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Bubs eyes long-term place on US market as FDA signals rule change

Bubs Australia CEO Kristy Carr. (Source: Bubs / Chris Hopkins)

Infant formula maker Bubs looks set to benefit from a significant policy change in the US which could pave the way for open access to one of the world’s largest markets. 

Fresh from announcing the partial completion of a $63 million capital raising program yesterday, Bubs founder and CEO Kristy Carr has revealed the US Food and Drug Administration (FDA) will develop a new framework to allow companies that stepped up to help resolve the US’ infant formula shortage this year with a path towards long-term supply. 

The temporary approval of manufacturers from Australia, New Zealand and other countries was granted to ensure parents could source infant formula from US retailers after a major supply shortfall caused by a supply-chain crisis and a massive recall of locally made formula. That approval lapses in November. 

According to a statement by Bubs, the FDA will issue further guidance in September on how companies that received temporary approval could meet FDA requirements to continue exporting beyond November. 

Carr said the news was welcome and Bubs would definitely pursue the opportunity. 

“Bubs was one of the first international manufacturers to apply to the FDA to import infant formula under the initial policy. Our long-standing commitment to the US market ensured our ability to provide rapid response … and satisfy the very stringent quality and safety nutrition requirements of the FDA, having first launched our toddler products in the US in 2021 with our retail partners.”

Bubs has confirmed its fifth air-frighted shipment of US-bound formula will leave Australia this coming Sunday and a sixth on July 21, comprising around 180,000 tins of formula. 

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