FDA Rejects PFAS Food Tolerances Petition

FDA denied a petition for PFAS food tolerances in June 2025, leaving suppliers and manufacturers in a regulatory gray zone.

No binding PFAS food tolerances exist at the federal level. FDA formally rejected a petition requesting limits on 26 to 30 PFAS across produce, dairy, seafood, and animal feed. The denial, reported by JD Supra via Shook, Hardy & Bacon, signals a long road ahead for supply chain certainty.

The TL;DR

• FDA denied the PFAS tolerance petition in full on June 17, 2026.
• No federal action levels for most PFAS in food currently exist.
• Seafood and high-contamination-region suppliers face the sharpest scrutiny.
• FDA retains enforcement authority without set limits under FD&C Act section 402(a)(1).
• Cumulative PFAS exposure assessment methods are still in development.

Why FDA Rejected PFAS Food Tolerances

The original petition, filed November 1, 2023, asked FDA to set limits at the method detection limit. A May 15, 2025 supplement expanded the request. FDA concluded the petition lacked sufficient toxicological reference values, exposure data, and feasibility analyses.

FDA also rejected a zero-tolerance argument under the Delaney Clause. PFAS are regulated as contaminants under adulteration provisions, not as food additives. That distinction matters enormously for how enforcement can proceed.

What Operators Face Now on PFAS Food Tolerances

Significant. FDA retains authority to act against any food it deems injurious to health under FD&C Act section 402(a)(1), even without formal limits. That creates real compliance uncertainty for manufacturers and suppliers.

FDA is actively testing thousands of food samples and expanding detection methods. The agency is also reviewing EPA drinking water standards for bottled water applications. Operators in seafood and products from known contamination regions face the most immediate monitoring pressure.

Watch this. FDA has not closed the door on action levels entirely. It committed to considering them as data accumulates. Clean-label brands tracking PFAS exposure should treat expanded FDA surveillance as a leading indicator, not background noise.

Source: JD Supra (Shook, Hardy & Bacon L.L.P.). https://www.jdsupra.com/legalnews/food-and-beverage-litigation-and-4079850/