and Human Services shall not consider the food 
to be ‘‘healthy’’ unless 100 percent of the 
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 
(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 
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(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. 
(b) FORMAT REQUIREMENTS.—The format require-
ments described 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 
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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 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)), including with 
respect to the regulations described in 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— 
‘‘(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 
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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’’. 
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: 
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‘‘(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 
the Food and Drug Administration’s 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’’; 
(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 ‘‘food allergen’’ each place it appears in sub-
paragraphs (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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‘‘(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 
(2) report to the Committee on Energy and 
Commerce of the House of Representatives and the 
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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 on April 15, 2016 
(81 Fed. Reg. 22176), on folic acid intake in the United 
States population by race and ethnicity, comparing actual 
exposure with modeled exposure 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. 
SEC. 16. SALE OF FOOD ONLINE. 
(a) IN GENERAL.—Section 403 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 343), as amended by 
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section 13, is further amended by adding at the end the 
following: 
‘‘(ii)(1) If it is a food offered for sale online or by 
other remote written electronic means, unless all informa-
tion required to appear on the label or labeling is available 
to consumers at the point of selection prior to purchasing 
the food. 
‘‘(2) The Secretary shall by regulation specify the for-
mat and manner in which the information required under 
subparagraph (1) is to be made available online to con-
sumers. Such regulations shall include— 
‘‘(A) a requirement that the nutrition informa-
tion shall be in the same format as the nutrition in-
formation required under paragraph (q); and 
‘‘(B) a requirement that the nutrition informa-
tion required under paragraph (q), the ingredient in-
formation required under paragraphs (g) and (i), 
and the allergen information required under para-
graph (w) shall— 
‘‘(i) appear on the first product informa-
tion page that appears for the product on a mo-
bile device, internet website, or other landing 
page; 
‘‘(ii) appear prominently and conspicuously 
(as compared with other words, statements, or 
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designs on the mobile device, internet website, 
or other landing page) so as to render the infor-
mation likely to be read and understood by the 
ordinary individual under customary conditions 
of online purchase; and 
‘‘(iii) not contain intervening marketing in-
formation.’’. 
(b) PROHIBITED ACTS.— 
(1) IN GENERAL.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is 
amended by adding at the end the following: 
‘‘(jjj) In the case of a person providing a platform 
for, or otherwise assisting, the sale of food online or by 
other remote written electronic means, the prevention by 
the person of the provision to consumers of information 
required under section 403(z) or the charging by such per-
son of an additional fee for the provision of such informa-
tion.’’. 
(2) PENALTIES.—Section 303 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333) is 
amended by adding at the end the following: 
‘‘(h)(1) Notwithstanding subsection (a), any person 
who violates section 301(jjj) shall be liable to the United 
States for a civil penalty in an amount not to exceed 
$10,000 for each such violation, and not to exceed 
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$1,000,000 for all such violations adjudicated in a single 
proceeding. 
‘‘(2) The Secretary shall provide the person subject 
to a penalty under paragraph (1) with a warning and op-
portunity to correct the violation prior to issuing the first 
civil penalty under that paragraph. 
‘‘(3) In determining the amount of a civil penalty 
under paragraph (1), the Secretary shall take into consid-
eration whether the person is making efforts to correct 
the violation for which such person is subject to such civil 
penalty. 
‘‘(4) No person shall be subject to criminal penalties 
as described in subsection (a) for a violation of section 
301(jjj).’’. 
(c) CIVIL MONETARY PENALTIES FOR VIOLATION OF 
REQUIREMENTS FOR SALE OF FOOD ONLINE.—Section 
303 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 333) (as amended by subsection (b)(2)) is amended 
by adding at the end the following: 
‘‘(i)(1) Notwithstanding subsection (a), any person 
who introduces into interstate commerce, delivers for in-
troduction into interstate commerce, receives in interstate 
commerce, or manufactures a food that is misbranded as 
described in section 403(z), or misbrands the food as de-
scribed in that section, shall be liable to the United States 
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for a civil penalty in an amount not to exceed $10,000 
for each such violation, and not to exceed $1,000,000 for 
all such violations adjudicated in a single proceeding. 
‘‘(2) The Secretary shall provide the person subject 
to a penalty under paragraph (1) with a warning and op-
portunity to correct the violation prior to issuing the first 
civil penalty under that paragraph. 
‘‘(3) In determining the amount of a civil penalty 
under paragraph (1), the Secretary shall take into consid-
eration whether the person is making efforts to correct 
the violation for which such person is subject to such civil 
penalty. 
‘‘(4) No person shall be subject to criminal penalties 
as described in subsection (a) for a violation described in 
paragraph (1).’’. 
SEC. 17. 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: 
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‘‘(tt) 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 
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 
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‘‘(3) any food or ingredient that the Secretary 
specifies by regulation to be artificial for purposes of 
this Act. 
‘‘(uu) 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. 
‘‘(vv) 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. 
‘‘(ww) 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. 
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‘‘(xx) The term ‘online’ means on or by any system 
of data communication and transmission, such as the 
internet. 
‘‘(yy) 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 
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 
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(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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