Food facilities must renew between October 1 and December 31 of each even-numbered year, per 21 CFR 1.230. If a registration is not renewed by 11:59 PM on December 31 of the renewal year, it is considered expired. FDA Registration Assistance ensures your renewal is filed accurately and on time.

Your FDA food facility registration expires and your facility is no longer legally authorized to ship food to the United States. Shipments may be detained or refused at U.S. ports of entry, and the facility could face enforcement actions including warning letters, import alerts, and platform delistings. Contact us to get your renewal filed before the deadline.

Any domestic or foreign food facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States is required to renew its FDA registration. This includes food manufacturers, processors, co-packers, warehouses, and importers. Farms, retail food establishments, and restaurants are generally exempt under 21 CFR 1.226.

Yes. Foreign food facilities that export food to the U.S. are subject to the same biennial renewal requirement as domestic facilities. Foreign facilities must also maintain a U.S. Agent designation as part of the renewal under 21 CFR 1.227. FDA Registration Assistance handles renewals for facilities in over 135 countries.

A U.S. Agent is a mandatory legal requirement under 21 CFR 1.227 for all foreign food facilities registered with the FDA. The agent must be physically located in the United States and available 24/7 for emergency contact. The U.S. Agent designation must be confirmed and updated at every renewal. Learn more about U.S. Agent services.

To complete the renewal you will need: your existing FDA registration number, your facility's full legal name and physical street address, owner/operator contact information, your designated U.S. Agent's name and U.S. address, all trade names used, your DUNS number, and your FDA food product categories. Any changes since the last registration must be updated under 21 CFR 1.234.

The renewal is submitted electronically through the FDA's Unified Registration and Listing System (FURLS) using Form FDA 3537. FDA Registration Assistance manages the full submission on your behalf, ensuring all data is accurate and the filing is completed well before the December 31 deadline.

Yes. The renewal cycle is the ideal time to update any changes to your facility's name, address, ownership, U.S. Agent, or food product categories. Under 21 CFR 1.234, any change to required registration information must also be filed within 60 days of the change — independent of the renewal cycle. Our team reviews and updates all relevant information as part of the renewal process.

Our FDA food facility registration renewal service is $858 USD per year, bundled all-in: registration renewal filing through FURLS + U.S. Agent designation with 24/7 availability for the full year as required by 21 CFR 1.227. The FDA itself charges $0 for registration or renewal — the fee is for the professional service. Contact us for multi-facility pricing.

Once all required information is submitted to us, the renewal is typically completed and confirmed within 24–48 hours. The registration becomes effective immediately upon FDA acceptance, and you will receive confirmation from the FDA that your registration has been renewed.

FURLS stands for FDA Unified Registration and Listing System. It is the FDA's online portal at access.fda.gov where food facilities submit and manage their registrations and renewals. Form FDA 3537 is the food facility registration form filed through FURLS. While facilities can self-register through FURLS, many choose to work with a registration assistance service to avoid the common errors that delay or invalidate a filing.

No. The FDA does not charge any fee to register or renew a food facility registration. Service fees apply only when using a third-party registration assistance provider. Our $858/year fee covers the full renewal filing, U.S. Agent services, and year-round compliance support.

Any changes to your facility's name, address, ownership, U.S. Agent, or food product categories must be updated in FURLS within 60 days of the change under 21 CFR 1.234 — not only at renewal. If your information has changed, we will update all records as part of the renewal filing and any required interim updates to ensure full FSMA compliance.

Yes. Under Section 415(b) of the FD&C Act, added by FSMA, the FDA has authority to suspend a food facility's registration if it determines that food manufactured, processed, packed, or held by the facility has a reasonable probability of causing serious adverse health consequences. A suspended facility cannot legally import or distribute food in the United States until the suspension is lifted.

Yes. If your facility manufactures, processes, packs, or holds food sold to U.S. consumers — including through online platforms such as Amazon, Walmart Marketplace, Shopify, or direct-to-consumer websites — FDA food facility registration and biennial renewal are required. The sales channel does not affect the renewal obligation.

The renewal requirement is governed by Section 415 of the Federal Food, Drug, and Cosmetic Act (added by the Bioterrorism Act of 2002, as amended by FSMA Section 102). The implementing regulations are at 21 CFR Part 1, Subpart H — specifically 21 CFR 1.230 for renewal and 21 CFR 1.231 for the filing form. FDA Registration Assistance ensures full compliance with all applicable regulations.

Yes — $858/year is fully bundled, no surprise add-ons. It covers: (1) the biennial registration renewal filing through FURLS using Form FDA 3537 when the renewal window opens, (2) U.S. Agent designation with 24/7 FDA availability for the full year as required by 21 CFR 1.227, (3) FURLS account creation and ongoing maintenance, (4) filing of facility-information changes within the 60-day window required by 21 CFR 1.234, and (5) year-round compliance monitoring with renewal-window reminders. If you combine the renewal with our initial Foreign Food Facility Registration, the initial registration is filed once and then maintained inside the same $858/year subscription going forward.

