WASHINGTON, D.C. — The Food and Drug Administration has released a congressionally mandated review of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products, concluding that scientific evidence is too limited to determine whether most of the chemicals are safe for consumers.
The report, required under the Modernization of Cosmetics Regulation Act of 2022, examined the intentional use of PFAS in cosmetics and found significant gaps in toxicological data. According to the FDA, those gaps prevent regulators from reaching firm safety conclusions for the majority of PFAS currently used in makeup, skincare, and other personal care products.
FDA Commissioner Marty Makary said the agency completed the assessment as directed by Congress but found that reliable safety data are missing for most of the substances reviewed. Makary said the uncertainty demands further research and said the FDA will continue coordinating with the Centers for Disease Control and Prevention and the Environmental Protection Agency to strengthen recommendations tied to PFAS across consumer and food supply chains.
Using mandatory cosmetic product listings submitted to the agency, the FDA identified 51 PFAS used in 1,744 cosmetic formulations. The review focused on the 25 most commonly used PFAS, accounting for about 96 percent of PFAS intentionally added to cosmetics. For most of those chemicals, the FDA reported that toxicological information is incomplete or unavailable, limiting its ability to assess health risks.
The agency said five PFAS appeared to pose low safety concerns under their intended conditions of use, while one PFAS raised a potential safety concern with substantial uncertainty remaining. The safety profile of the rest could not be established due to the lack of accessible data, much of which is not publicly available.
The report examined PFAS intentionally added as ingredients and did not address PFAS that may be present as contaminants. PFAS are synthetic chemicals valued for properties such as water resistance, durability, and texture modification, but their persistence in the environment and potential links to health effects have drawn mounting scrutiny from regulators worldwide.
There are currently no federal rules that specifically ban PFAS intentionally added to cosmetic products. The FDA said it will take enforcement action if safety concerns emerge and will continue monitoring new scientific evidence while dedicating additional resources to close data gaps.
The agency said the effort supports the Department of Health and Human Services’ Make America Healthy Again initiative, which aims to reduce PFAS exposure through expanded testing, monitoring, and surveillance across consumer products.
More information on PFAS in cosmetics is available on the FDA’s website at https://www.fda.gov/cosmetics/cosmetic-ingredients/and-polyfluoroalkyl-substances-pfas-cosmetics.
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