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FDA's Outrageous New Claim: Your Body Is a Drug -- and They Can Regulate It

Dr. Mercola

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Feb. 25, 2012

Adult stem cells (as opposed to embryonic stem cells, which are at the heart of the stem cell controversy) are a truly exciting part of the future of medicine, with seemingly limitless potential for anti-aging, arthritis and far more...

But the U.S. Food and Drug Administration (FDA) is attempting to regulate stem cell procedures at a Colorado clinic, stating that stem cells are drugs that fall under FDA jurisdiction.

Outrageously, the FDA is making this claim even though the stem cells being used in the procedure come from the patient's own body, which means they are essentially claiming that they can regulate a part of your body.

What Makes Stem Cell Treatments so Exciting?

What makes stem cells so special is their potential to develop into many different cell types.

When a stem cell divides, it either becomes another type of cell, such as a muscle cell or cartilage, or it remains a stem cell.

Furthermore, these cells act as an internal repair system in many types of tissues, dividing a seemingly indefinite number of times to replenish other cells.

As you age, your stem cells diminish in quality and quantity, so just when you require strong stem cells the most, you're becoming increasingly deficient. Hence your organs and tissues eventually wear out and need to be restored or replaced.

The procedure in question by the FDA is known as Regenexx-C™. It involves taking a sample of your blood and bone marrow, and using a centrifuge machine to separate out the stem cells. The cells are then cultured to create more cells before they are injected back into your body to help with tissue repair. It is the fact that the cells are cultured that the FDA has attacked, saying this makes them "unregulated drugs."

As a result the clinic now only offers the procedure outside of the United States, whereas within U.S. borders they use a similar procedure that is done in one day and does not involve culturing. This, reportedly, is less effective because fewer stem cells are delivered to the injury site. As for the promise of stem cell treatments in treating osteoarthritis pain, the positive results appear to be significant, including:

  • Increases in cartilage volume in joints
  • Up to 75 percent pain reduction in osteoarthritis
  • Avoidance of surgery among patients previously told they would require total knee replacement surgery

Can the FDA Regulate Your Own Stem Cells?

While it would seem impossible for the FDA to claim authority over cells that come from your own body, the FDA has used the culturing process to gain a foothold in their attempts to label stem cells as unregulated drugs. In what the Alliance for Natural Health has called an "outrageous power-grab," the FDA has claimed that the stem cells used for the Regenexx-C™ procedure are subject to their regulation because they are cultured to increase their numbers.

Furthermore, they also claim the clinic is engaging in interstate commerce because some of the components for the procedure are shipped in from out of state. This, the FDA claims, also makes it subject to FDA approval (the FDA has used a similar interstate commerce strategy to crack down on raw milk). According to the FDA:i

"FDA cautions consumers to make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA. FDA has approved only one stem cell product, Hemacord, a cord blood-derived product manufactured by the New York Blood Center and used for specified indications in patients with disorders affecting the body's blood-forming system."

Stem cell treatments likely represent one of the exciting promises for the future of medicine. If stems cells can be directed to turn into specific cell types, they could offer an ongoing source of replacement cells and tissues, and be used to treat diseases above and beyond arthritis and joint pain, including spinal cord injuries, Alzheimer's disease, diabetes and stroke, just to name several.

There's little risk of rejection when using your own adult stem cells and side effects appear to be minimal. The largest safety concern is the possibility that the cells could migrate from their injection site and possibly change into inappropriate cell types or grow excessively, leading to tumors. As stem cell treatment is still being developed, this concern needs to be researched further. Whether the FDA should be able to weigh in on the matter is another issue entirely, as again adult stem cells from your own body are your own property. As Alliance for Natural Health reported, it seems once again the FDA is seeking to regulate a product more for its own financial gain, and to protect the drug industry, than for public health. In court documents it's stated:

"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.'"

Is the FDA Really Looking Out for Your Health?

The FDA has a sordid history of attacking natural products and procedures that threaten to interfere with big business, including pharmaceuticals, agriculture and more, while allowing obviously harmful products to remain on the market. Here are but a few examples:

  • In December 2011, the FDA reneged on its plan to withdrawal approval of penicillin and tetracycline antibiotics intended for use in food-producing animal feed – a measure it had been planning since 1977.
  • In September 2011, the FDA issued a proposed draft policy on dietary supplements that could effectively kill your right to purchase nearly all of your favorite natural vitamins and supplements; the proposed policy treats vitamins and other supplements as if they are drugs but many manufacturers will not be able to afford the FDA drug trial process. This could either force supplement companies out of business or make supplements so expensive you won't be able to afford them.
  • The FDA has been fighting a war against raw milk, which is really an unconstitutional assault on one of your most basic rights, i.e. your right to choose what you want to eat and drink; they have stated that Americans have "no absolute right to consume or feed children any particular food."
  • The FDA has long been the world's number one supporter of mercury fillings (amalgams), despite the evidence showing the health hazards of mercury; after making repeated promises to make an announcement about dental amalgam by the end of 2011, they let the deadline pass by unmet.
  • The FDA sent a warning letter to Diamond Food for making truthful, scientifically backed health claims about the health benefits of omega-3 fats in walnuts. Because the research cited health claims that omega-3 fats in walnuts may prevent or protect against disease, the FDA said walnuts would be considered "new drugs" and as such would require a new drug application to become FDA-approved.

Knowledge truly is power, so the more you know about the real motives behind the FDA approval process, the better you'll be able to make informed health care decisions, especially if you're looking for alternatives to drugs and surgery. The FDA has gone after vitamin C. They've gone after raw milk, supplements, cherries and walnuts. And now they're going after your own cells in an effort to protect drug industry profits...

Stay tuned for more on this topic as the events unfold. The reality is that as people become more educated stem cell therapy and other forms of regenerative medicine are only going to continue to grow.