Do You Need a Nutrition Label? FDA Exemptions Explained

This page summarizes the federal rule, 21 CFR 101.9(j), and the FDA's small business exemption page (as of October 2026). It is a summary, not legal advice. State rules, especially for cottage food, sit on top of it.

The short version

Your situation	Nutrition Facts label?
You sell straight to consumers, with total sales up to $500,000 a year or food sales up to $50,000	Exempt, no notice
Fewer than 100 full-time equivalent employees and fewer than 100,000 units of the product sold in the US a year	Exempt with yearly notice
…and also fewer than 10 employees and fewer than 10,000 units of the product, and you're not an importer	Exempt, no notice
Food made and sold in your own bakery, deli or candy shop and not sold anywhere else	Exempt
Any of the above, but the label, your website or your ads mention a nutrient ("high protein", "low sugar", "10g fiber")	Label required
Packaged food sold through grocery stores, other shops or online, above those limits	Label required

The retailer exemption: $500,000 or $50,000

If you sell directly to consumers, the way a retailer does (your own shop or market stand, for example), your food is exempt when your annual gross sales to consumers are no more than $500,000, or your annual sales of food to consumers are no more than $50,000. Either test is enough. Sales are averaged over the most recent two years; a business younger than that uses a reasonable estimate. You don't file anything for this one.

The low-volume exemption: 100 employees, 100,000 units

This one covers manufacturers and distributors, including small makers selling to stores. A product qualifies for a 12-month period if, over the previous 12 months, your business (with its affiliates) averaged fewer than 100 full-time equivalent employees and sold fewer than 100,000 units of that product in the US. For a new product, use the units you reasonably expect to sell. Full-time equivalents are total paid hours divided by 2,080.

It's counted per product, and you have to file a notice with the FDA every year, before the period you're claiming. The exception: if you're not an importer and have fewer than 10 full-time equivalent employees, you don't need to file for a product selling fewer than 10,000 units a year.

The FDA takes these notices online (from October 5, 2026, through its FDA Industry Systems site) or on paper using its model form; both are linked from the FDA's exemption page. If a product grows past the limits during the year, you have 18 months from then to put a label on it.

Bakeries, delis and restaurants

Food served in restaurants, cafeterias and similar places for eating right away is exempt. So is ready-to-eat food that's made mainly in a retail bakery, deli or candy shop and sold only there, even to take home. The moment the same cookies go to a coffee shop or grocery store down the road, this exemption no longer covers them, and you'd look at the two above.

What cancels every exemption

All of these exemptions require that the food bears no nutrition claims or other nutrition information on the label, in labeling, or in advertising. "Keto friendly: 2g net carbs", "a good source of fiber", or a calorie count on your product page all count. Make one, and the food needs a full Nutrition Facts label.

What an exemption doesn't cover

The nutrition exemptions are about the Nutrition Facts panel only. A packaged food still needs its other required label parts, such as the name of the food, the net quantity, the ingredient list in descending order by weight, and the name and place of business of the maker, packer or distributor. Packaged foods containing any of the nine major food allergens (milk, egg, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, sesame) must declare them.

Cottage food

Cottage food laws are state laws for food made in a home kitchen. Each state sets what can be sold, where (often only directly to consumers, sometimes online or through stores), how much, and what the label has to say. Many require a statement that the food was made in a home kitchen that isn't inspected. Whether a Nutrition Facts panel is needed depends on your state's rules and on the federal exemptions above, and a nutrition claim brings it back either way. Check your state's cottage food rules, usually published by its department of agriculture or health.

When you'll want a label anyway

Being exempt doesn't stop a buyer from asking. A store or distributor can make a Nutrition Facts panel a condition of carrying your product, and customers with dietary needs often look for one. If your product is moving toward wholesale, it's usually cheaper to make the label once than to redo packaging later.

Do you need a Nutrition Facts label?