed foods. 
Sec. 3. Claims for conventional foods. 
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Sec. 4. Use of specific terms. 
Sec. 5. Nutrition facts panel compliance date. 
Sec. 6. Ingredient labels. 
Sec. 7. Caffeine content on information panel. 
Sec. 8. Food allergen labeling for sesame. 
Sec. 9. Information about major food allergens in nonprepackaged foods. 
Sec. 10. Submission and availability of food label information. 
Sec. 11. Definitions. 
Sec. 12. Applicability; regulations. 
SEC. 2. ADDITIONAL REQUIREMENTS FOR FRONT-OF-PACK-
AGING (FOP) LABELING FOR PROCESSED 
FOODS. 
(a) SUMMARY
NUTRITION
LABELING
INFORMA-
TION.—Section 403 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 343) is amended by adding at the 
end the following: 
‘‘(z)(1) SUMMARY NUTRITION INFORMATION.—Ex-
cept as provided in subparagraphs (3), (4), and (5) of 
paragraph (q), if it is food (other than a dietary supple-
ment) intended for human consumption and is offered for 
sale and otherwise required to bear nutrition labeling, un-
less its principal display panel bears summary nutrition 
information that reflects the overall nutritional value of 
the food or specified ingredients, as specified in accord-
ance with regulations of the Secretary, and does not con-
tain any summary nutritional information which is in ad-
dition to or inconsistent with the information required 
under this subparagraph. 
‘‘(2) REQUIRED CRITERIA FOR IMPLEMENTING REG-
ULATIONS.—Final regulations regarding the summary nu-
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trition information required under subparagraph (1) shall 
meet the following criteria: 
‘‘(A) There shall be a single, simple, standard 
symbol system that displays calorie information re-
lated to the serving size determined under paragraph 
(q)(1)(A), and information related to the content of 
saturated and trans fats, sodium, added sugars, and 
any other nutrients that the Secretary determines 
are strongly associated with public health concerns. 
‘‘(B) The system shall employ an approach that 
clearly distinguishes between products of greater or 
lesser nutritional value. This system may include— 
‘‘(i) a warning symbol or symbols for prod-
ucts high in saturated or trans fats, sodium, 
added sugars, or other nutrients the consump-
tion of which should be limited or discouraged; 
or 
‘‘(ii) a stop-light, points, star, or other 
commonly recognized signaling system to scale 
or rank foods according to their overall health 
value. 
‘‘(C) The information shall appear on all prod-
ucts that are required to bear nutrition labeling. 
‘‘(D) The information shall— 
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‘‘(i) appear in a consistent location on the 
principal display panels across products; 
‘‘(ii) have a prominent design that visually 
contrasts with existing packaging design; and 
‘‘(iii) be sufficiently large to be easily leg-
ible. 
‘‘(3) PRINCIPLES
FOR
IMPLEMENTING
REGULA-
TIONS.—In promulgating regulations regarding the sum-
mary nutrition information required under subparagraph 
(1), the Secretary shall take into account published re-
ports by the Health and Medicine Division of the National 
Academy of Sciences regarding such information, and base 
regulations on the following principles: 
‘‘(A) Consumers should be able to quickly and 
easily comprehend the meaning of the symbol system 
as an indicator of a product’s contribution to a 
healthy diet without requiring specific or sophisti-
cated nutritional knowledge. 
‘‘(B) The nutrition information should be con-
sistent with the Nutrition Facts Panel and with the 
recommendations of the Dietary Guidelines of Amer-
icans. 
‘‘(C) The information should aim to facilitate 
consumer selection of healthy product options, in-
cluding among nutritionally at-risk subpopulations. 
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‘‘(D) The Secretary should periodically evaluate 
the front-of-package information to assess its ability 
to help facilitate consumer selection of healthy prod-
uct options and the extent to which manufacturers 
are offering healthier products as a result of the dis-
closure. 
‘‘(E) The implementation of the information 
disclosure should be accompanied by appropriate 
consumer education and promotion campaigns deter-
mined by the Secretary.’’. 
