The FDA has released final industry guidance to support compliance with its Voluntary Qualified Importer Program.

  • The Food Safety Modernization Act (FSMA) (Pub. L. 111-353) required FDA to establish a voluntary, fee-based program called the Voluntary Qualified Importer Program.  This program aims to facilitate the expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains. This control includes: (1) importation of food from facilities that have been certified in accordance with FDA’s program for Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (see previous blog coverage on FDA’s final rule concerning the Accreditation of Third-Party Certification Bodies here) and (2) other measures that support a high level of confidence in the safety and security of the food they import.  The Agency thinking here is that expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public health by permitting FDA to focus its resources on food entries that pose a higher risk to public health.
  • Today, FDA released final guidance for industry to support compliance with its Voluntary Qualified Importer Program. The final guidance, set forth in question-and-answer format, explains how this program will work. In brief, this guidance document addresses:
    • The benefits VQIP importers can expect to receive;
    • The eligibility criteria for VQIP participation;
    • Instructions for completing a VQIP application;
    • Conditions that may result in revocation of participation in VQIP; and
    • Criteria for VQIP reinstatement following revocation.
  • An FDA Fact Sheet on the Final Guidance is also available here.  The release of this final guidance represents the latest in a slew of FSMA related guidance documents issued by FDA over the past several weeks.