The FDA is once again taking swift and “decisive action,”1 this time against stem-cell clinics.
And on Monday, the FDA issued a “warning letter to US Stem Cell Clinic’s chief scientific officer, Kristin Comella, for marketing stem-cell products without the agency’s approval,”2 and gave them 15 days to explain how they planned to fix what they called “significant deviations” in their manufacturing practices, which, according to the FDA, puts their products at risk of contamination and patients at risk of infection. They also said that the US Stem Cell Clinic tried to impede their investigation, which is a violation of federal law.
While they were initially targeting just the three stem-cell treatment centers, FDA commissioner Dr. Scott Gottleib has announced plans to step up investigations on all of the country’s nearly 600 stem-cell clinics. He claims they are doing it to protect us from the treatments they offer which have not been shown to be safe or effective. (Do you believe that?)
“Gottlieb said he has directed his agency to ‘vigorously investigate these kinds of unscrupulous clinics.’ The FDA’s actions ‘should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk.'” 3
For the most part, these companies had flown under the radar but the bigger they got, the bolder they got, both in the claims they made and their manipulation of stem cells (cells that haven’t yet taken a specialized function). There is a lot of buzz surrounding their potential healing power and they have become a staple at regenerative medicine treatment clinics. However, since most trials are experimental, make any claims about their healing power and the FDA will be after you.
The FDA also plans to investigate how StemImmune Inc. was able to obtain the smallpox vaccine as it is normally only available for people who are at risk of exposure to smallpox, like military personnel and health care workers.