Key Takeaways

Ongoing litigation and a recently published report by FDA signal a continuing focus by the agency to investigate PFAS in food and cosmetics. The agency notes that toxicological data are lacking for PFAS compounds that are viewed as having a potential safety concern.

As previously reported, the U.S. Food and Drug Administration (“FDA”) is defending a suit alleging that the agency did not timely respond to a citizen’s petition to set enforceable limits of per- and polyfluoroalkyl substances (“PFAS”) in certain foods. Tucson Envtl. Justice Task Force v. U.S. Food & Drug Admin., No. 4:25-cv-35 (D. Ariz.). In the citizen petition filed November 1, 2023, the plaintiffs “exclusively seek mandatory enforceable temporary tolerances, rather than action levels.” Id. Then, in May 2025, the plaintiffs asked the FDA to review additional PFAS and establish action levels. In the final days of 2025, FDA sought until June 2026 to respond to the petition, citing “unforeseen circumstances” because the plaintiffs had added “action levels” to the regulatory relief sought. Mot. at 3. The FDA explained that more time was needed to assess the change in relief requested because “tolerances and action levels involve somewhat different scientific inquiries under different regulatory provisions.” Id. at 2 (citing 21 CFR §§ 109.6(b), (d)). Tolerances “are established by rulemaking,” and action levels are “established through agency guidance.” Id. The FDA also cited reductions in staff and furloughs. Id. at 4. The plaintiffs oppose further delay in the case. Opp. at 2-3.

In addition to defending its actions regarding PFAS in food, FDA’s recent PFAS activity also extends to cosmetics. FDA’s report of December 29, 2025, evaluated twenty-five of the most frequently used PFAS in cosmetics. The agency found that “the safety of most of the PFAS reviewed could not be definitively established due to insufficient toxicological data available to the FDA.” And for certain PFAS that FDA identified as having a “low safety concern” (polytetrafluoroethylene and perfluorodecalin) or “potential safety concern” (perfluorohexylethyl triethoxysilane), the agency noted that this evaluation remains significantly uncertain due to the lack of toxicological data. The agency stated in its report that it would continue to monitor PFAS as more information emerges on its use in cosmetics and safety.