Technically yes, but it is risky. 21 CFR 1.227 only requires the U.S. Agent to be physically located in the United States and available 24/7 to the FDA — it does not require credentials. A friend, family member, or unrelated contact who lacks compliance training, misses an FDA call, fails to respond to a Form FDA 482 notice, moves without updating the designation, or simply becomes unreachable can cause the entire registration to be invalidated. Professional U.S. Agent services exist specifically to remove this single point of failure, which is why this service is bundled into the $858/year renewal subscription for foreign facilities.

The FDA treats U.S. Agent non-response as a failure of the registration itself. The FDA may consider the U.S. Agent designation invalid, which can result in cancellation of the facility's FDA registration, refusal of shipments under PREDICT screening, and potential placement on an FDA Import Alert. The 24/7 availability requirement under 21 CFR 1.227 is strict — voicemail boxes, out-of-office responses, and after-hours non-response are not acceptable. Once a registration is invalidated for U.S. Agent failure, restoring it typically requires a new initial registration, not a renewal.

Log into FURLS at access.fda.gov, open the active food facility registration, and submit an update through Form FDA 3537 changing the U.S. Agent name, address, phone, and email. The new U.S. Agent must accept the designation electronically inside FURLS — without acceptance, the change does not take effect. Under 21 CFR 1.234, the U.S. Agent change must be filed within 60 days of the change. We handle this entire process — including agent acceptance and FDA confirmation — as part of the $858/year subscription.

Yes. The FDA's definition of "food" under 21 CFR 1.227 includes dietary supplements, animal food and feed, bottled water, beverages, infant formula, food ingredients, and food contact substances when held as food. Any facility manufacturing, processing, packing, or holding these products for U.S. consumption must register and renew biennially under 21 CFR 1.230 — there is no separate "supplement" or "pet food" registration carve-out.

No. Food facility registration under 21 CFR Part 1, Subpart H only covers food. Cosmetic facilities register separately under the Modernization of Cosmetics Regulation Act (MoCRA) at 21 CFR Part 710. Medical device establishments register under 21 CFR Part 807. A facility producing multiple product categories may need multiple registrations — they are not interchangeable.

Yes. Amazon, Walmart Marketplace, eBay, and most major e-commerce platforms request proof of active FDA food facility registration for grocery, supplement, beverage, and consumable categories. If your registration is expired or your U.S. Agent designation is invalid, marketplaces routinely delist products, freeze inventory, or suspend the seller account until valid FDA documentation is provided. Keeping the registration renewed protects revenue, not just compliance.

Log into FURLS at access.fda.gov using the credentials from your original registration and check the status field on the facility record — it will show "Active," "Expired," or "Suspended." The FDA does not publish a public lookup tool for food facility registrations, so verification must be done from inside the FURLS account. If you have lost FURLS access, FDA Registration Assistance can recover the account and verify status as part of the $858/year subscription.

No. 21 CFR 1.232 requires the physical street address of the food facility — not a P.O. Box, virtual office, coworking address, or mail-forwarding service. The U.S. Agent address must also be a physical U.S. street address where the agent can be reached during normal business hours. Filings with non-physical addresses are rejected by FURLS validation, leaving the facility unregistered until corrected.

Yes. Under 21 CFR 1.225, each individual food facility — including co-manufacturers, contract packers, and third-party logistics (3PL) warehouses that hold food for U.S. distribution — must have its own FDA registration. The brand owner's registration does not cover its co-manufacturers or storage providers. Each location is treated as a separate facility and must renew biennially on its own registration number.

Yes. Since FSMA introduced the Unique Facility Identifier (UFI) rule, the FDA requires a Dun & Bradstreet DUNS number as the UFI on every food facility registration submitted through FURLS. The DUNS number must match the facility's physical address and is free to obtain directly from Dun & Bradstreet. DUNS request assistance is available if you do not yet have one.

No. The Foreign Supplier Verification Program (FSVP) under 21 CFR Part 1, Subpart L is a separate obligation imposed on the U.S. importer of record. FSVP does not replace the foreign facility's own FDA food facility registration requirement under 21 CFR Part 1, Subpart H. Most foreign-sourced food into the U.S. requires both — the foreign facility renews its registration, and the U.S. importer maintains FSVP records for the supplier.

No. 21 CFR 1.225 requires a separate FDA food facility registration for each physical facility location. A company operating three plants needs three separate FDA registrations, each with its own renewal filing, its own DUNS number, and (for foreign locations) its own U.S. Agent designation. Multi-facility pricing is available for companies maintaining several registrations under one compliance subscription.

There is no such thing as an FDA "food facility license" or "FDA certificate of approval" for food facilities. The FDA only issues an 11-digit food facility registration number through FURLS after a Form FDA 3537 submission is accepted. Any company selling "FDA certificates," "FDA approval letters," or "FDA licenses" for food facilities is misrepresenting what the agency actually issues — and falling for it can leave a facility unregistered and exposed.