Do Sri Lankan 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 Sri Lanka exactly as it does to U.S. facilities. Typical Sri Lankan products we register include tea, cinnamon and spices, coconut products, seafood and snacks.
Your approvals from the Ministry of Health and, for tea, the Sri Lanka Tea Board 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
Tea and spices
Tea and spice packers and blenders need FDA registration for each facility that packs or stores the product for the U.S. market. FDA may also sample spices at the border, so testing before shipping helps avoid holds.
Seafood processors
Seafood processed for the U.S. must also follow FDA's seafood HACCP rules (21 CFR Part 123). Your U.S. importer will usually ask for your HACCP plan. Facility registration is the first step.
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 are approved by the Ministry of Health. Do we still need FDA registration?
Yes. Approvals at home cover Sri Lanka. For the U.S., each facility that makes, packs or stores the food must be registered with the U.S. FDA.
Do Sri Lankan 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.
Can you register more than one of our facilities?
Yes. Each address is registered separately. Additional facilities with the same owner are $169 each.
Registering from another country? See FDA registration by country.