Draft Guidance for Industry: FDA's Voluntary Qualified Importer Program

Contains Nonbinding Recommendations
Draft–Not for Implementation

This guidance is being distributed for comment purposes only.

Although you can submit comments on any guidance at any time (see 21 CFR 10.115(g) (2)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance within 75 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document, contact Domenic Veneziano (301) 796-0356 or Ted Poplawski (301) 796-6674.

U.S. Department of Health and Human Services
Food and Drug Administration
Office of Foods and Veterinary Medicine
Office of Regulatory Affairs
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine

June 2015

This This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance listed on the title page.

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) (FSMA) 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. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production. Under FSMA, 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 control includes importation of food from facilities that have been certified under FDA’s Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications regulations (FDA’s third-party accreditation regulations), when finalized, (proposed 21 CFR part 1, subpart M)1, 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 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.

This guidance document is presented in question and answer format. This guidance document may be modified (in accordance with FDA’s good guidance practices regulations (21 CFR 10.115)) as VQIP is implemented and evaluated. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required. This guidance represents FDA’s current thinking regarding what will be considered for participation in VQIP and how the VQIP program will expedite imports. However, we will consider alternative approaches and, as further discussed in this document, we retain our full authority with regard to import sampling and entry decisions.

The pronouns “I,” “me,” “you,” and “your” are used in this guidance to refer to the importer who may want to participate in VQIP. “Agency” and the pronouns “we” and “our” are used to refer to FDA. The term “food” has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(f)), except that, for the purposes of VQIP, food does not include food contact substances as defined in section 409(h)(6) of the FD&C Act (21 U.S.C. 348(h)(6)) or pesticides as defined in 7 U.S.C. 136(u).

The complete guidance is available in PDF (589KB).

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