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FDA food facility registration

FDA food facility registration and renewal

Facilities that make, pack or hold food for the United States must register with FDA and renew every two years. Allied files the registration or the renewal for $145, with an Allied CHB Certificate of Registration.

Order a registration or renewal2026 renewal dates
Our fee
$145
For a registration or a biennial renewal. Certificate included.
FDA fee
None
21 CFR 1.231(c)
2026 renewal
October 1 to December 31, 2026
Facility ID
DUNS number
Required since October 1, 2020

When is the 2026 renewal?

Food facilities renew their FDA registration every other year, from October 1 to December 31 of each even-numbered year (21 CFR 1.230(b)).

The 2026 renewal window opens October 1, 2026

Each registration made before October 1, 2026 must be renewed between October 1 and December 31, 2026. A registration that is not renewed by 11:59 p.m. on December 31 expires, and FDA cancels it (21 CFR 1.241).

Food from a foreign facility without a valid registration can be held at the port (21 CFR 1.285).

FDA food facility registration renewal dates
DateWhen
2026 renewal window opensOctober 1, 2026, 12:01 a.m.
2026 renewal window closesDecember 31, 2026, 11:59 p.m.
Next renewal windowOctober 1 to December 31, 2028

Who must register?

A facility that manufactures, processes, packs or holds food for consumption in the United States must register (21 CFR 1.225). This applies to domestic and foreign facilities. The owner, operator or agent in charge registers it, under section 415 of the Federal Food, Drug, and Cosmetic Act.

Food here has a wide meaning. It includes beverages (also alcoholic beverages and bottled water), dietary supplements, food ingredients and additives, and animal feed and pet food (21 CFR 1.227). A domestic facility registers even if its food never leaves the state.

  • These facilities register

    • Manufacturers and processors of food
    • Packers, repackers and labelers
    • Warehouses and cold stores that hold food
    • Foreign facilities whose food comes to the United States with no further processing abroad
    • Mixed-type facilities, for example a farm that also does activities outside the farm definition

  • These do not register (21 CFR 1.226)

    • Farms
    • Retail food establishments and restaurants
    • Nonprofit food establishments that prepare or serve food for consumers
    • Fishing vessels that do not process fish beyond what holding on board needs
    • Facilities regulated only by USDA for meat, poultry or egg products
    • A foreign facility whose food another foreign facility processes or packs further. Labeling alone does not count.

Register only when the rule requires it

On July 20, 2026, FDA warned about businesses that register when the rule does not require it. A registration that you do not need can bring inspections and confusion about your obligations. The rule covers places where food is made, packed or held. A private residence is not a facility (21 CFR 1.227).

What does FDA need for the registration?

The registration uses the fields of Form FDA 3537. It must be in English, in the Latin alphabet. Names of people, companies and streets can stay in the original language (21 CFR 1.231(d)).

Required data (21 CFR 1.232)

  • Facility name, full address and phone number
  • Unique facility identifier: a DUNS number
  • Preferred mailing address, if different
  • Parent company name, address and phone, if the facility is a subsidiary
  • All trade names that the facility uses
  • Owner, operator or agent in charge: name, address, phone and email
  • Food product categories and the activity type for each, as listed on Form FDA 3537
  • An assurance that FDA may inspect the facility
  • A certification that the information is true and accurate
  • Domestic facility: a contact email and an emergency contact
  • Foreign facility: the U.S. agent's name, address, phone and email, and an emergency contact

The DUNS number

Since October 1, 2020, each registration must include a unique facility identifier that FDA accepts. FDA accepts the DUNS number, which Dun & Bradstreet issues.

FDA checks the DUNS number, and the address on the DUNS record must match the address on the registration. FDA gives no registration number until both match (21 CFR 1.231(a)(3)).

Get or check the DUNS number first. FDA says a new DUNS number can take up to 45 days or more.

Does a foreign facility need a U.S. agent?

Yes. A foreign facility must name a U.S. agent in its registration (21 CFR 1.232(c)). The U.S. agent lives in the United States or keeps a place of business there, and is physically present. A mailbox, an answering machine or an answering service cannot be the U.S. agent (21 CFR 1.227).

FDA uses the U.S. agent as its link to the facility, for emergencies and routine matters. FDA treats what the agent says as the facility's own statement. FDA emails the U.S. agent to confirm that the agent agreed to serve. It gives no registration number until the agent confirms (21 CFR 1.231(a)(5)).

Allied does not act as U.S. agent

We do not offer U.S. agent service. We can explain the options, for example your U.S. importer, a U.S. subsidiary or a company that offers U.S. agent service. The agent must agree before we file.

Does FDA issue a registration certificate, and what do I get?

No. FDA does not issue registration certificates.

FDA also does not recognize a certificate of registration that a private business issues. It states that there is no fee to register, and that you do not have to use a third party or a registrar. Read the FDA statement.

You are registered when FDA confirms the registration and sends the registration number (21 CFR 1.231(a)(7)). After we file, you get an Allied CHB Certificate of Registration. It shows your FDA registration number, your UFI (DUNS number), the date we verified the registration in FDA's system and the next renewal period. Buyers, importers and customs brokers often ask for it.

The certificate is an Allied CHB document. It is not an FDA document, and it does not mean FDA approval. Allied CHB is not affiliated with FDA.

How do I keep the registration number and PIN safe?

