FDA Tightens PFAS Rules with New Enforcement and Safety Reviews
FDA invalidated 35 PFAS food contact uses and plans stricter bottled water limits.
Why it matters: Legal and compliance teams in food, beverage, and cosmetics sectors must address faster FDA regulation milestones and enforcement for PFAS chemicals.
- FDA plans to set enforceable PFAS limits in bottled water aligned with EPA's April 2024 standards.
- In January 2025, FDA invalidated 35 PFAS-related food contact notifications due to discontinued industry uses.
- FDA’s December 2023 cosmetic safety review found insufficient data on PFAS toxicity, delaying risk assessments.
- Over 1,900 food samples tested since 2019 showed 95% had PFAS below detection levels, but ongoing monitoring continues.
The FDA recently updated its official PFAS webpage, outlining key regulatory actions to strengthen oversight of per- and polyfluoroalkyl substances (PFAS). These synthetic chemicals, widely used for water- and stain-resistant properties, raise concerns due to their persistence in the environment and potential health risks.
One major FDA effort is a forthcoming regulation to establish enforceable limits for PFAS in bottled water. This proposal aligns with the EPA’s National Primary Drinking Water Regulation issued in April 2024, marking a significant step in limiting consumer exposure through drinking water.
In addition, on January 17, 2025, the FDA announced that 35 food contact notifications involving PFAS are no longer effective. These notifications mostly correspond to uses that manufacturers and suppliers voluntarily discontinued in response to regulatory and market pressures.
Regarding cosmetics, the FDA issued a safety review in December 2023 highlighting significant gaps in toxicological data needed to assess the safety of PFAS in cosmetic products. FDA Commissioner Robert M. Califf emphasized the need for more robust scientific data before establishing regulatory limits, stating, "Current scientific information about PFAS toxicity in cosmetics is incomplete, limiting our ability to ensure consumer safety." This limits immediate regulation but signals forthcoming scrutiny.
Since initiating its PFAS food testing program in 2019, the FDA has analyzed over 1,900 food samples from the U.S. marketplace. Results indicate that more than 95% of these samples contained PFAS levels below detection thresholds, suggesting limited contamination in tested goods though vigilance remains necessary.
For legal and compliance professionals, these developments mean accelerated FDA action on PFAS with clear phase-ins: bottled water regulations following EPA standards, immediate invalidation of obsolete food contact uses, and pending cosmetics rules pending data. Organizations should monitor evolving FDA timelines and adapt compliance programs accordingly to mitigate enforcement risks and legal liabilities.
By the numbers:
- 35 — PFAS food contact notifications invalidated by FDA in January 2025
- 95% — food samples tested by FDA since 2019 had PFAS below detection limits
- April 2024 — EPA issued National Primary Drinking Water Regulation for PFAS, prompting aligned FDA action
Yes, but: While the FDA is intensifying PFAS regulation, safety assessments for cosmetics remain incomplete, delaying immediate regulatory requirements in that sector.
What's next: The FDA is expected to publish a formal rule proposal for PFAS limits in bottled water during 2024, with stakeholder comment periods to follow.