Ann: FDA approval to supply infant milk formula to United States, page-48

@Riglife

Why do you "hope for my sake" that it gets extended? The USA market for IF will be challenging and competitive, not at all a given that it will be particularly profitable in the short term. I do think the long-term potential is sufficient that it is worth a shot. But it isn't critical for the company at all.

"you do realise the only reason the FDA even entertained the idea of importing baby formula was because of shortage of raw material supply and high demand. All of which will be alleviated by next year hence the short time for the approval."

That's not actually correct. The shortages prompted the current enforcement discretion policy. But the lack of competition and excessive reliance on too few domestic producers (what ultimately led to the crisis) is why the FDA announced a longer-term pathways for foreign producers to enter the market. They also stated that they want users of approved formulas to be able to continue using that formula and not have to switch.

Go and read the FDA's announcement "FDA Pathway Supports Long-Term Stability, Diversity of Safe and Nutritious Infant Formula Supply in the U.S." on 30 September 2022:

"Manufacturers currently marketing their products in the U.S. under enforcement discretion should send a letter to the FDA by Dec. 5, 2022, outlining their intent to pursue completion of all regulatory requirements. Upon receipt, the agency intends to evaluate the request to determine whether to extend the period of enforcement discretion and issue a new letter of enforcement discretion by Jan. 6, 2023. For manufacturers that receive a new letter of enforcement discretion, the FDA does not intend to object to the continued marketing of covered infant formulas in the U.S. through October 2025 while the manufacturers take steps to achieve compliance with all requirements that apply to their products. Some manufacturers may have most of the information needed to meet all U.S. requirements, and therefore, could achieve compliance fairly quickly, while others may need the full timeframe being provided. "

https://www.fda.gov/news-events/press-announcements/fda-pathway-supports-long-term-stability-diversity-safe-and-nutritious-infant-formula-supply-us