FDA News: Foreign Supplier Program Violation, Import Alerts: Week of April 20

Foreign Supplier Program Violation

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.

In the latest case, two FDA inspections of an importer’s facility found that the importer did not develop, maintain, and follow the required plans for strawberry filling, pineapple filling, and multicolor sprinkles manufactured in Mexico. 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 the violative products and subjecting them to detention without physical examination.

Import Alerts on Foods, Drugs, and Medical Devices That May be Detained

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

  • electronic products that fail to comply with performance standards or to have required certification
  • laser pointers, laser gunsights, laser levels, laser light shows, laser pointer key chains, and similar products
  • foods containing illegal and/or undeclared colors
  • dried peppers from Mexico
  • papaya from Mexico
  • fish/fishery products from foreign processors not in compliance with seafood HACCP
  • mahi mahi
  • fresh cilantro from the state of Puebla, Mexico
  • cosmetics
  • frozen and refrigerated guacamole and processed avocado products
  • ackees
  • electronic nicotine delivery systems lacking premarket authorization

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.

This article was originally published in the Sandler, Travis & Rosenberg Trade Report on April 22, 2020.

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