The US has granted approval to an Israeli-based company that aims to fill the shortage of baby formulas in the country, that’s become a major cause of concern for parents.
The U.S. Food and Drug Administration issued emergency guidance enabling the import of infant formulas produced abroad. Tel Aviv-based MyOr—an Israeli health-tech company—is among companies seeking FDA approval as its Mexican subsidiary, AlphaCare, produces and markets MyOr formulas from a plant in north-central Mexico.
Founded in 2018, MyOr provides preventive health-care solutions for infants at-risk with a specific focus on food allergies and nutritional sufficiency. Company products include a digital platform for predicting food allergies and eczema from birth, as well as a non-invasive hemoglobin test using a smartphone camera.
“We have 200,000 cans of formula ready to be shipped right now, with a capacity to produce another 250,000 a month,” said MyOr co-founder and chief technology officer Michael Brandwein. Once it receives FDA approval, he said, the company will be able to ship formula to homes and distributors in a matter of days, as many back-end arrangements have already been made.
Among the formula products AlphaCare makes are specialty ones in very short supply. “These are for premature babies and for infants dealing with food allergies and sensitivities,” said Brandwein. “They are produced by fewer companies and in smaller batches.”
He said the company remains hopeful that “approval will come in the next few days,” describing the process as akin to the frantic early approval process for COVID-19 vaccines.