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 four importers found that they did not develop, maintain, and follow the required plans for refined rice bran oil, grape seed oil, organic high oleic sunflower oil, roasted eggplant product, dried sumac and tahini products, roasted onion granules, roasted garlic granules, coarse black pepper, and enoki mushrooms.

Other violations noted for one or more importers included the following.

- claiming to be a very small importer but not providing documentation supporting that claim or demonstrating compliance with the FSVP requirements for small importers

- failing to register as a facility that manufacturers, processes, packs, or holds foods

- failing to provide documentation that the importer had reviewed and assessed its foreign supplier’s hazard analysis

- failing to establish and follow adequate written procedures to ensure only foods from approved foreign suppliers are imported

- failing to conduct and document one or more supplier verification activities for each foreign supplier before importing food from them

- failing to consider applicable food safety regulations during an onsite audit of the foreign supplier

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.

Face Masks, Hand Sanitizer, Disinfectants Among Items on Import Alerts

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

- soaps and detergents, antibiotics, disinfectants, hand sanitizer, skin care preparations, etc.

- medicated feeds containing monensin

- hard and soft candies containing chili pepper

- tamarind products (fresh and/or processed) from all shippers from all countries

- foods contaminated with heavy metals

- medical instruments from Pakistan

- low-acid canned foods or acidified foods

- cosmetics that are adulterated or misbranded due to color additive violations

- filtering facepiece respirators

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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