FDA Small Business Nutrition Labeling Exemption

Surprise: many small food businesses aren't legally required to have a Nutrition Facts panel at all. Two separate exemptions exist in 21 CFR 101.9(j) — and one sentence of marketing can void both.

Exemption 1: the small retailer (101.9(j)(1))

You're exempt if you sell directly to consumers and either:

• your annual gross sales are $500,000 or less, or
• your annual gross sales of food to consumers are $50,000 or less.

Sales are measured on the most recent two-year average. No filing needed.

Exemption 2: low volume (101.9(j)(18))

Larger small businesses can still be exempt if, over the preceding 12 months, the business (counting all affiliates) had:

• fewer than 100 full-time-equivalent employees, AND
• fewer than 100,000 units of that product sold in the US.

This one requires an annual notice filed with FDA before each exemption period — with one carve-out: non-importers with fewer than 10 FTEs don't need to file for products under 10,000 units/year. If you outgrow the thresholds, you get 18 months to add labels.

The catch that voids everything

Both exemptions disappear the moment your label, packaging, or advertising makes any nutrition claim or provides nutrition information. Write "low fat", "only 90 calories!", or "high protein" anywhere — including your website — and a full compliant Nutrition Facts panel becomes mandatory.

Should you use the exemption?

Legally allowed ≠ commercially smart. Retail buyers, online marketplaces, and plenty of customers expect the panel regardless; many small producers label voluntarily because it closes sales. A voluntary label must still be fully compliant — format, rounding, and all. That's the scenario this product exists for: exempt on paper, labeled in practice.

Also note: state cottage food programs have their own labeling rules that apply instead of or on top of federal ones — check your state's page in our cottage food section.