This article is one of a series of posts diving into each aspect of The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) as the industry awaits MoCRA’s full implementation. This installment focuses on MoCRA’s approach to the regulation of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products.
PFAS in Cosmetics
Per- and polyfluoroalkyl substances (PFAS) are a large group of synthetic chemicals used in consumer products around the world since about the 1950s. PFAS help keep packaging and cookware from sticking to food, make clothes and carpets resistant to stains, and enhance the firefighting capabilities of foam products. PFAS in consumer products have increasingly become the subject of intensive research, debate, and litigation due to the alleged link between some of these chemicals and adverse health effects, including liver damage, thyroid disease, obesity, fertility issues, and cancer. As a result, some states have begun regulating PFAS more heavily, while other states banned PFAS from consumer products all-together. For example, in 2021, Maine passed laws mandating that companies report the presence and amount of intentionally added PFAS in consumer products, and in 2023, Maine passed a PFAS phase-out with a complete ban in effect by 2030. More information related to PFAS and product law can be found on the Product Perspective.
The inquiry into PFAS has spread to the cosmetics world as well. PFAS have been used in some cosmetic products to smooth the skin, help make the product waterproof, or improve its consistency and texture. Class action lawsuits against cosmetic companies whose products contained PFAS began to emerge on the theory that such products should not have been marketed as “clean” or “sustainable.” A number of states have enacted laws aiming to regulate PFAS in cosmetics. Effective in 2025, California, Maryland, and Colorado laws will prohibit the presence of PFAS in cosmetics and personal care products. Other states are debating similar laws pertaining to cosmetics and personal care products, including Vermont, New York, Washington, Oregon, Illinois, Rhode Island, and Georgia. On the federal level, MoCRA represents an attempt by the legislature to take a position on PFAS, by initially empowering the FDA to investigate these compounds, followed by likely regulation of same.
MoCRA’s Approach
Prior to MoCRA, the FDA noted a lack of information related to the actual potential health risks that PFAS in cosmetics pose and emphasized the need for more research to determine the extent of PFAS absorption through the skin and the risk of that exposure. The FDA had been monitoring the use of PFAS through the Voluntary Cosmetic Registration Program. Based on this voluntary program, the FDA found that PFAS were an ingredient in some lotions, cleansers, nail polish, shaving cream, lipstick, eyeliner, eyeshadow, and mascara.
Under MoCRA, the FDA will be able to collect information pertaining to PFAS in cosmetics through the new recordkeeping and reporting requirements. All manufacturers, packagers, and distributors of cosmetics will be required to submit product ingredients, including PFAS, to the FDA. Section 3506 of MoCRA requires the FDA to gather information on the use, safety, and risks associated with PFAS and issue a public report that assesses the use of PFAS in cosmetic products. The FDA’s assessment will involve a consultation with the National Center for Toxicological Research to evaluate any dermal absorption risks allegedly associated with PFAS in cosmetics. The FDA is to publish a complete report summarizing its findings by December 29, 2025.
Preemption
While the FDA’s investigation into PFAS proceeds, MoCRA opens preemption considerations. MoCRA’s Section 614 precludes states and local governments from implementing or enforcing any other requirement for cosmetics with respect to registration and product listing, good manufacturing practices, records, recalls, adverse event reporting, or safety substantiation. However, additional cosmetic labeling requirements are not expressly preempted and Section 614 does not prevent states from prohibiting the use or limiting the amount of an ingredient in a cosmetic product or from continuing to enforce an ingredient reporting requirement that was in effect before MoCRA was enacted.
Primary Jurisdiction
The primary jurisdiction doctrine may also come into play in the cosmetic space, much like it did in the food products space. The primary jurisdiction doctrine is concerned with promoting proper relationships between the courts and administrative agencies charged with particular regulatory duties. Its invocation is appropriate when enforcement of the claim requires the resolution of issues which, under a regulatory scheme, have been placed within the special competence of an administrative body. In lawsuits alleging that a product is unsafe, and the determination of safety is subject of ongoing FDA investigation, the primary jurisdiction doctrine can serve as a basis for dismissal. For example, recently, in In re: Beech-Nut Nutrition Company Baby Food Litigation, Northern District of New York, Civ. A. No. 1:21-CV-133, 2023 WL 350818 (N.D.N.Y. Jan. 19, 2023), defendants prevailed on a motion to dismiss arguing that the FDA had primary jurisdiction over the determination as to whether heavy metals were harmful to human health. The court held that the plaintiffs’ claims alleging heavy metal contamination in baby food were premature and had to await the results of the FDA’s rule-making process to promote consistency and avoid waste of judicial resources. Now that MoCRA has granted the FDA the authority to assess the safety of PFAS in cosmetics, the primary jurisdiction doctrine may apply to dismiss such lawsuits pending FDA’s determination. Of course, much remains to be seen, so stay tuned for the Product Perspective’s updates on this developing MoCRA PFAs story.
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