The U.S. Food and Drug Administration released a congressionally mandated report finding insufficient data to determine the safety of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products, marking a critical assessment under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
The report, required under MoCRA's regulatory framework, evaluated the use of PFAS chemicals across various cosmetic products and identified significant data gaps that prevent the agency from making definitive safety determinations. PFAS, often called "forever chemicals" due to their persistence in the environment and human body, have been widely used in cosmetics for their water-resistant and long-lasting properties.
The Modernization of Cosmetics Regulation Act of 2022 represents the most significant update to cosmetics regulation in decades, granting the FDA enhanced authority to oversee the safety of cosmetic products and ingredients. Under MoCRA, Congress specifically directed the FDA to evaluate PFAS use in cosmetics and report its findings, recognizing growing concerns about these chemicals' potential health impacts.
PFAS chemicals have been detected in various cosmetic products, including foundations, mascaras, lipsticks, and other beauty items. These substances are valued by manufacturers for their ability to create long-wear formulations and provide water resistance. However, scientific studies have raised questions about PFAS exposure through cosmetic use and potential accumulation in the human body.
The FDA's determination that insufficient data exists to assess PFAS safety in cosmetics underscores the regulatory challenges facing the agency as it implements MoCRA's expanded oversight provisions. Unlike pharmaceutical products, which undergo extensive safety testing before approval, cosmetics have historically operated under a less stringent regulatory framework that relies primarily on industry self-regulation.
The report's findings could have significant implications for the cosmetics industry, which has increasingly faced scrutiny over ingredient safety and transparency. Major cosmetics companies have already begun voluntarily removing PFAS from their formulations in response to consumer concerns and regulatory uncertainty.
MoCRA grants the FDA new tools to address safety concerns, including the authority to require safety data from manufacturers, mandate product recalls, and establish good manufacturing practices. The law also requires cosmetics companies to register their facilities with the FDA and provide ingredient listings for their products.
The insufficient data finding may prompt the FDA to exercise these new authorities to gather additional safety information from cosmetics manufacturers. The agency could potentially require companies using PFAS in their products to submit safety studies or conduct additional research to support the continued use of these chemicals.
Consumer advocacy groups have long called for stronger oversight of PFAS in cosmetics, citing studies that suggest these chemicals can be absorbed through the skin and may persist in the body. The Environmental Working Group and other organizations have identified numerous cosmetic products containing PFAS and urged both regulatory action and industry reformulation.
The cosmetics industry trade association, the Personal Care Products Council, has maintained that PFAS used in cosmetics are safe when used as intended. However, some major brands have proactively moved to eliminate PFAS from their formulations, with companies like Sephora, CVS, and Walgreens announcing policies to phase out products containing these chemicals.
The FDA's report comes amid broader federal efforts to address PFAS contamination across multiple sectors. The Environmental Protection Agency has established drinking water standards for certain PFAS chemicals, while Congress has considered legislation to restrict PFAS use in various consumer products.
Industry observers expect the report to intensify regulatory pressure on cosmetics manufacturers to provide more comprehensive safety data for PFAS-containing products. The FDA's acknowledgment of data gaps may also encourage more companies to voluntarily reformulate products to eliminate these chemicals.
The report represents an early implementation of MoCRA's enhanced regulatory framework, demonstrating the FDA's commitment to using its expanded authority to address cosmetics safety concerns. As the agency continues to implement the law's provisions, additional safety evaluations and regulatory actions may follow.
Moving forward, the cosmetics industry will likely face increased scrutiny regarding PFAS use and may need to provide additional safety data to support continued use of these chemicals. The FDA's findings establish a foundation for potential future regulatory actions as the agency works to ensure cosmetic product safety under its expanded authority.