FSMA 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[1] that have been certified in accordance with FDA’s Accredited Third-Party Certification Program (also referred to as the Third-Party Program or TPP) (section 808 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384d)) and the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications regulation (also referred to as the TPP regulation) (see 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.

The 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.

This guidance document is presented in question and answer format.  This guidance document may be modified (in accordance with FDA’s good guidance practice regulation (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 VQIP will expedite entry of imports.

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 pesticides as defined in 7 U.S.C. 136(u).

Download the Guidance

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