FDA has issued draft guidance to implement the Food Safety Modernization Act (FSMA) Voluntary Qualified Importer Program (VQIP).

FSMA required FDA to establish the voluntary, fee-based VQIP 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 as following appropriate food safety practices under FDA’s Accredited Third-Party Certification regulations, also required by FSMA.

The program will provide participating companies with several benefits, including expedited entry and reduced sampling by FDA. The program is designed to incentive importers to adopt a robust system of supply chain management and enable FDA to focus resources on food entries that pose a higher risk to public health.

FDA anticipates that VQIP application review will be limited in the program’s first year due to the demands on resources. For the purpose of calculating the fee, FDA estimates it will be able to review 200 applications in the first year. The program is expected to be open for applications in January 2018 and applications will be reviewed in the order that they are submitted. 

FDA has preliminary estimated a possible fee amount based on an estimate of the number of importers expected to participate in VQIP (200 in Fiscal Year (FY) 2018) and an estimate of the costs of administering the program ($3.4 million in FY 2018). Using these assumptions, FDA’s preliminary estimate of the annual fee would be $16,400. This estimate is intended to help small businesses comment on the burden the fee might impose. After considering all comments received on these guidelines, FDA will publish the actual fee in a Federal Register notice at least 60 days prior to the start of the program.

FDA is providing a 75-day comment period to provide input on this draft guidance and the American Herbal Products Association (AHPA) will be submitting additional comments. AHPA met with key FDA staff in September 2014 for a preliminary discussion on the draft VQIP guidance and AHPA filed comments two months later. In these comments, AHPA stressed the importance of a VQIP fee structure that accommodates small and medium-sized firms and AHPA will continue to advocate this point.

FDA’s draft guidance document outlines VQIP provisions and provides information on:

• the benefits VQIP importers can expect to receive;
• eligibility criteria;
• instructions for completing a VQIP application;
• conditions that could result in revocation of VQIP participation; and
• criteria for VQIP reinstatement following revocation.