Senators Give Supplements a Lifeline

January 3, 2012
Print This Post Print This Post

LifelineWill it be enough to rein in FDA’s outrageous power grab?

ANH-USA, together with a number of supplement trade organizations, went to Capitol Hill to plead our case about the FDA’s profoundly flawed NDI (new supplement) draft guidance in the offices of two powerful senators and longtime friends of natural health, Sen. Tom Harkin (D-IA) and Sen. Orrin Hatch (R-UT). Our visit was preceded by all the letters you have been sending to Congress, which have immeasurably increased the visibility of this issue. As you know, if this draft guidance stands, it would allow FDA to arbitrarily deny the sale of any supplement created (or modified) in the past seventeen years. Immediately after this meeting, Sens. Harkin and Hatch wrote to FDA Commissioner Margaret Hamburg and formally asked the FDA to withdraw its guidance document.

The senators urged FDA to begin work on a new draft that provides needed clarification on what constitutes a New Dietary Ingredient (NDI)—but, in their words, does not undermine Congress’s desire to provide consumers with access to safe, affordable dietary supplement products. Exactly!

These senators were uniquely qualified to make such a request, since they were the principal authors of DSHEA, the Dietary Supplement Health and Education Act of 1994. “When Congress included language in the Food Safety Modernization Act (FSMA) directing FDA to clarify when a dietary supplement ingredient is a new dietary ingredient, the expectation was that the guidance would be consistent with DSHEA,” they write. “Unfortunately, the draft guidance serves to undermine DSHEA in a number of important respects.”

They go on to outline the various arguments that we have been making in these pages for some time:

  • The requirement for a manufacturer to submit an NDI notification for every dietary supplement containing an NDI is directly contrary to the language of DSHEA, which requires notification only of the intent to use an NDI;
  • This new requirement is burdensome and would impose substantial additional costs on manufacturers, would not provide additional safety benefits, and would undermine access to the safe, affordable nutritional supplements that DSHEA was designed to ensure;
  • The NDI guidance’s assertion that synthetic copies of ingredients can never be a dietary ingredient is without any statutory basis, and is contrary to longstanding FDA policy; and
  • This guidance is contrary to Congressional intent by grandfathering in only ingredients that were marketed before the enactment of DSHEA—such an argument is particularly specious since “the term dietary supplement wasn’t even defined prior to DSHEA”!

The senators requested that FDA meet with interested parties to work through all of the issues raised in our and others’ comments. Fortunately, FDA can’t just ignore the senators’ request, because the agency is required to work within legislative intent. Otherwise they would be creating new law—which legally they cannot do. This is one of the arguments we have been making all along—that FDA is in fact making new law with this draft guidance, and now Congress is calling them on it!

We would like to thank Senators Harkin and Hatch for being such stalwart champions of natural health, and for their leadership in this battle to prevent the FDA from usurping powers that they are not legally entitled to. We also want to thank every one of you for contacting Congress and the FDA and being such a vital part of this process.

We aren’t out of the woods yet—we’ll have another update soon with additional action items for you. The time may come for more specific legislative action, and we may find ourselves battling FDA in the courts as well. That’s why your continued support and activism is so terribly important. Together we can win this one, preserve your access to supplements, and keep supplements from costing as much as drugs.

106 Responses to “Senators Give Supplements a Lifeline”

  1. The fundamental problem with implementing affordable health care in America is the fact that it costs hundreds of millions of dollars to perform all the testing required by the FDA to get a substance approved as a drug, and if this drug can’t be patented, then there’s no profit motive for a company to pay for the testing. One reason a substance with healing/curative powers may not be patentable is if it is a naturally-occurring herb or vitamin. There are many cancer cures identified by published NIH research that fall into this category, including one that saved my life from Melanoma, just this past year, Curcumin. (See: http://www.ncbi.nlm.nih.gov/pmc/?term=cancer+curcumin+apoptosis ). Without this common supplement, Melanoma would have killed me, as there are NO FDA-Approved Drugs that are as effective at treating Melanoma as Curcumin. The AMA/FDA/Big-Pharma approach to treating Melanoma involves surgery, radiation, and Chemotherapy, the side effects of which are devastating, expensive, and on-average, ineffective. I was without Health Insurance, having been laid-off, and had to spend my own money and do my own research to find an alternative approach to treating Melanoma, myself. I managed to succeed, using Curcumin plus a few other vitamins and supplements available to me at the local vitamin store. In all, curing myself of Melanoma (with a 3-month prognosis) cost me about $1000, including treatments that I tried that proved ineffective. (Today, I could save someone from dying from Melanoma for about $100, using only supplements available from vitamin stores.)

