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

FSVPs Needed Even for Countries with Equivalent Food Safety Systems

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.

In a recent warning letter the FDA noted that one company official expressed a belief that the company did not need to comply with the FSVP regulation because the products were imported from a country the FDA has recognized as having an equivalent food safety system to that of the U.S. However, the FDA said such imports still require an FSVP, although the company could choose to follow the modified requirements in 21 CFR 1.513, including documenting that the foreign supplier is in good compliance standing with the foreign food safety authority.

The FDA therefore determined that the importer failed to develop, maintain, and follow FSVPs with respect to imports of three unnamed products. The importer has 15 working days to provide information on the specific things it is doing to correct these violations; 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 the importer to detention without physical examination.

Import Alerts: Cosmetics, Herbal Supplements, Gloves, Seafood, Produce

FDA import alerts affecting the following have been newly issued or modified in the past week.

- cantaloupes from Mexico

- cheese from Mexico

- cosmetics from Korea

- crabmeat from Thailand

- dried apricot from Uzbekistan

- dried fish maw from China

- fresh cilantro from the state of Puebla, Mexico

- ginger candy from China

- herbals and botanicals from Australia

- herbal supplements from Turkey

- medical instruments from Pakistan

- prickle pears from Mexico

- raw and cooked shrimp from India

- surgeon’s and patient examination gloves from Thailand

- tamarind from Mexico

- tilapia from China

- tuna from Indonesia

- wheat from Algeria

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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