(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|
|Vitamin A||International Units|
|Thiamine (Vitamin B1)||Do.|
|Riboflavin (Vitamin B2)||Do.|
|Folic acid (Folacin)||Do.|
|Vitamin C (Ascorbic acid)||Milligrams|
(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.