I 

118TH CONGRESS 

1ST SESSION H. R. 5399 

To substantially restrict the use of animal testing for cosmetics, and for 

other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 12, 2023 

Mr. BEYER (for himself, Mr. BUCHANAN, Mr. CA ́RDENAS, Mr. CALVERT, and 

Mr. TONKO) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To substantially restrict the use of animal testing for 

cosmetics, and for other purposes. 

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 ‘‘Humane Cosmetics 

5 Act of 2023’’. 

6 SEC. 2. ANIMAL TESTING. 

7 (a) PROHIBITION ON ANIMAL TESTING.—Beginning 

8 on the date that is 1 year after the date of enactment 

9 of this Act, it shall be unlawful to knowingly conduct or 


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1 contract for cosmetic animal testing that occurs in the 

2 United States. 

3 (b) PROHIBITION ON SALE OR TRANSPORT.—Begin4 ning on the date that is 1 year after the date of enactment 

5 of this Act, it shall be unlawful to knowingly sell, offer 

6 for sale, or transport in interstate commerce in the United 

7 States any cosmetic product that was developed or manu8 factured using cosmetic animal testing that was conducted 

9 or contracted for by any person in the supply chain of 

10 the cosmetic product after such date. 

11 (c) DATA USE.— 

12 (1) IN GENERAL.—No evidence derived from 

13 animal testing conducted after the effective date 

14 specified in subsection (a) may be relied upon to es15 tablish the safety of a cosmetic, cosmetic ingredient, 

16 or nonfunctional constituent under the Federal 

17 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

18 seq.), unless— 

19 (A) such animal testing is subject to an ex20 emption under subsection (d)(2); or 

21 (B) in the case of such animal testing on 

22 an ingredient or nonfunctional constituent— 

23 (i) there is no non-animal alternative 

24 method or strategy recognized by any Fed25 eral agency, the Interagency Coordinating 


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1 Committee on the Validation of Alternative 

2 Methods, or the Organisation for Economic 

3 Co-operation and Development for the rel4 evant safety endpoints for such ingredient 

5 or nonfunctional constituent for use in cos6 metics; and 

7 (ii)(I) such animal testing is subject 

8 to an exemption under subsection (d)(3); 

9 or 

10 (II)(aa) such animal testing is subject 

11 to an exemption under subsection (d)(4); 

12 (bb) there is documented evidence of 

13 the non-cosmetic intent of the test; and 

14 (cc) there is a history of use of the in15 gredient outside of cosmetics at least 1 

16 year prior to the reliance on evidence de17 scribed in the matter preceding subpara18 graph (A). 

19 (2) LIMITATION.—This section shall not be con20 strued to prohibit any entity from reviewing, assess21 ing, or retaining evidence generated from animal 

22 testing. 

23 (d) EXEMPTIONS.—Subsections (a) and (b) shall not 

24 apply with respect to animal testing— 


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1 (1) conducted outside the United States in 

2 order to comply with a requirement from a foreign 

3 regulatory authority; 

4 (2) requested, required, or conducted by the 

5 Secretary, following— 

6 (A) a written finding by the Secretary 

7 that— 

8 (i) there is no non-animal alternative 

9 method or strategy for the relevant safety 

10 endpoints for the cosmetic ingredient or 

11 nonfunctional constituent; 

12 (ii) there is information received by 

13 the Secretary of adverse health effects, 

14 other than minor and transient reactions 

15 or minor and transient skin irritations in 

16 some users, related to the cosmetic ingre17 dient or nonfunctional constituent; and 

18 (iii) the cosmetic ingredient cannot be 

19 replaced by another cosmetic ingredient ca20 pable of performing a similar function; 

21 (B) publication by the Secretary, on the 

22 website of the Food and Drug Administration, 

23 of the written finding under subparagraph (A) 

24 together with a notice that the Secretary in25 tends to request, require, or conduct new aniVerDate Sep 11 2014 18:56 Sep 13, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5399.IH H5399

