Importing Food Into the U.S.? Here’s What FDA Expects From Your Business
A Practical Look at Food Import Compliance If your company imports food into the United States—or plans to—you’ve probably heard about FDA requirements, inspections, and “FSVP.” What many businesses don’t realize is how hands-on FDA expects importers to be when it comes to food safety. The good news? You don’t need to be a regulatory expert to stay compliant—you just need the right structure in place. Why FDA Focuses So Heavily on Food Importers The U.S. Food and Drug Administration regulates imported food to ensure it meets the same safety standards as food produced in the U.S. Since FDA can’t be everywhere overseas, it places responsibility on U.S.-based importers to verify supplier compliance. This approach is part of the Food Safety Modernization Act (FSMA), which shifted food safety from reaction to prevention. In short: If you import food, FDA considers you a key gatekeeper. What “Being Compliant” Actually Means for Importers FDA doesn’t expect perfection—but it does expect documentation, oversight, and accountability. Most importers are required to maintain a written Foreign Supplier Verification Program (FSVP) that shows: Even small or low-volume importers are not exempt from oversight. Where Importers Commonly Run Into Trouble Many potential clients seek help after receiving an FDA notice. The most common issues include: These gaps usually exist not because companies don’t care, but because the requirements aren’t explained clearly. What Happens During an FDA FSVP Inspection? An FDA FSVP inspection typically focuses on records—not your physical facility. Inspectors may ask to see: If documentation is incomplete or missing, FDA may issue a Form 483 or follow up with additional enforcement actions. Preparing in advance is far less costly—and far less stressful—than reacting after the fact. Do You Need Outside Help With FSVP? Many importers choose to work with FSVP specialists to: While responsibility always remains with the importer, expert support significantly reduces compliance risk and internal workload. The Smart Way to Approach Food Import Compliance Food import compliance isn’t about checking boxes—it’s about having a defensible system that shows FDA you take food safety seriously. Whether you import one product or manage a global supply chain, clarity and preparation make all the difference. If you’re unsure whether your current program would hold up under FDA review, that uncertainty alone is often a sign that it’s time for a professional assessment.