What Is an FDA US Agent and Why Every Foreign Facility Needs One

Every foreign facility that registers with the FDA — whether for food, cosmetics, or drugs — must designate a US Agent. This is not optional, it is not waivable, and there is no alternative arrangement that satisfies the requirement. The US Agent serves as the communication link between the FDA and the foreign facility. If the FDA needs to contact your facility — about an inspection, a recall, an import alert, an adverse event, or any other regulatory matter — they contact your US Agent. If your US Agent is unreachable, unresponsive, or nonexistent, the FDA treats that as a compliance failure with immediate consequences.

What a US Agent actually does

The US Agent's role is defined by regulation, and the scope is narrower than many foreign manufacturers assume. The US Agent must reside or maintain a place of business in the United States, must be physically present in the US during normal business hours, and must be available to respond to FDA communications. The US Agent receives communications from the FDA on behalf of the foreign facility, assists the FDA in scheduling inspections of the foreign facility, and responds to questions from the FDA about the facility's registrations, product listings, and operations. The US Agent does not inspect your facility, does not certify your products, and does not approve your labels. The US Agent is a communications intermediary — nothing more and nothing less.

US Agent requirements by product category

The US Agent requirement applies across all major FDA-regulated product categories, but the specific regulations differ slightly. For food facilities, the requirement comes from 21 CFR Part 1.227 under the Bioterrorism Act. For drug establishments, the requirement comes from 21 CFR Part 207. For cosmetic facilities under MoCRA, the requirement mirrors the food facility model. For medical device establishments, the requirement comes from 21 CFR Part 807. In all cases, the US Agent must be identified by name, address, phone number, and email address in the facility's FDA registration. If the US Agent changes, the facility must update the registration immediately — not at the next renewal cycle.

What happens when you choose the wrong US Agent

Many foreign manufacturers appoint a US Agent based on cost alone, choosing the cheapest service they can find or designating an existing US business contact — a distributor, a friend, a freight forwarder — as their US Agent without understanding the consequences. The problems emerge when the FDA actually needs to reach the US Agent. If the FDA calls or emails the US Agent and receives no response within a reasonable timeframe, the agency may suspend the facility's registration (for food facilities), initiate enforcement action, or refuse shipments from the facility at the port. A US Agent who changed their phone number, went out of business, or simply does not check the email associated with the FDA registration creates a compliance gap that the foreign facility may not discover until a shipment is held or a registration is suspended.

The difference between a US Agent and a US importer

Foreign manufacturers frequently confuse the US Agent with the US importer. These are separate roles with separate regulatory functions. The US Agent is a regulatory communications contact registered with the FDA. The US importer is the entity that brings goods into the United States and is the importer of record with US Customs. A single entity can serve as both, but the roles are legally distinct. Designating your US importer as your US Agent may seem convenient, but it creates a dependency: if the business relationship with the importer ends, you lose both your import channel and your regulatory contact simultaneously. FDABridge recommends keeping the US Agent appointment independent of commercial relationships so that a change in business partners does not create a regulatory crisis.

How FDABridge serves as your US Agent

FDABridge provides US Agent services for foreign food, cosmetic, and drug facilities. Our team is US-based, available during business hours, and experienced in handling FDA communications across all product categories. When the FDA contacts us about your facility, we respond promptly and keep you informed in your language. US Agent service is included in our registration packages, so there is no separate fee or separate contract to manage. Visit fdabridge.com to see our registration services or fdabridge.com/contact to designate FDABridge as your US Agent.