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Import Alerts on Foods, Drugs, and Medical Devices That May be Detained

Wednesday, November 20, 2019
Sandler, Travis & Rosenberg Trade Report

Food and Drug Administration import alerts on the following have been modified in the past week

- foods containing illegal and/or undeclared colors

- fish and fishery products for importer and foreign processor combinations

- seafood and seafood products from specific manufacturers/shippers

- skin whitening creams containing mercury

- dried fungus (mushrooms) from Hong Kong and China

- aquacultured shrimp, dace, and eel from China

- low-acid canned foods or acidified foods

- products from firms refusing FDA foreign establishment inspection

- electronic products that fail to comply with performance standards or to have required certification

- cantaloupes from Mexico

[Click here for ST&R’s on-demand webinar on how to avoid costs and delays from FDA import alerts.] 

Importers of FDA-regulated goods are responsible for ensuring that such imports are in compliance with FDA laws and regulations. Before shipping into the U.S., importers should be aware of whether or not their product is listed on an import alert. 

Import alerts inform FDA field staff that the agency has enough evidence or other information to allow a product that appears to be in violation of FDA laws and regulations to be detained without physical examination at the time of entry. Import alerts may cover products from designated countries or areas (including from all foreign countries), manufacturers, or shippers. 

Firms and/or products on the “red list” of an import alert are subject to DWPE, 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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