FDA Nutrition Facts Label: Requirements and How to Make One

What the Nutrition Facts label is: scope and basic rules

The Nutrition Facts label is the table of nutrients on a U.S. food label. Under FDA regulations, nutrition labeling is required for food intended for human consumption and offered for sale unless an exemption applies, and packaged food must show it on the label in the prescribed format (21 CFR 101.9(a)).

Food exported from Japan is subject to the same rules once it is sold in the United States. U.S. labels declare nutrients per serving, and the serving size itself is derived from FDA reference amounts. The nutrients listed, the rounding rules and the format also differ from Japan's. Translating a Japanese label into English does not produce a U.S. label.

FDA does not approve individual food labels before products are marketed. Making a label that meets the rules, and being able to explain the basis for its values, is the responsibility of the company that labels the food.

Separately from labeling, facilities that manufacture, process, pack or hold food may need to register with FDA.

Read the FDA food facility registration renewal guide (2026)

How to make the label (overview)

A Nutrition Facts label is generally prepared in the following order. If a product may qualify for an exemption, checking step 7 first can save work.

Foods for infants and children 1 through 3 years, dietary supplements (labeled with "Supplement Facts" under 21 CFR 101.36), and foods that make nutrient content or health claims have additional rules that this guide does not cover.

Step 1: Find the RACC (look up the product category and reference amount in the table in 21 CFR 101.12)
Step 2: Set the serving size and the number of servings per container
Step 3: Gather the required nutrients and their values
Step 4: Round the values and calculate %DV (percent Daily Value)
Step 5: Decide the format and layout
Step 6: Check English-language and allergen labeling
Step 7: Check whether an exemption applies

Steps 1 and 2: Find the RACC and set the serving size

You cannot choose the serving size freely. It is derived, by prescribed procedures, from the "RACC" (Reference Amount Customarily Consumed per eating occasion) listed in the table in 21 CFR 101.12(b) (21 CFR 101.9(b)(2)). RACCs are based on people aged 4 years or older; foods for infants and young children have a separate table (101.12(a), (b)).

For products in discrete units (cookies, individually wrapped sweets and so on), the number of units per serving depends on how much one unit weighs relative to the RACC (101.9(b)(2)(i)). Large items usually divided for eating, such as cakes and pizzas, use the fraction closest to the RACC (for example 1/8); bulk products such as cereals and powders use the household measure closest to the RACC (101.9(b)(2)(ii), (iii)).

A product packaged and sold individually that contains less than 200 percent of the RACC is labeled as one serving for the whole package (101.9(b)(6)). If it contains 200 to 300 percent, it generally needs two columns, "per serving" and "per package" (101.9(b)(12)(i); exceptions apply, for example for small packages).

Some products have no category that fits exactly. In that case, record why you chose the closest category and, where needed, confirm it with your importer or a specialist.

How to write it: a household measure (cup, tbsp, piece and so on) followed by grams (milliliters for fluids) in parentheses (101.9(b)(7))
Conversions for labeling: teaspoon (tsp) 5 mL, tablespoon (tbsp) 15 mL, cup 240 mL, 1 fl oz 30 mL, 1 oz 28 g (101.9(b)(5)(viii))
Servings per container: generally rounded to a whole number; between 2 and 5 servings, rounded to the nearest 0.5 serving and shown with "about" (101.9(b)(8)(i))
Values are generally declared for the food as packaged (101.9(b)(9))

Step 3: Gather the required nutrients and values

The names and order of the nutrients are set in 21 CFR 101.9(c). Nutrients not listed there may not be included in the Nutrition Facts label.

If you add vitamins or minerals as a nutrient supplement, or refer to them on the label, they must be declared as well (101.9(c)(8)(ii)). On the other hand, saturated fat, trans fat, cholesterol, dietary fiber, total sugars and added sugars may in some cases be omitted when present in very small amounts and no related claim is made, with "Not a significant source of ..." stated at the bottom of the table (101.9(c)(2)–(c)(6)).

Nutrient definitions follow U.S. rules. For example, total fat is fatty acids expressed as triglycerides (101.9(c)(2)), and only carbohydrates that meet the regulatory definition count as dietary fiber (101.9(c)(6)(i)).

FDA states that it does not prescribe how an individual company determines nutrient content (laboratory analysis, databases, calculation from the formula and so on) (FDA guidance on nutrition labeling databases). When FDA checks compliance, however, it analyzes a composite of 12 units from a lot (101.9(g)(2)). For calories, total sugars, total fat, saturated fat, trans fat, cholesterol and sodium, the food is deemed misbranded if the actual value is more than 120 percent of the declared value. Naturally occurring protein, total carbohydrate, dietary fiber and similar nutrients must be at least 80 percent of the declared value, and added vitamins, minerals and similar nutrients at least 100 percent (101.9(g)(4), (5)).

For some nutrients, such as added sugars in a food that contains both naturally occurring and added sugars, the manufacturer must make and keep records supporting the declared value for at least 2 years and provide them to FDA on request (101.9(g)(10), (11)). Rather than reusing rounded or estimated values from a Japanese label, go back to the original analytical results or calculation records.

