Bubs Australia has announced the lodgement of its New Infant Formula Submission (NIFS) with the US Food and Drug Administration (FDA) to cover three infant milk formulas.
The three formulas, goat, 365-day grass fed, and essential, are already being sold in the US market.
According to Bubs Australia chief executive officer Reg Weine, the submission marks a critical milestone in the company’s final step in the FDA’s regulatory process to secure permanent entry into the American market.
“The submission of our NIFS represents an important milestone for Bubs in our journey to obtain permanent market access for the USA,” said Weine.
“With the USA already our biggest market and one 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.”
The company has been conducting a large-scale clinical trial, enrolling a total of 478 infants over 16 months for the USA Clinical Trial.
“The successful completion of what is understood to be the largest single clinical infant milk formula trial in the world, is a testament to the technical and operational capabilities of Bubs and our partners in both Australia and the US,” said chief operating officer at Bubs Australia Richard Paine.
“This submission represents an ‘industry-first’ for the Australian dairy industry and strongly positions Bubs as a globally credible manufacturer and brand.”
Formal notification from the FDA is expected by the end of the calendar year.