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FDA defers A2 Milk Company (ASX:A2M) application to supply baby formula to the US

ASX 200, Consumer
ASX:A2M      MCAP $4.076B
10 August 2022 11:00 (AEDT)

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The US Food and Drug Administration (FDA) has deferred The A2 Milk Company’s (A2M) request for enforcement discretion to import its infant milk formula products into the US.

In light of a critical shortage of infant formula in the States, the FDA temporarily relaxed its regulatory standards for infant formula imported into the country.

However, A2 Milk today said it had been advised by the International Dairy Foods Association that the regulator had deferred its application to sell infant formula to the US under the relaxed standards, and similar letters had been sent to all pending enforcement discretion applicants.

This indicates that the FDA is deferring any further review at this time of all pending applications.

Infant formula products from the likes of Nestle, Danone and fellow ASX-listed Bubs (BUB) have all been previously approved for sale in the US under the FDA’s enforcement discretion provision.

Last week, A2 Milk dismissed a report suggesting that its own request for enforcement discretion was approaching approval, claiming that the application was still under review.

Following today’s deferral, shares in A2 Milk have tumbled 9.39 per cent to trade at $4.63 data 10:53 am AEST.

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