FDA Rules DMAA Non-Natural - AnabolicMinds.com
    • FDA Rules DMAA Non-Natural


      By Stephen DANIELLS Nutra Ingredients USA

      After reviewing the response from USPlabs about the use of DMAA as an ingredient in dietary supplements, the FDA has concluded that the evidence is ‘insufficient’, NutraIngredients-USA can report.

      FDA issued 11 warning letters in 2012 to manufacturers and distributors of supplements containing DMAA, stating that DMAA was not a lawful dietary ingredient because it lacked a New Dietary Ingredient notification, and raised the issue of whether it is a so-called synthetic botanical.

      USPlabs, manufacturer of Jack3d and OxyElite Pro, both of which contain DMAA, responded to FDA on that issue, defending its use of the ingredient.

      In a Consumer Update from FDA, the agency notes: “All but one of the companies sent a Warning Letter have agreed to stop using DMAA as an ingredient in their dietary supplements. The one company that has yet to agree to such action, USPLabs, has responded to FDA's warning by submitting published studies that purport to challenge FDA's conclusions.

      “However, after reviewing the studies provided by USPLabs, FDA has found the information insufficient to defend the use of DMAA as an ingredient in dietary supplements.”

      In a telephone interview with NutraIngredients-USA, Daniel Fabricant, PhD, director of FDA's Division of Dietary Supplement Programs, confirmed that FDA will finalize a formal response to the firm “rather shortly” to reflect its findings.

      The Consumer Update also notes that the agency has received “60 reports of illnesses and death associated with supplements containing DMAA”.

      “We want to be clear about where we are. We don’t want people using DMAA,” added Dr Fabricant.

      Dietary supplement regulations and DMAA in particular are at the center of a report to be broadcast on NBC’s Rock Center this evening. For NBC’s preview article and short video, please click here.

      DMAA

      DMAA (also known as methyl hexaneamine (MHA) and several other names) has been a subject of intense debate about whether it is in fact a constituent of geranium. The ingredient was first manufactured synthetically by drug giant Eli Lily in the 1940s.

      The ingredient has come under scrutiny across the globe and is currently banned in six countries, as well as by the US military.

      Only three analyses have reported it to be a natural constituent of geranium: The controversial ‘Ping Paper’ by Chinese researchers published in the Journal of Guizhou Institute of Technology (1996, Vol. 25, pp. 82-85), and two recently published papers in Analytical Chemistry Insights funded by USPLabs.

      On the flip side, there are more studies that have failed to find DMAA in geranium plant material, including an analysis published in the Journal of Analytical Toxicology in June 2012 described as ‘comprehensive’ and ‘robust’ by respected members of the industry.

      CRN: We appreciate that FDA has made its decision

      Steve Mister, president & CEO of the Council for Responsible Nutrition (CRN), welcomed the Agency making a decision on the ingredient.

      “For over a year, DMAA has been an ingredient under question. CRN has looked to FDA to determine whether this ingredient is safe or not safe, as well as whether this product could be considered a legal dietary ingredient for use in supplements. As the primary agency charged with regulating dietary supplements, FDA is in the best position to evaluate the safety of the ingredient and determine whether it should be available to consumers," said Mister.

      "No CRN member companies manufacture the ingredient or products containing DMAA, and much of the research on DMAA is not publicly available, so we have relied on FDA to evaluate the evidence. CRN appreciates that FDA has made its decision with this announcement.

      "It is clear from FDA’s Consumer Advisory that, having evaluated the evidence, FDA views DMAA as unsafe and warns that it presents unreasonable health risks to consumers. FDA also stated that, in its view, products containing DMAA are illegal and should not be sold as dietary supplements. With this conclusion, CRN now calls on dietary supplement manufacturers to stop manufacturing these products and further advises consumers to stop using them.

      "The safety and well-being of consumers is always our highest priority. Given the agency’s serious warnings about DMAA, we expect the agency will use the full range of its regulatory authority under the Dietary Supplement Health and Education Act (DSHEA) and take further action beyond the Consumer Advisory. DSHEA provides the agency with a variety of tools, many of which FDA mentions in its Advisory (e.g., detentions, seizures, voluntary and mandatory recalls, injunctions, criminal prosecution, etc.), to protect consumers.

      "Exercising that authority will demonstrate that the current law provides a robust framework to protect consumers when the agency believes a product regulated under its jurisdiction is unsafe. We recognize that a thoughtful and thorough scientific evaluation of the data takes time, as it should, but now that a determination has been made, we encourage FDA to do what is necessary to resolve this issue.”

      Source: http://mobile.nutraingredients-usa.c...s#.UWv1orXvuvI
      Comments 30 Comments
      1. HokiePride's Avatar
        HokiePride -
        Whatever!
      1. EatMoar's Avatar
        EatMoar -
        Haha anyone who ran dmaa lost their natty cards ;) ...according to the FDA ...
      1. lukehayd's Avatar
        lukehayd -
        "to protect consumers when the agency believes a product regulated under its jurisdiction is unsafe."

