[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1289 Introduced in Senate (IS)]
<DOC>
118th CONGRESS
1st Session
S. 1289
To amend the Federal Food, Drug, and Cosmetic Act to strengthen
requirements related to nutrient information on food labels, and for
other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 26, 2023
Mr. Blumenthal (for himself, Mr. Whitehouse, Mr. Markey, Mr. Booker,
and Mr. Cardin) introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
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 Representatives 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 2023''.
(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-package labeling for
foods.
Sec. 3. Claims for conventional foods.
Sec. 4. Use of specific terms.
Sec. 5. Format of ingredient list.
Sec. 6. Declaration of phosphorus in the ingredient list.
Sec. 7. Caffeine content on information panel.
Sec. 8. Food allergen labeling.
Sec. 9. Information about major food allergens and gluten-containing
grains.
Sec. 10. Submission and availability of food label information.
Sec. 11. Standards of identity.
Sec. 12. Study on fortification of corn masa flour.
Sec. 13. Sugar alcohols and isolated fibers.
Sec. 14. Infant and toddler beverages.
Sec. 15. Formatting of information on principal display panels.
Sec. 16. Sale of food online.
Sec. 17. Definitions.
Sec. 18. Regulations; delayed applicability.
SEC. 2. ADDITIONAL REQUIREMENTS FOR FRONT-OF-PACKAGE LABELING FOR
FOODS.
(a) Interpretive Nutrition Information.--Section 403 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at
the end the following:
``(z)(1) Except as provided in subparagraphs (3), (4), and (5) of
paragraph (q), if it is food (other than a dietary supplement) intended
for human consumption and is offered for sale and otherwise required to
bear nutrition labeling, unless its principal display panel bears
interpretive nutrition information.
``(2) Final regulations regarding the interpretive nutrition
information required under subparagraph (1) shall meet the following
criteria:
``(A) There shall be a standardized symbol system that
displays calorie information related to the serving size
determined under paragraph (q)(1)(A), and interpretive
nutrition information related to the content of added sugars,
sodium, saturated fat, and any other nutrients that the
Secretary determines the highlighting of which will assist
consumers in maintaining healthy dietary practices, including
by highlighting products containing high levels of such
nutrients.
``(B) The system shall clearly distinguish between products
of greater or lesser nutritional value.
``(C) The information shall--
``(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 legible.
``(3) In promulgating regulations regarding the interpretive
nutrition information required under subparagraph (1) and the
standardized symbol system required under subparagraph (2)(A), the
Secretary shall take into account published reports by the Health and
Medicine Division of the National Academy of Sciences, Engineering, and
Medicine regarding interpretive nutrition information, and base
regulations on the following principles:
``(A) Consumers should be able to quickly and easily
comprehend the meaning of the system as an indicator of a
product's contribution to a healthy diet without requiring
specific or sophisticated nutritional knowledge.
``(B) The nutrition information should be consistent with
the Nutrition Facts Panel and with the recommendations of the
Dietary Guidelines for Americans.
``(C) The information should aim to facilitate consumer
selection of healthy product options, including among
nutritionally at-risk subpopulations.
``(4) The Secretary should periodically evaluate the standardized
symbol system required under subparagraph (2)(A) to assess its
effectiveness in facilitating consumer selection of healthy product
options and the extent to which manufacturers are offering healthier
products as a result of the disclosure.
``(5) The implementation of this paragraph should be accompanied by
appropriate consumer education and promotion campaigns determined by
the Secretary.''.
