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

Wednesday, June 19, 2019
Sandler, Travis & Rosenberg Trade Report

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

- products from firms refusing FDA foreign establishment inspection

- drugs from firms that have not met drug good manufacturing practices

- produce contaminated with human pathogens

- processed foods and raw agricultural products for pesticides

- papaya from Mexico

- medical instruments from Pakistan

- raw and cooked shrimp from India

- foods containing illegal and/or undeclared colors

- apple juice and other juice

- food and seafood products due to the presence of Salmonella

- fish and fishery products for importer and foreign processor combinations

- low-acid canned foods or acidified foods

- food products that appear to be misbranded

- spices and spice products

- fresh produce that appears to have been prepared, packed, or held under insanitary conditions

- dairy products manufactured under insanitary conditions

- devices from firms that have not met device quality system requirements

- surgeon’s and patient examination gloves

- pig ears and other pet treats

- unapproved new drugs promoted in the U.S.

- cosmetics that are adulterated and/or misbranded due to color additive violations

- tamarind products (fresh and/or processed)

- uneviscerated fish or partially eviscerated fish that are either salt-cured, dried, smoked, pickled, fermented, or brined

- processed seafood and analogue seafood (surimi) products

- foods containing undeclared major food allergens or foods that fail to properly label major food allergens

- bulk dietary ingredients that are or contain Mitragyna speciosa or Kratom

- candy with excessive lead levels

[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 to overcome the appearance of the violation, the product will be subject to refusal of entry into the U.S.

For more information on FDA import alerts, including how to get a product removed from an import alert, please contact trade attorney Shelly Garg at (305) 894-1043.

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