Scottsdale, Ariz.-based R3 Stem Cell responded to an FDA letter that raised safety and legality concerns over R3's stem cell offerings.
What you should know:
1. The FDA warned that R3 was marketing its products for an array of unapproved procedures, including Lyme disease, kidney failure, Parkinson's disease and diabetes. The FDA also warned of potential contamination risks during administration.
2. The FDA said the stem cell products on R3's website would qualify as drugs, and, therefore, needed to FDA approved to be legally sold.
3. R3 disputed contamination concerns. R3 said FDA-regulated tissue banks manufacture and distribute its products. R3 noted that it played no part in the manufacturing, packaging or distribution of the product, eliminating any potential contamination risks from R3's perspective.
3. R3 also said it would commence a "comprehensive review of its business," and its website to ensure compliance. R3 did not address the fact that its treatments are considered illegal.
R3 CEO David Greene, MD, said, "We respect and appreciate the role of the U.S. FDA in regulating and providing guidance regarding human cells, tissues, and cellular and tissue-based products and share FDA's goal of promoting public health and safety."
ProPublica reports that Dr. Greene lost his license to practice medicine in 2009, after botched surgeries resulted in deaths and permanent injuries.