0256 21cfr107

Food and Drug Administration, HHS

§ 107.10

by telephone, to the Director of the appropriate Food and Drug Administration district office specified in part 5,
subpart M of this chapter. After normal business hours (8 a.m. to 4:30 p.m.)
the FDA emergency number, 301–443–
1240, shall be used. The manufacturer
shall send a followup written confirmation to the Center for Food Safety and
Applied Nutrition (HFS–605), Food and
Drug
Administration,
5100
Paint
Branch Pkwy., College Park, MD 20740,
and to the appropriate Food and Drug
Administration district office specified
in part 5, subpart M of this chapter.
[47 FR 17025, Apr. 20, 1982, as amended at 54
FR 24891, June 12, 1989; 61 FR 14479, Apr. 2,
1996; 66 FR 17358, Mar. 30, 2001; 66 FR 56035,
Nov. 6, 2001; 69 FR 17291, Apr. 2, 2004]

PART 107—INFANT FORMULA
Subpart A—General Provisions
Sec.
107.3

Subpart A—General Provisions
§ 107.3 Definitions.
The following definitions shall apply,
in addition to the definitions contained
in section 201 of the Federal Food,
Drug, and Cosmetic Act (the act):
Exempt formula. An exempt infant formula is an infant formula intended for
commercial or charitable distribution
that is represented and labeled for use
by infants who have inborn errors of
metabolism or low birth weight, or who
otherwise have unusual medical or dietary problems.
Manufacturer. A manufacturer is a
person who prepares, reconstitutes, or
otherwise changes the physical or
chemical characteristics of an infant
formula or packages the infant formula
in containers for distribution.
References. References in this part to
regulatory sections of the Code of Federal Regulations are to chapter I of
title 21, unless otherwise noted.
[50 FR 48186, Nov. 22, 1985]

Definitions.

Subpart B—Labeling

Subpart B—Labeling
107.10
107.20
107.30

Nutrient information.
Directions for use.
Exemptions.

Subpart C—Exempt Infant Formulas
107.50

Terms and conditions.

Subpart D—Nutrient Requirements
107.100

Nutrient specifications.

Subpart E—Infant Formula Recalls
107.200 Food and Drug Administration-required recall.
107.210 Firm-initiated product removals.
107.220 Scope and effect of infant formula
recalls.
107.230 Elements of an infant formula recall.
107.240 Notification requirements.
107.250 Termination of an infant formula recall.
107.260 Revision of an infant formula recall.
107.270 Compliance with this subpart.
107.280 Records retention.
AUTHORITY: 21 U.S.C. 321, 343, 350a, 371.
SOURCE: 50 FR 1840, Jan. 14, 1985, unless
otherwise noted.

§ 107.10 Nutrient information.
(a) The labeling of infant formulas,
as defined in section 201(aa) 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 of
each of the following nutrients supplied by 100 kilocalories:
Nutrients
Protein .............................................
Fat ...................................................
Carbohydrate ...................................
Water ...............................................
Linoleic acid ....................................
Vitamins:
Vitamin A ..................................
Vitamin D .................................
Vitamin E ..................................
Vitamin K ..................................
Thiamine (Vitamin B 1) .............
Riboflavin (Vitamin B 2 .............

Unit of measurement
Grams.
Do.
Do.
Do.
Milligrams.
International units.
Do.
Do.
Micrograms.
Do.
Do.

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§ 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.
Do.
Do.
Do.
Do.
Milligrams.
Do.
Do.
Milligrams.
Do.
Do.
Do.
Do.
Micrograms.
Do.
Do.
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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