FDA Says No to the Senators Who Drafted DSHEA

February 7, 2012
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FDA HHSAccording to our sources, the rogue agency is digging in its heels on the NDI draft guidance that threatens so many supplements, refusing to listen to Congress or follow the intent of the law.

Senators Orrin Hatch and Tom Harkin met with Dr. Daniel Fabricant of the FDA on January 26 to request that the FDA withdraw its NDI draft guidance altogether—a meeting that ANH-USA, together with some trade groups, helped set up. They were following up on their recent letter to FDA Commissioner Margaret Hamburg asking the FDA to stop the process altogether, withdraw the guidance, and start again after meeting with interested parties to address the list of significant concerns expressed by consumers and industry.

You may recall that the landmark Dietary Supplement Health and Education Act of 1994 (DSHEA) required that guidelines be established for supplement manufacturers to notify FDA when a new dietary ingredient was introduced into the marketplace. The FDA’s Draft Guidance for New Dietary Ingredients was supposed to fulfill that requirement.

Unfortunately, the FDA’s proposed regulations are in fact completely contrary to the intent of Congress when DSHEA was passed, and Sens. Harkin and Hatch wanted to make that clear to FDA. They should know—they were the two principal authors of the legislation!

According to our sources, FDA has turned down the senators’ request. FDA in effect said that it is refusing to reconsider its interpretation of what the NDI section of DSHEA means, regardless of what Sens. Hatch and Harkin say they meant when they wrote the law.

Does this mean FDA intends to use the NDI process as a de facto pre-market approval system—something which regulatory observers believe was specifically excluded by DSHEA? In a word, yes. We have been told that FDA claims the NDI process is the only “preventive control” for dietary supplements in federal law. Whatever “preventive control” means, it is completely untrue that supplements are uncontrolled under federal law or that the FDA lacks the power presently to regulate them.

In refusing to follow the intent of the law as clearly stated by the law’s authors, the FDA is acting as a rogue agency. If you haven’t done so already, please ask your legislators to make a one-minute floor speech opposing the FDA’s guidance document. FDA’s plan would sweep many supplements off the shelf and make the ones that survive much more expensive.

169 Responses to “FDA Says No to the Senators Who Drafted DSHEA”

  1. Karen Jurson says:

    Please, we love our supplements and believe the FDA is out of control, We need to pull the rug our from under FDA!!!!!!

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  2. James T Grayson says:

    You may recall that the landmark Dietary Supplement Health and Education Act of 1994 (DSHEA) required that guidelines be established for supplement manufacturers to notify FDA when a new dietary ingredient was introduced into the marketplace. The FDA’s Draft Guidance for New Dietary Ingredients was supposed to fulfill that requirement.

    Unfortunately, the FDA’s proposed regulations are in fact completely contrary to the intent of Congress when DSHEA was passed, and Sens. Harkin and Hatch wanted to make that clear to FDA. They should know—they were the two principal authors of the legislation!

    Leave our supplements alone. I take numerous supplements on a daily basis. They help keep me healthy. I would consider it a criminal act to make it impossible or even (simply) more difficult to obtain supplements that I have relied on for years and YES I eat a very healthy diet and exercise regularly.

       0 likes

  3. J.R. Jarvis says:

    It should be enough to remind the FDA that they are required to follow the letter of the law. If they want to reinterpret their mandate, it should be a matter for considerable public comment and review.

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  4. Laurie Marriott says:

    My freedom of health is being threatened in the world’s supposedly most free land. I should have the right to buy supplements without a prescription, therefore further lining the pockets of big pharma. It is very sad that in the brightest democracy in history, the FDA is representing the will of the few and privileged under the disguise of representing the protection of the people. Therefore this is just another brick added to FDA contribution to make our lives more expensive. This is what happens when a bunch of bureaucrats are abusing the powers we the people entrust them with. This is how so called in service of we the people becomes an enemy of us the people.

       1 likes

  5. lowell watson says:

    Is the following: science! FDA approves of mercury in dental fillings, Mercury and aluminum in vaccines. Floride toxic waste in the water supply, mercury is a toxic waste, how economical to the business’s to get rid of it at the health of the people. No wonder our heath care costs are sky rocoting. another so clalled scitence, agent orange Round Up ready seeds, which gets absorbed by the plants and we eate it,,(that is science? It destroys the nutrition of the plant, a self defeating venture to say the least. Eliminate the use of natural vitamans and minerals made by God to sustain life. Of course the FDA us in the pocket of the drug , agriculture , medical , dental etc. Currupt trach science, is not science. Check it out. L. Watson

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  6. Peter Wick says:

    Some foods and nutritional substances have natural medicinal value since the FDA is so biased against against the nutritional industry another agency should have oversite over nutrition.There are millions of people like myself that do not want to take harmful pharmaceuticals.The FDA is a rogue agency that is just trying to protect the profits of the pharmaceutical industry.

