BSCG Designate Golden Shilajit as BSCG Certified Quality ™

BSCG is pleased to welcome Golden Shilajit to its rigorous BSCG Certified Quality™ program.

BSCG Certified Quality™ focuses on ingredient identity, label claim verification, and contaminant testing in dietary supplements and natural products. To ensure that what is listed on a supplement label is what is in the product, a company must infuse quality at every step of the process, from raw materials, to manufacturing, and ultimately to the finished product.

Shilajit is a natural herbal extract that exists in solid or paste form and contains more than 80 minerals, including Fulvic acid, iron, calcium, magnesium, manganese, and Selenium. Gold Shilajit has the highest quality of the four types of Shilajit. (The others include Iron Shilajit, Zinc Shilajit, and Copper Shilajit.) Golden Shilajit aims to help consumers stay fit longer, ease stress and anxiety, improve sleep and relaxation, and improve stamina. The company sources the raw material of authentic Shilajit from the Himalayas and Karakoram mountains in Gilgit-Baltistan area in Pakistan.

For more information about this product, visit the Golden Shilajit website. Emails can be sent to info@GoldenShilajit.com.

Noopept could be the next big banned substance in sport after Meldonium

Noopept could be the next Meldonium

Written by Oliver Catlin, BSCG President

The question many of us ask, “What might be the next clandestine doping agent in sports?” might have a new answer: noopept. Popular in dietary supplements, noopept could be the next big banned substance in sport after meldonium.

As we watch the with the Russian doping scandal looming in the rearview mirror the notion that noopept could be the next big banned substance in sport after meldonium is interesting on its own. However, when one considers that both substances appear to be sold as medication in Russia, and that many of the meldonium findings early this year involved Russian athletes, the intrigue gets deeper. Because noopept is prevalent in the supplement marketplace around the world, if it is the next clandestine doping agent the potential issue would expand well beyond Russia.

A comparison between the substance noopept and meldonium supports our theory. Meldonium, which is suggested to improve blood flow, is approved for use as anti-ischemia medication in Eastern Europe and Russia. It is usually used to treat heart disease. Although clearly popular with athletes, based on the hundreds of adverse analytical findings for the drug in early 2016, meldonium is not commonly found as a dietary supplement, at least not yet.

Meanwhile, noopept, is patented by JSC LEKKO Pharmaceuticals, a Russian pharmaceutical company, in both the U.S. and Russia. It is commonly sold as a dietary supplement in the nootropic category around the world, but appears to be sold as a medication in Russia and Eastern Europe. Noopept is being studied for its potential to alleviate Alzheimer’s symptoms and treat other brain disorders. It is not an approved drug in the U.S.

Noopept does not appear to be a controlled substance in the U.S. or other countries, or at least that is what some . That does not mean, however, it would be legal to sell as a supplement. It would likely qualify as an unapproved drug according to the U.S. FDA, or other international equivalents. As such, it may be OK to sell for research purposes, but not as a supplement marketed for human consumption. Given that noopept was patented in 1996, was not in the food supply prior to 1994, and is synthetic, it does not appear to qualify as a legal dietary supplement ingredient in the U.S., according to .

Despite noopept being a dubious, if not illegal, supplement ingredient, it is commonly found packaged as a supplement and is available online at a wide range of distributors including and . Based on its prevalence in dietary supplements and on message boards, it seems it has become quite popular. With discussion on ‘,’ as far back as 2007, it appears folks that track performance-enhancing compounds have known about it for a number of years.

In fact, noopept has become so popular that even Reddit, who thankfully realizes the concern, has a note on noopept in ‘.’ The note describes that, “synthetic drugs (not DSHEA compliant) that have too little information on them to assess toxicity (Ex. Noopept or PRL-8-53)…, are in the grey area.”

So, what does noopept do and why might it be prohibited in sport?

As mentioned, noopept is typically marketed as a nootropic, or in simple terms a brain stimulant. Nootropics are different than central nervous system stimulants, but are suggested to have some psychostimulatory effects. Noopept’s effect is often compared to piracetam, which the does not consider prohibited in sport, and , which is prohibited in sport. An excerpt from compares phenylpiracetam to noopept as follows:

“Even though phenylpiracetam is considered 60 times more potent than piracetam, noopept is considered to be around 1000 times more effective. This is because it often works through the acetycholinergic system in ways that are different from the other racetams. Structurally speaking, noopept is not the same family as racetams, but it is similar and definitely acts in similar ways.”

So, noopept could perhaps be interpreted as prohibited in sport already based on the catch-all language used in the . Meldonium needed to be added to the list by name, where it now appears as a metabolic modulator. This is an important distinction, as there is precedent for related substances being considered banned in sport and resulting in positive drug tests even before they are on the WADA Prohibited List. That was the case with DMAA when the first positive was called in 2008, and recently occurred again with higenamine early in 2016.

The stimulant category includes fonturacetam [4-phenylpiracetam (carphedon)] as a non-specified stimulant. The catch-all language at the end of the category prohibits, “other substances with a similar chemical structure or similar biological effect(s).” Noopept, shown at left, may qualify as it is described as having a similar biological effect and seems to have a similar structure as phenylpiracetam. Interestingly, the phenyl group in the upper left corner is also shared by phenethylamine, which was added to the WADA Prohibited List in 2015.

We note that if fonturacetam is prohibited in sport then piracetam could also qualify under catch-all language in our view, but it does not according to the Global DRO. So, interpretation does not seem clear as to whether something that appears to have a similar chemical structure and structure to fonturacetam is prohibited in sport. Would other more potent racetams like aniracetam be interpreted to be prohibited? We believe they would be, but then noopept could be as well.

