Bubs Australia Wins Permanent FDA Clearance for Infant Formula, Shares Surge

Bubs Australia (BUB) secured permanent authorization from the US Food and Drug Administration to sell three infant formula products in the United States, sending its shares up as much as 45 per cent before closing 30 per cent higher — their strongest single-session gain in more than four years.

The approval covers three products: Bubs Goat, Bubs 365 Day Grass Fed, and Bubs Essential, placing the company among a small group of international manufacturers permitted to supply the US infant formula market on a permanent basis.

The company said it is also evaluating an entry into the US private label infant nutrition segment following the clearance — a move that could broaden its commercial footprint beyond branded sales.

The authorization arrives as infant nutrition companies across Australia and New Zealand navigate tightening regulations and persistent supply chain disruptions. Bubs reported an annual EBITDA loss of A$1.8mn for the most recent fiscal year, but said it expects a stronger first half of 2027, underpinned by growing US demand as it works to reduce its reliance on China.

The difficulties facing the sector were underscored last month by a2 Milk (ATM), the New Zealand-based dairy group, which said supply constraints weighed on earnings in its most recent annual results.