© [2020], Sandler, Travis & Rosenberg, P.A. Originally published in the [07/29/2020] issue of the Sandler, Travis & Rosenberg Trade Report. Reprinted by permission.

Application Period for Importer Program Expiring Soon

Importers have until July 31 to submit to the Food and Drug Administration their notices of intent to participate and completed applications for the Voluntary Qualified Importer Program for the fiscal year 2020 benefit period.

VQIP is a voluntary fee-based program that provides expedited review and importation of human and animal foods for approved applicants who achieve and maintain a high level of control over the safety and security of their supply chains. To participate, importers must meet certain eligibility requirements, which include ensuring that the facilities of their foreign suppliers are certified under the accredited third-party certification program.

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 did not (1) develop, maintain, and follow the required plans for canned black beans, canned red beans, canned fruit, fish snack foods, and custard cake, (2) verify and document that curry gravy, a low-acid canned food, was produced in accordance with the applicable regulations, (3) document its approval of foreign suppliers of curry gravy and tom yum soup paste, (4) establish and follow written procedures to ensure it imports foods only from foreign suppliers it has approved based on an evaluation of the supplier’s performance and the risk posed by the food, (5) establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the foods it imports, and (6) conduct and document one or more of the specified supplier verification activities for each foreign supplier before importing the food and periodically thereafter.

FDA inspections of another importer found that it did not develop, maintain, and follow an FSVP for canned coconut milk and aloe vera drink pomegranate products.

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 Domenic Veneziano at (202) 734-3939.

Medical Instruments, Avocado Among Items on FDA Import Alerts

Food and Drug Administration import alerts on the following have been modified in the past week.

– drugs (based on analytic test results)

– food products that appear to be misbranded

– seafood products (due to salmonella)

– processed seafood and analogue seafood (surimi) products

– products from firms refusing FDA foreign establishment inspection

– medical instruments from Pakistan

– frozen and refrigerated guacamole and processed avocado products

– cheese (due to microbiological contamination)

– cantaloupes from Mexico

For more information on import alerts and other FDA issues, please contact 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.