The Foreign Supplier Verification Program (FSVP) is one of the foundational rules from the Food Safety Modernization Act (FSMA). FSVP requires a food importer to create a due diligence program to review and approve its foreign suppliers. Then the importer must take action to verify that the food was produced in a manner that provides at least the same level of protection as the U.S. requirements, is not otherwise adulterated and does not contain an undeclared major food allergen. This supplier approval program seeks to prevent food safety problems; however, an importer can violate this requirement even without any indication that the food is unsafe.
How does FDA Inspect and Enforce FSVP?
FDA will inspect an importer to verify compliance with FSVP—FDA does not preapprove an importer’s FSVP. If FDA finds the program inadequate, the Agency will usually issue a Form 483, which is the investigator’s observations of potential non-compliance. After FDA issues a Form 483, the importer can make changes and submit supporting documentation to FDA for review to avoid possible compliance issues. If an importer fails to respond or FDA finds its response inadequate, FDA may issue a Warning Letter.
A Warning Letter is a notice used by FDA that seeks to obtain voluntary compliance through the threat of an enforcement action and public shaming (FDA posts Warning Letters on its website). In the warning, FDA explains the violation(s) and provides the importer an opportunity to voluntarily fix the problem. If it fails to do so adequately, FDA may take further action to obtain compliance. For FSVP, that further action will normally be to place the importer and the applicable food on Import Alert 99-41.
An import alert is an internal directive indicating that future shipments of a listing product can be stopped by FDA and possibly refused importation. Unlike other import alerts, FDA is not likely to consider product testing as persuasive evidence to seek an import release; rather, every shipment is likely to be refused. Like Warning Letters, FDA makes its import alert listings public so that others are aware when a company is placed on the alert.
Once on an import alert, the company will remain there until they’ve created and implemented a compliant FSVP regime, which must be submitted to FDA for review. If FDA finds the changes sufficient, then it will ultimately remove the importer from Import Alert 99-41. If FDA finds the changes insufficient, then the importer must make further changes and resubmit. Note that while this is occurring, the importer is effectively banned from importing the food until the issue is resolved to FDA’s satisfaction.