II 

117TH CONGRESS 

2D SESSION S. 4090 

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 

APRIL 26, 2022 

Mr. DURBIN (for himself and Mr. BRAUN) 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 2022’’. 


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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 inserting after section 403C of such Act the fol5 lowing: 

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

8 ‘‘(a) IN GENERAL.—Each dietary supplement shall 

9 be listed with the Secretary in accordance with this sec10 tion. 

11 ‘‘(b) LISTING SUBMISSIONS.— 

12 ‘‘(1) IN GENERAL.—Each responsible person, 

13 or, if the responsible person is a foreign entity, the 

14 United States agent, shall submit to the Secretary 

15 in accordance with this section the following infor16 mation for each dietary supplement that will be mar17 keted: 

18 ‘‘(A) Any proprietary name of the dietary 

19 supplement and the statement of identity, in20 cluding brand name and specified flavors, if ap21 plicable. 

22 ‘‘(B) The full name, address, and tele23 phone number for the responsible person, and 

24 the name and e-mail address of the owner, op25 erator, or agent in charge of the responsible 

26 person. 


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1 ‘‘(C) The full name, address, telephone 

2 number, and e-mail address for the United 

3 States agent, if the responsible person is a for4 eign entity. 

5 ‘‘(D) The full business name and address 

6 of all locations at which the responsible person 

7 manufactures, packages, labels, or holds the di8 etary supplement. 

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

10 dietary supplement, and an electronic copy of 

11 the package insert, if any. 

12 ‘‘(F) A list of all ingredients in the dietary 

13 supplement required to appear on the label 

14 under sections 101.4 and 101.36 of title 21, 

15 Code of Federal Regulations, including— 

16 ‘‘(i) the amount per serving of each 

17 listed ingredient, if such information is re18 quired to appear on the label; and 

19 ‘‘(ii) if required by section 101.36 of 

20 title 21, Code of Federal Regulations, the 

21 percent of the daily value of each listed in22 gredient. 

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

24 for each container size. 

25 ‘‘(H) The conditions of use. 


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1 ‘‘(I) Warnings and precautions. 

2 ‘‘(J) Statements regarding major food al3 lergens, as defined in section 201(qq) of the 

4 Federal Food, Drug, and Cosmetic Act (21 

5 U.S.C. 321(qq)). 

6 ‘‘(K) The dosage form, such as pill, cap7 sule, liquid, or powder. 

8 ‘‘(L) Any claim that— 

9 ‘‘(i) characterizes the relationship of 

10 any nutrient which is of the type required 

11 by section 403(q)(1) or section (q)(2) to be 

12 in the label or labeling of the food to a dis13 ease or a health-related condition; or 

14 ‘‘(ii) is subject to notification under 

15 section 403(r)(6) that appears in the sup16 plement’s labeling. 

17 ‘‘(M) The unique dietary supplement iden18 tifier for the product, provided in accordance 

19 with paragraph (3). 

20 ‘‘(2) FORMAT.—A listing submitted under this 

21 section shall be in such electronic form and manner 

22 as the Secretary may prescribe. The Secretary shall 

23 promptly confirm, electronically, receipt of a com24 plete listing under this section. 


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1 ‘‘(3) UNIQUE LISTING IDENTIFICATION NUM2 BERS.— 

3 ‘‘(A) IN GENERAL.—The Secretary shall 

4 establish a unique dietary supplement identifier 

5 system that shall be used by the responsible 

6 person under this section. 

7 ‘‘(B) RESERVATION OF NUMBERS.—The 

8 system shall allow a responsible person to re9 serve multiple dietary supplement identifier 

10 numbers in advance of listing. 

11 ‘‘(C) USE REQUIREMENT.—Any unique di12 etary supplement identifier shall be used only in 

13 connection with the product for which the iden14 tifier was used during the listing process. 

15 ‘‘(4) SUBMISSION DATES.—A responsible person 

16 under this section shall report to the Secretary the 

17 listing information described in paragraph (1) pur18 suant to the following timelines: 

19 ‘‘(A) IN GENERAL.— 

20 ‘‘(i) EXISTING DIETARY SUPPLE21 MENTS.—In the case of a dietary supple22 ment that is being offered in interstate 

23 commerce on the date that is 18 months 

24 after the date of enactment of the Dietary 

25 Supplement Listing Act of 2022, a listing 


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1 for each such dietary supplement formula2 tion introduced or delivered for introduc3 tion into interstate commerce by the re4 sponsible person for commercial distribu5 tion shall be submitted by the responsible 

6 person with the Secretary under this sec7 tion not later than 60 days after the date 

8 that is 18 months after the date of enact9 ment of such Act. 

