FDA’s New Claim: “Your Body Is a Drug—and We Have the Authority to Regulate It!”

January 31, 2012
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stem cellIn 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-C™ 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 Medical 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.

Last year we ran a two-part series on the current status of federal and state law—and FDA jurisdiction—and how it affects integrative treatments (part one and part two).

The Centeno-Schultz Medical Clinic takes your blood and bone marrow, puts it into a centrifuge machine that separates the stem cells, and cultures it to get more cells before a doctor puts them back in your body to repair damaged tissue. The FDA states that when the stem cells are cultured, they become FDA-regulated drugs. The clinic has argued numerous times that stem cells aren’t drugs because they are components of the patient’s bone marrow from his or her own body.

The FDA says otherwise: “Stem cells, like other medical products that are intended to treat, cure, or prevent disease, generally require FDA approval before they can be marketed. At this time, there are no licensed stem cell treatments.” There they go again, saying that components of your body are drugs and they have the authority to regulate them! It’s the only way the agency can claim that adult stem cell therapy is within FDA’s purview.

However, the agency seems to be of two minds. When ESPN magazine was doing a story on stem cell treatments, the FDA stated that US policy is to allow the injection of stem cells that are treated with “minimal manipulation,” which federal regulations define as “processing that does not alter the relevant biological characteristics of cells or tissues”—which is certainly the case with the Regenexx same-day procedure.

Despite this policy, FDA has been attacking the clinic for the past four years. They have tried injunctions and demanded inspections in their attempts to make the company bend; this court battle is merely the latest salvo.

The primary role of adult stem cells in a living organism is to maintain and repair the tissue in which they are found. The hard part has been to get enough of them. But new technology is giving doctors the ability to obtain more stem cells from a patient than previously thought possible, which is why we’re now seeing new treatments. Blood, fat, or tissue is withdrawn from the patient, stem cells are obtained using one of these new processes, and the cells are injected back into the patient where they can repair the patient’s tissue.

Gov. Rick Perry received this kind of stem cell therapy. We and others noted that the governor’s defense of freedom of healthcare choice when it came to his own treatment was starkly at odds with his directive to administer HPV vaccines to young girls against their own (and their parents’) wishes. It’s also at odds with his support for some of the most egregious witch-hunters on the Texas State Medical Board, which he appoints.

Behind Perry’s blatant inconsistency and the latest FDA attempted power grab lies the same problem: a medical system run by special interests under the leadership of the US government, the same government that is supposed to represent “we the people.”

Editors’ Note: An earlier version of this article reported that when blood and bone marrow were put into a centrifuge to separate the stem cells, the FDA considered the stem cells to be a drug and claimed authority to regulate them. The article has been updated to reflect that FDA only claims authority to regulate as drugs those stem cells which are cultured before being re-injected into the body.

138 Responses to “FDA’s New Claim: “Your Body Is a Drug—and We Have the Authority to Regulate It!””

  1. As long as God made man he/she are not a drug.
    Drugs are man made and that is the reason FDA was formed to control these men and companys that sell their man made drugs which is used in the human body.
    So I say do their job and leave God to what he started, is doing, and will do for them the rest of their lives

       0 likes

  2. Walter Gillmore says:

    FDA, bureaucracy running wild.

    As a 20+ year, 100% disabled American Veteran I regard this as just another reason why I am happy that I did not stay in the USA when I retired more than 30 years ago. With the clear evidence of the corruption extant in the FDA, shown in the story of the stem-cell stupidity they have exhibited, to even suggest that USDA should be put under their supervision reaches the ultimate height of government stupidity.

    Over the past many years, I have yet to see any decision from this agency that does any service to the public, for whose protection they supposedly exist. It would appear that the FDA spends all of its time in trying to gain extra political power by catering to the 1%, rather than protecting the 99%, which was surely what it was originally created to do.

    It is way past time that the upper echelons are rooted out, and forced to explain how their piratical behavior fulfills their mandate. This entrenched corruption and total disregard for the public should be anathema to all with eyes to see! The whole stinking mess needs a Hercules to sweep the ordure from their offices. But then of course, that is just about true of the whole stinking mess that is Washington after 8 years of the Shrub and another three years of a politician who claims to be a Democrat, but has nothing but Ultra Right advisors and aides.

    I am expecting that one day the bottom 10% will finally leave their TVs, and get up enough guts to do something about the top 9%. The 9% who are so happy with their lot as purveyors to the decadent and greedy 1%; who are so busy with their American Empire; that is so rapidly going the way of the Roman Empire as it sinks into decadence and sloth.

