Does FDA approve infant formulas before they are 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. If an infant formula manufacturer does not provide the elements and assurances required in the notification for a new or reformulated infant formula, the formula is defined as adulterated under Section 412(a)(1) of the FFDCA and FDA has the authority to take compliance action if the new infant formula is marketed.