(b) PERCENTAGE OF WHEAT AND GRAINS IN GRAIN- 
BASED PRODUCTS.—Section 403 of the Federal Food, 
Drug, and Cosmetic Act, as amended, is further amended 
by adding at the end the following: 
‘‘(aa) PERCENTAGE
OF WHEAT
AND GRAINS
IN 
GRAIN-BASED PRODUCTS.—If, in the case of food other 
than a dietary supplement, the principal display panel 
bears— 
‘‘(1) the terms ‘whole wheat’, ‘whole grain’, 
‘made with whole grain’, or ‘multigrain’; 
‘‘(2) a declaration of the whole grain content by 
weight; 
‘‘(3) the term ‘wheat’ on a wheat bread, pasta, 
or similar product that is typically made from wheat; 
or 
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‘‘(4) any similar descriptive phrases, terms, or 
representations suggesting the product contains 
whole grains, 
unless the amount of whole grains, expressed as a percent-
age of total grains, is conspicuously disclosed in immediate 
proximity to the descriptive phrase, term, or representa-
tion, using a font, color, and formatting of equivalent 
prominence to the descriptive phrase, term, or representa-
tion with respect to whole grain content.’’. 
(c) SWEETENERS, COLORING, AND FLAVORING.— 
Section 403 of the Federal Food, Drug, and Cosmetic Act, 
as amended, is further amended by adding at the end the 
following: 
‘‘(bb) SWEETENERS, COLORING, AND FLAVORING.— 
If, in the case of food other than a dietary supplement, 
it bears or contains any added artificial or natural color-
ing, any added artificial or natural non-caloric sweetener, 
or any added artificial or natural flavoring, unless such 
fact is prominently stated on the principal display panel 
of a package or container of the food.’’. 
(d) CONFORMING AMENDMENT.—The second sen-
tence of section 403(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343(k)) is amended by striking 
‘‘and (i)’’ and inserting ‘‘, (i), (z), (aa), and (bb)’’. 
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(e) CONSTRUCTION.—Nothing in this section shall be 
construed as affecting any requirement in regulation in 
effect as of the date of the enactment of this Act with 
respect to matters that are required to be stated on the 
principal display panel of a package or container of food 
that is not required by an amendment made by this section 
or as restricting the authority of the Secretary of Health 
and Human Services to require additional information be 
disclosed on such a principal display panel. 
SEC. 3. CLAIMS FOR CONVENTIONAL FOODS. 
(a) HEALTH-RELATED CLAIMS.— 
(1) IN GENERAL.—Section 403(r)(1)(B) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
343(r)(1)(B)) is amended by inserting after ‘‘health- 
related condition’’ the following: ‘‘, describes the ef-
fect that a nutrient may have on the structure or 
function of the human body, characterizes the docu-
mented mechanism by which that nutrient acts to 
maintain such structure or function, or describes 
general well-being from consumption of that nutri-
ent,’’. 
(2) 
SUBSTANTIATION
OF
CLAIM.—Section 
403(r) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 343(r)) is amended— 
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(A) by redesignating subparagraph (7) as 
subparagraph (8); and 
(B) by inserting after subparagraph (6) 
the following: 
‘‘(7) If the Secretary requests that a claim 
under subparagraph (1)(B) for food (other than a 
dietary supplement) be substantiated, then not later 
than 90 days after the date on which the Secretary 
makes such request, the manufacturer shall provide 
to the Secretary all documentation in the manufac-
turer’s possession relating to the claim.’’. 
(b) TRANS FATS.—Section 403(r)(2)(A) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
343(r)(2)(A)) is amended— 
(1) in subclause (iii)— 
(A) in the matter before item (I), by strik-
ing ‘‘fat or saturated fat’’ and inserting ‘‘fat, 
saturated fat, or trans fats’’; and 
(B) in item (II), by striking ‘‘fat or satu-
rated fat’’ and inserting ‘‘fat, saturated fat, or 
trans fats’’; 
(2) in subclause (iv), by striking ‘‘saturated 
fat’’ and inserting ‘‘saturated fat or trans fats’’ each 
place it appears; 
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(3) by redesignating subclauses (v) and (vi) as 
subclauses (vi) and (vii), respectively; and 
(4) by inserting after subclause (iv) the fol-
lowing new subclause: 
‘‘(v) may not be made with respect to the level 
of trans fats in the food unless the food contains less 
than one gram of saturated fat per serving or, if the 
food contains more than one gram of saturated fat 
per serving, unless the label or labeling of the food 
discloses the level of saturated fat in the food in im-
mediate proximity to such claim and with appro-
priate prominence which shall be no less than one- 
half the size of the claim with respect to the level 
of trans fats,’’. 
(c) ADDED SUGARS.—Not more than 2 years after 
the date of enactment of this Act, the Secretary of Health 
and Human Services shall promulgate a final rule revising 
section 101.14 of title 21, Code of Federal Regulations, 
to include a disqualifying nutrient level for added sugars. 
SEC. 4. USE OF SPECIFIC TERMS. 
