Nutrition Facts label requirements are set by the FDA under 21 CFR 101.9, which tells manufacturers exactly which nutrients to declare, how to calculate a serving, how to round every number, how the panel must look, and how close the actual food has to be to what the label says. The rules apply to nearly all packaged food sold in the United States, with narrow exemptions for raw produce, very small businesses, and a handful of other categories.
Nutrients That Must Appear on the Panel
The panel opens with total calories per serving. Below that, in a fixed order, the label must declare total fat in grams, with saturated fat and trans fat indented beneath it; cholesterol in milligrams; sodium in milligrams; total carbohydrate in grams, with dietary fiber, total sugars, and added sugars indented beneath it; and protein in grams.1eCFR. 21 CFR 101.9 – Nutrition Labeling of Food
Added sugars sit on their own indented line directly under total sugars, introduced by the word “Includes.” That line tells you how much sugar was put in during manufacturing rather than how much occurs naturally in the food.
Protein always shows a gram amount. A percent daily value for protein is only required if the manufacturer makes a protein claim on the package or if the product is marketed to infants up to 12 months or to children ages one through three.
Four micronutrients must appear below the macronutrients, in this order: Vitamin D, calcium, iron, and potassium. Each has to be shown as both a weight (milligrams or micrograms) and a percent daily value. Manufacturers can list other vitamins and minerals voluntarily, but those four are the only ones the regulation makes non-negotiable.
Serving Size and How It’s Set
Every number on the panel is meaningful only in relation to the serving size, which is why the FDA controls how serving sizes are calculated. Serving sizes come from Reference Amounts Customarily Consumed, or RACCs, which the FDA derived from national food consumption surveys conducted by USDA and CDC.2eCFR. 21 CFR 101.12 – Reference Amounts Customarily Consumed Per Eating Occasion They reflect how much people actually eat at one sitting, not how much they should eat. The RACC for yogurt is 170 grams, for cookies 30 grams, for carbonated beverages 360 milliliters.
On the label, the serving size must be written in common household terms (cups, tablespoons, pieces) followed by the metric equivalent. For discrete units like slices or crackers, the serving is the number of units closest to the RACC.3eCFR. 21 CFR 101.9 – Nutrition Labeling of Food Manufacturers cannot shrink the serving on paper to make the numbers look better.
When Two Columns Are Required
If a container holds between 200 and 300 percent of the RACC, the panel must show two columns: one for a single serving and one for the whole package.4Federal Register. Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion A 20-ounce soda bottle sits in that range because the beverage RACC is 360 mL (about 12 ounces). Someone drinking the whole bottle can then see the full calorie and nutrient total, not just the per-serving fraction.
Percent Daily Value
The percent daily value column converts grams and milligrams into context. Thirteen grams of fat means little on its own; knowing it represents about 17 percent of a day’s fat intake tells you where the food fits. All percent daily values are calculated against a 2,000-calorie reference diet.
For adults and children four and older, the FDA’s daily reference values are: total fat 78 g, saturated fat 20 g, cholesterol 300 mg, sodium 2,300 mg, total carbohydrate 275 g, dietary fiber 28 g, added sugars 50 g, and protein 50 g. For fat, sodium, and cholesterol the daily value is a ceiling; for fiber and vitamins it is a floor. A common rule of thumb: 5 percent DV or less per serving is low, 20 percent or more is high.
Every standard panel must carry this footnote, unmodified: “The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.” That text cannot be shortened or dropped.
Rounding Rules and Why “0g” Isn’t Always Zero
Manufacturers do not print raw laboratory numbers. The FDA sets rounding increments, and those increments create legal situations where a nutrient present in small amounts is declared as zero.
- Calories round to the nearest 5 up to 50, and to the nearest 10 above 50. Under 5 calories per serving can be listed as zero.
- Total fat and saturated fat round to the nearest half-gram below 5 g and to the nearest gram above 5 g. Under 0.5 g per serving is listed as zero.
- Trans fat follows the same half-gram rounding. A product with 0.4 g of trans fat per serving legally displays “0g.”
- Cholesterol under 2 mg per serving rounds to zero.
- Sodium under 5 mg per serving rounds to zero.
- Sugars under 0.5 g per serving round to zero.
The effect is real. A cooking spray with 0.4 grams of fat per quarter-second burst can market itself as fat-free at the suggested serving. Use a realistic amount and you consume several grams of fat the label never showed. The rounding thresholds matter most for products people routinely consume in multiple servings.
How the Panel Must Look
The physical appearance of the panel is tightly controlled. It must sit inside a box drawn with hairline rules, printed in black or a single color on a white or neutral contrasting background.5eCFR. 21 CFR 101.9 – Nutrition Labeling of Food Hairline rules separate each nutrient from the ones above and below, and thicker bars set off major sections like the calorie line and the vitamin block.
All text uses a single, easy-to-read type style. The FDA recommends the graphic specifications in Appendix B to Part 101, which uses Helvetica, but the regulation itself does not require a specific font family. The minimum sizes are:
- Calorie number: at least 22 points, bold or extra bold.
- The word “Calories”: at least 16 points, bold or extra bold.
- Nutrient names and values: at least 8 points.
- Footnotes and the serving-size heading: at least 6 points.
The calorie count is deliberately the most visually dominant element. The serving size declaration must be bolded at the very top of the panel so consumers see the basis for every number that follows.
