Title: Food Labeling Modernization Act of 2021
Policy area: Agriculture and Food

Summary:
Food Labeling Modernization Act of 2021
This bill imposes additional labeling requirements for food and addresses related issues.
A food intended for human consumption must include on its principal display panel a summary of nutritional information using a system that (1) clearly distinguishes between products of greater or lesser nutritional value; and (2) uses standardized symbols to provide warning about products that are high in certain substances, such as trans fats. The Food and Drug Administration (FDA) must promulgate regulations establishing the requirements for such a system.
Labels that use certain terms, such as whole wheat, fruit, or vegetable, must include additional information, such as the amount or quantity of that item in the food.
The FDA must promulgate certain regulations relating to the use of the terms natural or healthy on food labels. The bill also imposes labeling requirements for certain foods that contain added coloring, added flavoring, phosphorus, caffeine, gluten, allulose, polydextrose, sugar alcohols, or isolated fibers.
The FDA may, by regulation, deem a food ingredient to be a major food allergen.
The FDA must also impose certain restrictions on the types of beverages that may be identified as infant formula or formula.
The FDA must require food manufacturers to submit all information on the label of a food offered for sale in package form and update such submissions as necessary. The information must be made available in a public database on the FDA's website.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2594 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 2594

    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

                             August 3, 2021

Mr. Blumenthal (for himself, Mr. Whitehouse, and Mr. Markey) 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 2021''.
    (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) Summary Nutrition Labeling 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) Summary Nutrition Information.--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 summary nutrition information 
that reflects the overall nutritional value of the food or specified 
ingredients, as specified in accordance with regulations of the 
Secretary, and does not contain any summary nutritional information 
which is in addition to or inconsistent with the information required 
under this subparagraph.
    ``(2) Required Criteria for Implementing Regulations.--Final 
regulations regarding the summary 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 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 shall include--
                    ``(i) a warning symbol or symbols for products high 
                in saturated or trans fats, sodium, added sugars, and 
                any other nutrients the consumption of which should be 
                limited or discouraged; and
                    ``(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 products that are 
        required to bear nutrition labeling.
            ``(D) 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) Principles for Implementing Regulations.--In promulgating 
regulations regarding the summary nutrition information required under 
subparagraph (1), the Secretary shall take into account published 
reports by the Health and Medicine Division of the National Academy of 
Sciences, Engineering, and Medicine regarding such 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.
            ``(D) The Secretary should periodically evaluate the front-
        of-package information 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.
            ``(E) The implementation of the information disclosure 
        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) 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 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) Amount of Fruit.--
            ``(1) In general.--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) Quantities.--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) Nutrient-dense.--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) Amount of Vegetables.--
            ``(1) In general.--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) Quantities.--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) Nutrient-dense.--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) Amount of Yogurt.--
            ``(1) In general.--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) Quantities.--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) Coloring and Flavoring.--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.--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) Sweeteners.--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.''.
    (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) Phosphorus Content.--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''; 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 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 each 
        reference to ``food allergen'' 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 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 
``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) Allulose, Polydextrose, Sugar Alcohols, and Isolated 
Fibers.--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.

    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) In general.--If it is a food offered for sale online, 
        unless all information required to appear on the label or 
        labeling under this section is available to consumers at the 
        online point of selection prior to purchasing the food.
            ``(2) Form and manner.--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.
            ``(3) Exemption.--A food shall be exempt from the 
        requirements of this paragraph if it is a food that is 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 
        nutrient 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 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:
    ``(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 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.
    ``(tt) 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.
    ``(uu) 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.
    ``(vv) 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.
    ``(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 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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