Else Nutrition submits infant growth study protocol to FDA

The company said, "As part of the pathway to bring its Infant formulation to market under FDA and other authorities approvals, Else concluded two successful preclinical safety studies during 2021 and 2022 on its plant-based infant formula, to demonstrate safety and nutrient bioavailability of the infant formula and its ingredients. The results demonstrated proper growth, similar to dairy-based infant formula, in a neonatal preclinical model, as well as the infant formula protein efficiency and quality. Those are the key two steps out of three, on the path to obtaining the FDA and other regulatory permits to bring the product to market. In February 2023, the Company announced that the Institutional Review Board approved the infant growth study protocol for the testing of the Else Infant Formula. As a final step before initiating the study, the Company has now submitted the infant growth study protocol to the FDA for review and is awaiting the FDA response, as well as a comparator formula availability, currently unavailable due to the continuous infant formula shortage followed by several recent product recalls in the US. In 2023, a second clinical growth study on the healthy toddler population has started as part of the company’s plans to continue research activity demonstrating the safety, tolerability, and efficacy of its product range."