Last month the FDA released long awaited guidance regarding stem cell therapy. Essentially, "Guidance" is the law of the land pertaining to drugs, medical devices and more recently, stem cells and biologic materials for patient use. Unfortunately, like many laws, if they are not enforced, then people will break them. Most of us don't want to believe that physicians, chiropractors and naturopathic doctors intentionally break or ignore the law but that is exactly was has been going on for several years now. This explains the explosion of stem cell scams and unqualified drive-thru stem cell clinics offering unproven and even dangerous stem cell therapies. One clinic in Florida blinded 3 patients dispensing an unapproved stem cell therapy. Another group of chiropractors have organized a national network not unlike a Multi-Level Marketing (MLM) scheme they call an "affiliate" program to buy amniotic tissue products in bulk, which are devoid of any living stem cells and market them as a cure all stem cell therapy through these new overnight affliliate "stem cell clinics" thoughout the nation. You've probably seen their ads all over the internet and in newspapers everywhere.
My hope is that the FDA is not making idle threats this time and is in fact going to crack down on these "BAD ACTORS" who are doing nothing short of a disservice to the entire medical community. Stay tuned for updates on the FDA's actions.
READ RECENT FDA GUIDANCE DOCUMENT: https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM585403.pdf