The short answer
Some foods sold in small volumes can leave off the Nutrition Facts panel under FDA’s small business (low-volume) exemption. To use it, the firm claiming it must have fewer than 100 full-time equivalent employees (counting all domestic and international affiliates) and sell fewer than 100,000 units of the product in the U.S. in a 12-month period — and it must file a notice with FDA every year.
A small no-notice option exists for firms with fewer than 10 employees selling fewer than 10,000 units — but it is not available to importers. And the exemption is lost the moment the label makes a nutrient content or health claim.
| Exemption | Who qualifies | Notice to FDA? |
|---|---|---|
| Low-volume product (21 CFR 101.9(j)(18)) | Firm with fewer than 100 FTE employees (including affiliates) and fewer than 100,000 units of the product sold in the U.S. per year | Yes — every year |
| Very small firm | Not an importer, fewer than 10 FTE employees and fewer than 10,000 units of the product per year | No |
| Small retailer (21 CFR 101.9(j)(1)) | Retailer with annual gross sales of no more than $500,000, or food sales to consumers of no more than $50,000 | No |
Dietary supplements have matching exemptions in 21 CFR 101.36(h).
What counts
- Employees: full-time equivalents of the firm and all its domestic and international affiliates. A small exporter that belongs to a large group does not qualify.
- Units: the number of units of that product sold in the U.S. in a 12-month period — each flavor or size can be a separate product.
- Each year: the notice must be filed annually. FDA says that if it does not receive a completed notice each year, the exemption no longer applies. FDA does not send reminders or confirmations, so keep a copy.
What the label still needs
The exemption only removes the Nutrition Facts panel. Everything else is still required:
- Statement of identity (the name of the food)
- Net quantity of contents in U.S. and metric units
- Ingredient list in descending order of weight
- Major food allergen declaration — see the 9 major food allergens
- Name and place of business of the manufacturer, packer or distributor
- All of it in English
Example: an artisan biscuit brand from Italy
A family company in Italy with 25 employees and no affiliates sells about 8,000 packs a year of each of three biscuits through a U.S. specialty importer. It can claim the low-volume exemption, but because the product is imported, a notice covering each product must be filed with FDA every year — the no-notice option is not available to importers. If it later adds “no added sugar” to the pack, it loses the exemption and needs a full Nutrition Facts panel.
Is the exemption worth it?
- Many buyers want Nutrition Facts anyway. Large retailers, online marketplaces and distributors often require it, exemption or not.
- Growth ends it. Once you pass 100,000 units of a product in a year, you need the panel.
- Missing the annual notice ends it. A shipment can be detained for “NUTRIT LBL” if the exemption has not been properly claimed.
For most exporters planning steady growth, a correct U.S. Nutrition Facts panel from the start is simpler. The exemption suits genuinely small, specialty lines.
Our Standard FDA label review includes the Nutrition Facts panel, ingredients, allergens and a full compliance checklist. $550 per product.
Frequently asked questions
Can imported foods use the small business Nutrition Facts exemption?
Yes, if the low-volume criteria are met — but a notice must be filed with FDA every year. The no-notice option for very small firms is not available to importers.
How many units can I sell under the exemption?
Fewer than 100,000 units of the product in the U.S. in a 12-month period, with fewer than 100 full-time equivalent employees in the firm and its affiliates.
Do I lose the exemption if I say “sugar free” or “high protein”?
Yes. Nutrient content claims such as “sugar free” or “high protein”, health claims, or other nutrition information on the label, labeling or advertising remove the exemption for that product.
Does the exemption remove the ingredient list?
No. Only the Nutrition Facts panel is exempt. The ingredient list, allergens, net quantity and other required information remain mandatory.
Sources
- FDA — Small Business Nutrition Labeling Exemption Guide (revised October 5, 2026)
- FDA — Small Business Nutrition Labeling Exemption
Thresholds and rules checked against FDA sources on November 11, 2026. This article is general information, not legal advice.