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  7. pam badger says:

    This is ridiculous . Natural heal and big pharma trying to stop real healing. WHY Mhy must this be so??

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  8. The FDA needs be reminded that they are not a law making body, as that is the job of the House of Representatives and the Senate. It’s rather obvious, in a common sense way, that the FDA has chosen to pervert the law with their Guidance Document for food suppliments!!

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  9. Vioet Sunderland says:

    One of my 2xgr grandfathers was a Methodist circuit rider in Dakota Territory, founded 3 churches and served as Chaplain in the 3rd Territorial Legislature at Yankton. He carried herbal remedies in his saddlebags to help those he ministered to. I have used my Readers Digest “Magic and Medicine of Plants” since It was published in 1986. That makes 5 generations of one family and I know there are thousands more that have maintained good health the same way. The current mindset to cut, burn and/or poison in mainstream medicine does not have such a success rate so let’s not bow to the greed of the pharmaceutical corporations, especially in light of the fact that prescription med deaths now outnumber traffic fatalities.

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  10. Liberty G says:

    Unfortunately, I think that Senators making a floor speech, one minute or otherwise, is of no concern to the FDA. As I understand it, that agency is now pretty much under corporate control, especially by Monsanto transplants. Nothing short of a bit of spine from whoever is supposed to be overseeing the agency (Obama? A Congressional Committee?) , or a lawsuit against them for failing to do their job, is likely to have any effect. Note that the “spine” element could consist of firing the renegade(s).

    I am sorry to have such a downbeat view, but I think you can well understand it. The “land of the free” has become the land of the Corporate, and Big Pharma has replaced the friendly family doctor.

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  11. Arlette Beauchamps says:

    PLEASE make a one-minute floor speech opposing the FDA’s guidance document!

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  12. Alice Burkhart says:

    with neither dietary supplements many Americans health will suffer. I won’t go into the reasons why on a broad base, but will you PLEASE ask the FDA to pay attention to the bill drafted by Orrin Hatch and withdraw its NDI condemnation of supplements. I’m not going to buy prescriptions to replace my supplements – I’ll die first.

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  13. Linda N says:

    Yes, well, preventative control for the FDA means, controlling what the supplement companies make so that it does not interfere with drug sales. In other words, don’t let people keep themselves well so we and our partnership with Big Phama, can make millions of bucks off of people’s ill health. I hope this comment is not censored.

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  14. I rely heavily on natural supplements to keep healthy and prevent costly medical problems. Without the ability to use these supplements my medical costs would soar. We don’t need any new rules by the FDA to regulate what is already regulated. Please do all you can to alleviate FDA’s greivous actions to control us. We are not a bunch of bad children who need their adult supervision!! Please stop the NDI draft guidance they are proposing that threatens our access to valuable supplements. Thank you for your kind consideration of this request.

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  15. Jerry T. says:

    What irks me is that these doctors refuse to study herbs and food as medicine. Now they think they can make such determinations for the public?
    Vote like you’re life depends on it.

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  16. ron Cushing says:

    We the people do not want NDI or any other restrictive laws against supplements. My doctor prescribes many nutritional supplements for me as they are necessary for my health. Do not cave in to these lobbyists and misguided shills for the drug business.

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  17. Kenneth Webster says:

    FDA says no because their major cash contributor (Big Pharma) says no. Pharma wants supplements out of their equation due to market share. They have been brainwashing the American public (and the world) that ‘only a drug can treat, prevent, or cure a disease.’ All they want is the money to pay their shareholders, and for themselves. And the more money and power they can give to the FDA, (to pass and enforce their laws), the less competition they can have. This is my opinion, and I’m sure many others will agree.

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  18. coalmine canary says:

    To undercut business and refuse them their right to sell, is unconstitutional.

    To cut jobs and businesses at a time when our economy is already dangerously low, is treason.

    It is time for us to replace this rogue Congress and FDA with better people who give a care.

    Will YOU run for public office, dear reader? Thank you.

       0 likes

  19. Jerry Burge says:

    Fire thye whole group for disobeying supervisors , ie Congree, President of USA and Citizens. iT MIGHT TEch all of government that they are employes not dictators.ie. Writers of our nationslaws!!!

       0 likes

  20. Steven K. Carter says:

    The FDA unfortunately is no longer a proponent of the people and their well being. It has been populated with pro pharmaceutical lackeys who mindlessly follow the orders of their masters. We must be continually vigilant as they’ll do anything they can to help the bottom line of big pharma and their stockholders returns. What a morally repugnant group they are.

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  21. Andy Flores says:

    For all the harm they cause and money they waste, the FDA should be abolished. They are nothing but a bunch of stooges for Corporations that see the general public as a bunch of suckers to be ripped off and poisoned.

    An agency like the FDA should only be run by people that are benevolent.

    That has not been the case.

       0 likes

  22. WickedPickle says:

    We don’t need this, we really don’t.. What’s a ‘free market’ that’s crippling regulated called? Profit for them, higher prices for us. The process has worked up till now with those who CHOOSE supplements can afford them and those with little faith can go to big pharma.. But someone wants it all.. More profit by squeezing out the competition. And even if it’s rejected now, there’s always tomorrow while everybody is sleeping or those obscure fliers placed onto helpful programs for what (balance?). We need to keep our eyes on these gangsters and make sure thy don’t go through the back door once we demand they cease and the law backs us up.. What a sorry situation we’ve gotten ourselves in by electing thugs and gangsters to oversee our lives.

       0 likes

  23. Doug Grant says:

    I apoligize for my spelling and grammer.
    I meant to say I wonder if these two Senators ( Orin and Harken) are going to let the FDA get away with what they just did and let them do what they want like Facist. and let them alone or will they have the balls to to lay down the law and start prosecuting the law breakers

       0 likes

  24. Bill says:

    Well after all, the government can’t have healthy people running around. Healthy people fight back against government corruption . . . and we can’t have that, now can we????

       0 likes

  25. Peggy Coster says:

    why no print button?

       0 likes

  26. Why can’t we have our vitamins the way they are now?? It make no sense to interfere the way the FDA is . Unless, of course, there is some hidden agenda on their part. For heavens sake, leave our vitamins and supplements alone, and chase down some of these toxic meds that you permit on the market. All we want is control over our own health.

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  27. George says:

    Maybe the FDA thinks they’re in charge? With so many members of congress and representatives DOING WHATEVER THEY PLEASE instead of taking the requests of THEIR constituents… It’s easy to see that the FDA could get this TERRIBLY MISTAKEN IDEA! Who’s in charge here? FDA? Congress? The people?

       0 likes

  28. Dr. William H. Light says:

    It is difficult to be civil about a criminal and renegade agency like the FDA. They are guilty of systematically falsifying and fabricating results to suit their own un-Consitutional and illegal grab for absolute power over everything we Americans eat and consume. This agency is particularly vicious in its prosecution of anyone or anything that offers effective alternatives to Big Pharma’s tyrannical monopoly over our own bodies. They are less concerned about alternative approaches that are no effective. It is the threat of any competition to their pharmaceutical masters that they fear. The FDA is bought and paid for by the pharmaceutical agencies. It routinely lies about the supposed efficacy and adverse effects of the drugs its masters promote.

    This evil agency must be abolished for the monstrosity it has become! It has specifically stated that “there is no generalized right to bodily and physical health,” not do we have the right to eat those food or consume those supplements we wish. These people are nothing but traitors and Nazis!

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  29. Oreste W. Lombardi says:

    Dear Congeressman;
    The FDA must be subject to congrssional over sight. It must not be allowed to make interpretations of DSHEA that are contrary to congressional intent.
    I submit that the FDA should be 100 % tax payer funded so that it represents us and not the industry that it regulates.
    I submit that the FDA could be a leader in getting main stream medicine to embrace all science based therapies, medicines, diagnostics, etc.
    I submit that all natural substances that have been found to be generally safe over the past 40 years be automatically approved for medical use. Clinical trials should not be required of such subsrtances since clinical trials at best can only determine short term safety.
    If it is necessary to completly deconstruct and then reconstruct the FDA to make it obediant to congressional intent and to serve the tax paying public, so be it.

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  30. John McElrath says:

    The FDA has been trying to turn the vitamin industry over to big pharmaceuticals for decades. Just more greed being shown by the big wheels that are supposed to be looking out for the people. Maybe Occupy ought to occupy the FDA for a few months.

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  31. Neale E. Smith says:

    I don’t trust the FDA as it serves the interest of big Pharmaceutical Companies;
    by trying to make healtful alternatives unavailable to common citizens;;
    to force citizens to use prescription drugs that the FDA does not adecuately monitor.

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  32. Shirley says:

    Just verifies what most of us already knew – the FDA is out of control and there’s nothing anyone can do about it. Follow the money….

       0 likes

  33. Carole says:

    Please, do not allow the FDA to get away with it’s total disregard for the wishes of the people of this country. Do not allow the FDA to refuse to listen to congress. Please make a one minute speech on this issue of the FDA refusing to answer to the people or the government.

       0 likes

  34. Janelle Lear says:

    Again we beg for the freedom to choose our health, in this case dietary supplements. Please help us keep that choice.

