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

0

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.

Share.
  • sixsixsix

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

  • sixsixsix

    the fda also

  • http://www.holistic-mindbody-healing.com Val@Holistic MindBody Healing

    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.

  • http://sweattshop-graphic-artist.blogspot.com/p/portfolio.html Dennis Sweatt

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

  • Suzanne

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

  • George

    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!

  • ************

    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!!

  • Don

    the time has come to rid this country of the FDA

  • Ron Koenig

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

  • John Weinstein

    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.

  • Mare

    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/

  • gigi

    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.

  • Sharon Intilli

    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!

  • Jo

    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.

  • Dr. Richard Edlich

    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.

  • http://none klinton antich

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

  • Kelly

    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.

  • Jim

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

  • E.Myers

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

  • http://www.neurontogenics.com Dr. Robert

    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!

  • Shirley Weyand

    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.

  • Elizabeth Bernstein

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

  • Linda

    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.

  • http://None Bill Kornell

    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.

  • http://[email protected] Mrs LauraSischo

    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

  • http://none bill disbrow

    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!!

  • http://[email protected] Alice Ahern

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

  • SovereignMary

    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!

  • Ira Edwards

    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.

  • Don Ghidoni

    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.

  • Dorothy Roeder

    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.

  • Linda Headley

    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.!!!!!

  • John Broadbooks

    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.

  • Eloise Schwarz

    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.

  • Alan Lambert

    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.

  • Pat Anderson

    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?

  • Brenda Lawson

    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.

  • http://sitedeets.com lanh

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

  • http://rebeccakd,wordpress.com rdalmas

    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.

  • Jerry Burge

    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.

  • Arvina Copeland

    “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?

  • Kathy

    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??

  • Khail

    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?

  • debrarae

    FDA = Liberals unconstitutionally over reaching as usual!

  • http://ANH-USA Deborah

    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?

  • http://Yahoo Kathleen Kreiselmeyer

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

  • Pearl Swan Youth

    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.

  • Peter Sherinian

    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.

  • Walter Gillmore

    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.

  • http://NaturalHealth Matthew O. Fretz

    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

  • Lou Ann Giunta

    Enough power-grabbing by the misguided FDA. Whether it’s OUR own stem cells, donated stem celss which would have been otherwise discarded, or organic supplements, keep them OUT OF A PERSON’S business. Stop allowing these handouts to big pharma. Please, see it for what it is and get on with the business of helping Americans; not harming them.

  • http://? Grace Adams

    This is it,. Now that the FDA admits publicly that its whole mission is to protect the oligopoly of the patent drug industry, it is high time to abolish the FDA altogether.

  • Julie Johnson

    What this action by the “owned” FDA shouts to me is that this stem cell therapy truly works and will be taking money away from Big Pharma concerning their peddled poisons. The FDA has pulled this same type of crap against Dr. Guestbook and his cancer cures! Hell hath no fury like that of the multitudes who have finally had enough of being lied to!

  • Nanc

    Where does the FDA get off saying that our bodies are a drug and they are to be in control of it I think that we need to get rid of the FDA.

  • http://www.jam2day.blogspot.com Johann Mitchell

    This is insane!

    What can we do about it?

  • Mary Losh

    My choice is natural foods which according to historical review, “Let your medicine be your food and your food be your medicine”.
    If this is my choice for my health, then no government should be able to take away that right. It should not be illegal nor more expensive to choose this root.
    It should be criminal for the drug companies to be able to make “Poisons” and market them as medicine for ill people. There is vast documentation that they kill people. Whereas you will be hard pressed to find documentation verifying death by the natural foods and plants.

    • Jenna Richards

      I just found out about a healing diet that exemplifies Let Food Be Thy Medicine.

      It’s called Ream’s Biological Theory of Ionization (RBTI).

      Look it up – it’s amazing! There are Yahoo groups for it, too.

    • wruttle

      the WHO (wold health orginization) wants to make sure any animal that you will eat must have innoculations for disease. the vegetables we eat are all in control of MONSANTO, which is the most evil corporation that ever was, in my opinion. HOW CAN YOU PATENT LIFE????