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  3. Peter Sherinian says:

    I have read this before. I found it unbelievable then I’m still finding it unbelievable now. is clear that’s a new laws need to be inacted which takes control out of the hands of the fda in into our own hands. yes it’s true our body is 1 giant chemical manufacturing facility if you wanna look at it that way. The pituitary gland comes to mind, but that should not mean that the fda has a right to control it, nor consider it a drug manufacturing facility along with anyting else in my body. This will not stand, it is outrageous, and it is not right, and the people running the fda are out of their minds.

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  4. Pearl Swan Youth says:

    Since FDA won’t recognize herbal plants flowers or fruits or vegetable or meats of all kinds or food as medicine and therefore has no business to recognzie anything living to be medicine except their stupid manmade nonliving chemicals that are not same as alive stem cell.

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  5. When will greed stop motivating the people elected to protect the citizens of this great and abundant country?- there is enough for all.

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  6. Deborah says:

    My only comment is: Why aren’t we given the opportunity to send information about this to our Senators and House members like we did for the previous article?

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  7. debrarae says:

    FDA = Liberals unconstitutionally over reaching as usual!

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  8. Khail says:

    So if you were in the desert and put your own urine in a solar still to produce water to treat your dehydration, would that water be considered a drug?

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  9. Kathy says:

    Sorry FDA. MY stem cells are a part of MY body, in which I reside. No government agency will ever live in MY body.
    The logic behind this whole idea is just moronic!! Where on earth do they come up with these ideas??

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  10. Arvina Copeland says:

    “depress the market for out- of- state drugs that are approved by FDA” That is strange. I did not realize that the FDA was a marketing representative for drug companies. Wonder which companies?

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  11. Jerry Burge says:

    It is really time for the citizens of this country to take some time to limit the control and operation of govenrment agencies such as the FDA . To save their one postions, power and profit they continue to support those thst hhave no desire to help our health other than to makk as $$$$$$$$$ AS THEY CAN.

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  12. rdalmas says:

    In the documentary Burzynski The Movie- Cancer is Serious Business , the serious business is the profit grabbing by our government agency. This agency is now profiting from taking control of therapies using all kinds of “reasonings” bullied onto the consumer.
    This system of profit does not work, it allows a pyramid to be built where controls are then forced on every level. Even in education we are not taught, because if we could read and process information rapidly, we would fearlessly stand against the syllogisms presented by the FDA, a collection of people standing behind a curtain pretending a power that is really unacceptable to life, disregarding life, destroying life.
    It is time to stand up and vote for a system of equality.
    Forgive all debt, it is a corruption as well, demand a Basic Income Grant, and put an end to profits for the few. Here these abusive profit grabbing practices will end.
    To have a profit one must create a need, or enslave. Create disease and then offer seeming solutions, but not cures, because a cure would not enslave and tie one to a pill for the rest of life.
    All these chemicals, all the toxins are being excreted into the world’s water and the water spreads EVERYWHERE infecting us with what we have all accepted and allowed. No one will escape.
    We have valued profit over life. And thus we will face the consequences of our acts unless we stop.

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  13. lanh says:

    It should be regulated but the saying oh stem cells is a drug is just a bad accused.

       0 likes

  14. Brenda Lawson says:

    I’m sorry but I do not understand what you are saying. How does the lab get your blood? Does someone give it willingly? Does the lab take it from someone’s test? When do they put it back into someone’s body? Do people donate their stem cells? Are you talking about stem cells found in the part of the umbilical cord that is between a mother and her baby when it is delivered, which is usually thrown away? My thoughts: If someone donates their blood, or if it is found in something that is going to be thrown away usually, then what is the problem? This can help so many people from suffering from such horrible diseases. You may not like my response, but this is it.

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  15. Pat Anderson says:

    If Stem Cells were drugs, so would be Blood transfusions, Transplants of organs etc. Have they read the original interstate commerce law? it was meant to protect interstate commerce preventing one state from not allowing shipment to or through their state, it was not meant even for control of drugs. It does have control of transports that are illegal like untaxed cigarettes etc. It is time they followed the law instead of interpreting it to benefit themselves. It is time we teach such laws in schools again as they did when I was in school. Knowledge is the best protection against an abusive government. Wait a minute, wasn’t that what Hitler did. Use the schools to first prevent kids from learning such things then teaching them what he wanted to for control?

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  16. Alan Lambert says:

    There have been, and continue to be, increasing attempts on the part of the federal bureaucrats to increase their control of just about everything. The FDA moves are but one part of the process, and need to be prevented as would any attack on our freedoms. Government does not, as a rule, want to increase individual freedom, as the more that freedom prevails, the less the government controls. Try to fight it if you can. It’s important.

