FDA, FTC Send Arizona Company Warning Letter for Marketing Unapproved Cellular Products as COVID-19 Treatment
December 01, 2020
The Food and Drug Administration and Federal Trade Commission issued a warning letter to Arizona-based Vibrant Health Care, Inc. for the company’s unlawful marketing of a cellular therapy product derived from umbilical cord as a treatment for COVID-19. The company also markets the product online as a treatment for several other autoimmune diseases and conditions.
In a Nov. 18 letter
, the agencies noted that the product is a human cells, tissues, or cellular or tissue-based product (HCT/P) and should be regulated as both a drug and biological product. To lawfully market the product, a valid biologics license application or IND application must be in effect, as specified by FDA regulations. FDA and FTC advised the company to review its websites, product labels, and other labeling and promotional materials to ensure that the company is not misleadingly representing the product as safe and effective for a COVID-19-related use for which it has not been licensed, approved, or authorized by FDA. The agencies also asked Vibrant Health Care to describing the specific steps it has taken to correct these violations within 48 hours.