If you make, pack or store food that will be sold in the United States, the FDA expects your facility to be registered with it. For a foreign producer, this is the first compliance step and one of the easiest to get wrong. A registration that is missing, expired or carries the wrong details can mean food held at the border, a buyer who walks away, or a shipment that never leaves.
This guide explains who has to register, what the process involves, how the DUNS number and the US agent fit in, how to renew, and the mistakes we see most often. It also covers the current renewal window, which is open now and closes on 31 December 2026.
This is a practical overview and not legal advice. Registration rules depend on your facility and product, and they change, so confirm the details on the FDA's website or with a qualified adviser before you submit.
What is FDA food facility registration?
Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the FDA requires food facilities to register with it. The Food Safety Modernization Act (FSMA), passed in 2011, then added requirements: more registration information, an assurance that the FDA can inspect the facility, and a duty to renew every two years. It also gave the FDA the power to suspend a registration where food from a facility has a reasonable probability of causing serious adverse health consequences or death.
Registration gives the FDA a list of the facilities that supply food to the US, so that it can inspect, trace and respond to problems. For you, it is a condition of selling into the country. Your importer and customs broker will need your registration number, and the FDA can check it when your shipment arrives.
Two things are often misunderstood.
Registration is free. The FDA does not charge for registration or renewal. Be careful with private companies that suggest they are affiliated with the FDA or that you must pay them. You can register yourself, or hire a consultant for help, but the FDA fee is zero.
Registration is not approval. A registration number does not mean the FDA has inspected or approved your facility or your product. It means you are on the list and have met the registration duty.
Who has to register?
A domestic or foreign facility must register if it manufactures, processes, packs or holds food for consumption in the United States. In practice, that includes:
Food manufacturers and processors.
Companies that pack or repack food, including those that label products.
Warehouses and cold stores that hold food before export.
Producers of ingredients, beverages and supplements that are classed as food.
Some types of facility are exempt, including farms, restaurants, retail food establishments and certain others, and there are special rules where a foreign facility's food is further processed or packed by another facility before it reaches the US. Exemptions are narrow and depend on the exact activity, so check the FDA's guidance before you assume that one applies to you.
What about private label and contract manufacturing?
If someone else makes your product, the facility that makes or packs it must be registered, and it is that facility's registration your shipment relies on. A brand owner that does not make, pack or hold food itself generally does not need its own facility registration, though it may take on other duties, such as being the importer under FSVP. If you hold stock in your own warehouse, that warehouse is a facility that holds food. Check the roles in your contract. Our guide to private label food manufacturing explains how the roles can be split.
What you need before you start
Registration is an online form, but it is quicker if you collect these first:
The facility's name and address, exactly as they should appear in the registration.
A DUNS number for the facility, which the FDA uses as its unique facility identifier.
A US agent, because you are a foreign facility.
Emergency contact details, including a phone number that is answered when the facility is not open.
The product categories the facility handles, chosen from the FDA's list.
A parent company name and details, if applicable.
An FDA Industry Systems account, which you create to log in to the registration system.
The assurance that the FDA will be permitted to inspect the facility, which the form asks you to confirm.
Step by step: how to register
Step 1: Confirm that you need to register
Check what the facility does. If it manufactures, processes, packs or holds food for the US, you almost certainly do. If you are unsure whether an exemption applies, ask the FDA or an adviser before you decide not to register.
Step 2: Get a DUNS number for the facility
The FDA requires a unique facility identifier with every registration, and the only identifier it currently recognises is the DUNS number, assigned by Dun & Bradstreet. The FDA checks that the address on the registration matches the address Dun & Bradstreet holds for the number, so the name and address on both must match exactly, including how street names and company suffixes are written. A mismatch is a common reason for rejected or cancelled registrations.
If your facility already has a DUNS number, verify it and check that the address is correct. If not, request one through Dun & Bradstreet and allow time, as it can take longer than expected. Start this step first, especially with the renewal deadline close.
Step 3: Appoint a US agent
Every foreign facility must name a US agent, a person or business with a place of business in the United States who acts as the FDA's communication link with you. We explain the role, the choice and the contract points in a separate guide to FDA US agents for foreign food facilities. Agree on the arrangement before you submit, because the FDA verifies that the agent has accepted the role. Under the FDA's voluntary US agent identification system, an agent can hold an identification number for your facility, and using it during registration can speed up the FDA's verification.
Step 4: Create your FDA Industry Systems account
Registration is done online through the FDA Industry Systems (FIS) account, which you create on the FDA's access site. Use an email address that will still be monitored in two years, because the FDA sends renewal reminders and other messages to the contact on the account. The FDA also suggests adding its email domains to your safe sender list so notices are not missed.
