FDA Food Facility Registration U.S. Agent

When Food Facilities Need a U.S. Agent (Plain Language)

If you're manufacturing, processing, packing, or storing food outside the U.S. for consumption here, you need a U.S. Agent. Here's when this requirement applies.

Foreign manufacturing is the main trigger. If you're making food products outside the U.S. (maybe in Mexico, Canada, Europe, Asia, wherever) and importing them into the U.S., you must register your foreign facility with FDA. Part of that registration is designating a U.S. Agent. This applies whether you're making packaged foods, beverages, supplements, or any other food product. The location of your facility determines the requirement, not the type of food.

Processing and packing also require it. Even if you're not manufacturing the food itself, if you're processing (maybe canning, freezing, or cooking) or packing food in a foreign facility for U.S. import, you need registration and a U.S. Agent. This catches companies that buy bulk ingredients and process them for the U.S. market. FDA wants a U.S. contact point for these operations.

Storage facilities need agents too. If you're storing food (maybe in a warehouse or cold storage facility) outside the U.S. for eventual U.S. import, you need registration and a U.S. Agent. This is less common but still covered by FDA requirements.

The requirement comes from FSMA. The Food Safety Modernization Act (FSMA) requires foreign food facilities to register with FDA and designate a U.S. Agent. The requirements are similar to medical devices and drugs: physical U.S. address, availability during business hours, forwarding FDA communications. But food facilities have some unique aspects, like biennial renewal requirements.

FDA communications go through the agent. When FDA needs to reach you—whether it's a registration confirmation, renewal reminder, inspection notice, or regulatory correspondence—they send it to your U.S. Agent's address. The agent forwards it to you. This is the core function. Without a reliable agent, you'll miss FDA communications, which can cause compliance problems and even import holds.

Biennial renewal requires agent confirmation. Food facility registrations must be renewed every two years. During renewal, your U.S. Agent must confirm their designation. If your agent is unresponsive during renewal, your registration can't complete, which can cause import delays. This is why choosing a reliable agent is critical—you need someone who will be available for renewals every two years.

Inspection coordination is part of the role. FDA may contact your U.S. Agent to schedule inspections of your foreign facility. The agent helps coordinate dates, understands your time zone constraints, and ensures you're prepared. This is especially valuable if you're not familiar with FDA inspection processes. Some agents offer basic forwarding only, while others provide inspection coordination support (usually as an add-on service).

Important note: U.S. food facilities don't need a U.S. Agent. Only foreign facilities (located outside the U.S.) must designate one. If your facility is in the U.S., you register directly without an agent. But if you're manufacturing abroad and importing, the agent requirement applies.

What the U.S. Agent Does in Practice (Communications)

For food facilities, the U.S. Agent's job is similar to other FDA-regulated industries, but with some food-specific nuances. Here's what actually happens.

Receiving FDA communications is the core function. FDA sends all regulatory communications to your agent's address—registration confirmations, renewal reminders, inspection notices, warning letters, import alerts, you name it. The agent receives these (usually via postal mail, sometimes email) and forwards them to you. This sounds simple, but it's where many providers differ. Some forward within 24 hours, others might take 3-5 days. For urgent matters like import holds or inspection notices, that difference matters significantly.

Renewal support is critical for food facilities. Food facility registrations must be renewed every two years (biennial renewal). During renewal, your U.S. Agent must confirm their designation. If your agent is unresponsive during renewal, your registration can't complete, which can cause import delays. We've seen food companies miss renewal deadlines because their agent didn't respond to confirmation requests. This is why choosing a reliable agent is especially important for food facilities—you need someone who will be available for renewals every two years.

Forwarding speed varies significantly. The regulation doesn't specify how quickly agents must forward communications, so SLAs vary. Basic agents might guarantee 48-hour forwarding, premium ones offer same-day or even same-hour for urgent matters. For food facilities, where import holds can happen quickly, fast forwarding is valuable. We've seen companies miss import holds because their agent was slow to forward FDA communications.

Receipt code confirmation is mandatory. When you designate or change a U.S. Agent, FDA sends a notification receipt code to the agent's email. The agent must confirm receipt of this code to complete your registration. This sounds simple, but we've seen agents miss these emails (maybe they went to spam, or the agent doesn't check email regularly), which delays registration. Make sure your agent understands this is a critical step.

Inspection notices require fast forwarding. When FDA schedules an inspection of your foreign facility, they send the notice to your U.S. Agent. The agent forwards it to you, and ideally helps coordinate dates and logistics. This is where good agents earn their keep—they understand FDA inspection processes, help coordinate scheduling, and may even provide preparation guidance. Basic agents just forward the notice and say "good luck."

Regulatory correspondence can be complex. FDA sends various types of regulatory correspondence—maybe warning letters about food safety issues, import alerts, or requests for additional information. Your agent forwards these, but good agents can help you understand what they mean and how to respond. This isn't required (basic forwarding is enough), but it's valuable if you don't have internal regulatory staff.

Additional support is usually optional. Some providers offer inspection coordination, regulatory consulting, or document preparation assistance as add-on services. These cost extra (typically $300-1,000/year more), but they can be worth it if you need the help. Basic U.S. Agent service is just communication forwarding and receipt code confirmation. Everything else is optional.