FDA’s New Sneak Attack on Supplements

July 5, 2011
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Just before the July 4 holiday weekend, hoping to limit media attention, the FDA dropped a bomb on dietary supplements. Don’t let them get away with it! A new Action Alert.

On July 1, the US Food and Drug Administration issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols contained in the Dietary Supplement Health and Education Act (DSHEA). Ever since DSHEA was enacted in 1994, supplement manufacturers have had very little guidance on what counts as an NDI and when or how to send an NDI notification. The government has arbitrarily ignored or enforced this section of DSHEA, doing as it liked, without spelling out the rules.

Why does this matter? Because when you hear New Dietary Ingredient (NDI), substitute “New Supplement” in your mind. What we are dealing with here is whether the supplement industry is allowed to innovate and create new supplements—and if so, under what rules.

Now, seventeen years after the passage of DSHEA, the FDA has finally come out with draft guidance on NDIs—that is, on new supplements. They had to do this because it was mandated by the recent Food Safety Modernization Act.

We have reviewed the very complicated new regulations in detail. In the hands of an agency charged with regulating supplements fairly—one not hostile to supplements the way FDA is—they might be made to work. But in the hands of the FDA, which wants everything, supplements and drugs alike, to go through the vastly expensive new drug approval process, we fear the new rules will be used to forbid the development or sale of any new supplements—where “new” means anything after 1994, when DSHEA was passed.

Please note that many important supplements sold today were developed after 1994. Others the FDA will say were developed after 1994, even though they are just variants of what was “grandfathered” by DSHEA. For example, the FDA has already banned a critical form of vitamin B6, pyridoxamine, because that particular form of B6 couldn’t be shown to have been sold prior to 1994, even though B6 in general was certainly sold prior to 1994.

There are many other important new supplements that could be banned depending on how the NDI process is run. We won’t mention the names because to do so would be to put a target on their back. But we can assure you they are important and many of you are taking them.

The FDA already has the power to pull from the market any supplement, whether “grandfathered” or not, if they are unsafe, do not comply with Good Manufacturing Practices, etc. The oft-repeated claim that the supplements market is unregulated or “the Wild West” is patently false. But the FDA cannot pull a grandfathered supplement arbitrarily. They must show cause. What we don’t want is for the FDA to have the power to ban all new supplements arbitrarily. We fear that they will use this power to ban any supplement innovation unless the supplement is turned into a drug and brought through the drug approval process.

Since nobody can afford to pay for the new drug approval process if the substance is not patented, and supplements generally already exist in nature and cannot therefore be patented, to require full new drug approval is to ensure that there will be no new supplements. This should suit the drug industry very well and, based on past behavior, the FDA as well.

Our Concerns with the New Draft Guidance

The draft guidance clearly outlines the conditions under which an ingredient is considered an NDI (a new supplement) and when it is considered grandfathered. Further, it details the circumstances under which it is necessary to submit a notification for an NDI and when it is not. Not surprisingly, the FDA has applied a very narrow definition of grandfathered dietary ingredients, and so by extension a very broad definition of NDI.

Consequently, according to the draft guidance, almost all new supplements are NDIs, and thus are subject to NDI notification.

Please look carefully at this word “notification.” The term implies that the supplement company is just telling the FDA about the new product. But this is not the case. It is actually an approval process, and the FDA turns down most NDI applications.

Under the new rules, all ingredients/supplements in the food supply before 1994 that have been chemically altered in any way are considered NDIs and therefore subject to NDI notification. Moreover, the definition of “chemically altered” is extremely broad, describing multiple manufacturing processes that include:

  • certain types of fermentation
  • exposing ingredients to high temperature baking and cooking (if such treatment is not usually applied to the ingredient in conventional food)
  • use of a botanical ingredient at a different life stage than previously used—for example, an extract of unripe apples instead of ripe apples

So if the ingredient is not absolutely identical to its pre-1994 counterpart, then it is considered an NDI and subject to NDI notification/approval.

