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FDA Releases Draft Guidance for Voluntary Qualified Importer Program
Craig Levitt
January 1, 2018
2 Min Read
On June 4, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance regarding its Voluntary Qualified Importer Program (VQIP), a voluntary program that will offer an expedited importation process to food importers who maintain a high level of control over the safety and security of their supply chain. VQIP regulations were mandated by the Food Safety Modernization Act (FSMA). Benefits of participating in the VQIP will include, but are not limited to:
Expedited U.S. entry for foods included in an approved VQIP application (VQIP foods). FDA will program its PREDICT system to recognize and release VQIP foods
Examination and sampling of VQIP foods will be limited to situations where the food may be associated with a risk to public health
Access to an FDA VQIP Importers Help Desk
The option to be placed on a publicly available list of approved VQIP importers on FDA's website
VQIP benefits will last for one "VQIP year" (October 1 to September 30). VQIP applications must be submitted annually between January 1 and May 31. VQIP importer benefits will begin on October 1 following the importer's acceptance into the program. Importers are required to pay a fee for each year they are approved for VQIP participation. FDA will publish the fee for the next scheduled VQIP year on or before August 1 of each year. The VQIP is not limited to importers located inside the United States. FDA defines an importer as "the person that brings food, or causes food to be brought, from a foreign country into the customs territory of the United States." Manufacturers, owners, consignees, and importers of record can all be VQIP importers if they meet the criteria for VQIP participation. In order to be eligible for participation, the importer must, among other things:
Have 3-years of experience importing food into the United States
Have a Data Universal Numbering System (DUNS) number
Not import any food (including non-VQIP food) that is subject to an FDA Import Alert or Class 1 Recall
Not be the subject of an ongoing FDA administrative or judicial action or have a history of significant noncompliance related to food safety
Develop, implement, and document a VQIP Quality Assurance Program (QAP)
VQIP importers will also need a foreign supplier facility certification for each foreign facility they plan to import a VQIP food from. Facility certification must be issued by an FDA accredited auditor or certification body. FDA is expected to publish a final rule regarding third-party accreditation by October 31, 2015.
