Care A2+ receives FDA approval to supply infant formula to the US

Nutrition and wellness company Care A2+ has received US Food & Drug Administration (FDA) approval to provide up to 4.8 million tins of its Australian-made premium infant formula to help offset the ongoing shortage in the country.

The first shipment of 250,000 tins is due to depart Australia during the first week of August after the Sydney-based company was granted a ‘no objection’ approval by the FDA, which certified its formula met the required US standard.  

The Care A2+ premium infant formula, which contains iron and added lactoferrin, will be sold across 20,000 retail locations across the nation, including at CVS & Rite Aid Drug Stores, Whole Foods Market, Kroger, HCA Healthcare, Publix Super Markets, Safeway, The Vitamin Shoppe, Duane Reade Convenience Store and Peapod Online Grocer.

“Care A2+ understands the struggles US parents and caregivers are facing with the formula shortage and is dedicated to providing health and nourishment for children, and peace of mind for parents,” Care A2+ director Kerry Hyland said.

“Ours is a gentle, safe and premium formula that we are excited to commence exporting to the US.”

Founded by Dominic Galati in 2018, the business uses single-source ingredients with Australian A2 cow’s milk, which is 100 per cent traceable from grass to tin.

Every tin has a unique QR code which provides transparency on the farm location, weather conditions, information about the A2 herd, formula batch production, and nutritional composition.

The brand is currently pursuing a listing on the Australian Stock Exchange (ASX), with Care A2+ products already available in major retailer outlets Woolworths (ASX: WOW), Terry White Chemart and Chemist Warehouse.

Hyland said the company was proud to be playing a part in addressing the American formula shortage.

“Today’s announcement is not just important for US parents, it’s a significant milestone for our company. Our Australian farmers and manufacturers are delighted to be providing a premium product to support millions of American families,” she added.

In May, the FDA was given six months of enforcement discretion to export additional infant formula into the US to help alleviate a product shortage in the North American market.

The FDA has recently committed to fast-tracking companies who have supported the US to date, such as Bubs (ASX: BUB), in their quest to be allowed to provide infant milk to the US market permanently.

Last week President Biden announced that the US Department of Health and Human Services (HHS) would facilitate two additional flights to transport 180,000 cans of Bubs’ infant formula as part of Operation Fly Formula.