Cut the border bottleneck with FDA's VQIP program

As the global food and dietary supplements industry grows, companies are navigating both increased demand and greater regulatory scrutiny. For importers, one of the biggest challenges lies at U.S. entry points, where delays can hold up shipments for days or even weeks—disrupting manufacturing schedules, straining distribution timelines, and creating uncertainty for customers.

To address these issues, the Food and Drug Administration (FDA) established the Voluntary Qualified Importer Program (VQIP). VQIP, created under the Food Safety Modernization Act, provides a more efficient and predictable process for companies with strong food safety systems and compliance records. In practice, this means faster entry of approved food and dietary supplement imports, fewer border delays, and increased confidence in meeting production and distribution targets. Participation in VQIP intends to provide nutrition businesses with efficiency, dependability, and a clear competitive advantage when bringing products to market.

Background: A Shift from Reactive to Proactive.

When FSMA was signed into law in 2011, it marked the most sweeping reform of U.S. food safety laws in more than 70 years. Before FSMA, FDA was largely reactive—responding to contamination events, recalls, or outbreaks once they were already underway. FSMA transformed that model and focused the agency’s efforts on prevention of food safety issues.

Today, a single nutrition bar could contain protein from Europe, vitamins from Asia, and flavors developed in South America, all assembled and packaged in North America. These interconnected supply chains provide tremendous opportunities for innovation while also adding layers of complexity and risk. FSMA was enacted to reflect this reality, giving FDA new tools to monitor imported foods and hold corporations accountable for assuring safety across the supply chain.

Key provisions of FSMA included:

• Preventive Controls: Requiring companies to implement written food safety plans that identify hazards and outline preventive measures.
• Foreign Supplier Verification Programs (FSVP): Making importers responsible for verifying that their foreign suppliers meet U.S. safety standards.
• Third-Party Certification: Creating a framework that allows independent, FDA-accredited bodies to certify foreign facilities.
• Increased Inspection Authority: Allowing FDA to focus more inspections on facilities or shipments that pose greater risks.

In this same act, FSMA added a new section, 806, VQIP, which allowed FDA to streamline imports for companies that consistently meet the highest safety standards. Section 806(a)(2) of this Act required FDA to issue a guidance document related to participating in VQIP, much of which is described in this article.

Absent VQIP, FDA faced a bottleneck: every shipment had to be treated equally, whether from a well-established, compliant importer or a new operation. VQIP developed a more efficient approach. By identifying “trusted” importers, FDA could focus its resources where they were most needed, while allowing low-risk shipments to move quickly. Importers with strong systems and clean compliance histories can move through the process more quickly, while shipments that require closer scrutiny receive the attention they deserve.

For food and dietary supplement companies, these advantages translate into more efficient ingredient sourcing, fewer disruptions in manufacturing pipelines, and faster access to the U.S. market. However, there are certain conditions and limitations. Even under VQIP, FDA has the authority to conduct examinations or sampling “for cause” (e.g., suspected health risks), risk-based microbiological sampling, or auditing. Furthermore, expedited treatment is only applicable to foods listed in an approved VQIP application; non-covered imports are not eligible. Finally, if the importer fails to meet the eligibility requirements, FDA reserves the right to suspend any or all of the benefits.

Quality Assurance Program

As FDA guidance highlights, the Quality Assurance Program (QAP) is a key component of VQIP. This document demonstrates that an importer has implemented measures to maintain food safety and security across the supply chain. A strong QAP typically includes:

• A corporate quality policy statement and clear organizational chart.
• Policies on food safety and food defense.
• Employee qualifications and training requirements.
• Procedures for implementation, review, and improvement.

FDA evaluates each QAP for adequacy and may inspect facilities to ensure its implementation in practice.

Applications are submitted online through the FDA Industry Systems portal between January 1 and September 1 each year. FDA may conduct a VQIP inspection to verify eligibility and may request product labels to evaluate for any labeling gaps or deficiencies.

VQIP is a continuous approval process. Importers are required to update their applications anytime something changes, including:

• Adding or removing suppliers.
• Updating products or formulations.
• Changing brokers or filers.
• Revising food safety policies.

If issues arise, such as supplier violations, noncompliance, or inaccurate information, FDA reserves the right to revoke participation. In many cases, companies can correct deficiencies and regain eligibility. Serious violations, such as fraud, may result in immediate revocation and no reinstatement for the remainder of the fiscal year.

User fees

Each year, FDA sets the user fee for VQIP participation. The user fee for Fiscal Year (FY) 2026 is $9,620andmust be paid by October 1 to secure participation in the following fiscal year, as set in the Federal Register, 90 Fed. Reg. 35863.

The fee supports program administration, application review, inspections, and IT systems. While the cost may be significant, especially for smaller companies, many importers view it as an investment in efficiency.

When compared to the costs associated with delayed shipments (such as demurrage fees, warehousing costs, lost sales, or broken retailer commitments), the potential savings can outweigh the annual fee. For large-volume importers, the financial case for participation can be especially compelling.

Conclusion

VQIP provides a pathway to faster, more predictable imports while reinforcing a commitment to high compliance standards. This alignment is particularly valuable in a market where consumers increasingly expect transparency and accountability. A company’s inclusion on FDA’s public list of approved VQIP importers can serve as a visible sign of commitment to both safety and efficiency.