In an announcement of no surprise, the U.S. Food and Drug Administration (FDA) again officially warned a company it previously warned in June [2018] (due to substandard safety and infection control measures on unproven treatments for unapproved indications) whose “stem cell” products actually went on to cause considerable harm in patients. Additionally at play is the agency’s grace period for “enforcement discretion” that ostensibly encourages companies to do the right thing and seek early FDA regulator contact and involvement prior to November 2020. But, these efforts designed to spur discovery while reigning in patient harms have fallen demonstrably short. Despite these formal initiatives and even a global call to action by the worldwide scientific community (see here) to establish guidelines, this industry is ballooning and riddled with unsavory practices that have caused blindness to death.
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It is like the Wild West these days with marketing claims for relief from an exhaustive list of conditions, ranging from orthopedic injury to Alzheimer’s, pain and Parkinson’s Disease.
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Much of the “stem cell” industry makes false promises, performs invasive procedures that can cause primary and secondary harms with untested “potions” that are accompanied by higher and higher price tags for those most vulnerable. FDA warnings no longer cut it.
Read full, original post: FDA Warning Not Enough To Protect Patients From Dangerous Unproven ‘Stem Cell’ Products
