FDA has released its report evaluating the safety of PFAS intentionally added to cosmetic products, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The agency concluded that existing toxicological data are insufficient to determine the safety of most PFAS in cosmetics but stated it would continue dedicating resources to reducing PFAS exposure in food and cosmetic products.
What does the report say?
The report identifies 51 distinct PFAS intentionally added as ingredients in 1,744 listed cosmetic formulations—about 0.41% of products in FDA's mandatory cosmetic product listing database as of August 30, 2024. FDA prioritized the 25 most frequently used PFAS, which together account for more than 96% of PFAS uses, and found that for 19 of those substances (76%) the toxicological data are incomplete or unavailable, preventing a definitive safety conclusion. Five PFAS, including PTFE and perfluorodecalin, were characterized as presenting a low safety concern under current conditions of use, while perfluorohexylethyl triethoxysilane was identified as posing a potential safety concern when used at the highest concentration in body lotions, albeit with substantial uncertainty.
Why did FDA publish the report?
Section 3506 of MoCRA directs FDA to evaluate the use of PFAS in cosmetic products, assess the scientific evidence regarding their safety and risks, and publish a report summarizing its findings.
The report fulfills that statutory mandate and responds to the growing federal, state, and international scrutiny of PFAS in consumer products. Several states have already enacted, or are in the process of implementing, restrictions or bans on intentionally added PFAS in cosmetics, many of which take effect between 2025 and 2028.
What happens next and what should companies do?
Although there are currently no federal regulations specifically prohibiting intentionally added PFAS in cosmetics, FDA stated it will "take appropriate action" if safety concerns emerge for particular ingredients or products. The agency will also continue to monitor scientific data and will be devoting resources to help reduce PFAS in food and cosmetic products "through expanded testing, monitoring, and surveillance."
In the near term, cosmetic companies should (1) inventory PFAS use across portfolios; (2) prioritize reformulation away from PFAS in categories likely to face state bans or heightened consumer scrutiny; (3) bolster safety dossiers for any PFAS companies intend to keep using; and (4) review marketing claims to ensure they align with evolving PFAS risk and regulatory expectations.
Venable's Food and Drug Law team is monitoring PFAS-related developments impacting FDA-regulated industries and companies. Across the firm, Venable attorneys in practice areas including Environmental, Government Affairs, Products Liability, Insurance, and Litigation are working together to track the rapidly evolving PFAS landscape. Together, we can assist companies in assessing and mitigating exposure and risk, identifying regulatory obligations ad developing and implementing compliance strategies while identifying regulatory obligations and developing and implementing compliance strategies across the PFAS spectrum.