Banned Sports Doping Agents and Illegal Drugs Marketed as Dietary Supplements on Amazon.com

Designer steroids and prohormones, Selective Androgen Receptor Modulators (SARMs), growth hormone secretagogues, and new blood doping agents like FG-4592 all available to athletes and consumers through the online retailer, often under the guise of dietary supplements

The media has been swarming over possible concerns about Amazon’s poor treatment of its employees. Apparently there is less scrutiny on the products the retpillsailer has available for sale. Those interested in anti-doping and drugs in sport wonder how athletes manage to get their hands on banned doping agents to enhance their performance. One simple answer, products masquerading as dietary supplements on Amazon.com.

For years we have marveled at the easy access to steroids and other drugs via Amazon.com, and have written blog posts about it in 2010, 2011, 2013 and assisted with a Slate article in May 2014. Anabolic steroids like methasterone, new drugs like the SARM Ostarine, prescription drugs, and more have all been available. Ever since we realized the prevalence of doping agents on the site, some of which were on the list of DEA Controlled Substances, we have tracked the issue further.

We recently circled back again to see how Amazon has responded, especially after the passage of the new Designer Anabolic Steroid Control Act in December 2014 (DASCA). We applaud our friends at the United Natural Products Alliance (UNPA) for promoting this bill and the government for finally enacting stronger regulations in this arena.

So what is still available at Amazon.com in the way of sports doping agents, or designer drugs? Plenty. This week, a search for prohormones brings up 94 items. When we were here a week ago there were 96, and it went up to 97 while we were exploring, so the list is constantly in flux. Having reviewed the offerings before, and being reasonably familiar with the products, we focused our review on a few items of interest. It is good that we are familiar, because for some of these potentially dangerous products, which presume to be dietary supplements, no information is provided about the ingredients.

Real problems remain. Take Blackstone Labs Alpha-1 Max, the product description on Amazon merely says, “Great product.” Visiting Strong Supplement Shop online, you find the product, label information and the ingredient, 20mg of Methyl-1-Etiocholenolol-Epietiocholanolone. This drug is otherwise known in the vernacular as Alpha One, Methyl-1-AD, or Methyl-1-Alpha. PubChem lists it as Epietiocholanolone with 43 depositor-supplied-synonyms, so the naming conventions are broad for this one compound, which is part of the challenge in tracking it and others like it.

If you Google the drug name, many links come up. Just pick one and an explanation like the following appears: “Methyl-1-Etiocholenolol-Epietiocholanolone, aka Methyl 1-AD, M1A, or Alpha One is one of the strongest designer steroid/prohormone compounds on the market.” Alpha-1 Max is not alone, Xtreme Alpha-1 contains the same drug, according to the Amazon product description.

XtremeShedThe list of steroidal products available on Amazon continues with Xtreme Shed. Strong Supplement Shop has a version of the same product which is no longer available due to the prohormone ban in 2014. According to the Amazon product description Xtreme Shed includes: “(3,3-azo-17a-methyl-5a-androstan-17b-ol) 20mg (6a-Chloro-androst-4-en-17b-ol-3-one) 30mg”. The first ingredient is known as methyldiazirinol, the second hexadrone. Both are prohormones or designer steroids. The StrongSupplementShop listing for Xtreme Shed says the product contained 4-chloro-17a-methyl-androst-4-en-17b-ol3-one, otherwise known as methylclostebol.

Methylclostebol is a steroid that was added to the DEA Controlled Substances list under the DASCA legislation, probably why Xtreme Shed was discontinued at Strong Supplement Shop. The two compounds in Xtreme Shed on Amazon are not listed by name in the DASCA language. Perhaps the one on Amazon is a new version with the ingredients adjusted in hopes of getting around the DASCA legislation? If you thought the prohormone and designer steroid era was over, think again.

