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Do I Need a Nutrition Facts Label?

The free "Do I Need a Nutrition Facts Label?" checker walks you through the exemptions in 21 CFR 101.9(j). Answer seven questions to see which exemptions your product actually reaches, their thresholds, the notice you would have to file with FDA and what forfeits each one. It never tells you a product is exempt.

1. Where do you sell it?
2. What is it?
3. How is it sold?
4. Does anything claim a nutrition benefit?
5. Who sells it to the eater?
6. How big is the business?

FTE is total hours of wages paid by you and your affiliates divided by 2,080, owners and officers included. Leave a field blank if you do not know it yet.

7. How much label surface is there?
Answer
One exemption is worth checking

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.

21 CFR § 101.9(j)(18)

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)

Work through the full label checklist

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.

How nutrition labeling exemptions work

The default is a label

Under 21 CFR § 101.9, packaged food sold in the United States carries nutrition labeling unless a specific exemption applies. The exemptions sit in § 101.9(j), which runs to nineteen paragraphs, and each one is narrow: it reaches a particular kind of business, product or sales channel, under conditions written into the paragraph.

The checker asks seven questions and names the paragraphs your answers actually reach, with the conditions attached and what forfeits each one. It never returns "you are exempt". Most of the exemptions depend on your own sales and staffing figures, and the low-volume one also depends on a notice filed with FDA - none of which a web page can verify.

When the answer is a different rulebook

Some answers never lead to § 101.9(j), because the product sits under different rules:

  • Dietary supplements carry a Supplement Facts panel under § 101.36, not Nutrition Facts.
  • Meat and poultry products are generally labeled under USDA's Food Safety and Inspection Service rather than FDA.
  • Infant formula has its own labeling requirements.
  • Raw produce and raw fish fall under FDA's voluntary nutrition labeling guidelines for those foods (§ 101.45) rather than the mandatory panel.
  • Selling outside the US means the destination country's rules apply, and US exemptions do not travel with the product.

In those cases the checker points to the applicable regime rather than evaluating exemptions that were never available to you.

The figures it asks for

The size-based exemptions turn on a small number of figures, and each has a definition worth getting right before you rely on it:

  • Full-time equivalent employees are the total hours of wages paid by you and your affiliates, divided by 2,080, with owners and officers included. A business with part-time staff and a sister company can carry more FTEs than its own payroll suggests.
  • Units sold per year is counted for the product in question, not across your whole range.
  • Annual gross sales and food sales to consumers are separate figures. The second counts only food sold directly to consumers.
  • Total surface available for labeling, in square inches, is what the small-package provisions look at - the whole labelable surface, not one panel.

The thresholds those figures are tested against appear in the result, with the paragraph they come from. A field can be left blank while you find the number.

What forfeits an exemption

The exemptions small producers rely on are conditional on the product making no nutrition claim. A phrase such as "high in protein", "low sugar" or "good source of fiber" on the package, in an online listing or in advertising ends the exemption for that product, and so does voluntarily showing nutrition information. That is why question four asks about the listing and the advertising as well as the pack: the change that ends an exemption is often a line of marketing copy rather than any change in the business.

The low-volume exemption generally also depends on an annual notice filed with FDA, and qualifying figures do not carry forward on their own. Sales and headcount that fitted last year are not evidence for this year, so re-run the figures as the business grows.

An exempt package still needs a label

Section 101.9(j) exempts nutrition labeling and nothing else. An exempt product still needs its statement of identity, net quantity of contents, ingredient list, major allergen declaration and the name and place of business of the manufacturer, packer or distributor. "Exempt" is not "unlabeled", and a package can be exempt from the panel and still misbranded for missing any of these.

So the result ends with what the package carries either way, and the FDA label checklist works through those elements one at a time. If the answer is that a panel is required, the label generator builds one from your recipe.

If you sell in more than one market, see which countries we cover, and read how to use the FDA Food Labeling Guide in practice.

Reference information, not legal advice. Requirements change and turn on facts specific to your product - confirm against the current regulation before relying on it.

Common questions

Does every packaged food need a Nutrition Facts label?

In the United States, packaged food carries nutrition labeling under 21 CFR 101.9 unless one of the exemptions in 101.9(j) applies. There are nineteen paragraphs of them, each tied to a kind of business, product or sales channel and each with its own conditions. Some products sit outside that framework altogether: dietary supplements use a Supplement Facts panel, and most meat and poultry is labeled under USDA rules rather than FDA. Confirm which rule reaches your product before assuming either way.

What makes a product lose its nutrition labeling exemption?

Making a nutrition claim. A phrase such as "high in protein", "low sugar" or "good source of fiber" on the package, in an online listing or in advertising forfeits the exemption for that product, and so does showing nutrition information voluntarily. The low-volume exemption also depends on a notice filed with FDA. Figures that qualified a business last year do not carry forward automatically either, so re-check them as sales and staffing grow.

How are full-time equivalent employees counted?

Add up the total hours of wages paid in a year by your business and its affiliates, with owners and officers included, and divide by 2,080. The result is your full-time equivalent count. Part-time staff therefore count in proportion to the hours they work, and because affiliated businesses are included, a company with a small payroll of its own can carry a higher FTE figure than expected once related entities are added in.

If my product is exempt, what still has to be on the label?

Everything except the nutrition panel. Section 101.9(j) exempts nutrition labeling and nothing else, so an exempt package still needs a statement of identity, the net quantity of contents, an ingredient list where there is more than one ingredient, the major allergen declaration, and the name and place of business of the manufacturer, packer or distributor. Leaving any of those off misbrands the product whether or not it needs a Nutrition Facts panel.

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Check your own jurisdiction

This tool is not tied to one country's rules. What you declare on the label is, and the requirements differ.

Regulation libraryAll 152 label formats, each cited to the paragraph it follows.Coverage by countryFind the rules that apply where you sell.