  • paula Harrington

    my sten cells are mine, they are inside me They donot belong to the FDA nor any one else but me. if I chose to have some extracted and the re-inserted, thay are still mine. Live your hands off from me. Talk about abuse or inappropriate touching; leave your hands off of me.

  • http://[email protected] Bob Wallick

    It breaks my heart and boggles my mind that the public servants at the FDA feel their mission is to protect corporate interests while preventing the free exploration of the potential of our own human bodies. It is time to obliterate and reorganize the FDA that brings the focus down to the examination and regulation of synthetic substances and creating a system that limits the serious damage some of these substances have inflicted in the past.

    • Jenna Richards

      How does anybody in that organization sleep at night?

      Awful to think that people who go into public service for humanitarian reasons are eventually confronted with this sort of perversion of the system – frightening and sad.

  • joseph lucenti

    This is insane. If this is allowed then were saying there’s no lines to be drawn and we no longer have control over even our own bodies, basically. This is completely outlandish and one hundred percent unacceptable.

  • steamdwarf

    In case anyone missed the memo this is an election year. I hope this group, or another, will provide a short list of Congress and Senate members who are most supportive of this type of FDA power grab and expansion so we can discuss with each of our local circles of grass roots, family and friends, to defeat them. It’s tilting at windmills to take on each one of these individually, they will beat us down by shear numbers, we HAVE to start at the source, Congress and Senate.

  • Alan8

    The unprecedented corruption of the FDA is yet another sign of our nation’s slide into fascism.

    This is unaccountable power used in service of the 1% who OWN the pharmaceutical corporations that would lose profits to a treatment like this.

    These abuses of power occur under “Democratic” administrations as well as Republican administrations; both these parties are owned by the 1% who fund them through their corporations.

    The Green Party is the progressive alternative. The Green Party doesn’t accept corporate money and represents the 99%.

    5% of the vote will get the Green Party matching Federal funds.

    Your Green vote sends a message to the corporate parties that their corruption and destruction of OUR freedoms will cost them votes.

    And this message is sent even if the Green you vote for loses.

    VOTE GREEN!

  • Ruth

    Ugh, Choke, gasp; :( @@

  • Jean Ludwig

    A body part is not a drug by any definition. How is it possible that they can get away with this? Sadly, what de FDA (totally out of control – a law unto their own) says also affects people in other parts of the world. When will someone put a stop to this tyrany. I prefer not to live under a dictator’s rule.

    • Ogre

      you would think a bright lawyer could construe a title 42, section 1983 of the Federal Code to apply to anyone attempting violate a persons civil rights. Interfering with someone’s bodys parts (blood in this case) is already a violation. Since they already have taken action under color of authority they should be open for it. When they realize that govt. lawyers cant defend them and they must pay for their own might make a change in attitude.

  • Alan Martin

    The FDA is of course way out of line. My body belongs to me…and I will take care of it as I see fit. I have not and will not follow FDA guidelines…It is a money scam.

  • http://www.truthbasedlogic.com/ William Flax

    It is very obvious that the authority of the FDA to harass free citizens needs to be curtailed. The Federal Government really was never supposed to have a role in American Health Care, as the Police Power was reserved to the States in the Federal Constitution, and the Police Power is that which deals with the Health, Safety & Morals of a population.

    This is not to say that a role in measuring drugs would not be legitimate, under the “weights & measures’ clause, but using the Interstate Commerce clause to restrict personal freedom in this manner is totally antithetical to what the Founders intended. (See Constitutional Overview.)

    While posting, it should also be pointed out how much Federal meddling in American medical care has already raised health care costs in America. When you intrude a distant bureaucracy into local decision making, you muck up the process, even as you sq

  • Genie Danley

    My body, my decision,I am an American, that means I am free to choose. Don’t take my choices away.Then you take my freedom away

  • James George

    A MUST Watch Documentary is Burzinski Cancer is Big Business, The FDA is nothing but a Mob Boss Organization working for Big Money Interests.

    ABSOLUTELY leave our country for Any expensive medical procedure that you can. Put this guys out of business. Take care of your health, eat good Organic fool, no GMO’s, exercise and take care of your own health, health does not come in a pill, it comes in what you breath and what you eat. Please people do your part to bring this corruption to an end.