It doesn’t stop there. SARMs, a new category of developing drugs that aim to mimic the effects of anabolic steroids, remain available on Amazon.com in offerings like EPG OstaLean, or Osta, or Osta Laxogen. The names and product information suggest they contain the drug Ostarine, which appears on the WADA Prohibited List. Its scientific name is Enobosarm with a long name, (2S)-3-(4-cyanophenoxy)-N-[4-cyano-3-(Trifluoromethyl)phenyl]-2-hydroxy-2-methylpropanamide). In the case of Osta and Osta Laxogen, the Amazon product descriptions include the long name, the same way it is written in an FDA warning letter from December 11, 2014 addressing the sale of the SARM by another company.

Interestingly, if you purchase Osta the order is fulfilled by Amazon. What does it mean to be fulfilled by Amazon? According to the site, “Fulfillment by Amazon (FBA) is a service we offer sellers that lets them store their products in Amazon’s fulfillment centers, and we directly pack, ship, and provide customer service for these products. Something we hope you’ll especially enjoy.” So, in the case of Osta, fulfilled by Amazon apparently means that the product is currently inventoried in an Amazon warehouse, with Amazon shipping and providing customer service, all for a product described to contain a drug that the FDA has issued a warning letter against previously.

The FDA wrote the following in its warning letter, “androgenic modulator products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 355(a) and 331(d)] and are misbranded drugs sold in violation of sections 502 and 301(a) [21 U.S.C. §§ 352 and 331(a)] of the FDCA”. It goes on to say that SARMs, “are not dietary supplements.”

A Maxim magazine article focused on the popularity of SARMs, secretagogues and other unapproved drugs sold as supplements earlier this year. The DEA’s position on SARMs after the passage of DASCA is represented as follows in the article: “The way the statute is written, we have to be able to demonstrate a substance is chemically and pharmaceutically similar to testosterone,” says DEA spokesman Joseph Moses. “That makes them incapable of being controlled under the term anabolic steroid.” Nonetheless, SARMs certainly don’t qualify as legal dietary supplement ingredients, hence the FDA’s warning letter.

Unfortunately, the list of doping agents available at Amazon.com does not stop with steroids and SARMs. Blackstone Labs MK Ultra contains the drug Ibutamoren, also known as MK-677, according to the label and product information found elsewherefg-4592. Ibutamoren is in development for the treatment of growth disorders; in the doping realm it is known as a growth hormone secretagogue. Growth hormone secretagogues are listed generally on the WADA Prohibited List, but this specific drug does not appear yet by name. Even the new blood doping agent FG-4592 can be found on Amazon.com, although it is not currently available from the listed supplier nor is it clear if it is offered as a dietary supplement.

Athletes don’t need any kind of clandestine network to get sports doping agents; all they need is Amazon. The reality is banned and unapproved new drugs are at our finger tips often pretending to be dietary supplements. If you don’t believe this is a problem, picture a 16-year-old kid unknowingly buying a potent anabolic steroid on Amazon that can cause serious health issues, like Alpha-1 Max, and it might change your thinking. From the anti-doping perspective, we have a tough fight ahead if new doping drugs appear as supplements on Amazon.com as quickly as we can create the tests to detect them.

New Sports Doping Agent FG-4592 Not the Only HIF Drug Available to Athletes

fg-4592 What drugs are athletes using to dope? This is one of the most commonly asked questions in the realm of sports anti-doping. Recently the answer has been provided in glaring form. During the week of July 29, Dr. Don Catlin, BSCG’s chief science officer and former longtime director of the UCLA Olympic Analytical Laboratory, was interviewed by the New York Times regarding a new drug called FG-4592, which was detected in tests of at least two elite cyclists.

AstraZeneca, one of the drugs’ developers, summarizes FG-4592 as “a small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein that responds to oxygen changes in the cellular environment and meets the body’s demands for oxygen by inducing erythropoiesis, the process by which red blood cells are produced.”

