The FDA’s recent report evaluating the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products revealed significant uncertainty due to gaps in existing data on PFAS exposure through cosmetics. As a result, the agency did not reach definitive safety determinations.
“Our scientists found that toxicological data for most PFAS are incomplete or unavailable, leaving significant uncertainty about consumer safety,” said FDA Commissioner Marty Makary, M.D., M.P.H. “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.”
“Incomplete and Unavailable”
The report, congressionally mandated under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), reviewed available scientific evidence on potential safety concerns using mandatory cosmetic product listing data submitted to the FDA. The agency found that “toxicological data for a majority of these PFAS are incomplete or unavailable,” significantly limiting its ability to fully assess risk.
The FDA noted that its evaluation was further constrained because much of the available toxicology data is not publicly accessible. There are currently no federal regulations that prohibit PFAS intentionally added to cosmetic products. However, the agency has said it will continue to monitor emerging data and take action if safety concerns emerge.
Adding PFAS
PFAS are added to cosmetic products to improve texture, durability, and water resistance. According to mandatory cosmetic product listing data submitted to the FDA, there are 51 PFAS currently used in more than 1,700 cosmetic formulations.
The agency evaluated toxicology data on 25 of the most frequently used PFAS — representing approximately 96% of PFAS used in cosmetic products. While it was found that five PFAS exhibited low safety concerns, the FDA was unable to establish the safety of the remaining PFAS due to a lack of publicly available data. One PFA was identified as presenting a potential safety concern “with significant remaining uncertainty.”
Risks and Concerns
According to Heather D. Rogers, MD, FAAD, founder of Modern Dermatology and Doctor Rogers Skin Care, and a clinical faculty member at the University of Washington Department of Dermatology, PFAS are a large class of synthetic chemicals known for being extremely resistant to water, oil, heat, and breakdown due to the strength of the carbon–fluorine bond.
“They are used in nonstick cookware, known as polytetrafluoroethylene (PTFE), waterproof and stain-resistant textiles such as Gore-Tex, food packaging and firefighting foams,” she explained, adding that much of the existing safety data comes from these exposure pathways rather than in skin care.
“In cosmetics,” she added, “certain PFAS are added to improve texture, slip, spreadability, shine, and water resistance — particularly in long-wear or waterproof products.”
Dr. Rogers explained that environmental and occupational exposure data have linked certain PFAS with biological effects in humans, including immune and endocrine disruption, metabolic changes like elevation of lipid levels, and even cancers.
“PFAS are concerning because they are highly persistent, with some compounds remaining measurable in human blood for years, raising concern about cumulative exposure over time,” she said. “One consistent finding in humans is reduced antibody response to vaccines with higher PFAS exposure, which has been observed across multiple populations.”
Dr. Rogers believes PFAS should not be used in cosmetic products unless safety has been clearly demonstrated under real-world conditions, and there is a compelling reason for their inclusion. She added that it is “reasonable and responsible” to choose effective alternatives and minimize exposure to persistent chemicals that may have unknown cumulative effects — an approach underscored by the FDA’s inability to determine PFAS safety at this time.