The main nutrients and their order for general foods for people aged 4 years or older are as follows (101.9(c)).

Calories
Total Fat (with Saturated Fat and Trans Fat indented below)
Cholesterol
Sodium (milligrams of sodium, not Japan's "salt equivalent")
Total Carbohydrate (with Dietary Fiber, Total Sugars and Added Sugars indented below)
Protein
Vitamin D, Calcium, Iron, Potassium (both the amount and %DV)

See our Nutrition Facts label service

Step 4: Rounding and %DV (percent Daily Value)

Declared values are rounded to the increments set for each nutrient (101.9(c)). Calories are calculated from nutrient amounts before rounding (101.9(c)(1)(i)), and %DV may be calculated from either the declared value or the value before rounding (101.9(d)(7)(ii)). Keep the unrounded values on record as well.

%DV is the amount in one serving divided by the daily reference value set by FDA (DRV or RDI). For fat, sodium and similar nutrients it is shown as a whole percent (101.9(d)(7)(ii)). The main reference values for adults and children 4 years or older 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, protein 50 g, vitamin D 20 mcg, calcium 1,300 mg, iron 18 mg and potassium 4,700 mg (101.9(c)(7)(iii), (c)(8)(iv), (c)(9)). Trans fat and total sugars have no reference value, so no %DV is shown for them.

Protein %DV is calculated differently. It is based on the "corrected amount of protein": the protein amount before rounding multiplied by PDCAAS (protein digestibility-corrected amino acid score, capped at 1.00), a measure of protein quality (101.9(c)(7)(ii)). For general foods without a protein claim, protein %DV is voluntary. However, for foods for people 4 years or older with a PDCAAS below 0.20, you must either state "not a significant source of protein" or show the corrected %DV (101.9(c)(7), (c)(7)(i)).

The main rounding rules are as follows (101.9(c)).

Calories: under 5 as 0; up to 50 in 5-calorie increments; above 50 in 10-calorie increments ((c)(1))
Total fat, saturated fat, trans fat: under 0.5 g as 0; below 5 g in 0.5 g increments; 5 g and above in 1 g increments ((c)(2))
Cholesterol: 5 mg increments; under 2 mg may be shown as 0; 2 to 5 mg may be shown as "less than 5 mg" ((c)(3))
Sodium: under 5 mg as 0; 5 to 140 mg in 5 mg increments; above 140 mg in 10 mg increments ((c)(4))
Total carbohydrate, dietary fiber, total sugars, added sugars, protein: 1 g increments; under 1 g may be shown as "less than 1 g" and under 0.5 g as 0 ((c)(6), (c)(7))
Vitamin and mineral %DV: 2 percent increments up to 10 percent, 5 percent increments up to 50 percent, 10 percent increments above 50 percent. Below 2 percent of the reference value, you may show 0, use an asterisk note, or omit the line and state "Not a significant source of ..." ((c)(8)(iii))

Step 5: Format and layout

The format is set in detail in 21 CFR 101.9(d). For uniformity, FDA strongly recommends following the graphic specifications in Appendix B to Part 101 (101.9(d)(1)). The main rules for the standard vertical display are listed below.

If there is not enough continuous vertical space (approximately 3 inches), a tabular display may be used (101.9(d)(11)(iii)). Packages with 40 square inches or less available for labeling may use a tabular or linear display, prescribed abbreviations, and any label panel, among other options (101.9(j)(13)(ii)).

The label generally goes on the principal display panel (PDP) or the information panel immediately to its right (101.9(i), 101.2). If a package has more than 40 square inches available but the PDP and information panel cannot hold all required information, any alternate panel readily seen by consumers may be used (101.9(j)(17)).

Set the information off in a box with hairlines, in black or one color, on a white or other neutral contrasting background ((d)(1)(i))
Use a single easy-to-read type style, upper and lower case letters, and letters that never touch ((d)(1)(ii))
Make the "Nutrition Facts" heading larger than all other type except the calorie number, and set it the full width of the label where practical ((d)(2))
Place "servings per container" and "Serving size" right after the heading, generally in at least 10-point type, with Serving size in bold ((d)(3))
Set "Calories" in bold, at least 16 point, and the calorie number in bold, at least 22 point ((d)(1)(iii))
Nutrient lines are at least 8 point ((d)(1)(iii)). Added sugars are indented under total sugars as "Includes X g Added Sugars" ((c)(6)(iii))
End with the footnote "*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." ((d)(9); it may be omitted on foods with very few calories, among others)

Step 6: English-language and allergen labeling

All required label information must appear in English (21 CFR 101.15(c)(1)). If the label contains any representation in a foreign language, such as Japanese, all required information must also appear in that language (101.15(c)(2)). A bilingual Nutrition Facts label may be a separate label for each language or one label with the second language following the English (101.9(d)(14)). If you plan to put an English sticker on a Japanese package, check this point first.

Allergen labeling is set by section 403(w) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). A food that contains a major food allergen must name the food source either in parentheses after the ingredient name (for example "whey (milk)") or in a "Contains" statement immediately after or next to the ingredient list. The "Contains" statement may not be in smaller type than the ingredient list.

