(2) REVISIONS TO REGULATIONS.—In promul-
gating the regulations required by section 18, the 
Secretary of Health and Human Services shall revise 
section 101.13(h) of title 21, Code of Federal Regu-
lations, by— 
(A) updating the level of sodium requiring 
disclosure to align with the Daily Reference 
Value for sodium established in the final rule 
entitled ‘‘Food Labeling: Revision of the Nutri-
tion and Supplement Facts Labels’’ published 
by the Food and Drug Administration in the 
Federal Register on May 27, 2016 (81 Fed. 
Reg. 33742 et seq.); 
(B) including a level of added sugars re-
quiring disclosure based on the Daily Reference 
Value for added sugars established in the final 
rule referenced in subparagraph (A); 
(C) eliminating the requirement that meal 
products containing more than 26 grams of fat 
and main dish products containing 19.5 grams 
of fat per labeled serving must disclose that fat 
is present in the food; and 
(D) authorizing the use of express and im-
plied ‘‘low added sugar’’ claims on products 
containing 3 grams of added sugars or less per 
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reference amount customarily consumed (or per 
50 grams if the reference amount customarily 
consumed is 30 grams or less or 2 tablespoons 
or less). 
(c) 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) by redesignating subclauses (v) and (vi) as 
subclauses (vi) and (vii), respectively; and 
(2) 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, except on the Nutrition 
Facts Panel, unless the food contains less than one 
gram of saturated fat per serving or, if the food con-
tains more than one gram of saturated fat per serv-
ing, unless the label or labeling of the food discloses 
the level of saturated fat in the food in immediate 
proximity to such claim and with appropriate promi-
nence which shall be no less than one-half the size 
of the claim with respect to the level of trans fats;’’. 
(d) 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 
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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.—In promulgating the regula-
tions required by section 18, the Secretary of Health 
and Human Services shall include regulations— 
(A) relating to use of the term ‘‘natural’’ 
on the labeling of food (other than a dietary 
supplement); 
(B) specifically addressing the use of such 
term on the principal display panel and the in-
formation panel; and 
(C) requiring that any such use includes a 
prominent disclosure explaining what the term 
‘‘natural’’ does and does not mean in terms of 
ingredients and manufacturing processes. 
(2) DEFINITION.—The regulations promulgated 
pursuant to paragraph (1) shall define the term 
‘‘natural’’— 
(A) to exclude, at a minimum, the use of 
any artificial food or ingredient (including any 
artificial flavor or added color); and 
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(B) based on data, including data on con-
sumers’ understanding of the term as used in 
connection with food. 
(3) PROCESS.—In promulgating the regulations 
required 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 
(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.— 
(A) IN
GENERAL.—In promulgating the 
regulations required by section 18, the Sec-
retary of Health and Human Services shall in-
clude regulations to revise the regulations under 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) relating to the use of the 
term ‘‘healthy’’ on the labeling of a food (other 
than a dietary supplement) to take into account 
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the extent to which such food contains added 
sugars or whole grains. 
(B) REQUIREMENT.—In making the revi-
sions required by subparagraph (A) in the case 
of a food (other than a dietary supplement) 
that contains grains, the Secretary of Health 
and Human Services shall not consider the food 
to be ‘‘healthy’’ unless 100 percent of those 
grains are whole grains. 
(2) SODIUM.—In promulgating the regulations 
required by section 18, the Secretary of Health and 
Human Services shall revise the regulations under 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) relating to the use of the term 
‘‘healthy’’ on the labeling of a food (other than a di-
etary supplement) to align labeling requirements re-
lated to sodium with the daily value for sodium in 
the most recent Dietary Guidelines for Americans. 
(3) PRINCIPLES FOR IMPLEMENTING REGULA-
TIONS.—In promulgating regulations under para-
graphs (1) and (2) regarding the use of the term 
‘‘healthy’’, the Secretary of Health and Human 
Services shall— 
(A) consider both food and nutrient cri-
teria; and 
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(B) if requiring food labeled as ‘‘healthy’’ 
to contain healthful ingredients— 
(i) consider only ingredients that 
make up the core of a healthy eating pat-
tern; and 
(ii) consider these ingredients only in 
their nutrient-dense forms (as such term in 
defined in paragraphs (bb) and (cc) of sec-
tion 403 of the Federal Food, Drug, and 
Cosmetic Act, as added by section 2(b) of 
this Act). 
