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Round Table DMAA

1,3-Dimethylamylamine (DMAA)

1,3-Dimethylamylamine aka (DMAA, Methylhexanamine, Forthane, Geranamine) has rarely been out of the headlines of late in Australia (and all over the world). The stimulant has been featured on prime time television news broadcasts, being portrayed as a potentially lethal party drug. The print media have also shown a keen interest in the ingredient with numerous articles published on its regulatory status and safety. All of this attention has culminated in Australia’s local governing agency (the Therapeutic Goods Association) scheduling DMAA in Appendix C of the Poisons Standard, meaning it is banned from sale and possession.

What has followed is a new breed of supplement stimulants such as higenamine (Jack3d Micro) and N-Methlytyramine (APS Mesomorph 2.0).

To discuss the controversy around DMAA we have invited some of the brightest minds in the supplement industry to discuss their take on the DMAA ban and suggest some alternatives for those of us who look for a stimulatory boost pre workout.

DMAA Round Table


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The Participants

Patrick Arnold

Patrick Arnold

Patrick Arnold is currently the owner of E-Pharm and Prototype Nutrition and is the man behind the popularisation of DMAA. A true innovator, his company’s product AMP was the first to market with DMAA in 2006, with many others following suite. Patrick also posts on his personal blog which you can access here.

Adel Moussa (aka Dr Prof Andro)

Suppversity

Dr Prof Andro is the brainsbehind the SuppVersity Blog and a regular participant on the Super Human Radio Broadcast (amongst others). Dr Prof Andro brings with him an impressive culmination of nutrition and supplement articles with in depth scientific review and analysis.

Kurtis Frank

Examine.com

Kurtis Frank is a co-founder and the lead researcher of Examine.com, a science-based compendium on supplements, nutrition, fitness, and health.

Willem Koert (Ergolog)

Ergo Log

Ergo Log is a science based performance enhancement news website. It is widely referenced by supplement experts and is an industry leader in supplement science reporting.

Optimum Nutrition

It seems as though everyday an announcement is made on another country banning DMAA due to safety concerns. Do you think the legislators are getting it right and why?

Kurtis Frank

Unfortunately for athletes out there, I do believe they are getting it right. I will say outright that I do not agree with the degree of enforcement placed on it in Australia (being in the same category as heroin?!) but due to a lack of studies and general information on 1,3-DMAA, it is currently prudent to keep it out of the public's hands for now. The worst part about science is when there is none. With uncertainty about DMAA's toxicology, it is only prudent to limit access.

There is no research on what dosage of DMAA would be 'excessive', and thus we take the "better safe than sorry" approach.

At the same time, I cannot understand as to why it was classified under Schedule 9. There is no reason to associate it with drugs like heroin, LSD, or MDMA. S9 is excessive.

Dr Prof Andro

I suppose this is less of a question of “right” or “wrong”, rather a simple reaction to economical, public and media pressure on part of the legislators. Nevertheless, if you focus solely on the scarce evidence on which you could base a scientifically substantiated decision the answer may still be “yes” rather than “no”. Not because DMAA was the cardio toxic psychedelic as it is portrayed in the media, though, but rather due to the absence of convincing scientific evidence to the contrary.

Concerning the lack of scientific evidence, when the supplement industry finally realized that their multi-million dollar blockbuster products were about to be pulled off the market and USP Labs financed two small-scale studies the results of which were published in Nutrition and Metabolic Insights, a peer-reviewed, open-access online journal with comparably little impact on the public decision makers, it was already too late for such evidence to be presented. With their decisionto ban DMAA containing products, Health Canada, the Canadian equivalent of FDA, had already created precedents [3].

It was therefore not very surprising when the FDA followed their lead and sent an official warning to Exclusive Supplement, Fahrenheit Nutrition, Gaspari Nutrition, iSatori Global Technologies, LLC, Muscle Warfare, Inc., MuscleMeds Performance Technologies, Nutrex Research, SEI Pharmaceuticals, SNI LLC and, of course, USP Labs, LLC in April 2012. [4] In the letter in which it says that "synthetically-produced DMAA is not a 'dietary ingredient' and, therefore, isnot eligible to be used as an active ingredient in a dietary supplement", the officials specifically demand that...

"Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated”. [4]

In 2011, Health Canada had argued similarly, when they justified the ban of “geranium” based on assertion that “there is no credible scientific evidence that DMAA is captured as an isolate of a plant” [3]. They based their argument on a critique of a study by Ping et al. [5] that is often as scientific evidence for the natural occurrence of DMAA which was “full of errors” and the authors’ failure to fully isolate and characterize DMAA. “Together with the contradictory information from numerous other peer-reviewed scientific studies which show no natural occurrence of 1,3-demethylamyline as an isolate of a plant” [7], this was apparently enough to give the debate a whole new direction that rendered all of USP Labs’ last-minute efforts to provide scientific evidence in favor of the general safety of their products totally meaningless [7], [8].

If one of the ingredients of the products was not “naturally occurring” and can therefore not be sold as a DSHEA compliant dietary supplement, it does not even matter whether the products were safe or not. Or, to put it differently: It was not even necessary for the legislators to take a closer look at the data from the two USP Labs sponsored trials on OxyElite Pro and Jack3d [7],[8] to ban these and all other DMAA containing supplements from the market.

From a legal standpoint, it is therefore also unwarranted to draw any parallels to the ban of ephedra, which is – due to its natural abundance in mua huang – actually a DSHEA compliant supplement ingredient. Now, does that mean that Health Canada, the FDA and other government agencies who followed their lead just looked for a fast and bulletproof way to take away another of your favourite toys? Or were they simply trying to “play it safe” and thus acting in the very best interest of the public they ought to protect?

I guess, the proponents of the ban will certainly argue in favour of the “better safe than sorry” argument. If you discard the entire legal shenanigan and argue solely from a scientific point of view, though, you will however arrive at slightly different conclusions. If we do take a look at the epidemiological data from the Texas Poison Center [7], for example, one of the characteristic features of the dietary supplement that was responsible for 45 of the 56 reported, allegedly DMAA-related adverse side effects (80.4% for OxyElite Pro) contains more ingredients than just 1,3- demethylamyline. Of these, at least caffeine and yohimbine (in this particular case alpha-yohimbine) could just as well be the cause for the tachycardia (28.6%), nausea (16.1%) and vomiting (12.5%; figures in brackets indicate percentage of consumers complaining about the respective side effects) which have been reported to the government [9]. If you put any faith into USP Labs’ own claims about how the small violet caps in the white bottles are supposed to work, even the thyroid boosting effects of bacopa monnieri could be responsible for some of the adverse effects the consumers were complaining about.

Assuming that “consumer safety” was actually the mainconcern of the legislators, it would therefore have been imperative to scrutinize the individual and joint contribution of the said complementary ingredient, specifically the various currently available forms of yohimbine [10], to the aforementioned side effects. This would have been all the more important in view of the fact that we all know that their use and the respective dosages are going to increase, now that their “congenial partner in crime” (?) is off the market.

The reason that I still don’t shed a tear over DMAA -- and would suggest you don’t either -- is simple: While there is some evidence that DMAA, of which Swanson and Chen wrote in 1946 is a “3.5x more potent pressor agent than epinephrine” (a ‘pressor agent’ is any molecule that will induce the narrowing of a blood vessel ), can actually do serious harm to your heart and brain [12], [13], the latter cannot be said with respect to its purported ergogenic effects [15]. And if you look around or ask people at the gym you will get tons of anecdotal evidence that even those who initially enjoyed the short-lived energy burst eventually realized that chronic use and the necessity to take more and more of an increasingly useless stimulant will overtax your central nervous system and eventually send you right down into the abyss of over training and chronic fatigue.

Patrick Arnold

Safety concerns? If you mean that there is sufficient evidence that the product is harmful then I think they are completely getting it wrong. There has been nothing but some anecdotal reports such as with those kids in New Zealand that were taking party pills and a couple of military guys that fell out during physical training. These reports were simply correlative, they did not demonstrate that DMAA was a responsible factor at all. Other than that I don’t really know of other instances where DMAA was connected to serious adverse medical events. With a product that has had so many millions of doses consumed over the last 7 years one would actually expect a lot more instances of harm done to users if indeed the product was substantially dangerous.

