Who Needs an FDA U.S. Agent? Complete Guide for Foreign Facilities

What Is an FDA U.S. Agent?

An FDA U.S. Agent is an individual or organization located in the United States that acts as a communication link between a foreign facility and the FDA. Under 21 CFR §1.227 (food), 21 CFR §207.69 (drugs), 21 CFR §807.40 (devices), and FD&C Act Section 607(a) (cosmetics under MoCRA), every foreign establishment registered with FDA must designate a U.S. Agent.

The U.S. Agent's primary function is to serve as the point of contact for FDA communications, including facility inspections, recalls, and emergency notifications. FDA can contact the U.S. Agent in lieu of contacting the foreign facility directly, and the U.S. Agent must be able to respond within a reasonable time frame.

Importantly, the U.S. Agent is not a customs broker, an importer of record, or a legal representative. The role is specifically defined by FDA regulations and carries distinct responsibilities.

Who Is Required to Have a U.S. Agent?

The U.S. Agent requirement applies to foreign establishments across four major FDA-regulated product categories:

• Food facilities: Any foreign facility required to register under Section 415 of the FD&C Act (21 CFR Part 1, Subpart H). This includes manufacturers, processors, packers, and holders of food for human or animal consumption intended for U.S. export.
• Drug establishments: Foreign drug manufacturers, repackers, relabelers, and drug product salvagers required to register under Section 510 of the FD&C Act (21 CFR Part 207).
• Medical device establishments: Foreign device manufacturers, specification developers, contract manufacturers, and contract sterilizers required to register under Section 510 (21 CFR Part 807).
• Cosmetics facilities: Foreign facilities that manufacture or process cosmetic products for U.S. distribution, as required under MoCRA (FD&C Act Section 607).

If your facility falls into any of these categories and you export to the United States, you are legally required to designate a U.S. Agent before completing your FDA registration.

What Does a U.S. Agent Do?

The U.S. Agent's responsibilities, defined by federal regulation, include:

• Receiving and responding to FDA communications on behalf of the foreign facility, including inspection notices, warning letters, and recall requests
• Assisting FDA in scheduling inspections of the foreign facility
• Forwarding FDA correspondence to the foreign facility promptly
• Responding to questions from FDA about the facility's registration and product listings
• Serving as the emergency contact if FDA identifies a safety issue with the facility's products

The U.S. Agent does not assume liability for the foreign facility's products, nor is the agent responsible for filing import entries, paying FDA user fees, or obtaining product approvals. These are separate obligations that may require additional service providers.

Common Exemptions and Misconceptions

Not every foreign company needs a U.S. Agent. Key exemptions include:

• Farms: Farms that grow, harvest, or pack raw agricultural commodities are generally exempt from food facility registration and therefore do not need a U.S. Agent (21 CFR §1.227(b)).
• Retail food establishments: Facilities that sell food directly to consumers are exempt from registration.
• Foreign governments: Government agencies are not required to register.

A common misconception is that having a U.S.-based distributor eliminates the need for a U.S. Agent. This is incorrect. The U.S. Agent is a separate FDA designation, and a distributor does not automatically fulfill this role unless they have explicitly agreed to serve as your U.S. Agent and are listed as such in your FDA registration.

Consequences of Not Having a U.S. Agent

Operating without a designated U.S. Agent has serious consequences:

• You cannot complete or maintain your FDA facility registration, which means your products are subject to automatic detention at U.S. ports
• Your registration may be placed on inactive status, triggering Import Alerts
• FDA may refuse to process any submissions from your facility
• U.S. customers and importers may refuse to purchase from you

In short, not having a U.S. Agent effectively bars your products from the U.S. market. This makes the U.S. Agent one of the most critical compliance requirements for any foreign facility.

How to Designate Your U.S. Agent

Designating a U.S. Agent is straightforward but varies by product type:

1. Food facilities: Name your U.S. Agent during registration in the FDA Food Facility Registration Module (FFRM) at FDA's FURLS portal.
2. Drug establishments: Designate your U.S. Agent through the Drug Registration and Listing System (DRLS).
3. Device establishments: Add your U.S. Agent in the Unified Registration and Listing System (FURLS/DRLM).
4. Cosmetics facilities: Name your U.S. Agent during MoCRA registration through FDA's Cosmetics Direct portal.

You must provide the U.S. Agent's name, physical address, phone number, and email address. The agent must confirm their agreement to serve in this capacity.

Assurentry's U.S. Agent services cover all four product categories with a single, affordable annual fee. We provide same-day confirmation letters and handle all FDA communications on your behalf so you can focus on running your business.