The U.S. Food and Drug Administration has released a congressionally mandated report under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) evaluating the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products. While the report reviews available scientific evidence on potential safety concerns, the FDA’s evaluation did not reach definitive safety determinations and underscores significant uncertainty due to gaps in existing data on PFAS exposure through cosmetics.
“In accordance with our congressional mandate, the FDA released its assessment of PFAS in cosmetic products,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Our scientists found that toxicological data for most PFAS are incomplete or unavailable, leaving significant uncertainty about consumer safety. This lack of reliable data demands further research. Consistent with the MAHA Strategy Report, the FDA will continue working with the CDC and EPA to update and strengthen recommendations on PFAS across the retail and food supply chain.”
Based on mandatory cosmetic product listing data submitted to the FDA, 51 PFAS are used in 1,744 cosmetic formulations. To assess safety, the FDA evaluated the 25 most frequently used PFAS, which represent approximately 96% of PFAS intentionally added to cosmetic products. The agency found that “toxicological data for a majority of these PFAS are incomplete or unavailable,” limiting its ability to fully assess risk. The FDA’s ability to effectively collect toxicology data was limited by the fact that most of the data is not publicly available. While five PFAS appeared to present low safety concerns under their intended conditions of use, the safety of most PFAS could not be definitively established, and one PFAS was identified as having a potential safety concern with significant remaining uncertainty.
The report focuses on PFAS intentionally added to cosmetic products as ingredients, rather than PFAS that may be present as contaminants. PFAS are synthetic chemicals used for properties such as water resistance, durability, and texture modification, but their persistence and potential toxicity have raised health and environmental concerns and prompted increasing regulatory scrutiny at the state, federal, and global levels.
There are currently no federal regulations that specifically prohibit PFAS intentionally added to cosmetic products. However, consistent with FDA enforcement policies, the agency will take appropriate action if safety concerns emerge related to such cosmetic products.
The FDA will continue to monitor emerging scientific data and devote additional resources to address data gaps, supporting the Department of Health and Human Services’ Make America Healthy Again efforts to reduce PFAS across the food and consumer product supply chain through expanded testing, monitoring, and surveillance.