FDA WARNING_LETTER - pa green wellness llc - August 17, 2020

The FDA and FTC issued a Warning Letter to PA Green Wellness, LLC (dba Predictive Laboratories, Inc.) regarding their umbilical cord-derived product, CoreCyte™. The agencies reviewed the company's websites, www.pagreenwellness.com and www.facebook.com/PAGreenWellness, in August 2020.

CoreCyte™ is promoted for sale to patients in the U.S. with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA determined CoreCyte™ is a human cell, tissue, or cellular or tissue-based product (HCT/P) but does not meet the criteria for regulation solely under section 361 of the PHS Act (21 C.F.R. Part 1271). Specifically, it fails the homologous use criterion (21 C.F.R. § 1271.10(a)(2)) as its intended use for COVID-19 is not homologous to the umbilical cord's original function. Additionally, it appears to fail the minimal manipulation criterion (21 C.F.R. § 1271.10(a)(1)).

Therefore, CoreCyte™ is regulated as an unapproved new drug under section 505 of the FD&C Act (21 U.S.C. § 355) and a misbranded drug under