We started the regulatory process to achieve compliance for the infant formula (0-12 months) in the United States and Europe.
The FDA requires submission of new infant formula notification for every new infant formula to be marketed in the U.S. This notification included data on composition (that should be according to the nutritional composition in 21 CFR 107), stability, protein efficiency study and a clinical safety study.
Since the ingredients of the Company's products are innovative and new to this industry, this process starts with the evaluation of the regulatory status of its ingredients and the gaps for approving them for infant consumption.
The full process usually takes 24-36 months.