FDA WARNING_LETTER - Vibrant Health Care, Inc. - November 18, 2020

The FDA and FTC issued a Warning Letter to Vibrant Health Care, Inc. on November 18, 2020, following a review of their website and social media in November 2020. The company was found to be offering an umbilical cord-derived cellular product in the U.S. to mitigate, prevent, treat, diagnose, or cure COVID-19.

The product is classified as a human cell, tissue, or cellular or tissue-based product (HCT/P) under 21 C.F.R. § 1271.3(d). However, it fails to meet the criteria for regulation solely under section 361 of the PHS Act (42 U.S.C. § 264) and 21 C.F.R. Part 1271, specifically the homologous use criterion in 21 C.F.R. § 1271.10(a)(2). Consequently, the product is deemed an unapproved new drug under section 505 of the FD&C Act (21 U.S.C. § 355) and a misbranded drug under section 502 (21 U.S.C. § 352). It is also an unlicensed biological product under section 351 of the PHS Act (42 U.S.C.