Do I Need a Nutrition Facts Label?
Nineteen paragraphs of 21 CFR 101.9(j) exempt somebody from nutrition labeling. Answer seven questions and see which ones your product actually reaches, with the thresholds, the notice you would have to file, and what forfeits it.
These are the paragraphs your answers reach. Read the one that fits and confirm it against your own figures before you leave the panel off. This tool cannot see your books or your filings, so it names the rule rather than giving you a verdict.
Low-volume small business exemption
The one most small brands are actually looking for. It turns on employees and units, not on revenue.
Why you are seeing this: Enter employees and annual units to see whether the two tests reach you.
- Full-time equivalent employees
- fewer than 100 on average
- Units of that product sold in the US in 12 months
- fewer than 100,000
- Notice to FDA
- Form FDA 3570, filed before the period it covers
- Notice lifetime
- 12 months, then it must be filed again
Both tests have to hold. FTE is counted as total hours of salary or wages paid by the firm and its affiliates divided by 2,080, which includes owners and officers, not just production staff. The notice is per product and per period: FDA does not remind anyone when it is time to file again, and if a notice does not arrive the exemption stops. One carve-out: a business that is not an importer and has fewer than 10 full-time equivalent employees files no notice at all for a product selling fewer than 10,000 units a year.
What forfeits it: Any nutrient content claim, health claim, or other nutrition information, in the label, in labeling, or in advertising. Crossing either threshold part-way through the period also ends it, and the person who signed the notice has undertaken to tell FDA when that happens.
What the package carries either way
Section 101.9(j) exempts nutrition labeling and nothing else. This is the most common misreading of it. Every one of these is still required on an exempt package.
- Statement of identity21 CFR § 101.3
- Net quantity of contents21 CFR § 101.7
- Ingredient declaration21 CFR § 101.4
- Name and place of business21 CFR § 101.5
- Major food allergen declarationFD&C Act § 403(w), 21 USC 343(w)
This checker names the rule that reaches you. It does not tell you that you are exempt, and it cannot: the exemptions turn on your own figures and, for the low-volume one, on a notice filed with FDA that this page cannot see. Confirm the paragraph against your books before you leave the panel off. Citations verified 15 September 2026; paragraphs (j)(2), (j)(3) and (j)(9) are named without thresholds because their current text could not be re-verified.