II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Dietary Supplement 

5 Listing Act of 2024’’. 


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1 SEC. 2. REGULATION OF DIETARY SUPPLEMENTS. 

2 (a) IN GENERAL.—Chapter IV of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amend4 ed by adding after section 403C of such Act (21 U.S.C. 

5 343–3) the following: 

6 ‘‘SEC. 403D. DIETARY SUPPLEMENT LISTING REQUIRE7 MENT. 

8 ‘‘(a) IN GENERAL.—Beginning on the date specified 

9 in subsection (b)(4), each dietary supplement marketed in 

10 the United States shall be listed with the Secretary in ac11 cordance with this section. Each such listing shall include, 

12 with respect to the dietary supplement, the information 

13 specified in subsection (b)(1). 

14 ‘‘(b) REQUIREMENTS.— 

15 ‘‘(1) IN GENERAL.—The manufacturer, packer, 

16 or distributor of a dietary supplement whose name 

17 (pursuant to section 403(e)(1)) appears on the label 

18 of a dietary supplement marketed in the United 

19 States (referred to in this section as the ‘responsible 

20 person’), or if the responsible person is a foreign en21 tity, the United States agent of such person, shall 

22 submit to the Secretary in accordance with this sec23 tion the following information for a dietary supple24 ment that is marketed in the United States: 


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1 ‘‘(A) Any name of the dietary supplement 

2 and the statement of identity, including brand 

3 name and specified flavors, if applicable. 

4 ‘‘(B) The name and address of the respon5 sible person and the name and email address of 

6 the owner, operator, or agent in charge of the 

7 responsible person. 

8 ‘‘(C) The name, domestic address, and 

9 email address for the United States agent, if 

10 the responsible person is a foreign entity. 

11 ‘‘(D) The business name and place of busi12 ness the responsible person provided on the 

13 label pursuant to section 403(e)(1). 

14 ‘‘(E) An electronic copy of the label for the 

15 dietary supplement. 

16 ‘‘(F) A list of all ingredients in each such 

17 dietary supplement required under sections 

18 101.4 and 101.36, title 21, Code of Federal 

19 Regulations (or any successor regulations), to 

20 appear on the label of a dietary supplement, in21 cluding— 

22 ‘‘(i) where applicable, ingredients in a 

23 proprietary blend as described in section 

24 101.36(c) of title 21, Code of Federal Reg25 ulations (or any successor regulations); 


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1 ‘‘(ii) the amount per serving of each 

2 listed dietary ingredient; 

3 ‘‘(iii) if required by section 101.36 of 

4 title 21, Code of Federal Regulations (or 

5 any successor regulations), the percent of 

6 the daily value of each listed dietary ingre7 dient; and 

8 ‘‘(iv) the amount per serving of die9 tary ingredients within a proprietary blend. 

10 ‘‘(G) The number of servings per container 

11 for each container size. 

12 ‘‘(H) The directions for use. 

13 ‘‘(I) Warnings, notice, and safe handling 

14 statements, as required by section 101.17 of 

15 title 21, Code of Federal Regulations (or any 

16 successor regulations). 

17 ‘‘(J) Allergen statements for major food al18 lergens (pursuant to sections 403(w) and 

19 403(x)). 

20 ‘‘(K) The form of the dietary supplement 

21 (such as tablets, capsules, powders, liquids, 

22 softgels, and gummies). 

23 ‘‘(L) Any claim that appears on the label, 

24 package insert, or website of the responsible 

25 person who submits the listing that— 


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1 ‘‘(i) characterizes the relationship of 

2 any ingredient to a disease or a health-re3 lated condition and is described in section 

4 403(r)(1)(B); or 

5 ‘‘(ii) is subject to notification under 

6 section 403(r)(6). 

7 ‘‘(M) The dietary supplement product list8 ing number for the dietary supplement provided 

9 by the Secretary in accordance with subsection 

10 (c). 

11 ‘‘(2) FORMAT.—The Secretary may require that 

12 a listing submitted under paragraph (1) be sub13 mitted in an electronic format. Upon receipt of a 

14 complete listing under paragraph (1), the Secretary 

15 shall promptly notify the responsible person of the 

16 receipt of such listing. A listing is deemed complete 

17 once all fields of required information have been 

18 completed by the responsible person who represents 

19 that the product will be marketed in the United 

20 States as a dietary supplement. 

21 ‘‘(3) LISTING CONTENT.—A single listing sub22 mission for a dietary supplement under paragraph 

23 (1) may include multiple dietary supplements with 

24 identical formulations and forms, or formulations of 

25 the same form, that differ only with respect to color, 


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1 excipients, or flavorings, whether offered in a single 

2 package size or in multiple package sizes. 

3 ‘‘(4) TIMING.— 

4 ‘‘(A) IN GENERAL.— 

5 ‘‘(i) DIETARY SUPPLEMENTS ON THE

6 MARKET.—In the case of a dietary supple7 ment that is being offered in interstate 

8 commerce on or before January 1, 2025, a 

9 listing for each such dietary supplement in10 troduced or delivered for introduction into 

11 interstate commerce shall be submitted by 

12 the responsible person to the Secretary 

13 under this subsection not later than 18 

14 months after the date of enactment of the 

15 Dietary Supplement Listing Act of 2024. 

16 ‘‘(ii) NEW DIETARY SUPPLEMENTS.— 

17 In the case of a dietary supplement that is 

18 not being offered in interstate commerce 

19 on or before January 1, 2025, a listing for 

20 each such dietary supplement introduced 

21 or delivered for introduction into interstate 

22 commerce that has not been included in 

23 any listing previously submitted by the re24 sponsible person to the Secretary under 

25 this subsection shall be submitted to the 


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1 Secretary at the time of introduction into 

2 interstate commerce. 