FG-4592 is available in pill form and is orally active, unlike its cousin, recombinant erythropoietin, or EPO, which must be injected. Some have dubbed FG-4592 as oxygen in pill form. This new drug is a breakthrough for anemia treatment and other similar blood ailments.  doping-271623_640Unfortunately, an effective blood boosting drug in pill form is also the Holy Grail for endurance dopers. Though FG-4592 remains in third-stage clinical trials around the world, it is widely available as a research chemical on the Internet. Its apparent arrival in elite sport is troubling, yet predictable.

Similar to EPO, HIF drugs like FG-4592 help increase oxygen carrying capacity by spurring the production of red blood cells. Some researchers believe HIF stabilizers might be even more effective than EPO as they can help stimulate iron absorption and suppress the inflammation of cytokines.[1] FG-4592 was recently added to the WADA (World Anti-Doping Agency) Prohibited List for 2015, as have cobalt and other HIF stabilizers and activators in general.  No other HIF drugs are named though they would be prohibited if they are detected.

According to PubChem’s listing of Chemical Vendors, there are 18 suppliers of FG-4592 worldwide . One of the vendors, the Houston-based company APExBIO, has eight HIF-related biochemicals available on its website including BAY 87-2243, 2-Methoxyestradiol, PX 12, ML 228, KC7F2, Chetomin, DMOG, and its top seller, IOX2 (Glycine). On PubChem, there are 251 Related Compounds with Annotation to explore.

Recent positive drug tests of two elite cyclists suggest athletes have managed to obtain FG-4592 for use as a performance-enhancer. Though the chemical vendors listed on PubMed are not marketing the drug to athletes, another site does not seem as scrupulous, as it sells research peptides like FG-4592 alongside an array of “performance enhancers.”  Some research peptides at www.superhumanstore.com overlap the list of performance enhancers. Numerous drugs on the WADA Prohibited List are available on this site including Aicar, CJC-1295 (a growth hormone secretagogue), Erythropoietin-mimetic peptide 17 (EMP17), GHRP-2, Sermorelin, Thymosin Beta- 4 and more. Similar drugs are available that are not included on the WADA Prohibited List by name, like BAY 87-2243 and Follistatin 344 (a myostatin inhibitor).

The average cyclists pictureprofessional cyclist in the UCI Tour makes $142,000, according to Ernst & Young.  Top riders can earn up to $5 million. Currently, the average dose of FG-4592 is recommended at 1-2mg/kg, 3 times a week, so $780 for 500mg will buy a two- week’s supply. An athlete could buy a year’s supply for around $20,280. This is a relatively affordable rate, even to an average Tour rider. With the difference between the average salary and the top salaries in elite cycling so significant, the financial incentives to use this new drug, or its cousins, remains high.

The good news is FG-4592 is detectable with drug tests. Similar developing drugs will undoubtedly be pursued and tried by athletes in the not-too-distant future. Whether these other options, particularly those not specified on the WADA Prohibited List, are detectable only time will tell. One thing history has proven, these will not be the last athletes to test positive for a new sports doping agent.

By Oliver Catlin and Joe Taylor

[1] Medscape  (http://www.medscape.org/viewarticle/548667)

BSCG CERTIFIED DRUG FREE® CERTIFICATION PROGRAM ADDRESSES UNMET SUPPLEMENT ADULTERATION CONCERNS, AN ANALYSIS OF FDA STATISTICS CONFIRMS

BSCG Header imageFOR IMMEDIATE RELEASE

April 16, 2015

BSCG CERTIFIED DRUG FREE® PROGRAM ADDRESSES UNMET SUPPLEMENT ADULTERATION CONCERNS, AN ANALYSIS OF FDA STATISTICS CONFIRMS 

BSCG is the first to offer protection against drugs not banned in sport

(Los Angeles) – In broadening its services to include a range of new protections against supplement adulteration, including an expanded drug-testing menu for the protection of general consumers, BSCG (Banned Substances Control Group), a highly regarded independent dietary supplement certification provider, is filling important unmet needs in the realm of supplement quality control.  An analysis of the FDA’s Tainted Supplements List reveals that 76% of the hidden drugs found in supplements are not banned in sport—substances that only BSCG’s pioneering program covers.

