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FDA Issues Final Guidance for Voluntary Qualified Importer Program Under FSMA

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The U.S. Food and Drug Administration (FDA) has released a final industry guidance on the Voluntary Qualified Importer Program (VQIP). Under the Food Safety Modernization Act (FSMA), FDA was required to establish this voluntary, fee-based program for expedited review and importation of foods from importers that meet specified standards for food safety and security of their supply chain.  The guidance—presented in a question-and-answer format—provides information on topics including: 1) the benefits of VQIP, 2) eligibility criteria for participation, 3) how to complete a VQIP application, 4) conditions that may result in revocation of participation in the program; and 5) criteria for reinstatement.  

The guidance states that the term “food” has the meaning given in Section 201(f) of the Federal Food, Drug, and Cosmetic Act, except that it does not include pesticides. Under that definition all food additives are considered food, including food-contact substances (FCSs). “Importer” is defined as “the person that brings food, or causes food to be brought, from a foreign country into the customs territory of the United States,” and can be the manufacturer, owner, consignee, or importer of record of the food. The VQIP importer may differ from the importer for the purposes of FDA’s Foreign Supplier Verification Program (FSVP), which also applies to importers of food under FSMA. In the case of the FSVP, the importer is the U.S. owner or consignee at the time of entry into the U.S. or the U.S. representative of the foreign owner or consignee.

The eligibility criteria for participation in VQIP include a three-year history of importing food into the U.S. and a current facility certification issued in accordance with FDA’s third-party certification program for each foreign supplier of food an importer intends to bring in the U.S. under the program. (For background information on the third-party certification program, see the article, FDA Publishes Final Rule on FDA Publishes Final Rule on FSMA Third-Party Accreditation Program.) In addition, those who are the FSVP or HACCP importer of a VQIP food must be in compliance with FSVP, juice HACCP, or seafood HACCP regulations. Those who are not the FSVP or HACCP importer for a VQIP food must identify the FSVP or HACCP importer for that food, and ensure that they are in compliance with applicable regulations. While FCSs are subject to the FSVP, FDA recently extended the compliance date for FSVP verification activities for them from May 30, 2017 to May 28, 2019, noting that compliance with the 2017 date might not be feasible. (For more information, see the articles, FDA’s New FSVP Rule and the Implications for Food Packaging and FDA Extends Compliance Dates for FCSs Verification under FSVP Regulation.)

Importers must submit an application for each fiscal year that they wish to participate in VQIP. FDA will review the application and supporting documents to determining VQIP eligibility.  Once in the program, FDA will inspect the importer to confirm this eligibility.  FDA will begin accepting applications for FY2019 in January 2018. The Agency has not yet established the fee for those applications but has estimated an annual fee of approximately $16,400. FDA will publish the exact fee for participating in VQIP during FY2019 in the Federal Register on or before August 1, 2017 and by this date each year thereafter.

An FDA Fact Sheet on the Final Guidance is available on FDA's website.