I 

117TH CONGRESS 

1ST SESSION H. R. 6207 

To substantially restrict the use of animal testing for cosmetics. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 9, 2021 

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

TONKO, Mr. RUPPERSBERGER, Mr. LOWENTHAL, Mr. MALINOWSKI, Mr. 

QUIGLEY, Ms. CLARKE of New York, Mr. COURTNEY, Ms. TITUS, Ms. 

SCANLON, Ms. KAPTUR, Mr. GRIJALVA, Mr. CONNOLLY, Mr. MICHAEL

F. DOYLE of Pennsylvania, Mr. GARAMENDI, Mrs. NAPOLITANO, Mr. 

KILMER, Mr. JOHNSON of Georgia, Mrs. MCBATH, Mr. CARBAJAL, Mrs. 

AXNE, Mr. LANGEVIN, Mr. BRENDAN F. BOYLE of Pennsylvania, Ms. 

BROWNLEY, Ms. SHERRILL, Mr. KRISHNAMOORTHI, Ms. LEE of California, Mr. FOSTER, Mrs. CAROLYN B. MALONEY of New York, Mr. 

POCAN, Mr. DEFAZIO, Ms. ROYBAL-ALLARD, Ms. BONAMICI, Ms. 

DELBENE, Ms. NORTON, Mrs. MURPHY of Florida, Mr. WALTZ, Ms. 

STEVENS, Mr. SARBANES, Mrs. WATSON COLEMAN, Ms. ADAMS, Ms. 

HOULAHAN, Mr. BLUMENAUER, Mr. FITZPATRICK, Mr. SCHWEIKERT, 

Mr. KHANNA, Mr. TAKANO, Mr. LYNCH, Mr. COOPER, Ms. LOIS

FRANKEL of Florida, Mr. PRICE of North Carolina, Mr. KATKO, Mr. 

ALLRED, Mr. SOTO, Mr. LIEU, Ms. JAYAPAL, Mr. CICILLINE, Ms. 

MCCOLLUM, Ms. SA ́NCHEZ, Mr. LARSON of Connecticut, Ms. BLUNT

ROCHESTER, Mr. NADLER, Ms. UNDERWOOD, Miss RICE of New York, 

Mr. LAMB, Mr. NEGUSE, Ms. CHU, Ms. MALLIOTAKIS, Mrs. LURIA, Ms. 

DAVIDS of Kansas, Ms. LOFGREN, and Mrs. TRAHAN) 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. 


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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 2021’’. 

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 for any person, whether 

10 private or governmental, to knowingly conduct or contract 

11 for cosmetic animal testing that occurs in the United 

12 States. 

13 (b) PROHIBITION ON SALE OR TRANSPORT.—Begin14 ning on the date that is 1 year after the date of enactment 

15 of this Act, it shall be unlawful to sell, offer for sale, or 

16 knowingly transport in interstate commerce in the United 

17 States any cosmetic product that was developed or manu18 factured using cosmetic animal testing that was conducted 

19 or contracted for by any person in the cosmetic product’s 

20 supply chain after such date. 

21 (c) DATA USE.— 

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

23 animal testing conducted after the effective date 

24 specified in subsection (a) may be relied upon to es25 tablish the safety of a cosmetic, cosmetic ingredient, 


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1 or nonfunctional constituent under the Federal 

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

3 seq.), unless— 

4 (A) in the case of such testing on an ingre5 dient or nonfunctional constituent, there is no 

6 non-animal alternative method or strategy rec7 ognized by any Federal agency, the Interagency 

8 Coordinating Committee on the Validation of 

9 Alternative Methods, or the Organisation for 

10 Economic Co-operation and Development for 

11 the relevant safety endpoints for such ingre12 dient or nonfunctional constituent; and 

13 (B)(i) such animal testing is subject to an 

14 exemption under paragraph (2) or (3) of sub15 section (d); or 

16 (ii)(I) such animal testing is subject to an 

17 exemption under paragraph (4) of subsection 

18 (d); 

19 (II) there is documented evidence of the 

20 non-cosmetic intent of the test; and 

21 (III) there is a history of use of the ingre22 dient outside of cosmetics at least 1 year prior 

23 to the reliance on such data. 

