Do I need a Nutrition Facts label?
Often, no. But the answer depends on how much you sell, how many people you employ, and what you say on the package. This guide is a summary of the FDA rules in 21 CFR 101.9(j). It is not legal advice, so check the current rules for your case.
The two small-business exemptions
1. Low-volume products (101.9(j)(18))
A product can be exempt for a 12-month period if the business employs fewer than 100 full-time equivalent employees and fewer than 100,000 units of that product were sold in the United States in the prior period. The FDA says a notice must be filed with the agency each year to claim this exemption. If you stop qualifying, there is an 18-month grace period before the label is required.
2. Retail sellers (101.9(j)(1))
Food sold directly to consumers by the person who makes it can be exempt when total annual sales are not more than $500,000, or food sales to consumers are not more than $50,000. This is judged on the most recent two-year average. The FDA does not require a notice for this one.
What voids an exemption
A nutrition claim on the package, such as "low sugar" or "high fiber", means the exemption does not apply to that product. Other nutrition information on the package can have the same effect.
What is required even with an exemption
- Ingredient list in descending order by weight (21 CFR 101.4).
- Allergen declaration for the nine major allergens: milk, egg, fish, crustacean shellfish, tree nuts, peanuts, wheat, soy and sesame. Tree nuts, fish and shellfish must be named by type, such as almonds or salmon.
- Name of the food, net quantity, and the name and address of the maker. See the FDA labeling guide for the full list.
Why you may need the panel anyway
Grocery stores, marketplaces and wholesale buyers often ask for a Nutrition Facts panel whatever the law says. If you sell online across states or grow past the limits, the exemption can end. Having your recipes and numbers ready the day someone asks saves a rushed week.
Source: FDA, "Small Business Nutrition Labeling Exemption" and 21 CFR 101.9(j). Verify against the current regulation before you rely on any number here.