You can see why noopept could be the next big banned substance in sport after meldonium. It is widely available making it likely to be used by athletes. It could have the potential to enhance sports performance as it is described as having similar biological effects as phenylpiracetam, which is already banned in sport. It would likely satisfy the first and third conditions for a drug to be considered for addition to the WADA Prohibited List.

1 – Potential to enhance or enhances sports performance
2 – An actual or potential health risk to the athlete
3 – Use violates the spirit of sport (outlined in the Code)

With the 2016 Rio Olympic Games in progress we find ourselves wondering what drugs athletes might be using. Noopept is hiding in plain sight and could be exposed soon as the next clandestine doping agent. Whether that holds true depends on if, or when, WADA interprets the substance to be prohibited. That could happen at any time if they see the situation as we do.

n-methyltyramine supplement are prohibited in sports

N-methyltyramine supplements are prohibited in sport but the same substance is acceptable when naturally present in beer

In a recent blog post, we marveled at the seemingly absurd notion that beer might be banned in sport based on interpretation that a prohibited substance, N-methyltyramine (NMT), is present at around three milligrams per pint. After a pint or two, we thought more clarity was necessary for our fellow imbibers. When present naturally in beer NMT would be acceptable, while n-methyltyramine supplements are prohibited in sport. This presents an interesting dilemma to students of anti-doping regulations and lists.

How is it that that one substance can be both legal, and naturally present in beer, but also be a prohibited substance in sport? Who exactly is responsible for this absurdity? Well, you can blame it on the resurgence of n-methyltyramine as a stimulant and/or weight loss ingredient in dietary supplements and the addition of phenethylamine and its derivatives to the WADA Prohibited List in 2015.

The resurgence of NMT in the supplement arena came as far back as 2011, but the phenomenon has surged again recently as companies have looked for replacements for dubious ingredients like DMAA (dimethylamylamine, or methylhexaneamine). DMAA was often sold in disguise as natural geranium oil extract, but in reality what was on the market was the synthetic chemical DMAA. DMAA became perhaps the most popular stimulant pre-workout ingredient ever but has since run into regulatory action after adverse events and determination by the FDA, and international equivalents, that it is an illegal supplement ingredient. DMAA has also become the most common stimulant reported as an adverse analytical finding in the WADA system.

N-methyltyramine was a logical substance for the supplement makers to turn to since it is naturally present in barley as we pointed out previously, and citrus aurantium. Citrus aurantium also contains other stimulants like synephrine and octopamine (the later banned in all sport, the former banned in the NCAA). Citrus aurantium and synephrine have been popular stimulant and weight loss supplement ingredients for many years. So, the theory is that n-methyltyramine, being a phenethylamine derivative, and naturally present, would be a perfect replacement ingredient.

As a phenethylamine derivative, n-methyltyramine qualifies as a prohibited stimulant based on the WADA Prohibited List language in force today. While it qualifies as a stimulant, it may not be all that effective as a stimulant or weight loss agent. Nonetheless, this has not stopped the supplement community from peddling it as a weight loss ingredient still today. Even sites that promote NMT note the dubious efficacy of this relatively unstudied compound, as the excerpt below demonstrates.

“This compound is often included in weight loss formulations, despite evidence pointing to the fact that N-methyltyramine has been shown to inhibit fat breakdown and stimulate pancreatic hormones like anabolic insulin, and gastrin, which stimulate appetite (5). That said, the stimulant effect of this ingredient is likely to suppress appetite, and it is probable that N-methyltyramine will work for some people well but perhaps not for others. Additionally, the effect of N-methyltyramine as a stimulant has been called into question, because, like tyramine, it has low lipid solubility, therefore it is unlikely to cross the blood-brain barrier.”

The usual amount of NMT used as an active ingredient in supplements is around 200 milligrams. That compares to around 3 milligrams of NMT per pint of beer. So, you would need to drink around 70 beers to ingest the same amount of NMT you would get in a supplement. Stimulants generally clear the body fairly quickly. So, even if you had one beer a day or two before competition that would be unlikely to cause an NMT adverse analytical finding, while n-methyltyramine supplements are prohibited in sport.

Perhaps interpreting NMT as prohibited in sport will dissuade supplement manufacturers from making supplements with n-methyltyramine as an active ingredient. We rather doubt it, since often when something is banned in sport it encourages the proliferation of dietary supplements that contain the banned substance as an ingredient. This happened with Cobalt, SARMs, DMAA and others. Nonetheless, interpreting NMT as prohibited at least discourages athletes from using NMT supplements. We certainly support the prohibition of dubious stimulant and weight loss substances.

At the end of the day, n-methyltyramine supplements are prohibited in sport while the same substance is acceptable in beer. Many natural compounds share a similar predicament. They may be banned if synthesized and used as an active ingredient but acceptable in the natural form. We should be able to defend legitimate natural products, and beer, while also combating problematic synthetic compounds masquerading as legal supplement ingredients like DMAA. The problem is that determining whether a compound is natural, legal, or prohibited in sport can be a complex challenge when considering substances like N-methyltyramine.

Higenamine, a Natural Product Banned in Sports

Dietary Supplements and Banned Substances – A Case Study on Higenamine, a Natural Product Banned in Sport

Athletes should be allowed to focus completely on the sport at hand but instead they are frequently plagued with concerns over whether a dietary supplement, natural product, functional food, or medication they are taking will cause a positive drug test and derail their athletic career. The exercise of determining whether or not something is banned in sport can be extremely difficult. A perfect example of the challenge comes in the form of Higenamine, a natural product banned in sport.

