FDA: Your Stem Cells are a ‘Drug’ & We Can Regulate Their Use

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:

  1. 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!)
  2. 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.”

We discussed the very ambiguous issue of interstate commerce last September—it’s an argument the FDA frequently uses when the basis for their claim is otherwise lacking. As we noted then, the FDA holds that an “interstate commerce” test must be applied to all steps in a product’s manufacture, packaging, and distribution. This means that if any ingredient or tool used in the procedure in question was purchased out of state, the FDA would in its view have jurisdiction, just as they would if the final product had traveled across state lines.

This time the FDA just nakedly says in court documents that the agency wants to protect the market for FDA-approved drugs. No more beating around the bush—their agenda is right out in the open! This appears to be a novel interpretation of the Food Drug and Cosmetic Act (FD&C), as evidenced by the government’s failure to cite any judicial precedent for their argument.

The implication of the FDA’s interpretation of the law, if upheld by the court, would mean that all food, drugs, devices, and biologic or cosmetic products would be subject to FDA jurisdiction. The FDA is expanding its reach even to commerce within the state, which we argue is far beyond its jurisdiction, in order to protect drug company profits…

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2 Comments

  1. Greg Miller

    February 1, 2012 at 6:29 pm

    It appears these people have way too much free time. They are probably worried that stem cells will cure something and hurt the pocketbooks of their buddies at the pharmaceutical companies who want to “manage” disease, not cure it! 57,000 drugs on the market and not one that cures a disease! They call my treatments quackery even though more than 2000 people have survived emphysema and COPD as a result!

  2. Doug Atkins

    July 21, 2012 at 1:58 pm

    Thanks Greg. To those who think that our current bio-medical industry (to include Doctors & Scientists) is somehow conspiring to keep more effective treatments from We The People, I’ll just argue that conspiracy has nothing to do with it. It’s all right out in the open. For anyone who thoughtfully reads an occasional quality newspaper, the idea (actually fact) that our health care system is SUBSERVIENT to the economic corporate model is no surprise at all. Today’s defender of the medical status quo will simply argue that healthcare is a privilege and not a right. Fine! Then expect more drug developments which only treat rather than cure symptoms all the while causing other side effects which need even more drugs… to treat and not cure! What a boon to the Pharmaceutical Industry. They make their money patenting synthetics rather than looking to plant life or other natural sources as more effective treatments because it’s not lucrative to work with that which already exists outside of the laboratory. That is not a conspiracy. That’s just the way it is and our bio-medical industries have grown up with that model. The culture of making profits for those bigger than us permeates that model and is self perpetuating. See? No conspiracy. It’s just a culture. No smoking gun or secret documents either. In a sense it is all hiding in plain site and just needs a fresh set of eyes to interpret in a manner that does not rely on accepted methods of defending the powers that be.

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