Does my label need a Nutrition Facts panel?
Possibly not. Two exemptions exist for small businesses. One is based on your total sales and needs no paperwork. The other is based on low volume for a specific product and has to be notified to the FDA. Both disappear the moment you make a nutrient content claim on the label.
The sales-based exemption
The first exemption applies to businesses with annual gross sales of not more than $500,000, or with annual gross sales of food to consumers of not more than $50,000. If you are under those, no notice is filed with the FDA.
This is the one that covers most makers in their first year or two. It is also the one that quietly expires as the business works, because nothing tells you when you have crossed the line.
The low-volume exemption
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 claimed by filing a notice with the FDA, and it is claimed for a period rather than forever. If you rely on this one, it goes on the annual calendar alongside your facility registration renewal.
What voids the exemption
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.
Exempt is not the same as unlabelled
An exemption from the Nutrition Facts panel is not an exemption from the rest of food labelling. 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.
Why makers often add the panel anyway
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.
Common questions
Check this yourself
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.