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 four importers found a number of violations, including failure to (1) approve foreign suppliers on the basis of an evaluation of their performance and the risk posed by the food, (2) provide adequate assurance that hazards requiring a control in their imported foods have been significantly minimized or prevented, (3) develop, maintain, and follow an FSVP, and (4) register food production facilities with the FDA. These violations involved imported foods such as instant drink powder, spaghetti, rice, tahini, soup starter, chestnuts, mushrooms, olive oil, artichokes, and tomato sauce.
The FDA has given these importers 15 working days to provide information on the specific things they are doing to correct these violations; e.g., documentation of changes made and records to demonstrate implementation of an FSVP. If the importers do not act promptly the FDA may take further action, such as refusing admission of violative products and subjecting the importers to detention without physical examination.
Import Alerts: Cookware, Dietary Supplements, Medical Instruments, Produce
FDA import alerts affecting the following have been newly issued or modified in the past week.
- ceramic cooking pots from Mexico
- chicken poulet tikka from Canada
- chili peppers from Dominican Republic
- dehydrated tomato powder from Germany
- dietary supplements from Mexico
- herring from Canada
- honey from Dominican Republic and Yemen
- medical instruments from Pakistan
- mushrooms from China
- pig ears from Mexico
- red snapper from Brazil
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.
Copyright © 2023 Sandler, Travis & Rosenberg, P.A.; WorldTrade Interactive, Inc. All rights reserved.