Loading…
Infinant Health, Inc (formerly Evolve Biosystems Inc.) was cited for marketing Evivo with MCT Oil, a probiotic containing B. longum subsp. infantis EVC001 bacteria, as an unapproved new drug and unlicensed biological product in violation of the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. The company marketed the product for use in infants aged 0-36 months, including preterm infants in neonatal intensive care units, without obtaining the required FDA approval or licensure. The violations stemmed from statements on the company's website and product information sheets that made disease claims and indicated intended use in healthcare settings, which triggered drug classification and regulatory requirements the company had not met.