Who needs FDA food facility registration?
Every facility, in the U.S. or abroad, that manufactures, processes, packs or holds food for people or animals in the United States must register with FDA under the Bioterrorism Act. That includes dietary supplements, beverages, ingredients and pet food. Facilities outside the U.S. must also name a U.S. Agent.
Without a valid registration, shipments can be held at the U.S. port, and your importer cannot file Prior Notice correctly.
What's included
- Eligibility check: we confirm which of your facilities must register.
- D-U-N-S check: we compare your D-U-N-S record with your registration details. A mismatch is the most common reason FDA rejects or cancels a registration.
- Filing: we prepare and submit the registration (Form FDA 3537) with the correct FDA food product categories.
- U.S. Agent service: Regovant LLC acts as your U.S. Agent for one year, from our office in Casper, Wyoming.
- Confirmation: you receive your FDA registration number and a Regovant certificate of registration that anyone can check online.
- Reminders: we email you before the renewal window opens.
How it works
- Order online. Pay by card or PayPal. The price you see is the price you pay.
- Send your facility details. One short registration form: facility name and address, D-U-N-S number, products and an emergency contact.
- We check and file. We review your details within one business day, ask about anything missing, and submit to FDA.
- You receive your registration number. Usually within 1 to 5 business days of having complete details.
What you need before you start
- The facility's legal name and physical address (no P.O. boxes)
- A D-U-N-S number for that exact address. New numbers for non-U.S. companies can take several weeks, so request one early.
- An emergency contact phone answered 24 hours a day
- A list of the foods made or handled at the facility
Renewal
Food facility registrations must be renewed between October 1 and December 31 of every even-numbered year. Registrations not renewed by December 31, 2026 expire, and an expired registration can't be renewed later. See our 2026 renewal guide.
Questions
Does FDA charge a fee for food facility registration?
No. FDA does not charge for food facility registration. Our $269 covers filing, the D-U-N-S check and one year of U.S. Agent service.
Does registration mean FDA approved my products?
No. Registration is a legal requirement, not an approval. Your products must still meet FDA rules, such as labeling. We offer label reviews from $269 per product.
I sell on Amazon. Do I need this?
If you make, pack or store the food yourself, your facility needs to register. If you buy finished products from a manufacturer, the manufacturer's facility must be registered, and as the importer you may need an FSVP.
Does FDA issue a certificate?
No. FDA records the registration in its system and does not issue certificates. We provide a Regovant certificate of registration for your buyers and records.
Can I switch my U.S. Agent to Regovant?
Yes. We update your registration with our details and FDA asks us to confirm. Renewal is a good time to switch.