Nutritional adequacy and safety of infant formulas.

The Infant Formula Act contains specific requirements for minimum and, in some cases, maximum levels for a list of nutrients that may be revised as warranted by the development of new scientific information. Formulas are required to be manufactured in accordance with quality control procedures to ensure that the safety and nutritional potency of a formula is built into the manufacturing process. A formula that does not provide the minimum level for any required nutrient shall be deemed to be adulterated and may be subject to removal from the market. A manufacturer is required to promptly notify the Secretary of the Department of Health and Human Services of instances whereby a formula does not meet the nutrient requirements, is otherwise adulterated or misbranded, and, as such, presents a risk to human health. There are other provisions in the Act, but these establish that, for infant formulas, nutritional safety is clearly recognized as an integral part of food safety.