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GUIDANCE DOCUMENT

Guidance for Industry: FDA's Voluntary Qualified Importer Program March 2019

Final
Docket Number:
FDA-2011-N-0144
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables the Food and Drug Administration (FDA or the Agency) to better protect public health by helping to ensure the safety and security of the food supply.

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 control includes 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 FDA’s third-party certification regulations at 21 CFR part 1, subpart M), as well as other measures that support a high level of confidence in the safety and security of the food they import.

Expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public health by allowing FDA to focus its resources on food entries that pose a higher risk to public health.

This guidance document describes FDA’s policy regarding 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.

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Translations of the Guidance Document

Translations of the Fact Sheet


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-N-0144.