“To substantially restrict the use of animal testing for cosmetics, and for other purposes.”
No CRS summary available for this bill.
This section prohibits, beginning one year after enactment, (1) knowingly conducting or contracting for cosmetic animal testing in the United States; (2) knowingly selling, offering for sale, or transporting in interstate commerce any cosmetic product developed or manufactured using such testing conducted or contracted for after that date by any person in the product's supply chain; and (3) relying on evidence from such testing to establish the safety of a cosmetic, ingredient, or nonfunctional constituent under the Federal Food, Drug, and Cosmetic Act (FD&C Act) unless an exemption applies. (As background, cosmetics—defined in 21 U.S.C. 321(i) as articles applied to the human body for cleansing, beautifying, or altering appearance, excluding soap—are regulated by FDA for safety and labeling but generally do not require premarket approval, unlike drugs.) The section provides exemptions from these prohibitions for animal testing (1) conducted outside the U.S. to comply with foreign regulatory requirements; (2) requested, required, or conducted by the Secretary of Health and Human Services (HHS) following specified findings of need, public notice and comment, and determination of unavailable alternative data; (3) for products or ingredients regulated as drugs under FD&C Act chapter V (21 U.S.C. 351 et seq.); or (4) conducted for non-cosmetic purposes to meet federal, state, or foreign regulatory requirements. It further authorizes the Secretary to impose civil penalties of up to $10,000 per violation (with each animal and day of continuing violation treated separately), requires cosmetic manufacturers to provide FDA-requested records relied upon for certain exemptions, and preempts state or local laws on cosmetic animal testing, data use, or related requirements that are not identical to these provisions (while prohibiting states from requiring such testing).