The Food and Drug Administration (FDA) has sent an untitled letter to R3 Stem Cell, LLC of Scottsdale, Arizona for marketing unapproved stem cell products to treat a variety of diseases and conditions. The FDA has not approved the products offered by R3 Stem Cell, LLC and its affiliated centers or clinics throughout the United States.
The untitled letter describes how the Company falsely promotes stem cell therapies for numerous diseases or conditions, such as dementia and Parkinson disease, and directs patients with ALS, diabetes, kidney failure, Lyme disease, Parkinson disease and stroke to certain “R3 Stem Cell Centers of Excellence” for stem cell treatment. In addition, the Company’s website lists a variety of conditions treated at R3 Stem Cell Clinics, including rheumatoid arthritis, spinal stenosis, and trigeminal neuralgia.
“We continue to see companies and individuals use questionable marketing campaigns to take advantage of vulnerable patients and their families with unproven claims about their unapproved stem cell products, said FDA Acting Commissioner Ned Sharpless, 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.”
According to the FDA, the products offered by the Company would need to be regulated as drugs and biological products under the Federal Food Drug and Cosmetic Act and the Public Health Service Act. In order to lawfully market a drug that is also a biological product, the Company must demonstrate the product’s safety, purity, and potency for their intended uses.
“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,” added Sharpless.
Adverse events related to R3 Stem Cell, LLC products should be reported to the FDA’s MedWatch Adverse Event Reporting program.
For more information visit FDA.gov.