California Company Receives Untitled Letter from FDA for Marketing Unapproved HCT/Ps

July 27, 2021

The Food and Drug Administration recently issued an untitled letter to the director of the Regen Centers, a California company, regarding concerns about the marketing of unlicensed cellular products for which the company does not have an FDA-approved biologics license application (BLA) or investigational new drug (IND) application. 

The Regen Centers markets cellular products derived from human umbilical cord blood, umbilical cord tissue, amniotic membrane or adipose tissue, which the company calls “regenerative medicine therapy,” to treat various diseases or conditions. The company also lists exosome products as “being used in conjunction with regenerative medicine therapy” to treat numerous serious diseases and conditions. 

Based on a review of the company’s website, FDA stated that the company’s cellular products appear to be human cells, tissues, or cellular or tissue-based products (HCT/Ps) that should be regulated as both drugs and biological products. To lawfully administer and market these products, a firm must have a valid BLA, which is issued only after the company demonstrates the product is safe, pure and potent for the intended treatment of patients. While the investigational product is under development, the firm must have an FDA-approved IND, as specified by FDA regulations. FDA noted that exosome products are subject to premarket review and approval requirements.

The agency directed the company to its comprehensive regenerative medicine policy framework for HCT/Ps and requested a written response from the company within 30 days of receipt of the letter.