Regulate Formula Document For Free

Four companies -- Abbott, Perrigo, Nestle SA and Mead Johnson -- control 90% of the US supply of formula. The risks of that concentration only came into sharp relief recently, when the Food and Drug Administration recalled some of Abbott's brands.

Among the requirements for infant formulas, the FDA specifies 30 nutrients that must be included in infant formulas. There are minimum amounts for all 30 nutrients and maximum amounts for 10 nutrients. In addition, any ingredient used in infant formula must be safe and suitable for such use.

Does FDA approve infant formulas before they can be marketed? No, FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements and infant formula manufacturers must notify the FDA prior to marketing a new formula.

The US Food and Drug Administration (FDA) regulates commercial infant formulas to make sure they meet minimum nutritional and safety requirements. Iron-fortified infant formulas are recommended, and most commercial infant formulas sold in the United States contain iron.

The Food and Drug Regulations set conditions on the sale of infant formulas and HMFs, including: labelling requirements for these products and stopping the sale and advertising if evidence shows that the infant formula or the HMF is not nutritionally adequate or that the expiration date is not valid.

It may take up to 1-2 weeks for a baby to adjust to a new formula.

FDA reviews all infant formulas sold legally in the United States to make sure they meet minimum nutritional and safety requirements. FDA also makes sure that the water used to make formulas meets safety standards set by the US Environmental Protection Agency.