Humane Cosmetics Act of 2023
This bill generally prohibits animal testing in the evaluation of cosmetic products, and it prohibits the sale or transport of cosmetics developed using animal testing, subject to civil penalties. These prohibitions begin one year after enactment.
The bill specifies exceptions to these prohibitions, including if such animal testing (1) is conducted outside the United States to comply with a foreign regulatory authority; (2) is pursuant to a specified finding that there are no nonanimal alternatives to test the safety of a potentially dangerous cosmetic product or ingredient; (3) is of a product or ingredient for a drug or device subject to regulation by the Food and Drug Administration (FDA); or (4) is required for a noncosmetic purpose pursuant to a state, federal, or foreign regulatory authority.
Further, no animal-testing evidence may be used to establish the safety of a cosmetic product or ingredient that is regulated by the FDA after the effective date of this bill, subject to limited exceptions.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5399 Introduced in House (IH)]
<DOC>
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. Cardenas, 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.
Be it enacted by the Senate and House of Representatives 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 contract for cosmetic animal testing that occurs
in the United States.
(b) Prohibition on Sale or Transport.--Beginning 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
manufactured 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 establish 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 exemption
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 Federal
agency, the Interagency Coordinating Committee
on the Validation of Alternative Methods, or
the Organisation for Economic Co-operation and
Development for the relevant safety endpoints
for such ingredient or nonfunctional
constituent for use in cosmetics; 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
ingredient outside of cosmetics at least 1 year
prior to the reliance on evidence described in
the matter preceding subparagraph (A).
(2) Limitation.--This section shall not be construed to
prohibit any entity from reviewing, assessing, or retaining
evidence generated from animal testing.
(d) Exemptions.--Subsections (a) and (b) shall not apply with
respect to animal testing--
(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 ingredient or
nonfunctional constituent; and
(iii) the cosmetic ingredient cannot be
replaced by another cosmetic ingredient capable
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 intends to request, require, or
conduct new animal testing, and providing a period of
not less than 60 calendar days for public comment; and
(C) a written determination by the Secretary, after
review of all public comments received pursuant to
subparagraph (B), that no previously generated data
that could be substituted for, or otherwise determined
sufficient to replace, the data expected to be produced
through new animal testing is available for review 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 pursuant 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
Secretary.
(2) Multiple violations.--Each violation of this section
with respect to a separate animal, and each day that a
violation of this Act continues, constitutes 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 reasonable manner, and in
either electronic or physical form, at the expense of such
manufacturer. The Secretary's request shall include a
sufficient description of the records requested and reference
this subsection.
(2) Confirmation of receipt.--Upon receipt of the records
requested under paragraph (1), the Secretary shall provide to
the manufacturer confirmation of receipt.
(3) Inspection authority.--Nothing in this subsection
supplants the authority of the Secretary to conduct inspections
otherwise permitted under the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.).
(g) State Authority.--No State or political subdivision 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 subsection (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 external application or
exposure of any cosmetic product, cosmetic ingredient, or
nonfunctional constituent 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 cosmetic
product or a cosmetic ingredient or nonfunctional constituent
for use in a cosmetic product.
(3) Nonfunctional constituent.--The term ``nonfunctional
constituent'' means any incidental ingredient as defined in
section 701.3(l) of title 21, Code of Federal Regulations, on
the date of enactment of this section.
(4) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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