Does my label need a Nutrition Facts panel?

The first exemption is for food sold by a business that sells directly to consumers — FDA's guidance calls them retailers — with annual sales to consumers of not more than $500,000, or annual sales of food to consumers of not more than $50,000. If you qualify, no notice is filed with the FDA.

It fits a maker who sells their own product at markets, from their own shop or online to the people who eat it. A maker selling wholesale to shops is not selling directly to consumers, so for those sales this route generally does not apply and the low-volume one below is the one to look at.

The second is per product rather than per business. It applies where the person claiming it employs fewer than 100 full-time equivalent employees and fewer than 100,000 units of that product are sold in the United States in a twelve-month period.

Unlike the sales-based one, this exemption is usually claimed by filing a notice with the FDA every year, before the year it covers — FDA does not remind you. There is one exception: a business that does not import the product, has fewer than 10 full-time equivalent employees and sells fewer than 10,000 units of the product a year does not have to file a notice. If you file one, it goes on the annual calendar alongside your facility registration renewal.

Make a nutrient content claim — low sodium, high fibre, a source of protein — or a health claim, and the exemption no longer applies to that product. The moment you want that sentence on the front of the pack, you are buying a Nutrition Facts panel with it.

This is worth deciding early, because it changes the label design and the cost of the first print run.

An exemption from the Nutrition Facts panel is not an exemption from the rest of food labeling. You still need the statement of identity, net quantity, an ingredient list in descending order of predominance, allergen declaration, and the name and place of business of the manufacturer, packer or distributor.

Allergen declaration in particular is not something to be casual about. It is the single highest-consequence thing on a small maker's label.

Retail buyers ask for it. Distributors and many retailers expect a full panel regardless of whether the law requires one from you, and some category managers will not take a product without it. If wholesale is the goal, plan for the panel even while the exemption technically covers you.

This is general information for U.S. food businesses, not legal advice, and rules change. Check it against the sources below and against your own state's rules before you rely on it.

• FDA — Small Business Nutrition Labeling Exemption
• 21 CFR 101.9 — Nutrition labeling of food
• FDA — Small business nutrition labeling exemption guidance

What each state’s cottage food law says, in its own words: sell by state. Every kind of product: sell by product.