Why is Higenamine a natural product banned in sport? This happens because of the philosophy and approach to creating banned substance lists and the use of catch-all language to cover substances that are related or similar to those on the list but are not named. Amazingly, in some environments like Olympic sport, Higenamine is interpreted as prohibited but does not actually appear on the list. So an athlete has to know how to interpret that such a compound is prohibited.

is a naturally present compound found in a number of different plant species including certain aconitum ( the napellus variety is shown at left), bamboo, poppy, lotus, and magnolia tree varieties. If derived from a natural source, it is a legal dietary supplement ingredient in the US, UK, EU and Canada. A , or biological effect. Since beta-2 agonists are banned by some sporting groups, Higenamine became prohibited based on the interpretation of the list language.

In the case of the various versions of catch-all language are used in the different prohibited categories. Some categories say that, ‘substances with a similar chemical structure or similar biological effect(s)’ are banned. Other categories use ‘including, but not limited to’ language to cover compounds that are not listed. Overall, WADA lists approximately 280 drugs on the Prohibited List but many more could be interpreted to be prohibited based on catch-all language. The extent of the interpretation is not known and is at WADA discretion.

Germane to Higenamine is the language in section S3 – Beta-2 Agonists of the WADA Prohibited List. It says, ‘All beta-2 agonists, including all optical isomers, e.g. d- and l- where relevant, are prohibited.’ This is very broad language that seems to include Higenamine by interpretation since at least one study shows that Higenamine has some beta-2 agonist activity.

Meanwhile, the NCAA takes a similar approach to prohibiting drugs by category, but they include a much smaller list of examples. The list includes a note that, ‘Any substance that is chemically related to the class, even if it is not listed as an example, is also banned.’ They go on to note, ‘There is NO complete list of banned substances,’ and ‘It is your responsibility to check with the appropriate or designated athletics staff before using any substance.’

In the NCAA they actually include Higenamine, and its alternate nomenclature Norcoclaurine, as examples of beta-2 agonists along with traditional pharmaceutical beta-2 agonists like Salbutamol. Under the NCAA list language anything that is chemically related to Higenamine could also be considered banned, even if the related substances have not shown activity as a beta-2 agonist. There are many . So, by interpretation, Higenamine and a variety of other compounds could potentially be banned in the NCAA.

If you look at the situation in professional sport taking MLB as an example, the situation with Higenamine gets even more interesting. A review of the unveils that MLB does not appear to prohibit beta-2 agonists. Beta-2 agonists are not mentioned as a prohibited category. MLB does stipulate that ‘the following is a non-exhaustive list of substances that shall be considered prohibited,’ but without mentioning beta-2 agonists as a category it is hard to imagine these would be interpreted to be banned. No beta-2 agonists are included in the MLB list as examples.

In golf, soon to make its return to the Olympics in Rio after 112 years of absence, the consideration of whether Higenamine is banned is of particular interest. It turns out that both the PGA and LPGA follow the MLB example and do not prohibit the category of beta-2 agonists. The lists do have catch-all language like others, but with the category not being mentioned the catch-all language is not likely to cover beta-2 agonists. So, it appears that beta-2 agonists are not prohibited in professional golf.

Now imagine you are a golfer progressing from the NCAA to the PGA or LPGA and now have the opportunity to play in the Olympics and are subject to WADA rules. In the NCAA, Higenamine is explicitly prohibited, in professional golf it appears not to be prohibited, while at the Olympics Higenamine appears to be prohibited by interpretation. Got that straight?

Not to confuse things further, but we should point out that in our view Higenamine would actually be more appropriately prohibited as a stimulant not a beta-2 agonist. Higenamine typically appears in pre-workout stimulant supplements as a replacement for previously popular ingredients like DMAA, or methylhexaneamine, which was first banned in sport in 2009 classified as a stimulant. If someone were to consider Higenamine as a stimulant then the compound could be considered banned in professional sports like MLB, or golf under the catch-all language for stimulants. As you can see it all comes down to interpretation.

The question of whether Higenamine was prohibited by interpretation was challenged recently when a for it prior to the 2016 Europa League Final. He was originally sanctioned but the sanction was lifted after the player successfully argued that there was an absence of negligence because Higenamine was not on the list of banned substances despite the category being banned. Whether this argument would prove to be a successful defense in other situations where the WADA list language is relevant is not known. WADA is reviewing the case.

As you can see, whether or not Higenamine is banned in sport is quite an interesting question. In WADA, it is not listed as a prohibited substance but is interpreted to be a beta-2 agonist and has led to positive drug tests. In the NCAA, Higenamine appears as an example of a prohibited beta-2 agonist, even though it is technically not chemically related to other pharmaceutical beta-2 agonists like salbutamol. Finally, in MLB, PGA, or the LPGA, Higenamine does not appear to be prohibited unless it is interpreted to be a stimulant as we would argue it could be.

Higenamine, a natural product banned in sport, is a good example of the challenges athletes and others face when trying to interpret whether natural products or supplement ingredients are prohibited. Do not try this at home!

We encourage athletes not to make such interpretations without the assistance of a qualified expert. We are happy to review products for athletes or their personnel anytime. We also recommend that athletes consider products that have been certified to be free of banned substances in sport by a third-party. We proudly offer certification under the BSCG banner.

!

Beer Contain a Prohibited Substance in Sport, N-methyltyramine

N-methyltyramine, prevalent in beer, is interpreted as prohibited in sport based on the World Anti-Doping Agency Prohibited List.