SEC. 5. FORMAT OF INGREDIENT LIST. 
(a) IN GENERAL.—In promulgating the regulations 
required by section 18, 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))— 
(1) for the purpose of improving the readability 
of such information on the label of the food (other 
than a dietary supplement); and 
(2) that are, as determined by the Secretary, 
necessary to assist consumers in maintaining healthy 
dietary practices. 
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(b) FORMAT REQUIREMENTS.—The format require-
ments referred to in subsection (a) shall include require-
ments for font size, uppercase and lowercase characters, 
serif and noncondensed font types, high-contrast between 
text and background, and bullet points between adjacent 
ingredients with appropriate exemptions for small pack-
ages or other considerations. 
(c) ENFORCEMENT OF INGREDIENT LIST.—Not later 
than 2 years after the enactment of this Act, and every 
2 years thereafter, the Secretary of Health and Human 
Services shall submit a report to the Congress on the Sec-
retary’s enforcement of— 
(1) section 403(i) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 343(i)), as amended 
pursuant to subsection (a); and 
(2) regulations of the Food and Drug Adminis-
tration on labeling of ingredients in section 101.4 of 
title 21, Code of Federal Regulations. 
SEC. 6. DECLARATION OF PHOSPHORUS IN THE INGRE-
DIENT LIST. 
Section 403 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 343), as amended by section 2(d), is fur-
ther amended by adding at the end the following: 
‘‘(gg) 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 paragraphs (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. 
(a) IN GENERAL.—Section 201(qq) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)) is 
amended by adding at the end the following: 
‘‘(3) Any other food ingredient that the Sec-
retary determines by regulation to be a major food 
allergen, based on the prevalence and severity of al-
lergic reactions to the food ingredient.’’. 
(b) UPDATE TO COMPLIANCE POLICY GUIDE.—Not 
later than 2 years after the date of enactment of this Act, 
the Secretary of Health and Human Services shall update 
Compliance Policy Guide, section 555.250, to conform 
with applicable laws related to major food allergens and 
gluten-containing grains, including requirements under 
sections 9 and 10 of this Act. 
SEC. 9. INFORMATION ABOUT MAJOR FOOD ALLERGENS 
AND GLUTEN-CONTAINING GRAINS. 
(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)’’; 
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(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— 
‘‘(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 paragraphs (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 paragraphs (g) and (i), placed on a 
sign adjacent to the food (in a type size no smaller 
than the name of the food item).’’; 
(5) by inserting ‘‘or gluten-containing grain’’ 
after each reference to ‘‘food allergen’’ in subpara-
graphs (1), (2), (4), and (7); and 
(6) in subparagraph (7)(A)— 
(A) by striking ‘‘paragraph (6)’’ and in-
serting ‘‘subparagraph (6)’’; and 
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(B) by striking ‘‘allergen labeling require-
ments of this subsection’’ and inserting ‘‘aller-
gen and gluten-containing grain labeling re-
quirements of this paragraph’’. 
(b) HAZARD
ANALYSIS
AND
PREVENTIVE
CON-
TROLS.—Section 418 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 350g) is amended— 
(1) in subsection (b)(1)(A), by inserting ‘‘and 
gluten-containing grains,’’ after ‘‘allergens,’’; and 
(2) in subsubsection (o)(3)(D), by inserting 
‘‘and gluten-containing grain’’ after ‘‘allergen,’’. 
(c) INSPECTIONS RELATING TO FOOD ALLERGENS.— 
Section 205 of the Food Allergen Labeling and Consumer 
Protection Act of 2004 (21 U.S.C. 374a) is amended by 
inserting ‘‘and gluten-containing grains,’’ after ‘‘aller-
gens’’ each place it appears. 
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.— 
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‘‘(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 
Secretary all information to be included in the label 
of the food, including— 
‘‘(A) the nutrition facts panel; 
‘‘(B) the ingredients list; 
‘‘(C) an image of the principal display 
panel; 
‘‘(D) major allergens and gluten-containing 
grains; 
‘‘(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-
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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 
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. STANDARDS OF IDENTITY. 
(a) IN GENERAL.—Not later than 2 years after the 
date of enactment of this Act, the Secretary of Health and 
Human Services shall— 
(1) review standards of identity prescribed by 
regulation which require foods to contain— 
(A) minimum levels of nutrients that the 
Secretary determines are strongly associated 
with public health concerns; or 
(B) minimum levels of ingredients con-
taining high levels of such nutrients; and 
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(2) report to the Committee on Energy and 
Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate on the findings of such review. 
