FDA Food Facility Registration & US Agent Guide

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 free, done entirely online, and takes 1–3 business days to process. Missing it means your shipment can be held or refused at the US border.

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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.
• Registration is a prerequisite for filing prior notice on each shipment.

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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

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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.

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

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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)
• Facility contact person (name, phone, email)
• Parent company name (if applicable)
• All food categories produced at the facility (FDA's structured category list — beverages fall under "Beverages" with subcategories for water, juices, RTD tea/coffee, etc.)
• US agent information (see Step 3 below)
• Emergency contact information (US-based)

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 available during US business hours to receive communications from the FDA
• Be able to assist with FDA inspections if requested

The US agent is not the same as your importer of record. The importer of record handles customs and the FSVP. 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 (typically $200–$500/year). 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

The FURLS registration form takes approximately 20–40 minutes to complete once you have all information gathered. After submission, FDA processes most registrations within 1–3 business days and issues a 10-digit registration number. Keep this number — you will need it for prior notice filings.

Step 5 — Document and Archive

Archive your registration confirmation, your 10-digit registration number, your US agent agreement, and your facility's registered food categories. Store these securely — the registration number must be provided in every prior notice filing, and the FDA may request documentation during inspection or import review.

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Biennial Renewal: The Compliance Trap That Catches European Brands

FDA food facility registration must be renewed every two years, specifically during the period of October 1 through December 31 of even-numbered years (2026, 2028, 2030, etc.). If you registered in 2025, your renewal is October–December 2026.

This is the single most common compliance failure we see from European brands who have been operating in the US for 1–2 years. They complete the initial registration, begin shipping, build distribution — and then the registration lapses because nobody calendared the renewal. When the next container arrives in early 2027, the FDA system flags the registration as expired and the shipment can be detained.

Set a calendar reminder now for October 1, 2026 (and every even-numbered October thereafter). Biennial renewal is free and done through the same FURLS portal.

A lapsed registration does not mean your shipments are automatically refused — the FDA has discretion — but it is a material compliance violation that can result in import alerts, detention, or reinspection requirements. Do not let it lapse.

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US Agent vs. Importer of Record: The Key Distinction

These two roles are frequently confused by European founders entering the US market. They are distinct, serve different functions, and may be filled by different entities.

In practice, for a first-time US market entry, the fastest path is: (1) engage a US agent service immediately to handle registration; (2) designate your importer of record (Avenor, a third-party IOR, or your own US entity) who will manage the FSVP and prior notice filings.

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What Happens If You Ship Without a Registration?

The FDA screens all import entries. If a prior notice filing references an unregistered facility — or if no prior notice was filed — the FDA can:

• Issue a "hold" or "refusal" on the shipment
• Refuse admission of the shipment (which means it must be destroyed or re-exported)
• Place the facility on an import alert, which flags future shipments for automatic detention

An import alert is significantly harder to resolve than simply registering before shipping. The FDA's import alert database is public. Getting on it early in your US market entry is a reputational and operational problem.

The fix is straightforward: register the facility, get the registration number, and never ship a prior notice without it.

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In Our Experience Launching US Brands

In the Avenor launches we've run — Wild Idol, Paragraph, Niets — FDA facility registration is the first operational task we execute, often six to eight weeks before the target first-shipment date. The registration itself is fast; the time buffer is for unexpected delays (FURLS system issues, facility data discrepancies, US agent agreement execution) and to ensure the registration number is confirmed before prior notice filing begins.

We've also seen cases where a European brand's contract manufacturer was unregistered — they assumed their packaging facility had handled it, but the formulation facility had not. That required a registration and a delay to the shipment timeline. Always confirm registration at the formulation and production facility, not just the packaging facility.

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Written by Nick Bodkins, co-founder of Avenor, the US market-entry partner for overseas non-alcoholic beverage brands. Nick previously founded Boisson, the largest US non-alcoholic retail and e-commerce platform. Connect on LinkedIn.