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Regulation

Infants through 12 Months: FDA Nutrition Facts format

Special format for infant formula. An FDA Nutrition Facts layout under 21 CFR 101.9, generated free with correct rounding and Daily Values.

Reviewed against 21 CFR 101.9 (Nutrition labeling of food) · Page updated September 16, 2026

Jurisdiction
United States (FDA-regulated packaged food)
Regulation
21 CFR 101.9 (Nutrition labeling of food)
Effective
Current; 2016 rule (81 FR 33742) fully in force since 1 January 2021
Official source
www.ecfr.gov
Generate this labelUS FDA requirements guide

Nutrition labelling requirements for Infants through 12 Months

Packaged food sold in the United States must carry a nutrition declaration under 21 CFR 101.9 (Nutrition labeling of food). This page covers the Infants through 12 Months format: Special format for infant formula. A compliant nutrition label declares 15 mandatory nutrients: calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin d, calcium, iron and potassium. Values are declared per serving, with serving sizes set by the racc tables in 21 cfr 101.12, with energy in kcal, and sodium rather than salt. The panel is headed "Nutrition Facts". English is required on pack. There is no mandatory front-of-pack warning scheme. NFL builds a print-ready nutrition label from your recipe, applying the rounding rules and reference intakes for the United States automatically, and exports it as PDF, PNG, SVG, JPG or EPS.

Official regulation

Citation
21 CFR 101.9 (Nutrition labeling of food)
Effective
Current; 2016 rule (81 FR 33742) fully in force since 1 January 2021
Scope
United States (FDA-regulated packaged food)
Source

Key facts

Mandatory nutrients (15)
Calories, Total Fat, Saturated Fat, Trans Fat, Cholesterol, Sodium, Total Carbohydrate, Dietary Fiber, Total Sugars, Added Sugars, Protein, Vitamin D, Calcium, Iron and Potassium
Declaration basis
Per serving, with serving sizes set by the RACC tables in 21 CFR 101.12
Energy units
kcal
Sodium or salt
Declared as sodium, not salt
Panel heading
Nutrition Facts
Label language
English required on pack
Front of pack
No mandatory front-of-pack warning scheme

Which foods use the infant Nutrition Facts label

The infant Nutrition Facts format is mandatory under 21 CFR 101.9(j)(5), in force, for foods other than infant formula that are represented or purported to be specifically for infants through 12 months of age. Baby cereals, purees and other foods marketed for babies fall under it.

Infant formula is not covered. It has its own mandatory labeling rules in 21 CFR part 107, so the infant Nutrition Facts panel should never be used for formula.

The serving size for a food made for infants is based on the amount customarily eaten per occasion by infants up to 12 months. When a food is represented for both infants through 12 months and children 1 through 3 years, separate percent Daily Values for each group are mandatory, with equal prominence.

Source: 21 CFR 101.9(b) and (j)(5), eCFR.

Nutrients and infant Daily Values

The same core nutrients as the adult panel are mandatory: calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron and potassium.

The percent Daily Values, where allowed, use infant reference values in force under 21 CFR 101.9(c)(7) to (c)(9), not the adult ones. Examples are 30 g for total fat, 11 g for protein, 260 mg for calcium and 11 mg for iron.

Other vitamins and minerals are voluntary when naturally present, and mandatory when added as a nutrient supplement or when a claim is made about them, under 21 CFR 101.9(c)(8).

FDA's compliance guide notes that no Daily Values were set for infants under 7 months, so a food purported specifically for that younger group would not reflect Daily Values for it.

Source: 21 CFR 101.9(c), eCFR, and FDA Small Entity Compliance Guide.

What is not allowed on the infant panel

Percent Daily Values are prohibited on the infant panel for saturated fat, trans fat, cholesterol, sodium, dietary fiber, total sugars and added sugars. The gram or milligram amounts of those nutrients stay mandatory; only the percentages are left out.

Percentages are mandatory for the nutrients that do have infant reference values, such as total fat, total carbohydrate, protein, vitamin D, calcium, iron and potassium. FDA's official "Infants through 12 Months of Age" example shows this pattern.

The standard Daily Value footnote used on adult labels is not allowed on the infant panel. That is a visible difference from the adult label and also from the label for children 1 through 3 years, which carries its own footnote.

Source: 21 CFR 101.9(d)(9) and (j)(5), eCFR, and FDA, Examples of Different Label Formats.

Infant label versus the adult and toddler formats

The infant panel keeps the standard "Nutrition Facts" heading and the general rules for nutrient order, serving information, typography, rules and contrast. Only the reference values, the allowed percentages and the footnote change.

Compared with the adult label, it uses infant reference values and drops seven percentages. Compared with the label for children 1 through 3 years, it uses different reference values and has no footnote. A food sold for both age groups shows both sets of percentages side by side.

English is mandatory for required label information under 21 CFR 101.15(c), except for products distributed solely in Puerto Rico or another US territory where another language predominates. If the label uses another language for any representation, all required information must also appear in that language.

Source: 21 CFR 101.9 and 21 CFR 101.15, eCFR.

How NFL handles it

  • Applies the correct rounding rules for every nutrient
  • Uses the right Daily Value / Reference Intake table for this jurisdiction
  • Renders the required front-of-pack warnings automatically when thresholds are hit
  • Handles multilingual labels where required (bilingual EN/FR, EN/ES, Arabic + EN, etc.)
  • Exports print-ready vector PDF, PNG, SVG, JPG, and EPS

Common questions

Which foods use the infant Nutrition Facts label?
It is mandatory for foods, other than infant formula, represented or purported specifically for infants through 12 months, under 21 CFR 101.9(j)(5). Infant formula follows separate rules in 21 CFR part 107.
What does 21 CFR 101.9(j)(5) require for infant foods?
The usual nutrients must be declared, with percent Daily Values based on infant reference values where those exist. Percentages for seven nutrients and the standard footnote are left off.
Which Daily Values apply to an infant label?
The infant values in 21 CFR 101.9(c), for example 30 g for total fat, 11 g for protein and 11 mg for iron. Adult values must not be used.
What is not allowed on the infant Nutrition Facts panel?
Percent Daily Values for saturated fat, trans fat, cholesterol, sodium, dietary fiber, total sugars and added sugars, and the standard Daily Value footnote. The amounts of those nutrients are still declared.
How does the infant label differ from the adult label?
It uses infant reference values, omits seven percentages and has no footnote. The heading and general layout rules are the same.
Does the infant Nutrition Facts format apply to infant formula?
No. Infant formula is excluded from 21 CFR 101.9(j)(5) and is labeled under 21 CFR part 107.

How to generate one

  • Open the generator: free account, no credit card
  • Pick "Infants through 12 Months" from the format rail
  • Enter your ingredients (search USDA FoodData Central or add a custom ingredient)
  • The label renders live; export in one click

Generate a compliant Infants through 12 Months label now

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