Food and Drug Administration import alerts on the following have been modified in the past week.
- raw and cooked shrimp from India
- unapproved new animal drugs
- surgeon’s and patient examination gloves
- penis enlargers and erection maintaining rings
- foods containing illegal and/or undeclared colors
- uneviscerated or partially eviscerated fish
- fish/fishery products from foreign processors not in compliance with seafood HACCP
- unlicensed botulinum toxin productsproducts marketed as foods, including as dietary supplements, that contain an active pharmaceutical ingredient
- finished dosage drug products, active pharmaceutical ingredients, and inactive ingredients
- different forms of heparin and heparin-related products
- immune-augmentative therapy
- raw agricultural products
- dentifrice products containing diethylene glycol
- misbranded drugs and marketed new drugs without approved applications
- essiac and products containing essiac
- chlorhexidine gluconate oral rinse
- steroid alternatives
- foreign manufactured unapproved versions of clozapine
- polidocanol finished dosage form products and active pharmaceutical ingredients from all sources under all brand names
- redotex and other diet pills from Mexico
- 714x cancer/AIDS serum
- germanium products
- bulk/finished dietary supplements containing aristolochic acid
[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 consultant Shelly Garg at (305) 894-1043.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on May 1, 2019.