    • Jenna Richards

      You said it perfectly, and we individuals have a responsiblity on our part to do the right thing by our health.

      I mean, it’s hard even for me: I love coffee and chocolate and fast food – just am dosing it better.
      Plus I CERTAINLY try to avoid doctors and drugs and do alternative whenever I can.

      The new generation asthma meds actually make me feel WORSE (a common complaint now). Just researching the net, I am able to control it now with lacto-fermented veggies and raw milk cheeses.
      It’s the enzymes!

  • http://www,OnlyWay.com David A. McElroy

    Creative writing and leaps of logical boundaries are FDA staples. By their logic, and the political correctness now rampant, the Earth is a living creature, and therefore anything taken from the Earth is a drug, much as stem cells taken from your body are deemed drugs. The FDA could end up ruling the entire planet! Foods are drugs! Herbs are drugs! Minerals are drugs! Water is a drug! Death to the FDA and their Big Pharma masters! God help us to live free or die trying!

    • rise revolt

      I’m not

      a member of any of the three big religions but amen brother. I hope I see wrongs made right in my life time but it’ll be at a cost.

  • Terry Richmond

    The U.S. A. is a corporation run for the benefit of the shareholders. The average american is little more than an indentured servant; not a share holder in the corporation. When we wake up to our legal status, we will then be able to begin the arduous spiritual, mental, and physical tasks that will lead to our freedom from a corrupt and tyrannical legal and just-us system. Keep up the good work that you are doing!

    • rise revolt

      There’s gotta be a war before peace so our childrens childrens children arent going to live in a hell we are letting happen. Look at the mass idiots truly clueless that think their shoes and phones are the important things in life. Look at how content people are because of fear. I think a hundred years from now kids will look back on this time as dark and strange and with hate if we don’t stop this mecha consumer lifestyle. Quit watching your tv for a couple months and see how it is controlling our society minds. Then go back and watch it and see the dumbing down of america and now im all pissed off and you should be too!

      • wruttle

        excellent point. I wonder if anyone noticed how movies were slowly released in increments, better sound or video or extra scenes, to make as much money as possible. and now how often is apple releasing diff versions of the same damn product? it’s all to fuel the capatilism machine. We are no longer a nation of free thinking people. WE ARE NOW CONSUMERS. our childern are being raised to be good little consumers too.

  • Christine Rapoza

    FDA is too pro corporations and not doing it’s original purpose and protecting citizens from corporations.

  • Pati Gant

    This reinforces my desire to stay in Washington State.

  • http://yahoo jeanette haskell

    Stupidest thing I ever read. The FDA wont be happy until they control every process of our lives. And as far as Rick Pery is concerned it is one of those Its ok for me but everyone else needs to follw other rules.

  • Timothy E Hook

    ANOTHER example of Outrageous breech of Public trust by the FDA!… how much more of a twisted statement is needed in order for you as a representative FINALLY come to terms with the fact that your responsibilty is to SERVE your constituents, not empower an FDA buracracy?..A buracracy that consistantly shows US it’s main concern is enriching big pharma at the EXPENSE of Human Health??

    We the People DESERVE representation, not enablers of lies, govt power grabs and corporate profits at OUR Expense.

    If we actually had a working free press and our elections werent being stolen with the insecure and easily manipulated black box computers…This country wouldnt be the Big Lie that is it.

    What are YOU doing about it?

    Sincerely
    Sickened by the US Congress.

  • http://fda Joe Blow

    The FDA is a big peice of Crap and I say; that Crap should be flushed down the toilet.

  • walt

    Name one government affiliated organization (Including the Government) with any power which has never become corrupt and completely ridiculous- even obsolete sooner or later.

  • MGP

    If you read the case that’s linked in this article (http://www.hpm.com/pdf/blog/GovernmentSupportforSummaryJudgmentMotion.pdf), the claims made here are a gross misrepresentation. They are NOT stem cells taken from blood – they are extracted from the bone marrow. They undergo FAR more processing than a simple centrifuge spin before they are mixed with another chemical prior to being injected back into the patient. The only reference to drug companies is an aside that they are required to comply with safety regulations, which are not followed by the practitioners at the clinic.

