December 29, 2025 The U.S. Food and Drug Administration (FDA) has released a congressionally mandated report evaluating the safety of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products. Released under the Modernization of Cosmetics Regulation Act of 2022 (MOCRA), the report concludes that toxicological data for the majority of the most frequently used PFAS are “incomplete or unavailable,” leaving significant uncertainty regarding consumer safety. Consistent with the broader “Make America Healthy Again” (MAHA) strategy, the FDA has signaled it will continue working with the CDC and EPA to strengthen recommendations across the entire retail and food supply chain.
KEY FINDINGS FROM THE PERFLUOROALKYL AND POLYFLUOROALKYL SUBSTANCES (PFAS) 2025 REPORT
The FDA’s assessment focused on the 25 most frequently used PFAS, which account for approximately 96% of PFAS intentionally added to cosmetic products.
- Significant Data Gaps: For the majority of these substances, the agency found insufficient toxicological data to definitively establish safety.
- Public Availability Issues: The evaluation was severely hindered because most toxicology data is not publicly available.
- Safety Status: While five PFAS appeared to present low safety concerns under intended use conditions, one specific PFAS was identified as having a “potential safety concern” with significant remaining uncertainty.
- Usage Statistics: Listing data indicates that 51 different PFAS are currently used in 1,744 cosmetic formulations.
Why This Matters
While this report specifically targets cosmetics, the language used by FDA Commissioner Marty Makary, M.D., M.P.H., indicates a wider scope of regulatory scrutiny that includes the food and consumer product supply chain.
- Broader “MAHA” Strategy: The FDA is aligning its PFAS reduction efforts with the Department of Health and Human Services’ “Make America Healthy Again” initiative, prioritizing expanded testing and surveillance.
- Supply Chain Focus: The agency is explicitly looking to update recommendations across the “retail and food supply chain,” which encompasses dietary supplements and nutraceuticals.
- Future Enforcement: Although there are currently no federal regulations prohibiting these ingredients in cosmetics, the FDA stated it will “take appropriate action” if safety concerns emerge.
Impact on Nutraceutical and Supplement Manufacturers
The FDA’s “insufficient data” conclusion serves as a critical warning for manufacturers of ingestible health products. As the FDA shifts focus from identification to enforcement under the MAHA strategy, nutraceutical companies should anticipate similar scrutiny regarding “intentionally added” chemicals in coatings, packaging, and processing aids.
Recommended Actions:
- Audit Supply Chains: Review all raw material specifications for intentionally added PFAS, particularly in capsules, coatings, and packaging materials to ensure no “texture modification” ingredients contain these substances.
- Prepare Safety Data: The FDA’s primary barrier was a lack of public toxicology data. Manufacturers should proactively gather safety substantiation for any fluorinated compounds in their supply chain to avoid future regulatory bottlenecks.
- Monitor Guidance: Stay updated on joint FDA, CDC, and EPA recommendations as they expand their focus from cosmetics to the broader food supply chain.
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