(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:

(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.

In addition to the applicable labeling requirements in parts 101 and 105 of this chapter, the product label shall bear:

(a) Under the heading “Directions For Preparation and Use”, directions for:

(1) Storage of infant formula before and after the container has been opened, including a statement indicating that prolonged storage at excessive temperatures should be avoided;

(2) Agitating liquid infant formula before opening the container, such as “Shake Well Before Opening”;

(3) “Sterilization” of water, bottle, and nipples when necessary for preparing infant formula for use;

(4) Dilution of infant formula, when appropriate. Directions for powdered infant formula shall contain the weight and volume of powdered formula to be reconstituted.

(b) In close proximity to the “Directions for Preparation and Use” a pictogram depicting the major steps for preparation of that infant formula, such as (for a concentrated formula):

(c) A “Use by ______” date, the blank to be filled in with the month and year selected by the manufacturer, packer, or distributor of the infant formula on the basis of tests or other information showing that the infant formula, until that date, under the conditions of handling, storage, preparation, and use prescribed by label directions, will: (1) when consumed, contain not less than the quantity of each nutrient, as set forth on its label; and (2) otherwise be of an acceptable quality (e.g., pass through an ordinary bottle nipple).

(d) The statement “Add Water” or “Do Not Add Water”, as appropriate, to appear on the principal display panel of concentrated or ready-to-feed infant formulas. In close proximity to the statement “Add Water”, a symbol such as

(e) A warning statement beneath or in close proximity to the “Directions For Preparation and Use” that cautions against improper preparation or use of an infant formula, such as “THE HEALTH OF YOUR INFANT DEPENDS ON CAREFULLY FOLLOWING THE DIRECTIONS FOR PREPARATION AND USE”.

(f) A statement indicating that parents should consult their physicians about the use of infant formulas, such as “USE AS DIRECTED BY A PHYSICIAN”.

When containers of ready-to-feed infant formula, to be sold at the retail level, are contained within a multiunit package, the labels of the individual containers shall contain all of the label information required by section 403 of the Federal Food, Drug, and Cosmetic Act (the act), §§ 107.10 and 107.20, and all appropriate sections of part 101 of this chapter, except that the labels of the individual containers contained within the outer package shall be exempt from compliance with the requirements of section 403 (e)(1) and (i)(2) of the act; and §§ 107.10 (a) and (b)(2) and 107.20 (b), (e), and (f), provided that (a) the multiunit package meets all the requirements of this part; (b) individual containers are securely enclosed within and are not intended to be separated from the retail package under conditions of retail sale; and (c) the label on each individual container includes the statement “This Unit Not Intended For Individual Sale” in type size not less than one-sixteenth inch in height. The word “Retail” may be used in lieu of or immediately following the word “Individual” in the statement.