[Congressional Record Volume 170, Number 123 (Monday, July 29, 2024)]
[Senate]
[Pages S5553-S5554]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN:

[[Page S5553]]

  S. 4827. 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; to 
the Committee on Health, Education, Labor, and Pensions.
  Mr. DURBIN. Madam President, I ask unanimous consent that the text of 
the bill be printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 4827

       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

[[Page S5554]]

     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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