FDA Releases PFAS Cosmetics Safety Report

What does FDA's new PFAS report mean for cosmetics manufacturers and regulators amid growing state bans?

On Dec. 29, the U.S. Food and Drug Administration released its evaluation of per- and poly-fluoroalkyl substances (PFAS) used in cosmetic products, focusing on toxicity, safety, and exposure risks. "Report on the Use of PFAS in Cosmetic Products and Associated Risks" summarizes the results of FDA's assessment, as mandated by Section 3506 of the 2022 Modernization of Cosmetics Regulation Act (MoCRA).

The federal government does not currently prohibit the use of intentionally added PFAS in cosmetics; however, ten states have barred the use of intentionally added PFAS in cosmetics, and eight states have proposed legislation to ban or limit their addition or presence.

Where are PFAS being used in cosmetics? 

According to FDA, using the broad definition of PFAS proposed by the Organisation for Economic Co-operation and Development (substances that contain at least one fully fluorinated methyl or methylene carbon), 51 PFAS were identified in 1,744 cosmetic product formulations. The agency only reviewed and considered the reported intentional addition of PFAS and did not look at the potential for PFAS contamination in raw materials. 

The report lists eye shadows, face and neck products (e.g., leave-on moisturizers), eyeliners, face powders, and foundations as the top five product categories, together constituting approximately 56% of PFAS-containing cosmetics. Other common applications include lipsticks and nail polish. Cosmetics in these categories, as well as others, use PFAS to enhance emulsion stability, impart oil- and water-repellency, and enhance product durability, among other functions.

The agency focused its review on the top 25 PFAS used in 10 or more products, which it states accounts for over 96% of PFAS used in cosmetic products in the U.S. The three most frequently used PFAS reported by FDA, polytetrafluoroethylene (PTFE), perfluorononyl dimethicone, and trifluoroacetyl tripeptide-2, include significant differences in their chemical structures and associated properties. FDA assessed toxicological endpoints including acute toxicity, genotoxicity, carcinogenicity, and developmental and reproductive toxicity following potential exposure via dermal contact, inhalation, and incidental ingestion.

FDA determined that five PFAS — PTFE, perfluorodecalin, HC Yellow No. 13, perfluorohexane, and tetrafluoropropene — "pose low safety concerns in cosmetic products under intended use conditions." One PFAS, perfluorohexylethyl triethoxysilane, was identified as having a potential safety concern when used in body lotion at the highest reported concentration. However, the agency found that the safety of most of the 25 PFAS could not be determined due to a lack of toxicological data. The report highlights significant data gaps, including limited data on use levels, a lack of dermal and oral absorption data, missing mechanistic information, and the absence of dermal toxicity data. 

What ongoing FDA monitoring means for cosmetics manufacturers

FDA will continue to monitor emerging data on PFAS to support the continued safety of cosmetic products. The agency reports that use of PFAS in cosmetic products appears to be declining; however, the report emphasizes the need for further research to address data gaps and refine safety assessments, as well as the importance of ongoing regulatory efforts to monitor emerging information on PFAS and their environmental impact.

As regulations continue to evolve, companies can benefit from thorough, proactive cosmetic ingredient and product safety assessments to manage the potential or perceived risks associated with PFAS, including exposure assessments, safety data gap analyses, read-across evaluations, formula evaluations, and supply chain auditing. The unintended presence of PFAS — either through degradation of parent compounds or the use of PFAS-contaminated materials — represents an ongoing challenge, not directly addressed by the FDA report, that may require additional evaluation across complex ingredients, packaging, and manufacturing vendors and processes.