FDA Warns Company to Stop Selling Unapproved Stem Cell Therapies

Bloomberg Law tracks recent federal government administrative actions and warnings directed toward pharmaceutical and life sciences entities.

R3 Stem Cell LLC

• Issuing Office: Food and Drug Administration, Center for Biologics Evaluation and Research
• Recipient: David Greene (chief executive officer)
• Date: May 28 (posted May 30)
• Review of company website at https://r3stemcell.com/.

Alleged Infractions

• Marketed unapproved stem cell products as “regenerative therapies” to treat a variety of diseases including diabetes, Parkinson’s disease, stroke, kidney failure, and amyotrophic lateral sclerosis.
• Marketed drugs without demonstrating they were safe and effective for their intended uses.
• Marketed drugs that are also biological products ...