On December 29, 2022, President Biden signed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) into law. (See Consolidated Appropriations Act, 2023, Pub. L. No: 117-328, § 3501-06.) MoCRA substantially expands the authority of the Food and Drug Administration (FDA) to promulgate new regulations over cosmetics and initiate enforcement against manufacturers and distributors of cosmetic products that present health risks. Most MoCRA provisions, including those dealing with facility registration and product listing, take effect on December 29, 2023, and existing facilities will have to register and comply with its product listing requirements as of this date.
Increasing awareness regarding the incorporation of per- and polyfluoroalkyl substances (PFAS) in cosmetics was a driving force behind MoCRA. Recent years have witnessed several consumer fraud lawsuits against cosmetics companies, such as Shiseido, Almay, Burt’s Bees, L’Oreal and Coty (including its Noxell Corp. unit), regarding the use of PFAS for waterproofing purposes, and plaintiffs’ firms such as Weitz and Luxenberg maintain entire webpages dedicated to holding cosmetics companies accountable for allegedly exposing the public to harmful PFAS. Moreover, several states including California, Colorado and Maryland have passed consumer protection laws prohibiting the use of PFAS in cosmetics, which will go into effect in 2025, and proposed legislation is being developed or finalized in other states including Vermont, New York, Washington, Oregon, Illinois, Rhode Island and Georgia. Other states, such as Maine, have promulgated sweeping notification laws requiring reporting to the state of the presence, amount and purpose of PFAS in consumer products containing intentionally added PFAS.
The FDA, too, has acknowledged the potential inclusion of PFAS as additive ingredients to products such as lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow and mascara. However, the FDA has also noted the limited nature of research regarding the presence of PFAS in cosmetics and whether PFAS in cosmetics are absorbed through the skin at levels that could be harmful to human health.
In this connection, the FDA’s tools for monitoring the presence of PFAS in cosmetics are practically limited, since cosmetics have historically not been subject to FDA premarket approval. Under the FDA’s Voluntary Cosmetic Registration Program, manufacturers could, but were not required to, disclose the ingredients that comprise their products. However, this program was unexpectedly suspended late last month due to the FDA’s “plans to develop a program for submission of the facility registration and product listings mandated by [MoCRA].” Although it is too early to tell for sure, this forthcoming program may have the practical effect of incentivizing cosmetics manufacturers to demonstrate the safety of their products before bringing them to market.
To address the lack of existing research and regulatory mechanisms, Section 3506 of MoCRA requires the Department of Health and Human Services (HHS) to assess the use of PFAS in cosmetics, including any risks associated with such use. HHS may consult with the National Center for Toxicological Research in conducting its assessment. HHS must publish a report on its assessment of PFAS in cosmetics by December 29, 2025.
More FDA Authority May Lead to More Aggressive Enforcement
Although MoCRA does not impose a pre-market approval requirement on cosmetics, it includes substantial new reporting requirements for cosmetic manufacturers that could have the practical effect of incentivizing them to undertake, at minimum, rigorous health and safety reviews before placing products, including those containing PFAS, on the market or, in some instances, remove products with potentially controversial ingredients, such as PFAS, from the market. Among other things, MoCRA:
- Requires all facilities that manufacture or process cosmetic products intended for sale in the United States to register with the FDA.
- Requires manufacturers, packagers and distributors of cosmetics to submit lists of ingredients contained in their products to the FDA to allow the agency to assess the extent to which chemicals, such as PFAS, are prevalent in cosmetics.
- Authorizes the FDA to take significant protective action, including product recalls and injunctions requiring the cessation of facility operations, if the administration determines that a registrant’s product carries a reasonable probability of causing serious adverse health consequences.
- Requires manufacturers, packagers and distributors of cosmetics to register each cosmetic product each year with the FDA and disclose information including the manufacturing or processing facility’s registration number and product ingredient lists.
- Requires manufacturers, packagers and distributors of cosmetics to maintain records, such as studies and tests, demonstrating to a reasonable certainty that a product is safe (with different requirements for coal-tar hair dye that otherwise complies with the requirements of 21 U.S.C. § 361, applicable to adulterated cosmetics).
- Requires manufacturers, packagers and distributors of cosmetics to report any adverse events (i.e., resulting in death, hospitalization or other health issues) in connection with a cosmetic product to the FDA within 15 days after receiving a report of such event and maintain records regarding the same.
- Prohibits the sale of cosmetics that fail to meet the above registration and reporting requirements, with some exceptions.
- Authorizes the FDA to inspect various records relating to the above requirements.
- Requires additional information on cosmetic product labels, including contact information through which a responsible person can receive adverse event reports, among other requirements. (This requirement goes into effect on December 29, 2024—one year after the other requirements of MoCRA go into effect.)
The substantial recordkeeping and reporting requirements under MoCRA will essentially provide a record to the FDA of those manufacturers, packagers and distributors participating in the U.S. cosmetics industry that use PFAS in their products.
In addition to FDA enforcement powers described above, MoCRA has significant private enforcement and litigation implications. For example, any information gathered by the FDA that is not designated as a trade secret or confidential commercial information will be accessible to the public through Freedom of Information Act (FOIA) requests. Plaintiffs’ firms—which have already been pursuing consumer protection lawsuits involving companies’ use of terms such as “nontoxic” and “clean” on product labels for years—will likely seize the opportunity to request and scrutinize this information for opportunities to challenge allegedly unfair, deceptive or misleading claims on product labels, as well as potentially inadequate safety information. Moreover, there is a possibility that information gathered under MoCRA will be used to link certain facilities that historically manufactured, packed or distributed cosmetics on a large scale to sites contaminated with PFAS, prompting site investigations and cleanups for which cosmetic companies may be liable.
Conclusion
Although PFAS cannot be regarded as the only consideration underlying the enactment of MoCRA, it certainly factored into the development of this law, which represents a significant uptick in the manner of FDA regulation of the cosmetics industry. Aside from imposing unprecedented registration and reporting obligations on cosmetics manufacturers, packagers and distributors, this new federal legislation has potentially far-reaching consequences regarding the liability exposure of such businesses with respect to PFAS. Most importantly, the law stands to create a record of cosmetic companies with a connection to PFAS, which, in turn, may make such businesses attractive enforcement and litigation targets.
Given this significant regulatory development, cosmetic companies that know or suspect that their products contain PFAS may wish to consider the benefits of taking proactive measures to evaluate the PFAS content of their products, not to mention potential obligations under MoCRA. Companies may also wish to consider whether substitutes for PFAS are available to minimize the potential for private consumer fraud claims, or explore insurance products that might cover such claims.
Pillsbury has extensive experience assisting clients on matters related to PFAS and with respect to consumer protection laws, in general. If you are unsure whether your business is subject to or in compliance with PFAS regulation, contact Pillsbury for more information.
(The authors would like to thank student law clerk Steve R. Brenner for his contributions to this article.)