Do Canadian food companies need FDA registration?
Yes. Under U.S. law, every facility that manufactures, processes, packs or holds food for people or animals in the United States must be registered with the U.S. Food and Drug Administration. This applies to facilities in Canada exactly as it does to U.S. facilities. Typical Canadian products we register include maple products, baked goods, confectionery, seafood, snacks, beverages and natural health products sold as dietary supplements.
Your Safe Food for Canadians licence from the Canadian Food Inspection Agency (CFIA) is still needed at home, but it does not replace FDA registration. Without a valid FDA registration, your shipments can be held at the U.S. port and your importer cannot file Prior Notice correctly.
What you need
- The facility's legal name and exact physical address
- A D-U-N-S number for that address. It is free from Dun & Bradstreet but can take several weeks, so request it early.
- An emergency contact phone answered 24 hours a day
- A list of the foods made, packed or stored at the facility
Trucking across the border?
Every food shipment into the U.S. needs Prior Notice, including trucks crossing at land borders. Your carrier or customs broker usually files it, and they will need your FDA registration number. We can also file Prior Notice for $25 per shipment.
Bilingual labels
English and French labels are fine in the U.S. as long as all the information FDA requires appears in English. Canadian nutrition labels do not meet the U.S. Nutrition Facts format, so U.S.-bound products usually need a U.S. version of the label. We offer label reviews from $269 per product.
How Regovant helps
- Order online and pay by card or PayPal in U.S. dollars. $269 per facility per year.
- Send your details through one short registration form.
- We check and file. We check your D-U-N-S details, file with FDA and act as your U.S. Agent.
- You receive your FDA registration number and a Regovant certificate of registration your buyers can verify.
Food facility registrations are renewed between October 1 and December 31 of every even-numbered year. We email you before each renewal. See the 2026 renewal guide or our step-by-step registration guide.
Questions
My company is registered with CFIA. Do I still need FDA registration?
Yes. CFIA licensing covers Canada. To sell food in the U.S., each facility that makes, packs or stores it must also be registered with the U.S. FDA.
Do Canadian facilities need a U.S. Agent?
Yes. Every food facility outside the U.S., including in Canada, must name a U.S. Agent located in the United States. It is included in our $269 price.
Can my U.S. buyer register my facility for me?
Your buyer can act as your U.S. Agent if they agree, but the registration is still for your facility and must be accurate and renewed. Many Canadian companies prefer an independent agent so they are not tied to one buyer.
Registering from another country? See FDA registration by country.