The US Food and Drug Administration has granted approval for The a2 Milk Company to import its a2 Platinum (Stages 1 and 2) infant milk formula. The decision comes after the FDA deferred its decision on a2 Milk’s application in August.
The approval runs until 6 January.
Products going to the US have the same formulation but different scoops, mixing instructions, and labelling to meet FDA requirements.
A2 Milk said products for the US will need to be manufactured as there is not enough in its current inventory. The company had told the FDA that if approval was granted by 30 September, it would have capacity through Synlait Milk to manufacture nine million cans of a2 Platinum by 30 June 2023.
It said while supply plans will need to be updated, it expected to be able to supply the same volume over a nine-month period.
While the company sees the US market as a significant opportunity, it cautioned on making sales projections.
“The company believes sales will be significantly below indicated manufacturing capacity unless the situation changes… Actual sales will ultimately depend on customer demand, consumer offtake, supply shortages, and market conditions at the time,” it said.
CEO and managing director David Bertolussi said the company was well positioned.
“We have scalable production capacity in New Zealand with Synlait, plus existing a2 Milk US sales, marketing, and supply chain capability that can be leveraged.
The company has had a liquid a2 Milk business in the US for seven years, producing a2 Milk Whole, 2% Reduced Fat, Fat Free, Half and Half, and Hershey’s a2 Milk. It has an existing distribution through 27,000 stores.