For tree nuts, name the type of nut (for example almonds); for fish and Crustacean shellfish, name the species (for example cod, shrimp) (403(w)(2)). Allergens in flavorings, colorings and incidental additives are also covered (403(w)(4)). Ingredients themselves are listed by common or usual name in descending order of predominance by weight (21 CFR 101.4(a)(1)).

There are nine major food allergens (FD&C Act section 201(qq)). Sesame was added effective January 1, 2023 (FDA, "Food Allergies"). Both the list and the labeling method differ from Japan's system, so check each item when moving from a Japanese label.

Milk
Egg
Fish
Crustacean shellfish
Tree nuts
Wheat
Peanuts
Soybeans
Sesame

Step 7: Check whether an exemption applies

21 CFR 101.9(j) lists foods that are exempt from nutrition labeling or subject to special requirements. Those most relevant to Japanese companies are listed below.

Many exemptions apply only if the label, labeling and advertising carry no nutrition claims or other nutrition information. If they do, the exemption cannot be used.

FDA's information page on the low-volume exemption ((j)(18)) does not say how it applies to foreign companies. Decide who files the notice and how affiliates are counted after discussing it with your importer.

(j)(4) Foods with insignificant amounts of all nutrients: foods that contain only amounts allowing every required nutrient to be declared as 0 ("less than 1 g" for total carbohydrate, dietary fiber and protein). The regulation gives coffee beans, tea leaves, plain unsweetened instant coffee and tea, condiment-type dehydrated vegetables, flavor extracts and food colors as examples
(j)(9) Food shipped in bulk for further manufacturing: food not for distribution to consumers in that form and used solely to make other foods, or to be processed, labeled or repacked at another site
(j)(13) Small packages: packages with a total surface area available for labeling of less than 12 square inches. The label must give an address or telephone number consumers can use to obtain nutrition information
(j)(18) Low-volume products: for the preceding 12 months, fewer than an average of 100 full-time equivalent employees (including all domestic and foreign affiliates) and fewer than 100,000 units of the product sold in the United States. A notice generally must be filed with FDA before the exemption period begins (no notice is needed for a person that is not an importer, has fewer than 10 full-time equivalent employees, and sells fewer than 10,000 units of the product a year)

Check which FDA requirements apply to you with the free FDA Requirements Checker

Frequently asked questions

Can we just translate our Japanese nutrition label into English?

No. U.S. labels declare nutrients per serving, derived from the RACC, and 21 CFR 101.9 sets the nutrients, their order, rounding and format. Your Japanese values are a starting point, but the numbers and the table need to be redone under U.S. rules.

Can FDA review or approve our label?

FDA does not approve individual food labels before products are marketed. Making the label comply with the rules, and being able to show the basis for the declared values, is the responsibility of the company that labels the food.

Is laboratory analysis required?

FDA states that it does not prescribe how an individual company determines nutrient content (analysis, databases, calculation and so on). However, FDA compares its own analysis with the declared values; for example, sodium or total fat more than 120 percent of the declared value makes the food misbranded (21 CFR 101.9(g)). If you calculate values, keep the supporting records.

Can we keep the Japanese text and add English labeling?

Yes. However, if the label contains any representation in a foreign language, all required information must also appear in that language (21 CFR 101.15(c)(2)). The Nutrition Facts label can combine both languages in one label or use a separate label for each language (101.9(d)(14)).

Do we need a label if we export only small quantities?

If the conditions of the low-volume exemption (21 CFR 101.9(j)(18)) are met, the product may be exempt. Conditions include fewer than an average of 100 full-time equivalent employees (including domestic and foreign affiliates) and fewer than 100,000 units of the product sold in the United States in 12 months, and a notice generally must be filed with FDA. FDA says that from October 5, 2026, online notices are submitted through FDA Industry Systems (FIS). The exemption cannot be used if the product makes nutrition claims. FDA's page does not address foreign companies, so discuss it with your importer.

Do we need a label when shipping product as an ingredient for manufacturers?

Food shipped in bulk that is not for distribution to consumers in that form and is used solely to make other foods, or is to be processed, labeled or repacked at another site, is exempt (21 CFR 101.9(j)(9)). If the food is repacked for retail sale in the United States, check again whether that package is subject to 101.9.

How does the label change if one package holds two or more servings?

A product packaged and sold individually that contains less than 200 percent of the RACC is labeled as one serving for the whole package (21 CFR 101.9(b)(6)). From 200 to 300 percent, it generally needs two columns, "per serving" and "per package" (101.9(b)(12)(i)). Above 300 percent this dual-column requirement does not apply, and the label shows values per serving and the number of servings per container.

Primary sources (FDA and federal regulations)

This page provides general information prepared by PORTA (operated by Japan Mountaineering Club Inc.) based on FDA's official information and U.S. federal regulations. It is not legal advice. We are a private company with no connection to the U.S. Food and Drug Administration (FDA) and are not affiliated with FDA. Requirements may change; please confirm current requirements with FDA.

Request a Nutrition Facts label

U.S. Nutrition Facts Labels: Requirements and How to Make One