FDA approval?

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The F.D.A.  granted stem-cell businesses a three-year grace period in 2017. Hence, the F.D.A. has mostly ignored them and waited for businesses to comply with the rules voluntarily. This grace period will finish November 2020.

So far, the F.D.A. has sent warning letters. Thus, these enforcement actions do not appear to have the power of injunction or other legal obligations.   

In fact, Dr. Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics, said the legal ruling was “meaningful.” He was also quoted saying the following: “It’s not going to automatically make hundreds and hundreds of businesses disappear. Some will decide they’re not up for a fight with the F.D.A.”  Moreover, there are other techniques that use bone marrow and other techniques that would not be considered a drug.

Indeed, Dr. Turner suggested there are 716 stem-cell clinics in the United States, an amount that he considers a substantial undercount. The actual number is probably more than 1,000, he estimated, and slightly more than half are selling fat-derived injections, like the ones given by U.S. Stem Cell.

The next best alternative of stem cells was bone marrow, which also does not have F.D.A. approval except for when it’s used to treat cancer or certain genetic diseases.

Furthermore, Dr. Turner believes clinics might shift from using fat to bone marrow or other substances. Finally, medical practitioners can use umbilical-cord blood, the cord itself, or extracts from the amniotic membranes or placenta to retrieve stem cells. Such treatments are also not F.D.A. approved (though cord blood is approved to treat leukemia).

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