How is infant formula regulated in the United States?
Because infant formula is a food, the laws and regulations governing foods apply to infant formula. Additional statutory and regulatory requirements apply to infant formula, which is often used as the sole source of nutrition by a vulnerable population during a critical period of growth and development. These additional requirements are found in section 412 of the FFDCA and FDA’s implementing regulations in 21 CFR 106 and 107. To view the FFDCA and regulations in 21 CFR, see FDA Federal Register Documents, Code of Federal Regulations & Food, Drug, and Cosmetic Act.
