0256 21cfr107

§ 107.20

21 CFR Ch. I (4–1–06 Edition)
Nutrients

Unit of measurement

Vitamin B 6 ................................
Vitamin B 12 ..............................
Niacin .......................................
Folic acid (Folacin) ...................
Pantothenic acid ......................
Biotin ........................................
Vitamin C (Ascorbic acid) ........
Choline .....................................
Inositol ......................................
Minerals:
Calcium ....................................
Phosphorus ..............................
Magnesium ...............................
Iron ...........................................
Zinc ..........................................
Manganese ..............................
Copper .....................................
Iodine .......................................
Sodium .....................................
Potassium ................................
Chloride ....................................

Do.
Do.
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Milligrams.
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Milligrams.
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Micrograms.
Do.
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Milligrams.
Do.
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]

§ 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):

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Food and Drug Administration, HHS

§ 107.30

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]

Exemptions.

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

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EC01MR93.000

§ 107.30

ER01JA93.366

(c) A ‘‘Use by lll’’ 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