Drug companies can exploit this process by trying to patent common dietary ingredients as drugs before supplement companies have an opportunity to submit their NDI notifications. Once a drug company investigates an ingredient for drug purposes and publishes their findings, the ingredient can no longer be used in supplements. This has happened before—it happened with the pyridoxamine form of vitamin B6 we mentioned above. In other words, what was once a supplement available to consumers at low cost will now be an expensive prescription-only drug, if it is available at all. (And it’s not only the drug that costs more: you’ll need to pay your doctor for an office visit just to get the prescription!)

The draft guidance also states that a synthetic copy of a supplement constituent, or an extract of an herb or other botanical, is not considered a dietary ingredient at all (much less an NDI). Isn’t this good—isn’t it better not to be an NDI? No. If the FDA says it is not an NDI, that means they are saying it can only be sold as a drug—period. This could knock out a number of important supplements currently sold.

The guidance discusses at length the evidence required for a notification (approval)—and the requirements are extensive, including a strong recommendation to include human studies. We sometimes forget that human studies, in addition to being very costly, do not always fit supplements.

In effect, it appears that the draft guidance pushes the scientific standard for NDI notifications closer and closer to the pharmaceutical  standard. As we have mentioned many times before, supplements are much safer than drugs, yet because of the big Catch-22 (supplements cannot usually be patented, and no non-patentable substance can be taken through a drug approval process which, on average, costs a billion dollars), it is very difficult for supplement manufactures to meet these standards. If they are met, it will push the price of supplements—already high—beyond consumers’ reach. The industry will die.

In these proposed rules, the FDA has effectively created a de facto pre-market approval system without any of the protections of such a system. The FDA has a very high bar that a supplement manufacturer must reach before they can file, but FDA reserves the right to reverse its decision about the safety of an ingredient at any time. It is important for the FDA to  recognize the NDI process was meant by Congress to be an actual notification system, not a pre-approval process run according to arbitrary rules set up by the FDA. Congress gave the FDA power to say no, but this was expected to be rare, while the FDA currently vetoes more often than not, often on trivial grounds.

In general, the draft guidance creates a process that is extremely burdensome and redundant—and is impossible for the FDA to realistically implement anyway.

The FDA even makes the NDI notification specific to the manufacturer, not the ingredient. So if two manufacturers are marketing the same ingredient, at the same quantity—they still each have to submit an NDI notification. They can’t hire a third party to do it for them as a group. This is arbitrary and punitive—there is no reason for this requirement at all.

The FDA also expects a different notification for the same ingredient for every different version of the supplement it is in. For example, the same ingredient at a higher concentration needs a separate notification/approval. Or the same ingredient in a different combination of ingredients requires yet another notification/approval.

The bottom line is that when new and unreasonable burdens are placed on supplement manufacturers, it immediately becomes a financial increase for consumers. And if the pressure becomes too great, the nutritional supplements on which you rely may simply become unavailable.

Please contact the FDA immediately and voice your strong opposition to the New Dietary Ingredient draft guidance!


TO SEND YOUR MESSAGE TO THE FDA

Click THIS LINK to go to the Action Alert page. Once there, fill out the form with your name and address, etc., and customize your letter. We have a suggested message for you, but please feel free to add your own comments to the letter.

We’d also love to hear your comments about this article—just add your thoughts below—but remember that the messages below are only seen by our ANH-USA readers and not the FDA, Congress etc.

105 Responses to “FDA’s New Sneak Attack on Supplements”

  1. jim says:

    Wake up people. Most of you sound ignorant of the true motives of the elite. They want you dead. They poison your water with FLUORIDE, your food with GMOs, your air with CHEMTRAILS, vaccinate you with MERCURY AND OTHER POISONS, are trying their best to destroy your food and natural health alternatives, and now they do not want you growing your own food or finding your own supplement alternatives. Find the famous quotes on de-population and eugenics. They want to reduce population to a billion or less. Easier to control you then.