We have made a frothy discovery. As it turns out, beer contains a prohibited substance in sport. This was a surprising realization to us as we are sure it is for you, but it appears to be true, at least by interpretation. Seriously? It’s ludicrous to consider that beer contains a prohibited substance in sport. Here are the facts behind this intoxicating notion.

In 2015, the World Anti-Doping Agency (WADA) added new prohibited substances to the WADA Prohibited List, as they do each year. “Phenethylamine and its derivatives” were added to the list with little fanfare or attention, which is likely because the implications of that addition had not been fully considered. The significance, in fact, is vast and potentially affects hundreds of natural products and plant extracts. The scope of adding this language can be understood after reading one publication alone, “Phenethylamine and related compounds in plants”, which was published in Phytochemisrry in 1977.

The paper characterizes approximately 200 plant species that naturally contain phenethylamine or its derivatives. Phenethylamine derivatives are a very broad category of substances. They include psychoactive substances or controlled substances like; amphetamine, cathine, ephedrine, methamphetamine, octopamine, and pseudoephedrine, all of which are specifically mentioned on the WADA Prohibited List by name. We are fully supportive of these dangerous substances, and any closely related derivatives, being regulated as controlled substances and banned in sport.

Some phenethylamine derivatives, however, are naturally occurring in plants and animals like tyramine (the scientific name of which is 4-hydroxyphenethylamine), or dopamine (the scientific name of which is 3,4-dihydroxyphenethylamine), or adrenaline. Tyramine is present in significant quantities in chocolate, avocados, plums, pork and cheese. Are these naturally occurring phenethylamine derivatives really considered banned in sport by interpretation? Do they really qualify as controlled substances, as tyramine has been deemed to be under Schedule 1.c. #66 in the Sunshine State of Florida? Well that logic just may be tested with beer.

Barley, it turns out, is one of the plants that naturally contains a derivative of phenethylamine. Specifically, it contains a compound called N-methyltyramine (NMT), also known as 4-hydroxy-N-methylphenethylamine. A casual review of NMT’s Wikipedia listing reveals some startling facts that have been apparent from publications as far back as the 1950s and 1960s:

“NMT was isolated as a natural product for the first time, from germinating barley roots, by Kirkwood and Marion in 1950. These chemists found that 600 g of barley, after germination and 10-day growth, yielded 168 mg of N-methyltyramine.[5] Since barley, via its conversion to malt, is used extensively in the production of beer, beer and malt have been examined by several groups of investigators for the presence of NMT. Citing a 1965 study by McFarlane,[6] Poocharoen reported that beer contained ~ 5–8 mg/L of NMT.[7]

We did the math for you: A friendly neighborhood pint of beer contains between 2.3 – 3.8 mg/pint of N-methyltyramine. It should be noted that milligram quantities are relatively high amounts, not trace levels. Medications and dietary supplement ingredients are commonly found in milligram quantities. Ingesting milligram quantities of a stimulant banned in sport would be highly likely to result in an athlete testing positive.

If you think this is only a theory we brewed up, that’s not the case, I’m afraid. We consulted the Global Drug Reference Online, or Global DRO. The Global DRO is a ‘partnership between UK Anti-Doping (UKAD), the Canadian Centre for Ethics in Sport (CCES) and the United States Anti-Doping Agency (USADA). The Japan Anti-Doping Agency (JADA) and the Australian Sports Anti-Doping Authority (ASADA) are official Global DRO licensees.’ The Global DRO ‘provides athletes and support personnel with information about the prohibited status of specific substances under the rules of sport based on the current World Anti-Doping Agency (WADA) Prohibited List.’ For those unfamiliar with it, the Global DRO is a great site for Olympic athletes to explore whether medications or other substances are banned in sport. Supplement ingredients are not often considered, but the site is nonetheless a good resource.

We wanted to see if tyramine was considered prohibited, but it did not come up in Global DRO search results so we could not explore whether it would be interpreted as banned. What did come up was N-methyltyramine, which was indicated as Prohibited under the S6 – Stimulant category. This makes NMT prohibited in competition but not out of competition. This prompted us to explore the possible natural presence of NMT, which led us to the conclusion that beer contains a prohibited substance in sport. This is not good news to even casual beer-drinking athletes. (Interestingly, dopamine, also appears in the Global DRO database but it is not interpreted to be prohibited despite being a phenethylamine derivative.)

Surely there must be some explanation. If NMT is interpreted as prohibited there must not be enough to cause a positive drug test, right? Well, let’s consider the details. NMT would be considered a specified stimulant in the WADA system under category S6.b, which means urine thresholds would apply to avoid positives from environmental presence. However, as we noted earlier, one ingests MILLIGRAM quantities of N-methyltyramine in just one pint of beer.

Hopefully athletes are not drinking a lot of beer while in competition, but could a beer on a night off a cycling race, or three beers one week before a swim meet potentially impact a drug test? Perhaps there are urine excretion studies that can answer more definitively how much beer you would have to drink, and when, in order to test positive for N-methyltyramine. We have not fully explored this. Ultimately, we believe the answer to this whole dilemma is that N-methytyramine falls into a strange category of substance. A compound banned by interpretation but not in practice, at least not in all forms.

By this we mean a substance that could be interpreted to be banned based on catch-all language in the WADA Prohibited List like ‘including but not limited to,’ or ‘substances with a similar chemical structure or similar biological effect(s).’ Catch-all language appears in every category of the WADA Prohibited List except for S4.5 – Metabolic Modulators (where meldonium appears), S7. – Narcotics, and S8 -Cannabinoids (all categories we suggest could be worthy of catch-all language).

