- The a2 Milk Company (A2M) gains the FDA’s tick of approval to export its infant milk formula to the United States
- Following the onset of supply disruptions to infant milk formula (IMF) stocks in the US since February, the FDA released a temporary measure that offered a fast-tracked regulatory process to IMF producers
- A2 Milk first submitted its application on May 2 and — despite initial setbacks — has now received approval to import, sell and distribute its Platinum IMF product from New Zealand to the States through to January 6, 2023
- The product has the same formulation as a2 Platinum but uses different scoops, mixing instructions and labelling requirements so as to meet the FDA’s requirements
- Shares in a2 Milk are up 8.35 per cent to $5.71 at 10:45 am AEDT
The a2 Milk Company (A2M) has gained FDA approval to export its infant milk formula to the United States.
Following the onset of supply disruptions to infant milk formula (IMF) stocks in the US since February, exacerbated by a contamination scare involving the US’ largest formula manufacturer, Abbott, the FDA released a temporary measure that offered a fast-tracked regulatory process to international IMF producers.
Bubs Australia (BUB) was among the first to jump on the opportunity, and it secured approval shortly after, followed by Bellamy’s Organic.
A2 Milk submitted its own application on May 26 but received the news on August 10 that its submission — along with submissions from several other companies — had been deferred.
Despite the setback, A2M continued to engage with the FDA to meet its requirements and reconsider the application.
The company today reported it had received confirmation that its application to import, sell and distribute its Platinum IMF product from New Zealand has been approved through to January 6, 2023.
The a2 Milk Company Managing Director and CEO David Bortolussi said the company was pleased to be able to assist parents and caregivers in the US by providing access to significant volumes of high quality, a2 Platinum infant and toddler milk formula.
“We are increasing our supply to respond to this situation, while importantly ensuring that we continue to meet the needs of our other IMF consumers and trade partners in China and other markets,” Mr Bortolussi said.
“If the US requires further support over an extended period, we have the proven ability to scale up significantly.”
The Platinum IMF product has the same formulation as a2 Platinum but uses different scoops, mixing instructions and labelling requirements so as to meet FDA requirements.
A2M said this product was not currently available in inventory, and it needed to be manufactured as soon as possible.
The milk company previously indicated that if approval was obtained by 30 September 2022, it had the capacity to manufacture nine million cans of a2 Platinum by 30 June 2023 through Synlait Milk (SM1).
The company is also able to supply stage three toddler product, which does not require enforcement discretion.
Shares in a2 Milk were up 8.35 per cent to $5.71 at 10:45 am AEDT.