FDA approval for infant formula, page-3

Yeah it's a bit confusing but there's much more to it than that. The full details are here:

https://www.fda.gov/food/infant-formula-guidance-documents-regulatory-information/regulations-and-information-manufacture-and-distribution-infant-formula#manufacture

There is a section further down about a "submission" which is required and includes all details about the formula including evidence of quality factor requirements (which requires clinical trials to be conducted for the product). These must all be satisfied before it is legal to market the product.

It still sounds doable to me but these hurdles were insurmountable for another NZ company, Munchkin, which is also manufactured by Synlait. They gave up on obtaining FDA registration.

From what I've read, it's very hard for other countries to get products to meet the FDA specific requirements, so much so that there's a black market for European formula. You can read a bit more about it here:

https://www.nytimes.com/wirecutter/blog/us-parents-european-baby-formula/