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  1. #1
    Registered User KyleC471's Avatar
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    Why is creatine not FDA approved??????

    I noticed that pretty much all creatines and other supplements such as nitrix oxide and hormone enhances, are not approved or inspected by the FDA. Or they are "patent pending". How can you put something on the market if it is not approved by the FDA or have a patent. I am taking BSN cellmass and im just not sure if there are reasons that they are not approved.
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  2. #2
    Registered User saderpride's Avatar
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    Cool fda

    FDA (food and drug administration) creatine is not a food or a drug, therefore the fda does not have authorization to approve or not approve creatine... creatine is a supplement within your body already... i hope this answers your question........
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  3. #3
    Stable Mindframe Ashrym's Avatar
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    No dietary supplement is FDA approved lol. That's why all of them have "This is not used to treat or prevent any disease." They're also not aloud to put the use of the product on the bottle. Because only medication approved by the FDA supposedly can have any healthy affect on your body. Yet another example of the man trying to keep us down lol. It's basically the US being their capitalist selves. It's all for the $$$. That's also why the CODEX regulations are trying to be enacted. So the FDA can take the supplements away from the supplement industry so they can be considered "drugs". Allowing them to distribute them and make money. Sorry a gave you such a broad reply. I could go into this a bit deeper, but I gotta go.
    I shall send you from this world as you came: naked, bloody, screaming, and hairless.
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  4. #4
    not SOph101 SOhp101's Avatar
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    Originally Posted by KyleC471
    I noticed that pretty much all creatines and other supplements such as nitrix oxide and hormone enhances, are not approved or inspected by the FDA. Or they are "patent pending". How can you put something on the market if it is not approved by the FDA or have a patent. I am taking BSN cellmass and im just not sure if there are reasons that they are not approved.
    Nearly all supplements out there are not FDA approved because none of them actually take the time to get FDA to approve it, which takes years and years and likely won't get passed. So, why would a relatively small company that manufactures these supplements wait for years and years to get something into the market when the competition is already selling it and making a tidy profit?

    And of course, for those drugs that are actually complete duds, they obviously don't want to get tested by the FDA because they know that they will fail and that'll kill the potential of sales for the product.

    Be careful about patents. Just because you see something that is patented does NOT mean it works or that it's the best stuff out there. A patent is simply a government issued right to produce and market a product excusively without worrying about others "stealing" your formula (which is easily done with drugs) and selling their own versions. Of course it is natural for a person to think that patents would imply that a product works, but then again you could get a patent for detecting extraterrestrials in brussel sprouts.

    When you receive a patent, it only gives u the legal rights to exclusively produce it, or give others permission (with royalty fees; you gotta milk it for all it's worth). Many products state "Patent Pending" because it also takes awhile for patents to go through the system.
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  5. #5
    Registered User tsouri's Avatar
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    Exclamation Need to know

    According to DR CDR Mark S a regulatory review officer at the U.S. Food and Drug Administration (FDA), bodybuilding products that contain or claim not to contain any steroids or steroid-like substances are associated with potentially serious health risks, including liver injury. “Some of the liver injuries were life-threatening,” CDR Miller says.

    CDR Miller was the lead reviewer assessing hundreds of adverse event reports made to the FDA from July 2009 through December 2016. Thirty-five reports showed evidence of serious liver injury.

    In addition to liver injury, anabolic steroids have been associated with serious reactions such as severe acne, hair loss, altered mood, irritability, increased aggression, and depression. They have also been associated with life-threatening reactions such as kidney damage, heart attack, stroke, pulmonary embolism (blood clots in the lungs), and deep vein thrombosis (blood clots that occur in veins deep in the body).

    These bodybuilding products are promoted as hormone products and/or as alternatives to anabolic steroids for increasing muscle mass and strength. Many of these products make claims about the ability of the active ingredients to enhance or diminish androgen, estrogen, or progestin-like effects in the body, but actually contain anabolic steroids or steroid-like substances, synthetic hormones related to the male hormone testosterone.

    Bodybuilding Products May Contain Steroids

    Cara Welch, Ph.D., a senior advisor in FDA’s Office of Dietary Supplement Programs, explains that many of these bodybuilding products sold online as well as in retail stores, are labeled as “dietary supplements.” “In fact,” she says, “many of these products are not dietary supplements at all; they are illegally marketed, unapproved new drugs.” FDA has not reviewed these products for safety, effectiveness, or quality before these companies began marketing.
    CDR Jason Humbert, a regulatory operations officer in FDA’s Office of Regulatory Affairs, says that potentially harmful, sometimes hidden ingredients in products promoted for body building continue to be a concern. “The companies making these products are breaking the law by exploiting an easily accessible marketplace to get these products to consumers,” he says. “In the end, it’s consumers who are put in harm’s way by taking dangerous ingredients from products promoted as having miraculous results or making empty promises, and who may not understand the risks.”

    Some who use bodybuilding products engage in “stacking,” using multiple products (including stimulants or products providing false assurances of liver protection) to enhance results or “gains.” These combinations may put consumers at greater risk for serious and life-threatening reactions.
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  6. #6
    Cybergenics...it's bomb! lucia316's Avatar
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    lucia316 is offline
    Originally Posted by tsouri View Post
    .....Bodybuilding Products May Contain Steroids....
    Strong first post to join date necro with absolute ridiculousness! Not sure what OP will do 13 years later.

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    Disclaimer: The statement above reflects that of my own opinion & in no way that of MAN Sports. MAN products are not intended to diagnose, treat, cure, or prevent any disease.
    Disclaimer 2: I still think BCAAs are not necessary
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  7. #7
    Registered User Iluvmud's Avatar
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    Originally Posted by lucia316 View Post
    Not sure what OP will do 13 years later.
    Move on to the next chapter in his life?
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  8. #8
    Tonight, we make soap. compan's Avatar
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  9. #9
    Cybergenics...it's bomb! lucia316's Avatar
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    lucia316 is offline
    Originally Posted by Iluvmud View Post
    Move on to the next chapter in his life?
    OP has grandkids at this point.
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    Disclaimer: The statement above reflects that of my own opinion & in no way that of MAN Sports. MAN products are not intended to diagnose, treat, cure, or prevent any disease.
    Disclaimer 2: I still think BCAAs are not necessary
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