24 (2) LIMITATION.—This section shall not be con25 strued to prohibit any entity from reviewing, assessVerDate Sep 11 2014 17:08 Dec 17, 2021 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6207.IH H6207

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1 ing, or retaining evidence generated from animal 

2 testing. 

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

4 apply with respect to animal testing— 

5 (1) conducted outside the United States in 

6 order to comply with a requirement from a foreign 

7 regulatory authority; 

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

9 Secretary, following— 

10 (A) a written finding by the Secretary 

11 that— 

12 (i) there is no non-animal alternative 

13 method or strategy recognized by any Fed14 eral agency, the Interagency Coordinating 

15 Committee on the Validation of Alternative 

16 Methods, or the Organisation for Economic 

17 Co-operation and Development for the rel18 evant safety endpoints for the cosmetic in19 gredient or nonfunctional constituent; 

20 (ii) there is a reasonable probability 

21 that the ingredient or nonfunctional con22 stituent poses a specific and serious ad23 verse human health risk and the need to 

24 conduct an animal test is justified and 

25 supported by a detailed research protocol 


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1 that is proposed for the basis for evalua2 tion of the cosmetic ingredient or nonfunc3 tional constituent; and 

4 (iii) the cosmetic ingredient or non5 functional constituent is in wide use and, 

6 in the case of a cosmetic ingredient, cannot 

7 be replaced by another cosmetic ingredient 

8 capable of performing a similar function; 

9 (B) publication by the Secretary, on the 

10 website of the Food and Drug Administration, 

11 of the written finding under subparagraph (A) 

12 together with a notice that the Secretary in13 tends to request, require, or conduct new ani14 mal testing, and providing a period of not less 

15 than 60 calendar days for public comment; and 

16 (C) a written determination by the Sec17 retary, after review of all public comments re18 ceived pursuant to subparagraph (B), that no 

19 previously generated data that could be sub20 stituted for, or otherwise determined sufficient 

21 to replace, the data expected to be produced 

22 through new animal testing is available for re23 view by the Secretary; 

24 (3) conducted for any product or ingredient 

25 that is subject to regulation under chapter V of the 


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

2 351 et seq.); or 

3 (4) conducted for non-cosmetic purposes pursu4 ant to a requirement of a Federal, State, or foreign 

5 regulatory authority. 

6 (e) RULE OF CONSTRUCTION.—With the exception of 

7 records or other information demonstrating compliance 

8 with subsection (c)(1)(B)(ii), nothing in this section shall 

9 be construed to authorize the Secretary to impose any new 

10 recordkeeping requirements relating to cosmetic animal 

11 testing. 

12 (f) CIVIL PENALTIES.— 

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

14 penalties under applicable law, any person who vio15 lates this section may be subject to a civil penalty 

16 in an amount of not more than $10,000 for each 

17 such violation, as determined by the Secretary. 

18 (2) MULTIPLE VIOLATIONS.—Each violation of 

19 this section with respect to a separate animal, and 

20 each day that a violation of this Act continues, con21 stitutes a separate offense. 

22 (g) RECORDS ACCESS.— 

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

24 any records or other information from a cosmetic 

25 manufacturer that such manufacturer relied upon to 


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

2 manufacturer shall, upon such request of the Sec3 retary in writing, provide to the Secretary such 

4 records or other information, within a reasonable 

5 timeframe, within reasonable limits, and in a reason6 able manner, and in either electronic or physical 

7 form, at the expense of such manufacturer. The Sec8 retary’s request shall include a sufficient description 

9 of the records requested and reference this sub10 section. 

11 (2) CONFIRMATION OF RECEIPT.—Upon receipt 

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

13 Secretary shall provide to the manufacturer con14 firmation of receipt. 

15 (3) INSPECTION AUTHORITY.—Nothing in this 

16 subsection supplants the authority of the Secretary 

17 to conduct inspections otherwise permitted under the 

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

19 301 et seq.). 