    In doing my research, I found that Curcumin, along with a handful of other common supplements, can cure many other types of cancer, including the most common killers and the most-common childhood cancers. NeuroBlastoma is similar to Melanoma, and can be cured by Curcumin as easily, with few side effects. (Curcumin is simply the compound in common yellow mustard that makes it yellow.)

    Leukemia, the most-common childhood cancer, can be killed effectively by grape seed extract. (See: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2760842/?tool=pmcentrez ) Obviously, no Big Pharma corporation is going to pay hundreds of millions of dollars jumping through the FDA’s regulatory hoops to prove a yellow-mustard derivative or extract of common grape seeds can cure cancers when they already have a monopoly on more profitable (and less-effective) chemotherapeutic agents. It isn’t a matter that Big Pharma corporations are intrinsically evil, *wanting* children to die, it’s simply a matter that, according to corporate laws and SEC regulations, corporations’ first loyalties are to their SHAREHOLDERS’ PROFITS. A well-meaning CEO could spend the ~$500Million to prove that Curcumin or Grape Seed Extract is effective and harmless, and actually end up being PROSECUTED under current corporate laws for acting AGAINST the interests of the Shareholders’ Profits (by making alternatives to their own highly profitable/ineffective chemotherapeutic agents that CAN’T be patented, so anyone could buy a generic version as soon as the “drug” is proved safe and effective). Despite the fact that this would be to the great advantage of the health care system and to the benefit of those who have to pay for that health care, the current system, including the FDA, precludes the course of action that would allow these childhood cancer cures to be developed and used to cure the sick children stricken with cancer.

    Clearly, since the current system is actually PREVENTING KNOWN CURES for CHILDHOOD CANCERS from being used to SAVE THE LIVES OF CHILDREN WITH CANCER, THE CURRENT SYSTEM NEEDS TO BE OVERHAULED!

       5 likes

  2. justin says:

    Why dont people see that every bill that passes is just another step towards all of our fredom gone , its already half gone .We need lots of help.

       2 likes

  3. Unfortunately the type of ‘corruption’ you experience in America with large corporates lobbying the goverment to put restrictive practices in place that would enable them to sell more artificial chemicals is not limited to America. It’s spread to New Zealand, too. We have a new ‘food bill’ which is being vehemently opposed by the public, the full details of which are here: http://www.legislation.govt.nz/bill/government/2010/0160/latest/DLM2995811.html. In brief it attempts to place a lot of restrictions on growing your own food and sharing seeds, which is exactly the type of thing Monsanto would love.
    Add to that some negative stories seeded in the media about the efficacy of supplements, plus ongoing attempts to regulate what supplements are allowed to be sold, what can be said on the packaging, etc, and you’ve got a perfect storm of corporate greed outweighing the common good.

       3 likes

  4. Amy says:

    Thank you!

       0 likes

  5. Madeline Loder says:

    Thanks!!!!!

       0 likes

  6. Beverly says:

    I was suprized and glad to read this article. I hope it sticks! Big Pharma has way too much power already, and they have No biz. playing GOD. they will pay for that by the way.

       0 likes

  7. thank god!! Great job!! Senators, that’s what we need. Let us come together and make this world a better place to live. Let’s eliminate at least 50% of the FDAs power.

       1 likes

  8. Terry Ellen Robinson says:

    Please note that Utah Senator Orrin Hatch is a great supporter of supplements as citizens of Utah fervently use supplements for health care. Relatedly the making of supplements is a major industry in Utah. I have purchased supplements from various companies there, and the products are sensational.

    Consequently, every time someone in Congress tries to stop the purchase of supplements I email Sen. Hatch to stop this attack and especially as Sen. Hatch has a lot of seniority. And he always comes through.

    We owe many thanks to Senator Hatch.

       1 likes

  9. William MacDonald says:

    Tell the FDA and Government to leave the supplements alone. I have been taking herbal supplements over the past 20 years and haven’t had any side effects or major illness. LEAVE THE SUPPLEMENTS ALONE FDA AND GOVERNMENT”””””’

       1 likes

  10. I want to just encourage everyone here who is an advocate of health freedom, to stand up and support our congressman in eveyway we can, especially to those who want to help keep our supplements on the market so we can continue to using them for as long as possible. A very big thank you goes out to Sen. Tom Harkin and Sen. Orrin Hatch for standing up for Americans to help us have access to our supplements. Their help is a big step in the right direction. Way to go senators, I wish both of you the best of luck.

