Bubs Australia secures permanent FDA approval for US infant formula sales

Bubs Australia Ltd shares surged significantly on Monday, rising as much as 45% following news that the company has secured permanent regulatory authorization from the U.S. Food and Drug Administration (FDA).

The FDA approval covers three specific infant formula products: Bubs Goat, Bubs 365 Day Grass Fed, and Bubs Essential. The authorization confirms that the products, manufacturing systems, and supporting scientific evidence meet U.S. requirements for safety, nutritional adequacy, and quality. This makes Bubs the only Australian infant formula brand, and one of a limited number of international manufacturers, to be permanently authorized to supply the U.S. market.

CEO Joe Coote described the approval as a “transformational milestone” that provides a platform to accelerate the company’s growth strategy in the United States. The U.S. is already Bubs' largest market, accounting for over half of its group revenue. Following this approval, the company is also evaluating a potential entry into the U.S. private-label infant nutrition segment.