Upgrade, page-84

Seems it is one of four requirements
Before a new infant formula can be marketed in the United States, the infant formula manufacturer must provide FDA with a notification about the proposed infant formula as required under section 412 of the FFDCA. This premarket infant formula notification must contain detailed information about the formulation, an explanation of what has changed (if it is a reformulation), and nutritional and manufacturing assurances. The infant formula manufacturer must provide assurance that the formula will provide adequate nutrition for infants to thrive, that the formula will be manufactured under current good manufacturing practices including quality control procedures, and that every batch of the formula will meet all of the nutrient requirements under the FFDCA and its implementing regulations in 21 CFR. These regulations include:
21 CFR Part 106 - Infant formula quality control procedures
21 CFR Part 107 - Infant formula
21 CFR Part 110 - Current good manufacturing practice in manufacturing, packing, or holding human food
21 CFR Part 113 - Thermally processed low-acid foods packaged in hermetically sealed containers

Can't be easy - other wise Synliats Munckin would have done it.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-frequently-asked-questions-about-fdas-regulation-infant-formula#q10