20 (h) STATE AUTHORITY.—No State or political sub21 division of a State may establish or continue in effect any 

22 prohibition relating to cosmetic animal testing, or to the 

23 regulation of data use, labeling, and packaging related to 

24 animal testing, that is not identical to the prohibitions set 

25 forth in subsections (a), (b), (c), and (j) and that does 


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1 not include the exemptions contained in subsections (c), 

2 (d), and (j). No State or political subdivision of a State 

3 may require any entity to perform cosmetic animal testing 

4 that is not permitted by subsection (a). 

5 (i) FDA STRATEGIC PLAN FOR NON-ANIMAL TEST

6 METHODS.— 

7 (1) SCIENTIFIC INNOVATION.—To promote the 

8 development of, and provide for expedited review and 

9 acceptance of, new scientifically valid test methods 

10 and strategies that are not based on vertebrate ani11 mals, the Secretary shall— 

12 (A) not later than 1 year after the date of 

13 enactment of this Act, develop and publish on 

14 the website of the Food and Drug Administra15 tion a strategic plan to promote the develop16 ment and implementation of alternative test 

17 methods and strategies to replace vertebrate 

18 animal testing for assessing the safety of cos19 metics; 

20 (B) provide a period of not less than 60 

21 calendar days for public comment regarding 

22 such strategic plan; 

23 (C) include in the strategic plan developed 

24 under subparagraph (A) a list (which the Sec25 retary shall update on a regular basis, and 


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1 which shall be for informational purposes and 

2 shall not be deemed to constitute a list of the 

3 only acceptable non-animal test methods) of— 

4 (i) scientifically reliable and relevant 

5 non-animal test methodology as alter6 natives to animal testing that have been 

7 recognized by any Federal agency or an 

8 international regulatory agency; 

9 (ii) next generation risk assessment 

10 methods; and 

11 (iii) examples of alternative methods 

12 and strategies that have been accepted by 

13 the Secretary; and 

14 (D) to the maximum extent practicable 

15 given available resources, prioritize and carry 

16 out performance assessment, validation, and 

17 translational studies to accelerate the develop18 ment of scientifically valid test methods and 

19 strategies that replace the use of vertebrate ani20 mals. 

21 (2) PUBLIC MEETINGS.— 

22 (A) INITIAL MEETING.—Not later than 90 

23 days after the date of enactment of this Act, 

24 the Secretary shall convene a public meeting reVerDate Sep 11 2014 17:08 Dec 17, 2021 Jkt 029200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H6207.IH H6207

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1 garding the strategic plan described in para2 graph (1)(A). 

3 (B) SUBSEQUENT ANNUAL MEETINGS.— 

4 Not later than 1 year after the date of the pub5 lic meeting under subparagraph (A), and annu6 ally thereafter, the Secretary shall convene a 

7 separate public meeting or add as an agenda 

8 item to an already existing meeting, in-person 

9 or virtually, to inform the Secretary’s advance10 ment of alternative test methods and strategies 

11 to replace vertebrate animal testing for assess12 ing the safety of cosmetics. The Secretary shall 

13 include in such meetings scientific and aca14 demic experts, animal and consumer advocacy 

15 groups, and the regulated industry. 

16 (3) RULE OF CONSTRUCTION.—Nothing in this 

17 subsection shall be construed to limit the authority 

18 of the Secretary to address other tools to promote 

19 the development and implementation of alternative 

20 test methods and strategies to replace vertebrate 

21 animal testing for assessing the safety of cosmetics 

22 as part of the strategic plan described in paragraph 

23 (1)(A). 

24 (j) CONSUMER INFORMATION RELATED TO ANIMAL

25 TESTING.— 


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1 (1) IN GENERAL.—A cosmetic product manu2 facturer shall not include on the label of a cosmetic 

3 product or any of the product’s containers or wrap4 pers a claim that such cosmetic product was not 

5 tested on animals, including any claim or logo of 

6 ‘‘cruelty free’’ if— 

7 (A) such cosmetic product or any ingre8 dient or nonfunctional constituent contained in 

9 such cosmetic product was tested on an animal 

10 after the effective date specified in subsection 

11 (a); and 

12 (B)(i) the testing was conducted by or con13 tracted for by the cosmetic product manufac14 turer or another person in the supply chain at 

15 the direction or request of the cosmetic product 

16 manufacturer; or 

17 (ii) the cosmetic product manufacturer re18 lied upon evidence from such testing, pursuant 

19 to subsection (c)(1)(B)(ii), to establish the safe20 ty of such product, ingredient, or nonfunctional 

21 constituent under chapter VI of the Federal 

22 Food, Drug, and Cosmetic Act (21 U.S.C. 361 

23 et seq.). 

