Dear Retail Clients and Friends,

California has introduced a law that prohibits selling or importing into California any cosmetic product that involved testing on animals. Retailers have until January 1, 2020, to ensure compliance with the new law. This edition of Morgan Lewis Retail Did You Know? summarizes the new law and provides key takeaways and practical implications for retailers.

Background

California Governor Jerry Brown recently signed into law a bill that bans animal testing from all cosmetic products sold or imported in California.

The New Law

The new law, SB 1249, makes it unlawful for a cosmetic distributor or seller to "import into California" or "sell in California" any cosmetic that was developed or manufactured using an animal test that was conducted or contracted on or after January 1, 2020, but allows for certain exceptions including:

  • an animal test that is required by a federal or state regulatory authority if all of the following apply:

    • The ingredient is in wide use and cannot be replaced by another ingredient capable of performing a similar function
    • A specific human health problem is substantiated and the need to conduct animal tests is justified and is supported by a detailed research protocol proposed as the basis for the evaluation
    • There is not a non-animal alternative method accepted for the relevant endpoint by the relevant federal or state regulatory authority
  • an animal test that was 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 federal requirements for drugs and devices; or
  • an animal test that was 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. A manufacturer is not prohibited from "reviewing, assessing, or retaining evidence from an animal test conducted pursuant to this paragraph."

The law also does not apply to a cosmetic in its final form or to an ingredient, if the cosmetic or ingredient was sold in California or tested on animals before January 1, 2020, even if the cosmetic or ingredient is manufactured after that date. Violators of the new law will face an initial fine of $5,000 and an additional fine of $1,000 for each day the violation continues.

Key Takeaways

Cosmetics containing ingredients tested on animals will no longer be able to be sold in California as of January 2020. The new law recognizes potential compliance issues for cosmetic manufacturers selling in global markets requiring animal tests or where US federal or state regulators require animal testing to resolve safety issues around the ingredient. The law was also narrowed to only apply to testing that was conducted by or on behalf of the manufacturer, as the drafters of SB 1249 recognized that there are instances when unrelated third parties may conduct animal testing, which should not preclude its use as an ingredient by manufacturers.

In connection with these exceptions, however, SB 1249 raises a few unanswered questions given the lack of clarity in some of the terms used:

  • If an animal test is required by a federal or state regulatory authority,

    • how widely used must the ingredient be to fall under the exception?
    • what are examples of "specific health problem[s]" that fall under the exception?
    • will the state of California have to approve the "detailed research protocol" proposed as the basis for conducting the animal test?
  • In the event that a manufacturer must conduct animal testing abroad for market access, how will manufacturers be able to show that "no evidence derived from the [animal] test was relied upon to substantiate the safety of the cosmetic sold in California"? Does the mere existence of non-animal safety tests satisfy the requirement?

Practical Implications

  • Cosmetic ingredient and product distributors and sellers will need to put into place a compliance program to demonstrate there is no animal testing of the product or its ingredients for products sold in California
  • Product formulations and label may need to be modified to use and list ingredients free from animal testing. Alternative safety tests may need to be devised and conducted on new formulations
  • Entities in the distribution chain for cosmetics, including retailers, finished product manufacturers, and ingredient suppliers may begin to require certifications of no animal testing

Additional Resources

Our FDA colleagues recently authored an article published in Bloomberg BNA on the California Cruelty-Free Cosmetic Act.

This article is provided as a general informational service and it should not be construed as imparting legal advice on any specific matter.