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Understanding FDA's FSVP Rule (Foreign Supplier Verification Program)

Many of you may have heard that FDA is starting to implement a new program called Foreign Supplier Verification Program (FSVP).

According to the FDA, 15 percent of the U.S. food supply is imported, including nearly 50 percent of fresh fruit and 20 percent of fresh vegetables, and 80 pecent of seafood. FSVP is being implemented to ensure that the same preventive food safety standards apply to food consumed in the U.S., whether the food is imported or not. It requires that importers perform varying levels of risk-based activities to verify that food imported into the U.S. has been handled in a manner that meets applicable U.S. safety standards.

Who will be affected?

All U.S. owner or consignee of food and dietary supplement offered for import will be affected. If there is no U.S. owner or consignee at time of entry, it will be the U.S. agent/representative of the foreign owner/consignee, as confirmed in a signed statement of consent.

Are there any exemptions?

  • Juice and seafood from foreign suppliers in compliance with HACCP

  • Small quantities of food imported for research and evaluation purposes

  • Small quantities of food imported for personal consumption

  • LACF products are exempt with respect to microbiological hazards

  • Certain alcoholic beverages

  • American food returned

  • Certain meat, poultry, and egg products

Who will subject to modified (more flexible) FSVP requirements?

  • Dietary supplements that are subject to separate, pre-existing CGMPs

  • Small business (importer and/or supplier)

  • Importation from a foreign supplier in good compliance standing with a food safety System that FDA has officially recognized as comparable or equivalent to that of the United States

What shall I do to comply with FSVP?

Importers subject to modified requirements may need to perform the following activities:

  • Annual written assurance from foreign suppliers that they minimize or prevent any identified hazards

  • Identify the FSVP importer and appoint a qualified individual and a qualified auditor

  • Maintain records for at least 2 years

Importers subject to standard FSVP requirements may need to perform the following activities:

  • Use a qualified individual to develop an FSVP and to perform FSVP activities