Bubs Australia announced lodgement of the Letter of Intent to the U.S. Food and Drug Administration (FDA) as required under FDA Guidance for Industry ­ Infant Formula Transition Plan for Exercise of Enforcement Discretion (Transition Plan) issued on Saturday 1st October 2022 (Australian time). Bubs Australia is one of only eight infant formula manufacturers globally to receive FDA regulatory acknowledgement, enabling the safe import of all six Bubs® Infant Formula products under the enforcement discretion. The Transition Plan is applicable only to those that have received the enforcement discretion and provides a clear regulatory pathway and framework of requirements for Bubs® Infant Formula to gain permanent access without interruption to supply to American families.

The FDA intends to issue a Letter of Acknowledgement in response to the Letter of Intent, which if appropriate, will state that the enforcement discretion will be extended under the Transition Plan until October 2025, provided that the manufacturer continues to make meaningful progress toward compliance with the Transition Plan.