Increasing Enforcement of the Foreign Supplier Verification Program

1) Increasing Enforcement of the Foreign Supplier Verification Program

The FDA is increasing its enforcement of the Foreign Supplier Verification Program (FSVP) to ensure food importers comply with U.S. safety standards.

The FDA is increasing its enforcement of the Foreign Supplier Verification Program (FSVP) to ensure food importers comply with U.S. safety standards, according to Dan Solis, the assistant commissioner for import operations at the FDA’s Office of Regulatory Affairs. Many companies are still noncompliant, largely because they have not established an FSVP program, despite the legislation being in place since 2011. Solis emphasized that the FDA will heighten enforcement actions against companies without an FSVP, potentially barring imports or revoking registrations.

The FDA Food Safety Modernization Act (FSMA) of 2011 fundamentally shifted the focus of food safety in the U.S. from responding to contamination to preventing it. FSMA established new rules requiring preventive controls for food facilities that manufacture, process, pack, and hold food, along with science-based safety standards for produce grown on farms. These rules apply not only to domestic food producers but also to foreign producers exporting food to the United States.

A critical component of FSMA for the import community is the Foreign Supplier Verification Programs (FSVP) rule. This rule mandates that FSVP importers—those responsible for the food at the time of U.S. entry—ensure that imported foods meet U.S. safety standards. Importers must develop, maintain, and implement an FSVP for each food product they import, unless an exemption applies.

The purpose of the FSVP is to ensure that foreign food is produced under conditions that protect public health, align with preventive controls and produce safety regulations (where applicable), and that the food is neither adulterated nor misbranded in terms of allergen labeling.

Who is Covered by the FSVP Rule?

• The FSVP importer is defined as the U.S. owner or consignee of the food, meaning the entity that owns, has purchased, or has agreed in writing to purchase the food at the time of its entry into the U.S.
• If no U.S. owner or consignee exists at the time of entry, the FSVP importer becomes the U.S. agent or representative of the foreign owner/consignee, as designated by a signed statement of consent.

The key point is that there must be an FSVP importer located in the United States who is accountable for ensuring compliance with FSVP requirements, thereby safeguarding the integrity and safety of the food supply. More information on FSVP can be found here.