Most small food businesses don't need a Nutrition Facts label under federal law. FDA exempts businesses that sell small amounts directly to the people who eat their food, and products that small companies make in small numbers. Two things can still put a label on your package: a nutrition or health claim, such as "low fat" or "high protein", anywhere you sell or advertise the food, and a store or distributor that asks for one.
Where do you stand?
Go down this list and stop at the first one that fits you.
- You sell packaged food, and your package, signs, website or social posts make a nutrition or health claim ("low sodium", "high protein", "100 calories") or give any nutrition information. You need a full Nutrition Facts label, whatever your size. Why a claim changes the answer
- You sell directly to customers (at a market, in your own shop, or online), and your food sales are $50,000 a year or less, or your total sales are $500,000 or less. Food you sell that way doesn't need a label, and there's nothing to file. If some of your products also sit on store shelves, this covers only your direct sales; check item 3 for the rest. Who qualifies
- Your business has fewer than 100 full-time equivalent employees (part-time hours count), and you sell fewer than 100,000 units of a product a year in the US, wherever it's sold. That product doesn't need a label, though you may have to send FDA a short yearly notice. Who qualifies and whether you file
- You run a bakery, café, deli or food cart and sell what you make there, or you sell plain coffee or tea, or very small packages. A separate exemption probably covers you. Food sold from bulk bins is exempt from the package label too, but the nutrition information still has to be shown to customers at the bin. Which ones
- None of these fits. You need a Nutrition Facts label, and the guide to making one without a lab walks through the calculation, serving sizes and rounding.
Whatever your answer above, also check these:
- If you sell from your home kitchen under your state's cottage food law, the federal rules above still decide the nutrition label question, and your state decides the rest of the label. How cottage food laws fit in
- Exempt or not, ask every grocery store, distributor and online marketplace you sell through what they require. Many want a Nutrition Facts label, and their requirement overrides your exemption if you want to sell there. Selling wholesale
Any nutrition claim means you need a label
Both small business exemptions come with the same condition: no nutrition claims and no other nutrition information on the label, in other labeling or in advertising. Health claims, such as a statement linking a nutrient to a disease, count too, and the low-volume exemption names them outright. Make a claim and you need the full panel, however small you are.
A nutrition claim, in FDA's terms a "nutrient content claim", is any statement about how much of a nutrient a food has. FDA's definition gives examples. "Low sodium" and "contains 100 calories" say it outright. "High in oat bran" implies it, because it suggests a nutrient is there in a certain amount.
"Healthy" counts too. FDA updated what "healthy" means in a final rule announced December 19, 2024, which took effect April 28, 2025 after a delay. Companies have until February 25, 2028 to meet the new criteria, and until then the rule lets them use either the new criteria or the old definition.
"Labeling or advertising" reaches past the package. A "high protein" line on your website or market sign counts, even if the jar itself says nothing. So does printing calories on the front of the bag.
If you're exempt but print a Nutrition Facts panel anyway, it still has to follow FDA's format and rounding rules.
Who qualifies for the retail sales exemption?
This exemption covers food you sell directly to consumers. You qualify if either of these is true:
- your sales of food to consumers are $50,000 a year or less, or
- your total sales to consumers, food and everything else, are $500,000 a year or less.
Either test is enough. You lose the exemption only when you're over both. All of the exemptions in this post are in one paragraph of FDA's nutrition labeling regulation, 21 CFR 101.9(j), if you ever need to look one up. FDA's Food Labeling Guide lays out this one as a grid:
| Food sales to consumers | Total sales, food and non-food | Status |
|---|---|---|
| $50,000 or less | $500,000 or less | Exempt |
| $50,000 or less | $500,001 or more | Exempt |
| $50,001 or more | $500,000 or less | Exempt |
| $50,001 or more | $500,001 or more | Not exempt |
Sales are your average over the last two years. If you've been in business less than two years, use a reasonable estimate that you'll stay under the limits.
