Why should you not use homemade infant formula?

Homemade formulas should not be used, says Nick Duy, assistant to the director in FDA 's division of regulatory guidance. Homemade formulas based on whole cow's milk don't meet all of an infant's vitamin and mineral needs. In addition, the high protein content of cow's milk makes it difficult for an infant to digest and may put a strain on the baby's immature kidneys. Substituting evaporated milk for whole milk may make formula easier to digest, but it is still nutritionally inadequate when compared to commercially prepared formula. Use of soy drinks as an infant formula can actually be life-threatening (See accompanying article).

Commercially prepared formulas are regulated by the Food and Drug Administration as a food for special dietary use. "Infant formulas are the most heavily regulated food that there is," says Wallingford.

FDA regulations specify exact nutrient level requirements for infant formulas, based on recommendations by the American Academy of Pediatrics Committee on Nutrition. The following must be included in all formulas: Protein, fat, linoleic acid, vitamin A, vitamin D, vitamin E, vitamin K, thiamine (vitamin B1), riboflavin (vitamin B2), vitamin B, vitamin B12, niacin, folic acid, pantothenic acid, vitamin C, calcium, phosphorous, magnesium, iron, zinc, manganese, copper, iodine, sodium, potassium, and chloride.

In addition, formulas not made with cow's milk must include biotin, choline and inositol.

The safety of commercially prepared formula is also enhanced by strict quality control procedures that require manufacturers to analyze each batch of formula for required nutrients, to test representative samples for stability over the shelf life of the product, to code containers to identify the batch, and to make all records available to FDA investigators.