    Delineating all the inaccuracies would take me longer than it would take anyone that’s interested to read the case and find out what it actually says.

    • Happy

      Mole. The FDA and all Federal Government agencies that keep meddling in state business need to be banned! The FDA works for Big Pharma… PERIOD!!!

  • William P

    America is certainly spewing out the weirdest wacko crackpots the world has ever seen! I’d be totally ashamed to be American with this outrageous conduct. How can you people let this kind of stuff happen???

    • Kelli

      Funny…we regular Americans are victims just like the rest of the world. The power elite and the corporations they control are NOT just Americans. They are psycho lunatics of many nationalities.

  • Cliff

    If the FDA want control of all drugs they will be arrested. LOL

  • Kathy Washington

    Once again our society is showing a lack of good old common sense! It shows that if a buck can’t be made off of something then somethings wrong with it or that it needs to be contained! What’s wrong with this picture!!!! If Gov. Perry has this treatment, and it works! Then wants to so-call regulate it for other people!! Smells really fishy to me!! Wake up people!!! Speak out!! Don’t stand for it!!

  • http://www.anh-usa.org/fda-new-claim-body-is-a-drug/ Glenn Ross

    Again Mr. Obama has made another poor choice of managers.

    The FDA needs to be thoroughly examined, replace current management for being incompent, give the new management proper funding to allow the job of overseeing can be accomplished without excuses. That is what private industry does.

    No more excuses this agency has been improperly managed and does not have enough resources to do it’s appointed job. And it needs a TECHNICALLY QUAILFIED individual with a good strong back to stand up and run this agency with some real direction. Not just a reactionary response. This just plain common sense. It does not take a PHD to see how poorly funded and mismanaged the FDA. I here dumb things about them almost everyday!

    • Wild Bill

      They are only “poor choices” if you don’t recognize what Barry’s actual objective is.

      His goal is to turn this country into a third world Socialist/Communist Peoples’ Paradise with himself as Supreme Commander. Notice how he does as he pleases…Congress be damned.

      Does anyone remember his statement back in 2007/2008 that the US Constitution was
      “a flawed document”?

      He is the point man on establishing a world caliphate wherein “white, anglosaxon, protestants” will be all but extinct.
      And that’s not racism on my part, Larry, it’s simply the truth as demonstrated by Barry’s actions.

  • http://0 Judy Morris ND

    As a survivor of aneurysms and cancer with 12 years of education and 20 years in health food stores, I really believe in supplemnts and their strrength and the RIFE machine, red raspberry seed extract on the internet, PAWPAW available in HF stores or internet……..have no cancer and just a bit of damage to the brain after 7 operations. Had 5 cancer operations too. I GO ON…..thank you God as your emissary. No one but HE will control the decisions that are necessary for my life!

    • wruttle

      unfortionatly with Codex all suppliments/vitamins will be made pretty much useless so that only the pharmicutical companies products will work. As well any medical herbs will become outlawed. so if you use the herbs in your garden as home remidies, you are in posession of DRUGS.

  • houhuiui

    just another reason why nothing at all in this government is genuine and certainly not legitimate

    but what do you expect when you have 200+ years of freemason (WHO ARE LOYAL TO ENGLAND AND THE VATICAN) puppet presidents, congressmen, judges, industrialists, lying TV, poison in our air food and water, military mass death

    • jim M

      I agree. FDA is insane. Has the department converted to meth addicts? Our body is our body. Next they are going to start taxing us based on our cell, ovary, and sperm count.

      • jim M

        I think its time to cut the fat, terminate the directors, and hire executives who have spent their careers in private enterprise. Most of these FDA decision makers have never worked outside of the government sector. I have seen and worked with the FDA on a temporary emergency task force. The do not have a clue to think for themselves and micromanage everything!!!! I took over 2 divisions in less than 2 weeks on staff because I knew more than everyone with 20+ years on the job. Needless to say …. this created enemies.

        • LT Shepherd

          You would be surprised how many of them HAVE worked in the private sector. That’s part of the problem, they’re getting a government paycheck but still working for the private sector. Not working for the tax payer.

          Corporate lobbying should be illegal. Stop this practice and you WILL see a difference.

