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Saturday 20 August 2022

A2 Milk: No US FDA approval… yet

3rd August 2022 By Staff Reporter | | @foodtickernz

Trading has resumed in A2 Milk shares after the company moved to clarify reports that it received sign-off to sell its infant milk powder in the US.

Still waiting… A2 Milk says it has no certainty as to the outcome or timing of any potential FDA approval

The dual-listed company went into a trading halt yesterday after its share price rapidly climbed between 8% and 12% on the New Zealand and Australian stock exchanges following speculation that it was within days of getting Food and Drug Administration approval to export to the US.

An article in the Australian Financial Review said the company may get approval as soon as this week on its application to sell baby formula in the US, where authorities have relaxed import rules as they seek to plug a nationwide shortage.

In a stock exchange announcement on Tuesday, the milk processor said that while the FDA approval process was underway, it did not know if and when it might get approval.

“The company wishes to confirm that while we have been informed by the FDA that our application is under active review, at this stage there is no certainty as to the outcome of the application or the timing of any approval,” it said.

A2 Milk lost some of Tuesday’s NZX gains – its share price spiked to $5.59 from under $5 at market opening yesterday – to sit at $5.45 near the end of today.

A2 Milk joins other Australasian dairy companies keen to get their products on shelves left empty in the US as a result of global supply chain disruption compounded by a large scale product recall after contamination of the Abbott brand infant formula.

Fonterra and Bellamy’s Organic are both still going through the approvals process, with Bubs Australia the only company so-far to have received approved and subsequently shipping baby food the US – the world’s second-largest infant formula market.

A2 lodged its application with the FDA under an enforcement discretion policy in May. It already sells milk in the US.



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