Background

For more information on these and other Food and Drug Administration issues, please contact Domenic Veneziano at (202) 734-3939.

Foreign Supplier Program Violations

The FDA continues to issue warning letters to importers concerning noncompliance with requirements under the Foreign Supplier Verification Program, which requires importers to perform certain risk-based activities to verify that the human and/or animal food they import has been produced in a manner that meets applicable U.S. food safety standards.

Most recently, FDA inspections of the facilities of one importer found that it did not develop, maintain, and follow the required plans for crushed chili and sesame. The FDA states that within 15 working days this importer should provide information on the specific things it is doing to correct this violation; e.g., documentation of changes made and records to demonstrate implementation of an FSVP. If the importer does not act promptly the FDA may take further action, such as refusing admission of violative products and subjecting them to detention without physical examination.

Dietary Supplements, Canned Foods, Medical Instruments Among Modified Import Alerts

FDA import alerts on the following have been modified in the past week.

- seafood and seafood products from specific manufacturers/shippers

- products marketed as foods, including as dietary supplements, that contain an active pharmaceutical ingredient

- low-acid canned foods or acidified foods

- dried fungus (mushrooms) from Hong Kong and China

- medical instruments from Pakistan

- refrigerated (not frozen) raw fish and fishery products in reduced oxygen packaging

- human and animal foods imported by importers not in compliance with FSVP requirements

- foods containing illegal and/or undeclared colors

- shrimp

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, the product will be subject to refusal of entry into the U.S.

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