FDA Issues Draft Guidance On Voluntary Qualified Importer Program Under The Food Safety Modernization Act

The FDA recently issued a draft guidance titled, "FDA's Voluntary Qualified Importer Program" (VQIP). FDA was required to establish the VQIP by the Food Safety Modernization Act. The VQIP is 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. The guidance includes twelve sections and addresses numerous aspects of the VQIP in question and answer format, including:

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that may result in revocation of participation in VQIP Criteria for VQIP reinstatement following revocation The draft guidance lists the following benefits of the VQIP:

FDA will expedite entry into the U.S. for all foods included in an approved VQIP application (VQIP foods). FDA will limit examination and/or sampling of VQIP food entries to "for cause" situations (i.e., when the food is or may be associated with a risk to the public health), to obtain statistically necessary risk-based microbiological samples, and to audit VQIP. In the circumstances identified in the previous bullet, FDA will examine an entry and collect samples at the VQIP food destination or other location preferred by the VQIP importer. If exportation is warranted, FDA will assist in fulfilling an importer's request to U.S. Customs and Border Protection (CBP) to export from the port preferred by the importer. FDA will expedite its laboratory analysis of "for cause" or audit samples of VQIP entries to the extent possible in accordance with public health priorities. FDA will maintain a VQIP Importers Help Desk dedicated to responding to questions and resolving issues raised by VQIP importers. FDA will post a publicly available list of approved VQIP importers on a VQIP Web page. VQIP importers may choose not to be listed on the VQIP importers list. To be eligible for the VQIP, an importer must satisfy the following criteria identified in the draft guidance:

Have a three-year history of importing food into the U.S. Have a Data Universal Numbering System (DUNS) number. Use paperless filers/brokers who received a passing rating during their last FDA Filer Evaluation. Do not import food subject to an import alert or Class 1 recall. Not be subject to an ongoing FDA administrative or judicial action (e.g., Import Alert...