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New FDA Rule Proposal Will Ban Methylfolate from Supplements.

Discussion in 'Action Alerts and Advocacy' started by Ema, Mar 11, 2014.

  1. Ema

    Ema Senior Member

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    Time to write the FDA...all you have to do is follow the link and fill in a form.

    http://www.anh-usa.org/fdas-sneak-attempt-to-ban-another-b-vitamin/

    Last edited: Mar 11, 2014
  2. PennyIA

    PennyIA Senior Member

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    This sure seems to be pretty horrible if this were to succeed. I followed the link and sent an email off along with a personalization around how much these supplements have been able to help me recover from my 'undiagnosed' condition.
    taniaaust1, WillowJ and ggingues like this.
  3. caledonia

    caledonia

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    Turning methylfolate into a drug, no longer available in supplement form, would have serious consequences for the millions with MTHFR mutations and not enough money to pay for their no doubt overly expensive drug. I have signed the petition and encourage others to do so too.
    WillowJ, Star-Anise and minkeygirl like this.
  4. Martial

    Martial Senior Member

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    I have signed it and a equally outraged by this very greedy and selfish act they have commited. One thing I do not understand is how they would have the power to ban all methyl folate supplements though, as supplements for the most part fall far out of regulation and control if any at all by the FDA.

    Having Metafolin as a Merck product and claiming patent could be a huge issue though...

    Man seriously such a low blow, and sadly I hate to admit it but with that much potential revenue I doubt they would listen to any reason disputing the matter.

    I will definitely sign and spread this though as best I can!
    WillowJ, Star-Anise and ggingues like this.
  5. Sushi

    Sushi Moderator and Senior Member Albuquerque

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    I wonder if this is related to Deplin which is a prescription, isn't it? Don't they have to license methylfolate production even now? Or whatever company is behind Deplin?

    Sushi
    WillowJ and Dreambirdie like this.
  6. Dreambirdie

    Dreambirdie work in progress

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    Yup, Deplin is what came to mind for me too, @Sushi

    I have signed the petition and will post it on my FB page.

    I will definitely be stocking up on methylfolate. At the slow rate I go, it will take me at least 3 years to finish a bottle.
    dannybex likes this.
  7. ggingues

    ggingues $10 gift code at iHerb GAS343 of $40

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    I agree, but what I find laughable is that we, for the most part, think the gov't is going to help solve our medical dilemna, they seem to only muddy the waters! (IOM contract to define CFS via nonn-experts of our illness).

    Yes, the money for more research would be nice, but lets not hold our breath!!

    GG
  8. barbc56

    barbc56 Senior Member

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    While I don't think there are nefarious motives, if I understand correctly, it looks like this is more about labeling than banning? But my knowledge about the difference between the two, is limited.

    Last edited: Mar 11, 2014
    Little Bluestem likes this.
  9. Ema

    Ema Senior Member

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    If you can't put it on the label, you can't put it in the product.

    It's a tricky way for the FDA to ban something (folate) from supplements without saying so outright. Seems nefarious to me.
  10. beaverfury

    beaverfury beaverfury

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    Son of a gun. Is this even possible?

    This effects us in Australia too. Our equivalent agency TGA (Therapeutics goods agency) loves spooning the FDA.

    http://www.pharmacydaily.com.au/news/tga-works-with-ema-fda/4231

    "WORLD regulatory collaboration is one step closer, following the successful conclusion of two pilot programs of collaboration on inspections between the European Medicines Agency, the United States and Australia. The aim of the programs was to enhance global drug safety and quality via increasing international regulatory collaboration."

    Oh goody, they left out India and Mexico, my drug suppliers of choice.
  11. peggy-sue

    peggy-sue

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    Bother. I need to try to find methyfolate.
    Is there any brand anybody recommends?
  12. Soporificat

    Soporificat

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    Solgar Metafolin -- they use the Deplin formulation (licensed from Merck) I believe iHerb.com is the cheapest source.
  13. peggy-sue

    peggy-sue

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    Thank-you!:hug:
    I tend to trust Solgar - but my local health food shop, which does have Solgar, didn't know anything about it.
    On-line it will have to be.:(
  14. whodathunkit

    whodathunkit Senior Member

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    [Mods merged Ema's thread and a thread I started to create this one big thread. Apologies for the redundancy of posting the link to the petition--whodahunkit]

    Found this on another board I go to.

    http://www.anh-usa.org/fdas-sneak-attempt-to-ban-another-b-vitamin/

    One thing in this write-up that doesn't make sense to me is the assertion that Merck would make millions by patenting metafolin (if it's not already patented) and making it a drug. They're already there, I think, by licensing the rights to make Deplin.

    Point being, I'm not sure how Merck could make *more* money off of metafolin by putting up gatekeepers (i.e., pharmacies and doctors) between consumers and folate supplements. It's more likely they'd *lose* a bunch of money, if for no other reason than most doctors don't understand when or how to prescribe folate. Sales volume of metafolin would likely go so far down that they wouldn't be able to make up the profit even with an insane price hike on the prescription form. So if Merck is smart (big if, I know), they'll help keep metafolin on the free market where the real money is to be made.

    But if it's about control by agencies other than the actual ingredients manufacturers, the profit motive doesn't even enter into it.

    </editorializing>

    Anyway, this could be overblown, but sounds concerning enough to get a little riled up.
    Last edited: Mar 12, 2014
  15. PeterPositive

    PeterPositive Senior Member

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    taniaaust1 and WillowJ like this.
  16. Ema

    Ema Senior Member

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  17. PeterPositive

    PeterPositive Senior Member

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    So we can look at this from the bright side, most healthy people by producing l-methylfolate in their bodies could be sued by Merck for infringing their patents :D "Luckily" I am not among those ... as I am MTHFR C677T++ and I have no traces of methylfolate in my blood if I don't take supplements, so I won't have to appear in court. That's encouraging! :lol:
    GhostGum, WillowJ and PennyIA like this.
  18. peggy-sue

    peggy-sue

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    Thank-you too, Ema.:hug:
  19. whodathunkit

    whodathunkit Senior Member

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  20. PeterPositive

    PeterPositive Senior Member

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