2 Milk shares plunge after FDA says it had no notice to firms seeking infant formula approval

A 2 Milk Company Ltd said on Wednesday that the U.S. Food and Drug Administration FDA deferred its request to sell infant milk formula products in the United States, sending its shares down more than 12%.

The dairy producer and rival Fonterra has been advised by the U.S. based trade group International Dairy Foods Association IDFA that the FDA has sent similar letters to all firms seeking approvals to sell infant milk formula in the United States.

Fonterra told Reuters that it had not received any notice from the FDA.

An FDA spokesman told Reuters in an email that the FDA had sent letters to some firms, but not all, deferring further reviews of applications due to a list of issues.

The spokesperson said that, for firms that received letters, they do not mean that the infant formulas are unsafe, but rather that they indicate that we have found issues that would not be resolved quickly.

The FDA will not be reviewing the company's request for enforcement discretion to import infant milk formula products at this time, a 2 Milk said on Wednesday. The new came in and was headed for their biggest single day drop since Aug. 26, 2021, as much as 12.3% of the dnbRaA Shares of a 2 Milk fell to $4.94 at http://bit.ly 3 dnbRaA.

The FDA previously said it would allow baby formula sold in other countries into the United States under a temporary program with relaxed standards. The U.S. government has also flown in formula from overseas plants.

The FDA has exercised its enforcement discretion to import certain infant formula products from Bubs Australia Ltd, UK-based Kendamil, Nestle SA and Danone SA.

Companies like a 2 Milk, Fonterra, Switzerland's Holle and U.S. based Nature's One are yet to receive approvals.