On July 20, 2026, FDA told food facilities to protect their registration information. Some third parties ask for the registration number and PIN. Some seller platforms ask for a copy of the registration or a certificate.
  • Keep the PIN private. With your registration number and PIN, another party can link the registration to its own FDA account. Then it can view, change or cancel your registration.
  • Never share the username and password of your FDA Industry Systems (FIS-FURLS) account. Create subaccounts for your staff.
  • FDA does not require you to share your registration number with third parties. The registration information is not public (21 CFR 1.243).
  • For imports, give the number to the party that files prior notice for your food. This is often your customs broker.
  • Check your registration status only on the FDA website.
  • If you shared the number and the PIN by mistake, FDA suggests that you cancel the registration and register again.

We never ask for your FIS-FURLS username or password. To renew a registration that another account holds, we ask for the number and PIN only with your written authorization, and only for that filing.

What do I get for $145?

One price for a new registration or a biennial renewal, with the certificate included. The registration then runs until the next renewal window.

  • Eligibility check

    We check that your facility must register, or tell you which exemption applies. FDA does not want registrations that the rule does not require.

  • DUNS and address check

    We compare the DUNS record with the facility address before we file. FDA gives no registration number until the two match.

  • Registration or renewal filing

    We file in the FDA system as the individual that you authorize (21 CFR 1.225(c), 1.230(b)).

  • Allied CHB Certificate of Registration

    It shows your FDA registration number, your UFI (DUNS number), the date we verified the registration in FDA's system and the next renewal period. It is an Allied CHB document, not an FDA document.

Not included: U.S. agent service (we do not offer it). Registration updates and cancellations are quoted on request.

What if something changes between renewals?

Update the registration within 60 calendar days of any change, for example a new operator, agent in charge or U.S. agent (21 CFR 1.234(a)). A new owner does not update. The former owner cancels within 60 days, and the new owner registers again (21 CFR 1.234(b)).

Cancel the registration within 60 calendar days when the facility closes, stops supplying food for the United States, or is sold (21 CFR 1.235).

What about cosmetics and other FDA registrations?

Cosmetic facility registration and product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) follow separate rules. So do drug, medical device and other FDA registrations. We quote these on request. Cosmetics imports.

How does it work?

FDA confirms a registration only after the DUNS check and the confirmation emails. Send complete data to avoid a second round.
  1. You

    Send the facility details

    Facility name and address, DUNS number, owner or operator contact, food categories and activities. For a renewal, send the registration number.

  2. Allied

    Check eligibility and data

    We confirm that the facility must register. We compare the DUNS record and the address, and we list anything missing.

  3. You

    Authorize the filing

    Sign our authorization. A foreign facility also names its U.S. agent, and that agent must agree to serve.

  4. Allied

    File in the FDA system

    We submit the registration or the renewal. For a renewal with no changes, we use the abbreviated renewal.

  5. You

    Confirm the FDA email

    FDA emails the person who authorized the filing, and the U.S. agent of a foreign facility. FDA issues the number only after each one confirms.

  6. Allied

    Issue the certificate

    You get the Allied CHB Certificate of Registration with your FDA registration number, your UFI (DUNS number), the date we verified the registration and the next renewal period.

Request: FDA food facility registration or renewal

$145 for a registration or a biennial renewal

Do not send an EIN, a Social Security number or a password in this form. We ask for them securely later.

Or call (908) 291-8001 or email info@alliedchb.com.

FDA food facility registration: common questions

Does FDA charge a fee for food facility registration?

No. There is no FDA fee to register or to renew (21 CFR 1.231(c)). You do not have to use a third party. Our $145 is our fee for the work: the eligibility check, the data check, the filing and the Allied CHB Certificate of Registration.

Will I get a registration certificate?

Yes. You get an Allied CHB Certificate of Registration, included in the $145. It shows your FDA registration number, your UFI (DUNS number), the date we verified the registration in FDA's system and the next renewal period. FDA itself does not issue certificates of registration, and it does not recognize certificates that private businesses issue. Our certificate is an Allied CHB document. It does not mean FDA approval, and Allied CHB is not affiliated with FDA.

We registered in 2025. Do we renew in 2026?

Yes. A registration made before October 1, 2026 must be renewed between October 1 and December 31, 2026 (21 CFR 1.230(b), 1.241(b)).

What happens if we miss the renewal?

FDA treats the registration as expired and cancels it. FDA then treats the facility as not registered, which is a prohibited act (21 CFR 1.241). Food from an unregistered foreign facility can be held at the port (21 CFR 1.285). The facility must register again.

Is a DUNS number required?

Yes. Since October 1, 2020, each registration must include a unique facility identifier that FDA accepts (21 CFR 1.232(a)(2)). FDA accepts the DUNS number from Dun & Bradstreet. The address on the DUNS record must match the facility address.

Does a U.S. importer have to register?

Only for a facility that it owns or operates where food is made, processed, packed or held (21 CFR 1.225, 1.227). A warehouse that holds your food registers its own facility. We check your case before we file.

Can we use the short renewal?

Yes, if nothing in the registration changed since the last submission. FDA calls it the abbreviated registration renewal (21 CFR 1.230(c)). The fee is the same $145.

What if we change something between renewals?

Update the registration within 60 calendar days of the change, for example a new operator or U.S. agent (21 CFR 1.234). A new owner does not update: the former owner cancels, and the new owner registers again. We quote updates and cancellations on request.

Renew by December 31, 2026

Send the facility details and the registration number. We check the data, file the renewal and issue your Allied CHB Certificate of Registration. $145.

Call (908) 291-8001 or email info@alliedchb.com

Order a renewalContact us

Last reviewed September 26, 2026. This page explains customs rules in general terms. It is not legal advice. Duty rates and CBP procedures change often, and we confirm the figures for your shipment in writing before you commit.

Sources