The FDA’s testing has shown that products may contain harmful compounds falling outside the scope of those banned by the World Anti-Doping Agency (WADA) and elite and professional sports leagues including antihistamines, muscle relaxers, pain killers, weight loss drugs, PDE-5 inhibitors like sildenafil, and more dangerous agents. As the FDA warns, “this list only includes a small fraction of the potentially hazardous products with hidden ingredients.” BSCG is the only certification provider to focus on this concern.

“We knew that the FDA was finding a lot of prescription and over-the-counter drugs not banned in sport in the course of their testing,” said Oliver Catlin, BSCG President. “Recognizing the associated risks, we added those drugs and related compounds to our menu. We’re proud to take the lead in offering additional protection against these substances that are important for the protection of the general consumer.”

BSCG’s industry-leading drug testing menu includes more than 392 compounds, of which 185 are prescription or over-the-counter drugs and 207 are drugs banned in sport. BSCG not only has become the first certification program to safeguard against drugs not banned in sport but also offers the broadest and most finely tuned protection available in the supplement certification industry against substances prohibited by WADA, NFL, MLB, PGA, LPGA, NHL, MLS, ATP, WTA, NCAA, NASCAR and other sporting groups.

BSCG_FNLFounded in 2004 in Los Angeles by renowned sports anti-doping pioneer Don Catlin, M.D., his son, industry leader Oliver Catlin and respected attorney Ryan Connolly, BSCG grew out of the desire to protect elite athletes and professionals from ingesting hidden substances in supplement products that could lead to health concerns and positive drug tests. No product BSCG has certified has ever led to a positive drug test. In late 2014, the third-party company released its new BSCG Certified Drug Free® program.

In addition to security against drug contamination, the BSCG program includes annual testing for label claims and toxic contaminants and a Good Manufacturing Practices (GMP) audit. With fervent recent regulatory actions in New York and other states and added scrutiny on compliance with FDA’s 21 C.F.R. 111 – GMP quality control guidelines has come a renewed focus on ensuring that supplement products meet ingredient and finished product specifications for identity, purity, strength and composition and have been appropriately tested for potential contamination.

“Supplement consumers deserve assurance that products are not only drug free but that they meet label claim and contamination specifications and standards,” said Catlin. “BSCG recognizes the importance of these quality control elements and is pleased to include them as part our supplement certification services.”

The BSCG Certified Drug Free® program represents the gold standard in dietary supplement certification and can be applied to finished products, raw materials or manufacturing facilities. The Athlete Assurance Program offers protection directly to teams, leagues or individuals. BSCG’s certification allows clients to establish products and brands as reputable and drug free and offers assurance on product integrity to consumers and athletes. Look for the BSCG Certified Drug Free® seal.

For more about BSCG and the BSCG Certified Drug Free® program, call 1-800-920-6605 or e-mail info@bscg.org, visit its website at www.bscg.org and download its free brochure. Join Banned Substances Control Group on Facebook and @BSCGCertified on Twitter.

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For press inquiries, contact info@bscg.org or 800-920-6605, or Joseph Taylor, BSCG Public Relations Consultant, at joseph.taylor.pr@gmail.com.

Dietary Supplement Certification – BSCG Certified Drug Free®

BSCG_FNLDear friends, colleagues and fellow professionals in the anti-doping and supplement industries,

A decade ago our company Banned Substances Control Group (BSCG) helped found a nascent industry focused on dietary supplement certification to provide assurance that products are free of banned substances in sport.  We are pleased to have been a leader in the field since 2004 working with more than 40 companies to certify more than 100 products. As we look to the future, BSCG is leading the industry forward once again with our gold standard BSCG Certified Drug Free® program.

Our foundational supplement certification program was designed for the protection of elite athletes and professionals targeting drugs prohibited in sport—and this still remains a primary focus. We also realized that athletes are not the only consumers facing risks of drug contamination, nor are banned substances in sport the only culprits.  BSCG has responded by broadening our testing menu to focus on drugs of concern not only to athletes but to general consumers and also animals.

