The Food and Drug Administration has made available a draft guidance for industry on the Voluntary Qualified Importer Program, which will provide for expedited review and importation of human and animal food by participating importers. The FDA anticipates that fiscal year 2018 (which begins Oct. 1, 2017) will be the first year in which the VQIP will be operational. Comments on the draft should be submitted no later than Aug. 19 to ensure consideration before the FDA completes a final version.
The Food Safety Modernization Act requires the 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 the FDA’s accredited third-party audit program as well as other measures. The FDA believes that expedited entry under the VQIP will incentivize importers to adopt a robust system of supply chain management and further benefit public health by allowing the FDA to focus its resources on food entries that pose a higher risk to public health.
The draft guidance describes the eligibility criteria for, and benefits of, participation in VQIP. It also provides information on submitting an application for VQIP participation, obtaining a facility certification for the foreign supplier of a food imported under VQIP, the VQIP user fee, conditions that might result in the revocation of VQIP eligibility, and criteria for reinstatement of eligibility.
According to the draft, the FDA anticipates receiving and reviewing 200 applications to participate in the VQIP in the first year. Based on this data the agency estimates that the annual fee to be paid by all program participants would be approximately $16,400, although it is open to considering a lower fee for small businesses if the burden of this one is too great.