FDA small business labeling exemption

Some packaged foods are exempt from the Nutrition Facts panel, including low-volume small businesses — but any claim on the pack voids the exemption.

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Most packaged foods need a panel

Most packaged foods sold at US retail need a Nutrition Facts label. The exemptions are specific and narrow, so the safe default is to assume a panel is required and check whether a genuine exemption applies.

What can be exempt

Exemptions cover raw fruits, vegetables and fish; foods with insignificant nutrition; foods for immediate consumption; very small packages; bulk foods not sold at retail; and low-volume products from qualifying small businesses.

Small businesses have two routes in 21 CFR 101.9(j), and either is lost by a nutrition claim or other nutrition information on the label, in labeling or in advertising. Food offered for sale by a person who sells directly to consumers, such as a retailer, is exempt with no notice to FDA if that person's annual gross sales to consumers are not more than $500,000, or its annual food sales to consumers are not more than $50,000, averaged over the most recent two years (21 CFR 101.9(j)(1)). A low-volume product is exempt if the person claiming the exemption, counted with all its affiliates, employed an average of fewer than 100 full-time equivalent employees and fewer than 100,000 units of the product were sold in the United States in the preceding 12 months (or, for a product not sold in those 12 months, are reasonably expected to be sold during the period claimed), and a notice is filed with FDA each year, before the 12-month period it covers (21 CFR 101.9(j)(18)).

That notice is not needed if the person is not an importer, has fewer than 10 full-time equivalent employees and sells fewer than 10,000 units of the product a year (21 CFR 101.9(j)(18)(iv)); an importer cannot use this exception. These are exemptions from the Nutrition Facts panel only: the rest of the label — including the name of the food, the net quantity, the ingredient list and the name and place of business — is still required.

A claim voids the exemption

Any nutrient content claim or health claim — "low fat", "good source of fiber", "heart healthy" — voids the exemption and triggers the full Nutrition Facts panel. If you want to make a claim, you take on the panel that comes with it.

Exemptions can be lost

A nutrition claim or other nutrition information on the label, in labeling or in advertising ends a small-business exemption as soon as it appears. A low-volume product that no longer meets the limit of 100 full-time equivalent employees or 100,000 units has 18 months from the date it stopped qualifying to carry a Nutrition Facts panel (21 CFR 101.9(j)(18)(iii)). Where a notice is required and was not filed before the period began, the low-volume exemption does not cover that period. A person who reaches 10 full-time equivalent employees, or a product that reaches 10,000 units a year, no longer meets the no-notice exception; the low-volume route can still cover a later 12-month period whose notice is filed before that period begins, while the person stays under 100 full-time equivalent employees and the product under 100,000 units. LabelYog builds the full Nutrition Facts panel whenever you need one — LabelYog builds it from your recipe.

Sources

These routes were read at source on 21 October 2026 in 21 CFR 101.9 (eCFR, current to 19 October 2026), and FDA's two pages below were read the same day as corroboration, not as the rule.

• 21 CFR 101.9(j)(1) — eCFR
• 21 CFR 101.9(j)(18) — eCFR
• 21 CFR 101.9(j)(18)(iii) — eCFR
• 21 CFR 101.9(j)(18)(iv) — eCFR
• FDA guidance (corroboration, not the rule): Small Business Nutrition Labeling Exemption Guidance
• FDA page (corroboration, not the rule): Small Business Nutrition Labeling Exemption

At a glance

• Confirm the product actually qualifies for an exemption
• Small-business exemption: the retail-sales limits (101.9(j)(1)) or the employee and unit limits (101.9(j)(18)) met
• Low-volume route: notice filed with FDA before each 12-month period — not needed for a non-importer with fewer than 10 full-time equivalent employees and fewer than 10,000 units a year (101.9(j)(18)(iv))
• No nutrition claim or other nutrition information on the label, in labeling or in advertising
• Full Nutrition Facts panel ready if any condition fails

Questions

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