The FDA issues a warning against the use of SARMs

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  1. Oh we're actually talking about a different person then...I think.

    I actually assumed you were talking about RK/nitrates since he's the en-vogue litigator of the now.

    Talking about the people at Nutrition Distribution? If not them then I'm not sure who has a big litigation campaign over dshea that used to sell methylated orals. I'm a litigation wonk though so I'm intrigued.

    --

    Where these venture pharma companies run into issues is that they need to have a good rapport with the FDA.

    A lot of these drugs have admittedly performance enhancing off-label uses.

    They end up affecting the massive sports and sports doping industries.

    They end up in the hands of people who don't understand them/shouldn't be taking them.

    When the IOC complains to WADA who complains to the FDA who complains to GTX, if GTX wants any hope of their drug being approved in the future, they kinda have to cooperate and at least do something.

    They care to the extent that negative publicity from doping cases involving their drugs harms their future profit potential and future drug approval potential.
    SNS Representative - [email protected] .com


  2. Ok, so at the risk of coming off as lazy, I'm not clear on how substances/compounds are classified by the FDA. I've heard the phrase "naturally occurring" or "exists in nature", which seems to imply that this is one criteria used to determine how any substance might be deemed legal or illegal. But it doesn't make sense to me. Testosterone is a naturally occurring hormone and is illegal unless you have a script. DHEA is also a naturally occurring hormone but is legal without a script. Yeah, they're different, but still both naturally occurring. And the argument for keeping DMAA a legal supplement is that it is a naturally occurring substance found in geranium plants, thus should be legal, as if that's the sole determining criteria. Tobacco is legal, but is known to cause cancer and a host of other health issues. It goes on and on. So there is obviously more I'm missing here, cause a lot of it just doesn't add up to me.
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  3. Quote Originally Posted by hyperCat View Post
    Ok, so at the risk of coming off as lazy, I'm not clear on how substances/compounds are classified by the FDA. I've heard the phrase "naturally occurring" or "exists in nature", which seems to imply that this is one criteria used to determine how any substance might be deemed legal or illegal. But it doesn't make sense to me. Testosterone is a naturally occurring hormone and is illegal unless you have a script. DHEA is also a naturally occurring hormone but is legal without a script. Yeah, they're different, but still both naturally occurring. And the argument for keeping DMAA a legal supplement is that it is a naturally occurring substance found in geranium plants, thus should be legal, as if that's the sole determining criteria. Tobacco is legal, but is known to cause cancer and a host of other health issues. It goes on and on. So there is obviously more I'm missing here, cause a lot of it just doesn't add up to me.
    Money

  4. Quote Originally Posted by hyperCat View Post
    Ok, so at the risk of coming off as lazy, I'm not clear on how substances/compounds are classified by the FDA. I've heard the phrase "naturally occurring" or "exists in nature", which seems to imply that this is one criteria used to determine how any substance might be deemed legal or illegal. But it doesn't make sense to me. Testosterone is a naturally occurring hormone and is illegal unless you have a script. DHEA is also a naturally occurring hormone but is legal without a script. Yeah, they're different, but still both naturally occurring. And the argument for keeping DMAA a legal supplement is that it is a naturally occurring substance found in geranium plants, thus should be legal, as if that's the sole determining criteria. Tobacco is legal, but is known to cause cancer and a host of other health issues. It goes on and on. So there is obviously more I'm missing here, cause a lot of it just doesn't add up to me.
    Some of it is certainly related to money (isn't everything?) as ZachH said. However, one criticism of DSHEA is that it is relatively lenient to supplement makers in how the FDA regulates them. I could talk about this for days, but that's not the topic of this post.

    As the law stands, a compound can only be included in a supplement if it is derived from a natural source*. DMAA included in supplements was almost exclusively synthetic and not derived from an extract of geranium. There's also conflicting evidence about whether DMAA is found in geranium at all. If DMAA is not present in geranium, then it likely isn't compliant with DSHEA (regardless of whether you agree with the law, it remains the law). It is also illegal to market known drugs, either approved or investigational, as dietary supplements (even when they meet DSHEA criteria; anyone remember pyridoxamine? A B6 derivative marketed as a supplement for years, but banned since now its an investigational diabetes drug.)

    You are right in noting the sometimes arbitrary nature of this. Testosterone does occur in nature, but is also marketed as a drug for various purposes.

    Natural sources as defined in DSHEA*:

    a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients

  5. Quote Originally Posted by TheNietzsche View Post
    Some of it is certainly related to money (isn't everything?) as ZachH said. However, one criticism of DSHEA is that it is relatively lenient to supplement makers in how the FDA regulates them. I could talk about this for days, but that's not the topic of this post.

    As the law stands, a compound can only be included in a supplement if it is derived from a natural source*. DMAA included in supplements was almost exclusively synthetic and not derived from an extract of geranium. There's also conflicting evidence about whether DMAA is found in geranium at all. If DMAA is not present in geranium, then it likely isn't compliant with DSHEA (regardless of whether you agree with the law, it remains the law). It is also illegal to market known drugs, either approved or investigational, as dietary supplements (even when they meet DSHEA criteria; anyone remember pyridoxamine? A B6 derivative marketed as a supplement for years, but banned since now its an investigational diabetes drug.)

    You are right in noting the sometimes arbitrary nature of this. Testosterone does occur in nature, but is also marketed as a drug for various purposes.

    Natural sources as defined in DSHEA*:
    Thank you for the explanations. So, "derived from a natural source" basically means it must be extracted directly from that source and not synthetically produced, even if the synthetic form would be identical?
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  6. Quote Originally Posted by hyperCat View Post
    Thank you for the explanations. So, "derived from a natural source" basically means it must be extracted directly from that source and not synthetically produced, even if the synthetic form would be identical?
    That I'm actually not 100% sure if it is in the law or not (perhaps someone can chime in?). However, they used that fact as evidence that DMAA wasn't legal under DSHEA.

  7. Quote Originally Posted by hyperCat View Post
    Thank you for the explanations. So, "derived from a natural source" basically means it must be extracted directly from that source and not synthetically produced, even if the synthetic form would be identical?
    I think the point was that it was left quite obscure so the FDA could enforce it where it wanted to.

  8. Time to stock up!

  9. Quote Originally Posted by hyperCat View Post
    Thank you for the explanations. So, "derived from a natural source" basically means it must be extracted directly from that source and not synthetically produced, even if the synthetic form would be identical?
    The main points of DSHEA are that, if it wasn't marketed and sold as a supplement prior to 1994, then anything new must have an NDI, which DMAA does not.

    Hi Techs argument hinged on that DMAA was present in geraniums and identified prior to DSHEA, but the evidence has always been questioned from both parties.

    Vitamin C is mostly synthetic and is legal to sell so that criteria isnt hard and fast either. The main difference between vitamin C and DMAA in cases like this is the dispute between legality in the first place.
    Serious Nutrition Solutions Representative
    X-gels for strength, Focus XT for mental performance & Joint Support XT for pain free mobility
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