FDA Sends Nevada Company Untitled Letter Regarding Unapproved Cellular Products

November 20, 2020

FDA issued an untitled letter to Nevada-based Regenerative Cell Institute LLC regarding the company’s marketing of cellular therapy products derived from umbilical cord and adipose tissue. According to the Nov. 10 letter, the company markets these products online as treatments for several serious and life-threatening conditions. FDA noted that the products may be administered intravenously, intrathecally or by inhalation.

The agency believes that the products appear to be human cells, tissues, or cellular or tissue-based products (HCT/Ps) and should be regulated as both drugs and biological products. To lawfully market these products, a valid biologics license application or IND application must be in effect, as specified by FDA regulations. The agency directed the company to FDA’s comprehensive regenerative medicine policy framework for HCT/Ps and requested a written response from the company within 30 days of receipt of the letter.