The FDA has released final industry guidance to support compliance with its Voluntary Qualified Importer Program.
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The Food Safety Modernization Act (FSMA) (Pub. L. 111-353) required FDA to establish a voluntary, fee-based program called the Voluntary Qualified Importer Program. This program aims to facilitate 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: (1) 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 and (2) other measures that support a high level of confidence in the safety and security of the food they import. The Agency thinking here is that expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public health by permitting FDA to focus its resources on food entries that pose a higher risk to public health.
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Today, FDA released final guidance for industry to support compliance with its Voluntary Qualified Importer Program. The final guidance, set forth in question-and-answer format, explains how this program will work. In brief, this guidance document addresses:
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The benefits VQIP importers can expect to receive;
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The eligibility criteria for VQIP participation;
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Instructions for completing a VQIP application;
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Conditions that may result in revocation of participation in VQIP; and
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Criteria for VQIP reinstatement following revocation.
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An FDA Fact Sheet on the Final Guidance is also available here. The release of this final guidance represents the latest in a slew of FSMA related guidance documents issued by FDA over the past several weeks.