Debating this theory may seem like an amusing matter, but athletes’ careers hang on these very types of questions. Our business of dietary supplement certification at BSCG also hinges on the interpretation of whether supplement ingredients, natural products, or functional foods contain substances banned in sport. When one considers that hundreds of plants species including things like barley, spinach, or aloe vera contain phenethylamine or its derivatives that may be banned in sport, the concern is greatly magnified.

If the Global DRO interprets that N-methyltyramine, which is present in beer in milligram quantities, is prohibited, exactly where does the scope of this start or stop? That remains a good question, and one that we hope is not answered by first having an athlete fall victim to testing positive from the natural presence of phenethylamine or its derivatives. It would be a true shame if that were to happen simply from enjoying a pint.

So, what is the solution? We suggest perhaps refining the nomenclature to list ‘Synthetic psychoactive phenethylamine derivatives.’ This option would alleviate the interpreted prohibition of benign natural phenethylamine derivatives like tyramine while still covering substances like the N-alpha-diethylphenethylamine (N-a-DEPEA) derivative identified in the Craze pre-workout supplement, which is what prompted the prohibition of phenethylamine derivatives in the first place.

We fully support combating dangerous phenethylamine derivatives like N-a-DEPEA–but not beer. We have to do a better job of clarification and interpretation of the prohibited substance list language on behalf of the athletes that rely on anti-doping rules to protect, not inadvertently derail, their careers and passion for competing. The Olympic Motto is Citius, Altius, Fortius. Let’s add Magis.

Although beer contains a prohibited substance in sport, at least by interpretation, it does not appear that drinking beer will cause a positive drug test in practice. Cheers to that!

Athlete, Are you Doping on Accident with Hidden Banned Substances in Supplement?

Hidden banned substances in supplements can keep athletes out of the Olympic Games: Jessica Hardy and Pavle Jovanovich cases serve as a warning

A number of athletes have tested positive from the hidden presence of banned substances in supplements and have lost the opportunity to compete at the Olympic Games. This summer on the road to Rio, Olympic athletes of every stripe would be wise to recall the case of American swimmer Jessica Hardy and others like American bobsledder Pavle Jovanovich who have fallen victim to supplement contamination. Third-party dietary supplement certification, like our BSCG Certified Drug Free® program, is a way for athletes to mitigate the risk of testing positive from banned substances in supplements.

2008 Beijing Olympic Games Swimming – Photo by Oliver Catlin

Eight years ago, a twenty-one-year-old Hardy was pulled from the 2008 Summer Olympic team heading to Beijing after testing positive for the banned anabolic agent clenbuterol at the Olympic Trials. Instead of getting to swim the 100-meter breaststroke, 50-meter freestyle, and 4×100-meter freestyle relay for which she had qualified, she was smacked with a two-year ban. Not only that, her career was now marred with a doping violation, casting a shadow over all of her athletic achievements.

Hardy maintained her innocence, saying she had never before heard of clenbuterol. Some in her entourage, including a coach, pointed to the possibility of banned substances in supplements she had been consuming as a potential culprit for the positive drug test.

Under WADA (World Anti-Doping Agency), USADA (U.S. Anti-Doping Agency) and IOC (International Olympic Committee) rules, however, ignorance about a substance being banned or lack of awareness of how a banned substance entered the body, referred to as ‘inadvertent use,’ are not valid excuses. Athletes are responsible for any banned substance they ingest, regardless of the means, which is known as ‘strict liability.’

At the time, the USOC (United States Olympic Committee) Athlete Ombudsman suggested to Hardy and her team that she consider having her supplements tested by renowned anti-doping guru Dr. Don Catlin, BSCG’s Chief Science Officer. After rigorous testing, Dr. Catlin and his team at the nonprofit/NGO Anti-Doping Research did indeed find trace amounts of clenbuterol in a legally sold supplement Hardy had been taking, Arginine Extreme, a sports-nutrition drink produced by AdvoCare. AdvoCare’s own testing of the product had come up clear of any banned substances.

At an American Arbitration Association panel in 2009, Dr. Catlin testified on Hardy’s behalf. He explained his test results and noted that AdvoCare might not even have been aware of the drug’s presence, as supplements have a supply line of ingredients and these ingredients can be contaminated. Indeed, banned substances often infiltrate products at the raw material stage, and in many circumstances the supplement brand has no knowledge of the issue.

In consideration of Dr. Catlin’s review and the inadvertent use of clenbuterol by Hardy, the panel halved Hardy’s ban to a year. The next year, following an appeal by WADA, the Court of Arbitration for Sport upheld the decision. Unfortunately for Ms. Hardy, she had spent much time and effort to reduce her sanction and repair her reputation.

Though Hardy returned to the sport she loves, went on to break world records in the breaststroke, and won relay medals, including gold, at the 2012 Summer Olympics in London, there will always be a gap in her career as well as the one Olympic Games she can never get back.

“I hear about (those medals) all the time,” she told the Wall Street Journal in 2012, of the races won by other swimmers at Beijing. “Hardy never used to be an angry person,” the same article stated. “But after the disqualification fiasco, her coach, Dave Salo of the Trojan Swim Club in Los Angeles, says she became prone to ‘act out and storm off’ after occasional bad swims.” Hardy has sought therapy in order to manage the anger and negative thoughts fostered by her unfortunate circumstances.

