Bubs Australia has received permanent regulatory authorisation from the US Food and Drug Administration (FDA) for its three infant formula products – Bubs Goat, Bubs 365 Day Grass Fed, and Bubs Essential.
The authorisation confirms Bubs’ products, manufacturing systems and scientific evidence satisfy US regulatory requirements for safety, nutritional adequacy and quality, providing a permanent pathway to supply one of the world's largest infant formula markets.
The US infant formula market is one of the most highly regulated consumer categories globally, with substantial scientific, regulatory and manufacturing requirements for entry.
Permanent FDA authorisation strengthens Bubs' competitive position as the only Australian infant formula brand and one of a limited number of international manufacturers able to participate in this market.
The approval provides a foundation for continued growth across Bubs' branded portfolio, while creating strategic optionality for future product innovation and market expansion.
“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,” said Joe Coote, managing director and CEO of Bubs.
“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.
“Importantly, it also creates additional opportunities to broaden our product offering and evaluate participation in the US private label infant nutrition segment.
“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.”
Bubs will host an investor webinar to discuss the FDA authorisation and the Company's US growth strategy on Thursday 10 September 2026.
Details on how to register and participate will be provided separately and made available via the ASX and the Bubs Investor Centre.
