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 one importer found that it violated the FSVP regulations with respect to imported pineapple syrup, honey syrup, and red beans by failing to do the following.

- provide documentation that it reviewed and assessed its foreign supplier’s hazard analysis

- provide documentation that it had reviewed and assessed a third-party evaluation of the foreign supplier and that the evaluation was conducted by a qualified individual

- establish and follow written procedures to ensure it imports foods only from approved foreign suppliers

- establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted on its imported foods

- verifying and documenting that thermally-processed low-acid foods packaged in hermetically sealed containers were produced in accordance with applicable regulations

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 the importer to detention without physical examination.

Import Alerts: Pet Chews, Laser Markers, Medical Instruments, Candy

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

- arrow root from China

- dried fish skin jerky pet chews from Iceland

- laetrile (amygdalin)

- laser markers and engravers from China

- medical instruments from Pakistan

- shark cartilage soft capsules from China

- soft candy from Japan

- sweet basil from Mexico

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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