       0 likes

  11. I’m wondering why online, catalog and retail stores who deal in supplements don’t mention the issues/problems/attacks ANH-USA articulates.

       1 likes

  12. Helen says:

    You all know the AMA, the FDA, the pharma drug peddlers and anyone who benefits from being connected with them is diligently trying to rid the medical profession of chiropractors, naturopaths and holistic providers. Our health is being manipulated by those in power.
    I’m not sure the two people mentioned are not “wolves in sheeps clothing”
    I have experienced the severe effects of several pharma drugs and my health has been impaired by them

       1 likes

  13. Madeline Loder says:

    I have been taking supplements from health food stores, too, for 30 years or more! They are one of the reasons I am in very good health.Please leave our supplements alone. The companies that provide these natural substances do an excellent job of providing quality products to their customers.

       0 likes

  14. Ted Conway says:

    A positive small step. But look into previous employment of FDA (and other agency) officials
    and researchers.

       0 likes

  15. andrew baker says:

    i’m totally in agreement with both senators’ efforts to prevent the FDA from taking on the natural supplements industries. besides, natural supplements have been the mainstay of medicine for many thousands of years and it should continue that way.

       0 likes

  16. Suzanne says:

    True the FDA needs to be reigned in on a lot of things. This is a good start as is doing away with S510.

       0 likes

  17. Jerilyn Capaccione says:

    I pray that the FDA will not be allowed to get rid of our natural supplements. I’ve also been using them for over 35 years and if we can’t buy them anymore, I don’t know what I’m going to do–I don’t believe in conventional meds at all and haven’t used them for about about 35 years. Keep signing petitions everyone!

       0 likes

  18. GERRY says:

    They need to use the vitamins and natural alternatives to be used as medications as a medication for our health on the income tax forms. This would help many citizens. Then the doctors would have the ability to work with their patients and make sure that they will survive instead of dying from pharmaceudical medications.

       0 likes

  19. GERRY says:

    In 2003 I had a heart attack that led me to by-pass surgery, quad, then two years later stents. The medications the doctors were prescribing made me worse, that’s why the stents had to be applied.
    The medications became toxic to my body, everyone they tried gave me more health problems. I told my cardiologist this and he wouldn’t listen. So I did the next best thing, I changed cardiologist. I found one that listened and he agreed that I start vitamins instead of the poison medications that were killing me. I have lived on vitamins, herbs, homeopathics and natural alternatives since 2005. The heart medications not only were poisoning me, but they put weight on. Naturally the Doctors do not tell you that these medications will put on weight, especially with women. The medications also screwed up my thyroid, metabolism, and created other health problems until I start my vitamin therapy.
    Thank you Senators, otherwise there would be a lot more deaths caused from medications. I live in Maryland, Maryland does not allow Naturalistic Doctors in our state. In fact, they frown upon any Natural Medications, so doctors are not allowed to prescribe a natural alternative as medication. Now all we need is to have the Senators allow natural alternatives to be used as real medications and be allowed to take the vitamins, herbs, and other natural medications off as medications for health purposes. If it wasn’t for the vitamins I would have been dead by now. I use certain vitamins as antibiotics and that’s what keeps me alive.

       0 likes

  20. Jen says:

    Let’s get the Gov’t out of our personal lives.

    If you have not done so already, please take a serious look at Ron Paul for 2012.

    Thank you

       0 likes

  21. Ann Cockrell says:

    I am almost 72 and TAKE NO PRESCRIBED MEDS and I am extremely healthy. I have reversed by osteoporsis with a multiple, Vit D-3 (10,000 IU) Vit K and a few others. I only exercise about twice a week for 30 minutes. I do walk a lot around the house every day.

    PLEASE STOP THE FDA TAKEOVER of SUPPLEMENTS ! ! ! !

       0 likes

  22. Vanessa says:

    In the past 27 years there have been 0 deaths from the usage of vitamins in comparisson to over 3 million from the usage of prescription medication! It is rediculous that the FDA is regulating vitamins when they let pharmaceutical companies get away with murder. They protect them, hide dangerous data and say it’s safe, attack alternative medicine, have loopholes in their system which allow organizations to poison us with pesticides and carcinogens in our food and consumable products, and let pharmaceutical organizations to put new, biasly, barely and unsubstantially tested medications on the market. They need to start doing their job! They say they do not have enough funding to put into substantiating pharmaceutical companies bias testing, but it seems they must since they have so much funding to waste going after natural supplement manufacturers!