The BSCG Certified Drug Free® standard testing menu covers more than 392 drugs, including 207 banned in sport and 185 prescription and over-the-counter drugs not banned in sport. Our optional equine and canine screen includes more than 1,200 drugs banned by the Federation Equine International (FEI) offering protection to racing animals and against feed contamination concerns. With this expanded menu the BSCG Certified Drug Free® program not only offers the best protection available to athletes and sport nutrition products but is the first to safeguard against additional drugs relevant across the spectrum of consumers and products.

Protection against adulteration with drugs is only one element of the BSCG Certified Drug Free® program. With a growing focus on quality control in general, athletes, consumers, nutritionists, doctors, trainers, sport regulators, among others, are starting to demand assurances that products meet quality specifications and are free of toxic contaminants. Recognizing the importance of these elements, BSCG includes annual contaminant and label verification testing and an audit for 21C.F.R.111 – GMP compliance in its program.

The BSCG Certified Drug Free® program, which can be applied to raw materials and manufacturing facilities as well as supplement products, is the most complete quality control solution available in the dietary supplement industry. Our mission is to ensure products and ingredients are free of drugs and other harmful agents that can lead to health concerns or positive drug tests and that quality control specifications are met. Our certification allows clients to establish their products as reputable and drug free and provides athletes and consumers with trusted supplement options.

To explore our program further please download the BSCG Certified Drug Free® brochure. We are always happy to provide further education and support on supplement or anti-doping topics.  Please contact us at 1-800-920-6605, e-mail us at info@bscg.org, or explore our website at www.bscg.org. Thank you in advance for your consideration, we welcome your feedback and comments.

Sincerely,
Oliver Catlin
BSCG President

DRUG TESTING RULES FOR NARCOTIC PAINKILLERS IN THE NFL, MLB, NCAA AND OLYMPIC SPORT

The world is focused once again on the NFL, after a DEA investigation into the possible illegal use of prescription painkillers in the sport, as first reported Sunday by Sally Jenkins and Rick Maese of the Washington Post.

The issue centers on how such drugs are used and dispensed within pro football. According to DEA regulations, controlled substances like narcotic painkillers, known as analgesics in the medical field, can only be monitored and prescribed by licensed medical personnel and only within states where the license applies.

Controlling the use and abuse of analgesics is not an isolated issue faced by the NFL. The problem is prevalent across sport and society. Alarmingly, the CDC reported deaths from prescription drug overdose had risen steadily through 2008 reaching the same level as deaths from vehicle accidents. Thankfully, the CDC reports this trend has slowed in recent years, but the issue remains present and acute.

To understand the issue better one needs to know what drugs we are talking about. Most of the concern is centered on narcotic opioid analgesics, substances that can be dangerous and addictive. These include morphine, heroin, codeine and their synthetic derivatives and analogs. Fentanyl, tramadol, meperidine (demerol), hydrocodone (vicodin), oxycodone are common examples of drugs in this category. Narcotic analgesics are to be distinguished from other drugs used to treat pain like muscle relaxers or non-steroidal anti-inflammatory drugs.

While controlled substance laws dictate how narcotic analgesics are managed in society, drug-testing programs in sport dictate how these drugs are treated within the sport in question.  We look deeper into the drug-testing policies and banned substance lists in sport to see how these drugs are governed and managed.

The World Anti-Doping Agency (WADA) Prohibited List governs international Olympic sport and is often used as a model by other sporting groups when considering what to ban. Some narcotic analgesics are on the WADA Prohibited List in the S7. Narcotics category, but not all the common ones mentioned above would be included.  The language for narcotics is shown below.

S7. NARCOTICS

The following are prohibited: Buprenorphine, dextromoramide, diamorphine (heroin), fentanyl and its derivatives, hydromorphone, methadone, morphine, oxycodone, oxymorphone, pentazocine, pethidine.

