Do Japanese 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 Japan exactly as it does to U.S. facilities. Typical Japanese products we register include soy sauce and seasonings, green tea and matcha, noodles, confectionery, seafood products, sake and other drinks.
Your business permits under Japan's Food Sanitation Act 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
Canned and bottled shelf-stable foods
Shelf-stable low-acid or acidified foods in sealed containers, such as some canned or bottled sauces and vegetables, need extra FDA filings: a Food Canning Establishment (FCE) registration and a process filing for each product. We handle both. See prices.
Sake and other drinks
Breweries and distilleries must register with FDA too. Separately, your U.S. importer needs label approval from the Alcohol and Tobacco Tax and Trade Bureau (TTB).
Japanese cosmetics and skincare
Japanese cosmetics companies selling in the U.S. must register their manufacturing facilities and list their products with FDA under MoCRA. Many Japanese skincare products with SPF, and some products sold as quasi-drugs in Japan, are regulated as OTC drugs in the U.S., which have stricter rules. See our MoCRA registration service ($369 a year with U.S. Agent). Before you order, see who must register, how product listing works and U.S. label rules. Products with SPF are regulated as drugs in the U.S. (cosmetic or drug?).
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 licensed in Japan. Do we still need FDA registration?
Yes. Japanese permits cover Japan. For the U.S., each facility that makes, packs or stores the food must be registered with the U.S. FDA.
Do Japanese 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 work with us by email in English?
Yes. We work entirely by email, and our forms are short and simple, so a basic English reply is enough.
Registering from another country? See FDA registration by country.