California law currently prohibits manufacturers and contract testing facilities in California from testing cosmetics on animals if alternative test methods have been scientifically validated. A new California law now imposes similar animal testing prohibitions on manufacturers that import cosmetics into the state.
On and after January 1, 2020, a manufacturer may not import for profit, sell or offer for sale in California any cosmetic that was developed or manufactured using an animal test that was conducted or contracted by the manufacturer, or any supplier of the manufacturer, subject to certain exceptions. An “animal test” is “the internal or external application of a cosmetic, either in its final form or any of its ingredients, to the skin, eyes, or other body part of a live, nonhuman vertebrate.” A “manufacturer” is the person identified as the manufacturer on the label as defined by U.S. Food and Drug Administration (FDA) regulation (21 C.F.R. § 701.12). A “supplier” is any entity that supplies, directly or through a third party, any ingredient used in the formulation of a manufacturer’s cosmetic. The law does not, on its face, apply directly to retailers.
The law recognizes some instances where animal testing is unavoidable. Accordingly, the following are exceptions to the general prohibition against animal testing.
- An animal test of any cosmetic required by a federal or state regulatory authority is not subject to the ban on animal testing if all of the following apply: (A) The ingredient is in wide use, and another ingredient capable of performing a similar function is not available. (B) A specific human health problem is substantiated, and the need to conduct animal tests is justified and is supported by a detailed research protocol. (C) The relevant federal or state regulatory authority does not accept a non-animal alternative method for the relevant endpoint.
- An animal test conducted to comply with a requirement of a foreign regulatory authority, if no evidence derived from the test was relied upon to substantiate the safety of the cosmetic sold in California by the manufacturer.
- An animal test that was conducted on any product or ingredient subject to the requirements of Chapter V of the Federal Food, Drug and Cosmetic Act (which addresses FDA regulation of drugs and devices).
- An animal test conducted for non-cosmetic purposes in response to a requirement of a federal, state or foreign regulatory authority, if no evidence derived from the test was relied upon to substantiate the safety of the cosmetic sold in California by the manufacturer.
The law contains a significant “grandfather” provision locking in the lawfulness of current products. The grandfather provision applies to both certain finished cosmetics and certain cosmetic ingredients. Specifically, the prohibition on animal testing does not apply to:
- A cosmetic, if the cosmetic in its final form, was sold in California or tested on animals prior to January 1, 2020, even if the cosmetic is manufactured after that date
- An ingredient, if the ingredient was sold in California or tested on animals prior to January 1, 2020, even if the ingredient is manufactured after that date.
District attorneys and city attorneys are authorized to enforce the law. Enforcers may request information in connection with a potential prosecution, which can be provided subject to trade secret protection. Violations are punishable by a fine of $5,000 and an additional $1,000 for each day the violation continues. Interestingly, the law provides that cosmetic inventory in violation of the law may still be sold for a period of 180 days, essentially providing for a sell-through period for nonconforming products.