News Details

The U.S. Food and Drug Administration (FDA) has released a congressionally mandated report under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which evaluates the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products. The report highlights major scientific uncertainties and concludes that the current data are insufficient to make definitive safety determinations for most PFAS intentionally used in cosmetics. 

Key Findings from the Assessment 

Using mandatory cosmetic product listing data submitted under MoCRA, the FDA identified: 

• 51 PFAS intentionally added to cosmetic products 

• 1,744 cosmetic formulations containing PFAS 

• 25 PFAS accounting for approximately 96% of intentional PFAS use 

The FDA focused its safety evaluation on these 25 substances, due to their widespread use in cosmetic formulations. 

Safety Evaluation Outcomes 

The agency found that toxicological information for most PFAS remains limited: 

• Toxicity data for the majority of PFAS are incomplete or unavailable. 

• Five PFAS appeared to pose low safety concerns under the intended conditions of use. 

• One PFAS was identified as potentially raising safety concerns at higher use levels, although significant uncertainty remains. 

• For most PFAS, the FDA could not conclusively determine safety. 

The lack of publicly available toxicology data further restricted the agency’s ability to fully assess potential risks to consumers. 

Scope and Regulatory Context 

The report addresses PFAS intentionally added as cosmetic ingredients but not those present as impurities or contaminants. PFAS are used for their functional benefits, including water resistance, durability, and improved texture. However, concerns over their persistence and possible toxicity have intensified regulatory scrutiny globally. 

FDA’s Next Steps 

• No federal regulations currently ban PFAS intentionally added to cosmetics. 

• The FDA will take appropriate enforcement action if safety concerns emerge. 

• Continued collaboration with other federal agencies, including the Centers for Disease Control and Prevention (CDC) and the Environmental Protection Agency (EPA), will support stronger PFAS guidance 

The FDA has also indicated that it will expand its research, testing, and surveillance activities in order to address data gaps and improve its understanding of PFAS exposure from consumer products.