Pallets of Bubs baby formula sit ready for loading onto a cargo plane at Melbourne Airport last month.Credit:Asanka Ratnayake/Getty Images
“Many of the companies providing these formula products have expressed interest in continuing to serve the American market permanently,” Califf said in a statement.
“These flexibilities have been successful in helping to bring safe and nutritionally adequate infant formula products into the US marketplace on a temporary basis to address the formula shortage.
“Given that success,the FDA has determined that a more streamlined pathway that leverages information we have received for the products for which we are temporarily exercising enforcement discretion would help provide for the long-term availability and marketing of many of them.”
The FDA will issue further guidance to formula makers in September on this topic.
Bubs founder and CEO Kristy Carr said she welcomed the FDA’s announcement and looked forward to working with it to keep supplying Bubs’ formula in the long term.
“Our long-standing commitment to the US market ensured our ability to provide rapid response at the speed of safety,and satisfy the very stringent quality and safety nutrition requirements of the FDA,” she said.
Executive chair Dennis Lin said the business was “well-resourced” to keep supplying formula to the US after itsrecent $63 million capital raising.