The report, published Dec. 29, examined PFAS intentionally added to cosmetic formulations and found that insufficient data prevents the agency from reaching definitive safety conclusions for most substances currently on the market.
Required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the assessment draws on newly mandatory cosmetic product listing data alongside a review of published scientific literature.
In the report, the FDA described MoCRA as a turning point for cosmetic regulation. Among its provisions, the law directed the FDA to examine whether PFAS used in cosmetics pose potential risks to consumers.
Focus on intentionally added ingredients
The agency was careful to define the scope of its analysis as “limited to PFAS that are intentionally added to cosmetic products as an ingredient and does not include PFAS that may be present in the final product as contaminants,” the FDA wrote.
PFAS are used in some cosmetics to deliver performance benefits such as water resistance, durability and texture modification. At the same time, their persistence in the environment and potential toxicity have led to growing scrutiny worldwide.
“PFAS…have been widely used in industrial and consumer products, including cosmetic products because they are water- and oil-resistant, and are long-lasting,” the agency wrote. “However, their use has raised significant health and environmental concerns.”
Product listing data show where PFAS are used
Using cosmetic product listing data submitted under MoCRA, the FDA identified 51 PFAS intentionally added to 1,744 cosmetic product formulations sold in the United States.
PFAS-containing products represented about 0.41% of all listed cosmetic products as of August 2024, the FDA noted in its report. Eye shadows, face and neck products, eyeliners, face powders and foundations made up more than half of those formulations.
Polytetrafluoroethylene was the most frequently reported PFAS ingredient, appearing in 490 products.
Most PFAS lack sufficient safety data
To narrow its review, the FDA prioritized 25 PFAS that together account for more than 96% of PFAS used in cosmetic products marketed in the United States.
Even with that focus, data gaps remained significant.
“The safety of most (N=19 or 76%) of the reviewed PFAS could not be definitively determined due to the lack of critical toxicological data,” the FDA wrote.
Five PFAS were considered to pose low safety concerns under their intended conditions of use. One substance, perfluorohexylethyl triethoxysilane, raised a “potential safety concern” when used at the highest concentration reported in body lotion, the FDA noted.
Regulatory backdrop continues to evolve
The FDA stated that cosmetic ingredients generally do not require premarket approval, aside from color additives, and that “PFAS that are intentionally added to cosmetic products as an ingredient are not currently prohibited and do not, based on presence alone, render the cosmetic product adulterated or misbranded.”
At the same time, the report pointed to increasing state-level action, with 11 states having passed legislation to ban intentionally added PFAS in cosmetics between 2025 and 2028.
“Our assessment underscores significant data gaps for PFAS used in cosmetic products,” the FDA wrote. “The FDA will continue to monitor emerging data on PFAS to ensure the continued safety of cosmetic products.”