Step 5: Complete the Food Facility Registration form
Log in and complete the form with the details above. Check every field before you submit. Common errors are an address that differs from the DUNS record, wrong product categories, and a US agent who has not confirmed the role.
Step 6: Receive your registration number
Once the FDA has processed and verified the registration, including the US agent for foreign facilities, you receive a registration number. Keep it with your export documents. Your importer, customs broker and any logistics partner will ask for it.
Step 7: Give the number to the people who need it
Send the registration number and the details to your importer and your customs broker. They will use it for the FDA Prior Notice for each shipment, and it must match the facility named there. Our guide to FDA Prior Notice explains that step.
Step 8: Keep the registration up to date
You must update the registration within 60 days if any of the required information changes, such as the address, contact details, product categories or US agent, and you must cancel the registration within 60 days if the facility stops operating. Put reminders in your calendar.
The 2026 renewal: what to do before 31 December
Registrations must be renewed every two years, between 1 October and 31 December of every even numbered year. The 2026 window opened on 1 October and closes on 31 December 2026. The FDA reminded facilities of this on 29 September 2026, and it has said that it will consider the registration of any facility that fails to renew by 31 December to be expired.
An expired registration is a serious problem. Your importer may not be able to file Prior Notice that matches a valid registration, and your shipment could be held until the registration is restored.
How to renew
Log in to your FDA Industry Systems account.
Open your existing registration and start the renewal.
Review and update every field, including the DUNS number, address, contact, product categories and US agent.
Confirm the assurance and submit.
Save the confirmation for your records.
Renewal is also free, and it is required even if nothing has changed.
Qualified facilities must file an attestation
A qualified facility is generally a business that is very small and has modified requirements under FSMA's preventive controls rules. Qualified facilities must submit an attestation supporting that status in the same renewal period, and the facility must have a valid registration to file it. If you are not sure whether you qualify, check the FDA's guidance on qualified facility status.
If you have missed it
If you have not renewed by 31 December 2026, the registration is treated as expired. Contact the FDA, and talk to your importer straight away. Do not ship until the position is clear.
What happens if you are not registered
If a facility is required to register and has not, food from that facility can be refused admission and held at the port of entry, and the importer faces delays and storage costs. The FDA can also suspend the registration of a facility in serious cases where food has a reasonable probability of causing serious adverse health consequences or death. Beyond the legal consequences, an unregistered facility will not pass the due diligence checks that US importers run under the Foreign Supplier Verification Program, which we explain in our guide to FSVP.
The six mistakes we see most often
A DUNS address that does not match the registration. Check both records and fix the one that is wrong before you submit.
Leaving the renewal to the last week. A new DUNS number, a new US agent or a correction can take time.
Using a personal email address on the FDA account that nobody monitors later.
Assuming the contract manufacturer's registration covers everything. If you hold stock yourself, or pack or label products in a different facility, that facility may need its own registration.
Not updating changes within 60 days. A new address, product category or agent should be reported promptly.
Paying a company that is not the FDA, and believing the fee is an FDA requirement. Registration and renewal are free.
Frequently asked questions
Does a foreign company need to register with the FDA to sell food in the US?
If the facility manufactures, processes, packs or holds food for US consumption, yes. A foreign facility must also have a US agent.
How much does FDA food facility registration cost?
The FDA charges nothing for registration or renewal. Consultants and agents may charge for their help.
What is a DUNS number and why does the FDA ask for it?
A DUNS number is a unique nine digit business identifier assigned by Dun & Bradstreet. The FDA uses it as the unique facility identifier and checks that the address on the registration matches the address held for the DUNS number.
How often do I have to renew?
Every two years, between 1 October and 31 December of even numbered years. The current window closes on 31 December 2026.
What happens if my registration expires?
The FDA treats the registration as expired. Your importer may not be able to file valid Prior Notice and your shipments can be held until you register again, so renew on time.
Do I need to register separately for each product?
No. A registration covers the facility, and you select the categories of food it handles. You must keep the categories accurate.
Do I need to register if I only sell private label products made by another company?
If another company makes and packs the food, that facility must register. A brand owner that does not make, pack or hold food generally does not, but you may still have importer or labelling duties. Check your role with an adviser.
Can a consultant register my facility for me?
Yes. A consultant can prepare and submit the registration for you, coordinate the DUNS number and US agent, and set reminders for renewal.
Is the FDA registration number the same as an approval or certificate?
No. It shows that the facility is registered. It does not mean the FDA has inspected or approved the facility or product.
Where we can help
At VC Agriculinary Consulting we help international food producers get ready for the US market, including FDA coordination, registration and renewal, Prior Notice, FSVP support, labelling and the documents that go with them. If you need to renew before 31 December or register for the first time, contact us and tell us about your facility and product. See our full range of services, or read our practical checklist for food export compliance for the wider picture.