Last year I started studying the supplement industry after reading an article in the USA Today about Matt Cahill and how he and his company Driven Sports had gotten away with formulating and selling products while he had such a questionable background. You can read the full perspective here.
I have continued to research and investigate the federal regulations surrounding the supplement industry, and how loopholes have allowed so many dangerous products to enter the world and harm people. But this last week I read an article that truly caught my attention due to the fact one of the ingredients mentioned (AMP Citrate), which I knew was being HYPED as the newest answer to weight loss. But… As I studied the ingredient, and which companies were using it, I quickly realized that a new direct selling company was pushing it through one of their flagship products and that concerned me.
This article is not to slam the company or even mention it’s name. This article is to shed some light on the questionable ingredient and to allow folks the ability to determine if the health and ethical risk is worth marketing or taking any product with the AMP Citrate.
The Dietary Supplement Health and Education Act of 1994 has left a huge loophole in the laws that allow even known felons with no real scientific education the ability to create any formulate they desire without any regulatory or even industry oversight.
The law defines a supplement as follows:
DSHEA defines the term “dietary supplement” to mean a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients.
And one of the biggest loopholes for unethical formulators is the following:
Under the act, supplement manufacturers do not need to receive FDA approval before marketing dietary supplements.
Let’s look at all the names used for AMP Citrate:
4 amino-2-Methylpentane citrate
Now what I found most interesting as I dug into AMP Citrate is that the majority of the proponents of the ingredient state that it is of natural origin and comes from Pouchong Tea, however when we take a look at the first name above for AMP Citrate, here is what we find.
Methylhexanamine, commonly known as 1,3-dimethylamylamine or DMAA, was invented and developed by Eli Lilly and Company and was marketed by Lilly as an inhaled nasal decongestant pharmaceutical drug from 1944 until Lilly voluntarily withdrew it from the market in 1983. Methylhexanamine is an indirect sympathomimetic drug.
Now the proponents will tell you that the above is a mistake and that Methylpentanmine aka DMAA is not the same as AMP Citrate which is DMBA.
Personally I think that one of the reasons the formulators don;t want people to realize that AMP Citrate (DMBA) has anything to do with DMAA is the follow excerpt I found on Wikipedia…
Since 2006 methylhexanamine has been marketed extensively under many names as an energy-boosting dietary supplement under the claim that it is similar to certain compounds found in geraniums, but its safety has been questioned as a number of adverse events and at least 5 deaths have been associated with methylhexanamine-containing supplements. It has been banned by many sport authorities and governmental agencies.
Since DMAA is manmade and has been banned doe to health risks, any mention of AMP Citrate being a cousin could cause huge issues.
And since I am not a scientist I can’t argue the formulators point personally, I figured I will refer to some of the scientist who have studied the ingredient.
Here is a small glimpse as well as the link to the full report by Pieter A. Cohen,a* John C. Travisb and Bastiaan J. Venhuisc.
A synthetic stimulant never tested in humans, 1,3-dimethylbutylamine (DMBA), is identified in multiple dietary supplements
A synthetic stimulant never before studied in humans, 1,3-dimethylbutylamine (DMBA), was suspected of being present in dietary supplements. DMBA is an analogue of the pharmaceutical stimulant, 1,3-dimethylamylamine (DMAA), which was recently banned by the US Food and Drug Administration. We obtained all dietary supplements sold by US distributors that listed an ingredient on the label, such as AMP Citrate, that might be a marketing name for DMBA. Supplements were analyzed for the presence and quan- tity of DMBA. Fourteen supplements met our inclusion criteria and were analyzed by two separate laboratories using ultra high per- formance liquid chromatography (UHPLC) – mass spectrometry and a reference standard. The identity of DMBA was confirmed in 12 supplements in the range of 13 to 120 mg DMBA per serving. Following recommendations on the supplement label for maximum daily intake, customers would consume from 26 to 320 mg of DMBA per day. Supplements containing DMBA were marketed to improve athletic performance, increase weight loss and enhance brain function. DMBA has never before been detected in supple- ments. The stimulant has never been studied in humans; its efficacy and safety are entirely unknown. Regulatory agencies should act expeditiously to warn consumers and remove DMBA from all dietary supplements. Copyright © 2014 John Wiley & Sons, Ltd.
