Do Mexican 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 Mexico exactly as it does to U.S. facilities. Typical Mexican products we register include salsas and sauces, snacks and confectionery, tequila and other drinks, avocados and fresh produce packed for export, and spices.
Your approvals from COFEPRIS or SENASICA are still needed at home, but they do 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
Farms and packing houses
A farm that only grows and harvests its own crops is generally exempt from FDA facility registration. A packing house or processor that packs, washes, cuts or stores produce for the U.S. usually must register. We check which of your sites need it before filing.
Trucking across the border
Every food shipment into the U.S. needs Prior Notice, including trucks at land crossings. Your broker usually files it with your FDA registration number. We can also file Prior Notice for $25 per shipment.
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
We have COFEPRIS approval. Do we still need FDA registration?
Yes. COFEPRIS and SENASICA cover Mexico. For the U.S., each facility that makes, packs or stores the food must be registered with the U.S. FDA.
Do Mexican facilities need a U.S. Agent?
Yes. Every food facility outside the U.S. must name a U.S. Agent located in the United States. It is included in our $269 price.
Does our farm need to register?
A farm that only grows and harvests on its own land is generally exempt. If the same site also packs or processes food for other farms, it may need to register. Tell us how your site works and we will confirm.
Registering from another country? See FDA registration by country.