FDA Rules that stem cell procedures are illegal – 7/26/12


Federal Courthouse, Washington, DC

The District Court of Washington, D.C., has just ruled in favor of the United States Food and Drug Administration that the procedure of culturing stem cells from a patient’s own blood or bone marrow and injecting them back into the patient is illegal in humans (the procedure is called Regenexx®).  The cultured cells were defined as a drug under the Federal Food, Drug, and Cosmetic Act (FDCA).

CLICK HERE to read about the court decision.

What does this mean for horses?  Well, frankly, it means that stem cells are also considered a drug in horses and other animals.  To be legal the companies should be filing an new animal drug application (NADA) and going through the testing process, just like any other drug.

Testing is not likely to happen, however.  I mean, why test to see if something works if you don’t have to?  You might find out that your product doesn’t work, and then no one would buy it.

The good news – for stem cell companies anyway – is that the court ruling probably won’t be enforced on the animal side.  The FDA has limited resources, and, honestly, they just don’t seem to have the interest in regulating this stuff.  It’s one thing if humans are harmed – apparently another thing altogether if it’s “just” an animal.

Lincoln Still, it’s something to think about, isn’t it?  The current rage in treatment for a variety of conditions in the horse is:

1)  Unproven

2)  Illegal (on the human side)

3)  Expensive, and

4) Not likely to result in a better outcome for your horse.

Other than that, Mrs. Lincoln….


Print Friendly, PDF & Email
scroll to top