FDA WARNING_LETTER - Evolutionary Biologics Inc. - January 28, 2025

The FDA issued a Warning Letter to Evolutionary Biologics on December 30, 2024, citing the sale of unapproved new drugs and unlicensed biological products: EXO RNA™, EVO JEL™, and EVO HYBRID™. The FDA reviewed the company's website, www.evolutionarybiologics.com/rx, and determined these products are intended for disease treatment or to affect body structure/function, making them drugs and biological products.

EVO JEL™ (umbilical cord-derived) and EVO HYBRID™ (umbilical cord, "placental tissue," and amniotic membrane-derived) are also Human Cells, Tissues, or Cellular or Tissue-Based Products (HCT/Ps). They fail to meet the criteria for regulation solely under section 361 of the PHS Act and 21 CFR Part 1271. Specifically, EVO JEL™ and EVO HYBRID™ are not for homologous use (e.g., treating inflammation, joint tears, or regenerating tissue is not homologous to umbilical cord/amniotic membrane function). They also fail the minimal manipulation criterion, as processing into a "flowable" form alters their original structural characteristics.

EXO RNA™ (exosome product) is also deemed an unapproved new drug and unlicensed biological product. The FDA noted a public safety notification regarding exosome products due to serious adverse events.

The company lacks approved biologics license applications (BL