    It just doesn’t make any sense!

       1 likes

    • Patricia M says:

      I would like to say thank you to the Senators that fight for us. We should have the right to use supplements if we choose. It is the pharmacy drugs that have dangerous side effects. My Mom always used supplements and was very healthy. I feel better when I use them. You don’t need those energy drinks if you take supplements.

         0 likes

  23. Linda says:

    I hope we keep our rights to have our herbal medicine. I trust it more than what the FDA approves. We keep seeing how people are dying from approved medication. We have to keep in control of what we take.

       0 likes

  24. Linda says:

    I hope we keep our herbal medicine. We have more control over our health. I trust it more than what the FDA approves. All you hear is how the medications are killing people and the terrible side effects. Shows you how much they know. We need to have say over what we take.

       0 likes

  25. Everything you need to know about Codex and then some is right here in this google video titled Nutricide,-Criminalizing Natural Health.

    http://video.google.com/videoplay?docid=-5266884912495233634

       0 likes

  26. Pauly says:

    Good job. I was going to get some COq10 just because it was on the list. It must be good for someone if it’s on the FDA’s list.

       0 likes

  27. Lee Horner says:

    There is so much more that the FDA is doing that they shouldn’t be doing, such as finding legal ways to ensure competing treatments don’t upset the business of cancer in this country. I think their actions are (or should be considered to be) legally criminal. The big pharmaceutical companies, the National Cancer Institute and the American Cancer Society are all colluding to keep viable cancer treatments; even some that have passed stage II of the FDA’s own trials out of the public eye and out of the market. This at a time that the FDA has placed or is trying to place limitations about what the public can know about the food supply and the relationship to increasing cancer rates.(for example: antineoplastons – there is a documentary out about it, I am hoping everyone will see it. at:http://www.burzynskimovie.com

       1 likes

  28. Modern medicine says God is a “quack.” I guess I’m in good company. This is not a religious issue, but it could profoundly impact the freedom that all Americans very often take for grated. Don’t ever presume they will stop trying to seize and control the natural substances that keep us out of the doctor’s office…or the hospital. The sooner people understand that the medical system is not about healing, but money, repute, prestige, and the right to put on a white coat and wear a stethoscope around your neck, the sooner they will fully comprehend the pervasive attitude and the mental processes that truly manifest the lunacy of both the medical and pharmaceutical professions.

    If you get the chance, watch the YOUTUBE video, “The Town of Allopath.” It’s very interesting.

       0 likes

  29. Michael Graham says:

    TO ALL WHO WORKED AND STUDIED to bring COMMON SENSE to the issue of supplements: a very big hurrraaahhhh !!

    Keep this the greatest country in the world by celebrating and continuing to employ that wonderful part of the human brain called common sense.

    Think about it: common sense is the sense that is common to a group of enlightened individuals: it is the product of the thought and reflection of a number of people looking at an issue from a number of points of view.

    It goes back to Plato’s discourses, it is essential, it is the bedrock that protects of from transient dogmas…..KEEP IT UP and THANK YOU

       0 likes

  30. Toni Francis says:

    I think it would be a great idea to provide all of us with a message we could sign thanking Senators Tom Harkin and Orrin Hatch for their instruction to the FDA to rewrite their NDI Draft Guidance and also letting them know how critical access to dietary supplements is to our health and well being. I’m very relieved to know that we now have a “lifeline.”

       0 likes

  31. Frank Marino says:

    Thank you for being a voice of reason.

       0 likes

  32. David Shelton says:

    Our government and its huge agencies has gotten out of control, and is more of a danger to citizens than a help. The life span of a democracy is about 200 years, and we are now past that. Time to reshuffle the cards.

       0 likes

    • Steve says:

      Right on brutha!! What happened to the Obama promise to get rid of all the “duplication & redundency”
      In the federal government? The CBO came out 3 weeks after he made this promise for the 3rd time & said they found over $200 billion a year in this waste. Now he has given the FDA totally unconstitutional power. We reshuffle this November 2012!!!

         0 likes

  33. Karen says:

    It’s nice to see direct evidence of the influence we exert as individuals and collectively. I have one word Schweet!!! Let’s keep this up.

