The team at FDAImports.com successfully persuaded FDA to return an exporter to the Green List for Import Alert 16-131 (Detention Without Physical Examination of Aquacultured Catfish, Basa, Shrimp, Dace, and Eel from China- Presence of New Animal Drugs and/or Unsafe Food Additives). This import alert is a countrywide alert against aquaculture from China.
Unless on the Green List, FDA will automatically detain imported product from a supplier and require the importer to test the product to confirm that it does not contain unapproved animal drug residues. Unlike most other countrywide alerts, FDA will not put a company on the Green List unless its facility has been inspected by an “appropriate third-party.”
One major problem: FDA does not recognize any appropriate third party. Only an FDA inspection will do. If the facility is not one of the very few foreign food facilities that FDA happens to inspect, then ordinarily it has no chance of being placed on the Green List. This is true even for a foreign manufacturer that has a long history of exporting compliant product.
Our team of affiliated attorneys, including Benjamin L. England and John F. Johnson III, filed an import alert petition seeking removal of one of its Chinese aquaculture shrimp processing clients. FDA denied the petition and FDAImports.com thought FDA’s denial was illegal. England and Johnson challenged FDA’s denial to the point of filing a lawsuit in court against FDA with the help of trial litigator Daniel Jarcho. As a result, FDA placed our client onto the Green List, exempting them from Import Alert 16-131, without ever needing to take the case to court. FDA ultimately agreed our client was an exporter of safe, unadulterated aquaculture shrimp and placed them on the Green List for Import Alert 16-131.
FDA Import Alerts are never permanent and sometimes they are illegal. If your company is on Import Alert, contact us to review your case!
