FDA Releases Draft Guidance for Voluntary Qualified Importer Program (VQIP)

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The U.S. FDA is establishing a program to offer an expedited import process to food importers that maintain a high level of control over the safety of their supply chain. Registrar Corp reports on details of the program and criteria for eligibility.

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VQIP importers must not import any food (including non-VQIP food) that is subject to an FDA Import Alert or Class 1 Recall

On June 4, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance regarding its Voluntary Qualified Importer Program (VQIP), a voluntary program that will offer an expedited importation process to food importers who maintain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.

Registrar Corp can help U.S. food importers obtain eligibility for VQIP participation. Registrar Corp can obtain a DUNS number for a facility. Registrar Corp's FDA Compliance Monitor allows importers to monitor food companies around the world for FDA Import Alerts and will soon monitor for recalls, import refusals, and more. For more information about FDA's VQIP, contact Registrar Corp at 1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at http://www.registrarcorp.com/livehelp.

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David Lennarz

Liviana Callahan
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Registrar Corp
since: 04/2011
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