Recent PFAS Updates: FDA and Federal Court Demand Reasoned Basis for PFAS Rules

Two recent developments are noteworthy at the intersection of per- and polyfluoroalkyl substances (“PFAS”) and products liability. First, the FDA updated public statements about PFAS in medical devices on its webpage. As previously covered in Re:Torts, the FDA recognizes that fluoropolymers, a particular type of PFAS comprised of large molecules, are essential for use in many medical devices. The FDA reaffirmed that “PFAS in the form of fluoropolymers” are “used in many thousands of devices,” “remain essential materials for many devices,” and that “no toxicity issues have been connected to the use of fluoropolymers in devices.” The FDA further explained that “in most cases, no other materials have been shown to possess the combination of unique properties” necessary for medical devices. Citing its investigations as well as investigations by independent researchers, “[t]he FDA is not aware of any evidence that suggests the fluoropolymer PFAS materials in medical devices have harmful public health effects, and the FDA has determined there is no reason to restrict their use in devices.”

Second, a federal district court preliminarily enjoined a New Mexico PFAS labeling regulation enacted under the PFAS Protection Act that would require manufacturers to affix a label to products containing intentionally added PFAS. Am. Chem. Council v. Kenney, No. 1:26-cv-2130, 2026 WL 2740634, at *1 (D.N.M. Sept. 16, 2026). Applying the Supreme Court’s standard for compelled commercial speech, the district court found the label—an “outline of an Erlenmeyer flask with the word ‘PFAS’ inside”—did not have a “reasonable fit” with the government’s asserted interests in consumer and environmental health. Id. at *9–10. In its briefing, the State characterized the label as a “consumer awareness” tool, not a “warning label.” Id. at *9. The court found this fatal, noting the inconsistency in the State’s position: while the government denied that the label addressed any hazard or risk, the government simultaneously relied on its purported interest in protecting consumer health. Id. Because a label that “serves to promote consumer curiosity about the content of various products” is insufficient to satisfy the required “reasonable fit” between the label and the State’s stated goals, the court preliminarily blocked the labeling mandate while the case proceeds. Id. The court left other measures of the law unaffected. Id. at *11.