FDA Sends Florida Company Untitled Letter Regarding Unapproved Cellular Products

November 06, 2020

FDA issued an untitled letter to Florida-based Young Foundational Health Center, LLC, regarding the company’s marketing of an unapproved cellular product derived from umbilical cord blood. According to the Oct. 30 letter, the company markets the products online on social media as a treatment for several serious and life-threatening conditions. FDA noted that the products may be administered intravenously.

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.