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FDA News: Foreign Supplier Program Violations, Import Alerts

Wednesday, May 20, 2020
Sandler, Travis & Rosenberg Trade Report

Foreign Supplier Program Violations

The Food and Drug Administration continues to issue warning letters to importers concerning noncompliance with requirements under the Foreign Supplier Verification Program. The FSVP 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 three separate importers found that they did not develop, maintain, and follow the required plans for (1) frozen vegetarian food and Chinese noodles, (2) tahina and canned chick peas/garbanzo beans, and (3) seaweed chips and other snacks. In addition, one importer did not evaluate its foreign supplier’s performance or perform foreign supplier verification activities.

In each case, the FDA states that within 15 working days the importer should 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 them to detention without physical examination.

For more information on the FSVP, please contact FDA consultant Domenic Veneziano at (202) 734-3939.

Import Alerts on Foods, Drugs, and Medical Devices

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

- fresh produce that appears to have been prepared, packed, or held under insanitary conditions

- seafood products

- human and animal foods imported from foreign suppliers by importers not in compliance with the requirements of the FSVP regulation

- food products that appear to be misbranded

- foods containing illegal and/or undeclared colors

- fresh cilantro from the state of Puebla, Mexico

- foods containing undeclared major allergens or that fail to properly label major food allergens

- medical instruments from Pakistan

- raw and cooked shrimp from India

For more information on import alerts and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939.

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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