Import Alerts on Foods, Drugs, and Medical Devices That May be Detained: Week of January 20

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

  • low-acid canned foods or acidified foods
  • medical instruments from Pakistan
  • refrigerated (not frozen) raw fish and fishery products in reduced oxygen packaging
  • food products that appear to be misbranded
  • different forms of heparin and heparin-related products
  • pig ears and other pet treats

For more information on import alerts and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939.

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 th

This article was originally published in the Sandler, Travis & Rosenberg Trade Report on January 22, 2020.

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