II 

117TH CONGRESS 

1ST SESSION S. 3357 

To substantially restrict the use of animal testing for cosmetics. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 9, 2021 

Mr. BOOKER (for himself, Mr. PORTMAN, Mr. HICKENLOOPER, Ms. COLLINS, 

and Ms. ROSEN) introduced the following bill; which was read twice and 

referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To substantially restrict the use of animal testing for 

cosmetics. 

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 


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1 for cosmetic animal testing that occurs in the United 

2 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 sell, offer for sale, or 

6 knowingly 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 cosmetic product’s 

10 supply chain 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) in the case of such testing on an ingre20 dient or nonfunctional constituent, there is no 

21 non-animal alternative method or strategy rec22 ognized by any Federal agency, the Interagency 

23 Coordinating Committee on the Validation of 

24 Alternative Methods, or the Organisation for 

25 Economic Co-operation and Development for 


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1 the relevant safety endpoints for such ingre2 dient or nonfunctional constituent; and 

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

4 exemption under paragraph (2) or (3) of sub5 section (d); or 

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

7 exemption under paragraph (4) of subsection 

8 (d); 

9 (II) there is documented evidence of the 

10 non-cosmetic intent of the test; and 

11 (III) there is a history of use of the ingre12 dient outside of cosmetics at least 1 year prior 

13 to the reliance on such data. 

14 (2) LIMITATION.—This section shall not be con15 strued to prohibit any entity from reviewing, assess16 ing, or retaining evidence generated from animal 

17 testing. 

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

19 apply with respect to animal testing— 

20 (1) conducted outside the United States in 

21 order to comply with a requirement from a foreign 

22 regulatory authority; 

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

24 Secretary, following— 


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1 (A) a written finding by the Secretary 

2 that— 

3 (i) there is no non-animal alternative 

4 method or strategy recognized by any Fed5 eral agency, the Interagency Coordinating 

6 Committee on the Validation of Alternative 

7 Methods, or the Organisation for Economic 

8 Co-operation and Development for the rel9 evant safety endpoints for the cosmetic in10 gredient or nonfunctional constituent; 

11 (ii) there is a reasonable probability 

12 that the ingredient or nonfunctional con13 stituent poses a specific and serious ad14 verse human health risk and the need to 

15 conduct an animal test is justified and 

16 supported by a detailed research protocol 

17 that is proposed for the basis for evalua18 tion of the cosmetic ingredient or nonfunc19 tional constituent; and 

20 (iii) the cosmetic ingredient or non21 functional constituent is in wide use and, 

22 in the case of a cosmetic ingredient, cannot 

23 be replaced by another cosmetic ingredient 

24 capable of performing a similar function; 


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1 (B) publication by the Secretary, on the 

2 website of the Food and Drug Administration, 

3 of the written finding under subparagraph (A) 

4 together with a notice that the Secretary in5 tends to request, require, or conduct new ani6 mal testing, and providing a period of not less 

7 than 60 calendar days for public comment; and 

8 (C) a written determination by the Sec9 retary, after review of all public comments re10 ceived pursuant to subparagraph (B), that no 

11 previously generated data that could be sub12 stituted for, or otherwise determined sufficient 

13 to replace, the data expected to be produced 

14 through new animal testing is available for re15 view by the Secretary; 

16 (3) conducted for any product or ingredient 

17 that is subject to regulation under chapter V of the 

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

19 351 et seq.); or 

20 (4) conducted for non-cosmetic purposes pursu21 ant to a requirement of a Federal, State, or foreign 

22 regulatory authority. 

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

24 records or other information demonstrating compliance 

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


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1 be construed to authorize the Secretary to impose any new 

2 recordkeeping requirements relating to cosmetic animal 

3 testing. 

4 (f) CIVIL PENALTIES.— 

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

6 penalties under applicable law, any person who vio7 lates this section may be subject to a civil penalty 

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

9 such violation, as determined by the Secretary. 

10 (2) MULTIPLE VIOLATIONS.—Each violation of 

11 this section with respect to a separate animal, and 

12 each day that a violation of this Act continues, con13 stitutes a separate offense. 

