Do I Need a Nutrition Facts Label?

Packaged food sold in the United States must carry nutrition labeling unless an exemption applies (21 CFR 101.9(a); exemptions in 101.9(j)). Dietary supplements follow the same idea under 21 CFR 101.36(h).

This page summarizes the federal exemptions that small food businesses ask about most. It is a starting point, not legal advice. Your facts, and your state's rules, decide the answer.

Cottage food labels are a state matter

"Cottage food" laws are written by individual states. They decide whether you can sell food made in a home kitchen, where you can sell it, and what the label must say. Many cottage food labels require specific wording or contact details, and the wording differs from state to state.

Check with your state's department of agriculture or health, or your local extension office. The federal nutrition labeling rules below apply in addition to any state requirements.

Quick self-check

Answer these in order:

Do your label, website, social posts or ads make any nutrition claim or give nutrition information? Examples: "low fat," "sugar free," "high protein," "keto," "only 90 calories," a carb count. If yes, the small-business exemptions below don't apply. You need a full label (101.9(j)(1), (j)(18)).
Do you sell directly to consumers, with small total sales? See "Small retailer exemption" below.
Is the product low-volume, and is your business small? See "Low-volume product exemption" below.
Does one of the other exemptions fit? See "Other exemptions" below.

If none apply, you need a Nutrition Facts label. Our Nutrition Facts label generator can make one.

Small retailer exemption (no FDA notice)

Food is exempt when it is offered for sale by a person who makes direct sales to consumers (for example, a retailer) and who has either:

annual gross sales made or business done in sales to consumers of not more than $500,000, or
annual gross sales of food to consumers of not more than $50,000.

This applies only if the food bears no nutrition claims or other nutrition information in any context on the label, in labeling or in advertising (21 CFR 101.9(j)(1)(i)).

Sales are based on the most recent 2-year average. Businesses under 2 years old use reasonable estimates (101.9(j)(1)(ii)).
No notice has to be filed with FDA (FDA, Small Business Nutrition Labeling Exemption).

Low-volume product exemption (annual notice, usually)

A product can be exempt for a 12-month period if, for the preceding 12 months, both of these held (21 CFR 101.9(j)(18)(ii)):

the business averaged fewer than 100 full-time-equivalent employees, and
fewer than 100,000 units of that product were sold in the U.S. For a new product, the test is fewer than 100,000 units reasonably expected.

Key details from the regulation and FDA's guide:

File a notice before the exemption period starts, every year.
- FDA does not remind you, and does not send a confirmation, so keep a copy.
- If FDA doesn't receive a completed notice each year, the exemption no longer applies.
Smallest-business carve-out. No notice is needed if you are not an importer, have fewer than 10 FTEs, and the product sells fewer than 10,000 units a year (101.9(j)(18)(iv)).
FTEs = total paid hours for you and all your affiliates ÷ 2,080 (101.9(j)(18)(vi)(D)).
A "product" is one food in any package size, from a single manufacturer or under the same brand name, with the same statement of identity and similar preparation methods. Different recipes are counted separately (101.9(j)(18)(vi)(B); FDA guide).
A "unit" is the package, or, if the food is unpackaged, the form in which it is offered to consumers (101.9(j)(18)(vi)(A)).
If you outgrow it, you have 18 months from the date the product stopped qualifying to comply (101.9(j)(18)(iii)).
No claims. Labels, labeling and advertising must not give nutrition information or make nutrient content or health claims.

New in October 2026: online notices move to FDA Industry Systems (FIS)

FDA's Small Business Nutrition Labeling Exemption page states that starting October 5, 2026, web-based exemption notices must be submitted through FDA Industry Systems (FIS). FDA still accepts notices on its model form by mail and fax. Its guide also gives an email address for notices (FDA SBNLE page and guide, both revised October 5, 2026).

Other exemptions (short list)

From 21 CFR 101.9(j). Each has conditions, and most are cancelled by claims:

Restaurants and immediate-consumption food, such as cafeterias, bakeries with seating and food carts ((j)(2)). Restaurant menu labeling rules are separate.
Ready-to-eat food made and sold in the same retail store, such as an in-store bakery or deli, when it is not sold elsewhere ((j)(3)).
Foods with insignificant amounts of all required nutrients, such as plain coffee beans, tea leaves and many spices ((j)(4)).
Bulk food for further manufacturing, not for sale to consumers in that form ((j)(9)).
Raw fruits, vegetables and fish, with voluntary guidelines in 101.45 ((j)(10)).
Very small packages with under 12 square inches available for labeling. The label must give an address or phone number where consumers can get the nutrition information ((j)(13)).

What an exemption doesn't cover

Exemptions apply only to nutrition labeling. You still need the rest of the required label information:

the statement of identity
net quantity of contents
the ingredient statement
the name and address of the manufacturer, packer or distributor (FDA SBNLE guide)
major food allergen declarations. See allergen labeling.

If you need a label

Food: Nutrition Facts label generator, or follow the steps in the nutrition label maker guide.
Supplements: Supplement Facts label maker.

Sources

21 CFR 101.9(a), (j): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-A/section-101.9
FDA, Small Business Nutrition Labeling Exemption: https://www.fda.gov/food/labeling-nutrition-guidance-documents-regulatory-information/small-business-nutrition-labeling-exemption
FDA, Small Business Nutrition Labeling Exemption Guide: https://www.fda.gov/food/labeling-nutrition-guidance-documents-regulatory-information/small-business-nutrition-labeling-exemption-guide

Last checked October 22, 2026. Not legal advice. FactsReady is not affiliated with FDA.