Evivo is a food product and falls under FDA Food Regulations.  FDA does not "approve" food products in the same way drugs are approved.  Some regulations Evivo falls under include Current Good Manufacturing Practices (cGMPS) and manufactured in compliance with the requirements of the Food Safety Modernization Act.   The safety of B. infantis EVC001 (Evivo) for use as an infant food has been established through the GRAS process as specified by FDA regulations.  If your baby is preterm, immunocompromised, or has underlying health issues, please consult your physician.