[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.10]

[Page 190-191]
 
                        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. 107.10  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                       Unit of measurement
------------------------------------------------------------------------
Protein...................................  Grams.
Fat.......................................  Do.
Carbohydrate..............................  Do.
Water.....................................  Do.
Linoleic acid.............................  Milligrams.
Vitamins:
  Vitamin A...............................  International units.
  Vitamin D...............................  Do.
  Vitamin E...............................  Do.
  Vitamin K...............................  Micrograms.
  Thiamine (Vitamin B 1)..................  Do.
  Riboflavin (Vitamin B 2.................  Do.
  Vitamin B 6.............................  Do.
  Vitamin B 12............................  Do.
  Niacin..................................  Do.
  Folic acid (Folacin)....................  Do.
  Pantothenic acid........................  Do.
  Biotin..................................  Do.
  Vitamin C (Ascorbic acid)...............  Milligrams.
  Choline.................................  Do.
  Inositol................................  Do.
Minerals:
  Calcium.................................  Milligrams.
  Phosphorus..............................  Do.
  Magnesium...............................  Do.
  Iron....................................  Do.
  Zinc....................................  Do.

[[Page 191]]


  Manganese...............................  Micrograms.
  Copper..................................  Do.
  Iodine..................................  Do.
  Sodium..................................  Milligrams.
  Potassium...............................  Do.
  Chloride................................  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]