(a) USE OF THE TERM ‘‘NATURAL’’.— 
(1) IN GENERAL.—Not later than 2 years after 
the date of enactment of this Act, the Secretary of 
Health and Human Services shall promulgate a final 
rule— 
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(A) relating to use of the term ‘‘natural’’ 
on the labeling of food (other than a dietary 
supplement); and 
(B) including provisions to specifically ad-
dress the use of such term on the principal dis-
play panel and the information panel. 
(2) DEFINITION.—The rule promulgated pursu-
ant to paragraph (1) shall define the term ‘‘nat-
ural’’— 
(A) to exclude, at a minimum, the use of 
any artificial food or ingredient (including any 
artificial flavor or added color); and 
(B) based on data, including data on con-
sumers’ understanding of the term as used in 
connection with food. 
(3) PROCESS.—In promulgating the rule re-
quired by paragraph (1), the Secretary of Health 
and Human Services shall— 
(A) conduct consumer surveys and studies 
and issue a timely call for relevant public sub-
missions regarding relevant consumer research, 
including with respect to consumer under-
standing of the term ‘‘natural’’ in relation to 
the term ‘‘organic’’; and 
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(B) fully consider the results of such sur-
veys and studies, as well as such public submis-
sions. 
(b) USE OF TERM ‘‘HEALTHY’’.— 
(1) ADDED SUGARS AND WHOLE GRAINS.—The 
Secretary of Health and Human Services shall revise 
the regulations under the Federal Food, Drug, and 
Cosmetic Act relating to the use of the term 
‘‘healthy’’ on the labeling of a food (other than a di-
etary supplement) to take into account the extent to 
which such food contains added sugars or whole 
grains. 
(2) REQUIREMENTS.—In making the revisions 
to regulations required by paragraph (1)— 
(A) in the case of a food (other than a die-
tary supplement) that contains grains, the Sec-
retary shall not consider the food to be 
‘‘healthy’’ unless at least half of those grains, 
by weight, are whole grains; and 
(B) the Secretary shall not allow a food to 
be labeled ‘‘healthy’’ if the food contains more 
than 10 percent of the daily value of added 
sugar per serving. 
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SEC. 5. NUTRITION FACTS PANEL COMPLIANCE DATE. 
The Secretary of Health and Human Services shall 
not extend the compliance dates in the final rule entitled 
‘‘Food Labeling: Revision of the Nutrition and Supple-
ment Facts Labels’’ published by the Food and Drug Ad-
ministration in the Federal Register on May 27, 2016 (or 
any successor rule), beyond the compliance dates proposed 
in the proposed rule entitled rule entitled ‘‘Food Labeling: 
Revision of the Nutrition and Supplement Facts Labels 
and Serving Sizes of Foods That Can Reasonably Be Con-
sumed at One Eating Occasion; Dual-Column Labeling; 
Updating, Modifying, and Establishing Certain Reference 
Amounts Customarily Consumed; Serving Size for Breath 
Mints; and Technical Amendments; Proposed Extension of 
Compliance Dates’’ published by the Food and Drug Ad-
ministration in the Federal Register on October 2, 2017. 
SEC. 6. INGREDIENT LABELS. 
(a) FORMAT OF INGREDIENT LABELS.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall include requirements for the 
format of the information required under section 
403(i) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 343(i))— 
(A) for the purpose of improving the read-
ability of such information on the label of the 
food (other than a dietary supplement); and 
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(B) that are, as determined by the Sec-
retary, necessary to assist consumers in main-
taining healthy dietary practices. 
(2) FORMAT REQUIREMENTS.—The format re-
quirements referred to in paragraph (1) shall include 
requirements for upper- and lower-case characters, 
serif and noncondensed font types, high-contrast be-
tween text and background, and bullet points be-
tween adjacent ingredients with appropriate exemp-
tions for small packages or other considerations. 
(b) CHARACTERIZING INGREDIENTS
IN NAME
OR 
PRIMARY DISPLAY PANEL.— 
(1) IN GENERAL.—Section 403 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 343), as 
amended, is further amended by adding at the end 
the following: 
‘‘(cc) If the name or primary display panel of the food 
(other than a dietary supplement) refers to any character-
izing ingredient or component of the food, unless— 
‘‘(1) the characterizing ingredient or component 
is a predominant ingredient in the food; or 
‘‘(2) the primary display panel of the food in-
cludes, in letters not less than one-half the height of 
the letters used in the name of the food, the percent-
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age of each characterizing ingredient or component 
contained in the food.’’. 
