[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4061 Introduced in House (IH)]

<DOC>






114th CONGRESS
  1st Session
                                H. R. 4061

    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

                           November 18, 2015

  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 2015''.
    (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. Modernization of the Nutrition Facts Panel.
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. Effective date; regulations.

SEC. 2. ADDITIONAL REQUIREMENTS FOR FRONT-OF-PACKAGING (FOP) LABELING 
              FOR PROCESSED FOODS.

    (a) Summary Nutrition Labeling Information.--
            (1) In general.--Section 403 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 343) is amended by adding at the end 
        the following new paragraph:
    ``(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 
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) Principles for implementing regulations.--In 
        promulgating regulations regarding the summary nutrition 
        information required under the amendment made by paragraph (1), 
        the Secretary of Health and Human Services shall take into 
        account published reports of the Institute of Medicine of the 
        National Academy of Sciences regarding such information and 
        base regulations on the following principles:
                    (A) There should be a single simple, standard 
                symbol system that displays calorie information related 
                to a common serving size, and information related to 
                nutrients strongly associated with public health 
                concerns.
                    (B) 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.
                    (C) The information should appear on all products 
                that are required to bear nutrition labeling.
                    (D) The information should--
                            (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.
                    (E) The nutrition information should be consistent 
                with the Nutrition Facts Panel and with the 
                recommendations of the Dietary Guidelines of Americans.
                    (F) The information should aim to facilitate 
                consumer selection of healthy product options, 
                including among nutritionally at-risk subpopulations.
                    (G) 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.
                    (H) 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(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
343(z)), as added by subsection (a)(1), is further amended by adding at 
the end the following new subparagraph:
    ``(2) If, in the case of food other than a dietary supplement, the 
principal display panel bears--
            ``(A) the phrase `made with whole grain', the term 
        `multigrain', or similar descriptive phrases, terms, or 
        representations with respect to whole grain content, unless the 
        amount of whole grains, expressed as a percentage of total 
        grains, is conspicuously disclosed in immediate proximity to 
        such descriptive phrase, term, or representation; or
            ``(B) the terms `wheat' or `whole wheat' on breads, pasta, 
        crackers, or similar wheat-based products, unless the 
        percentage of whole wheat by weight contained in the food is 
        conspicuously declared in immediate proximity to that term or 
        there is a conspicuous declaration that the food `contains no 
        whole wheat' in immediate proximity to that term.''.
    (c) Sweeteners, Coloring, and Flavoring.--Section 403(z) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(z)), as amended, is 
further amended by adding at the end the following new subparagraph:
    ``(3) 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), and (z)''.
    (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) Regulations and guidance.--Not later than three years 
        after the date of enactment of this Act, the Secretary of 
        Health and Human Services shall--
                    (A) promulgate a final rule clarifying the 
                application of section 403(r) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 343(r)) with respect 
                to the mechanisms by which a nutrient in food (other 
                than a dietary supplement) is intended to affect the 
                structure or any function of the human body, or 
                characterize the documented mechanism by which a 
                nutrient in such food acts to maintain such structure 
                or function; and
                    (B) issue guidance clarifying the application of 
                such section 403(r) with respect to the substantiation 
                of claims pursuant to a request under section 403(r)(7) 
                of such Act, as added by paragraph (2).
            (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 3 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 two 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) or any synthetic substance; 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 
                as determined by the Secretary under section 
                403(q)(1)(F)(i) of the Federal Food, Drug, and Cosmetic 
                Act, as added by section 5(c) of this Act.

SEC. 5. MODERNIZATION OF THE NUTRITION FACTS PANEL.

