Last year, we wrote an article about PFAS, which included information about what they are, how people are exposed to them, what they do in humans, safe levels of exposure, and efforts taken by various countries to limit exposure. For additional background, we recommend reading that article before continuing.
New FDA Actions to Reduce PFAS Exposure
Previously, the only steps taken by FDA to limit exposure to PFAS were limited to a ban of these chemicals as grease-proofing agents on paper and paperboard for food contact. Since the blog was issued, additional steps have been or will be taken by FDA to limit exposure to PFAS.
As mentioned on their site entitled “Per- and Polyfluoroalkyl Substances (PFAS)”, which was updated on June 16, 20261, there are three main action areas for regulation of PFAS by FDA.
PFAS Limits in Bottled Water
The FDA is working on a regulation to establish levels for PFAS in bottled water. Currently, they are in the process of reviewing EPA’s regulations on PFAS in drinking water to help determine the appropriate limits for PFAS to add to the standard for bottled water (21 CFR 165.110).
FDA Enforcement on PFAS Contamination in Seafood
The FDA continues to take action on PFAS contamination in seafood through the issuance of Import Alert 99-48 and the listing of eight firms on the red list due to PFOA contamination in imported clams. Clams were mentioned in our previous blog as being a high-risk food for PFAS contamination. FDA is currently reviewing available data from recently initiated bivalve testing to evaluate future actions, including but not limited to, additional risk management actions for clams.
PFAS Monitoring Expands to Infant Formula
FDA is expanding their list of foods to be analyzed for PFAS to infant formula as Part of Operation Stork Speed.2 Information about this initiative and additional contaminants in infant formula that are being monitored by FDA can be found in a companion blog, Protecting the Next Generation: Advances in FDA’s Monitoring of Contaminants in Infant Formula.
What's Next for PFAS Regulation?
Based on results of PFAS analyses in bivalves and infant formula, it is altogether possible that FDA will impose limits on PFAS in these foods or issue action levels in the near future. If you are developing a new infant formula ingredient, make sure to analyze it for PFAS and determine whether the concentration will be safe as part of a GRAS Determination. Better yet, be proactive and do this for any food ingredient you are developing.
How SGS Nutrasource Can Help
As regulatory expectations for PFAS continue to evolve, staying ahead of emerging requirements is essential for companies developing food, dietary supplement, and pharmaceutical products. Proactive testing, robust safety assessments, and a thorough understanding of the regulatory landscape can help minimize risk and support successful product development.
SGS Nutrasource provides scientific and regulatory expertise to help companies navigate PFAS-related challenges through analytical testing, safety assessments, and regulatory consulting. Whether you're evaluating a new ingredient, preparing for evolving regulatory requirements, or strengthening your product safety strategy, our team can help you move forward with confidence.
About the Author
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With over 30 years of experience as a toxicologist, Dolan is responsible for scientific research and generation of safety dossiers related to GRAS, NDIN and safety assessments at GRAS Associates, a SGS Nutrasource Company.
Dolan is a Diplomate of the American Board of Toxicology (DABT), Fellow of the American College of Nutrition (FACN) and a past president of the Food Safety Specialty Section of the Society of Toxicology (SOT), bringing a wealth of knowledge and skill to the GRAS Associates team.
Prior to joining SGS Nutrasource, Dolan was most recently employed as a Senior Toxicologist in the Contaminant Assessment Branch at the FDA Center for Food Safety and Nutrition, where she routinely performed risk assessments for metal, toxin, chemical and pesticide contaminants. Dolan also has experience working as a consulting toxicologist, and a toxicologist for Procter and Gamble. She received her Bachelor of Science in Chemistry from SUNY Oswego before completing her PhD in Pharmacology/Toxicology at Michigan State University.
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