(b) Percentage of Wheat and Grains in Grain-Based Products, and
Amount of Real Fruit, Vegetable, and Yogurt in Products Bearing Fruit,
Vegetable, and Yogurt Claims.--Section 403 of the Federal Food, Drug,
and Cosmetic Act, as amended by subsection (a), is further amended by
adding at the end the following:
``(aa) If, in the case of food other than a dietary supplement, the
principal display panel bears--
``(1) the term `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
``(4) any similar descriptive phrases, terms, or
representations suggesting the product contains whole grains,
unless the amounts of whole grains and refined grains, expressed as a
percentage of total grains, are conspicuously disclosed in immediate
proximity to the most prominent descriptive phrase, term, or
representation using a font color and formatting of equivalent
prominence to the descriptive phrase, term, or representation with
respect to whole grain content, or unless 100 percent of the grains in
the food are whole grains.
``(bb)(1) If, in the case of food other than a dietary supplement,
the principal display panel bears--
``(A) the term `fruit', `fruity', `froot', `frooty', or
`fruit-flavored';
``(B) representations, depictions, or images of such
ingredients; or
``(C) any similar descriptive phrases, terms, or
representations suggesting the product contains fruit or any
specific type of fruit,
unless the quantity per serving and form of fruit, including only the
nutrient-dense forms, is declared on the principal display panel in a
common household measure that is appropriate to the food,
conspicuously, and in immediate proximity to the most prominent term,
representation, depiction, or image of fruit.
``(2) The Secretary shall by regulation establish quantities below
which such declaration shall state that the food does not contain any
full serving of fruit.
``(3) In this paragraph, the term `nutrient-dense', with respect to
the form of an ingredient derived from a fruit, means the whole, cut,
dried, pulp, puree, 100-percent juice, or fully reconstituted
concentrate form, and not concentrates, powders, and other ingredients
that are not whole, cut, dried, pulp, puree, 100-percent juice, or
fully reconstituted concentrates.
``(cc)(1) If, in the case of food other than a dietary supplement,
the principal display panel bears--
``(A) the term `vegetable' or `veggie';
``(B) representations, depictions, or images of such
ingredients; or
``(C) any similar descriptive phrases, terms, or
representations suggesting the product contains vegetables or
any specific type of vegetable,
unless the quantity per serving and form of vegetable, including only
the nutrient-dense form, is declared on the principal display panel in
a common household measure that is appropriate to the food,
conspicuously, and in immediate proximity to the most prominent term,
representation, depiction, or image of vegetable.
``(2) The Secretary shall by regulation establish quantities below
which such declaration shall state that the food does not contain any
full serving of vegetable.
``(3) In this paragraph, the term `nutrient-dense', with respect to
the form of an ingredient derived from a vegetable, means the whole,
cut, dried, pulp, puree, 100-percent juice, or fully reconstituted
concentrate form, and not concentrates, powders, and other ingredients
that are not whole, cut, dried, pulp, puree, 100-percent juice, or
fully reconstituted concentrates.
``(dd)(1) If, in the case of food other than a dietary supplement,
the principal display panel bears the term `yogurt', unless--
``(A) the quantity per serving of yogurt is declared on the
principal display panel in a common household measure that is
appropriate to the food, conspicuously, in immediate proximity
to the term; or
``(B) the first ingredient is cultured milk, cultured
cream, cultured partially skimmed milk, or cultured skim milk.
``(2) The Secretary shall by regulation establish quantities below
which such declaration shall state that the food does not contain any
full serving of yogurt.''.
(c) Coloring and Flavoring.--Section 403 of the Federal Food, Drug,
and Cosmetic Act, as amended by subsection (b), is further amended by
adding at the end the following:
``(ee) If, in the case of food other than a dietary supplement, it
bears or contains any artificial dye, or any added artificial or
natural flavoring, unless such fact is prominently stated on the
principal display panel of the packaging of the food. For the purposes
of this paragraph, the term `artificial dye' refers to a batch-
certified dye certified under part 74 of title 21, Code of Federal
Regulations (or any successor regulations).''.
(d) Sweeteners.--
(1) In general.--Section 403 of the Federal Food, Drug, and
Cosmetic Act, as amended by subsection (c), is further amended
by adding at the end the following:
``(ff) If, in the case of food other than a dietary supplement, it
bears or contains any added artificial or natural noncaloric sweetener,
unless such fact is prominently stated on the principal display panel
of the packaging of the food.''.
