Quick Answer
A US Agent is required for all foreign establishments that export FDA-regulated products to the United States, including food, drugs, medical devices, cosmetics, and tobacco products. The US Agent must be a person or business located in the US who serves as the communication link between the foreign facility and FDA, available 24/7 for emergency contact.
Regulatory Authority: 21 CFR 1.227 (food), 21 CFR 207.69 (drugs), 21 CFR 807.40 (devices)
What Is an FDA US Agent?
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ImmutableAn FDA US Agent is a person or company located in the United States that is required by federal regulation for any foreign establishment exporting FDA-regulated products (food, drugs, devices, cosmetics, tobacco) to the US. The US Agent serves as the official communication link between the foreign facility and FDA under 21 CFR 1.227 (food), 21 CFR 207.69 (drugs), and 21 CFR 807.40 (devices). For official FDA guidance on registration requirements, see the FDA food facility registration portal and the FDA device registration page.
The US Agent requirement exists because FDA needs a reliable way to contact foreign facilities, especially during emergencies such as product recalls, disease outbreaks, or safety concerns. Time zone differences and communication barriers can make direct contact with foreign facilities challenging.
Foreign Facility
Any facility located outside the United States that manufactures, processes, packs, or holds FDA-regulated products for export to the US
US Agent
A person or business physically located in the United States who represents the foreign facility in FDA matters
Communication Link
Receives and responds to FDA communications, forwards information to the foreign facility, and assists with regulatory matters
Compliance Partner
Many US Agents also provide compliance support, helping foreign facilities navigate FDA requirements
Who Needs an FDA US Agent?
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A US Agent is required for foreign establishments in the following categories:
Food Facilities
Under the Bioterrorism Act and FSMA, foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the US must register with FDA and designate a US Agent. See our food facility US Agent page for details.
Drug Establishments
Foreign drug establishments that manufacture, repack, relabel, or perform drug salvaging operations for drugs distributed in the US must register and have a US Agent.
Medical Device Establishments
Foreign medical device establishments that manufacture, prepare, propagate, compound, assemble, or process devices for US distribution must register and designate a US Agent.
Cosmetics Facilities (MoCRA)
Under the Modernization of Cosmetics Regulation Act, foreign cosmetics facilities must now register with FDA and designate a US Agent.
Tobacco Products
Foreign establishments that manufacture, prepare, compound, or process tobacco products for US import must register and have a US Agent.
What Does an FDA US Agent Do?
A US Agent has specific responsibilities defined by FDA regulations. Understanding these responsibilities is crucial both for foreign facilities selecting an agent and for entities considering becoming a US Agent.
Core Responsibilities
- Receive communications from FDA: Accept all FDA correspondence, including warning letters, recall notices, and inspection requests
- Respond to FDA inquiries: Provide timely responses to FDA questions and requests for information
- Forward communications: Promptly transmit FDA communications to the foreign facility
- Assist with regulatory processes: Help coordinate inspections, registrations, and other regulatory matters
Availability Requirements
The US Agent must be available to FDA. While regulations don't explicitly require 24/7 availability, FDA expects to be able to reach the US Agent during normal business hours and receive a response within a reasonable timeframe. In emergency situations, FDA may need to contact the US Agent outside normal hours.
Important Limitation
A US Agent cannot refuse to accept service of a regulatory action. When FDA delivers a warning letter, import alert, or other action to the US Agent, it is considered delivered to the foreign facility. The foreign facility cannot claim they didn't receive notice.
How Is a US Agent Different from an Importer or Distributor?
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"Procedures for verifying supplier controls were not adequately established."
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It's important to understand the distinction between a US Agent and other roles in the import/distribution chain:
| Role | Primary Function | Location | Required? |
|---|---|---|---|
| US Agent | FDA communication link | Must be in US | Yes, for foreign facilities |
| Importer of Record | Customs entry and duties | Usually in US | Yes, for imports |
| FSVP Importer | Food safety verification | Must be in US | Yes, for food imports |
| US Distributor | Product distribution | Usually in US | Commercial need |
While these roles can be performed by the same entity, they have different regulatory requirements and responsibilities. A US Agent does not automatically become the importer or assume FSVP responsibilities.
What Qualifications Does a US Agent Need?