       0 likes

  2. Traute Klein says:

    Americans are asleep and will wake up when it is too late. Canadians have been fighting this war for years. The Canadian federal government has drafted legislation which is far more stringent than what the FDA is proposing. If that legislation passes, an inspector can come into my garden and destroy all the medicinal herbs which I am growing. If I continue to advise people about natural remedies, something I have done free of charge all my life, I can be sent to jail. Here is how we are fighting the government: http://nhppa.org

       0 likes

  3. Brenda Rogers says:

    The whole FDA system appears to be a sick, sad, sorry bunch of killers who are in bed with the money-mad drug and chemical companies and they should be the ones taking the heat. They’re not even slightly interested in what’s good for the people but are only after preserving their own greedy selves, their jobs and their control-freak self serving ways. How about the recent attacks on Vitamin C injectible form after there were some practically miraculous incidents of people being healed from near death states by using large amounts in harmless doses. They just can’t stand the competition. They appear to be more interested in killing, stealing and destroying than for healing that would leave people alone to enjoy peace, love, joy and really good health that can only be built with good, wholesome, organic foods – not with chemicals and drugs.

       0 likes

  4. Brenda Rogers says:

    FDA is a sick, sad, sorry bunch of killers who are in bed with the money-mad drug and chemical companies and they should be discontinued altogether. They’re not even slightly interested in what’s good for the people but are only after preserving their own greedy selves and their jobs and their control-freak self serving. How about the recent attacks on Vitamin C injectible form AFTER some near miraculous incidents of people being healed from near death states by using large HARMLESS doses. They just can’t stand the competition. They’re more for kill, steal and destroy than for healing that would leave people alone to enjoy peace, love, joy and good health.

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  5. Penny says:

    Sir: What in the world are u thinking….If you were sick and you knew that the supplements would help you get better or cured… What do you think you would do… THINK…God had made some men and women to help others.. not to be rich, but to HELP….THINK……..THINK

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  6. C Williams says:

    Go ahead and be done with it. Just ban all foods. That will solve all of our problems.

       0 likes

  7. It seems like at least twice a month I have to fight this same battle over again. Handing our ability to choose healthy foods, herbal remedies and correctly made supplements of our own choosing is, for once, a clear case of a threat to National Security, and is treasonous on its face! Most of the drugs the FDA approves are vetted on the basis of how of the FDA’s budget the makers paid for, not of effective or safe they are! They’re forced to recall an unconscionable percentage of new medications very quickly – unconscionable because all too often thousands of patients (and in the cases of SSRIs and gabapentin, innocent bystanders) DIE! Healthy foods, herbal medical treatments and supplements are constantly under threat by the FDA at the behest of big Pharma. How about if we push for a more realistic charge for once, and have those involved up on charges of treason? We could add attempted mass murder by poisoning, suppression of life-saving treatments for cancer, with many of them actual cures as well!

    We are under attack in so many ways from so many different directions, some well-hidden, some blatant, that it’s getting impossible to keep track of them all, much less to catch them. I am disabled with massive nerve damage (and have been so for 28 YEARS!), the sole correct treatment for my own condition is legal, scheduled, very safe and well-understood – and doctors dare not prescribe those medications because the government refuses to recognize the science behind the Medical Standard of Care the rest of the civilized world (so-called) uses so as to allow those with otherwise untreatable chronic pain to have near-freedom from pain, and often it even cures the condition! Without treatment we are crippled, unable to work, we lose everything from jobs to spouses and children, homes, and our own self-image. The DEA attacks our doctors as thought they had been caught standing in schoolyards selling drugs to first graders, and with 800 or so of them in prison we are left with no treatment at all. Doctors refuse to see us; clinics ‘aren’t taking new patients.” Emergency Rooms mock us and the doctors there take workshops on how to browbeat us and pressure us into walking out with not so much as an exam, much less even temporary treatment so we can sleep for an hour or two – if we’re lucky. The advice we get amounts to “Then die. You’re worthless anyway.” Henry Kissinger’s name for us was, “Useless eaters.” Seems to me that the parasites who’ve been destroying the economy and every supposed regulatory agency we (used to) have in this country would fit that better than people like me. We worked hard before we got hurt, and would again if we could find decent food, medicine that doesn’t make us worse when it doesn’t kill us, and a few honest Federal Judges and Prosecutors. If they still exist.

