FDA Agent Service — Food & Supplements
All foreign food facilities must designate a U.S. FDA Agent as part of their FDA registration. LMG provides U.S. Agent services for food, dietary supplement, and nutraceutical facilities worldwide.
US FDA Agent Services for Foreign Food Facilities
If you operate a foreign facility that manufactures, processes, packs, or holds food or dietary supplements intended for consumption in the United States, appointing a US FDA Agent is not just a best practice—it is a mandatory legal requirement under the Federal Food, Drug, and Cosmetic Act and the Bioterrorism Act of 2002. This requirement applies to all foreign food establishments regardless of size, product type, or volume of exports to the US market.
Why Do You Need a US FDA Agent?
The FDA requires every foreign food facility registered under 21 CFR Part 1, Subpart H to designate a US Agent who serves as the primary point of contact between the foreign establishment and the agency. This designation ensures that the FDA can communicate efficiently with your business regarding routine inspections, registration renewals, prior notice submissions, import alerts, and urgent food safety matters such as contamination concerns or product recalls. Without a properly designated US Agent, your FDA food facility registration cannot be completed, and your products may face automatic detention at US ports of entry, causing costly shipping delays and potential loss of business.
Key Requirements for a US FDA Agent
To remain compliant with FDA regulations and maintain active food facility registration, your designated US Agent must meet the following specific criteria established under 21 CFR 1.227:
Physical Presence in the United States: The US Agent must reside in the United States or maintain a physical place of business within the US territory. PO Boxes are not acceptable—FDA requires a verifiable physical address where the agent conducts business. This ensures that the agent can be located and contacted by FDA officials when necessary.
Business Hour Availability: The US Agent must be reachable by phone or have qualified staff available during regular US business hours to respond to FDA inquiries. This availability requirement is critical because food safety matters often require immediate attention, and delays in communication could escalate regulatory concerns into enforcement actions.
Communication Bridge: The US Agent serves as the official communication link between the FDA and your foreign facility for all regulatory correspondence, including establishment inspection notifications, prior notice questions, and emergency notifications regarding contamination or safety issues. Unless an alternative emergency contact is specifically designated during registration, the US Agent receives all urgent communications on behalf of your facility.
One Agent Per Facility: FDA regulations permit only one US Agent per registered foreign food facility. The agent designation must be updated promptly with FDA if you change your representative, and any changes must be reported within 60 days through an amended registration submission.
Why Choose Liberty Management Group as Your US FDA Agent?
Navigating US food regulations from a foreign location presents significant challenges including time zone differences, language barriers, and unfamiliarity with FDA procedures. Liberty Management Group simplifies this complex regulatory landscape by providing reliable, professional US Agent representation that keeps your facility in good standing with the FDA throughout the year. Our experienced regulatory team monitors all FDA communications addressed to your facility, responds promptly to agency inquiries within required timeframes, coordinates emergency communications during food safety events, manages your biennial registration renewals to prevent lapses, and maintains complete documentation of all FDA interactions for your records.
Our comprehensive US FDA Agent service protects your ability to export food and dietary supplement products to the lucrative US market while ensuring full compliance with American food safety regulations. We have served as US Agent for thousands of foreign food facilities across more than 150 countries since 2009, building the regulatory expertise and FDA relationships that benefit our clients during routine compliance activities and critical safety events alike.
.
U.S. Agent Designation
LMG is designated as your official U.S. FDA Agent — fulfilling the mandatory requirement under the FDA Food Facility Registration regulation for all foreign food establishments.
FDA Communication Relay
We receive and relay all FDA communications regarding your food facility registration — including import alerts, inspection notices, and regulatory inquiries.
Prior Notice
As your U.S. Agent, LMG can assist with FDA Prior Notice submissions — required for all food and dietary supplement imports before arrival at U.S. ports of entry.
Learn More
Registration Certificate
LMG issues an FDA Registration Certificate to all U.S. Agent clients — verifiable by importers and customs brokers.
Learn More
How It Works
Frequently Asked Questions
Is a U.S. Agent required for food facilities?
Yes. All foreign food facilities must designate a U.S. Agent located in the United States as part of their FDA food facility registration — this is a mandatory requirement under the Bioterrorism Act.
What does the U.S. Agent do for food facilities?
The U.S. Agent receives FDA communications on behalf of the foreign food facility — including import alerts, inspection scheduling, and regulatory correspondence — and relays them promptly.
Can I use my importer as my U.S. Agent?
The FDA does not restrict who can serve as U.S. Agent — but using a regulatory specialist like LMG ensures proper handling of FDA communications and regulatory expertise.
What happens if I do not have a U.S. Agent?
Without a U.S. Agent, a foreign food facility cannot complete FDA registration. Unregistered facilities may have their food products refused entry or detained at U.S. ports.
Need a U.S. FDA Agent for Your Food Facility?
LMG provides U.S. Agent services for food facilities in 150+ countries — fast designation with same-day certificate.
Get Started View Fees