FDA on PFAS in Cosmetic Products: Everything You Need to Know
The U.S. Food and Drug Administration recently released a report on its evaluation of PFAS in cosmetic products, concluding insufficient data to make a determination on safety.
The report, entitled Report on the Use of PFAS in Cosmetic Products and Associated Risks, is mandated by Congress under the Modernization of Cosmetics Regulation Act of 2022. It details the agency’s review of available scientific data on the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) intentionally added to cosmetic formulations. The FDA report focuses on PFAS intentionally added to cosmetic products as ingredients, rather than PFAS that may be present as contaminants.
The FDA said 51 PFAS are used in 1,744 cosmetic formulations. Slightly more than half of those were found in five product categories: eye shadows, face and neck products (leave-on), eyeliners, face powders and foundations.
The FDA evaluated the 25 most frequently used PFAS, which represent approximately 96 percent of PFAS intentionally added to cosmetic products. It concluded it did not have enough toxicological data on 19 of those to make a safety determination. Five PFAS were considered to pose low safety concerns in cosmetic products when used as intended. The FDA identified one, perfluorohexylethyl triethoxysilane, as having a potential safety concern when used in body lotion at the highest use level, although with substantial uncertainty.
“In accordance with our congressional mandate, the FDA today released its assessment of PFAS in cosmetic products,” said FDA Commissioner Marty Makary. “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. 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.”
PFAS are known for their flame-retardant, water-resistant and stain-resistant qualities. They’re commonly used throughout substances, products and industries and are ubiquitous in the environment. Allegations regarding adverse health impacts from exposure to these “forever chemicals” have given rise to increased litigation and regulation, forcing companies and their attorneys to educate themselves and take appropriate action.
There are currently no federal regulations that specifically prohibit PFAS from intentionally being added to cosmetic products. The FDA has issued Our Current Understanding of the Human Health and Environmental Risks of PFAS and maintains a page on PFAS in cosmetics on its website. Several states have already implemented, or are considering implementation of, limits or bans on intentionally added PFAS in cosmetics.
The FDA said it will continue monitoring scientific data and will seek ways to reduce PFAS in food and cosmetic products “through expanded testing, monitoring, and surveillance.” It added that it will take appropriate enforcement action if safety concerns emerge.
Harris Beach Murtha attorneys have a great deal of experience with PFAS regulations and lawsuits. Our PFAS team monitors all developments and reports out new developments to keep clients aware and to be prepared to defend clients.
We recommend cosmetic companies audit products for the presence and kinds of PFAS and be prepared to pivot as new regulations emerge. Monitor both federal and state action on PFAS and ensure products being marketed are labeled in honest and lawful ways.
If you have any questions or concerns about PFAS, please contact Kelly Jones Howell, leader of our Medical and Life Sciences Industry Team, at 212-912-652 and khowell@harrisbeachmurtha.com; Abbie L. Eliasberg Fuchs, leader of the firm’s Mass Torts and Industry-Wide Litigation Practice Group, at (212) 313-5408 and afuchs@harrisbeachmurtha.com; attorney Marina Plotkin at (212) 313-5409 and mplotkin@harrisbeachmurtha.com; or the Harris Beach attorney with whom you usually work.
This alert is not a substitute for advice of counsel on specific legal issues.
Harris Beach Murtha’s lawyers and consultants practice from offices throughout Connecticut in Bantam, Hartford, New Haven and Stamford; New York state in Albany, Binghamton, Buffalo, Ithaca, New York City, Niagara Falls, Rochester, Saratoga Springs, Syracuse, Long Island and White Plains, as well as in Boston, Massachusetts, and Newark, New Jersey.
