FSVP Related Warning Letters For Food Importers On The Rise

We have seen a recent increase in food businesses across the U.S being warned by the FDA for Foreign Supplier Verification Program (FSVP) related issues. The FSVP program, enacted by the FDA in 2016, requires businesses importing food for human and animal consumption to verify that their foreign suppliers meet applicable FDA safety standards.

Is your business required to register for the FSVP program?

The FSVP rule covers importers of food (animal & human). Under the rule, an importer is the U.S. owner or consignee of a food offered for import into the United States. Do you qualify as importer?

    • If you are the U.S. owner or consignee of a food offered for import into the United States, you are considered an importer under FSVP regulations.
    • If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent.

If you meet the definition of importer, you are responsible for performing the following process:

    • Hazard Analysis
    • Evaluation of Food Risk and Supplier Performance
    • Supplier Verification
    • Corrective Actions
    • Exemptions and Modified Standards
    • Unique Facility Identifier*

*The final FSVP rule requires that an importer provide its name, electronic mail address, and unique facility identifier (UFI) recognized as acceptable by the FDA for each line entry of food product offered for importation into the United States. The FDA has recognized the Data Universal Numbering System (DUNS) number as an acceptable UFI for FSVP.

Bustos Law Group is an FDA regulatory compliance law firm. If you have questions or need assistance with the Foreign Supplier Verification Program, please go to www.bustoslawgroup.com and book a free consultation with one of our regulatory attorneys.