       0 likes

  35. Leland Nichols says:

    So why ask our legislators to make a one minute floor speach etc. etc, and instead why not use a little psychology and write letters to Hatch and Harkin pointing out that they wrote the DSHEA with the NDI process included and now the FDA is kicking sand in their face. Ask them who is in charge?
    The congress or a lessor federal agency? Why don’t they show their statemanship and just introduce legislation to abolish the FDA? Even if it didn’t pass you can bet they would get the FDAs attentiion. The senators would be surprised how much support they would receive to either eliminate the FDA or greatly reduce it’s budget and power. Seems to me as if it would make more sense to just let the free enterprise system deal with the problem. Since when is it the government’s right to tell me what I can put in my body? Actually, there are several ways to deal with the problem of a company bringing a product to market that is dangerous or ??? for the consumer, the solution to which does not require a gov. agency to be involved. When will the People wake up to the fact that government is the problem not the solution!!

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  36. Ric A Ohge says:

    The FDA seems to be a Rogue Agency…period. It conducts paramilitary raids on alternative treatment centers, on Health Food Stores, licensed Cannabis Dispensaries, and in general on anyone doing anything it doesn’t like. Often these raids are without due process and end without charges filed, even when people are detained, but nearly always with terror, destruction, and with goods being seized to never be seen again. It’s time to not only rein in this agency, but consider disbanding it and replacing it with something that represents sanity. At the end of the day, the modern consumer is a good deal more savvy than the folks it was invented to protect. It uses OUR money and taxes to suppress our choices. There should be nothing that inefficient or contradictory to the people’s wishes allowed to continue to function in our Government. Enough.

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  37. Leonard Korinek says:

    More proof how corrupt the FDA really is.

       0 likes

  38. Lannie Moore says:

    How dare the FDA tell congress to bug off and arrogantly say we aren’t. changing nothing! I,m more angry at congress then I am the FDA. Is that all congress can do is give speeches? Some heads need to be rolling out the doors of the FDA over this.

       0 likes

  39. joe says:

    this bully federal government has got to be stopt

       0 likes

  40. Michael Jones says:

    Teh FDA is truly a rogue agency controlled by big Pharm.

       0 likes

  41. Morris Hayden says:

    I think the FDA should be made to comply with the intent of the law. Vitamins and herbs are very helpful in keeping us healthy and we should be able to have access to all of them at a reasonable cost. My wife and I are 89 yeaars old and would not be enjoying pretty good health if we had not had access to alternative medicine.

    It appears that the FDA wants to make the law. PLEASE STOP THEM!!!!!!!

       0 likes

  42. Jolie says:

    Please do all you can to stop the madness. Be light warriors.

       0 likes

  43. Robert Morrow says:

    It only shows that these Agencies like the FDA, EPA and others have no controls as your own elected Official has given up all controls. We have what I refer to is controlling Shadow Communist commitees that now rule you and I, for we no longer have any rights under the Consitution of Bill of rights. So Comrades shut up and do as your are told or the Gestapo Swat Teams will pay you a visit and imtimanate you in to obedience with they guns drawn and you and your family lined against the wall.

       0 likes

  44. tekwyzrd says:

    Time to disband the FDA. It is obvious from years of approving unsafe drugs and medical devices that the FDA isn’t concerned with protecting anything other than the manufacturers. Those who approve dangerous drugs and devices should be criminally prosecuted, as should those who submit the often edited studies that are used to “prove” their safety.

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  45. Michael J. Agri Jr. says:

    It’s time to disestablish the FDA.

       0 likes

  46. george beisel says:

    i guess that the fda is now the obamafda

       0 likes

  47. Dan Vandre says:

    Keep our supplements free.

       0 likes

  48. Linda Zigich says:

    What is it about our government, specifically the FDA, the USDA, and our beloved Congress that fight so hard against things that keep us well, whether it be organic foods, nutritional supplements, or even labeling what goes into our foods? Clearly we have representatives bent on creating a world of consequence due to arrogance, ignorance, and deep pockets. A huge overhalul is needed and the leaders to do so

       0 likes

  49. Robert Morrow says:

    Of course the FDA is against anything that would cut into the Blood Satined 30 Pieces of Sillver. Just why has the FDA (Murder for Profit Inc.) beed stopped? It is a fact that they have approved poison drugs that kill thousands and allow thousands of toxins to be place in foods, yet your corrupt elected Official goes along with it. For their hands have the blood of people on then and all for profits. It is there just looked up. In the mean time I hope that you enjoy your next slice of Bread filled with poison foam Plastics.

       0 likes

  50. Get a petition going. Give us something to sign!

       0 likes

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