Import Alerts on Foods, Drugs, and Medical Devices That May be Detained
Food and Drug Administration import alerts on the following have been modified in the past week.
- foods containing undeclared major food allergens or that fail to properly label major food allergens
- seafood products
- raw and cooked shrimp from India
- soft cheese and soft ripened cheese from France
- plastic bandages and cotton pads
- essiac and products containing essiac
- surgeon’s and patient examination gloves
- medical instruments from Pakistan
- medicated feeds containing monensin
- cosmetics that are adulterated or misbranded due to color additive violations
- food products that appear to be misbranded
- dried preserved fruits from indicated countries/areas
- fresh cilantro from the state of Puebla, Mexico
- dietary supplement products from firms that have not met dietary supplement good manufacturing practices
- papaya from Mexico
- food products containing sulfites
[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 Shelly Garg at (305) 894-1043.