(b) AMENDMENTS.—In promulgating the regulations 
required by section 18, the Secretary of Health and 
Human Services shall amend standards of identity regula-
tions to— 
(1) provide for the use of salt substitutes where 
appropriate; and 
(2) require that yogurt, lowfat yogurt, and non-
fat yogurt contain a minimum level of live and active 
cultures per gram. 
SEC. 12. STUDY ON FORTIFICATION OF CORN MASA FLOUR. 
Not later than 2 years after the date of enactment 
of this Act, the Secretary of Health and Human Services 
shall submit a report to Congress on the effect of the final 
rule titled ‘‘Food Additives Permitted for Direct Addition 
to Food for Human Consumption; Folic Acid’’ published 
by the Food and Drug Administration in the Federal Reg-
ister on April 15, 2016 (81 Fed. Reg. 22176 et seq.), on 
folic acid intake in the United States population by race 
and ethnicity, comparing actual exposure with modeled ex-
posure estimates from the final rule. 
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SEC. 13. SUGAR ALCOHOLS AND ISOLATED FIBERS. 
Section 403 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 343), as amended by section 6, is further 
amended by adding at the end the following: 
‘‘(hh) If it is a food intended for human consumption 
that is offered for sale and contains allulose, polydextrose, 
sugar alcohols, or isolated fibers, unless such fact is 
prominently stated on the principal display panel of the 
packaging of the food. The Secretary shall by regulation 
establish quantities above which such labeling shall include 
a warning that the food contains a level of allulose, 
polydextrose, sugar alcohols, or isolated fibers per serving 
determined by the Secretary to cause deleterious health 
effects.’’. 
SEC. 14. INFANT AND TODDLER BEVERAGES. 
In promulgating the regulations required by section 
18, the Secretary of Health and Human Services shall re-
vise— 
(1) section 101.3 of title 21, Code of Federal 
Regulations, to prohibit any beverage in powder or 
liquid form, other than infant formula, represented 
or purported to be for use by children more than 12 
months old, from being identified as ‘‘infant for-
mula’’ or use the term ‘‘formula’’ in combination 
with any other term; and 
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(2) part 102 of title 21, Code of Federal Regu-
lations, so that— 
(A) in the case of any powdered or liquid 
milk-based beverage that claims to be for con-
sumption by children 12 to 36 months of age, 
such beverage shall— 
(i) use as its common or usual name 
a descriptive term such as ‘‘milk-based 
drink’’; and 
(ii) if the beverage contains added 
sugars, 
nonnutritive 
sweeteners, 
or 
flavorings, include in such common or 
usual name a qualifying term such as 
‘‘sweetened’’ or ‘‘flavored’’; 
(B) in the case of any powdered or liquid 
nondairy-milk-based beverage that claims to be 
for consumption by children 12 to 36 months of 
age, such beverage shall— 
(i) use as its common or usual name 
an appropriately descriptive term identi-
fying the source of protein, such as ‘‘soy- 
based drink powder for 12–36 month 
olds’’; and 
(ii) if the beverage contains added 
sugars, 
nonnutritive 
sweeteners, 
or 
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flavorings, include in such common or 
usual name qualifying terms such as 
‘‘sweetened’’ and ‘‘flavored’’ when applica-
ble; and 
(C) the labeling of a beverage described in 
subparagraph (A) or (B) shall— 
(i) contain a disclaimer that— 
(I) cautions against consumption 
of the beverage by infants, such as 
‘‘DO NOT SERVE TO INFANTS 
UNDER 12 MONTHS OLD’’; and 
(II) such beverages are not rec-
ommended for children 12 to 24 
months of age and such consumption 
of such beverages is not required for 
a healthy diet, such as ‘‘This product 
contains added sugars. The Dietary 
Guidelines for Americans recommend 
to avoid food and beverages with 
added sugars for children younger 
than 24 months of age.’’; and 
(ii) not contain any statement sug-
gesting a recommended intake of such bev-
erages, such as ‘‘one cup a day’’. 
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SEC. 15. FORMATTING OF INFORMATION ON PRINCIPAL 
DISPLAY PANELS. 
