Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
The U.S. Food and Drug Administration has stated that it does not have enough scientific evidence to ascertain the safety of per- and polyfluoroalkyl substances, commonly referred to as PFAS, in cosmetic products, as indicated by a report mandated by Congress that was released this week.
This report, which is a requirement of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), examines PFAS that are deliberately included in cosmetics like lipsticks, eyeshadows, moisturizers, nail polish, blush, and cleansers. Although the agency analyzed existing studies and data provided by the industry, it refrained from drawing firm safety conclusions due to considerable deficiencies in toxicological and exposure data.
“Our scientists found that toxicological data for most PFAS are incomplete or unavailable, leaving significant uncertainty about consumer safety,” FDA Commissioner Marty Makary said in a statement. “This lack of reliable data demands further research.”
PFAS represent a wide range of synthetic chemicals valued for their qualities like water resistance, durability, and the ability to enhance texture. Nevertheless, numerous PFAS remain in the environment and can build up in the human body over time, leading to worries about possible health and environmental hazards.
Using mandatory cosmetic product listing data, the FDA identified 51 PFAS used in 1,744 cosmetic formulations. The agency focused its safety review on the 25 most frequently used PFAS, which account for about 96 percent of PFAS intentionally added to cosmetics. For most of these substances, the FDA said toxicological data were insufficient or unavailable, limiting its ability to assess risk. Five PFAS appeared to pose low safety concerns under their intended conditions of use, while one showed a potential safety concern accompanied by significant uncertainty.
The report focuses solely on PFAS that have been deliberately included as ingredients, excluding those that might be present unintentionally due to contamination, impurities in raw materials, or chemical degradation. Additionally, the FDA pointed out that a significant portion of the pertinent toxicology data is not accessible to the public, which adds to the complexity of its analysis.
There are currently no federal regulations that specifically ban PFAS intentionally added to cosmetics. The FDA said it would take enforcement action if safety concerns emerge and pledged to continue monitoring new scientific evidence. The agency plans to work with the Centers for Disease Control and Prevention and the Environmental Protection Agency to address data gaps and strengthen recommendations as part of the Department of Health and Human Services’ “Make America Healthy Again” initiative.
MoCRA represents the most significant expansion of the FDA’s authority over cosmetics since 1938. Among its requirements, the law directed the FDA to assess PFAS use in cosmetics and publish a public report by late December 2025.
For consumers seeking to avoid PFAS, the FDA advises carefully reading ingredient labels, which must list components in descending order by predominance. Common PFAS ingredients found in cosmetics include polytetrafluoroethylene (PTFE), perfluorononyl dimethicone, and methyl perfluorobutyl ether, according to information submitted to the agency.
The FDA said it will continue to devote resources to expanded testing, monitoring and surveillance as research on PFAS and their potential health effects evolves.
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