FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Cites Arizona Stem Cell Firm for Unapproved Products

June 7, 2019
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The FDA issued an untitled letter to Arizona-based R3 Stem Cell for marketing unapproved stem cell products with claims to treat serious illnesses such as Lyme disease, Parkinson’s, diabetes, stroke, kidney failure and ALS.

The company’s website also claimed its products can treat other conditions such as rheumatoid arthritis, spinal stenosis and nerve pain.

The agency was clearly not impressed with the disclaimer on the R3 Stem Cell website (r3stemcell.com) that says “R3 is not promising a particular outcome or making ANY claims. The FDA considers stem cell therapy experimental. Results vary.”

Acting FDA Commissioner Ned Sharpless said the agency continues 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. 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.”

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