Client Alert: FDA Import Alert for Food Products Containing PFAS

On March 20, 2024, the U.S. Food and Drug Administration (FDA) issued a Detention Without Physical Examination (DWPE) import alert for food products with detectable levels of chemical contaminants, including per- and polyfluoroalkyl substances (PFAS), that may present safety concerns for human health. The DWPE allows the FDA to prevent entry of human food products into the U.S. if they are found to be contaminated with human-made chemicals such as PFAS.

What are PFAS?

PFAS are a diverse group of human-made chemicals that can be found everywhere and are used in a wide range of consumer and industrial products. PFAS are highly resistant to breakdown, and some types have been shown to accumulate in the environment and our bodies. PFAS can enter the food supply through plants and animals grown, raised or processed in contaminated areas, or through food packaging, processing and cookware.  

The FDA typically assesses, on a case-by-case basis, whether a chemical contaminant, such as PFAS, in food poses a health concern such that the food may pose a risk to human health. For each case, the FDA looks at different factors, including whether there is an established action level or tolerance, consumption levels of the food, level of contaminant detected in the food and level of toxicity. If a product is found to be harmful to health, it may be detained without physical examination. 

FDA’S PFAS Study for This Import Alert 

In 2022, the FDA conducted a targeted survey for PFAS in 81 seafood products collected from retailers, including clams, cod, crab, pollock, salmon, shrimp, pina, and tilapia. Most of these products were imported to the U.S. The FDA determined the estimated exposure to perfluorooctanoic acid (PFOA), a type of PFAS, from certain sampled canned clams from China is likely a health concern subject to DWPE. The FDA plans to conduct an additional survey of molluscan shellfish this year. 

Release or Removal from Detention Without Physical Examination

Foods found with chemical contaminants that may pose a risk to human health may be subject to DWPE under this import alert. Companies do, however, have the opportunity to remove themselves or their products.  

To release articles subject to DWPE, the owner, consignee, and/or another responsible party to the shipment may provide evidence to the FDA that the shipment is not adulterated. Such evidence may include the results of private laboratory analysis of a representative sample of the shipment, which demonstrates that the product does not bear or contain levels of chemical contaminants that may render it injurious to health.

Removing a company or product from DWPE requires providing the FDA with an adequate demonstration that the company in question has resolved the conditions that gave rise to the alleged violation so that the agency will have confidence that future entries will comply. 

If you have questions about this import alert or any compliance issues related to PFAS, please reach out to our Retail practice co-chair, Alecia Cotton (acotton@rjo.com) or Alexis Morris (amorris@rjo.com) in our Retail practice group.