Hardy is not the only Olympic athlete to have been affected by banned substances in supplements. Just prior to the 2002 Salt Lake Olympic Games American bobsledder Pavle Jovanovich tested positive for the anabolic steroid 19-norandrostenedione. The result had a serious effect on him. “‘It was just a nightmare for me,” he said in an interview later, adding that he felt “completely detached” from family and friends and that he “did battle alcohol.” He blamed the finding on a dietary supplement called Nitro-Tech and ultimately received a settlement from Century Foods. (This short piece, in the San Diego Union-Tribune, summarizes the cases of seven other athletes who also filed suits against supplement companies in relation to positive drug tests.)

These examples serve as a reminder to all athletes and Olympians to be aware of what they are putting into their bodies, at all times. Inadvertent presence of banned substances in supplements can result in serious penalties. Recent studies have revealed the majority of elite athletes consume dietary supplements, making supplement safety and risk management strategies for these athletes vital.

There are simple ways for athletes to mitigate the risks, as we describe on the Supplement Information for Athletes page of our website. One of the most effective methods is to only use supplements that have been certified by a third-party to be free of banned substances, like those that participate in our BSCG Certified Drug Free® supplement certification program (click here for a third-party dietary supplement certification program comparison). After more than 12 years of offering certification, no supplement BSCG has certified has ever led to a positive drug test.

Athletes, don’t let banned substances in supplements keep you out of the Olympics or tar your achievements there. To protect yourselves, your careers and your sports, make sure you consider taking only dietary supplements and natural products that have been certified by a trusted third-party provider to be free of banned substances.

Stay Clean and Win Clean! Support Clean Sport!

The Russian Doping Scandals and the International Olympic Charter Against Doping in Sports

Backstory: The Russian Doping Scandal, the Olympics, and the International Olympic Charter Against Doping in Sport

Sadly, an ongoing Russian doping scandal has challenged the central tenets of the International Olympic Charter Against Doping in Sport. The debate rages at the highest levels of sport about whether Russian athletes should be allowed to participate in this summer’s Olympic Games in Rio. This follows an investigation overseen by former WADA president Dick Pound last fall finding Russia’s track and field program was corrupt and riddled with systematic doping. Earlier this year, a large number of Russian athletes tested positive for the banned substance meldonium. And two weeks ago, the head of drug testing for the 2014 Sochi Winter Olympics, Professor Grigory Rodchenkov, alleged a scheme in which he, at the behest of the Russian government, oversaw doping of Russian Olympic athletes and result tampering.

Back in 1988, at an international sports anti-doping conference in Ottawa, Canada, 85 delegates of sport, doping control, and government representing 27 nations and the IOC (International Olympic Committee) met to refine and approve the first International Olympic Charter Against Doping in Sport. The guide was meant as an official code of conduct for sporting organizations, countries, and athletes participating in the Olympics.

BSCG’s Chief Science Officer, Dr. Don Catlin, a longtime IOC Medical Commission member who founded and directed the UCLA Olympic Analytical Laboratory prior to the Los Angeles 1984 Summer Olympics, worked with a small group of colleagues to first propose the idea of the charter and was a co-writer of the document. The need for a more definitive set of principles and rules had been building since an anti-doping declaration of athletes and coaches at Baden-Baden in 1981 and a call from the IOC’s Athletic Commission in 1985 for stronger doping controls and more severe sanctions.

The original charter, written in both English and French, was approved by the IOC and endorsed unanimously by all represented countries and related organizations. Meant as both a values statement and a practical guide, it contained a preamble outlining principles and seven sections covering such topics as banned drugs, sample testing, and guidelines for out-of-competition and short-notice testing.

The charter describes the importance of anti-doping rules to sport. Doping agents in sport, it states, are “both unhealthy and contrary to the ethics of sport,” so it is necessary to set rules with the intent to “protect the physical and spiritual health of athletes, the values of fair play and of competition, the integrity and unity of sport, and the rights of those who take part in it at whatever level.”

At the end of the charter’s preamble, the countries agree the “following elements are fundamental elements of a common anti-doping policy and strategy, and that they should be applied by governments and sports organizations, acting both individually and in co-operation” as well as “to implement those measures which are within their competence, and to encourage their partners to implement those which fall within their powers.”

The document acknowledged national anti-doping programs could vary from nation to nation depending on the particular government or sport structure, but that certain program elements were considered fundamental to any national anti-doping program. These essentials included a published national anti-doping policy, national coordination, an anti-doping experts advisory group, accredited laboratories, doping control via scientific testing, due-process mechanisms, and education programs.

Annex 6 related to the rights and responsibilities of sports organizations, athletes, and their entourage. The responsibilities of sports organizations were clearly stipulated: “To take all the appropriate steps to organize fair competitions and, in particular of this context, free from doping and to protect athletes and competitors who compete in a fair and equal manner and to exclude those who attempt to benefit from undue use of banned doping classes or methods.”

Since its 2013 report on the ‘Lack of Effectiveness of Testing Programs‘, WADA has been suggesting that a key challenge for the global anti-doping effort is getting stakeholders such as sporting organizations and governments to buy into the ideal of clean sport and has acknowledged that this hasn’t been achieved. The ongoing clamor surrounding the Russian doping scandal illustrates the point well, as it only takes one stakeholder such as Russia to go awry for the whole Olympic system to be thrown out of balance and the credibility of the Games to be undermined.

Whether Russian athletes will be allowed to participate in the upcoming Summer Games remains to be seen. But the letter and spirit of the International Olympic Charter Against Doping in Sport have been clear for 28 years. From the start, the Olympics’ official code of ethics was a useful tool in identifying whether a country was in violation of doping standards, and it remains so today.

Dehydrochlormethyltestosterone MLB Positive Drug Tests – Could Supplements be the Culprit?

