Key Highlights

  • Bubs Australia (ASX:BUB) shares climbed 49.43% over the week to close at AUD 0.13 on 7 September 2026.
  • The US Food and Drug Administration granted permanent authorisation for Bubs Goat, Bubs 365 Day Grass Fed and Bubs Essential infant formula products.
  • The approval places Bubs among a limited group of non-US manufacturers permitted to Supply the US infant formula market on an ongoing basis.
  • Management flagged potential future participation in the US private label infant nutrition segment, subject to further regulatory and commercial steps.

Bubs Australia Limited (ASX:BUB) shares moved sharply higher this week, rising 49.43% to close at AUD 0.13 on 7 September 2026, after the company announced it had received permanent regulatory authorisation from the United States Food and Drug Administration for three of its infant formula products.

FDA Grants Permanent Authorisation

The Melbourne-based infant nutrition company confirmed that the FDA has permanently authorised Bubs Goat, Bubs 365 Day Grass Fed and Bubs Essential infant formula products for sale in the United States. The authorisation follows an assessment of the company's products, Manufacturing systems and supporting scientific evidence against US regulatory requirements covering safety, nutritional adequacy and quality.

Bubs Australia noted that the US infant formula category is among the most heavily regulated consumer segments globally, with substantial scientific, regulatory and manufacturing requirements attached to market entry. The company said the permanent authorisation provides an ongoing pathway to supply one of the largest infant formula markets in the world, rather than the temporary or conditional access arrangements that have applied previously.

Competitive Positioning in the US Market

With the authorisation now in place, Bubs Australia said it is positioned as the only Australian infant formula brand, and one of a limited number of international manufacturers, able to participate in the US market on a permanent basis. The company said this status is intended to support continued growth of its branded portfolio and create additional strategic Options for future product development and market expansion.

Joe Coote, Managing Director and Chief Executive Officer of Bubs, said the permanent FDA authorisation is a transformational milestone for the company and reflects the strength of its farm-to-formula supply chain, manufacturing capability and product quality. He said the approval provides a platform to accelerate the company's US growth strategy, deepen retailer partnerships, and expand consumer reach in a market where Bubs products are already stocked in more than 10,000 stores nationwide.

Private Label Opportunity Under Evaluation

Bubs Australia said the approval also creates the option to broaden its product offering and evaluate participation in the US private label infant nutrition segment over time. The company was clear that any move into private label supply remains subject to further regulatory, technical and commercial milestones, and does not represent a confirmed near-term plan.

To provide additional detail on the authorisation and its implications for the company's US growth strategy, Bubs Australia said it will host an investor webinar on Thursday, 10 September 2026, with registration details to be released separately through the ASX and the company's investor centre.

Conclusion

The permanent FDA authorisation represents a structural change in Bubs Australia's regulatory standing in the United States, replacing a more limited or conditional access arrangement with an ongoing pathway to supply the market. The announcement coincided with a marked rise in the company's share price over the trading week, reflecting investor attention to the milestone, while management has been careful to frame further steps, including any private label participation, as subject to additional regulatory and commercial conditions still to be worked through.