US company put on notice for marketing unapproved stem cell products

The company, R3 Stem Cell, LLC in the US state of Arizona, offers unapproved stem cell products to treat a variety of diseases and conditions, such as Lyme disease, diabetes, Parkinson’s disease, stroke, kidney failure and amyotrophic lateral sclerosis (ALS) through its affiliated centres or clinics. The products offered by R3 Stem Cell, LLC are not approved by the US Food and Drug Administration and therefore it has sent an untitled letter to R3 Stem Cell, LLC and its chief executive officer, David Greene, MD. 

“The reality is that at this time, there isn’t enough evidence to support the use of stem cells for purposes other than reconstitution of blood formation and the immune system,” said FDA Acting Commissioner Ned Sharpless, MD. “We’ve made it clear to the industry and the public that while we are taking a risk-based approach to regulatory actions, the FDA will continue to protect patients from the most egregious actors in this field. We will prioritise appropriate regulatory actions against those who place people’s health at risk by promoting unapproved products.”

In its review of the R3 Stem Cell, LLC website, the FDA found that the company promotes stem cell therapies for numerous diseases or conditions to certain ‘R3 Stem Cell Centers of Excellence’ for stem cell treatment. 

It appears that the products offered by the company would be regulated as drugs and biological products under the Federal Food Drug and Cosmetic Act and the Public Health Service Act. Prior to marketing, such products require a demonstration that the products are safe and effective for their intended uses.

Manufacturers who fail to comply with FDA requirements may be subject to enforcement action, such as seizure, injunction, or prosecution.

“We encourage firms to engage with the FDA about regulatory oversight of this field and work with the agency for appropriate development, including designing clinical trials, to explore the safety and potential benefits of these products,” added Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “We intend to step up our oversight of those sponsors who have not engaged the regulatory process in the proper development of their stem cell products that are regulated as drugs, devices, and/or biological products under the statutes and existing regulations, and whose products create more significant potential risks because of the way that they’re manipulated or delivered.”