Dehydrochlormethyltestosterone MLB Positive Drug Tests

Dehydrochlormethyltestosterone MLB positive drug tests have been flying through the news faster than home runs in Denver. The early season so far this year has seen Daniel Stumpf and Chris Colabello test positive for this drug, also called Oral Turinabol (Oral-T), and Wednesday ESPN reporter T.J. Quinn wrote that several more dehydrochlormethyltestosterone MLB positive drug tests will soon be announced. We examine the theories on how someone could test positive for this old drug from the 1970s.

Three theories have been put forth in the discussion about dehydrochlormethyltestosterone MLB positive drug tests to date. First, the players took the drug itself, second the players took a dietary supplement that was contaminated with Oral-T (perhaps without their knowing), and third a designer steroid present in a supplement could convert or metabolize into Oral-T.

As for the first theory, Oral-T became popular because it is a powerful oral anabolic agent. It was a known and well-characterized drug that the Germans used during their state-sponsored doping in the 1970s. Some people have considered Oral-T to be a drug of the past, yet it remains widely available on the internet. In a brief search, we found Oral-T available in ready-to-take form on at least two different websites from Canada and other countries. So, it appears that it remains available.

According the Anti-Doping Database, dehydrochlormethyltestosterone was reported five times in 2012, 72 times in 2013, then dropped to 17 in 2014 and to 14 in 2015. Prior to 2012 it was only reported one or two times a year. What caused the spike in 2013 is an interesting question, as another spike seems to be occurring now in MLB.

The ESPN article also discussed improved testing sensitivity for Oral-T urine metabolites. In simple terms, additional research has identified new long term metabolites that can extend the window of detection. The improvements in detection capabilities may be contributing to the current spike. An off-season Oral-T doping regimen that would previously be expected to clear the body quickly based on experience may not be useable anymore with the improved detection capabilities. Given that these positives are coming from preseason or early season testing, this theory seems strong.

Dehydrochlormethyltestosterone MLB Positive Drug Tests – Could Supplements be the Culprit?

As for the theory that a supplement that contained dehydrochlormethyltestosterone could have caused the positives, that is also very plausible. As T.J. noted in his piece, there is a supplement on the USADA High Risk Dietary Supplement List, Alpha-4D sold by Shredded Labs, that contains Oral-T. To be more precise, there are actually two more supplements on the high-risk list that either mention or have been shown through testing to contain the drug: Orla Test from Chem 33 and OstaRx from IronMagLabs. Several more supplements on the high risk list contain the closely related drug turinabol.

In most cases the products did not list Oral-T on the label. For example, OstaRx from IronMagLabs was labeled to contain the SARM Ostarine but instead showed the presence of Oral-T. This demonstrates a primary challenge for athletes, that some supplements can be contaminated with banned substances even if they are not on the label. The concern is heightened for supplement brands, like IronMagLabs, that choose to sell products with illegal or banned substances on the label, like the SARM Ostarine in the case of OstaRx from IronMagLabs.

The final theory of how dehydrochlormethyltestosterone MLB positive drug tests have been occurring considers the possibility that a designer steroid closely related to Oral-T and sold as a dietary supplement could be the culprit. Sadly, many illegal dietary supplements that contain designer steroids continue to be sold despite efforts to regulate them. These include infamous designer steroid ingredients like methasterone, or MADOL, or Halodrol.

Halodrol is of particular interest to consider. If you look at the message boards for Halodrol, you can see the potential behind the theory for why such a designer could be responsible for dehydrochlormethyltestosterone MLB positive drug tests. One board provides the following information on Halodrol: “Originally brought to market by Gaspari Nutrition as ‘Halodrol 50,’ this compound is the diol version of the steroid the East Germans were taking to cheat at the Olympics in the late 60s and early 70s, Oral Turinabol (4-Chlorodehydromethyltestosterone). Halodrol is said to convert to the active steroid Turinabol by experts at around 5-8% so it’s a very low conversion rate but the inactive metabolites of Halodrol have very anabolic properties by themselves.” Strong Supplement Shop has five Halodrol supplements available, so these designer variants of Oral-T remain widely available.

The interesting thing about designer steroids is that it can be difficult to pinpoint the urine metabolites to use for doping detection because some of these designers are not well made and have remnants of other compounds present. Other times, the new drugs are simply things we haven’t seen before and haven’t done a urine study to evaluate. Some of these new drugs, or recycled old drugs, may share metabolites with known drugs and thus would be detectable.

Evaluating this theory further, we consider that the positive drug tests in the MLB have specifically been called for dehydrochlormethyltestosterone. This means that the lab likely identified the parent drug as well as metabolites that are indicative of use. If the findings were called based on the presence of metabolites only, those metabolites would need to be specific to Oral-T in order to make a definitive identification. Under that scenario, there is a slight possibility that a designer steroid like Halodrol could share similar metabolites with Oral-T and result in a finding for Oral-T. Most of the time similar steroids can be differentiated based on unique metabolites or the presence of the parent drug itself.

If the player used Oral-T itself, they obviously should be held accountable. If they used a designer steroid like Halodrol thinking it would not be detectable, again they should be held accountable. If it was determined a benign supplement like a vitamin or protein powder was contaminated, that could be considered for a reduced sanction. Given that so far the players have given up appeals and accepted sanctions, we have to think one of the first two theories holds true.

The risk of banned substance contamination in supplements is very real for athletes, regardless of whether one is a culprit in the recent dehydrochlormethyltestosterone MLB positive drug tests or not. Athletes who don’t want to risk a supplement being contaminated with prohibited drugs should consider products that have been certified by a third party like BSCG Certified Drug Free®. Such programs evaluate and test supplement products to ensure they are free of banned substances and help athletes to mitigate the risks of supplement use.