    (a) Disclosure of Calorie Information.--Section 403(q)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(1)) is amended--
            (1) by striking the period at the end of clause (E) and 
        inserting a comma;
            (2) by inserting after clause (E) the following new clause:
                    ``(F) in the case of food other than a dietary 
                supplement--
                            ``(i) the percent of recommended daily 
                        calories that are provided by one serving of 
                        the product, based on a recommended daily 
                        consumption of calories determined by the 
                        Secretary to be appropriate for members of the 
                        general population; and
                            ``(ii) at the discretion of the Secretary, 
                        the percent of recommended daily calories that 
                        are provided by one serving of the product--
                                    ``(I) for members of any 
                                subpopulation identified by the 
                                Secretary; and
                                    ``(II) based on a recommended daily 
                                consumption of calories determined by 
                                the Secretary to be appropriate for 
                                members of such subpopulation.''; and
            (3) by adding, after the flush text following clause (F), 
        as added by paragraph (2), the following: ``The information 
        required under clause (C)(i) shall, in the case of food other 
        than a dietary supplement, appear in a typeface and design 
        which is more prominent and conspicuous than that used for 
        other information required under this subparagraph.''.
    (b) Serving Size.--Section 403(q)(1)(A)(i) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 343(q)(1)(A)(i)) is amended by 
inserting ``, or, in the case of a food (other than a dietary 
supplement) that is packaged in an amount that could reasonably be 
consumed in a single-eating occasion, which is an amount equal to the 
amount of food contained in the package'' before ``, or''.
    (c) Disclosure of Information Relating to Sugar on Nutrition Fact 
Panel.--
            (1) In general.--Section 403(q)(1) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 343(q)(1)), as amended by 
        subsection (a), is amended--
                    (A) in subparagraph (D), by striking ``sugars'' and 
                inserting ``sugars (and, in the case of food other than 
                a dietary supplement, total sugars, and of that, added 
                sugars, disclosed in teaspoons as well as grams)''; and
                    (B) by inserting after clause (F) the following new 
                clause:
                    ``(G) in the case of food other than a dietary 
                supplement--
                            ``(i) the percent of added sugars 
                        recommended for daily consumption that are 
                        provided by one serving of the product, based 
                        on a recommended daily consumption of calories 
                        determined by the Secretary to be appropriate 
                        for members of the general population; and
                            ``(ii) at the discretion of the Secretary, 
                        the percent of added sugars recommended for 
                        daily consumption that are provided by one 
                        serving of the product--
                                    ``(I) for members of any 
                                subpopulation identified by the 
                                Secretary; and
                                    ``(II) based on a recommended daily 
                                consumption of calories determined by 
                                the Secretary to be appropriate for 
                                members of such subpopulation.''.

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) is amended by adding at the end 
        the following new paragraph:
    ``(aa) 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 the characterizing 
        ingredient or component contained in each serving of 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(aa) 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).

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.

    (a) Definition of Major Food Allergen.--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''.
    (b) Regulation.--Not later than 3 years after the date of enactment 
of this Act, the Secretary of Health and Human Services shall 
promulgate a final regulation under section 403(w) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 343(x)) determining the manner in 
which sesame must be disclosed.

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) any natural or artificial flavoring;
                    ``(D) an image of the primary display panel;
                    ``(E) allergy warnings or information;
                    ``(F) claims under section 403(r)(1)(A) (popularly 
                referred to as `nutrient-content claims');
                    ``(G) claims under section 403(r)(1)(B) (popularly 
                referred to as `health-related claims'); and
                    ``(H) other relevant information as determined by 
                the Secretary.
            ``(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) is for a public database of searchable, sortable 
        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 
        but 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. EFFECTIVE DATE; REGULATIONS.

    (a) Effective Date.--The amendments made by--
            (1) sections 3, 4, 5, 6, 7, 10, and 11(b) shall take effect 
        on the date that is 2 years after the date of enactment of this 
        Act; and
            (2) sections 2 and 9 shall take effect 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 sections 3, 4, 5, 6, 7, 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 such date of 
                enactment, to implement the amendments made by sections 
                3, 4, 5, 6, 7, 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.
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