From the FDA website: 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. Because infant formula is a food, the laws and regulations governing foods apply to infant formula.Yes, FDA has requirements for nutrients in infant formulas, which are located in section 412(i) of the FFDCA and 21 CFR 107.100. These nutrient specifications include minimum amounts for 29 nutrients and maximum amounts for 9 of those nutrients. Substances used in food, including infant formula, must be safe and lawful. Substances that may be used in infant formulas are food ingredients that are generally recognized as safe (GRAS). Yes, FDA monitors infant formula products as part of its responsibility to the Federal Food, Drug, and Cosmetic Act (FFDCA).  There is more on the FDA website at: 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-frequently-asked-questions-about-fdas-regulation-infant-formula#:~:text=No%2C%20FDA%20does%20not%20approve%20infant%20formulas%20before,the%20FDA%20prior%20to%20marketing%20a%20new%20formula.

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