Australian baby milk and infant formula producer Bubs Australia [ASX:BUB] announced the submission of a letter to the US FDA to extend trade in the US beyond the initial date of October 2025.
BUB rose a modest 2% on the news in late afternoon trade on Monday.
BUB shares are up 40% over the past 12 months.
Source: Trading View
Bubs seeks approval from FDA for permanent US market access
Bubs is petitioning the US regulatory body FDA for permanent market access.
BUB — along with seven other manufacturers — received temporary dispensation to export its infant formula product following a shortage in the US.
Now Bubs wants to make its trade relationship permanent, lodging a letter of intent with the FDA.
BUB expects the FDA to return the epistolary favour by issuing a Letter of Acknowledgement. Bubs anticipate the letter to extend the import discretion afforded to BUB until October 2025.
Bubs CEO Kristy Carr commented:
‘Since first receiving a green light from the FDA on 27 May 2022, allowing Bubs to import all six of our safe and clean infant formula products into the United States, we have worked closely with the Biden Administration, the U.S. Department of Health and Human Services, the FDA, and leading retailers across the country to ensure continued supply of Bubs Infant Formula were directed to those areas with the greatest need,
‘Given the overwhelming positive response that we have received from American parents, caregivers, health care professionals and retailers, we are pleased to be able to commit that Bubs Australia will remain in the United States for the long term.
‘Importantly, the FDA announcement also provides continued support for the ongoing expansion of our U.S. distribution footprint, as we look forward to launching Bubs Infant Formula products in various new retail groups in the months ahead.’
BUB to break regional trade milestone
Bubs’ Executive Chair Dennis Lin stated most of the hard work has been achieved by already satisfying the US’s nutritional requirements, offering confidence in safety to customers.
Mr Lin said:
‘Our long-standing commitment to the United States means we are ready to move expeditiously to complete the FDA process outlined today by Commissioner Califf as we continue to expand our U.S. team and ramp up production,
‘This, together with the other important regulatory milestone of the new SAMR GB registration pathway for Bubs China Label Infant Formula products, means we are truly placed in the ideal position of being able to access the world’s top two infant formula markets – China and the USA. Once achieved, this will be a global first for any Australian or New Zealand company.’
Incoming central bank digital currencies
Central bank digital currencies (CBDCs) are soon to become an everyday reality.
The digital yuan is already live; it featured prominently at the Beijing Winter Olympics.
But China isn’t the only country experimenting with CBDCs.
Our own Reserve Bank of Australia admits it’s ‘actively researching central bank digital currency as a complement to existing forms of money’.
We must come to terms with the possible implications of its potential adoption and fast.
To learn more about CBDCs, check out this presentation.
Regards,
Kiryll Prakapenka,
For Money Morning
