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Thursday, April 08, 2021 1:12:04 AM
As for whether USRM violated the law, that would depend on whether one's own stem cells are in fact a drug.
Unfortunately, it depends on the FDA's interpretation. Not what the public or medical professionals like myself think. We know stem cells are not a drug. We know that SVF does not manipulate stem cells in such a way that the end product becomes a drug. But until the court forces the FDA to change their interpretation private stem cell businesses like USRM will be seen as operating outside federal law. That is a fact.
The court does not need to regulate the stem cell industry. The FDA needs to stay in their lane which is to regulate food, drugs, medical devices, and consumer products. Not surgical procedures involving tissue transplants. The court should look to local medical boards and state legislators to establish treatment guidelines. The sooner they recognize this the better.
Have a nice evening.
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