Bubs Wins Permanent FDA Authorisation for US Formula

Bubs Australia Limited (ASX:BUB) has received permanent regulatory authorisation from the United States Food and Drug Administration for its three infant formula products: Bubs Goat, Bubs 365 Day Grass Fed and Bubs Essential. The company said the authorisation confirms that its products, manufacturing systems and scientific evidence satisfy USA regulatory requirements for safety, nutritional adequacy and quality, providing a permanent pathway to supply one of the world's largest infant formula markets. Bubs said the authorisation establishes it among a limited group of non-US manufacturers authorised to supply the US infant formula market, strengthens its position as the only Australian infant formula brand able to participate in that market, and unlocks opportunities to expand product innovation and to pursue participation in the US private label infant nutrition segment.

Managing Director and Chief Executive Officer Joe Coote said permanent FDA authorisation is a transformational milestone for Bubs that validates the strength of its farm-to-formula value chain, manufacturing capability and product quality, and provides the platform to accelerate the company's US growth strategy, deepen retailer partnerships, strengthen consumer awareness and expand consumer reach across a market where Bubs is already represented in more than 10,000 stores nationwide. He said the authorisation also creates additional opportunities to broaden the product offering and evaluate participation in the US private label infant nutrition segment, while noting that any private label expansion remains subject to further regulatory, technical and commercial milestones. Bubs will host an investor webinar on Thursday, 10 September 2026 to discuss the authorisation and its US growth strategy, with registration details to be provided separately. The release does not quantify any revenue or volume impact.