I repeat...FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. This list is banishing folks from “drug” applications. Last I checked my own cells reintroduced to my own body is not a drug. It is great that there is a list like this helping protect people from unsafe harmful DRUGS...Nice work FDA!!! Please Educate me on any procedures that were harmful in the 10,000 plus performed other than the golden girls! Safety first here folks is impeccable!
Furthermore, This adipose tissue isolation is widely used worldwide and becoming more well known that attempting to single out a pioneering Female in this space would open up a can of worms for the FDA. Rosa parks had to go to the front of the bus and IMO Kristen is going to go down in American History for human rights to their own cells. Don’t underestimate the FDA? I would argue don’t estimate KC and your rights to your own body and its cells.
To play devils advocate, if there was all this compelling evidence of these treatments being harmful I too would want them regulated, but I don’t see any evidence of rejection or harm other than the 4 Golden Girls which was experimental and not performed a note. It makes me think that those who want this regulated have hidden agendas other than safety of patients. those who argue this shouldn’t be allowed I urge you to reach out to folks who have had their lives changed by this. Tarek El Moussa the most recent we’ll known case. He was on large amounts of opioid pain management and is now 80% better after one adipose SVF treatment. Ask yourself this... should the FDA decide that He doesn’t deserve to be drug free and out of pain? Or should he be required to travel out of the country to get help? Very selfish IMO of anyone who thinks this way.
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