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