Do I need to register with the FDA to sell my food product?
If you manufacture, process, pack or hold food in the United States, you generally have to register that facility with the FDA — and registration is free. Farms, restaurants, retail food establishments and private residences are exempt. The exemption people miss is that it is the facility that matters, not the business: rent time in a commercial kitchen and that kitchen is the facility.
Who has to register
The requirement sits on facilities, not on products or companies. If a place manufactures, processes, packs or holds food for consumption in the United States, the owner or operator registers it, unless it falls into one of the listed exemptions.
That framing catches people out in both directions. A one-person hot sauce business producing in a shared commercial kitchen is working in a facility that needs to be registered. A maker who thinks of themselves as far too small to be on the FDA's radar is usually still in scope.
Who is exempt
These are exempt from food facility registration:
- Farms, both primary production and secondary activities farms
- Restaurants
- Retail food establishments
- Nonprofit food establishments
- Private residences — a home is not a facility
- Certain fishing vessels, and facilities regulated throughout by USDA
The private-residence line is narrower than it sounds
A private residence is not a facility, which is why home-based cottage food operations do not register with the FDA. But cottage food is a state programme, and it is the state that decides what you may make at home, how much you may sell, and whether you may sell wholesale at all. Most cottage food laws stop at direct-to-consumer sales, which is exactly the line you cross when a shop wants to stock you.
So the honest answer for most makers who want to be on a shelf is that the home exemption stops being useful at the moment the business starts working.
Registration is free, and people get charged for it
The FDA does not charge a fee to register a food facility. There are third-party sites that will do it for you and charge for the privilege, some of them presented to look official. The FDA has published guidance specifically because of this. You can register yourself, and you should.
The renewal nobody remembers
Registration is not once and done. It has to be renewed every two years, during a window that runs from 1 October to 31 December of each even-numbered year. Miss it and the registration can be considered expired.
Put the renewal window in a calendar the day you register. It is two years away, which is exactly long enough to forget.
Common questions
Check this yourself
This is general information for U.S. food businesses, not legal advice, and rules change. Check it against the sources below and against your own state's rules before you rely on it.