Ann: FDA approval to supply infant milk formula to United States, page-12

I think it is just that the legislation was for the original enforcement discretion policy to expire in Jan 2023. The shortages are obviously persistent and and systemic, so the FDA flagged a longer term discretionary approvals for those already approved.

It seems very unlikely they would be granted approval now and not extended to 2025.

Contrary to what a lot of people seem to expect, the US market will be tough and low margins. I think it may prove damaging to some of the smaller competitors who got in early and threw all the stock they could produce at it. With some existing brand recognition, distribution networks, decent supply, and cash reserves, I think A2M is better positioned then most to capitalise in the long run though.