Someone mentioned A2 Milk FDA approval for the infant formula. On the FDA web site there is explanation that no FDA approval is needed for an infant formula. It has to meet FDA guidelines, but there is no approval process.
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. Source: Excerpted from Guidance for Industry: Frequently Asked Questions about FDA's Regulation of Infant Formula March 1, 2006.
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