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1 mal testing, and providing a period of not less 

2 than 60 calendar days for public comment; and 

3 (C) a written determination by the Sec4 retary, after review of all public comments re5 ceived pursuant to subparagraph (B), that no 

6 previously generated data that could be sub7 stituted for, or otherwise determined sufficient 

8 to replace, the data expected to be produced 

9 through new animal testing is available for re10 view by the Secretary; 

11 (3) conducted for any product or ingredient 

12 that is subject to regulation under chapter V of the 

13 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

14 351 et seq.); or 

15 (4) conducted for non-cosmetic purposes pursu16 ant to a requirement of a Federal, State, or foreign 

17 regulatory authority. 

18 (e) CIVIL PENALTIES.— 

19 (1) IN GENERAL.—In addition to any other 

20 penalties under applicable law, the Secretary may 

21 impose on any person who violates this section a 

22 civil penalty in an amount of not more than $10,000 

23 for each such violation, as determined by the Sec24 retary. 


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1 (2) MULTIPLE VIOLATIONS.—Each violation of 

2 this section with respect to a separate animal, and 

3 each day that a violation of this Act continues, con4 stitutes a separate offense. 

5 (f) RECORDS ACCESS.— 

6 (1) IN GENERAL.—The Secretary may request 

7 any records or other information from a cosmetic 

8 manufacturer that such manufacturer relied upon to 

9 meet the criteria in subsection (c)(1)(B)(ii)(II). 

10 Such manufacturer shall, upon such request of the 

11 Secretary in writing, provide to the Secretary such 

12 records or other information, within a reasonable 

13 timeframe, within reasonable limits, and in a reason14 able manner, and in either electronic or physical 

15 form, at the expense of such manufacturer. The Sec16 retary’s request shall include a sufficient description 

17 of the records requested and reference this sub18 section. 

19 (2) CONFIRMATION OF RECEIPT.—Upon receipt 

20 of the records requested under paragraph (1), the 

21 Secretary shall provide to the manufacturer con22 firmation of receipt. 

23 (3) INSPECTION AUTHORITY.—Nothing in this 

24 subsection supplants the authority of the Secretary 

25 to conduct inspections otherwise permitted under the 


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1 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

2 301 et seq.). 

3 (g) STATE AUTHORITY.—No State or political sub4 division of a State may establish or continue in effect any 

5 prohibition relating to cosmetic animal testing, or to the 

6 regulation of data use related to animal testing, that is 

7 not identical to the prohibitions set forth in subsections 

8 (a), (b), and (c), and that does not include the exemptions 

9 contained in subsections (c) and (d). No State or political 

10 subdivision of a State may require any entity to perform 

11 cosmetic animal testing that is not permitted by sub12 section (a). 

13 (h) DEFINITIONS.— 

14 (1) COSMETIC.—The term ‘‘cosmetic’’ has the 

15 meaning given such term in section 201(i) of the 

16 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

17 321(i)). 

18 (2) COSMETIC ANIMAL TESTING.—The term 

19 ‘‘cosmetic animal testing’’ means the internal or ex20 ternal application or exposure of any cosmetic prod21 uct, cosmetic ingredient, or nonfunctional con22 stituent to the skin, eyes, or other body part (organ 

23 or extremity) of a live non-human vertebrate for the 

24 purpose of evaluating the safety or efficacy of a cosVerDate Sep 11 2014 18:56 Sep 13, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5399.IH H5399

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1 metic product or a cosmetic ingredient or nonfunc2 tional constituent for use in a cosmetic product. 

3 (3) NONFUNCTIONAL CONSTITUENT.—The term 

4 ‘‘nonfunctional constituent’’ means any incidental in5 gredient as defined in section 701.3(l) of title 21, 

6 Code of Federal Regulations, on the date of enact7 ment of this section. 

8 (4) SECRETARY.—The term ‘‘Secretary’’ means 

9 the Secretary of Health and Human Services. 

Æ 


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