Import Alerts: Medical Instruments, Pet Chews, Honey, Seafood

Food and Drug Administration import alerts affecting the following have been newly issued or modified in the past week.

– blood glucose monitors from China

– dietary supplements from Thailand

– fresh radish from Mexico

– frozen canned lobster meat from Canada

– glucosylated steviol glycoside 80 products from China

– honey from Türkiye

– medical scopes from Japan

– medical devices from India

– medical instruments from Pakistan

– noodles from India

– pet chews from Poland

– red raisins from Afghanistan

– shrimp from Indonesia

– spinach from Afghanistan

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.

For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.