[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.20]

[Page 196-197]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 107_INFANT FORMULA--Table of Contents
 
                           Subpart B_Labeling
 
Sec.  107.20  Directions for use.

    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):

[[Page 197]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.366

    (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
[GRAPHIC] [TIFF OMITTED] TC01MR93.000


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''.

[50 FR 1840, Jan. 14, 1985, as amended at 67 FR 9585, Mar. 4, 2002]