Who has to register a food facility with FDA
The rule is about places, not products. If a building under one owner makes, processes, packs or holds food that people in the United States will eat, the owner, operator or agent in charge registers it. It doesn't matter whether the food ever crosses a state line.
| Activity | What FDA counts | Typical small business |
|---|---|---|
| Manufacturing/processing | Making food from ingredients, including baking, bottling, canning, cooking, mixing, packaging and labeling | A commercial bakery, a sauce plant, a co-packer |
| Packing | Putting food into a container other than packaging it, including re-packing | A business that re-packs bulk nuts into bags |
| Holding | Storing food, in places like warehouses and cold storage | A warehouse that stores finished goods for distribution |
Who does not have to register
FDA's rule lists the facilities it doesn't apply to. These are the ones small food businesses run into most:
- Farms
- Retail food establishments
- Restaurants
- Nonprofit food establishments that prepare food for, or serve it directly to, the consumer
- Facilities regulated only by USDA under the meat, poultry or egg products inspection laws, throughout the whole facility
A private home is left out in a different way: it isn't a facility at all. That is why a cottage food maker baking in a home kitchen never registers with FDA.
Home food businesses and FDA registration
FDA's question and answer guidance spells out how far the home rule reaches. A home business that makes food and sells it at farmers markets, to stores or over the internet doesn't register, as long as the home still meets customary expectations for a private residence.
| Situation | Register with FDA? |
|---|---|
| Jam made in your home kitchen, sold at markets and to stores | No |
| Cookies sold online from your home | No |
| A detached garage on your property still usable as a garage | No |
| A separate building on your property turned into a production room | Yes, unless another exemption fits |
| Your own commercial plant away from home | Yes, unless another exemption fits |
Skipping FDA registration doesn't mean skipping rules. Your state decides whether you may sell homemade food at all, and the label rules still apply to what you sell.
Cottage Food Law →The retail exemption: selling mostly to consumers
A shop can bake, cook and pack food on site and still be exempt, as long as selling food directly to consumers is its primary function. FDA measures that in dollars: direct-to-consumer food sales must be more than food sales to everyone else. Businesses are not consumers.
- A bakery that makes 60% of its sales directly to consumers and 40% to wholesale buyers stays exempt (FDA's own example)
- There is no income limit: a large shop qualifies as easily as a small one
- A distribution center or warehouse at another address doesn't share the shop's exemption
- Once direct sales no longer exceed sales to other buyers, the retail exemption is gone
Brand owners, brokers and co-packers
If a co-packer makes your product, its plant registers. Your own office doesn't, as long as your business never makes, packs or holds the food. FDA says the same about brokers. If you rent a warehouse and keep pallets of finished product there, that building holds food and may need its own registration.
How to register a food facility with FDA
Registration happens online, in the Food Facility Registration Module of FDA Industry Systems. Register before the facility starts manufacturing, processing, packing or holding food. Paper and fax are only for facilities that FDA has given a waiver. Have this ready:
- Facility name, full address and phone number, and a mailing address if it differs
- A unique facility identifier (UFI), such as a DUNS number, at the same address as the facility
- Parent company details, if the facility belongs to one
- Every trade name the facility uses
- Owner, operator or agent in charge, with email address
- An email contact for the facility and an emergency phone number and email
- The food product categories you handle and the activity for each, such as manufacturer/processor, packer/repacker, labeler/relabeler or acidified food processor
- An assurance that FDA may inspect the facility, and a certification that the information is true
FDA checks the UFI and its address before it confirms the registration. You count as registered once FDA sends the confirmation and registration number. A registration number is not an approval: FDA says it conveys no approval or endorsement of the facility or its products.
What FDA food facility registration costs: nothing
Private companies sell registration packages, renewal reminders and framed certificates. None of that is required. FDA says registration is free, you can register yourself, and certificates from private businesses mean nothing to FDA. The one paid service FDA mentions is a U.S. agent, which only foreign facilities need, and that fee is between the facility and the agent.
Renewal, updates and cancellation
| When | What you do | Rule |
|---|---|---|
| Every other year, October 1 to December 31 of each even-numbered year | Renew. Nothing changed? Use the abbreviated renewal and confirm the details | 21 CFR 1.230(b), (c) |
| Within 60 calendar days of a change | Update the registration | 21 CFR 1.234(a) |
| Within 60 calendar days of closing, stopping food for the US, or selling | Cancel the registration. A new owner registers again | 21 CFR 1.234(b) · 1.235(a) |
A new facility that registered earlier in a renewal year still renews in that October to December window. Miss the renewal and FDA treats the registration as expired, which counts as failing to register: a prohibited act under the Federal Food, Drug, and Cosmetic Act.
A second registration for acidified and canned foods
Pickles, salsas, hot sauces and other acidified foods, and low-acid canned foods, have their own FDA registration on top of this one. The plant registers as a food canning establishment on Form FDA 2541 and files a process for each product. FDA's electronic system for that second step only opens to facilities already registered as food facilities that list themselves as an acidified or low-acid food processor.
Registered or exempt, your label is next
Registration tells FDA where your food is made. The label tells your customers what is in it, and it is what a store buyer or inspector checks first. Every packaged food needs a name, net quantity, ingredient list, allergen information, your business name and address and, unless an exemption fits, Nutrition Facts.
Our tool makes the regulated panel from your recipe: USDA data per ingredient, FDA rounding, the ingredient list in order of weight and a Contains line for the major allergens. You download a print-ready PDF plus a calculation report that shows how each number was made.
FDA Food Labeling Requirements →Start your label free →