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The FDA New Legislation- An Attempt To Prevent Any Future Research On Nutrients

Discussion in 'Other Health News and Research' started by liverock, Nov 15, 2014.

  1. liverock

    liverock Senior Member

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    http://www.anh-usa.org/the-fda-doesn...our-nutrients/

    What the latest legislation is saying is if any nutrient studies are published in future showing health improvements, then that nutrient ceases to be classed as a dietary supplement and becomes a drug and can no longer be sold as a supplement.

    This will effectively prevent any future research being published on supplements used by members such as folate, B12 and TMG,affecting any improvement in any health condition. If it is published then the supplement(s) can be banned and no longer manufactured.

    An example of this has already happened in the past to a vitamin B6 dietary supplement compound called pyridoxamine in 2009.

    Pyridoxamine was used by millions of diabetes sufferers to prevent Advanced Glycation End Products(AGE's) and was very effective so much so, that a Pharma company petitioned the FDA to have it declared a drug and ban any supplements from being manufactured in future.

    This was passed by the FDA and millions of people where denied a cheap treatment by a dietary supplement in favor of a pharma drug (which is still not on the market).

    http://www.lef.org/magazine/2009/7/f...xamine/Page-01
    The article gives information about sending comments to the FDA about this scandal. I think all US members should voice their concern about the possible future infringement of their rights to purchase supplements they may have come to rely on over many years.



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    Last edited: Nov 16, 2014
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  2. ahmo

    ahmo Senior Member

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    OMG!!!:bang-head:
     
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  3. liverock

    liverock Senior Member

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    The irony of this is for years Big Pharma has been saying supplements have no power to affect health only drugs. Now they are so frightened of supplements because of studies that could show they can improve health and cut their profits, they want to ban them and make drugs out of them.:devil:
     
    Last edited: Nov 16, 2014
  4. Hip

    Hip Senior Member

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    I can't find this story in any reliable new sources. If it were true, it would be major news. It makes me think the Alliance for Natural Health may have got their facts wrong.
     
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  5. liverock

    liverock Senior Member

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    The reason it's not in most media is because it's 'oldhat' being a long standing proposed FDA Act that started in 2008, and has been the subject of redrafting many times, as various parties have put forward their cases for modification including all the major food product manufacturers,the pharma industry as well as dietary supplement manufacturers. The supplement industry is a small part of the FDA Act.

    Once any comments are dealt with and any action taken as a result it will be finalised after which it may get some publicity in the media. This is the reason why the Natural Alliance is asking for comments to be sent to the FDA before finalisation.

    The FDA Draft Guidelines has a section on dietary supplements and this is a piece from another section on FAQ's;

    The average cost of an FDA IND is $2.3M (byebye any supplement research in future)

    http://www.fda.gov/downloads/Drugs/Guidances/UCM229175.pdf

    The references to the FD&C Act (1938) section 201 and section 301, for foods and supplements, are only referred to by name in the draft guidelines.
    To obtain an explanation of what these sections mean go halfway down the page on this:

    http://www.anh-usa.org/exciting-compound-apples/

    The supplement which FDA is considering whether it can be classed as a drug at the present time is P5P submitted by a pharma group called Medicure. If succesful all B6 supplements would have to be synthetic as P5P would be banned.

    http://www.anh-usa.org/vitamin-b6-p5p/

    The way they are acting with insisting on folate be labelled as 'Folic Acid' on supplement labels also could be they are lining up folate as a drug in future and will ban it in supplements. This could mean getting folate for MTHFR methylation treatments by script from the pharmacy at anything up to $10/pill. :eek: Think its impossible? Lets wait and see.

    http://www.anh-usa.org/ssrifolate-connection/
     
    Last edited: Nov 18, 2014
  6. Hip

    Hip Senior Member

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    @liverock
    The Alliance for Natural Health (ANH-USA) also bungled their article about the FDA and folate labeling. See the post here on how ANH-USA got that wrong too.

    The Alliance for Natural Health appear to be an incompetent bunch that wouldn't know the difference between a proton and a crouton.
     
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  7. liverock

    liverock Senior Member

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    The simple question that the FDA has to answer is will they allow the labelling of one of the proprietary brands of methylfolate, such as Metafolin, in say a B Complex, to be described as methylfolate, or would it have to be described as 'Folic Acid' Their answer will clear it all up.
     

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