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FDA Issues Final Guidance on VQIP

FDA today announced the availability of its finalized “FDA’s Voluntary Qualified Importer Program: Guidance for Industry.”  It also published a Fact Sheet on the Final Guidance, as well as Instructions for Submission of Voluntary Qualified Importer Program (VQIP) Application.

The FDA Food Safety Modernization Act (FSMA), signed into law in January 2011, provided FDA with new authorities to ensure that foods imported into the United States meet the same safety standards as those set for domestically produced foods.   In addition to establishing mandatory standards for importers of food under the Foreign Supplier Verification Program (FSVP), FSMA added section 806 to the FD&C Act (21 U.S.C. § 384b), which required FDA to establish a VQIP for importers who achieve and maintain a high level of control over the safety and security of their supply chains.  This control includes importation of food from facilities that have been certified as following appropriate food safety practices under FDA’s Accredited Third-Party Certification regulations, also required by FSMA.

Benefits of participating in the VQIP include:

  • FDA will expedite entry into the U.S. for all foods included in an approved VQIP application.
  • This means that FDA will set up its import screening system to recognize shipments of food that are the subject of an approved VQIP application and, in most cases, immediately release the shipment after the receipt of entry information.
  • FDA will limit examination and/or sampling of VQIP food entries to “for cause” situations in which there is a potential threat to public health, to obtain statistically necessary risk-based microbiological samples, and to audit VQIP.
  • In the event that FDA examines or samples a VQIP food, the location of such sampling or examination would, to the extent possible, be at the VQIP food’s destination or another location chosen by the importer.
  • In the event that FDA samples a VQIP food, laboratory analysis of such samples would be expedited.
  • The FDA will establish a VQIP Importers Help Desk dedicated to responding to questions and concerns from VQIP importers.  The Help Desk will be available for assistance with completing the VQIP application, facilitating a review of VQIP food that does not receive an immediate release, and answering other questions from VQIP importers related to the program.

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