Industry Response To FDA Stance On DMAA - AnabolicMinds.com
    • Industry Response To FDA Stance On DMAA


      By Stephen DANIELLS Nutra Ingredients USA

      Daniel Fabricant, PhD, director of FDA's Division of Dietary Supplement Program, told us: “We want to be clear about where we are: We don’t want people using DMAA.”

      The process has worked

      Loren Israelsen, executive director of the United Natural Products Alliance (UNPA), told us: "The Dietary Supplement Health and Education Act (DSHEA) contemplated occasions where the regulatory status of a dietary ingredient could be in dispute, and as we have seen in the case of DMAA, this process has worked.

      "The Agency has undertaken a careful review of the safety literature and has concluded there is inadequate evidence to support the dietary ingredient status of DMAA. As such we believe it is incumbent on industry to conform trade practices accordingly."

      USADA

      Commenting on the FDA stance, Dr Amy Eichner, special advisor on drugs and supplements for the US Anti-Doping Agency (USADA), told us: "We first addressed the fact that DMAA is a drug and not a dietary ingredient back in 2009, and we are pleased to see that the FDA has formed the same opinion.

      “This issue highlights why it is so important for legislators to fix the loop holes in DSHEA, so that it can fulfill its original intent to give consumers the protection they need when choosing to take supplements."

      ‘No credible published scientific evidence to support the contention that DMAA is a naturally-occurring phytochemical’

      Mark Blumenthal, founder & executive director of the American Botanical Council (ABC), an independent nonprofit research and education organization, told NutraIngredients-USA: “Based on the available information, ABC is gratified that the FDA has taken action on this issue.

      “Based on the research conducted by ABC on DMAA to date, insofar as there does not seem to be any reasonably credible published scientific evidence to support the contention of some DMAA marketers that DMAA is a naturally-occurring phytochemical, and that from a regulatory perspective it is a New Dietary Ingredient, the submission of safety data for FDA review is required. So far as ABC is aware, such safety data has not submitted by marketers of DMAA.

      “As many ABC members and readers of NutraIngredients-USA may recall, in the past year ABC has published two peer-reviewed articles on the DMAA issue. To help ensure accuracy, as is customary at ABC, both ABC articles were extensively peer reviewed by chemists and other experts knowledgeable with the literature on DMAA, including some of the authors of the university-based papers that were reviewed.

      ‘Concerns about the scientific validity of these marketer-funded papers’ conclusions’

      Blumenthal continued: “The first of ABC's articles dealt with the two university-based articles that showed no presence of DMAA in properly-authenticated samples of geranium plants and geranium oil.

      “The second ABC article reviewed the two analyses that were funded by a primary marketer of DMAA-containing products and were published in a so-called "pay-to-publish" journal — I.e., the authors had to pay ca $1800 per article to the journal as a condition of publication. The various experts consulted for this second ABC article raised numerous significant concerns about the scientific validity of these marketer-funded papers’ conclusions that there is DMAA in the geranium leaf and oil samples tested.

      “Since ABC believes that DMAA is not a natural plant-derived compound, and since ABC is an organization that deals with beneficial plants, we do not intend to conduct a literature review and expert assessment of the safety of DMAA. We believe that the determination of the safety of DMAA is the responsibility of the marketer or the FDA.”

      Michael McGuffin, president of the American Herbal Products Association (AHPA) added: “We all recall that FDA issued warning letters regarding DMAA last year, and this latest communication provides further information about FDA’s position regarding DMAA. If the ingredient is not lawful, the agency has full authority to remove it from the market.”

      Next steps

      Cara Welch, senior vice president of scientific and regulatory affairs for the Natural Products Association (NPA) added that the FDA has made its case, but the "manufacturers looks ready to stand its ground, so let's wait and see what the next steps are".

      Steve Mister, president & CEO of the Council for Responsible Nutrition (CRN), added: “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," he said.

      "[Following the announcement of FDA’s conclusions], CRN now calls on dietary supplement manufacturers to stop manufacturing these products and further advises consumers to stop using them.”

      To read the full CRN statement, please click here http://www.nutraingredients-usa.com/...he-use-of-DMAA

      Source: http://www.nutraingredients-usa.com/...%2BText%2BNews
      Comments 9 Comments
      1. determinator's Avatar
        determinator -
        goodbye OEP and Jack3D
      1. musclefool's Avatar
        musclefool -
        Man **** the FDA that's a load of bull****
      1. AdonisBelt's Avatar
        AdonisBelt -
        Originally Posted by musclefool View Post
        Man **** the FDA that's a load of bull****
        Yep. Just an easy fix to relieve the worry that arose from those that abused dmaa-related supplements. Don't blame the .0001% of users that ****ed up, punish everyone for the .0001%'s mistakes and demonize a product!!
      1. musclefool's Avatar
        musclefool -
        Originally Posted by AdonisBelt View Post

        Yep. Just an easy fix to relieve the worry that arose from those that abused dmaa-related supplements. Don't blame the .0001% of users that ****ed up, punish everyone for the .0001%'s mistakes and demonize a product!!
        Yeah it's dumb I enjoy these products. The OG craze was really good now they made it shltty
      1. Lhns2's Avatar
        Lhns2 -
        Yeah FDA... because this is what you should be focusing on.
      1. schmidt's Avatar
        schmidt -
        Everybody seems to be blaming the FDA. I for one am a little upset at the supplement companies for trying to add DMAA under the guise of "Dietary Ingredient" when it clearly isn't.

        If there is no control over what goes into these products and who can get their hands on them, it will only be a matter of time before we have another Thalidomide disaster on our hands. (Google it if you don't remember)
      1. fueledpassion's Avatar
        fueledpassion -
        Originally Posted by schmidt View Post
        Everybody seems to be blaming the FDA. I for one am a little upset at the supplement companies for trying to add DMAA under the guise of "Dietary Ingredient" when it clearly isn't.

