Your operation may meet the requirements of the Food Safety Modernization Act (FSMA), but what about your suppliers that don't report directly to the FDA? The FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals aims to address just that.
While international suppliers are not required to follow FDA regulations in their own facilities, they must adhere to the regulations outlined in the FSMA if they do business with U.S. manufacturers and distributors. For U.S. importers, FSVP is the way to verify and approve international businesses' products for the U.S. market.
But what does this entail, and what happens if you don't follow these guidelines? Read on to learn how following FSVP guidelines could save your business from falling out of compliance.
What is FSVP?
FSVP is a final rule imposed by the FDA for "importers of food for humans and animals" that requires businesses to verify whether products imported from foreign suppliers are produced safely, unadulterated, and properly labeled. Note: There are some exceptions and modifications to this rule that apply to certain businesses, which you can identify with the FDA's "Am I subject to FSVP?" guide.
For applicable U.S. businesses that import food from foreign suppliers — whether finished food products or ingredients for manufacturing — this rule means carefully vetting suppliers and food products to ensure they meet FDA compliance standards.
If a business imports from multiple suppliers, FSVP documentation is required for each supplier. The same is true if a business imports multiple products from a single supplier, with each product requiring its own documentation.
International manufacturers must also adhere to these regulations if they plan to export products to the U.S. These exporters must appoint a U.S.-based representative to ensure they comply with FDA regulations and follow an effective FSVP program. However, much of the responsibility for upholding these standards rests with importers.
While this rule is important for maintaining the integrity of your food safety program, it also adds to the complexity of food safety audits. Inspectors will expect proper documentation and verification of FSVP efforts — which makes it vital that you understand and meet this program's core requirements.
Core Requirements of FSVP
As part of an effective FSVP program, your business must conduct and document a few essential steps. These requirements verify that your suppliers meet the expectations set by U.S. food safety standards.
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Hazard analysis: As an importer, you must determine the known or reasonably foreseeable hazards with each food product — including biological, chemical, and physical hazards. Businesses must assess the probability of identified hazards without proper controls and the severity of illness or injury if they do.
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Risk evaluation: Businesses are responsible for evaluating the risks posed by imported food products. This evaluation is based on the results of the hazard analysis and an assessment of foreign suppliers’ past and current food safety performance.
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Supplier approval and verification: Based on the results of your risk evaluation, you must create and follow written procedures to verify that your business is only importing from approved suppliers. Once you've established these protocols, you must also decide which supplier verification activities your businesses will enact — including annual on-site audits (when required), sampling and testing, or a review of relevant supplier safety records.
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Corrective actions: In the event that you discover your supplier isn't using the proper processes and procedures, has adulterated products, or is mislabeling allergens, you must apply the appropriate corrective actions based on the circumstances. This could include discontinuing business with said supplier until the cause of this issue is addressed.
Meeting these requirements will help you stay compliant (and avoid the repercussions of failing to do so).
Consequences of FSVP Non-Compliance
Compliance with FSVP allows you to import products with confidence, secure in the knowledge that your imports adhere to U.S. food safety regulations. On the other hand, non-compliance can not only leave your business vulnerable to potential hazards, but also result in significant consequences, including:
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Financial penalties such as recalls and fines
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Regulatory actions in the form of import alerts
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Reputational damage caused by recalls and loss of consumer trust
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Operational scrutiny from the FDA — including increased inspections and supply chain disruptions
But how do you know if you're out of compliance with FSVP before it's too late? Staying aware of common violations can help you avoid trouble with the FDA.
Common FSVP Violations
According to the FDA's Data Dashboard, only 47% of food businesses inspected in 2025 were found in compliance with FSVP regulations. While FSVP may be a newer rule compared to other food safety regulations, its role is no less important — especially thanks to the increasing complexity of global supply chains. This makes non-compliance a serious threat to your business and the safety of your consumers.
Understanding the core issues inspectors encounter can help you meet expectations.
Not having an FSVP program
The top FSVP violation isn't something easily missed or overly complex. It's a complete lack of FSVP programs altogether. This issue is so common that it accounted for more than 40% of all FSVP citations issued in 2025 and 52% of all FSVP citations issued since the rule's initial compliance date.
Lack of/inadequate supplier evaluation and verification
Some importers place too much faith in their suppliers — expecting exporters to follow the same standards as their business partners. But even if a supplier is up to code with their food safety procedures, it's still an importer's responsibility under FSVP to evaluate and verify these practices. This misstep can lead to potential hazards being overlooked, putting consumers at risk.
Missing documentation of procedures and protocols
Even if you follow the proper FSVP procedures and protocols, inspectors require documentation to verify your efforts. From supplier verification to hazard analyses, as an importer, you must be capable of producing documentation for every step of your FSVP program.
Incomplete or missing hazard analysis
The hazard analysis is the first step of any FSVP program — one that informs the rest of your decision-making along the way to approval. By either skipping or neglecting this step, you are essentially driving blind. Vulnerabilities can go undetected, hazards can slip through the cracks, and your procedures will be unfounded.
How to Remain Compliant With FSVP
Knowing FSVP missteps may be a good start to avoiding non-compliance, but the actions you take to stay on track are even more important. Approaching FSVP with dedication and care will protect both your consumers and your business.
As you begin your FSVP journey, follow these steps to maintain compliance and elevate your commitment to food safety.
1. Create an effective FSVP program
Since the most common FSVP is missing a program entirely, the best first step is to create one. Using FDA resources, along with help from outside experts, you can build a program that meets FSMA requirements and maintains your compliance. This will not only stave off negative consequences, but also help protect your customers and brand reputation.
2. Conduct regular supplier audits
A common supplier verification method preferred by the FDA, regular on-site audits provide the best perspective on exactly how well your suppliers are adhering to FSMA regulations. Supplier audits are important for food safety in general, but they’re absolutely essential for identifying high-risk or non-compliant suppliers for your FSVP program.
Streamlining your approach to food supplier audits can help secure food safety up and down your supply chain — helping you build trustworthy, long-term relationships with your business partners.
3. Establish robust documentation processes
Your FSVP documentation is the key evidence inspectors will use to determine your compliance. By creating a comprehensive documentation process, you can accurately display the steps you've taken to meet FDA guidelines and why your international suppliers are reliable. As part of this process, be sure to establish the importance of thorough documentation with your team and embed it into the principles of your food safety culture.
Verifying Your FSVP Compliance
Now that you understand why FSVP compliance is so important and what you can do to remain above board, ask yourself: Are you in compliance with FSVP? Don't risk finding out during an inspection. Consider bringing in expert help from AIB International to perform an FSVP Compliance Audit.
A second set of eyes from an unbiased third party can help you identify weak points in your program, discover opportunities for improvement, and verify your procedures — so you can get back to business with confidence.
