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21 C.F.R. § 107.100 : Food and Drugs — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES — FOOD FOR HUMAN CONSUMPTION — INFANT FORMULA — NUTRIENT REQUIREMENTS — Nutrient specifications

(a) An infant formula shall contain the following nutrients at a level not less than the minimum level specified and not more than the maximum level specified for each 100 kilocalories of the infant formula in the form prepared for consumption as directed on the container:

Nutrients Unit of measurement Minimum level Maximum level
Protein Grams 1.8 4.5
Fat Do. 3.3 6.0
Percent calories 30 54
Linoleic acid Milligrams 300
Percent calories 2.7
Vitamins
Vitamin A International Units 250 750
Vitamin D Do. 40 100
Vitamin E Do. 0.7
Vitamin K Micrograms 4
Thiamine (Vitamin B1) Do. 40
Riboflavin (Vitamin B2) Do. 60
Vitamin B6 Do. 35
Vitamin B12 Do. 0.15
Niacin1 Do. 250
Folic acid (Folacin) Do. 4
Pantothenic acid Do. 300
Biotin2 Do. 1.5
Vitamin C (Ascorbic acid) Milligrams 8
Choline2 Do. 7
Inositol2 Do. 4
Minerals
Calcium Do. 60
Phosphorus Do. 30
Magnesium Do. 6
Iron Do. 0.15 3.0
Zinc Do. 0.5
Manganese Micrograms 5
Copper Do. 60
Iodine Do. 5 75
Selenium Do. 2 7
Sodium Milligrams 20 60
Potassium Do. 80 200
Chloride Do. 55 150

1The generic term "niacin" includes niacin (nicotinic acid) and niacinamide (nicotinamide).

2Required only for non-milk-based infant formulas.

(b) Vitamin E shall be present at a level of at least 0.7 International Unit of vitamin E per gram of linoleic acid.
(c) Any vitamin K added shall be in the form of phylloquinone.
(d) Vitamin B 6 shall be present at a level of at least 15 micrograms of vitamin B 6 for each gram of protein in excess of 1.8 grams of protein per 100 kilocalories of infant formula in the form prepared for consumption as directed on the container.
(e) The ratio of calcium to phosphorus in infant formula in the form prepared for consumption as directed on the container shall be no less than 1.1 and not more than 2.0.
(f) Protein shall be present in an amount not to exceed 4.5 grams per 100 kilocalories regardless of quality, and not less than 1.8 grams per 100 kilocalories of infant formula in the form prepared for consumption as directed on the container when its biological quality is equivalent to or better than that of casein. If the biological quality of the protein is less than that of casein, the minimum amount of protein shall be increased proportionately to compensate for its lower biological quality. For example, an infant formula containing protein with a biological quality of 75 percent of casein shall contain at least 2.4 grams of protein (1.8/0.75). No protein with a biological quality less than 70 percent of casein shall be used.

21 C.F.R. § 107.100

50 FR 45108, 10/30/1985; as amended at 80 FR 35841, 6/23/2015