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  17. Eloise Schwarz says:

    Adult stem cells therapy and any of these type of high tech microscopy medical services are still considered ultra services that are not “common” for everyone and anyone. To be ‘farmed’ out and considered as an article of purchase or something that can be grabbed and owned is far from the truth and erroneous. While gains have been made in the field of stem cell research – to say that commerce and regulations now own exclusive rights to it is folly when little understanding of the complexity of stem cells and what it can and will do is still unknown! Science + Medicine + Research DO NOT transcend and cross over well with regulations – especially when we have only just begun. Stay away from opening a Box of Troubles and a Can of worms – there will be difficulties ahead if the two are mixed together.

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  18. John Broadbooks says:

    This is a battle which I can relate to personally. I am presently in the initial stages of preparing for the Regenexx-SD procedure (hopefully in the next month or two). I have severely arthritic ankles, with very little cartilege left. My insurance company was prepared to authorize total joint replacement in both ankles (at a cost of 35-40,000), but will not pay for this procedure (at a cost of 5000 or less) as it is not FDA approved. It’s sad to see the egregious abuse of power that this federal agency demonstrates, and continues to demonstrate.

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  19. Linda Headley says:

    I am very tired of reading about the FDA getting more and more involved in our personal lives. This is not a communist country and you need to realize it. We will not stand for this.!!!!!

       0 likes

  20. Dorothy Roeder says:

    The FDA assertion that it has the right to regulate the Centeno-Schultz Clinic is way too much over reaching. They should not have jurisdiction over anyone’s body or personal parts. Stem cells are not drugs. Let the FDA stick to policing the dangerous drugs which actually kill people every day.

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  21. Don Ghidoni says:

    Since when does the FDA have the same mandate as the US Chamber of Commerce? The FDA’s job is to protect the public from corrupt, price gouging corporations not fortify the corporate bottom line. When will government get out of the corporate pocket? It’s high time to OCCUPY the FDA. Far too many drugs every year kill or injure people. Drugs that the FDA has approved for its apparent master the pharmaceutical drug industry.

    Contact your reps as I am to re-establish the FDA’s mandate.

       1 likes

  22. Ira Edwards says:

    Why does the FDA, which claims to not have enough funds to regulate drugs, try to expand their power in every other direction? They are best friends with agribusiness and drug companies, but enemies to simple people like me who want access to good nutrition.
    Margaret Hamberg and Michael Taylor have ties that conflict FDA purposes. They do not serve the people.

       0 likes

  23. SovereignMary says:

    I believe it is long past due to give these unlawful federal alphabet soup agencies a mental “instability” test. Talk about having at least one pilot light blown out!

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  24. Alice Ahern says:

    Greed, power grab for more Big Pharma. Leave supplements alone

       0 likes

  25. bill disbrow says:

    Do these morons even know what interstate commerce is? Does the “substantial effects” test apply here? If so—how? Any thing, once it arrives in “the state” where it is to be used or consumed is an end of interstate commerce, just like the mail when it gets to the post office nearest you location. Why doesn’t someone get up in these peoples face and tell them that any thing they do which has a harmful effect on our bodies is an act of war!!

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  26. please stop the fighting The work being done at this clinic is what Christopher Reed was fighting for before he died totally paraylized ,he was bringing awarness to what Stem Cells could do which wsas to repair the stem cells that were destroyed .
    I think it’s marvelous that we have so much research that is trying to fix a human body without drugs ,STEM CELLS ARE NOT DRUGS THEY ARE PART OF OUR BEING ,IT IS WHAT IT IS .PLEASE HELP FIGHT FOR THIS CAUSE thank you Mrs Laura H Sischo

       0 likes

  27. Bill Kornell says:

    I believe it is time to launch an offensive against the FDA. We need to go to the Senate and house and get them to do away with the FDA as we know it today. Those that do not see the light of day go after them big time when the come up for re-election. After all how can they be against better health, unless the are on the take from drug companies. We can no longer afford to fight a defensive battle. We must take the fight to them. The other we have to let more people understand that the government is not doing there job. If I do not do mine I get fired, they should be also.

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  28. Linda says:

    So I guess UV therapy, where they remove some of my blood, expose it to a certain level of UV light, and then return it to my body, is also regulated under the “interstate commerce clause”. What a bunch of horse hockey.

       0 likes

  29. Elizabeth Bernstein says:

    Don’t take away our supplements they are affective and have no side effects.

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  30. Shirley Weyand says:

    The people of the FDA and a few others are insane – if they can’t have it one way they will make up something egegious in order the get their way. We just have to vote into the presidency Ron Paul he would rid us all of many of these nutty bureaucratic nightmares.

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  31. Dr. Robert says:

    The FDA’s position is interesting in another regard: they are essentially taking the position that they part of their purview and responsibility is protecting the profits of companies that stand to lose if people are helped by Regenexx.
    Will they do the same for my patients who go out of state to receive a procedure that they cannot get in my office? Only fair!

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  32. E.Myers says:

    If our bodies are drugs,does that mean they want to shoot us up to.

