Draft Guidance for Industry on the Voluntary Qualified Importer Program for Food Importers

The Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry on the Voluntary Qualified Importer Program (VQIP) for importers of human or animal food.

What do Importers need  to know about the Voluntary Qualified Importer Program (VQIP)?

  • It enables FDA to better protect public health by helping to ensure the safety and security of the food supply.
  • It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.
  • Under FDA Food Safety Modernization Act, those that import food have a responsibility to ensure that their suppliers produce food that meets U.S. safety standards.
  • FSMA also requires FDA to establish a voluntary, fee-based program for 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 guidance document describes FDA ’s policy regarding requests for participation in FDA’s Voluntary Qualified Importer Program (VQIP) by importers of food for humans or animals.

This document provides guidance on:

  • 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


So Why Participate to the VQIP?

Importers participating in VQIP will receive the following benefits:

  • FDA will expedite entry into the United States for all foods included in an approved VQIP application (VQIP foods)
  • FDA will set screening in its Predictive Risk based Evaluation for Dynamic Import Compliance Targeting (PREDICT) import screening system to recognize shipments of food which are the subject of an approved VQIP application to expedite the entry of such food.The system is designed to recognize the information and immediately release the shipment, unless examination and sampling are necessary for public health reasons.
  • FDA will limit examination and/or sampling of VQIP food entries to “for cause” situations (i.e., when the food is or may be associated with a risk to the public health), to obtain statistically necessary risk based microbiological samples,and to audit VQIP.
  • In the examination and/or sampling circumstances identified in the previous bullet,FDA will examine an entry and collect samples at the VQIP food destination or other location preferred by the VQIP importer. If exportation is warranted, FDA will assist in fulfilling an importer’s request to U.S. Customs and Border Protection (CBP) to export from the port preferred by the importer.
  • FDA will expedite its laboratory analysis of “for cause” or audit samples of VQIP entries, to the extent possible in accordance with public health priorities.
  • FDA will maintain a VQIP Importers Help Desk dedicated to responding to questions and resolving issues raised by VQIP importers about VQIP food and this guidance document
  • FDA will post a publicly available list of approved VQIP importers on FDA’s VQIP Web page.  VQIP importers may choose not to be listed on the VQIP importers list.

Estimated Fees:

FDA estimates, at this time, that the annual fee would be approximately $16,400, if an equal fee were assessed on each of 200 participants. This number is only a preliminary estimate and intended to provide small businesses with an estimate of what the program might cost so that they can comment on any burden the fee might impose. After considering all comments on these guidelines, we will publish the actual fee in a Federal Register notice published in accordance with section 743(b)(1) of the FD&C Act prior to the fiscal year when we begin program benefits.

There is no requirement for an importer to pay a fee unless the importer decides to participate in the program.

Please click the link to read FDA’s Voluntary Qualified Importer Program Draft Guidance to the Industry:


The Federal register: