FDA U.S. Agent
FDA U.S. Agent for foreign food, drug, device and cosmetic companies
FDA U.S. Agent service for foreign facilities that must register with the U.S. Food and Drug Administration: we are named as your U.S. Agent and handle FDA communication in U.S. business hours.
AFI acts as U.S. Agent under a written appointment. Registration, listing and compliance remain your company’s responsibility.
Who needs an FDA U.S. Agent
FDA requires many foreign facilities to name a U.S. Agent when they register. That includes facilities that manufacture, process, pack or hold food for U.S. consumption, drug establishments, medical device establishments and, under the Modernization of Cosmetics Regulation Act, cosmetic facilities.
The U.S. Agent must live in the United States or keep a place of business here, and be physically present in the U.S. FDA uses the agent as its point of contact with the foreign facility, including for routine questions and emergencies.
What your U.S. Agent for FDA registration does
As your U.S. Agent, AFI is named in your FDA registration with a U.S. address and phone number. We receive FDA communications for your facility, reply to routine questions, and pass anything that needs your action to your team the same business day.
FDA can treat information given to the U.S. Agent as given to the facility, so response time matters. We keep a written log of every FDA contact and the action taken.
The U.S. Agent role does not make AFI responsible for your product’s compliance. Registration, product listing, labelling and regulatory advice stay with your company and your regulatory consultant. Food facilities renew their registration every two years, between October and December of even-numbered years, and we remind you before each window.
How it works
How AFI becomes your FDA U.S. Agent
- Step 01
Facility details
You send your facility, product types and current FDA registration status.
- Step 02
Written appointment
We sign a U.S. Agent agreement that sets out what we do and how fast.
- Step 03
Registration update
Your company or consultant names AFI as U.S. Agent in the FDA registration; FDA may contact us to confirm.
- Step 04
Ongoing contact
We handle FDA communication and report every contact to your team.
Questions about fDA U.S. Agent
Does every foreign company need an FDA U.S. Agent?
No. It depends on what you make. Foreign food, drug, medical device and cosmetic facilities that register with FDA generally need one. Check your product type with FDA or a regulatory consultant.
Can our U.S. importer act as our FDA U.S. Agent?
Yes, if they agree and meet FDA’s requirements. Many manufacturers use an independent agent instead so the role does not change when importers change.
Do you register our facility with FDA?
No. Your company or regulatory consultant submits the registration and names AFI as U.S. Agent. We confirm the appointment when FDA contacts us.
Is the U.S. Agent responsible for our product’s compliance?
No. Compliance with FDA rules stays with your company. The U.S. Agent is the communication link between FDA and your facility.
Related services
Each service works on its own or as part of AFI's U.S. market representation services.
- U.S. market entry Market assessment, entry route and launch plan, then the work to carry it out.
- U.S. trademark registration Clearance search and USPTO filing through a licensed U.S. trademark attorney, managed by AFI.
- U.S. sales representation A U.S. representative who finds buyers, attends meetings and follows up for you.
- U.S. distributor search We identify, vet and approach U.S. distributors for your category.
- Trade show representation Meetings booked before the show, your booth staffed, and follow-up after.
- U.S. business representative A U.S. phone line, email and named contact for buyers and partners.
- For Chinese companies U.S. sales, distribution and contact for manufacturers based in China.
- Amazon market entry Brand Registry, U.S. listings and launch planning for brands entering Amazon.com.
- Texas registered agent Registered agent and registered office in Austin for Texas companies with owners abroad.
Book a consultation
Tell us what you make and what you need from fDA U.S. Agent. We reply by email within 24 hours to arrange a call.
- Phone
- +1-512-877-1986
- Office
- 9308 Swooping Bat Dr, Austin, TX 78744