Nutrasource Blog

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

When it comes to infant formula, there is virtually no margin for error. As a critical source of nutrition for millions of infants, every ingredient and every manufacturing step must meet rigorous safety standards.

The Growing Importance of Food Coloring in Product Development

Whether you're involved in product development, quality assurance, or ingredient sourcing, chances are you’ve encountered the topic of food coloring more than once. In the U.S., food color additives play a central role in how consumers perceive and experience products, particularly in categories like snacks, beverages, baked goods, and confectionery. However, the FDA announced in April 2025 it was planning on phasing out petroleum-based synthetic food dyes (FDA, 2025c). With growing scrutiny from regulators, in addition to advocacy groups and consumers, it's important for food ingredient professionals to understand what’s in their color palette.

What are PFAS and how am I exposed to them?

Per- and polyfluoroalkyl substances (PFAS) are a group of synthetic chemicals that have been used in various products since the 1940s. The definition of PFAS varies according to different regulatory agencies, but in general PFAS contain chains of carbon molecules with varying numbers of fluorine molecules attached to the carbons. They are known as “forever chemicals” because of their resistance to breaking down and have been shown to be hazardous to humans and other species.

The Association of American Feed Control Officials (AAFCO) maintains a list of feed ingredient names and the definitions in the AAFCO Official Publication. This list is central to harmonizing inter-state trade for animal feed and is referenced by international organizations. In late 2024, it was announced that the AAFCO “ingredient definition” process was going to change when the memorandum of understanding between AAFCO and the FDA came to an end. The FDA quickly put forward a draft guidance that has since been finalized for Animal Food Ingredient Consultation (AFIC) process as an alternative pathway, complementing the Food Additive Petition (FAP) and Generally Recognized as Safe (GRAS) notifications that exist currently. Similarly, AAFCO released a draft proposal from Kansas State University (KSU) for a new AAFCO ingredient definition process that does not involve the FDA.

Whether you’re a startup brand introducing your first product or an established brand with many SKUs, the regulatory requirements are the same: companies are responsible for ensuring that their dietary supplements comply with U.S. laws governing safety, quality, and labeling.

The dietary supplement market in the U.S. includes a diverse range of products, including vitamins, minerals, herbal preparations, probiotics, and specialty nutrients. These products fall under the jurisdiction of the Food and Drug Administration (FDA) and are regulated differently than conventional foods or drugs. Unlike some countries, such as Canada or members of the European Union, where pre-market approvals are required, the U.S. system relies primarily on post-market oversight.

When it comes to food and supplement labeling, there are significant differences between the US and Canada – even spelling the word “labelling (labeling)” is different. Both markets have their own set of regulations which detail the mandatory content required on a product label. The regulations also give guidance on voluntary content such as claims. It’s important to know which governing bodies have oversight, which regulations apply and how to properly classify your product to make sure you use the right set of regulations from the beginning.