FSVP and VQIP Update: Important Information for Importers

Posted in Regulatory Compliance, FDA & USDA Inspections

Are you ready for your first FSVP inspection?

The food industry is one of the most rapidly globalizing industries.  Competitive companies must increasingly rely upon international suppliers of ingredients.  Simultaneously, companies are responsible for ensuring that their suppliers are FSMA compliant.  

This creates tension between the need to remain competitive with the difficulties of ensuring products manufactured outside of the United States are safe.  To address this tension, FSMA is designed to ensure parity of food safety oversight between all food companies, foreign and domestic.  Because FDA lacks direct overseas jurisdiction over foreign food companies, achieving parity between foreign and domestic food companies requires FDA to employ a different set of tools and programs.  Taking advantage of those programs will likely prove advantageous for companies in terms of both food safety and profitability.  

Yesterday, we heard from Dr. Donald Prater, FDA’s Assistant Commissioner for Food Safety Integration and Veterinary Medicine on the topic of imported food.  As Dr. Prater explained, the FDA’s vision regarding imports has undergone a significant paradigm shift under FSMA.  Rather than focusing primarily on the interdiction of noncompliant imports, FDA has shifted its focus further upstream to increase confidence that imported food is safe when it arrives.  

FDA has begun enforcing is Foreign Supplier Verification Plan (FSVP) requirements in earnest. For each foreign supplier and imported product, FDA will expect to see, among other things, a hazard analysis, supplier evaluation and approval, verification activities and corrective actions to be followed in the event of a deviation.  In 2017, FDA conducted a total of 285 FSVP inspections.  While FDA issued a total of 174 483a forms (for noncompliant FSVPs), the agency did not issue any Warning Letters.  This year, FDA is on pace to complete close to 500 FSVP inspections.  

Common failures noted by FDA during inspections include the failure to have a FSVP altogether, the failure to document the review and assessment of a foreign suppliers’ food hazard analysis and preventive controls, the failure to have the “approval” of foreign suppliers documented, and the failure to have any documented verification activities.  Given the increasing pace of FDA FSVP inspections, if you have not already been contacted by the agency requesting to see your FSVP, you should anticipate and start preparing for an FSVP inspection in 2019.

While the maintenance of a FSVP program can be tedious and time consuming for many FSMA importers, FDA has some additional programs that can ease the burden.  FDA’s Voluntary Qualified Importer Program (VQIP), for instance, is now seeing implementation.  VQIP is a voluntary program that offers expedited review of imported food products.  Participation, however, is limited to importers who meet all the eligibility criteria, including the use of foreign suppliers that are certified under FDA’s accredited third-party program.  After some minor setbacks, the program is close to full implementation.  By all indications, FDA will be releasing additional materials and information pertinent to importation in the coming days or weeks.  

Companies that participate in programs like VQIP, provided they are diligent in monitoring supplier compliance, may enjoy significant upside.  In addition to increased confidence in foreign suppliers from a food safety standpoint, participants will also enjoy additional import efficiencies and speed, along with reduced regulatory scrutiny as compared to importers whose suppliers are not certified under FDA’s accredited third-party program.  

We will keep you posted with additional updates as they arrive.