FDA WARNING_LETTER - Infinant Health, Inc formerly Evolve Biosystems Inc. - September 28, 2023

The FDA issued a Warning Letter to Infinant Health, Inc. on September 28, 2023, following a review of their website (www.evivo.com) and marketing materials for "Evivo with MCT Oil." The product, marketed as a probiotic containing *B. longum subsp. infantis EVC001* for infants aged 0-36 months, is deemed an unapproved new drug and unlicensed biological product, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act).

The FDA determined the product is an unapproved new drug and unlicensed biological product because its marketing claims, including statements about use in healthcare settings and NICUs, indicate intent for mitigation, treatment, or prevention of disease. A valid biologics license application (BLA) or an investigational new drug (IND) application is required, neither of which is in effect for Evivo with MCT Oil.

Furthermore, the product is considered an adulterated food under the FD&C Act because, when intended for consumption by preterm infants, *B. longum subsp. infantis EVC001* is an unsafe food additive. The FDA found no food additive regulation authorizing its use and no basis for it to be Generally Recognized As Safe (GRAS) for preterm infants, citing serious safety concerns due to their physiological immaturity and risk of opportunistic infections.

Infinant Health