The language does not include the ‘similar chemical structure or similar biological effect’ language or the ‘including but not limited to’ language used in other categories to cover additional substances not listed. In the case of narcotics, the only substances not listed that are covered are fentanyl and its derivates. Codeine and derivatives like hydrocodone and tramadol are not covered by the WADA language. WADA prohibits the use of narcotics in-competition, but these agents are not tested for out of competition.

Interestingly, the language included on the WADA Prohibited List is different than that used by Olympic sport prior to WADA. In 2000, Olympic sport was still governed by the International Olympic Committee (IOC) and the rules in the Olympic Movement Anti-Doping Code. At the time, the narcotics section included ‘and related substances’ but a specific list of narcotic analgesics was permitted, as shown below.

  1. NARCOTICS

Prohibited Substances in class (B) include the following examples: buprenorphine, dextromoramide, diamorphine (heroin), methadone, morphine, pentazocine, pethidine, … and related substances

NOTE: codeine, dextromethorphan, dextropropoxyphene, dihydrocodeine, diphenoxylate, ethylmorphine, pholcodine, propoxyphene and tramadol are permitted.

The issue is different when one evaluates how narcotic analgesics are treated in professional sport leagues and college. We review the NFL, MLB and NCAA policies here. A review of how other sport groups might deal with these drugs is more difficult as drug-testing policy language is not always publicly available.

The NFL covers narcotic analgesics under its Policy and Program on Substances of Abuse. The policy says that, “Players shall be tested only for the following substances.” Narcotic analgesics are covered as follows: “Opiates (total morphine and codeine) ≥ 300 ng/mL, Opioids (e.g., hydrocodone, oxycodone) ≥ 300 ng/mL.” The language is somewhat vague but it should broadly cover narcotic analgesics depending a bit on how the testing provider interprets the listing of opioids (are only hydrocodone and oxycodone included or all opioids?). Looking at how the testing policy is applied in the NFL, one discovers that testing for drugs of abuse only occurs Pre Season, Pre-Employment, during an Intervention Program or by Agreement. During the season, when narcotic analgesics would be expected to be used, the drugs are not typically included in the drug-testing parameters.

In the MLB, narcotic analgesics are covered under Drugs of Abuse in Major League Baseball’s Joint Drug Prevention and Treatment Program. The MLB language describing the compounds covered is broader and more inclusive than WADA’s or the NFL’s and includes: “Opiates (e.g., Oxycodone, Heroin, Codeine, and Morphine),” “…and their analogs,” and “any and all drugs or substances included on Schedules I and II of the Code of Federal Regulations’ Schedule of Controlled Substances.” However, the application of the testing in the MLB is more restrictive as testing is only done for drugs of abuse in the case of reasonable cause or if a player is in a treatment program. No other testing for drugs of abuse is allowed.

In college sport narcotic analgesics are covered still differently in the NCAA Drug Testing Program. The 2014-2015 NCAA Banned Drugs list includes one opiate, heroin, under Street Drugs. The entire list is governed by language stating, “any substance that is chemically related to the class, even if it is not listed as an example, is also banned!” In the case of narcotic analgesics it is unclear if this would be interpreted narrowly to include only drugs chemically related to heroin or whether it would be interpreted more broadly to include opiates or opioids. This language leaves it vague as to the analgesics that are or are not approved. Use of banned substances can be allowed by medical exception, but “no medical exception review is available for substances in the class street drugs.” As for application, testing for street drugs, and any narcotic analgesics interpreted to be included, can occur year round for selected athletes.

It is fascinating to review the treatment of narcotic analgesics and see the lack of consistency between sport drug-testing programs as to the substances that are banned and the application of the testing. This is an example of the challenges faced when considering what to ban and how.

Perhaps the realization that significant differences exist in the treatment of narcotics will prompt a larger review of other categories of banned substances and the differences that exist across sport in the management of performance-enhancing drugs in general. After more than three decades of modern drug testing, we should be able to achieve greater consistency and clarity in drug-testing policy and the protections afforded therein to the sports and the athletes represented.

