What form and system are used?

Form FDA 3537, submitted electronically through FDA’s Unified Registration and Listing System (FURLS) after you create an FDA Industry Systems account (21 CFR 1.231). Electronic filing is required unless FDA grants a waiver under 21 CFR 1.245. Spell it FURLS — FDA Unified Registration and Listing System. Cosmetics Direct is a different portal and is wrong for food.

When is the next biennial renewal?

1 October through 31 December 2026, then the same dates in every even-numbered year (21 CFR 1.230(b)). There is no grace period. If you do not renew, the registration is no longer current and food from the facility is adulterated (21 CFR 1.241). Axentra files the 2026 renewal and keeps the FURLS account alive between cycles.

Do foreign food facilities need a U.S. Agent?

Yes. 21 CFR 1.227 and 1.232 require a foreign facility to designate a U.S. Agent — a person or company located in the United States, available during U.S. business hours — as part of registration. If FDA cannot reach the agent, the registration may be suspended and imports held. A mailing address or answering service does not qualify. Delivery of an FDA document to the agent is delivery to you.

Is there an FDA fee for food facility registration?

No. FDA does not charge a user fee to submit, renew, or update Form FDA 3537. 21 CFR 1.231(c) states plainly: "No registration fee is required." Any fee you pay is a professional service fee to a consultant, not a government charge. FDA maintains a public warning about private firms that imply an FDA affiliation while charging registration fees. Axentra’s public U.S. Agent Market Access Bundle is $299 per year per facility and covers official U.S. Agent appointment, facility registration, and communications handling. FSVP plans, Prior Notice operational support, and label review are separate engagements and are not priced on this page.

Does facility registration satisfy FSVP?

No. FSVP is 21 CFR Part 1, Subpart L. It is an obligation of the U.S. FSVP importer (typically the U.S. owner or consignee at entry) to verify that the foreign supplier produces food as safe as U.S. law requires. The U.S. Agent named on Form FDA 3537 is a different role. You can have a perfect registration and still fail an FSVP inspection of the importer.

Do I still need Prior Notice if I am registered?

Yes. Registration identifies the facility. Prior Notice (21 CFR Part 1, Subpart I; Form FDA 3540) identifies the shipment. File it no more than 15 calendar days before arrival and not later than the cutoff in 21 CFR 1.279: 2 hours before arrival by land, 4 hours by air, 8 hours by water. Prior Notice is not in the $299 U.S. Agent bundle; it is typically filed by the importer or customs broker. Shipments without valid Prior Notice are subject to refusal of admission.

What happens if we miss the 2026 window?

The registration is no longer current. 21 CFR 1.241 treats food from a facility that is required to register and has failed to register, or whose registration is cancelled or suspended, as adulterated. In practice, FDA and CBP can detain or refuse lots, and in-transit shipments stall. There is no grace period. Re-registration after a lapse is possible but does not automatically release product already held.

Who this covers

Food & beverage makers · co-packers · warehouses · dietary supplements (regulated as food) · pet food & animal feed · matcha/tea, snacks, sauces, infant-adjacent products

Starting at $299 per year per facility for FFR and U.S. Agent. Form 2541 process filing and TTB work are not in that fee. Not an FDA fee.

Food Facility Registration — Frequently Asked Questions

When is the 2026 FDA food facility registration renewal deadline?

The renewal window runs from 1 October to 31 December 2026. Under 21 CFR 1.230(b) registration must be renewed "every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year", and 2026 is an even-numbered year.

Does FDA charge a fee to register a food facility?

No. 21 CFR 1.231(c) states plainly: "No registration fee is required." Any fee you pay is a professional service fee to a consultant, not a government charge. FDA maintains a public warning about private firms that imply an FDA affiliation while charging registration fees.

What happens if I miss the biennial renewal window?

The registration expires and FDA cancels expired registrations. Under 21 CFR 1.241, failing to register or renew is a prohibited act, and shipments from a facility without an active registration can be refused at the U.S. port. Restoring a lapsed registration is slower than renewing on time.

Who must register a food facility with FDA?

The owner, operator, or agent in charge of a domestic or foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States, unless exempt under 21 CFR 1.226.

Is FDA Form 2541 / LACF process filing the same as food facility registration?

No. Acidified and low-acid canned foods have a separate establishment registration and scheduled-process filing under 21 CFR 108 (Form FDA 2541, and process filing on Forms FDA 2541d, 2541e, 2541f, or 2541g). Food facility registration does not satisfy that filing.

Does FDA food facility registration or a U.S. Agent replace a TTB alcohol permit?

No. Alcoholic beverages are food for FDA facility registration. TTB — not FDA — issues the Federal Basic Permit, COLA, and collects alcohol excise. Axentra’s work here is FDA food facility registration and U.S. Agent only. We do not obtain TTB licenses or COLAs.

FDA Food Facility Registration & 2026 Biennial Renewal

Every foreign facility that manufactures, processes, packs, or holds food or beverages for U.S. consumption must register with the FDA and appoint a U.S. Agent — and re-register every two years. The next renewal window is Oct 1 – Dec 31, 2026. Miss it and your registration is deactivated, and shipments stop at the port. Axentra files it right, on time, every cycle.