Does Your Food Product Need a Nutrition Facts Panel? The FDA Small Business Exemption

A Nutrition Facts panel is one of the first things a food founder thinks about when building a label. The formatting rules are strict, the nutrient values have to be accurate, and getting it wrong after the label prints is expensive. So the news that FDA does not require a Nutrition Facts panel for every product in every circumstance tends to catch people off guard.

The exemption is real. Under 21 CFR 101.9(j), small businesses and low-volume products can qualify to skip the Nutrition Facts panel. The conditions are specific, the annual notice requirement catches people off guard, and a single sentence on the label can void the exemption immediately. The regulation is not complicated, but a few details matter a great deal.

Two paths to an exemption

The regulation has more than one way to qualify. Which one applies depends on who you are and how you sell.

The retailer exemption, found at 21 CFR 101.9(j)(1), applies if you sell directly to consumers and your annual gross food sales to consumers are $50,000 or less, or if your total annual gross sales across all goods are $500,000 or less. Either threshold qualifies. No notice needs to be filed with FDA. The exemption applies automatically for businesses that meet the criteria.

This path fits a narrow profile: a small producer selling entirely out of their own shop, at a single storefront, with genuinely modest revenue. Most founders building toward retail distribution will not stay in this category for long.

The low-volume product exemption at 21 CFR 101.9(j)(18) is the one most packaged food producers encounter. You qualify if two conditions are both true: you employ fewer than an average of 100 full-time equivalent employees, and fewer than 100,000 units of that specific product are sold in the United States during any 12-month period.

Both prongs must be satisfied at the same time. A company with 80 employees that sells 120,000 units cannot claim the exemption for that product. A company with 150 employees that sells 3,000 units also cannot. The thresholds apply together, not separately.

This is a per-product exemption, not a company-wide one. If you make three products, each is evaluated individually against the unit threshold. A product that crosses 100,000 units loses its exemption. Your other products, if they are still under the threshold, remain eligible.

USDA-regulated products, meat and poultry specifically, work under a parallel framework through FSIS regulations at 9 CFR 317.400 and 9 CFR 381.500. The structure is similar, but the administering agency and filing process are different.

The annual notice you have to file yourself

The low-volume exemption does not maintain itself. To use it, you must file a notice with FDA annually using FDA Form 3570. The form captures your legal business name, the 12-month period you are claiming, your average FTE employee count across that period, and for each product: its name, unit sales, and the name and address of the manufacturer or distributor.

You can submit it online through FDA’s Nutrition Labeling Exemption web portal, by email to sbusiness@cfsan.fda.gov, or by mail to CFSAN, HFS-820, 5001 Campus Drive, College Park, MD 20740-3835. The notice should be filed before the start of the period for which you are claiming the exemption.

FDA does not send reminders. If you do not file, the exemption lapses for that product and a compliant Nutrition Facts panel becomes required. No warning letter arrives first.

There is one exception to the notice requirement. If you are not an importer, you employ fewer than 10 full-time equivalent employees, and you sell fewer than 10,000 units of the product per year in the US, you are not required to file a notice at all. This covers the earliest stage of a brand, before there is meaningful distribution volume. Importers must always file regardless of size.

One claim on the label ends it

This is where founders run into the most trouble.

The small business exemption covers only the Nutrition Facts panel itself. It says nothing about what claims you can make without one. If your label, labeling, or advertising includes any nutrient content claim or health claim, the exemption is void for that product, immediately.

A nutrient content claim is any statement that characterizes the level of a nutrient in the product. “Low sodium.” “High in fiber.” “Good source of protein.” “No added sugar.” “Fat free.” “Reduced calorie.” Any of those phrases ends the exemption on that label. The standard applies to advertising as well, not just the physical label.

A health claim is any statement that suggests a relationship between a food or nutrient and a disease or health condition. These are separately regulated and generally require FDA authorization, but any language on the label or in materials that links the product to a health outcome can trigger the same result.

If you want to put any of those statements on your label, you need a compliant Nutrition Facts panel to support them. Many founders assume the exemption is a way to keep the label simple while still describing the product’s nutritional qualities. The regulation does not work that way. Claims and the panel go together.

Products that cannot use the exemption

Some categories are excluded from 21 CFR 101.9 entirely. They are governed by separate labeling requirements, and the small business exemption does not apply to them regardless of company size or sales volume.

Infant formula is governed by section 412 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 107. Mandatory nutrition labeling for infant formula has no small business carve-out. A Nutrition Facts panel formatted to the Part 107 specifications is required.

Dietary supplements are excluded from 21 CFR 101.9 and must instead carry a Supplement Facts panel under 21 CFR 101.36. A parallel small business exemption exists at 21 CFR 101.36(h)(2), with the same less-than-100-FTE and less-than-100,000-unit thresholds, and the same annual notice requirement through FDA Form 3570. The applicable regulation and panel format are different from conventional food, though the size thresholds match.

Medical foods as defined in section 5(b) of the Orphan Drug Act are also excluded. A medical food is one formulated to be consumed under physician supervision for the dietary management of a disease or condition with specific nutritional requirements established by medical evaluation. These follow their own requirements and the small business exemption does not apply.

Foods represented for infants and children under two years of age must carry a Nutrition Facts panel regardless of business size. The format for that age category differs from the standard adult panel, but the panel itself is mandatory.

Why Canada works differently

Canada’s Nutrition Facts table operates under a separate regulatory framework with no direct equivalent to the US volume-based small business exemption.

The Nutrition Facts table requirements are set out in section B.01.401 of the Food and Drug Regulations and enforced by the Canadian Food Inspection Agency (CFIA). Canada’s exemptions from the table are based on where and how a product is prepared and sold, not on the size of the business making it.

The main Canadian exemption covers food prepared and sold only at the same retail premises where it was produced. A bakery selling entirely out of its own shop can qualify. So can a producer selling in person at specified venues such as farmers’ markets, roadside stands, craft shows, or fairs, provided the person who made the product is also the one selling it directly to consumers. A product manufactured off-site and sold through any other retailer, even a single independent grocery, does not qualify for this exemption.

Canada also has a small package exemption based on physical label size. A product with an available display surface of less than 15 square centimeters is fully exempt from the Nutrition Facts table, regardless of who makes it or where it is sold. A product with less than 100 square centimeters of available display surface can omit the table if the label provides a way for consumers to obtain the nutrition information on request.

There is no Canadian equivalent to the annual notice system. A small Canadian food brand moving into grocery distribution, regardless of how few units it sells, must carry a bilingual Nutrition Facts table in the format prescribed by the Food and Drug Regulations. Sales volume does not change that.

When to include the panel anyway

Meeting the threshold for an exemption does not always mean skipping the Nutrition Facts panel is the right choice.

Many retailers require a panel regardless of what FDA mandates. Natural grocery buyers, specialty food distributors, and co-packers often list it as a condition of doing business. A product without a panel in a retail environment where every competing product carries one can look like an oversight rather than a deliberate choice.

There is also the growth question. A brand that grows from 8,000 units to 120,000 units has to add a compliant panel before crossing 100,000. That means scheduling a reprint mid-growth, which compresses timelines and adds cost at exactly the moment when everything else is also accelerating. Building the panel into the label from the start, even while technically exempt, avoids that forced interruption later.

For products that are genuinely small-batch and local, the exemption can simplify the label. For products on a path toward retail distribution or any kind of scale, it often makes more sense to build the panel in from the beginning.

Whether the exemption applies to your product depends on your specific formula, your markets, your employee count, and your distribution plan. If you want to talk through what applies to your situation and what the label actually needs, book a free call to start. We can look at your product specifically.