If you sell packaged food in the United States, 21 CFR 101.9 is the regulation behind the Nutrition Facts panel on your label. It is long and written for lawyers, so this guide walks through what it actually asks of you, in the order you will meet it when you build a label. When you are ready to produce the panel, the free nutrition label generator applies the rounding and format rules for you.
Who 21 CFR 101.9 applies to
101.9 applies to conventional food sold in packaged form. Dietary supplements follow a different rule, 21 CFR 101.36, covered in our Supplement Facts vs Nutrition Facts guide. Some foods are exempt from Nutrition Facts altogether, which is covered below.
Step 1: Serving size and servings per container
Serving size is not a free choice. It is based on the reference amount customarily consumed (RACC) for your product category, set out in 21 CFR 101.12, expressed in a household measure with the metric weight in parentheses. Servings per container is then the package content divided by that serving size. Packages that could reasonably be eaten in one sitting have special rules, including the dual-column format. Details are in our serving size guide.
Step 2: The mandatory nutrients
The panel must declare these, in this order:
- Calories
- Total fat, saturated fat and trans fat
- Cholesterol and sodium
- Total carbohydrate, dietary fiber, total sugars and added sugars
- Protein
- Vitamin D, calcium, iron and potassium
Vitamins A and C stopped being mandatory in the 2020 update and can be listed voluntarily. Vitamin D and potassium were added at the same time. See what changed in 2020 for the history, and the complete requirements guide for each nutrient.
Step 3: Rounding the numbers
101.9 does not let you print raw lab or database values. Each nutrient has its own rounding rule. A few examples:
- Calories: under 5 is declared as 0, up to 50 rounds to the nearest 5, above 50 rounds to the nearest 10.
- Total fat: under 0.5 g is 0, under 5 g rounds to the nearest 0.5 g, 5 g or more rounds to the nearest 1 g.
- Sodium: under 5 mg is 0, 5 to 140 mg rounds to the nearest 5 mg, above 140 mg rounds to the nearest 10 mg.
Percent Daily Value is calculated from the FDA reference values and then rounded as well. Check the regulation for the full table before you finalise a label.
Step 4: Format and design
The regulation specifies the panel layout: the heading, the bold calories line, the hairline and bar rules, minimum type sizes and the footnote about percent Daily Value. Standard vertical is the default. Tabular, linear, dual-column and bilingual variants exist for different package sizes and audiences. Our font and formatting guide covers the type rules, and the label template page shows the layouts side by side.
Step 5: Check whether you are exempt
101.9(j) lists exemptions. The best known is the small business exemption, which depends on the number of full-time equivalent employees and the number of units sold in the US each year and must be claimed with the FDA. Some very small packages and some retail-level foods have different or lighter requirements. An exemption does not survive if the label makes a nutrition claim, so read the conditions carefully. Our small business exemption guide goes through the criteria. Home producers should also read the rules for their state in the cottage food laws directory.
Where 21 CFR 101.4 fits in
People often search 101.9 and 101.4 together because a complete food label needs both. 21 CFR 101.4 governs the ingredient statement: ingredients are listed by their common or usual name in descending order of predominance by weight, and sub-ingredients and additives follow designation rules. Allergens must also be declared under separate rules, see the allergen labeling guide. To draft a compliant ingredient statement, use the ingredient label generator.
Turn the rule into a label
Once you have your serving size and nutrient values, enter them in the NutriFacts generator. It formats the panel, applies the rounding and exports a PNG or PDF. You still need to make sure the nutrient data is accurate, and this guide is a general explanation rather than legal advice. For edge cases, check the current text of the regulation or ask the FDA.