As an example, take a farmers-market jam maker who sold $38,000 in 2024 and $46,000 in 2025. The two-year average is $42,000. That's under $50,000 in food sales, so the exemption applies whatever else the business sells. A bakery café with $620,000 in total sales, $580,000 of it food, is over both lines and needs another exemption or a panel.
You don't file anything with FDA for this exemption; FDA's small business exemption page says so directly. FDA doesn't keep track for you, either. The Food Labeling Guide says it's up to you to keep records, such as tax returns, that show you're under the limits.
Who qualifies for the low-volume exemption?
This one counts employees and packages instead of dollars, and it applies wherever the product is sold, including on a store shelf. A product is exempt for a 12-month period if, over the 12 months before it, your business averaged fewer than 100 full-time equivalent employees and fewer than 100,000 units of that product were sold in the US. For a new product, it's enough to reasonably expect fewer than 100,000 units in the period.
What counts:
- A unit is one package, or one piece if the food is sold without a package.
- A product is one food, in every package size, from one manufacturer or under one brand name, with the same name on the label and made in a similar way. Each product is counted on its own, not your whole business.
- Full-time equivalents are the total hours you paid employees for in a year, divided by 2,080 (40 hours times 52 weeks).
- Employees of affiliated businesses, such as a sister company, count toward your total.
If you outgrow the limits partway through a period, you have 18 months from the date the product stopped qualifying to put a compliant label on it.
Do you need to tell FDA you are exempt?
Usually, yes. To use the low-volume exemption you file a notice with FDA once a year, before the period you're claiming it for. The notice lists your contact details, the products, your average full-time equivalent employees and roughly how many units you sold. Someone responsible for the business signs it to certify that it's accurate, and promises to tell FDA if the business goes over the limits during the year.
You can skip the notice for a product if all three of these are true: you have fewer than 10 full-time equivalent employees, you don't import the food, and the product sells fewer than 10,000 units a year. Importers always file. Anyone below the line can still file voluntarily to put the claim on record.
Since October 5, 2026, FDA's page says, notices filed online must go through FDA Industry Systems. FDA still accepts notices by mail or fax on its model form.
A worked example: a granola company pays one part-time employee for 1,040 hours a year and pays the owner a salary for 2,080 hours. That's 3,120 ÷ 2,080 = 1.5 full-time equivalents. The original flavor sold 12,000 bags last year, and a new maple flavor is expected to sell about 4,000. Both are far under 100 employees and 100,000 units, so both are exempt. The maple flavor is also under 10,000 units, so it needs no notice. The original flavor is over 10,000, so the company files a notice for that one.
Which other foods and businesses are exempt?
These are the other exemptions most likely to fit a small food business:
| Who or what is exempt | What that covers |
|---|---|
| Restaurants and other places that serve food to eat right away | Includes bakeries, delis and candy shops with seating, and food carts and counters where people eat on the spot |
| Food sold only in those places | For example, pastries you make that are sold only through cafés |
| Ready-to-eat food made and sold on site, not sold anywhere else | Retail bakeries, independent delis and candy shops without seating, in-store bakery departments |
| Foods with almost no nutrients | Plain coffee beans and tea leaves, plain unsweetened instant coffee and tea, flavor extracts, food colors |
| Bulk food not sold to consumers in that form | Product shipped for use in making other foods, or to be repacked elsewhere |
| Packages with less than 12 square inches of label space | Tiny packages, as long as the label gives an address or phone number where customers can get the nutrition information |
| Food sold from bulk bins | The nutrition information must still be shown to customers, on the bin's label in plain view or on a display nearby |
Most of these carry the same no-claims condition as the small business exemptions. The coffee and tea exemption covers plain products only. FDA's labeling guide notes that some spices have enough nutrients to fall outside it, and a sweetened or flavored coffee or tea needs its own check.
