Fifty-one perfluoroalkyl and polyfluoroalkyl substances (PFAS) are currently used in 1,744 cosmetic formulations, according to a new report released today by the U.S. Food and Drug Administration. The agency’s assessment, mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), reveals significant gaps in safety data for these chemicals, raising questions about potential risks to consumers.

uncertainty Clouds Cosmetic PFAS Safety

The FDA’s report doesn’t definitively declare any cosmetic PFAS safe or unsafe, highlighting a critical need for more research.

  • One PFAS was identified as having a potential safety concern, but further research is needed.
  • Currently, no federal regulations specifically prohibit the intentional addition of PFAS to cosmetic products.

“In accordance with our congressional mandate, the FDA today released its assessment of PFAS in cosmetic products,” said FDA commissioner Marty Makary, M.D., M.P.H. “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.”

PFAS are a group of synthetic chemicals known for their water and oil-repellent properties, frequently enough used to create durable and smooth textures in cosmetics. Though, their persistence in the surroundings and potential health effects have prompted increasing scrutiny from regulators worldwide.

Data Gaps Hamper Risk Assessment

The FDA’s evaluation focused on PFAS intentionally added as ingredients,not those potentially present as contaminants. While five PFAS appeared to pose low safety concerns under their intended use, the agency couldn’t definitively establish the safety of most others. The limited availability of publicly accessible toxicology data considerably hindered the assessment process.

What are PFAS? Per- and polyfluoroalkyl substances are man-made chemicals that don’t break down easily in the environment or the human body. They’ve been linked to a range of health concerns, including immune deficiencies, liver problems, and certain cancers.

The agency emphasized that it will take action if safety concerns emerge regarding cosmetic products containing PFAS, consistent with existing enforcement policies. The FDA will continue to monitor new scientific data and allocate resources to address data gaps, supporting the Department of Health and Human Services’ Make America Healthy Again efforts to reduce PFAS exposure across the supply chain.

For more information on PFAS in cosmetic products, visit the FDA’s website: https://www.fda.gov/cosmetics/cosmetic-ingredients/and-polyfluoroalkyl-substances-pfas-cosmetics.

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the FDA protects public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and medical devices. The agency also safeguards the nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and regulates tobacco products.