FDA food facility registration renewal 2026: what foreign food exporters must do by 31 December

Estimate, not legal advice: verify with a licensed customs broker. Facts on this page were last checked on 2026-10-14 against the US Code of Federal Regulations (21 CFR part 1) and FDA's own pages.

If your factory, packing house or warehouse makes, packs or holds food that is eaten in the United States, it must be registered with the US Food and Drug Administration (FDA). A registration does not last forever: it must be renewed every other year, between 1 October and 31 December of each even-numbered year. The 2026 window is open now. A registration that is not renewed by 31 December 2026 expires, and food from an unregistered foreign facility can be held at the US port.

Key facts for 2026

FDA's user guide gives the times without a time zone. Do not leave the renewal to the last day.

Who must renew

The owner, operator or agent in charge of a domestic or foreign facility that manufactures, processes, packs or holds food for consumption in the United States must register it (21 CFR 1.225), and every registered facility must renew (21 CFR 1.230(b)).

The rule does not apply to (21 CFR 1.226):

• a foreign facility whose food is further manufactured or processed, including packaging, by another facility outside the United States. Adding a label or a similar minor step at the second facility does not count as further processing, so the first facility then still has to register;
• farms;
• retail food establishments and restaurants;
• nonprofit food establishments that prepare or serve food directly to the consumer;
• fishing vessels that harvest and transport fish, including those that head, gut or freeze fish only to hold it on board (vessels that otherwise process fish must register);
• facilities regulated, throughout the entire facility, only by the US Department of Agriculture (meat, poultry and egg products).

FDA also states that traders and brokers are not required to register (FDA questions page on registration fees).

If your facility left the US market, closed or was sold, the rule asks for a cancellation within 60 calendar days instead of a renewal (21 CFR 1.235(a)).

What you need before you start

The renewal contains the same information as a registration (21 CFR 1.232). Check each item before you log in:

1. Facility name, full address and phone number, and all trade names the facility uses.
2. The unique facility identifier (UFI). FDA verifies that the address tied to the UFI matches the registration address, and does not confirm a renewal that updates the UFI until it has checked this (21 CFR 1.231(a)(3)). FDA currently names the DUNS number as the accepted UFI.
3. Owner, operator or agent in charge: name, full address, phone and email.
4. US agent (foreign facilities): name, full address, phone and email. The US agent is a person who lives or keeps a place of business in the United States; a mailbox, answering machine or answering service cannot be the agent. FDA treats the US agent as its contact for routine and emergency communication (21 CFR 1.227). If you change the US agent during the renewal, FDA does not confirm the renewal until the new agent confirms (21 CFR 1.231(a)(5)).
5. Emergency contact phone and email (21 CFR 1.232(c)(2)).
6. Food product categories and the activity type for each one, for example manufacturer/processor, packer/repacker, or a storage warehouse (21 CFR 1.232(a)(7), (8)).
7. Two statements: an assurance that FDA may inspect the facility as the law permits, and a certification that the information is true and accurate (21 CFR 1.232(a)(9), (10)).

If nothing has changed since your last registration, renewal or update, the rule allows an abbreviated renewal: you confirm there are no changes and certify that the information is true and accurate (21 CFR 1.230(c)).

How to renew

• Online. Since 4 January 2020, registrations and renewals must be submitted electronically unless FDA has granted a waiver; with a waiver you may use Form FDA 3537 by mail or fax (21 CFR 1.231(a)(2), (b); 1.245).
• Someone may renew for you. The owner, operator or agent in charge may authorize another person to renew. That person certifies the information and their authority, and names the person who authorized them, with an email address; FDA then checks with that person before it confirms (21 CFR 1.230(b), 1.231(a)(4)).
• Confirmation. FDA sends an electronic confirmation of the renewal (21 CFR 1.231(a)(3)-(5)). Keep it with your shipping records.
• No paid registrar is required. FDA states that facilities do not need a third-party business or "registrar" to register. A US agent may charge for acting as your agent; that is a private matter between you and the agent (FDA questions page on registration fees).

