FDA Issues Import Alert for Food Products with Chemical Contaminants Including PFAS

Earlier this month, the FDA issued a new import alert for human food products with detectable levels of chemical contaminants that may present a safety concern to human health. The Import Alert 99-48, Detention without Physical Examination of Foods Due to Chemical Contamination, gives the FDA the ability to help prevent entry of human food products into the U.S. if they are found to be contaminated with a broad range of human-made chemicals including benzene, dioxins and polychlorinated biphenyls (PCBs), and per- and polyfluoroalkyl substances (PFAS), among others. This Import Alert is one of the tools FDA employs to reduce harmful exposure to chemical contaminants in the food supply.

PFAS are a diverse group of thousands of chemicals used in many different types of products. PFAS in the environment can enter the food supply through plants and animals grown, raised, or processed in contaminated areas. Very small amounts of certain PFAS can also enter foods through food packaging, processing, and cookware.

In 2022, the FDA conducted a survey for PFAS in 81 seafood samples collected at retail including clams, cod, crab, pollock, salmon, shrimp, tuna, and tilapia, most of which were imported into the U.S. The estimated exposure to perfluorooctanoic acid (PFOA), a type of PFAS, from certain samples of canned clams from China was determined to be a likely health concern. The FDA plans another targeted survey of molluscan shellfish this year, and this new Import Alert could be used to refuse entry of foods like seafood contaminated with PFAS.

The FDA generally takes the approach of assessing whether the type and level of a chemical contaminant found in food may pose a risk to human health, such that the food is considered to be adulterated. To make that determination, the FDA considers, on a case-by-case basis, such factors as an established action level or tolerance, how much of the food is typically consumed, the level of the contaminant detected in that food, and the toxicity of the specific contaminant(s). Specific firms and their food products found with levels of chemical contaminants that may pose a risk to human health may be subject to detention without physical examination (DWPE) under the new Import Alert.

To remove a firm/product from an Import Alert, evidence must be provided to the FDA to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future products will be in compliance. For guidance on removal, refer to FDA's RPM, Chapter 9-8, "Detention without Physical Examination (DWPE)."