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 Com-
mittee on Energy and Commerce 
A BILL 
To substantially restrict the use of animal testing for 
cosmetics, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Humane Cosmetics 
Act of 2023’’. 
SEC. 2. ANIMAL TESTING. 
(a) PROHIBITION ON ANIMAL TESTING.—Beginning 
on the date that is 1 year after the date of enactment 
of this Act, it shall be unlawful to knowingly conduct or 
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contract for cosmetic animal testing that occurs in the 
United States. 
(b) PROHIBITION ON SALE OR TRANSPORT.—Begin-
ning on the date that is 1 year after the date of enactment 
of this Act, it shall be unlawful to knowingly sell, offer 
for sale, or transport in interstate commerce in the United 
States any cosmetic product that was developed or manu-
factured using cosmetic animal testing that was conducted 
or contracted for by any person in the supply chain of 
the cosmetic product after such date. 
(c) DATA USE.— 
(1) IN
GENERAL.—No evidence derived from 
animal testing conducted after the effective date 
specified in subsection (a) may be relied upon to es-
tablish the safety of a cosmetic, cosmetic ingredient, 
or nonfunctional constituent under the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.), unless— 
(A) such animal testing is subject to an ex-
emption under subsection (d)(2); or 
(B) in the case of such animal testing on 
an ingredient or nonfunctional constituent— 
(i) there is no non-animal alternative 
method or strategy recognized by any Fed-
eral agency, the Interagency Coordinating 
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Committee on the Validation of Alternative 
Methods, or the Organisation for Economic 
Co-operation and Development for the rel-
evant safety endpoints for such ingredient 
or nonfunctional constituent for use in cos-
metics; and 
(ii)(I) such animal testing is subject 
to an exemption under subsection (d)(3); 
or 
(II)(aa) such animal testing is subject 
to an exemption under subsection (d)(4); 
(bb) there is documented evidence of 
the non-cosmetic intent of the test; and 
(cc) there is a history of use of the in-
gredient outside of cosmetics at least 1 
year prior to the reliance on evidence de-
scribed in the matter preceding subpara-
graph (A). 
(2) LIMITATION.—This section shall not be con-
strued to prohibit any entity from reviewing, assess-
ing, or retaining evidence generated from animal 
testing. 
(d) EXEMPTIONS.—Subsections (a) and (b) shall not 
apply with respect to animal testing— 
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(1) conducted outside the United States in 
order to comply with a requirement from a foreign 
regulatory authority; 
(2) requested, required, or conducted by the 
Secretary, following— 
(A) a written finding by the Secretary 
that— 
(i) there is no non-animal alternative 
method or strategy for the relevant safety 
endpoints for the cosmetic ingredient or 
nonfunctional constituent; 
(ii) there is information received by 
the Secretary of adverse health effects, 
other than minor and transient reactions 
or minor and transient skin irritations in 
some users, related to the cosmetic ingre-
dient or nonfunctional constituent; and 
(iii) the cosmetic ingredient cannot be 
replaced by another cosmetic ingredient ca-
pable of performing a similar function; 
(B) publication by the Secretary, on the 
website of the Food and Drug Administration, 
of the written finding under subparagraph (A) 
together with a notice that the Secretary in-
tends to request, require, or conduct new ani-
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mal testing, and providing a period of not less 
than 60 calendar days for public comment; and 
(C) a written determination by the Sec-
retary, after review of all public comments re-
ceived pursuant to subparagraph (B), that no 
previously generated data that could be sub-
stituted for, or otherwise determined sufficient 
to replace, the data expected to be produced 
through new animal testing is available for re-
view by the Secretary; 
(3) conducted for any product or ingredient 
that is subject to regulation under chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.); or 
(4) conducted for non-cosmetic purposes pursu-
ant to a requirement of a Federal, State, or foreign 
regulatory authority. 
(e) CIVIL PENALTIES.— 
(1) IN
GENERAL.—In addition to any other 
penalties under applicable law, the Secretary may 
impose on any person who violates this section a 
civil penalty in an amount of not more than $10,000 
for each such violation, as determined by the Sec-
retary. 
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(2) MULTIPLE VIOLATIONS.—Each violation of 
this section with respect to a separate animal, and 
each day that a violation of this Act continues, con-
stitutes a separate offense. 
(f) RECORDS ACCESS.— 
(1) IN GENERAL.—The Secretary may request 
any records or other information from a cosmetic 
manufacturer that such manufacturer relied upon to 
meet the criteria in subsection (c)(1)(B)(ii)(II). 
Such manufacturer shall, upon such request of the 
Secretary in writing, provide to the Secretary such 
records or other information, within a reasonable 
timeframe, within reasonable limits, and in a reason-
able manner, and in either electronic or physical 
form, at the expense of such manufacturer. The Sec-
retary’s request shall include a sufficient description 
of the records requested and reference this sub-
section. 
(2) CONFIRMATION OF RECEIPT.—Upon receipt 
of the records requested under paragraph (1), the 
Secretary shall provide to the manufacturer con-
firmation of receipt. 
(3) INSPECTION AUTHORITY.—Nothing in this 
subsection supplants the authority of the Secretary 
to conduct inspections otherwise permitted under the 
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Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.). 
(g) STATE AUTHORITY.—No State or political sub-
division of a State may establish or continue in effect any 
prohibition relating to cosmetic animal testing, or to the 
regulation of data use related to animal testing, that is 
not identical to the prohibitions set forth in subsections 
(a), (b), and (c), and that does not include the exemptions 
contained in subsections (c) and (d). No State or political 
subdivision of a State may require any entity to perform 
cosmetic animal testing that is not permitted by sub-
section (a). 
(h) DEFINITIONS.— 
(1) COSMETIC.—The term ‘‘cosmetic’’ has the 
meaning given such term in section 201(i) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321(i)). 
(2) COSMETIC
ANIMAL
TESTING.—The term 
‘‘cosmetic animal testing’’ means the internal or ex-
ternal application or exposure of any cosmetic prod-
uct, cosmetic ingredient, or nonfunctional con-
stituent to the skin, eyes, or other body part (organ 
or extremity) of a live non-human vertebrate for the 
purpose of evaluating the safety or efficacy of a cos-
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metic product or a cosmetic ingredient or nonfunc-
tional constituent for use in a cosmetic product. 
(3) NONFUNCTIONAL CONSTITUENT.—The term 
‘‘nonfunctional constituent’’ means any incidental in-
gredient as defined in section 701.3(l) of title 21, 
Code of Federal Regulations, on the date of enact-
ment of this section. 
(4) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
Æ 
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