FDA Issues Report On PFAS In Cosmetics Products

Highlights

• The U.S. Food and Drug Administration (FDA) published a report on December 29, 2025, titled "Report on the Use of PFAS in Cosmetic Products and Associated Risks."
• The report – mandated by the Modernization of Cosmetics Regulation Act of 2022 – details the FDA's findings following an assessment of the 25 most frequently used per- and polyfluoroalkyl substances (PFAS) in cosmetics. PFAS are a group of chemicals that are widely used in products spanning many industries, including cosmetics. The report also outlines the FDA's evaluation of the safety of using PFAS in cosmetic products based on the agency's review of available toxicological data.
• The report's publication, coupled with the December 18, 2025, release of draft guidance related to the FDA's mandatory cosmetics recall authority and subsequent guidance on records access for cosmetics, signals increased attention on cosmetics products from the FDA in 2026 and beyond.

In 2022, the Modernization of Cosmetics Regulations Act of 2022 (MoCRA) was signed into law, bringing about the largest expansion of the U.S. Food and Drug Administration's (FDA) authority to regulate cosmetics since passage of the Federal Food, Drug, and Cosmetic Act (FD&C) of 1938. Among the new, wide-ranging authorities the FDA gained as part of MoCRA was a mandated assessment on the use of per- and polyfluoroalkyl substances (PFAS) in cosmetics products and any potential associated safety risks.

The long-awaited study, "Report on the Use of PFAS in Cosmetic Products and Associated Risks," was finally released on December 29, 2025, and details the FDA's findings. As part of its review of cosmetic product listing data, the FDA prioritized the top 25 most frequently used PFAS. In its report, the FDA notes that the 25 products selected account for more than 96 percent of PFAS used in cosmetic products marketed in the U.S. Polytetrafluoroethylene (PTFE) was found to be the most commonly used PFAS in cosmetic products, found in approximately 28 percent of all such PFAS-containing products.

Notably, the FDA indicated it was unable to provide a definitive determination on the potential health risks associated with use of PFAS-containing cosmetic products "due to the lack of critical toxicological data" for 19 of the 25 PFAS assessed. Five of the remaining six PFAS were found to pose low safety concerns under intended use conditions, while one was found to have "potential" safety concerns at the highest level of use. The report's conclusion that insufficient data prevented a more comprehensive assessment signals that the FDA may pursue additional data collection and disclosure requirements, particularly with several MoCRA provisions still pending implementation.

Congressional Activity

Congressional efforts to implement further updates to MoCRA – particularly those included in the Safer Beauty Bill Package introduced by Rep. Jan Schakowsky (D-Ill.) – have yet to advance. In the absence of a federal ban, and with international bodies such as the European Union and Canada moving toward broad restrictions, U.S. states have stepped into the regulatory void, creating a complex compliance environment for the cosmetics industry.

Given that states are moving ahead at different paces and instituting varied approaches, a patchwork approach to the regulation of cosmetics ingredients and products will remain absent legislative action from the U.S. Congress. Additionally, more states are expected to introduce PFAS bans and reporting mandates in the new legislative year, further complicating the compliance landscape. As a result, companies must continue to monitor and comply with state regulations. For more on states that have finalized bans on the sale of cosmetics containing intentionally added PFAS, see Holland & Knight's previous alert, "PFAS in Cosmetics: State-Led Regulatory Surge Demands Proactive Compliance," August 11, 2025.

Conclusion

Absent congressional action, it's anticipated that 2026 will feature additional regulatory scrutiny on cosmetics products, with FDA Commissioner Dr. Martin Makary foreshadowing continued work in this space. In announcing the FDA's report, Commissioner Makary said that consistent with the Make America Healthy Again strategy, "the FDA will continue working with the CDC and EPA to update and strengthen recommendations on PFAS" across regulated industries.

Holland & Knight's Healthcare and Life Sciences teams will continue to closely monitor these changes and activities.

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