FDA · U.S. AGENT SERVICE
Private FDA compliance support company. Not affiliated with the U.S. Food and Drug Administration.
If your company is located outside the United States and manufactures, processes, packs, or holds food for the U.S. market, your FDA food facility registration must identify a U.S. Agent.
This is not optional. The U.S. Agent is the communication link between FDA and the foreign facility. FDA may contact the U.S. Agent for routine or emergency communications related to the registration.
The U.S. Agent must have a real presence in the United States. It cannot be only a mailbox, answering machine, virtual address, or a service where no individual is physically present.
That is why many exporters, manufacturers, packers, and warehouses in Latin America choose REGISTRO-FDA.US to serve as their U.S. Agent.
An FDA U.S. Agent is the person or company located in the United States that a foreign food facility designates as FDA’s communication contact for food facility registration purposes.
You likely need an FDA U.S. Agent if your company is outside the United States and your facility is involved in food products that will be consumed in the U.S.
Typical products include packaged foods, beverages, snacks, bakery products, canned foods, dietary supplements, ingredients, animal food, and other FDA-regulated food categories.
Important clarification: The FDA U.S. Agent requirement on this page is for food facility registration. It is not the same as the Responsible Person requirement under MoCRA for cosmetics. If you need cosmetic facility registration or MoCRA Responsible Person support, use the cosmetics service page instead.
Many foreign companies believe they can use a friend’s address, a virtual office, a mailbox, or a freight forwarder as their FDA U.S. Agent.
That can create problems.
For FDA food facility registration, the U.S. Agent must be a real person or entity in the United States that can act as a communication link between FDA and the foreign facility. FDA may treat communications to the U.S. Agent as communications to the foreign facility.
This means your U.S. Agent should be reliable, reachable, and prepared to forward important FDA notices quickly.
Why this matters in real life:
If FDA sends a message and nobody receives it, understands it, or forwards it, your company may miss important regulatory communication.
That can affect your ability to respond on time, update your registration, renew correctly, or handle FDA questions related to your facility.
REGISTRO-FDA.US provides a real U.S. contact point with bilingual support, practical experience with foreign exporters, and a process designed for fast communication.
REGISTRO-FDA.US helps foreign food companies designate a U.S. Agent for FDA food facility registration and ongoing communication support.
Our service includes:
What we do not do:
We help you manage the U.S. Agent designation and communication function required for the FDA food facility registration process.
Choose the term that fits your plans:
Send your facility details; we confirm whether you need U.S. Agent only or also FDA registration, renewal, update, or Prior Notice support.
We provide the U.S. Agent information needed for your FDA registration and manage the designation.
FDA communications received for your facility are forwarded to your authorized contact, and we keep your registration updated when your information changes.
We are based in Miami, Florida, a practical hub for Latin American exporters entering the U.S. market.
Your team can communicate with us in Spanish or English. This helps avoid confusion when FDA correspondence is written in English but your internal team operates in Spanish.
When FDA communication is received and your contact information is current, we forward correspondence in under 24 business hours after receipt.
We work with foreign companies that need to understand the U.S. entry process, FDA registration, renewal, Prior Notice, a label compliance check, and related compliance steps.
You know what the U.S. Agent service includes and what it does not include. No false promises, no “FDA certificate” claims, and no confusing language.
To begin, prepare:
You do not need to know every answer before contacting us. If you are unsure, we help you identify what applies to your case.
FDA food facility registration is not a product approval and does not mean FDA certifies your facility or your products.
Many foreign companies need more than the U.S. Agent designation. REGISTRO-FDA.US can also help with related administrative services for the U.S. market.
For foreign facilities that need to register before manufacturing, processing, packing, or holding food for the U.S. market.
For facilities that need to renew their food facility registration during the FDA renewal period or update outdated information.
For food shipments entering the United States that require Prior Notice before arrival.
For companies that need help preparing the facility identifier used in the registration process.
If your foreign food facility needs FDA registration, renewal, or an agent update, REGISTRO-FDA.US can serve as your U.S. Agent in the United States. We help you move forward with a real U.S. presence, bilingual communication, and a clear process. Based in Miami, serving food exporters and foreign facilities that need practical FDA registration support for the U.S. market.
REGISTRO-FDA.US is a private consulting and administrative support service. We are not affiliated with the U.S. Food and Drug Administration. Information on this page is educational and does not constitute legal advice. FDA requirements may vary depending on your facility, product, activity, and regulatory status.
