Nutrition Label Small Business Exemption, Plainly

A small food maker can often leave off the Nutrition Facts label, under one of two federal exemptions. The first covers food you sell directly to consumers, if your yearly sales to consumers are no more than $500,000, or your food sales to consumers no more than $50,000. The second, the low-volume exemption, covers products sold anywhere, including through shops, if you have fewer than 100 full-time equivalent employees and sell fewer than 100,000 units of that product a year in the US; you file a notice with FDA unless you have fewer than 10 employees, don't import, and sell fewer than 10,000 units. Both end the moment the label, the labeling or your advertising makes a nutrition claim or gives any nutrition information: "high protein," "low sugar," or a calorie count on your website. Below is each exemption, what ends them, a worked example, what the label still needs, and a free checker.

The short version

• Retail exemption: food you sell directly to consumers, with sales to consumers of no more than $500,000 (or food sales to consumers of no more than $50,000).
• Low-volume exemption: fewer than 100 full-time equivalent employees and fewer than 100,000 units of a product a year.
• File a notice with FDA for the low-volume exemption, unless you have fewer than 10 employees, don't import, and sell fewer than 10,000 units of the product.
• Any nutrition claim or nutrition information, on the label, in labeling or in ads, ends both exemptions.
• The rest of the label still applies: name, net quantity, ingredients, allergens, and who made it.
• Count units by product every year; growth can end an exemption.
• TaroStack keeps sales by product, so units are a sum. More below.

The retail exemption

The regulation exempts food offered for sale by a person who makes direct sales to consumers, such as a retailer, whose yearly sales to consumers are no more than $500,000, or whose yearly food sales to consumers are no more than $50,000, provided the food bears no nutrition claims or other nutrition information on the label, in labeling or in advertising (21 CFR 101.9(j)(1)). Sales are the most recent two-year average, or a reasonable estimate for a business under two years old. For a small maker, this covers what you sell yourself, at markets, from your kitchen door or your own website. It's an exemption for the seller, so jars you sell to a shop for resale rely on the next one.

The low-volume exemption

The low-volume exemption is product by product. A product qualifies for a 12-month period if, in the previous 12 months, the business claiming it had fewer than an average of 100 full-time equivalent employees and sold fewer than 100,000 units of the product in the US, or, for a new product, reasonably expects to sell fewer than 100,000 units. The label, labeling and advertising must not give nutrition information or make a nutrient content or health claim. A notice goes to FDA before the period starts, except that a business that isn't an importer and has fewer than 10 full-time equivalent employees doesn't have to file for a product with fewer than 10,000 units a year (21 CFR 101.9(j)(18)). A product that outgrows the limits has 18 months to get a Nutrition Facts label.

What ends both exemptions

A nutrient content claim is any statement about the level of a nutrient, said outright, like "low sodium" or "contains 100 calories," or implied, like "high in oat bran," or "healthy" alongside information about the food's nutrition (21 CFR 101.13). Either kind, or any other nutrition information, ends the exemptions for that food. So "high protein" on a granola, "sugar free" on a candy, or a calories line in a product's online listing means a full Nutrition Facts label. "Handmade," "small batch" and "made with Hammonton blueberries" aren't nutrition claims.

A worked example

Pine Barrens Pantry, a made-up small food maker in Hammonton, New Jersey, I use in these examples, has three full-time equivalent employees, doesn't import, and sells $180,000 a year to consumers at markets and online, plus jars to 12 shops:

The jam's 12,000 jars are over 10,000, so it needs the notice filed before the year it's claimed for. The protein granola needs a Nutrition Facts label everywhere because of two words on the front; dropping "high protein" would put it back under the exemptions, or the label can be made from a lab analysis or a nutrition database. Which rules apply to the rest of a small maker's operation is in FSMA requirements for small food businesses.

What the label still needs

An exemption from Nutrition Facts isn't an exemption from labeling. A packaged food still needs its name, the net quantity, the ingredients in order of weight, the major food allergens, and the name and place of business of the maker, packer or distributor; cottage food laws add their own lines, such as a statement that the food was made in a home kitchen. How to keep allergens straight across a product range is in allergen matrix template, and cottage food records in cottage food record keeping. This is general information, not legal advice; read the regulation, and ask your state food program if in doubt.

Get the checker

Download the nutrition label exemption checker. Type your average full-time equivalent employees, whether you import, and your yearly sales to consumers, then one row for each product with its units and whether it carries any nutrition claim or information. It shows, for each product, whether the retail exemption covers what you sell yourself and which low-volume answer covers what you sell through shops. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.

Where this stops working

Twenty products, three sizes of some, sales at markets, online and through a dozen shops, and a jam that's growing toward 10,000 jars. A notebook can't add up last year's units by product, or warn you in October that the jam will need a notice for next year.

How TaroStack does it

TaroStack keeps sales by product, so the units are a sum. Plainly: it doesn't make Nutrition Facts panels or work out nutrients; for that, use a lab or a nutrition database.

Sales by product. Market, online and shop sales are recorded against each product, and every list exports to CSV, so units by product for the last 12 months is a sum you can check each year against 10,000 and 100,000.

Recipes with versions. Each product is a recipe with versions, so a change of ingredient is a new version, and that's the moment to check the ingredient list and allergens on the label.

And lots. Every batch goes into a lot with its date, and one report walks a lot to every customer who got it, which a label's batch code points to.

Recipes, batches, lots, sales orders and CSV export are on every plan, from $49 a month. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.

Questions people also ask

Do I need a nutrition label on my homemade food?

Often not. Food you sell directly to consumers is exempt if your sales to consumers are no more than $500,000 (or food sales no more than $50,000), and products sold through shops can use the low-volume exemption, as long as there are no nutrition claims.

What foods do not require a nutrition label?

Among others, food sold by small retailers directly to consumers and low-volume products from small businesses, both only without nutrition claims or information. Restaurant food and some other categories have their own exemptions.

Do I have to file anything with FDA for the small business exemption?

For the low-volume exemption, a notice before the period, unless you have fewer than 10 full-time equivalent employees, aren't an importer, and sell fewer than 10,000 units of the product a year. The retail exemption needs no notice.

Does "high protein" on my label mean I need a nutrition facts panel?

Yes. "High protein" is a nutrient content claim, and any nutrition claim or nutrition information ends both small business exemptions for that food.