Amazon.com: An unfettered marketplace for banned and illegal drugs masquerading as dietary supplements

Banned and illegal drugs, by definition, should be hard to get, shouldn’t they? Unfortunately, the reality is quite the opposite; just explore Amazon.com, one of the largest marketplaces for banned or illegal drugs masquerading as dietary supplements.

Need steroids?  There are plenty of options.  New stimulant compounds that the FDA and other international authorities consider illegal and have proven harmful; no problem those are in stock.  What about new drugs that have yet to be approved for human consumption?  Sure you can get those too.  We explore a few startling examples of the illegal and potentially dangerous compounds available today at Amazon.com.

Steroids have been a concern for consumers and athletes for decades.  Pharmaceutical steroid development reached a pinnacle in the 1960’s with a handful of steroids like stanozolol and nandrolone approved for human use, after being evaluated for safety and toxicity. 

Since then a proliferation of prohormones, designer steroids or steroids in disguise,Superdrol appeared in the dietary supplement marketplace and in positive drug test results in sport.  Unlike approved steroids, the safety, toxicity and approved dose of such compounds are unknown, and some, particularly 17-alpha-methylated steroids like Superdrol, have proven to be toxic and dangerous.  The drug caused liver failure and a positive drug test for an NCAA athlete Jareem Gunter in 2005.

With the BALCO scandal in 2003, that unearthed the doping escapades of Marion Jones, Tim Montgomery and Barry Bonds, came attention.  Steroids like ‘THG’ and ‘Madol’ were at its heart.  President George W. Bush focused on steroids in his 2004 State of the Union Address.  Later that year, Bush signed the Anabolic Steroid Control Act of 2004, which was enhanced with the passing of the Anabolic Steroid Control Act of 2012.

The FDA took prominent action in a highly publicized raid of Bodybuilding.com in November 2009.  In one of the largest regulatory actions to date, the FDA found 65 illegal steroid products for sale that contained five steroid compounds, “Superdrol,” “Madol,” “Tren,” “Androstenedione,” and/or “Turinabol.”  In 2012, as a result of this case, a fine of $7 million dollars was levied against Bodybuilding.com.

Unfortunately, Amazon did not heed the president’s 2004 State-of-the-Union message, nor the legal regulations in the Anabolic Steroid Control Acts, nor the prominent FDA enforcement action against Bodybuilding.com.

Amazingly, in January 2011 we noted in a blog post that products the FDA had raided Bodybuilding.com for in 2009 were still available at Amazon.com, namely CEL M-MDrolDrol, which contained ‘Superdrol’ (Superdrol, also known as methasterone, has the scientific name 2α, 17α-dimethyl-5α-androstane-3-one-17β-ol).  The Washington Post reported the story on January 19, 2011, numerous other news outlets followed with their own coverage.  We at The Catlin Consortium had hoped that by publicizing the issue Amazon would be put on notice allowing the company to address the issue responsibly.

That has not happened.  Instead, CEL M-Drol remained available at Amazon.com on September 10, 2013.  It has since mysteriously disappeared from the site after we
included the link in a supplement industry presentation in late September.  ‘Superdrol’, however, continues to appear in another product called M-Stane, which lists the compound on the label under the name 2a-17a-dimethyl-5a-androst-3-one-17b-ol.

MStaneTranadrol Image Purus Labs Nasty Mass

M-Stane is only the tip of the iceberg.  As of October 20, Amazon.com still had two products available that were named on the FDA raid list in 2009; Kilo Sports Trenadrol and Purus Labs Nasty Mass.   A search for ‘prohormones’ on Amazon.com returned 125 products on October 20.  Many likely contain steroids or related substances. 

But the concern doesn’t stop with steroids.  Dangerous new stimulants like methlyhexaneamine and methamphetamine analogs, appearing as pre-workout supplements, remain available at Amazon.com.  Of particular concern is the original version of Jack3D from USP Labs and Craze from Driven Sports.