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FDA does not have specific qualification requirements for US Agents beyond being located in the United States. However, practical considerations make certain qualities important:
Legal Requirements
- US location: Must reside or maintain a place of business in the United States
- Physical address: Must have a physical US address (P.O. boxes are generally not acceptable)
- Contact availability: Must be reachable by phone and email
Practical Qualifications
- Regulatory knowledge: Understanding of FDA regulations for the relevant product type
- Communication skills: Ability to communicate effectively with FDA and the foreign facility
- Responsiveness: Ability to respond promptly to FDA communications
- Reliability: Stable business operations and consistent availability
How Do I Choose the Right US Agent?
Selecting the right US Agent is an important decision for foreign facilities. Consider these options and factors:
Options for US Agent
- US importer/distributor: Your business partner in the US may serve as US Agent
- US subsidiary: If you have a US office, an employee there can serve as US Agent
- Professional US Agent service: Companies like Assurentry specialize in US Agent services
- Attorney or consultant: A US-based regulatory professional can serve as US Agent
Factors to Consider
- Expertise: Does the agent understand FDA regulations for your product type?
- Availability: Will they be available when FDA calls?
- Communication: Can they effectively communicate with you across time zones?
- Additional services: Do they offer compliance support, registration assistance, or other services?
- Reputation: What is their track record with other clients?
- Cost: What are their fees and what services are included?
Why Professional US Agent Services?
While using an importer or distributor as your US Agent may seem convenient, professional US Agent services offer dedicated focus on FDA compliance, regulatory expertise, and consistent availability. If your business relationship with an importer ends, you'll need to quickly find a new US Agent and update your registration. Our US Agent Wizard can help you determine exactly what you need.
How Do I Change My US Agent?
You can change your US Agent at any time by updating your FDA registration. For a detailed walkthrough, see our step-by-step guide to changing your US Agent. Common reasons for changing US Agents include:
- Business relationship changes with current agent
- Desire for more comprehensive compliance support
- Cost considerations
- Performance issues with current agent
Process for Changing US Agent
- Identify and confirm new US Agent
- Log in to FDA registration system
- Update US Agent information in your registration
- Ensure new US Agent confirms their role
- Notify any relevant parties of the change
The change takes effect immediately upon successful submission. You should update your US Agent information within 60 days of any change.
Frequently Asked Questions About US Agents
How much does a US Agent cost?
Assurentry charges $399/year for US Agent services. Market rates typically range from $250-$900/year depending on the provider and level of service. Some providers bundle US Agent services with registration assistance or compliance monitoring.
Can I be my own US Agent?
No, the US Agent must be a person or company based in the United States that is separate from the foreign facility. A foreign facility owner cannot serve as their own US Agent, even if they have a US mailing address. The agent must reside or maintain a place of business in the US per 21 CFR 1.227.
How quickly can I get a US Agent?
Assurentry provides same-day acceptance letters for US Agent designation. Once you complete the onboarding process, we issue an official acceptance letter that you can use to complete or update your FDA registration immediately.
What are the legal requirements for a US Agent?
A US Agent must reside or maintain a place of business in the United States and be available during business hours to receive and respond to FDA communications (21 CFR 1.227). They must have a physical US address and be reachable by phone and email.
Can one US Agent represent multiple facilities?
Yes, a single US Agent can represent an unlimited number of foreign facilities. Professional US Agent services like Assurentry typically represent hundreds or thousands of foreign facilities across food, drug, device, and cosmetics categories.
What happens if my US Agent becomes unavailable?
If your US Agent becomes unavailable, you must update your FDA registration immediately with a new agent. A gap in US Agent coverage means FDA cannot contact your facility, which risks enforcement action including registration cancellation and import refusal.
Is the US Agent liable for the foreign facility's products?
No, the US Agent is not generally liable for product safety or compliance. Their role is to serve as a communication link between FDA and the foreign facility per 21 CFR 1.227. However, they can be liable for their own actions or misrepresentations to FDA.
Does the US Agent need to be registered with FDA?
No, the US Agent does not need separate registration with FDA. They are identified through the foreign facility's registration. There is no separate FDA registration requirement or fee for US Agents.
What happens if we don't have a US Agent?
Foreign facilities cannot complete FDA registration without designating a US Agent. Products from unregistered facilities can be refused entry at US ports under 21 CFR Part 1, Subpart H (food), 21 CFR 207.69 (drugs), or 21 CFR 807.40 (devices).
Can an individual be a US Agent?
Yes, an individual (not just a company) can serve as US Agent, as long as they reside or maintain a place of business in the United States and can fulfill the communication responsibilities defined in the applicable regulations.
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