California to Ban Cosmetics Tested on Animals, Require Full Labeling for Professional Cosmetic Products

California Governor Jerry Brown is expected to sign into law two bills concerning cosmetic products sold in California. The first bill, SB 1249, would ban animal testing from all cosmetic products sold in California. The second bill, AB 2775, would require cosmetics sold in California and used in professional settings to have a product label that satisfies all federal labeling requirements for cosmetics sold to consumers, such as listing the product ingredients.

The New Laws

Animal Testing Ban

SB 1249 would make it unlawful for a cosmetic manufacturer, packer, and distributor to “sell” any cosmetic in California that was developed or manufactured using an animal test that was conducted or contracted by the cosmetic manufacturer, or any supplier of the manufacturer, on or after January 1, 2020, but would allow 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 would also 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.

Professional Cosmetic Labeling

Currently, federal cosmetic labeling requirements are only applicable to cosmetics customarily sold at retail or used in the performance of services conducted within households. As a result, these federal requirements do not apply, for example, to products used at professional salons or samples distributed free of charge, unless such products are customarily also sold at retail, even if they were labeled "For professional use only."[1] As a result, AB 2775 would require a professional cosmetic[2] manufactured on or after July 1, 2020, for sale in California to have a label on the container that satisfies all of the labeling requirements for any other cosmetic pursuant to specific federal laws, such as listing the product ingredients. Pursuant to AB 2775, a violation of the new law would be a crime.

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 (e.g., NIOSH) 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?

Lastly, AB 2775 raises the potential applicability of the preemption provision under 21 USC § 379s relating to cosmetic products. Section 379s states that no state may establish or continue in effect any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics under the federal Food, Drug and Cosmetic Act (FDCA), the Poison Prevention Packaging Act of 1970, or the Fair Packaging and Labeling Act. Currently, none of these acts require ingredient labeling for professional cosmetic products.

Next Steps

• Cosmetic ingredient and product manufacturers 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

Consequently, cosmetic manufacturers and their suppliers will have a condensed timeline for compliance with the new law.

Contacts

If you have any questions on the issues discussed in this LawFlash please contact the following Morgan Lewis lawyers:

Washington, DC
Kathleen Sanzo

[1] US Food and Drug Admin., Cosmetic Labeling Guide (page last updated Nov. 15, 2017).

[2] “Professional cosmetic” means a cosmetic product that is intended or marketed to be used only by a professional on account of a specific ingredient, increased concentration of an ingredient, or other quality that requires safe handling, or is otherwise used by a professional.