  • Chris

    The government is completely out of control. People better wake up.

    • Wild Bill

      They can’t wake up because the alarm clock (the news media) has been co-opted.

  • Green Spirituality

    They’re not even TRYING to hide the fact they’re screwing us over! Too much power.

  • Adrian Tween

    I don’t care how many times the FDA says stem cells are drugs. They are not. Anyone who studied an ounce of Chemistry or Biology would understand that. They are my cells not the governments’. I will not stand like a pig for slaughter while they put bogus regulations. Enough.

  • Nathan K.

    My bodey not a Drug, Neith do whant big drug compens stop taker bodey way I know how.

  • Michelle

    For a country that preaches freedom and democracy this is bordering on socialism. This government agency wants to control our stem cells because of money? Capitalism at it’s finest!

    • Dana

      that’s not capitalism. Capitalism requires a free market and access to products or services. This is cronyism mixed into a big fat disgusting dose of socialism!

    • SeanKD

      Actually, this is mercantilism turned on its ear. What we have here is government regulation of the economy stifling innovation and wealth creation rather than engendering them. It is tyrannical in that the government is laying claim to our persons in defiance of the natural law. We all know that our bodies are our own and that no one has any claim to them unless we consent.

    • LT Shepherd

      This is not an example of free market capitalism. This is CRONY capitalism at it’s finest. Learn your enemy.

      • wruttle

        Actually it’s just stupid. plain and simple.

  • timothy price

    The FDA has become a terrorist organization.

  • wishbone

    my body is NOT, i repeat, NOT a drug and belongs to me, the FDA have NOOOOO rights to my body. we must remind them that we the people are NOT going to keep taking this “total control” crap.

    • Sarah

      I totally agree we must all of us and there are over 305 million of us in America, must Just Say No
      its time people. Practice saying NO and then go out and tell those that want to destroy our rights that we do not Consent.!

      • Wild Bill

        Sounds good, but unless we really do ALL do it as one body, we will simply end up in one of the “detention” camps that Ron Paul tried to tell everyone about when CNN suddenly had “technical troubles.”
        And as long as the communication technologies (TV, radio, newspapers) are controlled by the state propaganda machine the people will be scattered.

  • Genie Borrelli

    This is complete rubbish. Another power grab by the pharmaceutical industry and their FDA stooges. It’s so obvious that the FDA is, at least at the top levels, a completely corrupt organization and should be made accountable for the dishonest and dangerous decisions it has made that have resulted in damage to people and animals. A thorough “sweeping out” of the agency is at least is order.

    • Wild Bill

      That’s one of the creatures that Ron Paul would eliminate.
      If you believe the Pravda news media about anything important then you’re as blind as any bat.

  • Ricardo Santos

    The question is, what are we going to do?

    We are keeping taking more and more crap from government and we do not do anything (as a group, some individuals are fighting back) instead we attack and criticize and demonize those who are doing something.

    We deserve (again, as a group) what is happening to us, because of our cowardice to take the steps necessary to take our country back.

    • Joe

      WHAT HAPPENED TO BY THE PEOPLE FOR THE PEOPLE

      • Wild Bill

        It died when the bankers’ agent shot the man who said it.
        Go to You Tube and search “The Moneymasters”.
        It will make a lot of things clear.

  • David R

    So tweezers made in California are used by a small office in New York for removing splinters (pain treatment) must therefor be given a Cease and Desist order because that’s “interstate commerce”? Whiskey Tango Foxtrot!!!

  • Slann

    As others have noted, these are the same tactics the FDA used when it tried FOR YEARS to steal the work of Dr. Stanislaw Burzynkski, trying to ruin him and put him out of business. They also tried to steal his patents! THEY FAILED! David Kessler (then head of the FDA) is a criminal!
    But we, as taxpayers, had to foot the bill, not to mention that irreparable harm caused to cancer patients who could have been helped, but were denied access by the FDA. It was criminal, just as this persecution is criminal.

