21 CFR 101.100 and related provisions provide conditional exemptions from certain mandatory labeling requirements under 21 CFR Part 101. The most significant exemptions relate to the Nutrition Facts panel — which is not required for all packaged foods under all circumstances.

Small Business and Low-Volume Exemptions from Nutrition Labeling

There are two separate exemption pathways under 21 CFR 101.9(j):

Direct-Sales Retailer Exemption — 21 CFR 101.9(j)(1)

Under 21 CFR 101.9(j)(1), food offered for sale by a person who makes direct sales to consumers (e.g., a retailer) is exempt from Nutrition Facts requirements if that person has:

• Annual gross sales of $500,000 or less in total consumer sales, or

• Annual gross sales of $50,000 or less in food sales to consumers

This exemption applies based on dollar sales volume, not employee count or unit count. It applies only when the food bears no nutrition claims or other nutrition information in any context on the label, labeling, or advertising.

Low-Volume Product Exemption — 21 CFR 101.9(j)(18)

Under 21 CFR 101.9(j)(18), a food product qualifies for exemption for any 12-month period if, during the preceding 12 months, the person claiming the exemption:

• Employed fewer than an average of 100 full-time equivalent employees, and

• Sold fewer than 100,000 units of that product in the United States

Filing the exemption claim: The manufacturer must file a notice with FDA before the beginning of the time period for which the exemption is claimed. An exception: if the person is not an importer and has fewer than 10 full-time equivalent employees, no filing is required for products with annual sales of fewer than 10,000 total units.

How to qualify:
The exemption is lost if:

• The product's annual unit sales exceed 100,000 units (or full-time equivalent employees reach or exceed 100)

• The manufacturer makes a nutrient content claim or health claim on the exempt product — once a claim is made, Nutrition Facts labeling is required

• The person no longer qualifies, triggering an 18-month grace period to come into compliance

Small Package Exemption

Under 21 CFR 101.9(j)(13), packages with a total surface area of less than 12 square inches available for labeling are exempt from the Nutrition Facts panel requirement, unless the manufacturer makes a nutrient content claim or health claim on the package.

For these small packages, the manufacturer must provide a telephone number or address where consumers can obtain required nutrition information.

Important: The small package exemption only applies to the Nutrition Facts panel. Other mandatory label elements — the statement of identity, net quantity of contents, ingredient list, allergen declarations, and name and address — are still required unless otherwise exempt.

Exemptions Under 21 CFR 101.100 Specifically

21 CFR 101.100 covers a range of specific exemptions:

Bulk Foods Not for Retail Sale

Foods shipped in bulk containers to retail stores or food service establishments — where the food is not labeled for retail sale at the point of shipment — have modified labeling requirements. The labeling information must be available to the retail purchaser but may appear on shipping documents rather than on the individual bulk container.

Foods Sold at Retail Directly from Bulk Containers

When food is sold directly from bulk containers to consumers at retail (e.g., bulk bins, deli counters), the food is not required to bear an individual label if:

• The required information is displayed prominently on the bin, counter, or by a placard

• The information is readily visible to the consumer

This applies to unpackaged or loosely packaged bulk items — once the food is packaged for individual retail sale, standard labeling requirements apply.

Individual Portions Served with a Meal

Individual serving-size portions of food that accompany a complete meal — such as condiment packets, individual coffee creamers, or single-serve crackers — may be exempt from full labeling requirements when they are not intended for individual retail sale but are part of a meal service offering.

What the Exemptions Do Not Cover

Qualifying for an exemption from Nutrition Facts labeling does not exempt a product from:

The exemptions in 21 CFR 101.100 are specific to particular labeling requirements — qualifying for one exemption does not create a general labeling exemption.

Loss of Exemption When Claims Are Made

A critical rule: any nutrition-related claim on a label eliminates the exemption for the Nutrition Facts panel.

If a small business qualifies for the low-volume nutrition labeling exemption but places any of the following on the label, the Nutrition Facts panel becomes required:

• Nutrient content claims ("low fat," "high protein," "good source of vitamin C")

• Health claims (authorized or qualified)

• Structure/function claims that reference a specific nutrient

• Any statement about a specific nutrient content

This is a common compliance gap for growing small food and supplement businesses.

Dietary Supplement Exemptions

Dietary supplements have their own exemption provisions under 21 CFR 101.36(h), which parallel the food exemptions:

• Small dietary supplement manufacturers with fewer than 10 full-time employees and annual sales below threshold may qualify for Supplement Facts exemption

• Dietary supplements in small packages (less than 12 sq in) may qualify for modified labeling

• The same rule applies: making a nutrient content or health claim eliminates the Supplement Facts exemption

How Truli Helps with Labeling Exemption Compliance

• Exemption eligibility assessment: Truli evaluates whether a product may qualify for small business or small package labeling exemptions based on disclosed production volume and package dimensions

• Claim-triggered requirement detection: Truli identifies small-business exempt products that bear nutrient content claims, which would invalidate the exemption and require full Nutrition Facts labeling

• Compliance planning for growing brands: Truli tracks products approaching the threshold that would cause exemption loss and alerts brands before they are out of compliance

Related Regulations

• 21 CFR Part 101 — FDA food labeling overview

• 21 CFR 101.9 — Nutrition Facts Panel — Full requirements and exemption provisions for the Nutrition Facts panel

• 21 CFR 101.36 — Supplement Facts Panel — Supplement Facts exemption provisions

• FALCPA / FASTER Act Allergen Labeling — Allergen labeling requirements (separate exemption provisions)

Frequently Asked Questions

We're a small brand selling fewer than 10,000 units. Do we need Nutrition Facts on our label?
You may qualify for the low-volume exemption under 21 CFR 101.9(j)(18). The full threshold is fewer than 100,000 units AND fewer than 100 full-time equivalent employees. If you have fewer than 10 FTE employees, you do not need to file a notice with FDA for products under 10,000 units — but you still must meet the 100 FTE / 100,000 unit threshold for the exemption to apply. The exemption is lost immediately if you make any nutrient content or health claim on the label.

We use bulk bins in our store. Do the bins need Nutrition Facts?
Not in the traditional label format — required information may be displayed on placards or signs associated with the bulk bin rather than on individual product labels. However, you must still make required labeling information available to consumers in a conspicuous manner. Allergen information is particularly important to provide at point of sale for bulk foods.

We're approaching 100,000 units sold this year. When does the exemption end?
The exemption is evaluated against the preceding 12-month period for the next exemption claim. Once you exceed 100,000 units in a 12-month period, you lose the ability to claim the exemption for the following year and have 18 months to come into compliance. Plan to add Nutrition Facts labeling to your label design before you cross the threshold so that your inventory is compliant once the exemption lapses.

A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.

Last updated: April 2026. Reflects 21 CFR 101.100 and related provisions as of April 2026. Book a demo to see how Truli monitors food label compliance.