Here is what I feel os one of the most important finding in the report…
One study in Chinese by Chen and Ou purports to have found DMBA at levels of 0.012 ppm in Pouchung tea as a degradant upon storage; however, an authentic chemical reference standard was not used to confirm the identity or quantity of DMBA in this study. Even if DMBA were found at these very low levels, manu- factures would require at least 1000 kg of Pouchung tea to extract 12 mg of DMBA, and humans would not have previously been exposed to the high levels of DMBA that we found in dietary supple- ments. The only other study that we are aware of that purports to find DMBA in nature is a study in Chinese which analyzed the essential oil from the oleoresin of the Plains coreopsis (Coreopsis tinctoria), but the authors did not use a reference standard to con- firm the finding.
We are unaware of any scientific evidence that DMBA has ever been extracted from any plant, while synthetic DMBA is easy to synthesize and widely available. DMBA belongs to the family of pressor-amines including the medicines DMAA, tuamine, and propylhexedrine. The concentrations found in the supplements analyzed strongly suggest that DMBA is synthetically mass-produced to create pharmaceuti- cal effects. It would appear to be very difficult, if not impossible, to justify the inclusion of DMBA in any nutritional supplement.
The health risks from DMBA in pharmacological doses are unknown. DMBA has never been studied in humans and its physio- logic effects, to our knowledge, are only briefly mentioned in two small animal studies from the 1940s. One study examined DMBA’s effect, along with several other aliphatic amines, on an undisclosed number of pithed cats and another study examined its effect on five pithed dogs.[17,18] These two small animal studies provide preliminary evidence that, as its structure would suggest, DMBA has pressor effects and is somewhat less potent than DMAA. DMBA should therefore be considered an active pharmaceutical ingredient that requires rigorous clinical testing and evaluation prior to marketing. Unfortunately, unless the laws regulating dietary supplements are reformed to prohibit unproven claims such as ‘enhances athletic performance’ or ‘effective for weight loss’ – additional aliphatic amines such as 2-amino-5- methylhexane, 2-aminohexane and 2-amino-6-methylheptane are likely to be introduced as soon as regulatory bodies begin to move against DMBA.
Recently, the Netherland’s National Institute for Public Health and the Environment found DMBA in a supplement named ‘Un- stoppable’ sold by Dedicated. The supplement did not have a mar- keting name for DMBA on its label. The ‘Unstoppable’ sample was obtained from a user who had reported adverse effects to the Netherlands Anti-Doping Authority. So far, three cases of adverse effects were reported for this supplement. The symptoms were sim- ilar and included the feeling of rushing, difficulty sitting still, a sense of motion and increased focus. It is not known if DMBA was respon- sible for the adverse effects noted by consumers. However, analysis of ‘Unstoppable’ demonstrates that DMBA may be present in supplements that do not list the ingredient on the label. (The impli- cated supplement was not part of our current study because it did not meet our inclusion criteria.)
In addition to adverse health effects, DMBA poses significant risk to the career of athletes: the World Anti-Doping Agency (WADA) will probably consider DMBA to be a prohibited substance under section S6.b because of its similarity with tuamine.
Now I do need to be very clear and publish the following from the report…
Our study has several limitations. The sample size is too small for the quantitative findings to be representative. Nevertheless, quantitative data provide initial estimates of the amount of DMBA to which consumers might be exposed.
So, all who are reading this investigative perspective must use their own wisdom to decide if the risk is worth selling or taking any product with AMP Citrate or whatever it might be called!
Here are some additional stories surrounding this issue!