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  1. #1
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    Tell the FDA that You Do Not Support the Ban on P5P!

    I don't know why I forgot to post this here, but here you go:

    Cliffs:
    Big Pharma wants to screw over DSHEA once again and get a VITAMIN banned so that they can use it in one of their medications

    I ask that you sign a petition to the FDA to tell them you do not want this to happen

    FDA Petition to Ban P5P in Supplements?
    Grounds for the Ban Have Nothing to Do with Consumer Safety!


    The US Food and Drug Administration (FDA) is considering a petition filed by a pharmaceutical company. They?re requesting a ban on dietary supplements containing pyridoxal 5?-phosphate (P5P), a bio-active and natural form of vitamin B6.

    The escalating public concern over the pending petition stems from a ruling made by FDA this past January which banned the sale of pyridoxamine?one of the three forms of vitamin B6 found in nature?and declared pyridoxamine a ?new drug.? The ruling was in response to a petition filed by Biostratum, a pharmaceutical company that manufactures a drug based on pyridoxamine. By receiving a favorable ruling from FDA, Biostratum now has a solid monopoly on the sale of pyridoxamine.

    Our concern is that FDA?s January ruling is setting a precedent that draws into question the future of other vitamins and natural ingredients.

    The pending petition filed in November 2007 by Medicure Pharma admits that P5P is a naturally occurring molecule in the vitamin B6 family that qualifies as a dietary supplement. Medicure?s point of contention is that P5P in dietary supplements will infringe on their profits from a drug they are currently developing, which includes P5P as an active ingredient!

    With surprising candidness, Medicure states in their petition, ?Pharmaceutical companies developing new drugs must be protected from companies that may seek to market the ingredients in those drugs as dietary supplements. The marketing of such products has the potential to undermine the incentive for the development of new drugs, because many people may choose to purchase the supplements rather than the drugs?.

    Medicure also believes, according to the petition, that FDA?s role is to ?balance, on a case-by-case basis if necessary, the competing interests of dietary supplement and pharmaceutical companies.?

    Last we checked, FDA?s mission was to protect and advance the public health. So if P5P already exists in nature, has known health benefits, and is readily available for all consumers, then how does banning P5P further either of those goals?

    Medicure makes no consumer safety claims regarding P5P. Medicure simply wants the ban of a natural product in order to secure a monopoly, and says so quite nakedly. Medicure wants to protect their market and eliminate the availability of P5P to the general public except via their drug!

    Once again, your voice needs to be heard. Please contact FDA to let them know you want P5P to remain available. Thank you for taking the time?your involvement really does make a difference.

    Visit this website for more info and to sign the petition https://secure3.convio.net/aahf/site...wk1bl3.app304a

    Sign the petition!!!
    Last edited by Macrobolic; 03-31-2009 at 10:45 PM.
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  2. #2
    next level bro chasinSKURT's Avatar
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    Signed!

    Modified it slightly....
    -------------------------
    This letter is meant to voice my concern over Medicure Pharma's Citizen's Petition Request to Ban Pyridoxal 5'-Phosphate as a Dietary Supplement (FDA-2007P-0410).

    I request that FDA reject this request and that Congress address the disturbing trend of drug companies that attempt to manipulate the system and FDA.

    Medicure has requested that the agency ban the marketing of dietary supplements containing pyridoxal 5'-phosphate (P5P) because Medicure has a drug in development whose active ingredient is P5P. Medicure suggests that P5P is a new dietary ingredient, which is subject to pre-market approval requirements. However, within their own documents, Medicure admits that P5P is a NATURALLY OCURRING molecule which is part of the Vitamin B6 family. Vitamin B6 has been shown to be essential to good health.

    As such, P5P has in fact been a part of the human diet well before the 1994 passage of the Dietary Supplement Health and Education Act (DSHEA); therefore P5P is exempt from the New Dietary Ingredient pre-market notification requirements.

    This request is roughly akin to demanding the elimination of all previous manufacturers of ketchup, as their product contains a similar, naturally-ocurring ingredient, that being tomato. I do not believe Medicure's drug development should restrict my access to P5P as a food supplement.

    As an American who includes dietary supplements in my approach to health and wellness, I request that you place the rights of consumers ahead of the desires of industry and protect my freedom to access dietary supplements. Please reject Medicure's attempt to manipulate the marketplace through their Citizen's Petitions.

    Sincerely,
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  9. #9
    RIP Sweetie 2006-2010 Macrobolic's Avatar
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    bump


    and thanks to everyone who has signed it.
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    Lets give this thread a five star to catch people's attention

    It's definitely more important than discussing what is the best pro hormone
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    Signed and 5 stars for more sigs. Glad I have nice stock for now, when would this take effect?
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    Cool

    Signed IT, and I had my girlfriend sign it!

    These politicians better pay heed!

    We need to get a thread stickied with links and updates about what's in the lineup for FDA control.
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    yeah the FDA is gonna change their decision (or make it in the first place) based on waht a bunch of random people on a bodybuilding messageboard think (the majority of which whom have no scientific credentials)

    i think the FDA is well aware that there are many people who use this supplement and would like to continue using it, but have put forward this bill on some sort of danger to health platform , not saying the FDA is right or wrong here, but if they wanted a consensus it owuld be a scientific one and it would poll university researchers and such

    another lol@ senators better pay heed, im sure they are really concerned with the bodybuilding and powerlifting demographic
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  18. #18
    RIP Sweetie 2006-2010 Macrobolic's Avatar
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    Originally Posted by skinnycalves View Post
    yeah the FDA is gonna change their decision (or make it in the first place) based on waht a bunch of random people on a bodybuilding messageboard think (the majority of which whom have no scientific credentials)
    They banned ephedra because of the "public" with no scientific credentials.

    GJDM.

    i think the FDA is well aware that there are many people who use this supplement and would like to continue using it, but have put forward this bill on some sort of danger to health platform , not saying the FDA is right or wrong here, but if they wanted a consensus it owuld be a scientific one and it would poll university researchers and such
    You do realize that the FDA is in Big Pharma's pocket, right?

    another lol@ senators better pay heed, im sure they are really concerned with the bodybuilding and powerlifting demographic
    Actually, Orrin Hatch very much is. He's the one who got DSHEA passed and I'm sure he would not be happy that they are trying to overstep it.

    Next...
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    thats messed up...
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    A compound found in winstrol does infact interact negatively with *****. Apparently when they mix in the digestive system they create a foaming reaction (kinda like diet coke and mentos - youtube it). Ever seen a seagull pop?-Hatetank
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