Food and beverage companies must comply with foreign supplier verification to avoid penalties

Recently, the U.S. Food and Drug Administration is taking a closer look at whether food, beverage, and dietary supplement companies are compliant with the Foreign Supplier Verification Program (FSVP). What must companies do to prepare for scrutiny and avoid penalties?

Compliance background

The final rule of the FDA’s Food Safety Modernization Act (FSMA), the FSVP for importers of food for humans and animals, became effective on Jan. 26, 2016, with compliance dates commencing in 2018. This rule applies to human foods, pet foods, dietary supplements, and primary food packaging materials (i.e., materials where the food touches directly). Specifically, FSMA requires all applicable importers to perform certain “risk-based foreign supplier verification activities” to verify that imported food and primary packing materials are produced in a manner that meets U.S. food safety standards.

The FSVP requires importers covered by the rule to have a program to verify that foreign suppliers are producing food in a manner that provides the same level of public health protection as the FDA requires. The FSVP additionally ensures that the food is not adulterated or misbranded with respect to allergen labeling by the supplier. Food importers must ensure that they only import from foreign suppliers approved based on a risk analysis. Importers must perform the following actions:

• Determine reasonably foreseeable or known hazards for each food they import
• Evaluate the risk posed by food, based on the hazard analysis, and the foreign supplier’s performance
• Use the evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities
• Conduct supplier verification activities
• Conduct corrective actions

FDA enforcement

Enforcement of this rule began in 2020. When initially auditing importers, the FDA took the approach of educating, rather than penalizing, non-compliant importers. However, over the last two years, there has been an increase in audits as well as a shift to enforcement. More than 60 companies have been added to the import alert list for failure to comply with FSVP program requirements. This effectively means that those companies may no longer import food products specified in the import alert until they rectify their compliance deficiencies.

The consequences of noncompliance may result in the following:

• Issuance of observation form
• Shipment detention
• Unexpected storage and product testing costs
• Warning letter to importer or foreign facility
• Import alert (ban on importer or on foreign facility or food products)
• Import refusal (i.e., denial of entry by U.S. Customs)
• Product recall
• Product destruction