Code of Federal Regulations Title 21. Food and Drugs § 21.107.20 Directions for use

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

(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

if the addition of water is necessary. The symbol shall be placed on a white background encircled by a dark border.

(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”.