An Australian infant formula manufacturer that entered the US market during the 2022 shortage says it has been granted permanent authorization by the FDA to keep selling here. Bubs Australia announced on September 7 that the authorization covers three products, Bubs Goat, Bubs 365 Day Grass Fed and Bubs Essential, and said the agency confirmed its products, manufacturing systems and supporting scientific evidence meet US requirements for safety, nutritional adequacy and quality.
For families, the immediate significance is stability rather than novelty. These formulas already sit on shelves in more than 10,000 US stores. What changes is that their presence no longer depends on a temporary arrangement that has been repeatedly extended since 2022, which reduces the chance of an abrupt disappearance of a product a baby is already tolerating.