10 ‘‘(ii) NEW DIETARY SUPPLEMENTS.— 

11 In the case of a dietary supplement that is 

12 not being offered in interstate commerce 

13 on the date that is 18 months after the 

14 date of enactment. of the Dietary Supple15 ment Listing Act of 2022, a listing for 

16 each such dietary supplement formulation 

17 introduced or delivered for introduction 

18 into interstate commerce by the responsible 

19 person for commercial distribution which 

20 has not been included in any listing pre21 viously submitted by the responsible person 

22 to the Secretary under this section shall be 

23 submitted to the Secretary prior to intro24 ducing the dietary supplement into inter25 state commerce. 


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1 ‘‘(B) REFORMULATIONS.—A listing of each 

2 dietary supplement formulation introduced by 

3 the responsible person for commercial distribu4 tion that has a label that differs for such die5 tary supplement from the representative label 

6 provided under subsection (a) with respect to 

7 the product name, amount of dietary ingredi8 ents, or other distinguishing characteristics 

9 such as dosage form (such as pill, capsule, liq10 uid, or powder) shall be submitted to the Sec11 retary not later than 15 business days after in12 troducing the dietary supplement with the 

13 change into interstate commerce. 

14 ‘‘(C) DISCONTINUED DIETARY SUPPLE15 MENTS.—If the responsible person has discon16 tinued the commercial marketing of a dietary 

17 supplement formulation included in a listing 

18 submitted by the responsible person under sub19 paragraph (A) or (B), the responsible person 

20 shall report to the Secretary the date of such 

21 discontinuance, within 90 days of the dis22 continuance of the dietary supplement. 

23 ‘‘(5) SUPPLIER INFORMATION RECORD KEEPING

24 REQUIREMENT.—Each responsible person subject to 

25 the requirements of this subsection shall maintain a 


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1 record of the full business name and address from 

2 which the responsible person receives any dietary in3 gredient or combination of dietary ingredients that 

4 the responsible person uses in the manufacture of 

5 the dietary supplement, or, if applicable, from which 

6 the responsible person receives the dietary supple7 ment. The responsible person shall make this infor8 mation available to the Secretary within 72 hours of 

9 request from the Secretary. 

10 ‘‘(c) ELECTRONIC DATABASE.—Beginning not later 

11 than 2 years after the Secretary specifies a unique dietary 

12 supplement identifier system pursuant to subsection 

13 (b)(3), the Secretary shall maintain an electronic database 

14 that— 

15 ‘‘(1) is publicly accessible; 

16 ‘‘(2) is populated with information regarding di17 etary supplements that is provided under this section 

18 or any other provision of this Act; and 

19 ‘‘(3) enables the public to search the database 

20 by a dietary supplement’s unique dietary supplement 

21 identifier or other field of information or combina22 tion of fields. 

23 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For 

24 purposes of conducting activities under this section and 

25 hiring personnel to carry out this section, there are auVerDate Sep 11 2014 00:16 Apr 27, 2022 Jkt 029200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4090.IS S4090

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1 thorized to be appropriated $4,000,000 for fiscal year 

2 2022 and $1,000,000 for each of fiscal years 2023 

3 through 2026.’’. 

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

5 Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amend6 ed by adding at the end the following: 

7 ‘‘(z) If it is a dietary supplement for which a respon8 sible person is required to file a listing under section 403D 

9 and such responsible person has not made a listing with 

10 respect to such dietary supplement.’’. 

11 (c) NEW PROHIBITED ACT.—Section 301 of the Fed12 eral Food, Drug, and Cosmetic Act (21 U.S.C. 331) is 

13 amended by adding at the end the following: 

14 ‘‘(fff) The introduction or delivery for introduction 

15 into interstate commerce of a dietary supplement that has 

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

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

18 (d) RULE OF CONSTRUCTION.—Nothing in the 

19 amendments made by subsections (a) through subsection 

20 (c) shall be construed to expand the existing authorities 

21 of the Food and Drug Administration, other than as speci22 fied in such amendments. This subsection shall not be con23 strued to— 

24 (1) limit the existing authorities of the Food 

25 and Drug Administration; or 


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1 (2) limit the authorities specified in the amend2 ments made by subsections (a) through subsection 

3 (c). 

Æ 


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