The United States Food & Drug Administration (FDA) recently adopted policies that will affect every aesthetic practitioner that employs stem cells in any manner. In a recent mandate, the FDA determined that stems cells are drugs and as such, it has claimed jurisdiction over them.
I am personally familiar with the case in which the FDA determined that stem cells are drugs. I worked as a consultant on the project. A particularly disturbing aspect of this ruling is that the stem cells that were utilized in the particular orthopedic regimen were autologous, mesenchymal cells. Some credence could be given to a notion that stem cells are drugs if the cells were donor cells from another human or animal. However, the cells in this case were always from the patient. The cells were abstracted by this medical practice and amplified in the center’s own laboratory.
There is little doubt in my mind that this mandate will be reversed in federal court (the case in court is pending). However, the fact that the FDA has taken this measure is concerning and the prudent aesthetic practitioner should take precautions.
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