The a2 Milk Company says its application to import infant formula to the US has been deferred in a blanket move by the FDA, but Australian Diary Nutritionals says not for them.
Earlier this month (2 August) A2 Milk said the FDA was actively reviewing its application but there was no certainty on the outcome or timing.
On Wednesday (10 August) A2 Milk told the ASX the FDA had notified the company it was deferring its decision.
“The company has also subsequently been advised by the International Dairy Foods Association that equivalent letters have been sent to all pending enforcement discretion applicants, indicating that the FDA is deferring any further review at this time of all pending applications,” its market release said.
Australian Diary Nutritionals says Australian media reports the US Food and Drug Administration (FDA) has paused approvals for imported infant formula does not apply to its application.
“We understand the FDA sent out a deferral letter to many applicants whose application will not be progressed at this time however AHF did not receive this letter and the FDA has confirmed our application is still under active review,” the company said in a statement to the ASX.
The group’s Gradulac Gentle formula has three stages - newborn, follow-on, and toddler.