Small "qualified facilities" that use the modified requirements of the Food Safety Modernization Act must also submit their qualified facility attestation in the same October to December period (FDA constituent update, 29 September 2026).

What happens if you miss 31 December

• FDA considers a registration that is not renewed in the window to be expired, and treats the facility as having failed to register (21 CFR 1.241(b)). FDA cancels expired registrations (21 CFR 1.241(c)).
• Failing to register, renew, update or cancel as required is a prohibited act under section 301(dd) of the Federal Food, Drug, and Cosmetic Act (21 CFR 1.241(a)).
• Food imported from a foreign facility that is not registered is subject to being held at the port of entry. Unless it is exported at once with the agreement of US Customs and Border Protection, it must stay in the port (21 CFR 1.285(a), (b)). To resolve a hold, the facility must register and send the registration number to FDA within 30 calendar days of the hold notice (21 CFR 1.285(i)). Food that stays on hold without a registration number, a review request or export may only be sold for export or destroyed, unless CBP and FDA agree otherwise (21 CFR 1.285(g)).
• Food from an unregistered foreign facility that arrives by international mail is held for 72 hours for FDA inspection, and can be returned to the sender (21 CFR 1.285(k)).

After you renew

• Update within 60 calendar days of any change to the registered information, for example a new operator, agent in charge or US agent (21 CFR 1.234(a)).
• A registration is not an approval. A registration number means only that the facility is registered; it "does not in any way convey FDA's approval or endorsement of a facility or its products" (21 CFR 1.242).
• There is no FDA registration certificate. FDA states that it does not issue a certificate of registration and does not recognize such certificates issued by private businesses (FDA questions page on registration fees). A buyer who asks for "an FDA certificate" for food usually needs your registration number, not a certificate.

Checklist before 31 December 2026

1. Find your registration number and the login used last time.
2. Confirm your UFI and that its address matches the registration address.
3. Confirm with your US agent that they will keep acting for you and will confirm FDA's request.
4. Re-check product categories and activity types against what you ship now.
5. Renew (abbreviated if nothing changed) and save FDA's confirmation.
6. If you are a qualified facility, submit the attestation in the same window.
7. Send the registration number to your US buyer or importer.

Check your codes

Registration is one step; each shipment still needs the right tariff line. Use the free HS lookup to find the US code and duty layers for your product from Vietnam or China.

Related guides

• HS code for coffee 0901: US duty for Vietnamese coffee
• US tariffs on Vietnamese goods in 2026: what changed
• All guides are listed on Guides.

FAQ

Is there a fee to renew? No. FDA states that there is no fee associated with registration or renewal.

When is the deadline? The 2026 renewal window runs from 1 October to 31 December 2026 (21 CFR 1.230(b)). The next window is 1 October to 31 December 2028.

Do I need a US agent? A foreign facility must name a US agent in its registration, with name, full address, phone and email (21 CFR 1.232(c)(1)).

I registered in 2025. Do I still renew in 2026? Yes. The rule asks every registered facility to renew in each even-numbered year's window; it has no exception for recent registrations (21 CFR 1.230(b), 1.241(b)).

Does a renewed registration mean FDA approved my products? No. Registration "does not in any way convey FDA's approval or endorsement" (21 CFR 1.242).

Sources

Primary sources, checked on 2026-10-14.

• Code of Federal Regulations, 21 CFR part 1, subpart H: registration of food facilities, sections 1.225 to 1.245
• Code of Federal Regulations, 21 CFR 1.285: holds on food from unregistered foreign facilities
• FDA, constituent update of 29 September 2026: biennial renewal, no fee, qualified facility attestations
• FDA, user guide for the biennial registration renewal: renewal period and the accepted UFI
• FDA, questions page on registration fees and private certificates: no fee, no registrar, no certificate, traders and brokers

Published 2026-10-14. Last updated 2026-10-14.