FDA Issues Final Guidance on its Voluntary Qualified Importer Program
On November 10, 2016, the U. S. Food and Drug Administration (FDA) announced a final guidance for its Voluntary Qualified Importer Program (VQIP). VQIP is a “fee-based program to allow the expedited review and importation of foods into the United States from importers with a proven track record of food safety and security.” FDA expects to begin accepting applications for VQIP participation on January 1, 2018. Program benefits for accepted applicants will begin on October 1, 2018.
The guidance is in a question-answer format to better explain to importers how the program will work. Some examples of questions included in the guidance are below:
Q: What are the benefits of VQIP participation?
A: There are several benefits for importers who chose to participate in VQIP. These include:
- Expedited entry into the U.S. for foods included on an approved VQIP application
- Examination and sampling will be limited to situations where public health is at risk
- Expedited laboratory analysis of samples
- Sampling will be conducted at importer’s location of choice when possible
- Access to VQIP Importers Help Desk
- Importer is listed on FDA’s public VQIP list
Q: Who is eligible?
A: Importers, which are defined as “the person who brings food, or causes food to be brought, from a foreign country into the United States,” are eligible to participate in VQIP so long as they meet the following criteria:
- Importer must develop and implement a Quality Assurance Program (QAP)
- Importer must comply with supplier verification and other requirements under FSVP and HACCP
- Each foreign supplier of food intended for importation under VQIP must be certified under FDA’s Accredited Third-Party Certification
- Importer must have at least three years of experience importing food to the U.S.
- Importer and its supply chain cannot have any outstanding FDA judicial or administrative action against the food facility and no other history of non-compliance with food safety regulations.
- Importer must have a Data Universal Numbering System (DUNS) number
Q: How do I apply?
A: Importers who wish to apply for VQIP must establish an online account on the FDA Industry Systems website. After an online account has been established, importers will submit an online “Notice of Intent to Participate” in VQIP from January 1 to May 31 each year. Complete instructions for submission of a VQIP application can be found here. Applications must be renewed annually.
Q: Is there a user fee to participate in VQIP?
A: Yes, importers participating in VQIP are required to pay an annual fee to cover the cost of administering the program. In June 2015, FDA estimated fees would total $16,400. FDA will finalize fees for January 2018 by August 1, 2017. Fees must be paid by the beginning of the VQIP year (October 1) to receive benefits under the program.
Q: What kinds of foods are allowed under VQIP?
A: Food from both farms and facilities may be imported under VQIP so long as they are certified under FDA’s Accredited Third-Party Certification regulations for having appropriate food safety practices are allowed under VQI and are not subject to an import alert or Class 1 recall.
Q: Can the FDA revoke my participation in VQIP and how will I be notified?
A: Yes, FDA may revoke participation in VQIP for violating one or more of the program eligibility criteria, or participating in smuggling or other fraudulent activities. FDA will notify the contact person identified on your VQIP application with a “Notice of Intent to Revoke” your participation in VQIP by email.
Q: Can I obtain reinstatement of my participation in VQIP after a revocation?
A: Yes, you can obtain reinstatement of participation in VQIP after a revocation. Reinstatement may be requested after you have corrected any issues associated with your revocation. The request should include documentation of actions that have been taken to resolve the issues.
For more information on FDA’s final VQIP guidance, register for Registrar Corp’s free webinar on Wednesday, December 21.
Registrar Corp can help U.S. food importers obtain eligibility for VQIP participation. Registrar Corp’s FDA Compliance Monitor allows importers to monitor food facilities around the world for FDA Import Alerts. Registrar Corp can also help facilities obtain a DUNS number at no cost. You may contact Registrar Corp for more information at anytime by phone at 1-757-224-0177 or by 24-hour online chat at http://www.registrarcorp.com/livehelp.