The Secretary of Health and Human Services shall— 
(1) not later than 2 years after the date of en-
actment of this Act, conduct a study on the legibility 
of food labeling to determine updated recommenda-
tions for text size and color contrast that make food 
labeling information visually accessible to the major-
ity of consumers; 
(2) not later than 1 year after the completion 
of the study under paragraph (1), issue proposed 
regulations revising section 101.2(c) of title 21, 
Code of Federal Regulations, to— 
(A) set the scale of text size, taking into 
consideration the results of the study conducted 
under paragraph (1); and 
(B) establish new requirements for text 
and background color contrast, taking into con-
sideration the results of the study conducted 
under paragraph (1); and 
(3) not later than 2 years after the completion 
of the study under paragraph (1), finalize such pro-
posed regulations. 
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SEC. 16. SALE OF FOOD ONLINE. 
Section 403 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 343), as amended by section 13, is further 
amended by adding at the end the following: 
‘‘(ii) SALE OF FOOD ONLINE.— 
‘‘(1) If it is a food offered for sale online, un-
less all information required to appear on the label 
or labeling under this section is available to con-
sumers at the online point of selection prior to pur-
chasing the food. 
‘‘(2) The Secretary shall by regulation specify 
the format and manner in which the information re-
quired under subparagraph (1) is to be made avail-
able online to consumers. 
‘‘(3) Foods shall be exempt from the require-
ments of this paragraph if they are foods that are 
offered for sale by a retailer with annual gross sales 
of not more than $500,000, or with annual gross 
sales of foods or dietary supplements to consumers 
of not more than $50,000, so long as such retailers 
do not provide nutrition information or make a nu-
trient content or health claim at the online point of 
purchase.’’. 
SEC. 17. DEFINITIONS. 
(a) DEFINITIONS APPLICABLE IN THIS ACT.—In this 
Act, the terms ‘‘food’’ and ‘‘dietary supplement’’ have the 
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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-
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 an ingredient that has under-
gone traditional physical processes that do not 
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fundamentally alter the raw product or which 
only separate a whole intact food into compo-
nent 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 in food or any ingredient of food, means a sub-
stance that is formulated or manufactured by a chemical 
process or by a process that chemically changes a sub-
stance extracted from a naturally occurring plant, animal, 
or mineral source, except that such term does not apply 
to a substance created by naturally occurring biological 
processes. 
‘‘(uu) The term ‘gluten-containing grains’ means any 
one of the following grains (or any crossbred hybrid there-
of): 
‘‘(1) Wheat, including any species belonging to 
the genus Triticum. 
‘‘(2) Rye, including any species belonging to the 
genus Secale. 
‘‘(3) Barley, including any species belonging to 
the genus Hordeum. 
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‘‘(vv) The term ‘gluten’ means the proteins that— 
‘‘(1) naturally occur in a gluten-containing 
grain; and 
‘‘(2) may cause adverse health effects in per-
sons with celiac disease. 
‘‘(ww) The term ‘online’ means on or by any system 
of data communication and transmission, such as the 
internet. 
‘‘(xx) The term ‘online point of selection’ means any 
space in which consumers are allowed to purchase food 
online, including websites, e-commerce platforms, web ap-
plications, and mobile applications.’’. 
SEC. 18. REGULATIONS; DELAYED APPLICABILITY. 
(a) REGULATIONS.— 
(1) PROPOSED REGULATIONS.—Not later than 
1 year after the date of enactment of this Act, the 
Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall 
issue proposed regulations to carry out sections 2, 3, 
4, 5(a), 6, 7, 9, 10, 11, 13, 14, 16, and 17(b) and 
the amendments made by such sections. 
(2) FINAL
REGULATIONS.—Not later than 2 
years after the date of enactment of this Act, the 
Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall 
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finalize the regulations proposed pursuant to para-
graph (1). 
(3) FAILURE TO ISSUE FINAL REGULATION.—If 
the Secretary of Health and Human Services does 
not issue a final regulation as required by paragraph 
(2) by the deadline specified in such paragraph, the 
corresponding proposed regulation shall become final 
on such deadline. 
(b) DELAYED
APPLICABILITY.—The amendments 
made by sections 2, 3, 4, 5(a), 6, 7, 9, 10, 11, 13, 14, 
16, and 17(b) apply beginning on the date that is 3 years 
after the date of enactment of this Act. 
Æ 
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