U.S. Agent Services Food & Beverage
Foreign food and beverage facilities importing into the U.S. are legally required to designate a U.S. Agent. We serve as your trusted, primary point of contact with the FDA receiving all communications, coordinating inspections, and ensuring no critical information is ever missed due to time zones or language barriers.
⏱ We respond to all inquiries within 24 business hours
Your U.S. Agent relationship can stay connected to food facility registration, biennial renewal tracking, Prior Notice filings, and food label review through one accountable team. These are separate compliance services, not functions of a passive mailbox.
U.S. Agent Services Food & Beverage
Official Communication Hub
As your designated U.S. Agent, we act as the mandatory, primary point of contact for the FDA. All official correspondence, urgent notices, and regulatory inquiries come directly to us.
- Primary FDA point of contact
- All official correspondence received & forwarded
- No missed notices due to time zones or language
- Regulatory inquiry handling
Inspection Coordination
We assist in facilitating and scheduling FDA inspections of your foreign facility serving as the key liaison to coordinate logistics and ensure you are fully prepared.
- FDA inspection scheduling support
- Logistics coordination with your team
- Pre-inspection readiness guidance
- Post-inspection follow-up
Emergency Contact
In the event of a product recall or public health alert, the FDA contacts us immediately. We ensure time-sensitive communications reach your team without delay.
- Recall & public health alert response
- Rapid notification to your team
- Protects company & public safety
Regulatory & Registration Support
We assist with initial and biennial FDA food facility registration, ensuring your information is accurate, up-to-date, and your DUNS number is properly maintained.
- Food facility registration & renewal
- DUNS number maintenance
- Registration accuracy assurance
- Ongoing compliance support
Choosing the Right U.S. Agent Matters
Choosing the right FDA registered agent isn’t just about checking a box it’s about partnering with a team that provides the personal attention and expertise you need to succeed in the U.S. market. Contact us today to learn how our U.S. Agent services can safeguard your compliance and streamline your import process.
Getting FDA compliant has never been easier
Step 1: Register & Designate
Complete our short form and designate FDA Entry Point as your U.S. Agent.
Step 2: We Confirm
We confirm and submit your FDA registration update within 1 business day.
Step 3: Active Coverage
We receive all FDA communications on your behalf immediately.
Step 4: Ongoing Renewal
We track and file your registration renewal on schedule, so there’s never a lapse in coverage.
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Food & Beverage Services At a Glance
| Service | Who Needs It | Frequency | Timeframe | Pricing Starting at |
|---|---|---|---|---|
| U.S. Agent Services | Foreign facilities only | Annual | Before FDA registration; renew each year | $295/yr |
| Food Facility Registration | Domestic & foreign | Biennial | Oct Dec of even-numbered years | $249 |
| Prior Notice (Imports) | Foreign importers | Per unique product line | Before arrival at U.S. border | $30/filing |
| Food Label Review | All manufacturers | Per product/change | Before market entry or label change | $249/product |
| Dietary Supplements | Supplement manufacturers | Biennial + ongoing | Oct Dec biennial; NDI notification 75 days prior | $249 |
| Animal & Veterinary | Pet/animal food facilities | Biennial | Oct Dec of even-numbered years | $249 |
How to Change Your U.S. Agent
Already working with an agent? Here is how to switch to a new one without a gap in coverage.
Step 1: Select Your New U.S. Agent
Confirm the new agent agrees to the designation and provides a signed acceptance letter listing their U.S. address, phone number, and email address.
Step 2: Update Your Registration on FURLS
Log in to FURLS (the FDA Unified Registration and Listing System) and update the U.S. Agent fields on your facility registration with your new agent’s contact information.
Step 3: Submit the Update
The change takes effect immediately upon successful submission. The FDA does not charge a fee for this update.
Step 4: Confirm With Your New Agent
Verify that your new U.S. Agent has received the registration confirmation and is ready to act on your behalf.
Step 5: Notify Your Former Agent
Let your outgoing agent know the change is complete so there is no confusion if the FDA reaches out to them during the transition.
Important Timing Note
Federal regulations require you to update your U.S. Agent information within 60 days of any change. Do not leave a gap in U.S. Agent coverage: if the FDA attempts to contact your facility through an outdated or non-functional agent, it can trigger enforcement action, including import refusal and registration cancellation.
FAQs
Any foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States is legally required to designate a U.S. Agent. This requirement applies regardless of the size of the facility or the volume of product imported. It is established under Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Bioterrorism Act of 2002 and further reinforced by the Food Safety Modernization Act (FSMA). Domestic U.S. facilities are exempt; the requirement applies only to foreign facilities.
Your U.S. Agent serves as the FDA’s official point of contact for your facility while your products are in the U.S. market. Practically, this means the FDA can reach someone in the U.S. during business hours, and in emergencies at any hour, without navigating international time zones or language barriers. Your U.S. Agent receives all FDA correspondence and notices, assists in scheduling and coordinating facility inspections, responds to regulatory inquiries on your behalf, and ensures that recall notices or public health alerts are communicated to your team immediately. Without an active U.S. Agent, the FDA has no reliable channel to reach you, which creates significant compliance and import risk.
The consequences are serious and can directly disrupt your ability to sell in the U.S. market. The FDA can refuse or suspend your food facility registration if no valid U.S. Agent is designated. Without an active registration, your products can be detained or refused entry at the U.S. border. Under FSMA, the FDA has authority to suspend your facility’s registration outright, at which point distributing food in the U.S. is prohibited and shipments are subject to detention at U.S. ports of entry. Reinstating a suspended registration takes time and requires corrective action, during which your shipments remain at risk. A lapse in U.S. Agent coverage, even a brief one, can trigger these outcomes.
Food facility registrations must be renewed biennially, every two years, during the window of October 1 through December 31 of each even-numbered year. Missing this window results in an expired registration, which means your facility is no longer authorized to import food into the U.S. until the registration is reinstated. Your U.S. Agent designation must also remain current; if your U.S. Agent changes or goes out of business, you are required to update your registration promptly. We track renewal deadlines for all clients and proactively coordinate renewals so there is no lapse in coverage.
No. These are two distinct roles with different legal functions. Your importer of record (IOR) is the party responsible for customs entry and payment of duties when your products arrive at the U.S. border. Your FDA U.S. Agent is your designated representative for all FDA regulatory communications under 21 CFR Part 1, Subpart H. The two roles can be held by different companies, and in most cases they are. Your U.S. Agent must be available to the FDA on an ongoing basis, not just at the point of import, so a customs broker or freight forwarder who only touches your shipments at entry is generally not suited for the U.S. Agent role.