3 ‘‘(B) DISCONTINUED DIETARY SUPPLE4 MENTS.—The responsible person shall notify 

5 the Secretary not later than 1 year after the 

6 date the responsible person discontinues the in7 troduction into interstate commerce of a dietary 

8 supplement required to be listed with the Sec9 retary under paragraph (1). 

10 ‘‘(C) CHANGES TO EXISTING LISTINGS.— 

11 The responsible person shall submit to the Sec12 retary any change or modification to listing in13 formation submitted under paragraph (1) in14 cluded on the label of a dietary supplement not 

15 later than 30 days after the dietary supplement 

16 with the change or modification is first intro17 duced into interstate commerce. 

18 ‘‘(5) ADDITIONAL INFORMATION.—The respon19 sible person shall provide, upon request from the 

20 Secretary, not later than 10 calendar days after 

21 such request— 

22 ‘‘(A) the full business name and physical 

23 and mailing address of all locations at which 

24 the responsible person manufactures, packages, 

25 labels, or holds the dietary supplement; and 


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1 ‘‘(B) the full business name and physical 

2 and mailing address from which the responsible 

3 person receives a dietary ingredient or combina4 tion of dietary ingredients that the responsible 

5 person uses in the manufacture of the dietary 

6 supplement or, if applicable, from which the re7 sponsible person receives the dietary supple8 ment. 

9 ‘‘(c) PRODUCT LISTING NUMBER AND DIETARY SUP10 PLEMENT ELECTRONIC DATABASE.— 

11 ‘‘(1) DIETARY SUPPLEMENT PRODUCT LISTING

12 NUMBER.—The Secretary shall provide each dietary 

13 supplement listed in accordance with subsection 

14 (b)(1) a dietary supplement product listing number, 

15 which may apply to multiple dietary supplements 

16 with identical formulations, or formulations that dif17 fer only with respect to color, excipients, or 

18 flavorings, including dietary supplements offered in 

19 a single package size or in multiple package sizes. 

20 The Secretary shall provide a process for a respon21 sible person to reserve dietary supplement listing 

22 numbers in advance of listing under subsection 

23 (b)(1). 

24 ‘‘(2) ELECTRONIC DATABASE.—Not later than 

25 2 years after the date of enactment of the Dietary 


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1 Supplement Listing Act of 2024, the Secretary shall 

2 establish and maintain an electronic database that is 

3 publicly available and contains information sub4 mitted under subsection (b)(1) (except for the infor5 mation submitted under subparagraph (B), (C), and 

6 (F)(iv) of such subsection). The Secretary shall 

7 make such information maintained in the electronic 

8 database publicly searchable, including by dietary 

9 supplement product listing number, and by any field 

10 of information or combination of fields of informa11 tion provided under subsection (b)(1) (except for the 

12 information submitted under subparagraph (B), (C), 

13 and (F)(iv) of such subsection). 

14 ‘‘(3) CONFIDENTIAL INFORMATION.—In re15 sponse to a request under section 552 of title 5, 

16 United States Code, information described in sub17 paragraph (B), (C), and (F)(iv) of subsection (b)(1) 

18 that is derived from a listing under this section, and 

19 information described in subparagraph (b)(5), shall 

20 be withheld under section 552(b)(3) of title 5, 

21 United States Code. 

22 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec23 tion shall be construed— 

24 ‘‘(1) to limit the authority of the Secretary to 

25 inspect or copy records or to require the establishVerDate Sep 11 2014 21:29 Aug 23, 2024 Jkt 049200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S4827.IS S4827

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1 ment and maintenance of records under any other 

2 provision of this Act; 

3 ‘‘(2) to authorize the disclosure of information 

4 that is prohibited from disclosure under section 

5 301(j) of this Act or section 1905 of title 18, United 

6 States Code, or that is subject to withholding under 

7 section 552(b)(4) of title 5, United States Code; or 

8 ‘‘(3) to grant the Secretary authority to require 

9 the approval of a dietary supplement prior to mar10 keting. 

11 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

12 is authorized to be appropriated $7,872,984 for fiscal year 

13 2024, and $6,615,000 for each of fiscal years 2025 

14 through 2028, for purposes of conducting the activities 

15 under this section and hiring personnel required to carry 

16 out this section.’’. 

17 (b) MISBRANDING.—Section 403 of the Federal 

18 Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amend19 ed by adding at the end the following: 

20 ‘‘(z) If it is a dietary supplement for which a respon21 sible person or the United States agent of such a person 

22 is required under section 403D to file a listing, file a 

23 change to an existing listing, or provide additional infor24 mation to the Secretary, and such person or agent has 


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1 failed to comply with any such requirements under section 

2 403D with respect to such dietary supplement.’’. 

3 (c) NEW PROHIBITED ACT.—Section 301 of the Fed4 eral Food, Drug, and Cosmetic Act (21 U.S.C. 331) is 

5 amended by adding at the end the following: 

6 ‘‘(jjj) The introduction or delivery for introduction 

7 into interstate commerce of a dietary supplement that has 

8 been prepared, packed, or held using the assistance of, or 

9 at the direction of, a person debarred under section 306.’’. 

Æ 


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