Foreign Supplier Verification Program (FSVP) Services

The Foreign Supplier Verification Program (FSVP) requirements are detailed in 21 CFR 1, Subpart L.   As part of the Food Safety Modernization Act (FSMA), the regulation dictates that importers of human or animal food must establish FSVP plans to ensure that each food they import into the United States meets applicable U.S. requirements and is not adulterated or (for human food) misbranded with respect to allergen labeling.

Any U.S.-based owner or consignee of food imported to the US and intended for human or animal consumption must comply with FSVP requirements. It is important to note that FDA considers dietary supplements and supplement ingredients a subset of food.

The FSVP importer (US owner or consignee) must be located in the United States at the time of entry. An FSVP importer could be a person who resides in the United States or maintains a place of business in the United States. However, it would not be sufficient to merely have a mailbox or answering service.

U.S. owner or consignee means the person in the United States who, at the time of entry of the food into the United States, either owns the food, has purchased the food, or has agreed in writing to purchase the food.

The FSVP importer may be, but is not necessarily, the importer of record. Under the FSVP regulation, the FSVP importer is the person who is responsible for verifying that the imported food was produced in accordance with applicable U.S. food safety requirements. In contrast, the Importer of Record might be an express consignment operator with little to no knowledge of the safety regulations applicable to the products for which they obtain clearance from CBP for informal entries.

The foreign supplier of a food is the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature.

De minimis manufacturing/processing does not involve direct manipulation of food. An example is adding labels to a manufactured/processed food without directly manipulating the food.

The FSVP regulation does not apply to food you import for research or evaluation use, provided that:

• The food is not intended for retail sale and is not sold or distributed to the public;
• The food is labeled with the statement, “Food for research or evaluation use;”
• The food is imported in a small quantity that is consistent with a research, analysis, or quality assurance purpose, the food is used only for this purpose, and any unused quantity is properly disposed of; and
• When filing entry for the food with CBP, the food is accompanied by an electronic declaration that the food will be used for research or evaluation purposes and will not be sold or distributed to the public.

A qualified individual is a person who has the education, training, or experience (or a combination of these) necessary to perform an activity required under the FSVP regulation and can read and understand the language of any records that the person must review in performing this activity.

The FSVP Agent is a 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. The FSVP agent is the FSVP importer of the food and, thus, is responsible for meeting the FSVP requirements. 

An FSVP qualified individual (QI) is a person who represents the FSVP Importer and who conducts the FSVP activities. The FSVP QI has the education, training, or experience (or a combination of these) necessary to perform an activity required under the FSVP regulation and can read and understand the language of any records that the person must review in performing this activity.

• Taken courses or attended educational seminars that addressed the principles of hazard analysis,
• Taken science-related courses that provide information about specific hazards (e.g., microbiology courses that provide information on pathogens),
• Experience conducting hazard analyses, or
• A combination of these qualifications.

No, the FDA requirements for US Agent are not the same as those for FSVP Agent.

Yes, we can provide FSVP QI services on behalf of the FSVP Importer.

No, we cannot act as your FSVP Agent.

We provide on-site and live virtual facility assessment, mock FDA inspections, food safety / HACCP plan development, and regulatory strategy to ensure compliance before shipment to the U.S. Additional support includes label compliance reviews, US Agent, facility registrations, as well as assistance with resolving FDA detentions and import alerts.

Yes — our FDA-recognized FSVP Lead Instructors provide tailored on-site and virtual training for importers and suppliers.