VQIP Background

VQIP is a voluntary import approval and preclearance program that expedites the import review and entry process for human and animal foods from participating importers. Under the program, FDA’s examination and sampling of VQIP foods is limited to “for cause” situations where FDA suspects a potential risk to the public, which helps a participant avoid unexpected delays at the border.¹ In addition, when FDA intends to examine or sample a VQIP food, the examination or sampling occurs, to the extent possible, at the food’s destination or another location chosen by the importer. FDA also expedites any laboratory processing for samples taken for a food imported under this program.

To participate, importers must meet strict eligibility criteria.² In particular, VQIP foods must be produced in a foreign facility or on a farm that is certified by a certification body accredited under FDA’s Third-Party Certification Program. Additionally, FDA’s Guidance says that importers should have at least a three-year history of importing food into the United States and should be in compliance with supplier verification and other responsibilities under the Foreign Supplier Verification Programs (FSVP) rule. VQIP participation also requires the development and implementation of a Quality Assurance Program (QAP), which includes written policies and procedures regarding safety and security. Finally, VQIP participants must pay a user fee, which is approximately $10,000 for fiscal year (FY) 2025.³ For FY 2025, FDA’s website identifies seven importers that are enrolled in the program.⁴

Revised Guidance and VQIP Changes

FDA’s revised VQIP Guidance includes program changes that improve the incentives to enroll in the program and potentially could result in a lower user fee in the future.⁵ The Guidance provides updated information on the application process, including the facility certification requirement and FDA’s approach to reviewing VQIP applications.

The following new components of the Guidance are particularly notable:

• Additional VQIP Benefit: Participants now have the ability to add new foreign suppliers and foods to their existing program throughout the fiscal year.Previously, participants were required to wait until the start of the next fiscal year to make changes to their program.

• Extended VQIP Application Period: FDA is extending the timeframe to submit an application to participate in VQIP.Instead of requiring applications to be submitted between January 1 – May 31 in order to participate during the following fiscal year (beginning October 1), the window now has been extended from January 1– September 1. FDA says that the deadline was extended “to support our participants in obtaining a facility certificate from an accredited certification body under the Accredited Third-Party Certification Program.”

• Decreased Likelihood of VQIP Inspections for Applicants: Previously, FDA ordinarily conducted a VQIP inspection after an importer’s application was approved and prior to October 1 of the first year the importer would be participating in the program. Now, FDA is stating that in most cases the agency can evaluate VQIP eligibility by reviewing the applicant’s VQIP application and inspectional history, or an FSVP and/or HACCP inspection in lieu of conducting a VQIP inspection.

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