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. TheMovement's Avatar
        TheMovement -
        Eye opening and shocking that its 2013 and the FDA is just challenging Supplement powerhouses, USP still makes great products and if used correctly negative side effects are very hit and miss.
      1. ryane87's Avatar
        ryane87 -
        Originally Posted by TheMovement View Post
        Eye opening and shocking that its 2013 and the FDA is just challenging Supplement powerhouses, USP still makes great products and if used correctly negative side effects are very hit and miss.
        exactly
      1. iparatroop's Avatar
        iparatroop -
        If there were DMAA in cigarettes, no one would give a damn.
      1. ryane87's Avatar
        ryane87 -
        Originally Posted by iparatroop View Post
        If there were DMAA in cigarettes, no one would give a damn.
        I'm upset my bath salts were contaminated DMAA. Its appetite suppression made me eat less faces. Plus, it's stim-dick properties made my goods look smaller while I was running around naked.
      1. rockme's Avatar
        rockme -
        Originally Posted by swim15 View Post
        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
        Precisely. I used DMAA once and it made me feel like absolute horse szit. Therefore, I do think it's a dangerous supp. However, if they are going to ban it they may as well ban cigarettes and alcohol while they are at it. I mean the death toll on those has to make DMAA look like candy. Banning DMAA is an idiotic decision by people who really don't care about anything but money and government power.
      1. marblemadness's Avatar
        marblemadness -
        Originally Posted by Onceyougojack View Post
        Stock up time
        no problem to stock and find in future here in east europe;-);-);-)
      1. corsaking's Avatar
        corsaking -
        Originally Posted by rockme View Post
        Precisely. I used DMAA once and it made me feel like absolute horse szit. Therefore, I do think it's a dangerous supp. However, if they are going to ban it they may as well ban cigarettes and alcohol while they are at it. I mean the death toll on those has to make DMAA look like candy. Banning DMAA is an idiotic decision by people who really don't care about anything but money and government power.
        i still think many are missing the point -its no good quoting products such as cigarettes , alcohol etc in the same context because whether they have health problems associated with them or not , they have been approved by respective governments as suitable for human consumption , DMAA hasnt , simple as that.
      1. hardknock's Avatar
        hardknock -
        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?
        Because very few people will buy most any supplement on their own if it says "may cause death". The only reason why I may take any prescription med that says "may cause, death" is because I have had too, not by personal choice. If I have a free willing choice to take Jack3d, for example only, and it states "may cause excessive heart beats and heart attacks" then I probably am not going to buy it...
      1. hardknock's Avatar
        hardknock -
        Originally Posted by rockme View Post
        Precisely. I used DMAA once and it made me feel like absolute horse szit. Therefore, I do think it's a dangerous supp. However, if they are going to ban it they may as well ban cigarettes and alcohol while they are at it. I mean the death toll on those has to make DMAA look like candy. Banning DMAA is an idiotic decision by people who really don't care about anything but money and government power.
        Cigs and Alcohol have warning labels, Cigs are known to cause lung cancer and death, Alcohol is known to be the cause of deaths and it is readily accepted by the public. DMAA and just about every single supplement in existing isn't readily used by the MAJORITY of the public. Believe it or not, supplement use is in the minority even though it is a multi billion dollar industry it still pales in comparison to medicines, cigs, and alcohol.

        Few people are defending supplements (100 million) where as 5 billion are defending Cigs and Alcohol, for instance.

        I'm not advocating that DMAA causes death, I am just pointing out the facts.
      1. fueledpassion's Avatar
        fueledpassion -
        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.
        Which is why it is a shame. Our regulatory system is built around exceptions and hypocrisy. You could take your statement a step further regarding the tobacco industry and research how much revenue the government takes in taxes from the sale of tobacco. It's no wonder they "dont go there".