(2) Report.--
(A) In general.--Not later than 2 years after the
date of enactment of this Act, the Secretary of Health
and Human Services (referred to in this Act as the
``Secretary'') shall submit to Congress a report that--
(i) evaluates whether--
(I) manufacturers have increased
the use of low- and no-calorie
sweeteners; and
(II) the use of low- and no-calorie
sweeteners has risen to a level that
could result in negative health
consequences; and
(ii) describes actions that will be taken
by the Secretary to address any increased use
of low- and no-calorie sweeteners.
(B) Monitoring.--On completion of the report
described in subparagraph (A), the Secretary shall--
(i) periodically monitor for increased use
of low- and no-calorie sweeteners; and
(ii) take action to address the use of low-
and no-calorie sweeteners if the use has risen
to a level that could result in negative health
consequences.
(e) Construction.--Nothing in this section, including any amendment
made by this section, shall be construed as--
(1) 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
(2) 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 effect that a nutrient may have on the structure
or function of the human body, characterizes the documented
mechanism by which that nutrient acts to maintain such
structure or function, or describes general well-being from
consumption of that nutrient,''.
(2) Substantiation of claim.--Section 403(r) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)) is amended--
(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 manufacturer's possession relating to the
claim.''.
(3) Incompatible with maintaining healthy dietary
practices.--Section 403(r)(3)(A)(ii) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 343(r)(2)(B)) is amended by
striking ``increases to persons in the general population the
risk of a disease or health-related condition which is diet
related'' and inserting ``may not be compatible with
maintaining healthy dietary practices''.
(b) Nutrient Content Claims.--
(1) In general.--Section 403(r)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 343(r)(2)) is amended by
striking clause (B) and inserting the following:
``(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 may not be compatible
with maintaining healthy dietary practices, the label or labeling of
such food shall contain, prominently and in immediate proximity to such
claim, a statement which indicates the food is high in such
nutrient.''.
(2) Revisions to regulations.--In promulgating 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 Regulations, 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 Nutrition and Supplement
Facts Labels'' published by the Food and Drug
Administration on May 27, 2016 (81 Fed. Reg. 33741);
(B) including a level of added sugars requiring
disclosure based on the Daily Reference Value for added
sugars established in the final rule described 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 implied
``low added sugar'' claims on products containing 3
grams of added sugars or less per 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 Federal 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 following 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 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
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 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 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 regulations 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 information 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
(B) based on data, including data on consumers'
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 submissions regarding
relevant consumer research, including with respect to
consumer understanding of the term ``natural'' in
relation to the term ``organic''; and
(B) fully consider the results of such surveys and
studies, as well as such public submissions.
(b) Use of Term ``Healthy''.--
(1) Added sugars and whole grains.--
(A) In general.--In promulgating the regulations
required by section 18, the Secretary of Health and
Human Services shall include 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 the extent
to which such food contains added sugars or whole
grains.
(B) Requirement.--In making the revisions 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 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
dietary supplement) to align labeling requirements related to
sodium with the daily value for sodium in the most recent
Dietary Guidelines for Americans.
(3) Principles for implementing regulations.--In
promulgating regulations under paragraphs (1) and (2) regarding
the use of the term ``healthy'', the Secretary of Health and
Human Services shall--
(A) consider both food and nutrient criteria; 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 pattern; and
(ii) consider these ingredients only in
their nutrient-dense forms (as such term in
defined in paragraphs (bb) and (cc) of section
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 requirements described in
subsection (a) shall include requirements 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 packages 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
Secretary'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 Administration on
labeling of ingredients in section 101.4 of title 21, Code of
Federal Regulations.
SEC. 6. DECLARATION OF PHOSPHORUS IN THE INGREDIENT LIST.
Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
343), as amended by section 2(d), is further 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, reported in milligrams
per serving, is printed immediately 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
ingredients; or
``(2) the quantity of phosphorus contained in the product,
in milligrams, is reported in the Nutrition Facts Panel.''.
SEC. 7. CAFFEINE CONTENT ON INFORMATION PANEL.
Section 403(i) of the Federal Food, Drug, and Cosmetic 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:
``(3) Any other food ingredient that the Secretary
determines by regulation to be a major food allergen, based on
the prevalence and severity of allergic 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)'';
(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 information''
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 requirements 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 subparagraphs (1),
(2), (4), and (7); and
(6) in subparagraph (7)(A)--
(A) by striking ``paragraph (6)'' and inserting
``subparagraph (6)''; and
(B) by striking ``allergen labeling requirements of
this subsection'' and inserting ``allergen and gluten-
containing grain labeling requirements of this
paragraph''.
(b) Hazard Analysis and Preventive Controls.--Section 418 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350g) is amended--
(1) in subsection (b)(1)(A), by inserting ``gluten-
containing grains,'' after ``allergens,''; and
(2) in subsection (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
``allergens'' each place it appears.
SEC. 10. SUBMISSION AND AVAILABILITY OF FOOD LABEL INFORMATION.
The Federal Food, Drug, and Cosmetic Act is amended 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 require the
manufacturer or importer of any food that is introduced or
delivered for introduction into interstate 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) (commonly
known as `nutrient-content claims');
``(F) claims under section 403(r)(1)(B) (commonly
known 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 paragraph (1) with respect to the
food in order to keep the information up-to-date and complete.
``(3) Civil penalty.--Whoever knowingly violates 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 establish and maintain
a public database containing the information 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 containing high
levels of such nutrients; and
(2) report to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health,
Education, Labor, and Pensions 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 regulations to--
(1) provide for the use of salt substitutes where
appropriate; and
(2) require that yogurt, lowfat yogurt, and nonfat 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.
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 revise--
(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 formula'' or use the term ``formula'' in combination
with any other term; and
(2) part 102 of title 21, Code of Federal Regulations, so
that--
(A) in the case of any powdered or liquid 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 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 identifying 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 flavorings, include
in such common or usual name qualifying terms
such as ``sweetened'' and ``flavored'' when
applicable; 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
recommended 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 suggesting a
recommended intake of such beverages, such as
``one cup a day''.
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 enactment of
this Act, conduct a study on the legibility of food labeling to
determine updated recommendations for text size and color
contrast that make food labeling information visually
accessible to the majority 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 consideration
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 proposed 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 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 information 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 format and
manner in which the information required under subparagraph (1) is to
be made available online to consumers. Such regulations shall include--
``(A) a requirement that the nutrition information shall be
in the same format as the nutrition information required under
paragraph (q); and
``(B) a requirement that the nutrition information required
under paragraph (q), the ingredient information required under
paragraphs (g) and (i), and the allergen information required
under paragraph (w) shall--
``(i) appear on the first product information page
that appears for the product on a mobile device,
internet website, or other landing page;
``(ii) appear prominently and conspicuously (as
compared with other words, statements, or designs on
the mobile device, internet website, or other landing
page) so as to render the information likely to be read
and understood by the ordinary individual under
customary conditions of online purchase; and
``(iii) not contain intervening marketing
information.''.
(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 person of an additional fee for the provision of such
information.''.
(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 $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 opportunity 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 consideration 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 introduction 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
described in that section, 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 $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 opportunity 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 consideration 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 Federal 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:
``(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 synthetic 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 undergone
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 processes); or
``(B) food or an ingredient that has undergone
traditional physical processes that do not
fundamentally 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.
``(uu) The term `synthetic', with respect to a substance in food or
any ingredient of food, means a substance that is formulated or
manufactured by a chemical process or by a process that chemically
changes a substance 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 thereof):
``(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 persons with
celiac disease.
``(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 applications, 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
paragraph (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.
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