        HA!! They claim 60 deaths related to DMAA and want to ban it while they let the big pharmaceutical companies keep pumping out drugs that have in their disclaimer that it might kill you! Talk about the tail wagging the dog! It's all in how much the FDA crooks can shove in their pockets!
      1. bushyman's Avatar
        bushyman -
        I have to agree with lukehayd on that one. What about banning all drugs that might cause you a heart attack, give you thoughts of suicide, potentially give you the runs, cause you to sleepwalks and hallucinate! Seriously!!!!:rasp:
      1. Onceyougojack's Avatar
        Onceyougojack -
        Stock up time
      1. swim15's Avatar
        swim15 -
        There are 500 deaths a year from tylenol...who gives a **** about DMAA and thanks for taking away the choice from the consumer. Time to stock up and sell it at twice the price in a year
      1. EatLiftGrow's Avatar
        EatLiftGrow -
        Originally Posted by bushyman View Post
        I have to agree with lukehayd on that one. What about banning all drugs that might cause you a heart attack, give you thoughts of suicide, potentially give you the runs, cause you to sleepwalks and hallucinate! Seriously!!!!:rasp:
        Not to mention all of the people who are facing issues with substance abuse because they were given opiate based painkillers BY THEIR DR!
      1. dreammaker's Avatar
        dreammaker -
        ****ing morons
      1. R1balla's Avatar
        R1balla -
        remind you its the same people who took away PP.... hate this mess.
      1. purebred's Avatar
        purebred -
        but aspartame and MSG: "perfectly safe".

        riiiight!
      1. dmillz224's Avatar
        dmillz224 -
        Originally Posted by lukehayd View Post
        "to protect consumers when the agency believes a product regulated under its jurisdiction is unsafe."

        HA!! They claim 60 deaths related to DMAA and want to ban it while they let the big pharmaceutical companies keep pumping out drugs that have in their disclaimer that it might kill you! Talk about the tail wagging the dog! It's all in how much the FDA crooks can shove in their pockets!
        Preach on brotha!
      1. corsaking's Avatar
        corsaking -
        Originally Posted by bushyman View Post
        I have to agree with lukehayd on that one. What about banning all drugs that might cause you a heart attack, give you thoughts of suicide, potentially give you the runs, cause you to sleepwalks and hallucinate! Seriously!!!!:rasp:
        the difference is the drugs have been licenced and with any drug comes an information sheet enclosed It acknowledges thatsome drugs produce side effects which are listed-most common side effects listed first.If you suffer from any side effect you are advised to stop taking it and see your doctor
        With DMAA its not been extensively tested on humans to my knowledge so the side effects are not known until they happen to a consumer.

        its unfortunate that a ruling like this gets people backs up and start shouting what about this drug, that drug etc We have a population that smokes tobacco and drinks alcohol and we know the damage that they can do , but they are sold and consumed having been passed by the govt and thats the fundamental difference -DMAA hasnt.
      1. MillzKillz's Avatar
        MillzKillz -
        Time to stock up on some Crap 3D
      1. R1balla's Avatar
        R1balla -
        Originally Posted by purebred View Post
        but aspartame and MSG: "perfectly safe".

        riiiight!
        and prescribing opiates to people who "need" them...
      1. bushyman's Avatar
        bushyman -
        Originally Posted by corsaking View Post
        the difference is the drugs have been licenced and with any drug comes an information sheet enclosed It acknowledges thatsome drugs produce side effects which are listed-most common side effects listed first.If you suffer from any side effect you are advised to stop taking it and see your doctor
        With DMAA its not been extensively tested on humans to my knowledge so the side effects are not known until they happen to a consumer.

        its unfortunate that a ruling like this gets people backs up and start shouting what about this drug, that drug etc We have a population that smokes tobacco and drinks alcohol and we know the damage that they can do , but they are sold and consumed having been passed by the govt and thats the fundamental difference -DMAA hasnt.
        I see what you are saying and understand. But taking into consideration your statement, why not then have warning labels on supp products and let the consumer decide? Alcohol is sold and causes much more deaths than supplements and more soldiers die by committing suicide more than in actual combat. Root causes are never addressed. So then... where is the logic in banning DMAA?
      1. R1balla's Avatar
        R1balla -
        Originally Posted by bushyman View Post
        I see what you are saying and understand. But taking into consideration your statement, why not then have warning labels on supp products and let the consumer decide? Alcohol is sold and causes much more deaths than supplements and more soldiers die by committing suicide more than in actual combat. Root causes are never addressed. So then... where is the logic in banning DMAA?
        if they feel they need to ban DMAA, then they should also ban all cookies and sweets because they can cause diabetes...
      1. MANotaur's Avatar
        MANotaur -
        ...just dont ban sex cause it cause aids or blisters on your dick...


        thats all i care about..they can take away my stims but dont take away my poon!
      1. T-Bone's Avatar
        T-Bone -
        Originally Posted by Lifting View Post
        Amen

        Get ready for the sales!
      1. Zach Strom's Avatar
        Zach Strom -
        This is gonna cause more people to just purchase bulk DMAA and put themselves at a high risk of overdosing and hurting themselves. Bulk DMAA is a hell of a lot worse since most people take too much and can't properly dose it.
      1. ryane87's Avatar
        ryane87 -
        There are so many "legal" drugs that have far worse effects on people than DMAA could ever dream about. That hogwash from the poster who said it hasn't gone through the FDA obviously doesn't know how the FDA works. It's basically a giant pay off scheme to get product legalized. Why do you think things like MSG and aspartame and opiates are still legal? Big Pharma and Big Food spend a lot of their profitgs making sure that they stay that way. Big Pharma manipulates their studies so they can pass their product. Eli Lily got in trouble for this a few years back only because it was painfully obvious. Even dangerous drugs don't get pulled unless there is a SEVERE outcry. Or better yet, a couple of doctors looking to clear their conscience from peddling their wares look to have it banned. A lot of people are almost more screwed up GOING to the "trusted" doctor. I am personally not the biggest DMAA fan, I just think it sets a bad precedent. At the same time, some of the lowly and unscrupulous supplement companies need to stop f*cking it up for the rest of us and putting drugs and who knows what else in their products.

        Log in

        Log in

        Content Relevant URLs by vBSEO ©2011, Crawlability, Inc.