No dice from FDA for NZ dairy companies

10th August 2022 By Staff Reporter | news@foodticker.co.nz | @foodtickernz

Dairy companies lining up to restock empty baby formula shelves in the United States will not get the go-ahead anytime soon after the US Food and Drug Administration deferred all applications.

In a stock exchange update, A2 Milk confirmed that its application to import infant milk formula into the US had been put on ice by the FDA.

“The A2 Milk Company wishes to advise that earlier today it received notification from the US Food and Drug Administration (FDA) that, at this time, the FDA is deferring further consideration of the company’s request for enforcement discretion to import infant milk formula (IMF) products into the US.”

The company’s share price dropped 10% in early trading this morning, opening at $5.64 but falling to a low of $4.96, losing the gains it made last week when the Australian press reported that FDA sign-off was imminent.

A2 Milk said it had also been advised by the International Dairy Foods Association that equivalent letters had been sent to all pending enforcement discretion applicants, indicating that the FDA is deferring any further review at this time of all pending applications.

Fonterra and Bellamy’s Organic were both also going through the approvals process in an effort to get product 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’s James McVitty, manager of tade strategy, sustainability, and stakeholder affairs for the Americas, told the Ticker the company had not yet received notification from the FDA that it is deferring a decision on its application.

“However, the International Dairy Foods Association has advised us that the FDA is deferring any further review at this time of all pending applications.”

He added that Fonterra’s submission to the FDA was for a relatively small number of infant formula cans, which had originally been manufactured for the New Zealand market.

The submission was made in response to Operation Fly Formula and on humanitarian grounds to support US parents at the time of severe shortages in the US market, McVitty said.  

“We continue to support other infant formula manufacturers approved for sale in the US with base infant formula powder ingredients,” he added.

Fonterra produces paediatric base powders for select customers at its specialist plant in Darnum in Australia, and these are going to the US under the current emergency orders.

“We are now working through the process to ensure this is a long-term viable solution which includes meeting any additional US requirements for ongoing supply should permission be granted for our customers.”

Bubs Australia is the only company so far to have received approval allowing it to ship its baby food to the US – the world’s second-largest infant formula market.