FDA Food Facility Registration for Foreign Brands

Any facility that manufactures, processes, packs, or holds food for consumption in the US must be registered with the FDA before that food is imported. For a European NA beverage brand, that means your brewery, winery, distillery, or contract manufacturer needs an active FDA food facility registration — and a designated US agent — before your first container leaves port. Registration is done online through FDA's FURLS system (21 CFR 1.231), and FDA assigns the facility a registration number. Missing it means your shipment can be held or refused at the US border.

---

Key Takeaways

• FDA food facility registration is required for any overseas facility producing food (including beverages) for the US market.
• Registration is free and completed through FDA's FURLS (Unified Registration and Listing System) portal.
• A US agent must be designated at the time of registration — this is a separate requirement from your importer of record.
• Registrations must be renewed biennially during October–December of even-numbered years; lapses can result in shipment holds.
• Prior notice for each shipment asks for the manufacturer's registration number (21 CFR 1.281(a)(6)), and food from a facility that should be registered and is not is subject to being held at the port (21 CFR 1.285).

---

What Is FDA Food Facility Registration?

The Bioterrorism Act of 2002 — updated and strengthened by the Food Safety Modernization Act (FSMA) of 2011 — requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the US to register with the FDA.

For a foreign beverage producer, "food" includes your NA wine, NA spirits, NA beer, hop water, botanical mixer, or any other sub-0.5% product intended for sale in the US. The registration requirement applies to the production facility, not the product itself — and it applies before the first export, not after arrival.

Primary source: FDA Food Facility Registration

---

Who Needs to Register?

The registration requirement covers facilities that:

• Manufacture or process food for US consumption
• Pack food for US consumption
• Hold (store) food for US consumption

If your beverage is produced at a third-party contract manufacturer (which is common for European NA brands), that facility must be registered — not just your brand's entity. If you use multiple co-manufacturers or a separate warehousing facility, each needs its own registration, except a facility whose product is then further manufactured, bottled or packaged by another facility outside the US (21 CFR 1.226(a)).

Facilities that are exempt from registration include farms, restaurants, and retail food establishments — categories that do not apply to most beverage producers.

---

How to Register: Step-by-Step

Step 1 — Gather Your Facility Information

Before opening FURLS, collect the following for each facility you are registering:

• Facility legal name and physical address (street address, not P.O. Box)
• The facility's DUNS number, the unique facility identifier FDA accepts; FDA issues no registration number until it has matched it to the facility's address (21 CFR 1.232(a)(2), 1.231(a)(3))
• Facility contact person (name, phone, email)
• Parent company name (if applicable)
• All food categories produced at the facility (the list in Section 9a of Form FDA 3537 has no single "Beverages" heading; the drink categories are "Alcoholic beverages," "Beverage bases," "Coffee and tea," "Fruit or vegetable juice, pulp or concentrate products" and "Soft drinks and waters")
• US agent information (see Step 3 below)
• Emergency contact phone number and email (21 CFR 1.232(c)(2)); FDA uses your US agent as the emergency contact unless you name someone else, who need not be in the US

Step 2 — Create an FDA Account and Access FURLS

Go to FDA's FURLS portal. You will need to create an FDA FURLS account (free) if the facility does not already have one. Use a facility-level email address — not a personal email — as this account will need to be accessible during biennial renewals.

Step 3 — Designate Your US Agent

Every foreign food facility must designate a US agent at the time of registration. The US agent must:

• Be a person or entity physically located in the US
• Be reachable by the FDA 24 hours a day, 7 days a week, unless the registration names a different emergency contact (FDA Q&A, C.7.15)

The US agent is not the same as your importer of record. The importer of record handles customs; the FSVP belongs to the FSVP importer, who is often the same company but need not be (21 CFR 1.500). The US agent is a regulatory communication intermediary — the FDA's contact for your facility when they cannot reach you directly, or when they need to communicate inspection findings or public health concerns.

Many companies use specialized FDA US agent services, which set their own fees; FDA itself charges nothing and treats the fee as a matter between the facility and its agent (FDA). Some law firms and consultancies provide this service. If Avenor is your importer of record, we can advise on US agent setup.

Step 4 — Complete and Submit the Registration

FDA's own estimate for the registration form is between 1 and 12 hours per response, including the time to gather the information (Form FDA 3537). FDA then assigns the facility a registration number (FDA user guide), but only once it has verified the facility's DUNS number and the US agent has confirmed that it agreed to serve (21 CFR 1.231(a)(3), (5)). Keep this number: prior notice for processed food asks for the manufacturer's registration number (21 CFR 1.281(a)(6)).

Step 5 — Document and Archive

Archive your registration confirmation, your registration number, your US agent agreement, and your facility's registered food categories. Store these securely — prior notice asks for the manufacturer's registration number (21 CFR 1.281(a)(6)), and the FDA may request documentation during inspection or import review.

---