On June 5, the Food and Drug Administration (FDA) published its Draft Guidance for Voluntary Qualified Food Importer Program (the Draft Guidance). A copy of the Draft Guidance can be found here.
A central goal of the Food Safety Modernization Act (FSMA) is to establish a proactive focus on preventing food safety problems rather than relying on a reactive approach. In this context, FSMA required FDA to establish a voluntary, fee-based program for the expedited review and importation of foods from importers that maintain a high level of security and safety in their supply chains as part of FSMA’s Quality Assurance Program. Along the same lines, FDA has issued the Draft Guidance to establish and provide guidance regarding the Voluntary Qualified Importer Program (VQIP).
FDA asserts that the VQIP will benefit both consumers and industry. Industry will benefit because qualified importers will receive expedited review, resulting in their product getting to market faster. Consumers will benefit because food safety protections will be strengthened by requiring high levels of security and safety for VQIP members. On the other side of the coin, the program will help FDA and consumers identify importers that do not participate in the VQIP as potentially more likely to present a food safety public health risk.
The Draft Guidance provides the following information on VQIP participation:
- Benefits of VQIP participation
- Eligibility criteria
- Instructions for obtaining facility certifications for foreign suppliers
- Instructions for completing a VQIP application
- VQIP user fees
- Conditions that might result in revocation of VQIP benefits
- Criteria for reinstatement of VQIP benefits
FDA estimates that it will be able to review 200 applications for the VQIP in its first year of implementation (2018). The estimated annual fee would be approximately $16,400 if fees are split equally among participants. After the comment period—during which small businesses can state any burden the fees may impose—FDA will publish the actual fee prior to the program’s launch.
FDA further states that benefits of participation in the program include
- expedited entry of imported food into the United States,
- limited sampling of VQIP food entries to “for cause” situations,
- examination and collection of samples at the VQIP food destination or other location preferred by the VQIP importer,
- expedited laboratory analysis of “for cause” samples,
- access to a VQIP Help Desk to assist with both procedural issues and problems with specific imports, and
- a publicly available list of VQIP importers (importers may choose not to be listed).
Only food importers may participate in the VQIP. VQIP importers include the manufacturer, owner, consignee, and importer of record, provided that the importer can meet all the criteria for participation in the program.
To be eligible for the VQIP, an applicant must
- have at least a three-year history of importing food into the United States;
- have a Data Universal Numbering System;
- use a paperless filer/broker that received a passing rate during its last FDA Filer Evaluation;
- not have an imported food subject to a Class I recall;
- not be subject to an ongoing FDA administrative or judicial action;
- be in compliance with any applicable Foreign Supplier Verification Program or Hazard Analysis and Critical Control Point requirements;
- have current facility certification for each foreign supplier;
- develop and implement a VQIP Quality Assurance Program;
- have not been the subject of any US Customs and Border Protection penalties, forfeitures, or sanctions related to the safety and security of an FDA-regulated product; and
- pay the annual VQIP user fee.
The Draft Guidance also outlines the technical process for applying to the VQIP and how FDA will review applications.
Imported food safety enhancement is a major priority within FDA’s FSMA implementation scheme, and the agency views the VQIP as a critical tool for imported food safety advancement. Similar programs in the pharmaceutical industry have been successful in expediting the import process, with member companies seeing a competitive and commercial advantage as customers become able to access their products faster.
Accordingly, FDA hopes to persuade importers that the competitive advantage that the VQIP offers will more than offset the time and expense associated with participating in the program. As FDA suggests that participation in the VQIP offers a considerable competitive advantage, such suggestion also implies that the competitive disadvantage of nonparticipation could also be considerable.