New York Company Receives Untitled Letter for Marketing Unapproved HCT/Ps

November 17, 2021

The Food and Drug Administration recently sent an untitled letter to the owner of NYC Regenerative Medicine, Inc., a New York company operating as Colts Neck Stem Cells and Regenerative Medicine, regarding 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.

According to FDA, the company markets products that appear to be derived from human umbilical cord and umbilical cord blood as “stem cell therapy” to treat kidney disease and other conditions. Colts Neck Stem Cells also advertises exosomes for the treatment of chronic, non-healing wounds and alopecia.

Based on a review of the company’s advertisements, 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. The letter also reiterated that exosome products intended to treat diseases or conditions in humans are subject to the same regulations.

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