Mislabeling — or wrongly assuming you are exempt — can lead to a misbranding determination, which is far more expensive to fix after launch than before. The thresholds below are checked annually and certain claims remove the exemption entirely, so read to the end before you decide.
Do you need a Nutrition Facts label at all?
Under the Federal Food, Drug, and Cosmetic Act, most packaged food sold at retail must carry a Nutrition Facts label in the format set by 21 CFR 101.9. The default is that you label; the exceptions are specific exemptions you have to qualify for. There are two small-business exemptions for conventional foods, and they work differently.
Exemption 1 — low total sales (no FDA filing)
Under 21 CFR 101.9(j)(1), a business is exempt from the Nutrition Facts requirement if it has either:
- annual gross sales of $500,000 or less across all products, or
- annual gross sales of food to consumers of $50,000 or less.
If you meet this, you do not have to file anything with the FDA. The exemption applies automatically as long as you keep qualifying and you avoid the claims described below.
Exemption 2 — low-volume products (annual notice)
Under 21 CFR 101.9(j)(18), a low-volume product is exempt if the business:
- employs fewer than 100 full-time-equivalent employees (averaged), and
- sells fewer than 100,000 units of that product in the United States over a 12-month period.
Both conditions must be true. Unlike the first exemption, this one requires you to file a notice with the FDA every year, for each product you are claiming. There is one narrow break: if you have fewer than 10 full-time-equivalent employees and sell fewer than 10,000 total units of the product per year, the annual notice is not required.
Dietary supplements have parallel exemptions under [21 CFR 101.36(h)](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-C/section-101.36) — the same employee and unit thresholds, applied to the Supplement Facts panel.
What voids the exemption
Both exemptions disappear the moment you make a nutrient content claim or a health claim, or otherwise put nutrition information on the label or in advertising. Triggers include:
- calling a product 'low fat,' 'high fiber,' 'good source of protein,' or 'reduced sodium,'
- claiming a health benefit, such as 'supports heart health,'
- voluntarily printing any nutrition facts at all.
In short: if you want to say anything quantitative or health-related about nutrition, you take on the full labeling requirement. See the nutrient-content and health claims guide for what each term legally means and the thresholds behind it.
Even if you qualify today, the thresholds are re-checked every year. Growing past them — or adding a single qualifying claim — flips you into mandatory labeling. Many small producers simply label from the start, because it is less work than tracking the exemption annually and re-filing.
What the exemption does NOT cover
The small-business exemptions apply only to the Nutrition Facts panel. Every other piece of mandatory food labeling still applies, including:
- the statement of identity — what the product is,
- the net quantity of contents — weight or volume,
- the ingredient list, in descending order by weight,
- **allergen declarations** for the major food allergens,
- the name and address of the manufacturer, packer, or distributor.
So an exemption removes one panel, not the whole label — see the rest of the food label for how to get those parts right.
Cottage food laws are a separate, state-level matter
Many home-based food businesses operate under cottage food laws, which are set by individual states, not the FDA. They govern which low-risk foods you can make in a home kitchen and sell, and they carry their own labeling rules — often a statement that the product was made in a home kitchen not subject to state inspection. Cottage food rules vary widely by state and are separate from the federal Nutrition Facts requirement, so you may be subject to both. Check your state's department of agriculture or health for specifics.
If you do need a label, the fast path
When you are required to label — or you simply choose to — you do not need expensive software. You can build a compliant panel from your recipe in a few minutes:
- Calculate the nutrition for your recipe with the recipe nutrition calculator — it totals the ingredients and divides by servings.
- Generate the panel with the Nutrition Facts label generator, or choose a layout from all FDA label formats if you need tabular, linear, or dual-column.
- Add your statement of identity, net quantity, ingredient list, allergen statement, and business name and address.
- Check the serving size against the FDA reference amounts — see the serving sizes guide.
For dietary supplements, use the Supplement Facts generator instead.