A new approach to inspections and increased flexibility in adding suppliers and foods are key components of FDA’s newly updated guidance for FSMA’s Voluntary Qualified Importer Program (VQIP), released November 14. Intended to streamline processes, enhance flexibility, and elevate the program’s efficiency, the updates are effective immediately.
Before we delve into the updates, let’s remember what VQIP is all about!
VQIP expedites review and import entry of human and animal foods into the U.S. for importers who achieve and maintain a high level of control over the safety and security of their supply chains. By participating, importers can avoid unexpected delays at the point of import entry. However, the program is not automatic or free; importers must apply, meet specific criteria, and pay an annual fee. Importers can apply each year between January 1 and September 1 to be considered for the program which begins October 1. The current FY 2025 VQIP user fee is $9,999, with no adjustment for small businesses.
So, back to the updates. Based, and building, on feedback from stakeholders to streamline the process for participation, FDA is applying a new approach to inspections, which is designed to optimize program efficiency by leveraging other oversight activities and potentially reduce user fees. For VQIP participants, the FDA will limit inspections and/or sampling to “for cause” situations, to obtain statistically necessary risk-based microbiological samples, and/or to audit VQIP. A “for cause” inspection or sampling could be made if the food is or may be associated with a risk to public health, such as an outbreak of foodborne illness that has been linked to the type of food or to a foreign supplier covered in the VQIP application. By limiting its VQIP entry inspections, FDA is able to focus its resources on food entries that pose a higher risk to public health.
The agency will also try conducting the inspection and sampling at the VQIP food destination or other location preferred by the VQIP importer. If exportation is warranted, FDA will assist in fulfilling an importer’s request to U.S. Customs and Border Protection (CBP) to export from the port preferred by the importer.
Another update in the guidance is the ability for participants to add new foreign suppliers and foods to their existing program throughout the fiscal year, rather than only at the time of renewal. Specifically, participants can:
- Add a food from a foreign supplier already in their VQIP.
- Add a new foreign supplier and their food with a current facility certification issued in accordance with FDA’s Accredited Third-Party Certification regulation by a certification body accredited under the program who was not part of the current VQIP application. To support this, FDA has also extended the deadline for submitting the notice of intent to participate and application.
- Remove a food, the foreign supplier of a food, or the FSVP or HACCP importer for a food.
- Replace the foreign supplier (or FSVP or HACCP importer) for a food in the VQIP application, as long as the foreign supplier has a current facility certification.
- Add or remove a filer/broker.
In addition to streamlining the importation process and avoiding unexpected delays at import, VQIP participation can save importers time and money through reduced storage costs and can increase customer recognition of importer’s commitment to food safety.
To apply for VQIP, an importer must establish an account on the FDA Industry Systems website and submit online a “Notice of Intent to Participate” in VQIP. To determine eligibility, FDA will review all aspects of the application and may conduct an inspection. After the first year, FDA will reevaluate eligibility at least once every three years of participation and in the occurrence of certain events. These could include events such as an outbreak or recall linked to a food included in the VQIP application (or a similar food); a new hazard associated with a VQIP food; or intelligence data related to violations associated with one or more entities (e.g., foreign supplier, filer/broker) listed on the VQIP application.
Being part of VQIP certainly brings some value to the participant, so if you are not very familiar with it or if you need help, TAG regularly assists clients with VQIP applications and other import/export activities, including responding to Import Alerts and DWPEs. Give us a call!
All written content in TAG articles, newsletters, and webpages is developed and written by TAG experts, not AI. We focus on the realities and the science to bring you the most current, exacting information possible.