None of these exemptions, small business ones included, cover the rest of the label. You still need the name of the food, the net quantity, the ingredient list and the allergen declaration. Allergens have their own rules; the post on the Big 9 allergens and sesame covers them.
Does a cottage food law require a nutrition label?
Usually not. Cottage food laws are state laws that decide whether you can sell food made in a home kitchen, which foods, where, up to what sales limit, and what the label has to say. They generally don't add a Nutrition Facts requirement of their own, and state guidance tends to point back to the federal exemptions.
Utah's Department of Agriculture and Food, in its Basic Labeling Guidelines for Cottage Foods, says a nutrition statement is "not typically needed for products produced under cottage food law." It lists the federal exemptions and warns that a health or nutrition claim, such as "low fat" or "good source of calcium", voids them. The Harvard Law School Food Law and Policy Clinic's 2018 survey, Cottage Food Laws in the United States (a secondary source; some states have changed their laws since), found that labeling rules varied widely between states, and described California's law the same way: a Nutrition Facts panel is required if the label makes a nutrient content or health claim.
So for most cottage producers, the federal exemptions decide the Nutrition Facts question, and state law decides everything else on the label. Check your state's current cottage food rules with the agency that runs the program, because sales caps and label wording change.
What changes when you start selling wholesale?
The retail sales exemption only counts sales made directly to consumers. Once your product sits on someone else's shelf, the low-volume exemption is usually the one that covers you.
The exemption can survive the move to a store. FDA's labeling guide says that when a retailer simply repacks a qualifying small maker's food into smaller containers under the maker's name, the food stays exempt. That changes if the package carries the retailer's name or logo. And if you make products under a store's own brand, the company whose name is on the label is responsible for the nutrition information.
If you sell to a distributor that supplies restaurants, the restaurant exemption doesn't cover you when customers could reasonably buy the product directly, for example at a club store. In that case the responsibility for nutrition information falls on you as the manufacturer.
Some grocery stores, distributors and online marketplaces require a Nutrition Facts panel on what they carry, whether or not you're exempt. That's a buyer's requirement, not the law's. Utah State University Extension, in its guide to Nutrition Facts panels (a secondary source), puts it this way: even if FDA considers you exempt, "you might be required to have nutrition facts to sell through some grocery stores or online retailers."
Ask each buyer for their label requirements before you print packaging. If you're redesigning packaging for retail anyway, adding the panel at the same time saves a second print run. Scaling a recipe to production covers the other changes that usually come at the same point.
KitchenSync is nutrition label and recipe costing software for small food businesses. If a buyer asks you for a panel, it calculates one from your recipe and USDA FoodData Central data; see the nutrition label generator. Cottage food sellers lining up a first wholesale account can read how KitchenSync works for home-kitchen businesses.
This is general information about federal rules, not legal advice. State rules and the details of your own product can change the answer, so check with your state agriculture or health department about anything you're unsure of.
Sources
- 21 CFR 101.9, Nutrition labeling of food, Electronic Code of Federal Regulations
- 21 CFR 101.13, Nutrient content claims: general principles, Electronic Code of Federal Regulations
- Small Business Nutrition Labeling Exemption, U.S. Food and Drug Administration
- A Food Labeling Guide: Guidance for Industry, U.S. Food and Drug Administration
- Use of the "Healthy" Claim on Food Labeling, U.S. Food and Drug Administration
- Food Labeling: Nutrient Content Claims; Definition of Term "Healthy" (final rule, December 27, 2024), Federal Register
- Food Labeling: Nutrient Content Claims; Definition of Term "Healthy" (delay of effective date, February 25, 2025), Federal Register
- Cottage Food Laws in the United States (2018), Harvard Law School Food Law and Policy Clinic (secondary source)
- Basic Labeling Guidelines for Cottage Foods, Utah Department of Agriculture and Food
- Nutrition Facts Panels, Utah State University Extension (secondary source)