Some people say that you don’t need to have evidence of danger from the product, and that the lack of evidence for safety is enough cause for concern. If you buy that argument then to be consistent you would have to apply it to other nutritional supplement ingredients as well. Let’s just stick to other stimulant ingredients. Yohimbine, beta-phenethylamine, hordenine, synephrine – where are the clinical studies demonstrating the safety for these ingredients? Yohimbine especially is an awful compound and I guarantee it put more people in the hospital than DMAA ever did.

The fact is that there have been studies done on DMAA containing products where no adverse effects were seen. There have been zero studies on DMAA (or products containing it) that have shown it to be dangerous. Why haven’t any studies been done showing it is dangerous? Maybe studies have been undertaken that failed to yield the desired data and those were buried? Maybe authorities believe burden of proof is something that only is relevant to the industry, and thatthey reserve the right to act on something based on whatever flimsy evidence they find fit. I think that’s a damn crock.

The only argument against DMAA that makes any sense is the controversy as to whether it is naturally occurring and therefore legal in the US. There are conflicting reports on this and it has not been resolved. Furthermore, there is a debate over whether syntheticversions of natural compounds can be legal to sell as supplements. That too has not been resolved and remains an area of contention between the FDA and the supplement industry.

Ergo Log

No, I don't think they are. In my humble opinion, the legislators are making bad decisions concerning DMAA. As a science writer I have covered the Ephedra affair in 2002-2004, and during the DMAA affair in 2010-2012 I couldn't help noticing the differences between the ways administrations handled them.

Don’t get me wrong, I was against the Ephedra ban. Nevertheless, there was a rationale behind the governmental actions against Ephedra. When the Bush administration banned Ephedra in 2004, there was a growing amount of scientific literature to back up that decision. Studies described ischemic stroke in Ephedra users, dozens of cases of cardiovascular incidents and psychiatric effects. British pharmacologist Michael Radcliffe Lee recently wrote in a review article about Ephedra that "although we will never know exactly how many people were killed worldwide by Ephedra taken as a nutritional supplement, the figure must run into hundreds".

If those figures are correct, a ban might be an option. Another option, and in my opinion, a better option, is regulation of the apparently dangerous supplements. Experiences in Denmark have shown the world that properly produced supplements containing caffeine and ephedrine, the man active constituent in Ephedra, can be used safely by thousands of people.

But that’s not the point I want to make here. My point is that there are no documented and convincing reports about the dangers of DMAA. The few reports about cerebral hemorrhage in adults who used DMAA as a party drug or the two US soldiers that used DMAA as stimulant during training are tragic, but they don’t prove that DMAA is dangerous.

April 2012 the American FDA sent warning letters to distributors of DMAA supplements, stating it had received 42 adverse event reports on products containing DMAA. Some of the reports included cardiac disorders, nervous system disorders, psychiatric disorders, and death. However, “the complaints do not establish that DMAA was the cause of the incidents”, as the FDA wrote.

So – why then ban DMAA? It’s an irrational decision. Every day people die of overdosing caffeine and paracetamol, but we don’t ban them. Believe it or not, but people have died of drinking too much water. But we don’t ban water either.

Instead, we learn how to use caffeine, paracetamol and water safely. If our labs discover companies that put too much caffeine in their energy drinks, we ask them to correct the dosage. But we don’t ban caffeine. We put warnings on our paracetamol products, and warn against taking too much paracetamol. But we don’t ban paracetamol. We educate physicians, soldiers and athletes about water intoxications. But we don’t ban water.

The ban of DMAA says more about our Zeitgeist than about DMAA. We – our politicians, our legislators and our nations – allow fear to guide us, instead of rationality. I believe governments’ prime task is guaranteeing citizens’ freedom of expression, opinion and choice, not limiting it. Banning products is something governments should only do in rare and extreme circumstances. Neither the Ephedra affair nor the DMAAaffair was one of them.

What is your takeon DMAA being banned by most sporting associations?