14 (g) RECORDS ACCESS.— 

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

16 any records or other information from a cosmetic 

17 manufacturer that such manufacturer relied upon to 

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

19 manufacturer shall, upon such request of the Sec20 retary in writing, provide to the Secretary such 

21 records or other information, within a reasonable 

22 timeframe, within reasonable limits, and in a reason23 able manner, and in either electronic or physical 

24 form, at the expense of such manufacturer. The Sec25 retary’s request shall include a sufficient description 


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1 of the records requested and reference this sub2 section. 

3 (2) CONFIRMATION OF RECEIPT.—Upon receipt 

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

5 Secretary shall provide to the manufacturer con6 firmation of receipt. 

7 (3) INSPECTION AUTHORITY.—Nothing in this 

8 subsection supplants the authority of the Secretary 

9 to conduct inspections otherwise permitted under the 

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

11 301 et seq.). 

12 (h) STATE AUTHORITY.—No State or political sub13 division of a State may establish or continue in effect any 

14 prohibition relating to cosmetic animal testing, or to the 

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

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

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

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

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

20 may require any entity to perform cosmetic animal testing 

21 that is not permitted by subsection (a). 

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

23 METHODS.— 

24 (1) SCIENTIFIC INNOVATION.—To promote the 

25 development of, and provide for expedited review and 


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1 acceptance of, new scientifically valid test methods 

2 and strategies that are not based on vertebrate ani3 mals, the Secretary shall— 

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

5 enactment of this Act, develop and publish on 

6 the website of the Food and Drug Administra7 tion a strategic plan to promote the develop8 ment and implementation of alternative test 

9 methods and strategies to replace vertebrate 

10 animal testing for assessing the safety of cos11 metics; 

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

13 calendar days for public comment regarding 

14 such strategic plan; 

15 (C) include in the strategic plan developed 

16 under subparagraph (A) a list (which the Sec17 retary shall update on a regular basis, and 

18 which shall be for informational purposes and 

19 shall not be deemed to constitute a list of the 

20 only acceptable non-animal test methods) of— 

21 (i) scientifically reliable and relevant 

22 non-animal test methodology as alter23 natives to animal testing that have been 

24 recognized by any Federal agency or an 

25 international regulatory agency; 


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1 (ii) next generation risk assessment 

2 methods; and 

3 (iii) examples of alternative methods 

4 and strategies that have been accepted by 

5 the Secretary; and 

6 (D) to the maximum extent practicable 

7 given available resources, prioritize and carry 

8 out performance assessment, validation, and 

9 translational studies to accelerate the develop10 ment of scientifically valid test methods and 

11 strategies that replace the use of vertebrate ani12 mals. 

13 (2) PUBLIC MEETINGS.— 

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

15 days after the date of enactment of this Act, 

16 the Secretary shall convene a public meeting re17 garding the strategic plan described in para18 graph (1)(A). 

19 (B) SUBSEQUENT ANNUAL MEETINGS.— 

20 Not later than 1 year after the date of the pub21 lic meeting under subparagraph (A), and annu22 ally thereafter, the Secretary shall convene a 

23 separate public meeting or add as an agenda 

24 item to an already existing meeting, in-person 

25 or virtually, to inform the Secretary’s advanceVerDate Sep 11 2014 21:04 Dec 16, 2021 Jkt 029200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S3357.IS S3357

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1 ment of alternative test methods and strategies 

2 to replace vertebrate animal testing for assess3 ing the safety of cosmetics. The Secretary shall 

4 include in such meetings scientific and aca5 demic experts, animal and consumer advocacy 

6 groups, and the regulated industry. 

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

8 subsection shall be construed to limit the authority 

9 of the Secretary to address other tools to promote 

10 the development and implementation of alternative 

11 test methods and strategies to replace vertebrate 

12 animal testing for assessing the safety of cosmetics 

13 as part of the strategic plan described in paragraph 

14 (1)(A). 

