FDA Issues Report on PFAS in Cosmetics: Key Findings, Risks, and Regulatory Implications

They are most frequently used in eye shadows, leave-on face and neck products, eyeliners, face powders, mascaras, and foundations. Since there are currently no federal regulations restricting the use of PFAS in cosmetics, their mere presence would not render a cosmetic product adulterated or misbranded. 

The US Food and Drug Administration (FDA) recently published its 258-page “Report on the Use of PFAS in Cosmetic Products and Associated Risks,” described as providing the most comprehensive federal assessment to date of intentionally added PFAS in cosmetics, their functions and prevalence, available safety data, and associated risks. 

Scope 

The report evaluates only PFAS that are intentionally added as cosmetic ingredients and does not consider those that may be present simply as trace contaminants. The FDA identified the top 25 intentionally added PFAS by frequency of use utilizing data from cosmetic product listings made mandatory under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). 

Market Prevalence and Use Patterns

The FDA’s MoCRA product listings indicate that, as of August 30, 2024, 51 distinct PFAS are intentionally used in 1,744 US cosmetic formulations, but these represent just 0.41% of all registered cosmetic products. The top product categories in this group are eye shadows, face and neck leave‑on products, eyeliners, face powders, and foundations. 

Exposure and Concentration Information

Unsurprisingly, the FDA identifies dermal exposure as the primary route for cosmetic PFAS, although incidental inhalation from powders or sprays, ocular contact from eye makeup, and incidental ingestion from lip products are possible, depending on product type. Because US law does not require disclosure of ingredient concentrations in listings, the FDA extracted limited concentration data from Cosmetic Ingredient Review reports, suppliers, publications, and targeted industry outreach, and emphasizes that lack of systematic concentration data hampers exposure and risk assessments. 

Safety Conclusions and Data Gaps

The FDA reached definitive “low safety concern” conclusions for five of the 25 most prevalent PFAS under their intended conditions of cosmetic use: polytetrafluoroethylene (PTFE, known commercially as Teflon), perfluorodecalin, HC Yellow No. 13 (a colorant), perfluorohexane, and tetrafluoropropene (a propellant). Of these, PTFE, a fluoropolymer, is by far the most frequently used of all PFAS; it accounts for 490 (28%) of the 1,744 formulations. Together, the five PFAS of low safety concern account for about 37% of all PFAS-containing products. One other fluoropolymer (polyperfluoromethylisopropyl ether) is listed in the group of 25, but it lacked sufficient data to allow for a “low safety concern” determination, although the data that are available “suggest a low potential for toxicity” according to the FDA’s conclusion. Moreover, fluoropolymers in general are widely considered to be safe. If its usage (54, or 3.1%, of identified products) is included among those considered to be of low safety concern, it would bring that total to 40%. 

The one PFAS singled out as being a potential safety concern (perfluorohexylethyl triethoxysilane) is used in 124 (7.1%) identified products. The FDA’s concern is based on an unpublished European Union (EU) dossier reporting limited toxicity observed in rats that were orally (not dermally) administered repeated high doses. A major (but seemingly unlikely) assumption for the very conservative safety determination was that dermal absorption from topical application is the same as oral absorption resulting from ingestion, combined with the highest recommended use level of the PFAS in body lotion. Regardless of the validity of the FDA’s concern, market data suggests a recent decline in launches of products containing this PFAS.

For the remaining 18 PFAS (used in 53% of PFAS-containing products), the FDA found the data — primarily critical toxicological and toxicokinetic data, including dermal absorption and systemic exposure potential — simply insufficient to reach adequate safety conclusions. The FDA will continue monitoring and may refine assessments as new data emerges. 

It should be noted that the report, out of necessity, appears to consider each of the 1744 PFAS-containing formulations as if their share of the total cosmetic market was equally distributed. In reality, the market share represented by the PFAS-containing products with insufficient safety data may significantly differ from, and possibly be even lower than, 53% of the 0.41% (i.e., 0.22%) — a very small fraction — of all registered cosmetic products.

Regulatory Landscape: Federal, State, and International

Since there is no federal prohibition on intentionally added PFAS in cosmetics, it is individual states that are driving reformulation. Eleven states — California, Colorado, Connecticut, Maine, Minnesota, New Hampshire, New Mexico, Oregon, Rhode Island, Vermont, and Washington — have enacted laws prohibiting intentionally added PFAS in cosmetics on phased timelines beginning January 1, 2025, and extending to 2028, with some state laws becoming effective earlier if conditions are met. Additional states have proposed restrictions in the legislative pipeline. 

Internationally, New Zealand has adopted a phase‑out covering all intentionally added PFAS in cosmetics with import or manufacture bans from January 1, 2027, sales bans from January 1, 2028, and disposal deadlines by July 1, 2028. The EU is evaluating a broad restriction proposal for approximately 10,000 PFAS across uses, including cosmetics, while France has enacted a phased ban beginning with cosmetics by January 2026. Canada restricts certain long‑chain PFAS in cosmetics, and Korea prohibits intentional use of approximately 190 PFAS in cosmetics while allowing case‑by‑case evaluation for unintentional presence. 

Practical Implications for the Cosmetics Industry

The FDA’s analysis confirms that a small fraction of US cosmetics currently list intentionally added PFAS, but that use is concentrated in specific categories such as eye makeup, face powders, and foundations. Companies face an accelerating compliance burden as state prohibitions that began taking effect in 2025, together with global trends (New Zealand, France, potential EU restriction), further narrow the field for PFAS‑containing products. 

The risk picture is nuanced. A handful of PFAS (including PTFE, the most prevalent) present a low safety concern under intended conditions, but for the other most frequently used PFAS, the evidence is insufficient for a definitive safety judgment, and at least one commonly used PFAS may present a safety concern at higher use levels in certain applications. Challenges with the FDA’s access to concentration data, toxicokinetics, and high‑quality toxicology underscores exposure and risk uncertainties that may be of interest to regulators, advocacy groups, and litigants. 

Strategic Takeaways and Action Items

Considering current efforts to limit or prohibit the use of PFAS in cosmetics as well as many other consumer products, cosmetics companies should continue or accelerate PFAS reformulation programs, prioritizing PFAS with high use prevalence and insufficient safety data as identified in the FDA report. They should also strengthen their ingredient supplier diligence, including certifications as to PFAS content, indemnity agreements, and identification of specific PFAS that are present.

Bottom Line

• The FDA identified 51 intentionally added PFAS used in 1,744 US cosmetic formulations (just 0.41% of all listed products), with usage concentrated in certain makeup and skin‑care categories. 

• Of the top 25 PFAS by frequency, the FDA concluded that five are of low safety concern under intended use, 19 lack sufficient data for a safety conclusion (although one, a polymer, is likely to be safe), and one may present a safety concern at higher concentrations in a specific application. 

• State prohibitions beginning in 2025, alongside international phase‑outs and prospective EU‑wide restrictions, are already driving reformulation and supply‑chain changes. 

• The FDA has indicated that significant data gaps — especially concentration, dermal absorption, and systemic toxicity — remain; the FDA has indicated that it will continue monitoring published and unpublished safety data and may refine its conclusions as new evidence becomes available.

The Food, Drug, Medical Device & Cosmetics group and the Consumer Products group at ArentFox Schiff are ready to respond to any questions you might have about the issue of PFAS in cosmetics. Please feel free to reach out to any members of these groups.