(2) ENFORCEMENT
OF
CHARACTERIZING
IN-
GREDIENTS.—Not later than 2 years after the date 
of enactment of this Act and every 2 years there-
after, the Secretary of Health and Human Services 
shall submit a report to the Congress on the Sec-
retary’s enforcement of— 
(A) section 403(cc) of the Federal Food, 
Drug, and Cosmetic, as added by paragraph 
(1); and 
(B) regulations of the Food and Drug Ad-
ministration on characterizing ingredients and 
components, including section 102.5 of title 21, 
Code of Federal Regulations (and any successor 
regulations). 
(c) DECLARATION OF PHOSPHORUS ON THE INGRE-
DIENT LABEL.— 
(1) IN GENERAL.—Section 403 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 343 ), as 
amended, is further amended by adding at the end 
the following: 
‘‘(dd) If it is a food intended for human consumption 
that is offered for sale and contains phosphorus, unless— 
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‘‘(1) the phrase ‘contains phosphorus’, along 
with the quantity of phosphorus in the product, re-
ported in milligrams per serving, is printed imme-
diately after or is adjacent to the list of ingredients 
required under subsections (g) and (i), in a type size 
no smaller than the type size used in the list of in-
gredients; or 
‘‘(2) the quantity of phosphorus contained in 
the product, in milligrams, is reported in the Nutri-
tion Facts Panel.’’. 
SEC. 7. CAFFEINE CONTENT ON INFORMATION PANEL. 
Section 403(i) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 343(i)) is amended— 
(1) by striking ‘‘and (2)’’ and inserting ‘‘(2)’’; 
(2) by striking ‘‘and if the food purports’’ and 
inserting ‘‘, (3) if the food purports’’; and 
(3) by inserting ‘‘, and (4) if the food is food 
other than a dietary supplement and contains at 
least 10 milligrams of caffeine from all sources per 
serving, a statement (with appropriate prominence 
near the statement of ingredients required by this 
paragraph) of the number of milligrams of caffeine 
contained in one serving of the food and the size of 
such serving’’ after ‘‘vegetable juice contained in the 
food’’. 
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SEC. 8. FOOD ALLERGEN LABELING FOR SESAME. 
Section 201(qq)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(qq)(1)) is amended by strik-
ing ‘‘and soybeans’’ and inserting ‘‘soybeans, and ses-
ame’’. 
SEC. 9. INFORMATION ABOUT MAJOR FOOD ALLERGENS IN 
NONPREPACKAGED FOODS. 
(a) IN GENERAL.—Section 403(w) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 343(w)) is 
amended— 
(1) in subparagraph (1)(A), by striking ‘‘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)’’ and inserting ‘‘is 
printed as specified in subparagraph (8)’’; 
(2) in subparagraph (1)(B), by striking ‘‘in the 
list of ingredients required under subsections (g) 
and (i)’’ and inserting ‘‘as so printed’’; 
(3) in subparagraph (3), by striking ‘‘The infor-
mation’’ and inserting ‘‘Subject to subparagraph 
(8)(B), the information’’; and 
(4) by adding at the end the following: 
‘‘(8) The information required by subparagraph (1) 
to be conveyed to the consumer shall be— 
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‘‘(A) printed immediately after or 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) in the case of a nonpackaged food being 
offered for sale at retail, and not subject to the re-
quirements of subsections (g) and (i), placed on a 
sign adjacent to the food (in a type size no smaller 
than the name of the food item).’’. 
(b) APPLICABILITY.—The amendments made by sub-
section (a) apply beginning on the date that is 3 years 
after the date of enactment of this Act. 
SEC. 10. SUBMISSION AND AVAILABILITY OF FOOD LABEL 
INFORMATION. 
The Federal Food, Drug, and Cosmetic Act is amend-
ed by inserting after section 403C of such Act (21 U.S.C. 
343–3) the following: 
‘‘SEC. 403D. SUBMISSION AND AVAILABILITY OF FOOD 
LABEL INFORMATION. 
‘‘(a) SUBMISSIONS.— 
‘‘(1) REQUIREMENT.—The Secretary shall re-
quire the manufacturer or importer of any food that 
is introduced or delivered for introduction into inter-
state commerce in package form to submit to the 
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Secretary all information to be included in the label 
of the food, including— 
‘‘(A) the nutrition facts panel; 
‘‘(B) ingredients; 
‘‘(C) an image of the primary display 
panel; 
‘‘(D) allergy warnings or information; 
‘‘(E) claims under section 403(r)(1)(A) 
(popularly referred to as ‘nutrient-content 
claims’); 
‘‘(F) claims under section 403(r)(1)(B) 
(popularly 
referred 
to 
as 
‘health-related 
claims’); and 
‘‘(G) other relevant information required 
by law to be published in the labeling of the 
food. 
