- Bubs Australia (BUB) expresses its interest in helping to strengthen the US infant formula supply under the new US Food and Drug Administration (FDA) framework
- The new FDA framework aims to continue and expand access for US caregivers to international infant formula options it has assessed as safe and nutritious
- The framework also includes providing a pathway for companies that import, sell or distribute formula to continue to supply infant formula to the US past November
- Bubs also confirms two additional flights facilitated by the US Department of Health and Human Services will soon transport around 180,000 cans of its infant formula to California and Ohio
- Shares in Bub are down 5.74 per cent, trading at 57.5 cents as of midday AEST
Bubs Australia (BUB) has expressed an interest in helping to diversify and strengthen the US infant formula supply under the new US Food and Drug Administration (FDA) framework.
The new FDA framework is in development to continue and expand access for US parents and caregivers to international infant formula options it has assessed as being safe and nutritious.
Further, the FDA has committed to providing a pathway for companies that import, sell or distribute formula under its temporary enforcement discretion policy to continue to supply infant formula to the US past November.
CEO and Founder Kristy Carr said the company is looking forward to continuing to work with the FDA over the next few months to address any additional steps required.
“[This is to] ensure we can supply and market Bubs’ safe and nutritious formulas without interruption beyond November and over the longer term.
“Bubs was one of the first international manufacturers to apply to the FDA to import infant formula under the initial enforcement discretion policy.
“Our long-standing commitment to the US market ensured our ability to provide rapid response at the speed of safety, and satisfy the very stringent quality and safety nutrition requirements of the FDA.”
The company also confirmed that President Biden’s administration is sourcing two additional flights facilitated by the US Department of Health and Human Services (HHS) for Operation Fly Formula to transport additional Bubs Australia infant formula to California and Ohio on July 10 and 21 respectively.
These two deliveries will include the equivalent of approximately 180,000 cans of Bubs infant formula.
The FDA intends to issue further guidance in September on the topic of how companies that have already received temporary enforcement discretion could meet FDA requirements to continue to supply infant formula to the US beyond that time.
Shares in Bub were down 5.74 per cent, trading at 57.5 cents as of midday AEST.