The Food and Drug Administration issued March 20 a new import alert through which the FDA can bar imports of human food products with detectable levels of a broad range of chemical contaminants that may present a safety concern to human health, including benzene, dioxins and polychlorinated biphenyls, and per- and polyfluoroalkyl substances.
This action could affect a wide range of imported goods. For more information on how it may affect your business, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.
PFAS are a group of synthetic chemicals that have been in use since the 1940s and can be found in a wide array of industrial and consumer products. They are synthesized for many different uses, from firefighting foams, to coatings for clothes and furniture, to food contact substances, to the manufacture of other chemicals and products. They are used in a wide variety of products, including textiles, electronics, wires and cables, pipes, cooking and bakeware, sport articles, automotive products, toys, transportation equipment, and musical instruments, that may be imported into the U.S. as finished articles.
The new import alert will list specific firms and their food products determined by the FDA to contain levels of PFAS or other identified chemical contaminants that may pose a risk to human health, although no firms or food products are yet listed.
The FDA notes that it has not set levels for most chemical contaminants in food, including PFAS. However, it has generally taken the approach of assessing, on a case-by-case basis, whether the type and level of the contaminant found in the food may pose a health concern such that the food is considered to be adulterated. The FDA's assessment considers a number of factors, including whether there is an established action level or tolerance, how much of the food people typically eat, the level of the contaminant detected, and the toxicity of the specific contaminant(s).
Firms and/or products on the “red list” of an import alert are subject to detention without physical examination, while firms and/or products on the “green list” are not because they have met the criteria for exclusion. Some import alerts include a “yellow list” of firms, products, and/or countries subject to intensified surveillance because the nature of the violations may warrant further field examinations of individual entries and/or additional analyses. In addition, depending on the specific import alert, shipments of products subject to DWPE may still be imported into the U.S. if the importer has demonstrated that the shipment is in compliance.
If a product is detained without physical examination the importer has the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If no such evidence is submitted, or if the evidence provided is insufficient, the product will be subject to refusal of entry into the U.S.
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