15 (j) CONSUMER INFORMATION RELATED TO ANIMAL

16 TESTING.— 

17 (1) IN GENERAL.—A cosmetic product manu18 facturer shall not include on the label of a cosmetic 

19 product or any of the product’s containers or wrap20 pers a claim that such cosmetic product was not 

21 tested on animals, including any claim or logo of 

22 ‘‘cruelty free’’ if— 

23 (A) such cosmetic product or any ingre24 dient or nonfunctional constituent contained in 

25 such cosmetic product was tested on an animal 


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1 after the effective date specified in subsection 

2 (a); and 

3 (B)(i) the testing was conducted by or con4 tracted for by the cosmetic product manufac5 turer or another person in the supply chain at 

6 the direction or request of the cosmetic product 

7 manufacturer; or 

8 (ii) the cosmetic product manufacturer re9 lied upon evidence from such testing, pursuant 

10 to subsection (c)(1)(B)(ii), to establish the safe11 ty of such product, ingredient, or nonfunctional 

12 constituent under chapter VI of the Federal 

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

14 et seq.). 

15 (2) EXCEPTIONS.—Notwithstanding paragraph 

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

17 claim described in such paragraph on the label of a 

18 cosmetic product described in such paragraph or any 

19 of the product’s containers or wrappers if— 

20 (A) such testing qualifies for the exemp21 tion under subsection (d)(4); and 

22 (B)(i) in the case of animal testing con23 ducted by or contracted for by the cosmetic 

24 product manufacturer or another person in the 

25 supply chain at the direction or request of the 


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1 cosmetic product manufacturer, the cosmetic 

2 manufacturer did not rely upon evidence from 

3 such testing for the purpose of establishing the 

4 safety of the product, ingredient, or nonfunc5 tional constituent under chapter VI of the Fed6 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

7 361 et seq.); or 

8 (ii) in the case of animal testing conducted 

9 by or contracted for by a person that is not de10 scribed in clause (i), evidence from which the 

11 cosmetic product manufacturer relied upon, 

12 pursuant to subsection (c)(1)(B)(ii), to estab13 lish the safety of such product, ingredient, or 

14 nonfunctional constituent under chapter VI of 

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

16 U.S.C. 361 et seq.), the cosmetic product man17 ufacturer includes on the label a disclosure de18 scribing the circumstances surrounding the use 

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

20 by such manufacturer that includes a reference 

21 to the specific Federal, State, or foreign re22 quirement under which the animal testing was 

23 conducted or a reference to a publicly available 

24 internet website of such manufacturer that pro25 vides such disclosure. 


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1 (k) REPORT.—Beginning 2 years after the date of en2 actment of this Act, the Secretary shall biennially submit 

3 to the Committee on Health, Education, Labor, and Pen4 sions of the Senate and the Committee on Energy and 

5 Commerce of the House of Representatives, and make 

6 available on the website of the Food and Drug Administra7 tion, a report that includes, with respect to the previous 

8 2 fiscal years— 

9 (1) updates on the Secretary’s implementation 

10 of this section, including developments implementing 

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

12 (2) the number of times the Secretary re13 quested animal test data under subsection (d)(2), 

14 the ingredients involved, and the animal tests per15 formed; and 

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

17 under subsection (g)(1), the number of times manu18 facturers relied upon data pursuant to the exemp19 tion under subsection (d)(4) to establish the safety 

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

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

22 (l) DEFINITIONS.— 

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

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


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

2 321(i)). 

3 (2) COSMETIC ANIMAL TESTING.—The term 

4 ‘‘cosmetic animal testing’’ means the internal or ex5 ternal application or exposure of any cosmetic prod6 uct, or any cosmetic ingredient or nonfunctional con7 stituent, to the skin, eyes, or other body part (organ 

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

9 purpose of evaluating the safety or efficacy of a cos10 metic product or a cosmetic ingredient or nonfunc11 tional constituent for use in a cosmetic product. 

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

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

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

15 (4) NONFUNCTIONAL CONSTITUENT.—The term 

16 ‘‘nonfunctional constituent’’ means any incidental in17 gredient as defined in section 701.3(l) of title 21, 

18 Code of Federal Regulations, on the date of enact19 ment of this section. 

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

21 the Secretary of Health and Human Services. 

Æ 


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