After a successful entry into the USA during their recent dairy crisis, infant nutrition and dairy specialist Bubs Australia (ASX: BUB) has lodged a letter of intent to continue selling six Bubs Infant Formula products in the country till October 2025 and beyond.
The Australian Company is one of only eight infant formula manufacturers globally to receive FDA regulatory acknowledgement, thus allowing it to safely import all six Bubs Infant Formula products under the enforcement discretion.
Bubs Founder and 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 US 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.”
In response to the letter of intent, the FDA should issue a Letter of Acknowledgement, allowing the Company to sell its products there until October 2025 as long as it complies with the plan and regulations. Supply will remain unaffected during the transition.
The Bubs range already meets USA nutrient requirements, and the transition plan is applicable only to those that have received the enforcement discretion. The FDA has laid out a clear regulatory pathway and framework of requirements for Bubs to gain permanent access without interruption to supply to American families.
This year, America faced an acute infant milk formula shortage, giving companies across the world a chance to enter the market. Bubs took the opportunity and is looking to build on this relationship and seal a lucrative deal. The Company offers a range of clean, safe nutrition, including A2 protein cow milk formula, organic cow milk formula and easy-to-digest goat milk formula. These are now available in 6,500 stores in the US’s largest retailers, from Walmart, Kroger and Target to Whole Foods, Buy Buy Baby, Amazon Prime and more.
Elated by this new prospect, Bubs Executive Chair, Dennis Lin, shared, “Given Bubs Infant Formula products already satisfy all US nutrient requirements, consumers can continue to have the highest level of confidence in the safety and quality of our products while we work with the FDA to complete the regulatory requirements.”
He added that the Company’s commitment to the United States means that “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.”
The potential FDA approval is not the only regulation in the works right now. The Company is also on its path to achieving another regulatory milestone, with the new SAMR registration pathway for Bubs in China. If both of these deals go through, Bubs would be able to access the world’s top two infant formula markets: China and the USA, on its way to a full on global expansion.
Alinda is a Business Reporter for The Sentiment
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