The small-business exemption

Newest sealed read: 2026-09-08. We re-fetch this section each month and compare it word for word. We hold 18 sealed runs going back to 2026-09-08.

What this page is10 rows held · newest sealed read 2026-09-08

Every row is the text of 21 CFR 101.9 as published in the eCFR edition of 2026-09-01, fetched through the versioner API.
A long paragraph is trimmed at a word boundary and never edited. Follow the source link for the whole thing.
This is one of 18 rule pages on this family, each on a single question a food maker actually asks.
The panel builder on the family page applies these paragraphs to your own numbers and shows its working.
Read the section yourself: 21 CFR 101.9 on the eCFR. The $49 pack is the panel files for one product; these pages are free.

Real rows out of our sealed copies

Each row is one paragraph of the regulation, quoted from the eCFR and cut at a word boundary. The left column is the paragraph label so you can find it in the source.

10 paragraphs of 21 CFR 101.9 eCFR edition of 2026-09-01

Paragraph	What the regulation says
(j)	(j) The following foods are exempt from this section or are subject to special labeling requirements:
(1)(i)	(1)(i) Food offered for sale by a person who makes direct sales to consumers (e.g., a retailer) who 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, Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. Claims or other nutrition information subject the food to the provisions of this section, § 101.10, or § 101.11, as applicable.
(ii)	(ii) For purposes of this paragraph, calculation of the amount of sales shall be based on the most recent 2-year average of business activity. Where firms have been in business less than 2 years, reasonable estimates must indicate that annual sales will not exceed the amounts specified. For foreign firms that ship foods into the United States, the business activities to be included shall be the total amount of food sales, as well as other sales to consumers, by the firm in the United States.
(18)	(18) Food products that are low-volume (that is, they meet the requirements for units sold in paragraphs (j)(18)(i) or (j)(18)(ii) of this section); that, except as provided in paragraph (j)(18)(iv) of this section, are the subject of a claim for an exemption that provides the information required under paragraph (j)(18)(iv) of this section, that is filed before the beginning of the time period for which the exemption is claimed, and that is filed by a person, whether it is the manufacturer, packer, or distributor, that qualifies to claim the exemption under the requirements for average full-time equivalent employees in paragraphs (j)(18)(i) or (j)(18)(ii) of this section; and whose labels
(ii)	(ii) For all other food products, the product shall be eligible for an exemption for any 12-month period if, for the preceding 12 months, the person claiming the exemption employed fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product were sold in the United States, or in the case of a food product that was not sold in the 12-month period preceding the period for which exemption is claimed, fewer than 100,000 units of such product are reasonably anticipated to be sold in the United States during the period for which exemption is claimed.
(iii)	(iii) If a person claims an exemption under paragraphs (j)(18)(i) or (j)(18)(ii) of this section for a food product and then, during the period of such exemption, the number of full-time equivalent employees of such person exceeds the appropriate number, or the number of food products sold in the United States exceeds the appropriate number, or, if at the end of the period of such exemption, the food product no longer qualifies for an exemption under the provisions of paragraphs (j)(18)(i) or (j)(18)(ii) of this section, such person shall have 18 months from the date that the product was no longer qualified as a low-volume product of a small business to comply with this section.
(iv)	(iv) A notice shall be filed with the Office of Nutrition and Food Labeling (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740 and contain the following information, except that if the person is not an importer and has fewer than 10 full-time equivalent employees, that person does not have to file a notice for any food product with annual sales of fewer than 10,000 total units:
—	(D) The number of full-time equivalent employees. Provide the average number of full-time equivalent individuals employed by the person and its affiliates for the 12 months preceding the period for which a small business exemption is claimed for a product. The average number of full-time equivalent employees is to be determined by dividing the total number of hours of salary or wages paid to employees of the person and its affiliates by the number of hours of work in a year, 2,080 hours (i.e., 40 hours × 52 weeks);
—	(E) Approximate total number of units of the food product sold by the person in the United States in the 12-month period preceding that for which a small business exemption is claimed. Provide the approximate total number of units sold, or expected to be sold, in a 12-month period for each product for which an exemption is claimed. For products that have been in production for 1 year or more prior to the period for which exemption is claimed, the 12-month period is the period immediately preceding the period for which an exemption is claimed. For other products, the 12-month period is the period for which an exemption is claimed; and
—	(D) Full-time equivalent employee means all individuals employed by the person claiming the exemption. This number shall be determined by dividing the total number of hours of salary or wages paid directly to employees of the person and of all of its affiliates by the number of hours of work in a year, 2,080 hours (i.e., 40 hours × 52 weeks).

What this page cannot tell you

Quoted text is trimmed for length, so read the source before you rely on a paragraph.
The eCFR is a continuously updated version of the CFR and is not the official legal edition.
Meat and poultry under the Federal Meat Inspection Act or the Poultry Products Inspection Act are labelled under USDA rules, not this section.
Nothing here tells you which paragraph applies to your product.

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What you would be paying for: $49 once, for one product. Nothing recurring, nothing to cancel and no subscription behind it. You get a private web page for the product name you give at checkout, carrying the same calculator without the DRAFT stamp, and downloads of the Nutrition Facts panel as true vector SVG files in the vertical, tabular and linear formats, plus a JSON copy of your recipe and the ingredient and allergen text you typed. The numbers come from USDA FoodData Central, which is a public database of generic foods, not a laboratory analysis of your finished product; 21 CFR 101.9(g) describes compliance testing on a composite of 12 units and this is not that. Added sugars is a figure you supply. The ingredient statement and the allergen line are typed by you and are never generated. Regulation text is quoted from the eCFR, which is not the official legal edition of the CFR, and it may lag. Nothing we deliver says whether your label or your business is compliant, or whether an exemption applies — that is yours and your advisers' to decide. Meat and poultry labelling sits with USDA FSIS, not with 21 CFR 101. Print sizes must be checked against the printed proof. Refund on request within 14 days. There is no pay button on this page yet. The private page is delivered within 15 minutes of payment. Still not here after 15 minutes? Reply to your Stripe receipt.

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