After a long wait, the a2 Milk Company was told by the United States Food and Drug Administration that it had exercised its discretion and would allow the New Zealand company to import infant formula into the United States.
The company will now supply its Stage 1 and Stage 2 a2 Platinum infant formula product in the United States, as well as its Stage 3 toddler product which does not require FDA discretion.
a2 said New Zealand-based Synlait Milk Limited had previously indicated it had the capacity to supply nine million boxes of the product if needed, but “supply plans will need to be updated”.
Sales of up to one million cans were now expected before the end of FY23.
Although the product is the same as that sold in Australia and New Zealand, it will have different scoops, mixing instructions and labeling to meet FDA requirements.
a2 will now join Australian suppliers, including Bubs Australia, in sending formula to the United States, which is experiencing product shortages following a factory incident.
But while Bubs has been profiting from the market for months, a2 Milk Company had to wait since it applied on May 26 for access to the American market.
On August 10, a2 informed investors that the FDA had deferred consideration of its application. however, the company said it has continued to engage with the US regulator.
a2 Milk already sells a2 Milk liquid in the United States from an operation based in Boulder, Colorado.
Fluid milk is distributed through 27,000 retail stores.
Photo: a2 Milk Company