Sec. 109. Animal testing restrictions
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Section 601 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 ) is amended by adding at the end the following: If the cosmetic product, cosmetic formulation, or cosmetic ingredient was developed or manufactured using an animal test that was conducted or contracted by the manufacturer, or any affiliate or supplier of the manufacturer, unless one of the following applies: With respect to a cosmetic ingredient of the cosmetic product or cosmetic formulation, an animal test is required by the Secretary to evaluate the safety of such ingredient or formulation.
With respect to a cosmetic ingredient of the cosmetic product or cosmetic formulation, the cosmetic ingredient or cosmetic formulation is in wide use and cannot be replaced by another ingredient that is capable of performing a similar function without posing a potentially greater risk to human health and there is not an alternative method for testing the cosmetic ingredient that is accepted by the Secretary and the Interagency Coordinating Committee on Validation of Alternative Methods.
The animal test was conducted to comply with a requirement of another Federal agency or a State or foreign regulatory authority. In the case of a cosmetic product, cosmetic formulation, or cosmetic ingredient that is also a drug, the animal test was conducted with respect to the approval under chapter V of the application submitted with respect to such product, formulation, or ingredient. The animal test was conducted for purposes not related to developing or manufacturing the cosmetic product, cosmetic formulation, or cosmetic ingredient, and in response to a requirement of a Federal, State, or foreign regulatory authority. .
The amendment made by subsection
(a)shall apply with respect to cosmetic products or cosmetic formulations introduced or delivered for introduction into interstate commerce on or after the date that is two years after the date of enactment of this Act. Not later than 1 year after the date of enactment of this Act, the Secretary shall issue guidance on the acceptability of scientifically reliable and relevant alternatives to animal testing for the safety of cosmetic products, cosmetic formulations, and cosmetic ingredients, and encouraging the use of such methods. Not later than 180 days after the date of enactment of this Act, the Secretary shall publish information on the internet website of the Food and Drug Administration regarding resources available for information about non-animal methods, and methods that reduce animal usage, in testing for the safety of cosmetic products, cosmetic formulations, and cosmetic ingredients. Nothing in this section, or the amendment made by this section, shall be construed to prohibit any entity from reviewing, assessing, or retaining evidence generated from animal testing. Nothing in this section, or the amendment made by this section, shall be construed to prohibit the Secretary from accepting data from animal testing conducted— prior to the date specified in subsection (b); or on or after such date— in the case of a cosmetic product, cosmetic formulation, or cosmetic ingredient that is also a drug, with respect to the approval under chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.) of the application submitted with respect to such product, formulation, or ingredient; or pursuant to requirements of a Federal, State, or foreign regulatory authority.
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