January 24, 2020

Food Manufacturers: Compliance with FSMA’s Foreign Supplier Verification Program Must Include Specific Requirements

Foreign Supplier Verification Program (FSVP) compliance for food, animal feed and dietary supplement manufacturers must be tailored to the specific requirements of the program to avoid provoking the ire of the Food and Drug Administration (FDA).

FSVP compliance has been a focus of FDA since the start of the new year. Since January 1, 2020, the agency has issued at least three warning letters focused specifically on failure to comply with the FSVP requirements. The final FSVP regulation was issued in November 2015 and most food importers are required to be compliant with FSVP regulations.

The warning letters stemmed from inspections FDA conducted of facilities for the sole purpose of determining their FSVP compliance status. Although failure to have an FSVP policy was commonly cited in the letters, FDA noted that one company’s newly created program meant to correct findings in a 483 issued to the company was too general and was not specific to the supplier, ingredient or product. Indeed, FDA “note[d] that the guidelines [the company] provided are very general and do not reflect all of the requirements in the FSVP rule.”

Based on the regulations, along with FDA’s draft guidance, manufacturers must tailor their FSVP programs on specific requirements and there must be a plan developed for each imported food product. The FSVP regulation and its guidance documents provide a number of routes for companies to tailor their FSVP policies to their own circumstances under the requirements regarding:

  • Training and responsibilities of qualified individuals conducting a company’s FSVP program
  • Hazard analysis
  • Food and supplier evaluation
  • Foreign supplier verification
  • Corrective actions
  • Record keeping
  • Importer identification

For the most part, FDA is no longer exercising regulatory enforcement discretion, and will continue to focus on compliance with FSVP and evaluate adequacy of these programs. The agency did note in November 2019 that it intends to exercise enforcement discretion for certain situations involving contract manufacturing relationships where FSVP regulations may conflict with contractual commitments between a manufacturer and the brand owner. Food companies should consider these warning letters as they move forward with FSVP implementation.

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