    Ian

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  8. KB says:

    I called three supplement companies that I have done business with to let them know what the FDA is attempting (again) and whether or not they actually knew of this, and their various representatives responded with:

    1. “Oh, I’m sure they’re aware.” (i.e., when pushed for an answer, had no clear idea, made excuses, and did not really appear to care because the topic was outside her scripted replies)
    2. “I will definitely let my supervisors know” (i.e., this person was actually concerned as he took time to read the article I was referring to).
    3. “We’re not going to worry about that now. I’m sure this is way in the future. This has happened before.” (i.e., felt that this just would not happen to HER company and didn’t really care because they “are totally compliant with the FDA”).

    What apathy. Guess which company I will continue doing business with (you guessed it, Bachelor #2)

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  9. Bill Z says:

    Make no mistake, this is an egregious abuse of power. Remember what Jefferson said, it is the responsibility of the people to resist tyranny. Requiring NDI notifications under DSHEA, in the guise of compliance of the Food Safety Modernization act is a tyrannical attempt by the FDA to bend to the will of those interests that would like to eliminate supplements. This should make people angry as it is a misuse of the law. The fact that this was proposed on July 1, the day before a holiday weekend in the US, glaringly spotlights the fact that the FDA knows this will be controversial and was desperately trying to avoid media attention. This needs to be brought into the light of day and widely debated, fairly and responsibly. I think if this is done there is a good chance cooler heads will prevail and such an outrageous and ridiculous proposal will fade into the trashbin of history as just another failed idea of those who would put profit motives ahead of human health and the freedom to choose what supplements citizens can consume.

       0 likes

  10. jb says:

    The answer to this new, obscene FDA tyranny is simple.
    DISBAND THE FDA!
    It is past time.

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  11. Alan8 says:

    Let’s not mince words here: THIS IS A SYMPTOM OF THE BIPARTISAN FASCIST ATTACK ON CITIZENS.

    Fascism is the corrupt alliance of government and corporations against the people. This is being done to increase the profits of the health-related corporations that contribute to Republicans and Democrats.

    We have to stop playing the two corporate-funded parties’ rigged game. The Green Party doesn’t accept corporate money and represents CITIZENS’ interests. 5% of the vote will get the Green Party matching Federal funds, and send a strong message to the corporate parties that selling us out to corporate interests will lose them votes.

    VOTE GREEN!

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  12. Kelly Smith says:

    Power and Money: That’s what it is all about! They could care less about the health of the consumer.

       0 likes

  13. Diane Kavanagh says:

    Natural supplements should only be banned if there are complaints from users and thy are serious enough to warrant investigation. Pharmaceutical drugs which are approved by the FDA have killed and maimed hundreds of thousands of people. The FDA could be usefl if it randomly tested supplement bvrands for having the listed amount of ingredients in the product.

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  14. Michelle Friesenhahn says:

    It’s absolutely repugnant that the FDA could have the power to nix all vitamin supplements, while allowing Big Pharma to push synthetic drugs that eventually prove to be deadly. This issue will bring all people of different political persuasions, even radical opposing radical perspectives, together.

       0 likes

  15. JB says:

    FDA regulations that poison our food and drugs and try to take away our supplements reveal an agenda for population control and mass murder. Such govt. institutions are controlled by the same foreign financial powers who control our money supply, have us in debt and tank the economy at will. We’re living in a dark Orwellian age of evil. Not by mistake or accident but all by top 1% design.

       0 likes

  16. Abdi says:

    The fda is now hitler many people need vitamin b6

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  17. The FDA is guided by big pharma. This is the last straw for people feel that it is their right to take care of themselves. This will be a fight the FDA doesn’t want.

