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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4827 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  2d Session
                                S. 4827

 To improve transparency and the availability of information regarding 
 dietary supplements by amending the Federal Food, Drug, and Cosmetic 
  Act to require manufacturers of dietary supplements to list dietary 
           supplements with the Food and Drug Administration.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             July 29, 2024

  Mr. Durbin introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
 To improve transparency and the availability of information regarding 
 dietary supplements by amending the Federal Food, Drug, and Cosmetic 
  Act to require manufacturers of dietary supplements to list dietary 
           supplements with the Food and Drug Administration.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Dietary Supplement Listing Act of 
2024''.

SEC. 2. REGULATION OF DIETARY SUPPLEMENTS.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended by adding after section 403C of 
such Act (21 U.S.C. 343-3) the following:

``SEC. 403D. DIETARY SUPPLEMENT LISTING REQUIREMENT.

    ``(a) In General.--Beginning on the date specified in subsection 
(b)(4), each dietary supplement marketed in the United States shall be 
listed with the Secretary in accordance with this section. Each such 
listing shall include, with respect to the dietary supplement, the 
information specified in subsection (b)(1).
    ``(b) Requirements.--
            ``(1) In general.--The manufacturer, packer, or distributor 
        of a dietary supplement whose name (pursuant to section 
        403(e)(1)) appears on the label of a dietary supplement 
        marketed in the United States (referred to in this section as 
        the `responsible person'), or if the responsible person is a 
        foreign entity, the United States agent of such person, shall 
        submit to the Secretary in accordance with this section the 
        following information for a dietary supplement that is marketed 
        in the United States:
                    ``(A) Any name of the dietary supplement and the 
                statement of identity, including brand name and 
                specified flavors, if applicable.
                    ``(B) The name and address of the responsible 
                person and the name and email address of the owner, 
                operator, or agent in charge of the responsible person.
                    ``(C) The name, domestic address, and email address 
                for the United States agent, if the responsible person 
                is a foreign entity.
                    ``(D) The business name and place of business the 
                responsible person provided on the label pursuant to 
                section 403(e)(1).
                    ``(E) An electronic copy of the label for the 
                dietary supplement.
                    ``(F) A list of all ingredients in each such 
                dietary supplement required under sections 101.4 and 
                101.36, title 21, Code of Federal Regulations (or any 
                successor regulations), to appear on the label of a 
                dietary supplement, including--
                            ``(i) where applicable, ingredients in a 
                        proprietary blend as described in section 
                        101.36(c) of title 21, Code of Federal 
                        Regulations (or any successor regulations);
                            ``(ii) the amount per serving of each 
                        listed dietary ingredient;
                            ``(iii) if required by section 101.36 of 
                        title 21, Code of Federal Regulations (or any 
                        successor regulations), the percent of the 
                        daily value of each listed dietary ingredient; 
                        and
                            ``(iv) the amount per serving of dietary 
                        ingredients within a proprietary blend.
                    ``(G) The number of servings per container for each 
                container size.
                    ``(H) The directions for use.
                    ``(I) Warnings, notice, and safe handling 
                statements, as required by section 101.17 of title 21, 
                Code of Federal Regulations (or any successor 
                regulations).
                    ``(J) Allergen statements for major food allergens 
                (pursuant to sections 403(w) and 403(x)).
                    ``(K) The form of the dietary supplement (such as 
                tablets, capsules, powders, liquids, softgels, and 
                gummies).
                    ``(L) Any claim that appears on the label, package 
                insert, or website of the responsible person who 
                submits the listing that--
                            ``(i) characterizes the relationship of any 
                        ingredient to a disease or a health-related 
                        condition and is described in section 
                        403(r)(1)(B); or
                            ``(ii) is subject to notification under 
                        section 403(r)(6).
                    ``(M) The dietary supplement product listing number 
                for the dietary supplement provided by the Secretary in 
                accordance with subsection (c).
            ``(2) Format.--The Secretary may require that a listing 
        submitted under paragraph (1) be submitted in an electronic 
        format. Upon receipt of a complete listing under paragraph (1), 
        the Secretary shall promptly notify the responsible person of 
        the receipt of such listing. A listing is deemed complete once 
        all fields of required information have been completed by the 
        responsible person who represents that the product will be 
        marketed in the United States as a dietary supplement.
            ``(3) Listing content.--A single listing submission for a 
        dietary supplement under paragraph (1) may include multiple 
        dietary supplements with identical formulations and forms, or 
        formulations of the same form, that differ only with respect to 
        color, excipients, or flavorings, whether offered in a single 
        package size or in multiple package sizes.
            ``(4) Timing.--
                    ``(A) In general.--
                            ``(i) Dietary supplements on the market.--
                        In the case of a dietary supplement that is 
                        being offered in interstate commerce on or 