    • http://n/a Dr. Elizabeth Martin

      Sadly, Dr. Stan. Burzynski is being indicted for a FIFTH time in Texas. This man is a great scientist, a great humanitarian and an awesome human being! Totalitarianism is arising everywhere around us, the FDA is just another nasty monster that has turned on the people. The American medical monopoly has been at the forefront of fighting non-toxic healing methods., and because Dr. Burzinski is curing people, NON-TOXICALLY from “incurable” cancers, after all the other oncologists and researchers said buh-by, go home and get your things in order. I am inspired by his dedication.Elizabeth in Seattle

    • ZT

      The only criminal is Burzynski, who gave quack treatments to patients and told them they’d work without any scientific evidence to support his claims.

      • Joe

        WOW GUY IS THAT THE MOST INTELLIGENT RESPONSE YOU COULD CONJURE UP?!

  • Henwid

    I wonder why they haven’t gone after skin grafts.

  • paul

    Americans had their chance to vote the only candidate that shares our values – Dr. Ron Paul. But the sheep messed it up.

    • Larry Selnow

      The FDA is full of crap when it claims it has a right to regulate my body as for Ron Paul sorry I do not support him or his racist tinged views IF Mr Paul had his way the civil rights act would be repealed He has supported the KKK 7 people like them
      I can not in good consonance support a person like this

    • Joe

      FOLLOW THE MONEY TRAIL PEOPLE…FOR GOD SAKES, WOW!

  • Dan Boeller

    Really, really bad reportage and most of the commenters here don’t get it either.

    Did the writer even bother to read the actual edict?

    All that is happening here is that the FDA is arguing, reasonably, that the processed preparation this company uses is subject to regulation if it’s going to be marketed for administration into human bodies with the intent to cure or treat disease. That is the FDA’s job. Also, if I recall correctly, the company’s plant failed an FDA inspection.

    They are not saying your own stem cells are drugs or are to be regulated.

    They are saying that drug-like preparations made from stem cells – things like insulin and other treatments, made from human or animal stem cells and administered to humans to treat disease – need to be regulated for efficacy and cleanliness and to make sure they actually work.

    • John Bryant

      Hello,
      Dan is correct and too many people are being misled on this issue. It hasn’t been reported properly and seems to be only one sided. The FDA is protecting US citizens everyday by their regulations and most people are unaware of the safety that needs to be adhered to when any products are intended to be given to the public. This is a SAFETY issue and needs to be recognized in that aspect.

      • Ryan

        The FDA protects US citizens!? You naivety is unbelievable, and unfortunately, most likely shared by many Americans. The FDA is as corrupt as it gets. It can AND has been bought in the past. Just do some research about Donald Rumsfeld hand picking the FDA chairman (Hayes) in the 80s so that he would specifically get aspartame approved for soft drinks. Educate yourself before you stick up for a government agency that cares far more about money and power than safety,

  • Inforcer_Resister

    Most people will read this and get paranoid. stop and smell the roses people.
    The article is not saying that your own stem cells are drugs or are to be regulated.

  • Corin

    This seems quite dysfunctional of the FDA…I can see where it might be dangerous for people to donate stem cells, but to keep people from using their own? That’s just silly. And of course, the FDA shouldn’t exist to protect it’s own interests, or “profits”…it should exist to keep people as safe and as healthy as possible…Whoever is running it is totally lost and has their head in the clouds…

    • wruttle

      have a look into it. seems like somebody with pharmicutical ties is in charge of the FDA. This reeks of CODEX ALIMENTARIUS.

  • http://www.anh-usa.org/fda-new-claim-body-is-a-drug/ Judynz

    Get yourself into groups & take aspecst of the law to study.
    You cant sue Govts but you can sue Corporations.

    Each member of parliament is an individual Corporation, so they too can be sued. Corporations do everything via Contracts, everything they do is regarded as a contract.
    Thats why they make like a vote into power is their mandate to disregard public opinion,
    However even under their own laws, for a contract to exist, it demands that all parties have full understanding & knowledge. Just dont expect a member of the `BAR’ to have the courage help you or even admit this.

  • wruttle

    I wish i could say this is an american problem but it is spread around the world. govt is making the rules that support the 1% the only way to take back control of our own lives is to revolt. The govt doesn’t want an informed population. ever wonder why public schools are getting worse? IT’S SO THAT THE FUTURE POPULATIONS WON’T BE ABLE TO EDUCATE THEM SELVES ON WHAT THE GOVT IS DOING.

