```

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5425 Introduced in House (IH)]

<DOC>

115th CONGRESS
  2d Session
                                H. R. 5425

    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 HOUSE OF REPRESENTATIVES

                             April 2, 2018

  Mr. Pallone (for himself and Ms. DeLauro) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
    To amend the Federal Food, Drug, and Cosmetic Act to strengthen 
 requirements related to nutrient information on food labels, and for 
                            other purposes.

    Be it enacted by the Senate and House of 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 2018''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Additional requirements for front-of-packaging (FOP) labeling 
                            for processed foods.
Sec. 3. Claims for conventional foods.
Sec. 4. Use of specific terms.
Sec. 5. Nutrition facts panel compliance date.
Sec. 6. Ingredient labels.
Sec. 7. Caffeine content on information panel.
Sec. 8. Food allergen labeling for sesame.
Sec. 9. Information about major food allergens in nonprepackaged foods.
Sec. 10. Submission and availability of food label information.
Sec. 11. Definitions.
Sec. 12. Applicability; regulations.

SEC. 2. ADDITIONAL REQUIREMENTS FOR FRONT-OF-PACKAGING (FOP) LABELING 
              FOR PROCESSED 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 single, simple, standard 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 may include--
                    ``(i) a warning symbol or symbols for products high 
                in saturated or trans fats, sodium, added sugars, or 
                other nutrients the consumption of which should be 
                limited or discouraged; or
                    ``(ii) a stop-light, points, star, or other 
                commonly recognized signaling system to scale or rank 
                foods according to their overall health value.
            ``(C) The information shall appear on all 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 regarding such information, and base regulations on the 
following principles:
            ``(A) Consumers should be able to quickly and easily 
        comprehend the meaning of the symbol system as an indicator of 
        a product's contribution to a healthy diet without requiring 
        specific or sophisticated nutritional knowledge.
            ``(B) The nutrition information should be consistent with 
        the Nutrition Facts Panel and with the recommendations of the 
        Dietary Guidelines of 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 ability to help facilitate 
        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.--
Section 403 of the Federal Food, Drug, and Cosmetic Act, as amended, is 
further amended by adding at the end the following:
    ``(aa) Percentage of Wheat and Grains in Grain-Based Products.--If, 
in the case of food other than a dietary supplement, the principal 
display panel bears--
            ``(1) the terms `whole wheat', `whole grain', `made with 
        whole grain', or `multigrain';
            ``(2) a declaration of the whole grain content by weight;
            ``(3) the term `wheat' on a wheat bread, pasta, or similar 
        product that is typically made from wheat; or
            ``(4) any similar descriptive phrases, terms, or 
        representations suggesting the product contains whole grains,
unless the amount of whole grains, expressed as a percentage of total 
grains, is conspicuously disclosed in immediate proximity to the 
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.''.
    (c) Sweeteners, Coloring, and Flavoring.--Section 403 of the 
Federal Food, Drug, and Cosmetic Act, as amended, is further amended by 
adding at the end the following:
    ``(bb) Sweeteners, Coloring, and Flavoring.--If, in the case of 
food other than a dietary supplement, it bears or contains any added 
artificial or natural coloring, any added artificial or natural non-
caloric sweetener, or any added artificial or natural flavoring, unless 
such fact is prominently stated on the principal display panel of a 
package or container of the food.''.
    (d) Conforming Amendment.--The second sentence of section 403(k) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(k)) is amended 
by striking ``and (i)'' and inserting ``, (i), (z), (aa), and (bb)''.
    (e) Construction.--Nothing in this section shall be construed as 
affecting any requirement in regulation in effect as of the date of the 
enactment of this Act with respect to matters that are required to be 
stated on the principal display panel of a package or container of food 
that is not required by an amendment made by this section or as 
restricting the authority of the Secretary of Health and Human Services 
to require additional information be disclosed on such a principal 
display panel.

SEC. 3. CLAIMS FOR CONVENTIONAL FOODS.

    (a) Health-Related Claims.--
            (1) In general.--Section 403(r)(1)(B) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 343(r)(1)(B)) is amended by 
        inserting after ``health-related condition'' the following: ``, 
        describes the 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.''.