                        before January 1, 2025, a listing for each such 
                        dietary supplement introduced or delivered for 
                        introduction into interstate commerce shall be 
                        submitted by the responsible person to the 
                        Secretary under this subsection not later than 
                        18 months after the date of enactment of the 
                        Dietary Supplement Listing Act of 2024.
                            ``(ii) New dietary supplements.--In the 
                        case of a dietary supplement that is not being 
                        offered in interstate commerce on or before 
                        January 1, 2025, a listing for each such 
                        dietary supplement introduced or delivered for 
                        introduction into interstate commerce that has 
                        not been included in any listing previously 
                        submitted by the responsible person to the 
                        Secretary under this subsection shall be 
                        submitted to the Secretary at the time of 
                        introduction into interstate commerce.
                    ``(B) Discontinued dietary supplements.--The 
                responsible person shall notify the Secretary not later 
                than 1 year after the date the responsible person 
                discontinues the introduction into interstate commerce 
                of a dietary supplement required to be listed with the 
                Secretary under paragraph (1).
                    ``(C) Changes to existing listings.--The 
                responsible person shall submit to the Secretary any 
                change or modification to listing information submitted 
                under paragraph (1) included on the label of a dietary 
                supplement not later than 30 days after the dietary 
                supplement with the change or modification is first 
                introduced into interstate commerce.
            ``(5) Additional information.--The responsible person shall 
        provide, upon request from the Secretary, not later than 10 
        calendar days after such request--
                    ``(A) the full business name and physical and 
                mailing address of all locations at which the 
                responsible person manufactures, packages, labels, or 
                holds the dietary supplement; and
                    ``(B) the full business name and physical and 
                mailing address from which the responsible person 
                receives a dietary ingredient or combination of dietary 
                ingredients that the responsible person uses in the 
                manufacture of the dietary supplement or, if 
                applicable, from which the responsible person receives 
                the dietary supplement.
    ``(c) Product Listing Number and Dietary Supplement Electronic 
Database.--
            ``(1) Dietary supplement product listing number.--The 
        Secretary shall provide each dietary supplement listed in 
        accordance with subsection (b)(1) a dietary supplement product 
        listing number, which may apply to multiple dietary supplements 
        with identical formulations, or formulations that differ only 
        with respect to color, excipients, or flavorings, including 
        dietary supplements offered in a single package size or in 
        multiple package sizes. The Secretary shall provide a process 
        for a responsible person to reserve dietary supplement listing 
        numbers in advance of listing under subsection (b)(1).
            ``(2) Electronic database.--Not later than 2 years after 
        the date of enactment of the Dietary Supplement Listing Act of 
        2024, the Secretary shall establish and maintain an electronic 
        database that is publicly available and contains information 
        submitted under subsection (b)(1) (except for the information 
        submitted under subparagraph (B), (C), and (F)(iv) of such 
        subsection). The Secretary shall make such information 
        maintained in the electronic database publicly searchable, 
        including by dietary supplement product listing number, and by 
        any field of information or combination of fields of 
        information provided under subsection (b)(1) (except for the 
        information submitted under subparagraph (B), (C), and (F)(iv) 
        of such subsection).
            ``(3) Confidential information.--In response to a request 
        under section 552 of title 5, United States Code, information 
        described in subparagraph (B), (C), and (F)(iv) of subsection 
        (b)(1) that is derived from a listing under this section, and 
        information described in subparagraph (b)(5), shall be withheld 
        under section 552(b)(3) of title 5, United States Code.
    ``(d) Rule of Construction.--Nothing in this section shall be 
construed--
            ``(1) to limit the authority of the Secretary to inspect or 
        copy records or to require the establishment and maintenance of 
        records under any other provision of this Act;
            ``(2) to authorize the disclosure of information that is 
        prohibited from disclosure under section 301(j) of this Act or 
        section 1905 of title 18, United States Code, or that is 
        subject to withholding under section 552(b)(4) of title 5, 
        United States Code; or
            ``(3) to grant the Secretary authority to require the 
        approval of a dietary supplement prior to marketing.
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated $7,872,984 for fiscal year 2024, and $6,615,000 for each 
of fiscal years 2025 through 2028, for purposes of conducting the 
activities under this section and hiring personnel required to carry 
out this section.''.
    (b) Misbranding.--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) If it is a dietary supplement for which a responsible person 
or the United States agent of such a person is required under section 
403D to file a listing, file a change to an existing listing, or 
provide additional information to the Secretary, and such person or 
agent has failed to comply with any such requirements under section 
403D with respect to such dietary supplement.''.
    (c) New Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(jjj) The introduction or delivery for introduction into 
interstate commerce of a dietary supplement that has been prepared, 
packed, or held using the assistance of, or at the direction of, a 
person debarred under section 306.''.
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