Bubs Australia has received permanent authorisation from the US Food and Drug Administration (FDA) to supply its infant formula products in the US market.
In a statement issued today (7 September), the Australian infant-nutrition company said the FDA had provided permanent regulatory clearance for three products: Bubs Goat, Bubs 365 Day Grass Fed and Bubs Essential.
The decision confirms that Bubs’ product formulations, manufacturing processes and supporting scientific evidence “satisfy” US regulatory requirements, the company said.
Bubs also described itself as the “only Australian infant-formula brand” with permanent approval to supply the US market.
Bubs managing director and CEO Joe Coote said: “Permanent FDA authorisation is a transformational milestone for Bubs and validates the strength of our farm-to-formula value chain, manufacturing capability and product quality.
“This approval provides the platform to accelerate our US growth strategy, deepen retailer partnerships, strengthen consumer awareness of the Bubs brand and expand consumer reach across a market where we are already represented in more than 10,000 stores nationwide.”
The company began pursuing permanent market access in 2022, during a nationwide infant-formula shortage caused by a contamination incident at an Abbott Laboratories manufacturing facility.
The US administration subsequently introduced temporary exemptions allowing overseas suppliers, including Bubs, to export infant formula to the country and help address supply constraints.
Following the FDA approval, Bubs said it intends to expand into the US private-label infant nutrition market.
Coote added: “While any private-label expansion remains subject to further regulatory, technical and commercial milestones, the FDA authorisation represents a significant strategic asset that we consider enhances Bubs’ long-term growth potential.”
The regulatory milestone follows Bubs Australia’s latest financial results, which showed group revenue of A$111.9m ($80.56m) for the year ended 30 June. Revenue increased 9.2% compared with the previous year, supported by growth in the US business.
US revenue rose 24% to A$65.8m. In August, when releasing its annual results, Bubs attributed the increase to “driven by strong consumer demand in [the] premium goat segment, expanded store distribution and prioritisation of continuity of supply”.
Despite the higher sales, group gross profit declined 9.4% to A$44.5m. The company linked the reduction to “increased airfreight, regulatory and tariff-related costs”.