Since Evivo is a food, and food products do not receive FDA “approval” in the same way drugs do, our response is intended to provide information about the FDA food regulations under which Evivo falls. Those requirements are many, but include manufacturing Evivo under strict current Good Manufacturing Processes (cGMP) as defined by the FDA and ensuring that all ingredients are safe for their intended use. For B. infantis EVC001 (Evivo) as a food ingredient, safety for use in 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 disorders, please consult your physician.