The 12th Invest in ME Conference, Part 1
OverTheHills presents the first article in a series of three about the recent 12th Invest In ME international Conference (IIMEC12) in London.
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NDI Supplement Guidance is Just a Bait-and-Switchand Time Is Running Out to Stop It!

Discussion in 'Action Alerts and Advocacy' started by *GG*, Oct 26, 2011.

  1. *GG*

    *GG* Senior Member

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    Concord, NH
    October 26, 2011

    Only 38 more days to tell FDA and Congress that the proposed rules for supplements could lead to the elimination of thousands of supplements and make the surviving ones much more expensive.

    When FDA issued their draft guidance for New Dietary Ingredients (that is, supplements), the agency was perverting congressional intentthe congressmen who wrote the original legislation even told the FDA commissioner before the guidance was issued that it needed to be fully consistent with DSHEA! FDA was also attempting to circumvent the notification system Congress intended by instituting a scheme that mirrors the Waxman supplement pre-approval system, introduced in 1993, which DSHEA was intended to stop.

    Heres some important background for you.

    Supplement and integrative medicine champion Sen. Orrin Hatch made this statement when he introduced the bill for DSHEA, the Dietary Supplement Health and Education Act of 1994:

    In our free market society, consumers should be able to purchase dietary supplements and companies should be able to sell these products so long as the labeling and advertising are truthful, non-misleading, and there exists a reasonable scientific basis for product claims.

    Unfortunately, not everyone in our federal government shares these views. For more than three decades, FDA has tried to restrict severely the ability of the dietary supplement industry to sell and market its products and, consequently, the ability of consumers to buy them. The agency has repeatedly attempted to impose unnecessarily stringent standards that would leave many if not most supplement companies with no practical choice but to close their doors.

    In sharp contrast, Rep. Henry Waxman wanted dietary ingredients and nutritional supplements to be considered food additives and therefore subject to FDA approvalnot unlike the system that is used for drugs. So Waxman introduced the Dietary Supplement Access and Claims Moratorium Act of 1993. This bill would have amended the food additive definition to include dietary ingredients (supplements)thereby making supplements subject to the food additive approval process.

    Happily, cooler heads in Congress prevailed. Sen. Hatch explicitly stated:
    As you know, [DSHEA] makes clear that dietary supplements are not food additives or drugs, and that the burden of proof shall be on the FDA to prove that a product is unsafe.

    Consequently, when DSHEA was passed, dietary ingredients were specifically exempted from the definition of food additives, making supplements not subject to FDA pre-approval. All that was needed was a simple notification.

    Now FDA has offered its draft guidancewhich attempts to circumvent DSHEA as it was passed and create a new pre-approval system. Everything about this proposal is a perversion of congressional intent, and will (as Sen. Hatch told the world eighteen years ago) severely restrict your ability to buy nutritional supplements and leave manyif not mostsupplement companies with no practical choice but to close their doors.

    Time is running outthe comment period ends on December 2! Help us protect your access to supplements. We need everyone reading this to send their message to Congress and FDA right now to make sure the FDA and Waxman dont win! Take action today!

    http://www.anh-usa.org/ndi-supplement-guidance-is-just-a-bait-and-switch/

    https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=833
     
  2. richvank

    richvank Senior Member

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    Hi, all.

    I want to bump this thread up, because I think this issue is very important. I have emailed my congressman and senators and have also phoned their offices to register my opposition to these proposed new FDA regulations. I also plan to register my views today at www.regulations.gov. I would encourage others here to do so, also. Preserving availability of nutritional supplements is vital, in my opinion, to addressing the causes of ME/CFS as well as many other chronic conditions. I am not in the supplements business myself.
    If we are serious about wanting to lower the costs of health care and make it more effective, limiting availability of nutritional supplements is a move in the wrong direction, in my opinion.

    Best regards,

    Rich
     
  3. Sallysblooms

    Sallysblooms P.O.T.S. now SO MUCH BETTER!

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    Southern USA
    I have called my senators and congressman, white house also. I have signed all petitions I can find. I pray we all call every representative we possibly can. This is vital as Rich said. I had a thread on it also. I guess I will start calling again.

    Do not think your call will not help. When I called before, the people taking calls told me they have had many calls. Don't forget to call AND email, including the white house. It is all so easy and you can google for the phone numbers, emails etc.

    Without supplements we need we will be in trouble fast.

    Thank you both for the sites that everyone can go to. Don't forget to go to your senators etc in your state and the white house. Do all you can. Time is running out. Tragic.
     
  4. *GG*

    *GG* Senior Member

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    Concord, NH
    Good to see that you feel this is not just fear mongering or something to that effect!

    GG
     
  5. Sallysblooms

    Sallysblooms P.O.T.S. now SO MUCH BETTER!

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    Southern USA


    I wish it was just that...I have been emailing and calling again. This puts so much stress on me, I am not doing well with my POTS.
     

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