FDA Finds Data 'Insufficient' to Judge PFAS Safety in Cosmetics
Updated

The FDA cannot determine whether most PFAS used in cosmetics are safe, according to a congressionally mandated report released under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Toxicological data for the majority of the perfluoroalkyl and polyfluoroalkyl substances evaluated are incomplete or unavailable, leaving what the agency calls significant uncertainty about consumer exposure through cosmetic products.
"In accordance with our congressional mandate, the FDA released its assessment of PFAS in cosmetic products," FDA Commissioner Marty Makary, MD, MPH, said in a news release. "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."
Makary added that the agency "will continue working with the CDC and EPA to update and strengthen recommendations on PFAS across the retail and food supply chain," consistent with the MAHA Strategy Report.
Scope of the Review
The assessment rests on mandatory cosmetic product listing data submitted to the FDA under MoCRA. Those data show 51 PFAS across 1,744 cosmetic formulations. From that universe, the agency evaluated the 25 most frequently used substances, which together account for approximately 96% of PFAS intentionally added to cosmetic products.
The agency's review produced a mixed picture. Five PFAS appeared to present low safety concerns under their intended conditions of use. Most could not be definitively cleared — the toxicological record was too thin. One PFAS was identified as carrying a potential safety concern, though with significant remaining uncertainty.
A structural limitation shaped the entire exercise: most PFAS toxicology data are not publicly available, which constrained the FDA's ability to collect and analyze the evidence needed for a full risk assessment.
What the Report Covers — and What It Does Not
The report addresses only PFAS intentionally added to cosmetics as ingredients. It does not evaluate PFAS present as contaminants — a distinction that matters for manufacturers assessing supply-chain exposure and for clinicians fielding patient questions about "forever chemicals" in personal care products.
PFAS are synthetic chemicals prized for water resistance, durability, and texture modification. Their environmental persistence and potential toxicity have drawn escalating regulatory scrutiny at the state, federal, and global levels. No federal regulation currently prohibits the intentional addition of PFAS to cosmetic products. The FDA states that, consistent with its enforcement policies, it will take appropriate action if safety concerns emerge.
Context for Dermatology Practice
For dermatologists, the report lands amid growing patient awareness of PFAS in lipstick, foundation, sunscreen-adjacent products, and other leave-on formulations. The FDA's inability to reach definitive safety determinations means clinicians have no federal benchmark to cite when counseling patients — only the framing that the evidence base itself is deficient.
The finding that five PFAS showed low safety concern under intended use conditions offers a narrow reassurance. The single PFAS flagged for potential concern, identified with significant uncertainty, signals where future scrutiny may concentrate as data accumulate.
Next Steps
The FDA says it will continue to monitor emerging scientific data and devote additional resources to closing the identified gaps. Those efforts support the Department of Health and Human Services' Make America Healthy Again initiative, which aims to reduce PFAS across the food and consumer product supply chain through expanded testing, monitoring, and surveillance.
Interagency work with the CDC and EPA, already underway per the commissioner's statement, will drive updates to PFAS recommendations across retail channels. Whether that coordination produces the toxicological data the agency says it lacks — and whether it precedes state-level restrictions that have outpaced federal action — will define the regulatory picture for PFAS in cosmetics over the next several years.
Original: fda.gov
Daniel Okafor
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Staff writer covering people, launches and day-to-day practice in Clinical dermatology, inflammatory skin disease and biologics at Derm Field.