21 CFR 107.10 - Nutrient information.

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§ 107.10 Nutrient information.
(a) The labeling of infant formulas, as defined in section 201(aa) 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 of each of the following nutrients supplied by 100 kilocalories:
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 B 1) Do.
Riboflavin (Vitamin B 2 Do.
Vitamin B 6 Do.
Vitamin B 12 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.
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 National Academy of Sciences through its development of a recommended dietary allowance or an estimated safe and adequate daily dietary intake range, or has been identified as essential by the Food and Drug Administration through a Federal Register publication or establishment of a U.S. Recommended Daily Allowance, 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]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-07-15; vol. 79 # 135 - Tuesday, July 15, 2014
    1. 79 FR 41127 - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula; Correction
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; correction.
      Effective July 15, 2014.
      21 CFR Parts 106 and 107

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 107 after this date.

  • 2014-07-15; vol. 79 # 135 - Tuesday, July 15, 2014
    1. 79 FR 41127 - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula; Correction
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; correction.
      Effective July 15, 2014.
      21 CFR Parts 106 and 107