Russian Doping Scandal

The Russian Doping Scandal – What Does It Show Us?

The recent news about the Russian doping scandal has portrayed a systemic failure and corruption of sport anti-doping efforts. A report published by the World Anti-Doping Agency (WADA) in November 2015 accused Russian athletes of doping and utilizing illegal substances on a systematic, national level in track and field and reproached Russia for a widespread attempted doping cover-up following the investigation. Russian Federation – London 2012 Olympic Games – Photo by Oliver Catlin, BSCG The independent investigation alleged that Russian athletes were not only encouraged to cheat but were expected to. Serious consequences, such as not being allowed to compete, would result for those who did not. One Russian coach admitted that a Russian athlete “has no choice but to dope otherwise the athlete is off the team.”

Shockingly, contingency plans and other systems were put in place to circumscribe usual international protocols. So, in the event that a Russian athlete failed a drug test, he or she often was not named or punished. The report went on to outline how the Russian doping scandal was orchestrated at the highest levels of Russian sport administration, with the Russian sports minister, Vitaly Mutko, as one of the conductors as he is alleged to have ordered manipulation of certain drug testing samples. Drug testing operations were compromised with “direct intimidation and interference by the Russian state with the Moscow laboratory operations.” Lab offices were bugged and the lab director, Grigory Rodchenkov, was required to meet with the FSB (Russia’s equivalent of the FBI) weekly.

Mutko disputed the report according to a quote from Sportfakt mentioned in a review of the Russian doping scandal April 8, 2016 by AP’s The Big Story. “The General Prosecutor’s office carefully examined the report in question and did not find a single legally supported fact to open any kind of case,” he said. The report of the Russian doping scandal has put Russian athletes in real danger of not being allowed to participate in the Rio Olympics this summer. However, they are not the only country with serious deficiencies when it comes to anti-doping. Other countries such as Ethiopia, Morocco, Kenya, Ukraine and Belarus are described as being in “critical care”, with International Association of Athletics Federations (IAAF) President Sebastian Coe saying, “Ethiopia and Morocco, as a matter of urgency, need a robust testing programme put in place. Kenya, Ukraine and Belarus need to get compliant by the end of the year.”

The discussion continues as to whether Russian track and field athletes will be allowed to compete in Rio, as of March 11, 2016 the answer from IAAF was no. In our view, the Russian doping scandal is a sad example of what can happen if a national sporting authority tasked with building and developing Olympic quality athletes is co-mingled with the groups providing third-party administration of drug testing programs or laboratories that perform the analysis.

___________________________________________________________________________

Methylhexanamine – What is it

What is Methylhexanamine?

The world is awash with more and more news about methylhexaneamine (see Comment on Title below for alternative spelling “methylhexanamine”) and positive drug tests related to it. We have already written a couple blog posts about the compound. Yesterday we noted an article in The Herald Sun in Australia entitled: Athletes warned of supplement risk: FRESH warnings have been sent to Australia’s elite athletes outlining the risks of taking dietary supplements containing the banned substance methylhexaneamine.

The article describes an e-mail from the Australian Anti-Doping Authority (ASADA) warning athletes against taking dietary supplements containing methylhexaneamine…

“Athletes need to be aware that, under the policy of strict liability, they are responsible for any substance found in their body,” the ASADA e-mail reads.

“Athletes using supplements do so at their own risk. This substance is classed as an S6 stimulant on the Prohibited list and is prohibited in-competition. ASADA is advising all Australian athletes subject to in-competition doping control to carefully consider their use of supplements and products containing methylhexaneamine.”

The article then goes on to quote track star Tamsyn Lewis’ response to the warning: “There is simply not enough information and for younger athletes coming up through junior ranks, including the football codes, they’re driving blind,” Lewis said. “They haven’t been educated or informed about this banned substance and the specific supplements to avoid.”

So, where do you find information on methylhexaneamine if you’re an athlete and want to avoid positive tests related to the compound? Given all the attention on the compound recently we thought we would explore ASADA’s website to see what kind of information they have. We found four listings after putting ‘methylhexaneamine’ into the search box on the site, all in the last month. We also went to the USADA and WADA websites to see if information was available through their search boxes; surprisingly neither site returned any matching items.

Digging into the second link on the ASADA site, you can find ASADA’s formal advisory on methylhexaneamine that contains some very good information about the compound including a list of the various synonyms.

What seems to be missing is a listing of the various supplement products and label names, which hides the reality that methylhexaneamine is present. Many products, for example, contain geranium oil extract, a seemingly benign ingredient. In reality, geranium oil extract is a common label name for methylhexanamine in supplement products. Mistaken use of methylhexanamine can easily result.

We have responded ourselves to the methylhexaneamine issue by creating ADR’s Searchable Database of Banned Stimulants. The database includes banned stimulants, their synonyms, label names, and also brand names that contain this and other banned stimulants. With the hope of providing a simple tool for athletes and other drug-tested professionals to help avoid similar issues in the future, we are working on raising financial support to further develop the database and expand it to other categories of drugs. Please contact us at 310-482-6925 or info@antidopingresearch.org if you would like to help.

Comment on title: Perhaps you have noticed that we have spelled methylhexanamine in the title without the extra ‘e.’ This is because the compound is more commonly listed on internet sites without the ‘e’ even though the scientific name includes it, as a PubChem search demonstrates. The Wikipedia page is found by searching without the ‘e,’ yet the first line of the article includes the ‘e.’ This example further demonstrates the confusion that swirls around this compound….

________________________________________________________________________________________________