    (b) 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) in subclause (iii)--
                    (A) in the matter before item (I), by striking 
                ``fat or saturated fat'' and inserting ``fat, saturated 
                fat, or trans fats''; and
                    (B) in item (II), by striking ``fat or saturated 
                fat'' and inserting ``fat, saturated fat, or trans 
                fats'';
            (2) in subclause (iv), by striking ``saturated fat'' and 
        inserting ``saturated fat or trans fats'' each place it 
        appears;
            (3) by redesignating subclauses (v) and (vi) as subclauses 
        (vi) and (vii), respectively; and
            (4) 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 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,''.
    (c) Added Sugars.--Not more than 2 years after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
promulgate a final rule revising section 101.14 of title 21, Code of 
Federal Regulations, to include a disqualifying nutrient level for 
added sugars.

SEC. 4. USE OF SPECIFIC TERMS.

    (a) Use of the Term ``Natural''.--
            (1) In general.--Not later than 2 years after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall promulgate a final rule--
                    (A) relating to use of the term ``natural'' on the 
                labeling of food (other than a dietary supplement); and
                    (B) including provisions to specifically address 
                the use of such term on the principal display panel and 
                the information panel.
            (2) Definition.--The rule 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 rule 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.--The Secretary of Health 
        and Human Services shall revise the regulations under the 
        Federal Food, Drug, and Cosmetic Act relating to the use of the 
        term ``healthy'' on the labeling of a food (other than a 
        dietary supplement) to take into account the extent to which 
        such food contains added sugars or whole grains.
            (2) Requirements.--In making the revisions to regulations 
        required by paragraph (1)--
                    (A) in the case of a food (other than a dietary 
                supplement) that contains grains, the Secretary shall 
                not consider the food to be ``healthy'' unless at least 
                half of those grains, by weight, are whole grains; and
                    (B) the Secretary shall not allow a food to be 
                labeled ``healthy'' if the food contains more than 10 
                percent of the daily value of added sugar per serving.

SEC. 5. NUTRITION FACTS PANEL COMPLIANCE DATE.

    The Secretary of Health and Human Services shall not extend the 
compliance dates in the final rule entitled ``Food Labeling: Revision 
of the Nutrition and Supplement Facts Labels'' published by the Food 
and Drug Administration in the Federal Register on May 27, 2016 (or any 
successor rule), beyond the compliance dates proposed in the proposed 
rule entitled rule entitled ``Food Labeling: Revision of the Nutrition 
and Supplement Facts Labels and Serving Sizes of Foods That Can 
Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; 
Updating, Modifying, and Establishing Certain Reference Amounts 
Customarily Consumed; Serving Size for Breath Mints; and Technical 
Amendments; Proposed Extension of Compliance Dates'' published by the 
Food and Drug Administration in the Federal Register on October 2, 
2017.

SEC. 6. INGREDIENT LABELS.

    (a) Format of Ingredient Labels.--
            (1) In general.--The Secretary of Health and Human Services 
        shall include requirements for the format of the information 
        required under section 403(i) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 343(i))--
                    (A) for the purpose of improving the readability of 
                such information on the label of the food (other than a 
                dietary supplement); and
                    (B) that are, as determined by the Secretary, 
                necessary to assist consumers in maintaining healthy 
                dietary practices.
            (2) Format requirements.--The format requirements referred 
        to in paragraph (1) shall include requirements for upper- and 
        lower-case 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.
    (b) Characterizing Ingredients in Name or Primary Display Panel.--
            (1) In general.--Section 403 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 343), as amended, is further amended by 
        adding at the end the following:
    ``(cc) If the name or primary display panel of the food (other than 
a dietary supplement) refers to any characterizing ingredient or 
component of the food, unless--
            ``(1) the characterizing ingredient or component is a 
        predominant ingredient in the food; or
            ``(2) the primary display panel of the food includes, in 
        letters not less than one-half the height of the letters used 
        in the name of the food, the percentage of each characterizing 
        ingredient or component contained in the food.''.
