# 21 CFR § 107.10: Nutrient information

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-107.10

## Section

- **Citation:** 21 CFR § 107.10
- **Heading:** Nutrient information
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION > PART 107—INFANT FORMULA > Subpart B—Labeling

## Text

(a) The labeling of infant formulas, as defined in section 201(z) of the Federal Food, Drug, and Cosmetic Act, shall bear in the order given, in the units specified, and in tabular format, the following information regarding the product as prepared in accordance with label directions for infant consumption:
(1) A statement of the number of fluid ounces supplying 100 kilocalories (in case of food label statements, a kilocalorie is represented by the word “Calorie”); and
(2) A statement of the amount, supplied by 100 kilocalories, of each of the following nutrients and of any other nutrient added by the manufacturer:
Nutrients
Unit of measurement
Protein
Grams
Fat
Do.
Carbohydrate
Do.
Water
Do.
Linoleic acid
Milligrams
Vitamins
Vitamin A
International Units
Vitamin D
Do.
Vitamin E
Do.
Vitamin K
Micrograms
Thiamine (Vitamin B1)
Do.
Riboflavin (Vitamin B2)
Do.
Vitamin B6
Do.
Vitamin B12
Do.
Niacin
Do.
Folic acid (Folacin)
Do.
Pantothenic acid
Do.
Biotin
Do.
Vitamin C (Ascorbic acid)
Milligrams
Choline
Do.
Inositol
Do.
Minerals
Calcium
Milligrams
Phosphorus
Do.
Magnesium
Do.
Iron
Do.
Zinc
Do.
Manganese
Micrograms
Copper
Do.
Iodine
Do.
Selenium
Do.
Sodium
Milligrams
Potassium
Do.
Chloride
Do.
(b) In addition the following apply:
(1) Vitamin A content may also be declared on the label in units of microgram retinol equivalents, vitamin D content in units of micrograms cholecalciferol, vitamin E content in units of milligram alpha-tocopherol equivalents, and sodium, potassium, and chloride content in units of millimoles, micromoles, or milliequivalents. When these declarations are made they shall appear in parentheses immediately following the declarations in International Units for vitamins A, D, and E, and immediately following the declarations in milligrams for sodium, potassium, and chloride.
(2) Biotin, choline, and inositol content shall be declared except when they are not added to milk-based infant formulas.
(3) Each of the listed nutrients, and the caloric density, may also be declared on the label on other bases, such as per 100 milliliters or per liter, as prepared for infant consumption.
(4) One of the following statements shall appear on the principal display panel, as appropriate:
(i) The statement “Infant Formula With Iron”, or a similar statement, if the product contains 1 milligram or more of iron in a quantity of product that supplies 100 kilocalories when prepared in accordance with label directions for infant consumption.
(ii) The statement “Additional Iron May Be Necessary”, or a similar statement, if the product contains less than 1 milligram of iron in a quantity of product that supplies 100 kilocalories when prepared in accordance with label directions for infant consumption.
(5) Any additional vitamin may be declared at the bottom of the vitamin list and any additional minerals may be declared between iodine and sodium, provided that any additionally declared nutrient:
(i) Has been identified as essential by the Food and Nutrition Board of the Institute of Medicine through its development of a Dietary Reference Intake, or has been identified as essential by the Food and Drug Administration through a Federal Register publication; and
(ii) Is provided at a level considered in these publications as having biological significance, when these levels are known.
[50 FR 1840, Jan. 14, 1985, as amended at 67 FR 9585, Mar. 4, 2002; 79 FR 8074, Feb. 10, 2014; 80 FR 35840, June 23, 2015]

## Nearby sections

- [21 CFR § 107.1 § 107.1 Status and applicability of the regulations in part 107.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.1.md)
- [21 CFR § 107.3 § 107.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.3.md)
- [21 CFR § 107.10 § 107.10 Nutrient information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.10.md)
- [21 CFR § 107.20 § 107.20 Directions for use.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.20.md)
- [21 CFR § 107.30 § 107.30 Exemptions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.30.md)
- [21 CFR § 107.50 § 107.50 Terms and conditions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.50.md)
- [21 CFR § 107.100 § 107.100 Nutrient specifications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.100.md)
- [21 CFR § 107.200 § 107.200 Food and Drug Administration-required recall.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.200.md)
- [21 CFR § 107.210 § 107.210 Firm-initiated product removals.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.210.md)
- [21 CFR § 107.220 § 107.220 Scope and effect of infant formula recalls.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.220.md)
- [21 CFR § 107.230 § 107.230 Elements of an infant formula recall.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.230.md)
- [21 CFR § 107.240 § 107.240 Notification requirements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.240.md)
- [21 CFR § 107.250 § 107.250 Termination of an infant formula recall.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.250.md)
- [21 CFR § 107.260 § 107.260 Revision of an infant formula recall.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.260.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-107.10. Check the current official text before relying on it. Not legal advice.
