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The U.S. normally produces 98% of the infant formula that Americans buy, and four manufacturers ? Abbott, Mead Johnson Nutrition, Nestle USA and Perrigo ? control 90% of the domestic market.

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.

While the FDA Food Safety Modernization Act (FSMA) requires the agency to inspect domestic food facilities at least once every 3 to 5 years, the FDA has a policy of annually inspecting infant formula manufacturers because the products serve as the sole source of nutrition for some of our most vulnerable consumers.

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 new infant formula submission must include: 1) the product name and a description of the physical form, 2) an explanation of why it is a new infant formula, 3) the quantitative formulation of the infant formula, 4) a description of any reformulation of the formula or change in processing of the infant formula, 5)

About half of all formula sold in the U.S. is paid for by the Department of Agriculture, through its Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Each state signs an exclusive contract with one of the formula manufacturers to supply subsidized product for low-income families.

Is an infant formula manufacturer required to register with FDA under the Bioterrorism Act of 2002? Yes. Like all food manufacturers, infant formula manufacturers must register with FDA under the Bioterrorism Act of 2002.