            (2) Enforcement of characterizing ingredients.--Not later 
        than 2 years after the date of enactment of this Act and every 
        2 years thereafter, the Secretary of Health and Human Services 
        shall submit a report to the Congress on the Secretary's 
        enforcement of--
                    (A) section 403(cc) of the Federal Food, Drug, and 
                Cosmetic, as added by paragraph (1); and
                    (B) regulations of the Food and Drug Administration 
                on characterizing ingredients and components, including 
                section 102.5 of title 21, Code of Federal Regulations 
                (and any successor regulations).
    (c) Declaration of Phosphorus on the Ingredient Label.--
            (1) In general.--Section 403 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 343 ), as amended, is further amended 
        by adding at the end the following:
    ``(dd) If it is a food intended for human consumption that is 
offered for sale and contains phosphorus, unless--
            ``(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 subsections (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 FOR SESAME.

    Section 201(qq)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(qq)(1)) is amended by striking ``and soybeans'' and 
inserting ``soybeans, and sesame''.

SEC. 9. INFORMATION ABOUT MAJOR FOOD ALLERGENS IN NONPREPACKAGED FOODS.

    (a) In General.--Section 403(w) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343(w)) is amended--
            (1) in subparagraph (1)(A), by striking ``is printed 
        immediately after or is adjacent to the list of ingredients (in 
        a type size no smaller than the type size used in the list of 
        ingredients) required under subsections (g) and (i)'' and 
        inserting ``is printed as specified in subparagraph (8)'';
            (2) in subparagraph (1)(B), by striking ``in the list of 
        ingredients required under subsections (g) and (i)'' and 
        inserting ``as so printed'';
            (3) in subparagraph (3), by striking ``The 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 subsections (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 
        subsections (g) and (i), placed on a sign adjacent to the food 
        (in a type size no smaller than the name of the food item).''.
    (b) Applicability.--The amendments made by subsection (a) apply 
beginning on the date that is 3 years after the date of enactment of 
this Act.

SEC. 10. SUBMISSION AND AVAILABILITY OF FOOD LABEL INFORMATION.

    The Federal Food, Drug, and Cosmetic Act is 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) ingredients;
                    ``(C) an image of the primary display panel;
                    ``(D) allergy warnings or information;
                    ``(E) claims under section 403(r)(1)(A) (popularly 
                referred to as `nutrient-content claims');
                    ``(F) claims under section 403(r)(1)(B) (popularly 
                referred to as `health-related claims'); and
                    ``(G) other relevant information required by law to 
                be published in the labeling of the food.
            ``(2) Updates.--The Secretary shall require the 
        manufacturer or importer of food to update or supplement the 
        information submitted under 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. 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 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, 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.''.

SEC. 12. APPLICABILITY; REGULATIONS.

    (a) Applicability.--The amendments made by--
            (1) subsections (a) and (b) of section 3, subsections 
        (b)(1) and (c) of section 6, and sections 7, 8, 10, and 11(b) 
        shall apply beginning on the date that is 2 years after the 
        date of enactment of this Act; and
            (2) sections 2 and 9 shall apply beginning on the date that 
        is 3 years after such date of enactment.
    (b) Regulations.--
            (1) Proposed regulations.--The Secretary of Health and 
        Human Services shall propose regulations--
                    (A) not later than 1 year after the date of 
                enactment of this Act, to implement the amendments made 
                by subsections (a) and (b) of section 3, subsections 
                (b)(1) and (c) of section 6, and sections 7, 8, 9, 10, 
                and 11(b); and
                    (B) not later than 2 years after such date of 
                enactment, to implement the amendments made by section 
                2.
            (2) Final regulations.--The Secretary of Health and Human 
        Services shall promulgate final regulations--
                    (A) not later than 2 years after the date of 
                enactment of this Act, to implement the amendments made 
                by subsections (a) and (b) of section 3, subsections 
                (b)(1) and (c) of section 6, and sections 7, 8, 9, 10, 
                and 11(b); and
                    (B) not later than 3 years after such date of 
                enactment to implement the amendments made by section 
                2.
            (3) Deadline.--If the Secretary of Health and Human 
        Services does not issue a final regulation by the deadline 
        specified in subparagraph (A) or (B) of paragraph (2), the 
        corresponding proposed regulation under subparagraph (A) or (B) 
        of paragraph (1) shall become final on the respective deadline.
                                 <all>
```