Kurtis Frank

DMAA does share a urinary metabolite with amphetamine, so if it wasn't banned, people could take amphetamine and then claim they were using DMAA. As far as I know, they are still unable to distinguish between the two in urinalysis. Thus, I would agree with this decision.

Dr Prof Andro

If the sole reason to ban the use of a dietary supplement is to hinder athletes from abusing it to wrangle an unfair advantage over their competition, the ban of Methylhexaneamine, as the WADA list refers to DMAA in section 6b of the most recent Prohibited List [16],appears nonsensical. After all, we don't have a single well-controlled study that would support the notion that the ingestion of DMAA would make you "bigger, stronger [or] faster" [14]. So, unless the governing bodies of the WADA and similar organizations base their decisions on the hilarious marketing claims of supplement manufacturers and thwarted user reports on the Internet, it appears that the main argument here is – once again – based on DMAA’s non-DSHEA compliance,or, as the WADA puts it, its historical use as a "pharmacological substance classified as a stimulant that was commercialized up to the beginning of the seventies" [17].

I will leave it up to you to make up your mind on how reasonable this approach to distinguish legal from illegal stimulants is, specifically if you consider that caffeine, nicotine and synephrine may be in the 2013 monitoring program, but are still not considered "prohibited substances" [16] – just as phenylephrine, bupropion, phenylpropanolamine and pipradol by the way, although none of them would be legally considered a "dietary supplement".

Patrick Arnold

Stimulants are clearly banned by sporting associations with doping programs and for good reason because they work and they give a clear unfair advantage. DMAA is a very effective stimulant and I know for a fact it gives a performance edge. So therefore it makes sense it's on the list.

With that said I don’t believe that sports doping policy should have any impact on the availability of a banned substance to non-tested athletes or lay people. Some make the mistake of thinking that substances are banned because they are dangerous, or because they possess some intrinsic moral threat. That's stupid.

Ergo Log

If sporting associations are opposed to doping, banning DMAA is logical. If we are to believe the old Eli Lily studies on DMAA and related substances, DMAA is three times as powerful as epinephrine. It's very likely that DMAA might improve performance. Too bad it's taken from the market...

For Australians, DMAA is no longer an option, what would you suggest (outside of caffeine) for those who like a decent stimulant boost pre workout?

Kurtis Frank

It is sort of a tough call since most stimulants are understudieduntil they come to one of twoconclusions: either they are not that potent and they remain available on shelves, or, they are found to be quite potent and end up banned like DMAA and Ephedrine.

Currently, the best non-caffeine stimulants (take this with a grain of salt) that are currently available and legal would be L-Tyrosine, Acetyl-L-Carnitine (ACLAR), and Yohimbine. Yohimbine is the most potent of the three but also has stronger side-effects, whereas the other two are weaker. There are a few other options out there that are less studied, and for the same reasons as DMAA I would not currently recommend them.

Dr Prof Andro

*laughs* Since the question explicitly excludes the only "stimulant" I do recommend, i.e. caffeine – best taken in moderate amounts and with all the natural synergists in form of 2 small cups of coffee, (200-300mg of caffeine per day) – I guess my best advice is to ask yourself why you actually need a "stimulant boost"?

Unless it's the day of a competition (and 99% of the trainees don't compete, at all), you may well benefit more by simply listening to your body: Take a day off, do a regenerative cardio workout (like 20-30min walking on a treadmill) just to avoid lying or sitting around all day, play basketball, soccer or whatever you enjoy doing with friends, take your dog for a walk or be otherwise recreationally active! All that will be much more conducive to your goals than to pop some pills and continue to out-train your regenerative capacities.

Patrick Arnold

I wish I could suggest a natural alternative that is as good as DMAA but I can't. I assume ephedrine is illegal in Australia as well. It's a shame. The only natural ingredients that ever really did much for me were DMAAand ephedrine (both preferably co-administered with caffeine). If anything does come along again that works I suggest you stock up on it, because once it becomes popular it will be targeted just like DMAA was and it will be gone

Ergo Log

If Pat Arnold is speaking his mind about pre workout supplements, a science writer is not allowed to speak. He must keep his mouth shut – and listen in awe. Quid licet Iovi non licet bovi, you know.

 
References
Optimum Nutrition