Does FDA charge for a U.S. Agent?
No. FDA does not charge anything for naming a U.S. Agent, and it does not charge a fee for food facility or cosmetic facility registration. What you pay is the agent's own service fee. Medical device establishments are different: they pay FDA an annual establishment registration fee, separate from any agent fee.
What a U.S. Agent costs
Prices vary widely between providers. Some charge only for the agent service and bill registration, renewal or changes separately. Others, like Regovant, include the registration in one yearly price.
| Regovant food facility registration + U.S. Agent | $269 per year |
|---|---|
| Additional food facility, same owner | $169 per year |
| Cosmetic, device or drug facility + U.S. Agent | $369 per year |
What should be included
- A real U.S. address and phone that FDA can reach during U.S. business hours.
- Fast forwarding of FDA messages and inspection requests to you.
- Confirming the agent role when FDA asks after your registration or renewal.
- Renewal reminders, so your registration never lapses.
- Help with changes, such as a new address or contact.
Hidden costs to watch for
- Separate fees for registration, renewal or each update.
- Long contracts or automatic multi-year renewals.
- Per-message or per-inspection fees when FDA contacts the agent.
- Prices that leave out the D-U-N-S check, the most common reason registrations fail.
Questions
Can my importer or buyer be my U.S. Agent?
Yes, if they agree and have a U.S. address. Many companies prefer an independent agent so they are not tied to one buyer and do not lose their agent when they change customers.
Can I switch U.S. Agent?
Yes. The registration is updated with the new agent's details, and FDA asks the new agent to confirm. Renewal time is the easiest moment to switch.
Is the U.S. Agent responsible for my products?
No. The U.S. Agent is FDA's point of contact. Your company remains responsible for its products and its registration.
How Regovant can help
Regovant LLC registers food, cosmetic, device and drug facilities with FDA, checks your D-U-N-S details and acts as your U.S. Agent. Food facility registration with U.S. Agent service is $269 per year. See all guides or services and prices.