Washington, Dec. 30, 2025 — A congressionally-mandated review released today by the U.S. Food and Drug Administration concludes that the safety of three-quarters of the “forever chemicals” deliberately added to American-made cosmetics cannot be determined because manufacturers have never submitted the toxicology data required for a modern risk assessment.
The 258-page report, posted on the agency’s website ahead of the New Year, is the first comprehensive snapshot of per- and poly-fluoroalkyl substances (PFAS) in lipsticks, eyeshadows, lotions and other personal-care products since Congress ordered the study in the 2022 Modernization of Cosmetics Regulation Act (MoCRA).
Investigators identified 51 different PFAS currently marketed in 1,744 separate cosmetic formulations—roughly 0.4 % of the 430,000 products listed in FDA’s new mandatory registry. While the number sounds small, the agency notes that the count is almost certainly an under-estimate because small businesses are exempt from disclosure and not all companies have complied with the 18-month-old listing requirement.
“Most of these chemicals have never been tested for the way consumers actually use them—day after day, around the eyes and lips,” said Dr. Linda Katz, director of FDA’s Office of Cosmetics and Colors. “The bottom line is that for 19 of the 25 most frequently used PFAS we simply do not have enough information to say they are safe.”
One ingredient, perfluorohexylethyl triethoxysilane, was singled out for immediate concern. Used as a water-proofing agent in 124 products—mainly face powders and foundations—the silane-based compound caused progressive weakness and peripheral-nerve damage in rats at the lowest dose tested (100 mg/kg). Using a conservative “worst-case” exposure model—body lotion applied daily at the highest reported concentration (0.82 %)—FDA calculated a safety margin of only 50-fold, well below the 300-fold margin the agency considers protective for short-term animal data. The finding does not automatically trigger a recall, but FDA says it will “prioritize requests for additional data” from the 11 suppliers known to market the ingredient.
Five other PFAS, including the well-known polymer PTFE (Teflon), were judged “low concern” under current use patterns, although the report stresses that conclusion rests on limited, often decades-old studies or analogies to medical-device polymers.
Consumer groups reacted swiftly. “The report confirms what independent labs have warned for years: PFAS are quietly lurking in our makeup and the government has no idea whether they are safe,” said Melanie Benesh of the Environmental Working Fund, which detected PFAS in nearly half of 231 cosmetics it tested in 2021. “FDA should immediately use its new MoCRA authority to demand full safety files and, where data remain missing, suspend these ingredients.”
The Personal Care Products Council, the industry’s main trade association, emphasized that “cosmetic PFAS represent a minute fraction of the broader PFAS universe” and noted that many companies are already reformulating in anticipation of state bans. “We support science-based regulation and are committed to working with FDA to fill any legitimate data gaps,” the group said in a statement.
Federal landscape shifting
The report lands as Washington prepares for the first congressional session in which both parties have introduced legislation to restrict PFAS in consumer goods. California, Colorado, Maine, Minnesota and Washington already prohibit intentionally added PFAS in cosmetics, with identical bans in Connecticut, New Mexico, Oregon, Rhode Island and Vermont taking effect between 2026 and 2028. New York and Massachusetts are expected to debate similar bills this spring.
FDA officials say the agency lacks authority to impose an outright ban unless a product is proven “adulterated,” but MoCRA gives it new tools to mandate safety substantiation and issue ingredient-specific regulations. “We are exploring all options, including accelerated data calls, partnership with the National Toxicology Program, and possible rulemaking where risks exceed acceptable margins,” Katz told reporters.
What consumers should know
The report does not name brands, but it does list product categories. Eye-shadows account for the largest share of PFAS-containing items (20 %), followed by leave-on face and neck creams (16 %), eyeliners (8 %) and face powders (7 %). Lipsticks, mascaras and hair-care products round out the inventory.
Because U.S. law does not require PFAS to be declared on labels, shoppers cannot easily spot them. FDA says consumers who wish to avoid the chemicals should look for statements such as “PFAS-free” or “no fluorinated ingredients,” now appearing on some packages. The agency also posted the 51 INCI (ingredient) names on its website so consumers can cross-check labels if they appear.
Next steps
FDA will accept public comment for 90 days and will update the analysis as new toxicity studies arrive. The agency is also funding research to develop rapid-screening methods for dermal absorption and has asked the National Academies of Sciences to convene a workshop on PFAS testing strategies for low-dose, repeat-exposure scenarios common to cosmetics.
“Today’s report is a floor, not a ceiling,” said FDA Commissioner Dr. Robert Califf. “If companies want to keep these ingredients on the market, they must generate modern, high-quality data—and do it quickly.”
For now, the report concludes, “the burden of proof has shifted.” Either industry supplies the missing science, or regulators may soon supply the restrictions.
