Bubs Australia has lodged its New Infant Formula Submission (NIFS) with the US Food & Drug Administration (FDA) - the final step in the FDA’s regulatory process to gain permanent access to the American market.
Bubs’ NIFS covers its three infant formulas: goat, essential, and 365 day grass fed. All three are currently available in the US, with Bubs one of eight companies that are allowed to operate under the FDA’s Enforcement Discretion regulatory process.
Bubs CEO, Reg Weine, said the US is already the company’s biggest market.
“The US is a market in which we continue to see significant growth. It is pleasing to see that the overall regulatory progress remains firmly on track. This remains one of the company's strategic pillars and will underpin future sustainable growth,” Paine said.
At the end of 2FY24, Bubs completed its infant enrolment for a clinical trial in the US, with 478 infants enrolled over 16 months. The trial is a compulsory part of applying for permanent regulatory approval.
Bubs COO, Richard Paine, said the trial was understood to be the largest single clinical infant milk formula trial in the world.
“It is a testament to the technical and operational capabilities of Bubs and our partners in both Australia and the US.
“This submission represents an 'industry-first' for the Australian dairy industry and strongly positions Bubs as a globally credible manufacturer and brand,” Paine said.
