In another outrageous power-grab, FDA says your own stem cells are drugs—and stem cell therapy is interstate commerce because it affects the bottom line of FDA-approved drugs in other states!
We wish this were a joke, but it’s the US Food and Drug Administration’s latest claim in its battle with a Colorado clinic over its Regenexx-SD™ procedure, a non-surgical treatment for people suffering from moderate to severe joint or bone pain using adult stem cells.
The FDA asserts in a court document that it has the right to regulate the Centeno-Schultz Clinic for two reasons:
- Stem cells are drugs and therefore fall within their jurisdiction. (The clinic argues that stem cell therapy is the practice of medicine and is therefore not within the FDA’s jurisdiction!)
- The clinic is engaging in interstate commerce and is therefore subject to FDA regulation because any part of the machine or procedure that originates outside Colorado becomes interstate commerce once it enters the state. Moreover, interstate commerce is substantially affected because individuals traveling to Colorado to have the Regenexx procedure would “depress the market for out-of-state drugs that are approved by FDA.”
The world’s first “test-tube” meat, a hamburger made from a cow’s stem cells, will be produced this fall, Dutch scientist Mark Post told a major science conference on Sunday.
Post’s aim is to invent an efficient way to produce skeletal muscle tissue in a laboratory that exactly mimics meat, and eventually replace the entire meat-animal industry.
The ingredients for his first burger are “still in a laboratory phase,” he said, but by fall “we have committed ourselves to make a couple of thousand of small tissues, and then assemble them into a hamburger.”