       0 likes

  18. Kristen Zehner says:

    I cannot understand HOW Congress (mostly the GOP fascists) has the time to fiddle-faddle with these issues when it is doing absolutely nothing about jobs or the economy, let alone the debt ceiling. WHY has the deficit become the big topic of concern with the GOP when nobody cared a whim while the GOP was creating that same deficit that they all voted to approve?? NUT JOBS.

       0 likes

    • don says:

      ABATE the FDA,TSA,HLS,CIA,NSA,fedreserve industrial military complex these organizations has rotted our very core of our principals of american and world freedoms nothing but parasites

         0 likes

    • Kelly Fuc says:

      Wow Kristen. Take it down a notch, and back off the GOP. Obama’s been nothing but a failure. I’m sure you haven’t noticed…spending MORE MONEY which has done jack to unemployment, and giving us Obama-care which is nothing but a big disaster nobody wanted. Besides, it’s the D-E-M-O-C-R-A-T-S that routinely get big money from BIG PHARMA lining their pockets during election years. Hilary Clinton and Obama are at the top of the list.

      And Last time I checked, the majority of Conservatives are for LIMITED GOVERNMENT and personal freedom. Ron Paul even supports the production of Raw Milk. So if you’re for all the things this website stands for, you’re really in the wrong party. Wake up and smell the coffee: Obama’s going to be OUTTA THERE in 2013.

         0 likes

    • Daniel says:

      And the Democrats are sleeping around too >>> (NaturalNews) A new bill introduced by Sen. Dick Durbin (D-Ill.), S. 1310, the “Dietary Supplement Labeling Act of 2011,” threatens to undermine the dietary supplement industry by giving the US Food and Drug Administration (FDA) more power over it, despite…

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  19. David Forde says:

    Go get them

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  20. Tim Moore says:

    The FDA has not shown the evidence of their actions being fair .

       0 likes

  21. Laura B says:

    Keep your hands away from MY health and supplements.

       0 likes

  22. Ben Martinez says:

    Please reevaluate your policy of blocking all supplements for sale. I take a group of them and have found that they have been of much help to me. Thank you.

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  23. I keep hearing that the FDA is under funded and understaffed and that’s why regulations regarding the polluting of our planet can’t be kept up with. Yet, the FDA can allow the poison makers control our health and take away natural options to increase the cost of healhcare without improving the potential for accessing better healthcare. What is your purpose and/or intent? Will robbing us of healthcare options improve your health? If so, who the hell are you?

       0 likes

    • LK says:

      I think you may be confusing the FDA, which is the powerful Food and Drug czars, with the EPA, which has, as you suggest, been rendered toothless.

         0 likes

  24. Randy Alexander says:

    The FDA needs to but out. Look what a good job they have for the drug companies and they work for them not us. They need to be fired and put in jail for all of the bad drugs they have approved and that have killed so many people with their approval. Supplements are not drugs they are the missing part of the bad food we have to eat that the FDA already approves! I guess they do it for population control. I don’t know how they sleep at night.

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  25. none at this time

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  26. Kelley Harper says:

    The FDA has overstepped their bounds, They should but out!!!!!!

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  27. Please keep up the EXCELLENT and DILIGENT whistle-blowing. I know we have made a difference in other similar matters. ANH carries a very important torch. I salute you!!!

    Stephen M. Perkins
    Certified Natural & Holistic Health Practitioner

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  28. Kathleen Nicholson says:

    I really appreciate the e-mails that I receive from the Alliance for Natural Health. You have kept me abreast of what is happening in Congress and Washington. Without your e-mails, I would not know what they are doing and how it affects my freedoms and rights to purchase what I feel I need for my personal health. Please keep up your good work please keep helping me to know when and how I can be of help in these efforts.

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  29. George Halas says:

    Properly prescribed prescription drugs kill 110 thousand people a year in the USA. That is twice the number of our soldiers that were killed in Vietnam over 15 years.
    JAMA’s own report – Compare that with deaths from supplements yearly.