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  33. Jim says:

    I want to learn more about this and have my spinal discs treated.
    To Hell with the FDA Gestapo!!!

       0 likes

  34. Kelly says:

    According to this bill the stem cells in our bodies are considered drugs by the FDA and would be regulated like a drug. The FDA wants to stop people from traveling out of states to other states where stem cell treatments for arthritis is being successfully cured with adult stem cells. this is an attempt to protect drug company profits in the states where people live but have to leave that state to seek treatment elsewhere because the treatments they need are not available to them in thier own state. under this law you wil likely not be allowed to go out of state for medical treatments. this is another powergrab and money grab by big business drug companies and the government and it treats us all like less than human beings. According to this bill we would be no more than cattle to be harvested of our body tissues and fleeced of our money. they do not care at all that people are sick and dying and suffering they only care if they can prolong our suffering long enough to make a big profit. We cannot stand for this. Our nation is quickly eroding these days into fascism and nazi-ism, and this is just one more step in that direction.

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  35. Lets leave some alternatives for people,freedom of choice for the ill!

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  36. Dr. Richard Edlich says:

    The FDA should only take action if there is scientific documentation that the stem cells taken from and given to the same person is dangerous. Without documentation, the patient should be able to gain the benefit from stem cell therapy from his/her own body.

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  37. Jo says:

    This is MY body, no one elses. God gave me this body and in all reality…its Gods body, because He created it, not man, and we have a spirit in this body that God gave us and it belongs to us. God has the say so here, not those that think they are God. If you doctors and scienctist that want to experiment, then experiment on yourselves, but leave the rest of us alone.

       0 likes

  38. Sharon Intilli says:

    This information needs to be disseminated to those congressional representatives that seek to limit the FDA’s power! Please do what you can to see that they get this information! THANK YOU FOR ALL THAT YOU DO!

       0 likes

  39. gigi says:

    The US government or the FDA do not own our bodies, stemcells, dna etc. We own our own cells and do not need any government entity telling us what to do with our bodies. I know of people who are receiving stem cell therapy with cancer trying to survive. Should we stop them? What happened to privacy of choice between a patient and dr.? Of course we need regulations, but not tohe extent of trampling on our individual rights to make decisions that govern our health and bodies.

       0 likes

  40. Mare says:

    Our government IS a corporation and the sooner people realize this, the better. Corporations have long since been bribing Congressional members to accept their corrupt practices, and until the people put more pressure on, Congress will continue to favor the corporations……the money is too big of a temptation.
    There is one way to get around a lot of the federal overreach and that is for the states themselves to nullify these unconstitutional laws. States, should just tell the Feds, NO….we aren’t going to follow your stupid illegal mandates. This will require citizens to put more pressure at the state level and appeal to their state government to step in and put a stop to it.

    http://tenthamendmentcenter.com/

       0 likes

  41. John Weinstein says:

    If corporations are people, then people are corporations. And corporations make drugs. And the FDA regulates drugs. So simple, even a moron, or to go lower on the intelligence scale, even the FDA can follow the logic.

       0 likes

  42. Ron Koenig says:

    I wonder if the FDA regulates blood transfusions? The same arguments can be used for that procedure.

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  43. Don says:

    the time has come to rid this country of the FDA

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  44. ************ says:

    I’ve never heard anything so ridiculously absurd in my life! I think the Government needs to do away with the FDA. Your body is NOT a drug! Its Natural. All the crap that the FDA regulates for Pharmaceutical companies that are synthetic are drugs!! They don’t BELONG in your body. That’s why people have bad reactions and even DIE from use of drugs!

    The only reason Pharmaceutical companies don’t support natural supplements and herbs is because they can’t patent them and make money off the whole plant, so they only use part of it to make their drugs, and that’s why you may get side effects, because there might have been something to counter those side effects in the part of the plant they didn’t use. It all has to do with being greedy and about money. Its sickening!!

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  45. George says:

    Is there NO oversight for the FDA? Maybe it’s time for them to be abandoned/disolved and something like the consumer protection agency enacted in it’s place… ALONG WITH GOOD SOLID OVERSIGHT of course!

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  46. Suzanne says:

    This is horrible and ridiculous. Our bodies are our bodies. If people don’t want to take drugs, they shouldn’t be forced to.

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  47. These people repeatedly show an appalling lack of self awareness over their own greed.

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  48. This is really sad. At least they are being honest about their agenda now instead of pretending to look out for the welfare of the people like they are supposed to be doing. If they are going to be in the pockets of big pharma then they need to be dissolved as a government agency that is of the people and for the people.

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  49. sixsixsix says:

    the fda also

       0 likes

  50. sixsixsix says:

    666 has arrived. The FBI will reap what they have been sowing a million fold.

       0 likes

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