FDA Releases Draft Guidance on Voluntary Qualified Importer Program.

  • Under the FDA Food Safety Modernization Act (FSMA), FDA is required to establish a voluntary, fee-based program for the 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.
  • On June 5, 2015, FDA released Draft Guidance for industry on the Voluntary Qualified Importer Program (VQIP) for importers of human and animal food. The draft guidance outlines FDA’s planned implementation of the VQIP via a series of questions and answers addressing the benefits and eligibility criteria for participation, instructions on how to complete a VQIP application, conditions that may result in revocation of VQIP participation, and criteria for reinstatement following revocation. For the first year, FDA is estimating that a flat annual fee of approximately $16,400 will be paid by all VQIP participants.
  • Because VQIP participation hinges on certifications that must be issued by FDA-accredited third-party auditors/certification bodies, the VQIP program will not go into effect until after FDA’s third-party accreditation program is operational. FDA’s final rule to implement the third-party accreditation requirements is anticipated in November 2015.  At this point, importers should consult the Draft Guidance to develop a sense of how FDA envisions the role and operation of the VQIP.