    Hey FDA you’re parking up the wrong tree. Of course you won’t dare report any abuses of your future employers (Big Pharma) will you.

    How do you people (FDA) sleep at night.

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  30. Michele B. Ford says:

    Well little by little the American public is losing more control over our lives in regards to our health and well being. All for a dollar.

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  31. Mary says:

    I’ve been taking various vitamins most of my adult life. I think it should be continued as it was, since it has not caused anyone ill effects when you follow dose amounts. I usually do some research on my own regards some health issues, such as menapause, and found what I needed in vitamins to make the transition smooth. Several doctors tried to put me on hormone treatments even though I said I had no complaints. I then told them my regimen about two certain vitamins and the daily dose. Both of them knew what I was talking about, as they put down their pens after hearing me out. Most doctors are told by pharmaceutical companies to push their product, no matter what. I feel a natural solution should be the first choice then procede to other alternatives if that doesn’t work. Medicines only cover up the problem, it never resolves the cause of the disease.

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  32. alexander says:

    Please don’t hinder the Supplement market. Due to the pitiful lack of nutrition in factory farmed, processed and restaurant foods, we need to have these supplements in our diets or we are destined to chronic, nutrition-based diseases like candida, crones, diabetes, cancer, tuberculosis and others .

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  33. geminga says:

    The new world order better known as the rich and powerful feel that the planet is too crowded. Therefore what do you do?Take away healthy food with your massive agra profits.Take away supplements from the public who has no health care . In the meantime as folks get sick with no way to protect themselves,their supplements gone,will get increasingly more dangerous pharma drugs if they can afford them. Those who cannot afford medical care will just die needlessly. Many of my friends think I am a conspiracy theorist. Wait untill the long arm of the rich and powerful grabs them personally. I prefer to call thse rich folks better known as elite, as evil doers.They don’t care who they kill. Don’t believe me…..see the documentary”Burzynski the Movie”. You will never see the FDA or your so called government in the same way again.
    Call every congressment in your district and let them know you want the clear evil intentions of the FDA reined in now. Tell them you want the hostility toward supplements stopped and the power of Pharma in our public agency haulted.

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  34. Dorothy & Richard Chamberlin says:

    Compared to drugs, supplements generally are very safe and you do not see thousands dying every year from them as you do with drugs. Please remove some of these very dangerous drugs from the market and leave our supplements alone. Our health depends on these products as we avoid drugs best we can. Thank you.

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  35. Sarajane Hall says:

    Retaining the freedom to take the supplements I chose and that are not adulterated or disappeared by nonsensical actions that seem to me largely political (e.g., Big Pharma’s desire to control all health related matters) is a passion of mine. I urge you to organize rallies, marches, and online protests to combat the evil, greedy forces that don’t give a rap about my or anyone’s health, but instead care only about their bottom lines and their “reputations” as guardians of health food safety. Let’s band together and educate the public about the true state of food safety, and at the same time fight for ctizens’ right to design their own supplement programs in conjunction with the work of knowledgeable health professionals.

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  36. Harmony Salvatore says:

    I will use what I decide is safe!

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  37. Can any of you folks tell me why two of the three most important issues of a nation or in the life of an individual are controlled by two entities that cannot be touched. The Federal Reserve has the final and absolute say insofar as money is concerned, and it answers to noone. The FDA has the final and absolute say insofar as our food supply, drugs, medical treatments (such as stem cell therapy), vitamins and other nutrients are concerned.
    Why are these entities untouchable? The rest of our government has checks and balances, and although they often fall short in the integretity department, at least they can be chastised on election day.
    The third most important issue of our nation and in our individual lives is freedom, and the Federal Reserve and FDA, through the control of our bodies and our finances ,do a very good job of stripping us of that.

