> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA ‘Outmatched, Overwhelmed’ by Stem Cell Industry: Professor
- URL: https://www.fdaweb.com/fda-outmatched-overwhelmed-by-stem-cell-industry-professor/
- Published: 2021-09-30T12:00:00.000Z
- Updated: 2026-09-14T17:16:50.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150256

While FDA has invested some resources in trying to regulate private clinics marketing stem cell products, “they’re just outmatched and overwhelmed,” according to University of California Irvine bioethicist **Leigh Turner**. Speaking to the Associated Press, Turner [said](https://www.argus-press.com/news/national/article%5Fc195e2f6-85e9-5d15-ab78-e6ce3b82cd03.html?ref=fdaweb.com) the 2017 decision to give stem cell clinics three years to demonstrate their treatments were safe and effective “backfired. The scale of the problem is vastly larger for FDA today than it was at the start.”

AP says the continuing spread of such clinics promoting regenerative therapies “illustrates how quickly experimental medicine can outpace government oversight. No clinic has yet won FDA approval for any stem cell offering and regulators now confront an enormous, uncooperative industry that contends it shouldn’t be subject to regulation.”

There are no government figures on how many clinics operate in the U.S., the article says, but Turner says he counted more than 1,200 in 2019, up from the 570 he identified in 2016.

“FDA has repeatedly warned Americans to steer clear of unapproved and unproven stem cell therapies,” AP says, “which have occasionally caused blindness, bacterial infections, and tumors. During FDA’s three-plus years of ‘enforcement discretion’ (six months were added to the three years due to Covid), the agency sent formal Warning Letters to more than a dozen businesses performing the riskiest procedures. Regulators also prevailed in a Florida court case to shut down a major clinic offering unproven treatments. Another case against a similar prominent company is pending in California.”

The story says many stem cell doctors say their in-office procedures are outside the agency’s purview. FDA has said that processing stem cells and giving them to patients with serious diseases amounts to creating a new drug for which approval is required.

FDA hasn’t indicated how many clinics have sought approval during the enforcement discretion period after 2017\. The article quotes CBER’s **Wilson Bryan** as being “very disappointed in the number of clinics that have come in.” He said he is “extremely concerned” by how many stem cell and related offerings remain available.

The article says lawyers who represent clinics say they have no choice but to resist agency regulation. “FDA is pushing them into this drug development pathway, which nobody is adopting because it requires a million dollars worth of toxicology and animal studies just to show something is safe for human use,” said former FDA attorney **Marc Scheineson**.