Before the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) was largely responsible for ensuring that companies exporting food to the United States were complying with U.S. food safety regulations.  For the most part, importers of these food products went unregulated in terms of food safety. FSMA introduced the Foreign Supplier Verification Program (FSVP) rule, which placed new responsibility on the person who owns the food upon entry to the United States.  Now U.S. food importers must develop FSVPs for each product that they own at the time of entry.

Under the FSVP rule, Customs Brokers now must identify an “FSVP importer” for covered shipments when filing entries. This listed FSVP importer is the entity responsible for FSVP compliance and whom FDA will inspect in the case of a routine FSVP inspection or when a food safety concern arises.

Many importers have asked Registrar Corp if they can require their foreign suppliers to designate and list a different FSVP importer, as FSVP compliance can be complicated and time consuming. FDA defines the FSVP importer as “the U.S. owner or consignee of an article of food that is being offered for import into the United States.” Furthermore, FDA defines the U.S. owner or consignee as “the person in the United States who, at the time of entry of an article of food into the United States, either owns the food, has purchased the food, or has agreed in writing to purchase the food” (21 CFR1.500).  The exporting facility may not designate a different FSVP importer, nor may the importer refuse to be listed as the FSVP importer if they meet FDA’s definition.

Exceptions

According to FDA, “if there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the FSVP importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under the FSVP regulation.” When this is the case, the exporter must designate an FSVP importer, also referred to by some as an FSVP Agent. There are also cases where multiple entities meet the definition of FSVP importer for the same food and supplier; when this happens, one of the entities can act as FSVP importer on behalf of the others if they’ve agreed to do so as confirmed in a signed statement of consent.

Additionally, some imported products are exempt from the FSVP rule. For example, products not intended for sale or distribution in the United States are not usually subject to the FSVP regulation. These include products intended for personal consumption, research or evaluation, and food for processing and export. Alcohol, seafood, juice, meat, poultry, and egg products subject to USDA are also exempt and do not require an FSVP importer.

Nevertheless, most food products entering the U.S. do require an FSVP importer, and those who meet the definition should make sure to familiarize themselves with the relevant regulatory requirements.

What is Required of an FSVP Importer?

An FSVP importer is responsible for developing FSVPs in which they evaluate and regularly verify their foreign supplier’s compliance with the applicable FDA food safety regulations. They must have an FSVP for each product they import per foreign supplier. FSVPs serve to provide assurances that the food imported was produced in compliance with FDA food safety standards and that it will not present a risk to the health of citizens in the U.S.

The importer is responsible for determining foreseeable hazards associated with the type of food, evaluating the risk it poses, verifying that the foreign supplier’s processes and practices meet  FDA standards, evaluating the foreign supplier’s compliance history with FDA, ensuring product labels properly list the major allergens, as applicable, and conducting corrective actions when problems are found.

Importers that are not developing and implementing FSVPs for their products are subject to repercussions that can have a lasting impact on their brand and finances but most importantly their consumers’ health. FDA issues Warning Letters, Import Alerts, and other regulatory action against U.S. Importers that fail to comply with FSVP. This action may also extend against the foreign supplier if the U.S. importer’s FDA inspection reveals they are not producing food in accordance with the applicable FDA standards.