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  38. Sherry says:

    I prefer my supplements to dangerous prescriptions with terrible side effects. My family doctor even recomends use of certain natural supplements. It seems to me the pharmasutical companies want the polticians to step in and stop the use of supplements so they can make more money selling the dangerous medications, all while the politicians get their pockets lined in the process. The citizens are not being well represented when the medical community rules the politicans. We need to put a stop to this practise in America.

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  39. nancy says:

    Leave our supplements alone. The drugs are too darn expensive and the supplements are all we have.

       0 likes

  40. Kevin says:

    I am outraged! As a person who has been using natural medicine for almost half of my life, it is unconscionable to think that a bunch of bureaucrats in Washington, D.C. It could dictate to everyone else, what vitamins they can take. I have personally been helped by supplements and by natural doctors. I know what they can do for myself, and for other people. It always amazes me that they approve drugs, which we know has had some terrible effects on people’s life’s, and yet they go after these vitamins which we know, “have had very little problems” Their only crime. They have helped many people. In my case, they stopped my seizures. I know this does not always work in every case, especially with seizures. Every seizure is different, and it can be very dangerous, but it does work in some cases. It’s time to send our Representatives and Senators a message:
    Stop ruling by fiat, and start representing the people, as you were sent there to do.

       0 likes

  41. RIchard Vultaggio says:

    We do not need natural supplements regulated and/or not allowed for purchase in the USA. Big business & drug companies want this passed as they did in Europe(which is hard to understand why the people could not stop it as they have been leaders in natural healing & environmental issues, obviously big pharma, big business and possibly govt’s took over). This is unfair and unjust to limit ones access to Natural Supplements and Natural products. No one but God or whoever you believe to be the Creator, has a say in who is able to use or purchase natural products or ingredients.

    Richard Vultaggio

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  42. Susan says:

    Our rights are rapidly disintigrating. When we will be forced to choose between big pharma and all of it’s misgivings, and nothing else, because our natural meds/supplements will be gone; then, there is no more choice for us.

    “That whenever any Form of Government becomes destructive of these ends, it is the Right of the People to alter or to abolish it, and to institute new Government, laying its foundation on such principles and organizing its powers in such form, as to them shall seem most likely to effect their Safety” [health] “and Happiness.”

    Our for fathers did not know to add health in there, so I did. Fed up!

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  43. Wallace Shaunfield says:

    When will congress realize that the FDA really is a loby for the drug companies and are only interested in the profits of the drug companies and in filling their own pockets? Health of the American public is the last thing on their list of priorities.

       0 likes

    • Melinda says:

      What makes you think they don’t? Sadly, I believe they do know but it is the all mighty dollar running the show, Campaign contrabutions are very motivating you know…

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  44. Thank you for keeping the public updated on the FBA’s actions.

    Since the Food Supplements have made people healthier, many do not take any prescription drugs and the Pharmaceutical Companies are losing money. Many people have died from the wrong drugs. Everyone’s system is different and what affects one person a certain way may not apply to the next individual. Gender differences would naturally apply also. I do not believe enough research has been done on these very important issues.

    Natural food supplements very seldom cause any reactions on people, especially if they follow the instructions. I am a healthy active 88 year old lady who takes many health food supplements. If the Drug companies get involved and change or try to stop health food supplements and thus raise the cost much higher for these supplements, it would be an unnecessary tragedy for us Seniors or anyone who else who uses food supplements.
    As far as I know no deaths have occurred from taking food supplements whereas the pharmaceutical companies cannot make this claim.

    We must do all we can to stop the New Dietary Ingredient (NDI) laws enacted to stop the Natural food supplements in any way.
    Thank you. Keep up the vigilance on the FDA.

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  45. Pamela Powers says:

    this is what I added to the letter:

    If this a democracy, and I’m beginning to wonder, it is our right to choose our health regiment in the manner we see best. I had endocarditis twice, and I would have had open heart surgery to replace 2-3 valves, probably would have died, or been at the mercy of the pharmaceutical industry for the rest of my life, paying out my meager savings, put on welfare and die with dementia in an old folks home, stripped of my money, stripped of my health, stripped of my dignity.