‘‘(2) UPDATES.—The Secretary shall require 
the manufacturer or importer of food to update or 
supplement the information submitted under para-
graph (1) with respect to the food in order to keep 
the information up-to-date and complete. 
‘‘(3) CIVIL PENALTY.—Whoever knowingly vio-
lates paragraph (1) with respect to any food shall be 
liable to the United States for a civil penalty in an 
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amount not to exceed $10,000 for each day on which 
such violation continues with respect to such food. 
‘‘(b) PUBLIC DATABASE.—The Secretary shall estab-
lish and maintain a public database containing the infor-
mation submitted under this section that— 
‘‘(1) is available to the public through the 
website of the Food and Drug Administration; and 
‘‘(2) allows members of the public to easily 
search and sort information.’’. 
SEC. 11. DEFINITIONS. 
(a) DEFINITIONS APPLICABLE IN THIS ACT.—In this 
Act, the terms ‘‘food’’ and ‘‘dietary supplement’’ have the 
meanings given to such terms in section 201 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 321). 
(b) DEFINITIONS APPLICABLE
IN
THE FEDERAL 
FOOD, DRUG, AND COSMETIC ACT.—Section 201 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) 
is amended by adding at the end the following: 
‘‘(ss) The term ‘artificial’, with respect to food or any 
ingredient of food, means— 
‘‘(1) food or an ingredient that is synthetically 
produced whether or not it has the same chemical 
structure as a naturally occurring food or ingredient; 
‘‘(2) food or an ingredient that has undergone 
chemical changes through the introduction of syn-
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thetic chemicals or processing aids (such as corn 
syrup, high-fructose corn syrup, high-maltose corn 
syrup, maltodextrin, chemically modified starch, and 
cocoa processed with alkali), excluding— 
‘‘(A) food or an ingredient that has under-
gone traditional processes used to make food 
edible, to preserve food, or to make food safe 
for human consumption (such as smoking, 
roasting, freezing, drying, and fermenting proc-
esses); or 
‘‘(B) food or ingredient that has undergone 
traditional physical processes that do not fun-
damentally alter the raw product or which only 
separate a whole intact food into component 
parts (such as grinding grains, separating eggs 
into albumen and yolk, or pressing fruits to 
produce juice); or 
‘‘(3) any food or ingredient that the Secretary 
specifies by regulation to be artificial for purposes of 
this Act. 
‘‘(tt) The term ‘synthetic’, with respect to a sub-
stance, means a substance that is formulated or manufac-
tured by a chemical process or by a process that chemi-
cally changes a substance extracted from a naturally oc-
curring plant, animal, or mineral source, except that such 
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term does not apply to a substance created by naturally 
occurring biological processes.’’. 
SEC. 12. APPLICABILITY; REGULATIONS. 
(a) APPLICABILITY.—The amendments made by— 
(1) subsections (a) and (b) of section 3, sub-
sections (b)(1) and (c) of section 6, and sections 7, 
8, 10, and 11(b) shall apply beginning on the date 
that is 2 years after the date of enactment of this 
Act; and 
(2) sections 2 and 9 shall apply beginning on 
the date that is 3 years after such date of enact-
ment. 
(b) REGULATIONS.— 
(1) PROPOSED REGULATIONS.—The Secretary 
of Health and Human Services shall propose regula-
tions— 
(A) not later than 1 year after the date of 
enactment of this Act, to implement the amend-
ments made by subsections (a) and (b) of sec-
tion 3, subsections (b)(1) and (c) of section 6, 
and sections 7, 8, 9, 10, and 11(b); and 
(B) not later than 2 years after such date 
of enactment, to implement the amendments 
made by section 2. 
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(2) FINAL
REGULATIONS.—The Secretary of 
Health and Human Services shall promulgate final 
regulations— 
(A) not later than 2 years after the date 
of enactment of this Act, to implement the 
amendments made by subsections (a) and (b) of 
section 3, subsections (b)(1) and (c) of section 
6, and sections 7, 8, 9, 10, and 11(b); and 
(B) not later than 3 years after such date 
of enactment to implement the amendments 
made by section 2. 
(3) DEADLINE.—If the Secretary of Health and 
Human Services does not issue a final regulation by 
the deadline specified in subparagraph (A) or (B) of 
paragraph (2), the corresponding proposed regula-
tion under subparagraph (A) or (B) of paragraph 
(1) shall become final on the respective deadline. 
Æ 
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