On March 20, 2024, the US 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 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.
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. It is also possible for very small amounts of certain PFAS to enter foods through food packaging, processing, and cookware. As the FDA continues to update and enhance our approach and process for evaluating and monitoring chemicals, this Import Alert is one of the tools we can employ in our commitment to reducing harmful exposure to chemical contaminants like PFAS in the food supply.
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 this Import Alert.
In 2022, the FDA initiated a targeted survey for PFAS in 81 seafood samples collected at retail and determined that the estimated exposure to perfluorooctanoic acid (PFOA), a type of PFAS, from certain samples of canned clams from China is likely a health concern. The 81 samples in the survey consisted of clams, cod, crab, pollock, salmon, shrimp, tuna, and tilapia, most of which were imported to the U.S. The FDA plans an additional 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.
EAS Consulting Group will closely monitor these and other FDA updates throughout 2024 and beyond, communicating expectations and analyses to our clients as available.
In the meantime, if you need assistance with resolving an import alert or product detention, reach out to your regulatory partners at EAS Consulting Group with help determining regulatory compliance.
Posted in FDA and USDA Regulatory Update, Foods.