       0 likes

  34. Roger Fuller says:

    1-4-12
    Since Tom Harkin is from Iowa, the number 1 corn producing state in the nation, what is his position on genetically engineered ( without our permission ), insecticide producing corn that is over 85% of total corn production in the USA ? How could he accept this corn and be for natural supplements too, especially during the Iowa Presidential Primaries ? And why total silence on GE corn from all the candidates, that supposedly represent the People ?

       0 likes

    • Becky rom Tennessee says:

      Its all about MONEY of course, and unfortunately no tthe health of the American public!

         0 likes

  35. Jack Lucero says:

    I THINK THE FDA NEEDSN TO BE RAINED IN ON A LOT MORE ISSUES THAN THAT<BUT THAT IS A GOOD START ( THANK YOU ) Congressman, Thank You

       0 likes

  36. Gloria Jones says:

    I have been denied insurance coverage on the basis of my choosing safe and effective supplements in lieu of pharmaceutical poison that my doctor prescribed only on a trial basis, as he is a staunch supporter of supplements. However, he was pressured to prescribe more “traditional medicines” in order to keep his practice going. So I gave the poison a trial, and the side effects nearly landed me in the hospital. When the doctor found out, he took me off the stuff. But because of this, I am now considered “uninsurable.” I asked the insurance underwriter if I should have continued taking the poison until it killed me, and then would I have been posthumously eligible. He hung up on me.

       0 likes

  37. Dale says:

    It is about time the Senators stood up for our freedoms against the dictatorial FDA.

       0 likes

  38. Arlie Lavender says:

    Its nice to know someone is willing to fight for what is right.

       0 likes

  39. Rita Raftery says:

    thank the universe!!! i have been using supplements for over 30 years and without them, the AMA and doctors would have destroyed me and my body.

    what are the next steps? what can i continue to do to ensure unhindered access to supplements of my choice???

       0 likes

    • JAMES HOLLIDAY says:

      I agree with Rita, unfortunately any thing Orin Hatch is involved in makes be suspicious. My guess is the only reason he agreed to make a request is because he gets more money from the large multilevel marketing companies who sell over priced supplements than from multinational pharmaceutical companies. I fear a wolf in sheep’s clothing here and that the FDA, DEA, and Big Pharma have not fired their last shot.

         0 likes

      • Martha says:

        Thanks to Senators Hatch and Harkin. The medical profession has been bought by big Pharma and they are trying to shut down supplements. I have had so many adverse side effects from different chemical meds that I am afraid of taking anything that Drs. perscribe. I was in the hospital from New Years day to the 4th of Jan. and they pumped me full of antibiotics and now I am having to take something to counteract the effects of that. I had another reaction from 2 antibiotics. Now I am allergic to six antibiotics. If they try to shut down the supplements I do not know what I am going to do. I have had very good results from them. My cholesterol is down to normal. I could not take them because of bad side effects. I say great that these two Senators stood up for our rights.

           0 likes

      • Nancy Anderson says:

        If Orin Hatch had not been around in 1994, the supplement business would have been destroyed. I remember when the FDA came in and cleaned off the shelves at our little health food store in Vermont back then. It was frightening, to say the least, and now they are trying to write a law, which is not their right. Thanks to both the Senator Hatch and Harkin for the new bill.

           0 likes

    • Saima Davis says:

      I have been on supplements for 46 yrs. as a drug almost killed me then. I do not trust drugs unless they are absolutely required. I think the FDA should check their drugs first before attacking supplements as there are thousands that die from drugs but you don’t hear of any deaths from supplements. Shouldn’t that be any proof of safety for supplements? I think Big Pharma is worried of supplements taking over their drugs. Follow the money!!

         0 likes

      • To all the friends who support ANH-.org who are the senators who are supporting the fda and who are our fighters ,so that we can write to them and thank them and support them at elections time. I think its always important to know who is on our side. Its better to prevent, then to repent in this case it might be to late for us to fight back after the barn door is shut. why don twe receive more press and tv media on this does the chemical company have more clout then those of us who are fighting for our freedoms thanks for the opportunity to comment JAS

           0 likes

Leave a Reply

Comment Policy:
ANH-USA provides a comment forum for our readers to share their constructive thoughts and criticisms about our newsletter articles and engage in civil debate with other readers. All comments are pre-moderated regardless of author. We never censor comments based on political or ideological point of view. We only remove those comments that are abusive, off-topic, use foul language, include personal attacks, or are otherwise discourteous and uncivil. Please do not post comments in ALL CAPS; on the internet this is considered "shouting."

 characters available

Follow us on...