  • Somnath Basu

    Having gone through all these comments, it appears that there are lot of objection on FDA’s role to put regulation on patient’s own body cells. The focal point of contention is that one’s own cell if implanted by any mode by a doctor to his body what harm is going to happen? Yes, the question of rejection of autologous cell by one’s body is true. but this does not guarantee the procedure will remain safe and effective for long years to come unless it is a statistically proven fact. Moreover the cells extracted from one’s body is manipulated or at least added with some kind of phosphate buffer, cells are expanded to a certain numbers before giving it to him. The protesters of FDA’s regulation may once again think that there may be mushrooming of various procedures without scientific debates. In India too there are such advertisements coming very often on electronic and other media. But the failure rates are not highlighted. there are certain objections from patients that in the name of modern day medical practices they are cheated exorbitant amount without healing.

    • Truth Seeker

      Natural Embryonic or adult stem cells are not a drug and cannot be patented, but once they are manipulated they can be patented and sold. Big bucks for the companies and more power to a very corrupt FDA.
      There are people on their deathbed that would be willing to take a chance with embryonic cells but the government can’t let that happen because if it works those patented stem cells would be worth nothing. It’s all about the money, and that’s it.
      I know of a patient that was killed the night before he was to be transferred to a university hospital back in 2005 to have the procedure done – Of course the report said natural circumstances.
      It’s bad enough that the lawyers are crooks but now doctors have become murderers.

  • http://www.patientsforstemcells.org/ SammyJo Wilkinson

    I was hoping ANH would take not of this FDA overreach. How about a petition? We have several petition examples here http://www.patientsforstemcells.org/take-action/

  • http://www.allyoumed.com Brian Tilaro

    Okay folks, let’s look at this issue from a scientific and legal perspective, without chest-pounding or ineffective and trite comments.

    If the FDA can claim that a person’s own stem cells (manipulated, cultured, or not) are drugs and therefore have authority to regulate, then how can any abortions be legal when the same criteria is applied? Think about it. I am taking no position on abortion rights. This is purely an exercise in basic biology and semantics. Once a zygote is produced in the fallopian tube and is then fertilized by sperm, it becomes an embryonic stem cell ready to divide; becoming a fetus. The Supreme Court in Roe V. Wade ruled that a pregnant woman has a right to abort (or manipulate) an unborn fetus (a large collection of embryonic stem cells, at very early stages), because her body is her own property. This being the case, then how is that different than using your own adult stem cells for whatever purpose you like. Morality and political positions aside, the argument in Roe V. Wade is prima facie with regards to autologous adult stem cell manipulation. Therefore, if adult stem cells are classified as drugs and regulated by the FDA, then the FDA must likewise classify a fertilized zygote in the womb as a drug and regulate all abortions. Thus, taking away a woman’s reproductive rights as they currently exist; even to the extent of disempowering the Supreme Court’s decision in Roe V. Wade.

    Once again, I have no political or moral agenda in this essay. It is a scientific and semantic argument in favor of free and unfettered use of a person’s own adult stem cells.

  • wayne fenton

    You don,t have the right to dictate what my heritage and genetics has given me if you want to make money off my body parts buy it from me, The FDA formed in 1906 is trying to say they have more rights to your body than you , humans have gone back years ,decades ,century,s before 1906 ,and they think they should control us like a shop made product just to give pharmaceutical company,s a guarantee of their profits its barbaric and against your human rights and privacy.

    Is this allowed in any other Country.

    Food and Drug Administration

    Agency overview
    Formed 1906[1]
    Preceding agencies Food, Drug, and Insecticide Administration (July 1927 to July 1930)
    Bureau of Chemistry, USDA (July 1901 through July 1927)
    Division of Chemistry, USDA (established 1862

  • b

    Senate Document # 43; SENATE RESOLUTION NO. 62 (Pg 9, Para 2) April 17, 1933. ”The ultimate ownership of all property is in the State; individual so-called “ownership”is only by virtue of Government, i.e., law, amounting to mere user; and use must be in accordance with law and subordinate to the necessities of the State.