        If there is no control over what goes into these products and who can get their hands on them, it will only be a matter of time before we have another Thalidomide disaster on our hands. (Google it if you don't remember)
        There is an inherent problem with that theory of regulations.

        1) If the FDA didn't have so many restrictions and laws based around what used to be known as a free-market, the companies wouldn't be looking for loop-holes like they do. They'd just call it what it is and put a fair warning on the label, much like you'd see with many toxic cleaners, paint thinners, etc etc. Use with care and respect. That's the problem with our society - too many of us just want to abuse things in a pursuit of happiness. It's pathetic but true. And more regulations won't fix that problem. You have to do root-cause analysis to figure that one out.

        2) Companies are interested in selling what the market demands. If the market demands it, the company makes it. However, if something were impossible to use without having huge health risks involved, the market wouldn't demand it and thus would not buy it. That simple. If the cost outweighs the benefit no one will buy the product to begin with. It's a perception of value thing.

        There are people that think companies are and should be ultimately responsible for what is put on the market...but I say that is a good indicator of denial. The market, which is made up of individual consumers like you and I, controls the demand for something and thus drive the various industries to produce what they do. So here is the issue I have with government - it imposes certain beliefs, preferences, and ways of life onto the society which totally goes against our constitution and the concept of "freedom".

        The only regulation that should be forced is accurate labeling - which means to accurately label what the product is, does and it's health risks. That simple.

        If it's too dangerous to a point that the cost outweighs the benefits --> no one will buy it or not enough will buy it. That will drive the companies that create these things to go back to the drawing table and find something that we think is worth the hassle.
      1. AdonisBelt's Avatar
        AdonisBelt -
        Originally Posted by fueledpassion View Post

        There is an inherent problem with that theory of regulations.

        1) If the FDA didn't have so many restrictions and laws based around what used to be known as a free-market, the companies wouldn't be looking for loop-holes like they do... And more regulations won't fix that problem.

        2) Companies are interested in selling what the market demands. If the market demands it, the company makes it. However, if something were impossible to use without having huge health risks involved, the market wouldn't demand it and thus would not buy it. That simple.
        I agree with most of what your saying but as a financial economist I feel obligated to correct you on a few points...

        1) most issues with the market not being free and competitive is actually due to lacking enforcement from the FDA and DOJ in regards to monopolies being able to ruin competition, free market efficiencies, and willingness to invest in technologies. The issue is the public policy behind the FDA and DOJ that is screwing with priorities here. Our government should not be wasting time with outlawing ingredients, it should be regulating barriers to entry and general monopsonies. Regulation does not destroy the free market. When ran well, it protects it.

        2) it is true that the market sells what is demanded, but you cannot assume all consumers (and producers) carry perfect information. The best example of this is looking at what consumers demand despite any real benefits. Glutamine comes to mind here. Products that induce harmful effects apply here as well. In other words, health risks don't really affect whether a company will sell it. If steroids were legal, people would buy them. If dmaa was legal, people would buy it. If weed and prostitution was legal, we would sure as hell see a boom in that market.

        Cheers
      1. fueledpassion's Avatar
        fueledpassion -
        Originally Posted by AdonisBelt View Post
        I agree with most of what your saying but as a financial economist I feel obligated to correct you on a few points...

        1) most issues with the market not being free and competitive is actually due to lacking enforcement from the FDA and DOJ in regards to monopolies being able to ruin competition, free market efficiencies, and willingness to invest in technologies. The issue is the public policy behind the FDA and DOJ that is screwing with priorities here. Our government should not be wasting time with outlawing ingredients, it should be regulating barriers to entry and general monopsonies. Regulation does not destroy the free market. When ran well, it protects it.

        2) it is true that the market sells what is demanded, but you cannot assume all consumers (and producers) carry perfect information. The best example of this is looking at what consumers demand despite any real benefits. Glutamine comes to mind here. Products that induce harmful effects apply here as well. In other words, health risks don't really affect whether a company will sell it. If steroids were legal, people would buy them. If dmaa was legal, people would buy it. If weed and prostitution was legal, we would sure as hell see a boom in that market.

        Cheers
        Perhaps my second point really only holds true to informed buyers or buyers who study their purchases and provide continuing education for themselves. I'm one of those people. So naturally, I like to know both pros and cons before a purchase.

        And I agree that regulations, when done correctly, protect our market. I totally agree with that. But I don't think the regulators are enforcing the right regulations as you sort of eluded to.

        There has been a country in Central America (I'll have to look it up because I don't remember which country it was) that recently lifted all bans against cocaine, heroine & pot, then taxed them as a legal substance to purchase - like anything else. They actually saw a decrease in sale and use of the drugs thereafter. Turns out, people are less interested in harming their body to that extent when it is 100% legal and acceptable. Human nature to do what we're pressured not to do. There is simply so much evidence for this in our society its hardly arguable.

        Cigarettes are an interesting example - cigarette use has dropped by 30% in the last decade due to taxes, negative advertising and the laws against smoking in public places, yet according to the CDC, cigar use and pipe-smoking are up 223% & 482%, respectively. Turns out, cigars and pipe-smoking have less tax burdens than cigs and now companies are manufacturing them to be very similar to cigarettes in order to become a viable substitute. So people switch from one vice to the next.

        Perfect example of what I was trying to say earlier.

        I appreciate your corrections, but I guess I see a different philosophy at work here. I do not believe laws will correct behavior. They only bring to our attention the behavior that we currently have. To the law-abiding citizen, it instills pride. To the law-breaker, it instills fear & counteraction.

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