Infant-formula manufacturer Bubs Australia has confirmed it has applied to the US regulator for approval to supply products to the country on a permanent basis.
The company has lodged a letter of intent with the US Food and Drug Administration (FDA) and covers all six Bubs infant-formula products.
The US has suffered a shortage of formula for most of the year after a contamination scare at an Abbott Laboratories plant in Michigan. Foreign infant-formula providers, including Bubs Australia, have been given special dispensation by the Biden Administration to ship products into the market to help deal with the shortfall but that access is due to end next month.
Bubs Australia indicated in August it wanted to supply the US beyond the November cut-off date and said its talks with the regulator have been positive. It believes its ability to act quickly when the FDA sent out its distress call to international infant-formula companies has stood it in good stead.
The Biden administration had to invoke emergency legislation to open up the market to foreign providers when supermarket shelves started to empty of baby formula. It has made it clear the market needs to be opened up to more providers to prevent any future shortages. An internal review pointed to regulatory failings in dealing with the crisis.
On Friday, the FDA published guidance to help provide a pathway for infant-formula manufacturers operating under “enforcement discretion” in the US to remain in the market.
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It called on foreign manufacturers marketing their products in the country under the emergency rules to send a letter by 5 December, outlining their intent to pursue completion of all regulatory requirements.
Confirming it had already done so, Bubs Australia founder and CEO Kristy Carr said today (3 October): “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.
“Given the overwhelming positive response that we have received from American parents, caregivers, healthcare professionals and retailers, we are pleased to be able to commit that Bubs Australia will remain in the United States for the long term.”
Bubs Australia’s infant-formula products are stocked in 6,500 stores across 42 US states, including in branches of Walmart, Kroger and Target. As of the end of August, it had shipped 800,000 tins of formula to the US.
The company said its products will continue to be exported to the US throughout the “transition period” during which it is waiting for FDA approval.