Foreign Food Importers Beware: The FDA is Taking Enforcement Action For Noncompliance with the Foreign Supplier Verification Program Rule

The Foreign Supplier Verification Program (FSVP) as published by the Food and Drug Administration (FDA) in November 2015 requires that importers or their agents ensure foreign food suppliers meet the same food safety standards required of domestic food manufacturers. For the purpose of the FSVP, an importer is a U.S. owner or consignee of food imported into the U.S. This means that restaurants, grocery stores, food distribution companies, and the like may be subject to the FSVP if they are purchasing directly from foreign suppliers.

In general, the FSVP requires importers to implement safety measures to ensure that foreign suppliers produce food in compliance with applicable food safety provisions. The key requirements importers must follow are as follows:

  • Conduct a hazard risk analysis for each type of food to determine whether the product presents any biological, chemical, or physical hazards that require a control;
  • Use the hazard analysis to evaluate the risk posed by the food and determine whether the foreign supplier’s performance is adequate to control the risk and comply with FDA food safety requirements;
  • Establish and execute supplier verification activities sufficient to validate that foreign suppliers are producing food consistent with FDA requirements for known and reasonably foreseeable food risks, which may include audits of a foreign supplier’s facility, food testing, or review of a supplier’s food safety records; and
  • Conduct corrective action if a foreign supplier has used inappropriate processes and procedures or produces food that is adulterated or misbranded with respect to allergen labeling.

On August 13, 2019, the FDA announced that it issued its first warning letter to a U.S. food importer under the FSVP. Brodt Zenatti Holdings, LLC in Jupiter, Florida received an FDA warning letter in July after the FDA conducted a FSVP facility inspection due to the company’s tahini being implicated in a Salmonella outbreak and recall. The FDA found that the company failed to develop a verification program for the tahini as required by law. The company is required to demonstrate its plans to correct the violations to avoid being listed on an import alert board.

The FDA has been and will continue to inspect importer facilities as enforcement of the FVSP becomes more stringent. It is critical for all food businesses to stay up to date with food safety laws. If you operate a food business or are looking to start your business, be sure to contact our office.

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