    It is imperative that you stop interferring in our choices for health care, and let us choose our methods. With supplements and without pharmaceuticals I am nigh healthy. I refuse to be put in a position of taking those damnable prescription pills with all their side effects. Those are the pills you should be taking off the market , not messing with our supplements. How can you think you are doing something good, when you let these hellaciouos prescriptions continue on the market???

    I’ve never smoked, so this is like cigarettes vs marijuana. You can’t deny marijuana when you know cigarettes kill but you still let them on the market. In the same way you can’t make it harder for supplement makers when you allow these horrible prescriptions on the market.

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  46. jill warga says:

    The government has no problem approving drugs that kill and maim us, but they want to take away our freedom to buy supplements? They have no problem telling us we can’t smoke anywhere–they want us to take deadly drugs to quit like Chantix. They have no problem genetically modifying our foods; yet they don’t want the food to be labelled GMO. The government wants to tax soda–instead they want you to buy drinks laden with deadly nutrasweet. The government rewards big business and financial crooks, yet it’s us who has to pay more for health insurance, home and auto insurance, bank and credit card fees, mortgages. No one is helping the PEOPLE of America. I think it’s time they butt out of our lives and let us live as we choose. DON’T MESS WITH MY NATURAL SUPPLEMENTS!

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    • Gina Coker says:

      You have hit all the problems right on the button! This administration, like all the others, is toothless in the face of big business. If I was getting rich screwing the people who voted for me, as opposed to being on sale (like a whore) to the highest bidder, I would do everything I could to lie, beg, borrow, and steal. The government and big business are the ones who sent our jobs out of the country, beginning with Clinton and NAFTA; under the first Bush they robbed the S&Ls; under the second Bush, the banks robbed the people with the fake mortgages; and they caused a worldwide recession. Instead of bailing them out, someone should have gone to jail! Because they don’t want to pay us decent wages, give us health coverage, they shipped our jobs out. Now, they want to bust up the unions who had to be created in the first place because this is how they were treating us in the 1900s. People better wake up. We’ll all be in the poor house, or under the ground, or filled with cancer, because all they care about is amassing more money and don’t care who they kill to do so.

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  47. Patricia King says:

    Those of us who care about the quality of the food and supplements we ingest must not only be very vocal to agencies such as the FDA, we must also be very vocal directly to President Obama who has the responsibility for appointing people to head up these agencies. When I look at the decisions being made by the Department of Agriculture and the FDA I am not happy with the choices he has made to date. I have communicated my discontent to President Obama and I hope all of you will join me in the effort to persuade him to appoint people who are more attuned to the people and less attuned to the desires of agri-business and pharmaceutical manufacturers.

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    • jackie says:

      this is what I added to the top of ‘the letter’… ;)
      ‘First.. Why would the American people trust the FDA about anything? sadly their own record speaks for themselves.. Drug Corps have got richer and people have got sicker…So, the fact they have launched an all out war on ‘natural food and medicine’ because it is not safe??? is laughable and dangerous… I would appreciate it if you took the time to read the whole letter..
      A few things…’

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    • Linda N says:

      Done! Thanks for the tip.

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  48. I will keep posting articles like this on my website, http://www.drtchiro.com. I also tweet and facebook your action alerts. Thanks for the work you are doing.

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  49. Loren Mortensen says:

    We dont need your help we can think for ourselfs

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  50. debora tyler says:

    I wish the FDA would get it right!!!!!!!
    the fact that over 1700 drugs were black boxed. ( the last 2 years) and that psychiatric drugs do not work, and cause kidney , liver disease of heart attacks. diabetes on the rise thank you coke.
    and the drug companies have paid over 20 billion dollars on fines for mis representation of their pharmaceuticals. and it is found that we are one of the most obese of the developed nations, not under developed , thanks to HFC and aspertame.
    that GMO crops kill lab rats and mice
    fire the remaining FDA and hire real scientists , if you can find them. since we are running 48th worldwide in scienc and math, OMG

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