24 (2) EXCEPTIONS.—Notwithstanding paragraph 

25 (1), a cosmetic product manufacturer may include a 


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1 claim described in such paragraph on the label of a 

2 cosmetic product described in such paragraph or any 

3 of the product’s containers or wrappers if— 

4 (A) such testing qualifies for the exemp5 tion under subsection (d)(4); and 

6 (B)(i) in the case of animal testing con7 ducted by or contracted for by the cosmetic 

8 product manufacturer or another person in the 

9 supply chain at the direction or request of the 

10 cosmetic product manufacturer, the cosmetic 

11 manufacturer did not rely upon evidence from 

12 such testing for the purpose of establishing the 

13 safety of the product, ingredient, or nonfunc14 tional constituent under chapter VI of the Fed15 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

16 361 et seq.); or 

17 (ii) in the case of animal testing conducted 

18 by or contracted for by a person that is not de19 scribed in clause (i), evidence from which the 

20 cosmetic product manufacturer relied upon, 

21 pursuant to subsection (c)(1)(B)(ii), to estab22 lish the safety of such product, ingredient, or 

23 nonfunctional constituent under chapter VI of 

24 the Federal Food, Drug, and Cosmetic Act (21 

25 U.S.C. 361 et seq.), the cosmetic product manVerDate Sep 11 2014 17:08 Dec 17, 2021 Jkt 029200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H6207.IH H6207

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1 ufacturer includes on the label a disclosure de2 scribing the circumstances surrounding the use 

3 of the exemption under subsection (c)(1)(B)(ii) 

4 by such manufacturer that includes a reference 

5 to the specific Federal, State, or foreign re6 quirement under which the animal testing was 

7 conducted or a reference to a publicly available 

8 internet website of such manufacturer that pro9 vides such disclosure. 

10 (k) REPORT.—Beginning 2 years after the date of en11 actment of this Act, the Secretary shall biennially submit 

12 to the Committee on Health, Education, Labor, and Pen13 sions of the Senate and the Committee on Energy and 

14 Commerce of the House of Representatives, and make 

15 available on the website of the Food and Drug Administra16 tion, a report that includes, with respect to the previous 

17 2 fiscal years— 

18 (1) updates on the Secretary’s implementation 

19 of this section, including developments implementing 

20 the strategic plan under subsection (i)(1)(A); 

21 (2) the number of times the Secretary re22 quested animal test data under subsection (d)(2), 

23 the ingredients involved, and the animal tests per24 formed; and 


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1 (3) based on the data reviewed by the Secretary 

2 under subsection (g)(1), the number of times manu3 facturers relied upon data pursuant to the exemp4 tion under subsection (d)(4) to establish the safety 

5 of a cosmetic under chapter VI of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.). 

7 (l) DEFINITIONS.— 

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

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

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

11 321(i)). 

12 (2) COSMETIC ANIMAL TESTING.—The term 

13 ‘‘cosmetic animal testing’’ means the internal or ex14 ternal application or exposure of any cosmetic prod15 uct, or any cosmetic ingredient or nonfunctional con16 stituent, to the skin, eyes, or other body part (organ 

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

18 purpose of evaluating the safety or efficacy of a cos19 metic product or a cosmetic ingredient or nonfunc20 tional constituent for use in a cosmetic product. 

21 (3) LABEL.—The term ‘‘label’’ has the meaning 

22 given such term in section 201(k) of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 321(k)). 

24 (4) NONFUNCTIONAL CONSTITUENT.—The term 

25 ‘‘nonfunctional constituent’’ means any incidental inVerDate Sep 11 2014 17:08 Dec 17, 2021 Jkt 029200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H6207.IH H6207

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1 gredient as defined in section 701.3(l) of title 21, 

2 Code of Federal Regulations, on the date of enact3 ment of this section. 

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

5 the Secretary of Health and Human Services. 

Æ 


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