Small Packages
Packages with 40 square inches or less of total labeling space may use a tabular layout that runs the panel horizontally. Packages with less than 12 square inches may use a linear format, running the information across a single line of text.6eCFR. 21 CFR Part 101 – Food Labeling Those alternatives keep the label from becoming physically impossible on items like gum or single-serving candy.
English and Second Languages
Required labeling must be in English. If any part of the label uses a foreign language, then all required information, including the full Nutrition Facts panel, must also appear in that language.7eCFR. 21 CFR 101.15 – Food; Prominence of Required Statements Products sold only in Puerto Rico or other territories where another language predominates may use that language instead of English. Individual-serving packages of 1.5 ounces or less served at restaurants or on airlines are exempt from the bilingual requirement so long as the only non-English text is the food’s name.
Ingredient List and Allergen Disclosure
Every packaged food with more than one ingredient must carry an ingredient list, separate from the Nutrition Facts panel. Ingredients appear in descending order by weight. Ingredients present at 2 percent or less by weight may be listed in any order at the end, preceded by a phrase such as “Contains 2% or less of.”8eCFR. 21 CFR 101.4 – Food; Designation of Ingredients
Federal law requires disclosure of nine major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Sesame became the ninth allergen under the FASTER Act, effective January 1, 2023.9U.S. Food and Drug Administration. The FASTER Act: Sesame Is the Ninth Major Food Allergen
Allergens can be disclosed one of two ways. Either the food source appears in parentheses inside the ingredient list (for example, “casein (milk)”), or a separate “Contains” statement follows the ingredient list. A “Contains” statement must list every major allergen in the product and appear in the same font size as the ingredient list.10Food and Drug Administration. Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5)
Nutrient Content and Health Claims
Phrases like “low fat,” “high fiber,” and “excellent source of calcium” have specific quantitative definitions. A food that fails the threshold cannot use the phrase.
- “Low fat” means 3 grams of fat or less per reference amount customarily consumed.11eCFR. 21 CFR 101.62 – Nutrient Content Claims for Fat, Fatty Acid, and Cholesterol Content of Foods
- “High” or “excellent source of” means 20 percent or more of the daily value per reference amount for the claimed nutrient.12eCFR. 21 CFR 101.54 – Nutrient Content Claims for Good Source, High, More, and High Potency
If a manufacturer claims “high in fiber” on a product that is not also low in total fat, the label must disclose the fat content per serving in immediate proximity to the fiber claim, at a font size at least half as large as the claim itself.
Health claims go further, tying a nutrient to reduced disease risk (for example, “diets high in calcium may reduce the risk of osteoporosis”). Every such claim must clear the FDA’s “significant scientific agreement” standard through a formal petition and review process before it can appear on a product.13U.S. Food and Drug Administration. Authorized Health Claims That Meet the Significant Scientific Agreement (SSA) Standard Making any nutrient content claim or health claim on a product that was otherwise exempt from nutrition labeling immediately triggers the full labeling requirement.
Compliance Tolerances
Lab analysis does not have to match the label to the last milligram, but the tolerance is tighter than many manufacturers assume. The regulation divides nutrients into two enforcement classes.
For nutrients people want more of (vitamins, minerals, protein, fiber, total carbohydrate): if the nutrient was added to the food (Class I), the actual content must be at least equal to the declared value; if it occurs naturally (Class II), the actual content must be at least 80 percent of the declared value.
For nutrients people want less of (calories, total fat, saturated fat, trans fat, cholesterol, sodium, total sugars, and added sugars): the actual content cannot exceed the declared value by more than 20 percent. A product declaring 10 grams of fat that actually contains 13 grams is misbranded.
Reasonable overages of beneficial nutrients and reasonable deficits of the ones people want to limit are acceptable under good manufacturing practice. They exist to absorb natural variability in ingredients, not to cover sloppy testing.
What the FDA Does About Violations
When the FDA finds significant labeling violations, warning letters are the usual first step, typically with a deadline to fix the label. More serious violations can bring product seizures, injunctions halting sales until labeling is corrected, or criminal prosecution in extreme cases.14U.S. Food and Drug Administration. Compliance and Enforcement (Food) Nutritional analysis for a single product usually runs a few hundred dollars, which is small next to the cost of an enforcement action or a recall.
Products That Don’t Need a Nutrition Facts Panel
Several categories are exempt from 101.9, though each exemption has conditions that can void it.
Raw fruits, vegetables, and fish are exempt as single-ingredient foods typically sold without packaging that could carry a standard label.15eCFR. 21 CFR 101.9 – Nutrition Labeling of Food Retailers often post the information voluntarily near produce or seafood. Dietary supplements, infant formula, and medical foods are exempt from 101.9 but follow their own labeling rules.
Two exemptions cover smaller operations. A retailer with total annual gross sales of $500,000 or less, or annual food sales to consumers of $50,000 or less, is exempt so long as the product makes no nutrition claims.16U.S. Food and Drug Administration. Small Business Nutrition Labeling Exemption Separately, a company with fewer than 100 full-time equivalent employees can claim an exemption for a specific product that sells fewer than 100,000 units in the United States over a 12-month period.
Products with insignificant amounts of every required nutrient are exempt as well. Plain coffee, plain tea, and most spices are the standard examples. Any nutrition claim or health claim on the packaging kills the exemption and pulls the product back into the full labeling requirement.
One boundary worth flagging: these rules govern the Nutrition Facts panel on packaged food. Food served in restaurants, cafeterias, and similar establishments is a separate regime, and the menu calorie disclosures required of large chains operate under different sections of Part 101.