Your FDA registration is not finished until the US agent says yes

Updated 2026-08-24

The short answer

21 CFR 1.231 says that after a foreign facility submits an electronic registration, FDA will verify that the person identified as the US agent has agreed to serve. FDA will not confirm the registration or provide a registration number until that person confirms.

The FURLS user guide is the same story in plainer English: for foreign registrations, the US agent will need to confirm or deny the registration. Until that happens, you do not have a finished filing to show Amazon.

What the agent is confirming

Not the product. Not the Amazon listing. The agent is confirming that they agreed to be the communications link for that facility.

FDA emails the person using the email address on the registration. If nobody opens that mail, or the person clicks deny, the designation is unfinished. A new agent then has to be named and has to confirm again.

Updates and renewals use the same brake

If you change the US agent, FDA will not send the update confirmation until the new person confirms. The same is true when you update the agent as part of a biennial renewal.

Food facility registrations expire if they are not renewed from 1 October through 31 December of each even-numbered year. For 2026 that window is 1 October to 31 December. An expired registration is treated as a failure to register.

What sellers should not do while they wait

Do not re-register the same facility to “get a new number.” FDA tells facilities that have lost FURLS access to contact the agency, not to file again.

Do not send Amazon a draft screen-shot and call it a registration number. Assignment of a number, when it comes, means the facility is registered. It does not mean FDA approved the product. See registration is not approval.

Common questions

How long does the agent have to click?

The food-facility rule does not publish a click-by date in 21 CFR 1.231. What it does say is that confirmation and the number wait on the agent’s agreement. If the mail is sitting unopened, the filing is sitting unfinished.

Can I confirm as the brand owner instead?

The verification is of the person identified as US agent. A brand owner who is not that person cannot complete that step.

We used a friend’s Gmail and they left the company.

Update the agent. FDA will verify the new person. Until then, you do not have a confirmed update.

Does cosmetics registration work the same way?

MoCRA foreign facilities also name a US agent, through Cosmetics Direct, which is a different portal from food FURLS. Do not wait for a food-facility email if the products are cosmetics.

Is there an FDA fee for this confirmation?

No. There is no fee to register a food facility. Private agents may charge for being available to click and to relay mail.

Sources

• 21 CFR 1.231 — FDA will not confirm a foreign facility’s registration or provide a registration number until the named US agent confirms agreement to serve — ecfr.gov
• FDA Food Facility Registration User Guide — for foreign registrations the US agent must confirm or deny; domestic facilities do not require a US agent — fda.gov
• 21 CFR 1.230(b) and 1.241(b) — biennial renewal 1 October–31 December of each even-numbered year; an unrenewed registration is expired and treated as a failure to register — ecfr.gov
• FDA, food facility registration fees — do not re-register if you lost FURLS access; contact FDA instead; no registration fee — fda.gov

This guide is general information about US-agent confirmation of a food-facility registration, not legal advice, and it does not create a client relationship.