A place that makes, processes, packs or holds food for people or animals in the United States has to register with FDA before it starts, unless it's one of the places the rule exempts: farms, retail food establishments, restaurants, nonprofit food establishments, some fishing vessels, and places regulated only by USDA. A private home isn't a facility at all. Registered facilities renew every other year, between October 1 and December 31 of each even-numbered year, which makes the last three months of 2026 a renewal window. In the example below, a hot sauce maker selling to grocers registers, a bakery selling mostly over its own counter doesn't, and a home baker under cottage food law doesn't. Below is who registers, the exemptions, when, what the registration asks for, and a free checklist.
The short version
- Register before you start making, processing, packing or holding food, if no exemption fits.
- Exempt: farms, retail food establishments, restaurants, nonprofit food establishments, and places regulated only by USDA.
- A retail food establishment sells more than half its food, by value, directly to consumers.
- A private residence isn't a facility, so a cottage food home kitchen doesn't register.
- Renew between October 1 and December 31 of every even-numbered year, 2026 included.
- Registration asks for a unique facility identifier, product categories, activity types and an assurance FDA may inspect.
- Registering isn't an approval of your food, and it isn't a food safety plan.
- TaroStack keeps the records an FDA visit asks about: lots, batches, recalls. More below.
Who has to register
The owner, operator or agent in charge of a facility that manufactures or processes, packs or holds food for consumption in the United States registers it. The exemptions are listed in 21 CFR 1.226:
| Place | Registers? |
|---|---|
| A food maker selling to stores, distributors or restaurants | Yes |
| A warehouse holding someone else's food | Yes |
| A farm | No |
| A retail food establishment: more than half its food sales go directly to consumers | No |
| A restaurant | No |
| A nonprofit preparing or serving food directly to consumers | No |
| A place regulated only by USDA (meat, poultry, egg products) | No |
| A private home, such as a cottage food kitchen | No: a private residence isn't a facility |
The retail food establishment test is about money: a place's primary function is selling directly to consumers if its food sales to consumers are worth more over the year than its sales to everyone else, and consumers don't include businesses (21 CFR 1.227). A bakery that starts selling more to cafés than over its own counter can cross that line. This is general information, not legal advice.
An example: three food businesses
| Business | Sells | Registers? | Why |
|---|---|---|---|
| Blue Ridge Hot Sauce, Roanoke, Virginia | Hot sauce to grocers | Yes | A manufacturer selling to businesses |
| Red Clay Bakehouse, Athens, Georgia | Cakes and pies, mostly over its own counter | No | More than half its sales go directly to consumers |
| Prairie Hearth Bread, Fargo, North Dakota | Sourdough from a home kitchen under cottage food law | No | A private residence isn't a facility |
All three are made-up businesses I use in these examples. Blue Ridge registers as a manufacturer and processor and, for its hot sauce, an acidified food processor, which brings its own separate filing; how acidified foods are tested is in pH testing for acidified foods. Red Clay still holds the permits its state and county require; being exempt from FDA registration doesn't exempt it from those. Prairie Hearth follows its state's cottage food law instead; how to start under one is in how to start a cottage food business.
When to register and renew
Register before the facility begins to manufacture, process, pack or hold food, and renew every other year between October 1 and December 31 of each even-numbered year (21 CFR 1.230). A registration that isn't renewed in that window is treated as expired, and the facility as having failed to register (21 CFR 1.241). Registration and renewal are done electronically through FDA's registration site, by the owner, operator or agent in charge, or by someone they authorize.
What the registration asks for
| Item | Blue Ridge Hot Sauce's answer |
|---|---|
| Facility name, full address and phone | Its address in Roanoke |
| A unique facility identifier FDA accepts | Its DUNS number |
| Mailing address, parent company, trade names | Trade name: Blue Ridge Hot Sauce |
| Owner, operator or agent in charge: name, address, phone, email | The owner |
| Food product categories | The category its sauces fall under on Form FDA 3537 |
| Activity type for each category | Manufacturer/processor; acidified food processor |
| Assurance that FDA may inspect | Given |
| Certification that the information is true | Given |
| Contact person's email and an emergency contact | The owner's |
The list is in 21 CFR 1.232. The registration number FDA issues is what buyers and co-packers sometimes ask for, and what a traceability record can use as a lot code source reference. What else the food safety rules ask of a small maker is in FSMA requirements for small food businesses.
Get the checklist
Download the FDA food facility registration checklist. Two sheets: the questions that decide whether your place registers, each with its rule; and what the registration asks for, with a column for your answers before you sit down to file, and the 2026 renewal window. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
Registration is a form, filed once and renewed every other year. What an FDA investigator asks about when they visit is the food: which lots of peppers went into which batch, what was shipped to whom, and what's still on the shelf. A registration number on a certificate doesn't answer any of that.
How TaroStack does it
TaroStack keeps the records an FDA visit asks about: lots, batches, recalls.
Batches with their lots. Each batch of hot sauce records which lots of peppers, vinegar and bottles it consumed, automatically, and gets a lot of its own. Fields of your own on the batch record can hold the pH reading and who checked it.
Who got which lot. Each order records the lots each customer got as it ships, so one recall report shows which supplier lots went into which batches, which customers got them and what's still on your shelves.
Ready for a buyer's audit. Timed, logged traceability drills show how fast you can trace a lot, and every list exports to CSV.
| The job | Paper | In TaroStack |
|---|---|---|
| Lots in each batch | Written on a batch sheet | Recorded automatically |
| The pH reading | A notebook | A field on the batch record |
| Who got a lot | Search the invoices | One recall report |
| Proof you can trace | Hoped for | Timed, logged drills |
Lots, batches, recalls and traceability drills are on every plan, from $49 a month. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.