The FDA Nutrition Facts Exemption for Small Direct Sellers

A packaged food sold directly to consumers can lawfully skip the Nutrition Facts panel only under conditions that 21 CFR 101.9(j) spells out in specific dollar figures, a specific averaging method, and a specific carve-out for low-volume products. The regulation does not decide whether any one seller or product qualifies — it only sets the conditions a seller would have to meet.

This original record-reading guide is a general reading aid, not cited evidence. It does not depict a source record; the article text and source links provide the facts.

Key points

• Under 101.9(j)(1)(i), a direct-to-consumer seller may omit the panel if it has “annual gross sales made or business done in sales to consumers that is not more than $500,000 or has annual gross sales made or business done in sales of food to consumers of not more than $50,000” (21 CFR 101.9).
• That same provision conditions the exemption on the food carrying “no nutrition claims or other nutrition information in any context on the label or in labeling or advertising” (21 CFR 101.9) — making any nutrition claim anywhere forfeits the exemption.
• Under 101.9(j)(1)(ii), the sales figure used for that test is not a single year’s revenue: “calculation of the amount of sales shall be based on the most recent 2-year average of business activity” (21 CFR 101.9).
• A separate exemption in 101.9(j)(18) covers low-volume products of a small business; if a product stops qualifying, the rule gives a transition period of “18 months from the date that the product was no longer qualified as a low-volume product of a small business” (21 CFR 101.9).

Direct Sales Exemption

The regulation ties this exemption to two alternative sales tests, either of which can qualify a seller: overall annual gross sales or business done in consumer sales, or sales of food specifically to consumers. The rule states the exemption applies where a seller “has annual gross sales made or business done in sales to consumers that is not more than $500,000 or has annual gross sales made or business done in sales of food to consumers of not more than $50,000” (21 CFR 101.9).

That sales threshold is not the only condition. The same sentence attaches a proviso that removes the exemption the moment the label, labeling, or advertising says anything about nutrition: the exemption holds “Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising” (21 CFR 101.9). In other words, meeting the dollar threshold is necessary but not sufficient — a single nutrition claim anywhere on the packaging or in ads closes off this particular exemption.

Sales-threshold calculation

The regulation fixes the measurement method: “calculation of the amount of sales shall be based on the most recent 2-year average of business activity” (21 CFR 101.9). This article reports that stated averaging method without applying it to a particular seller.

Low Volume Exemption

Distinct from the direct-to-consumer sales exemption above, 101.9(j) also provides a low-volume-product exemption for small businesses, which the rule requires be claimed by advance notice rather than assumed automatically. The regulation also addresses what happens when a product outgrows that exemption, setting a fixed transition window: “18 months from the date that the product was no longer qualified as a low-volume product of a small business” (21 CFR 101.9). That 18-month period is the low-volume exemption’s own transition rule and is separate from the sales-threshold exemption in (j)(1)(i)–(ii).

What this article does not answer

This article reports the quoted conditions in 21 CFR 101.9(j). It does not determine whether any particular seller or product meets either exemption.

Source links

• https://www.ecfr.gov/current/title-21/section-101.9