Jack3dJack3D grew to be one of the most popular pre-workout supplements on the market over the last several years.  The original version contained the now infamous stimulant methylhexaneamine, otherwise known in the industry as DMAA, geranamine, geranium oil extract and other names.  Patrick Arnold, the BALCO chemist, filed a patent for the compound under the name geranamine and included it in his own pre-workout product.

The drug has become a huge concern for athletes.  Astonishingly, more than 758 positive drug tests for methylhexaneamine have been reported by World-Anti-Doping Agency (WADA) labs since 2008, when the first positive was called.  The drug was not banned in 2008.  It was added to the WADA Prohibited List in 2009.  In 2012 alone there were 320 positive test results representing 7.1% of the 4,500 total WADA findings that year, placing behind only testosterone (T/E, 1,202 findings) and marijuana (398 findings). 

Some manufacturers defended methylhexaneamine, claiming it was geranium oil extract and thus of natural origin and present in the food supply prior to 1994, which would make it legal according to the definition of an ingredient in the Dietary Supplement Health and Education Act of 1994.  However, the natural origin of the DMAA used in supplements proved unfounded and the FDA has challenged its legality and safety for several years and considers the synthetic compound to be an illegal ingredient

Of primary concern is the potential for the compound to cause serious harm, and even death.  Sadly, Jack3D was implicated in the death of Claire Squires, a runner in the 2012 London marathon.

Jack3d

USP Labs has since reformulated the product and Jack3D Advanced Formularemoved DMAA  as have other manufacturers.  Despite the significant attention and health risks, the original version of Jack3D continues to be available at Amazon.com.  The reformulated Advanced Formula Jack3D is also available, marketed differently, suggesting that the distinction between the two products is known.  Neither includes ingredient information on the site.

CrazeCraze is one of the second generation pre-workout products that began to proliferate when methylhexaneamine was addressed by authorities.  It was Bodybuilding.com’s New Supplement of the Year in 2012.  The Craze label says it contains Dendrobex™, a trademarked extract of dendrobium, an orchid.  The label suggests that several suspicious compounds are components of Dendrobex™: N,N-Diethyl-B-Phenylethylamine and N,N-Dimethyl-B-Phenylethylamine, a CAS registered compound that is .004 mass units away from methamphetamine.  Eventually, the compound present in Craze was shown to be a methamphetamine analog, N,α-diethylphenylethylamine, with no known natural presence.

USA Today, in its exhaustive reporting on Craze and its manufacturer Driven Sports, elicited a significant response from retailers in the dietary supplement industry.  Giants like Wal-Mart, eBay, and Bodybuilding.com have recently pulled the product, but not Amazon.com. As of October 20, Craze remained available from 8 Amazon sellers.

We conclude with perhaps the most amazing example of all, involving a new category of developing drugs called Selective Androgen Receptor Modulators, or SARMs for short.  SARMs are drugs that act like steroids by activating androgen receptors in the body.  SARMs are a relatively new category of drugs and thus many compounds are still in development and clinical trials where toxicity and safety are being evaluated.  One such drug is Ostarine, being developed for muscle wasting disease associated with cancer by a company called GT-X, under the name Enobosarm, GTx-024 and MK-2866

No need to wait for approval, it appears Ostarine is already for sale in dietary supplementsOstamax label - MK2866 at Amazon.com, IronMagLabs OstaRx and Cutting Edge Labs OstaMax are names that suggest the new SARM is an ingredient.  The label for OstaMax, included on Amazon.com, is astounding, stating, “FOR RESEARCH PURPOSES ONLY, NOT FOR HUMAN CONSUMPTION”, and yet there is a serving suggestion of one capsule daily!  The scientific name of Ostarine is on the label as is the MK-2866 naming convention used by GT-X.  Positive drug tests have already been seen with a female cyclist testing positive for Ostarine in June, and WADA reporting five SARMs as a whole in 2012.

The Amazon mission statement is “to be Earth’s most customer-centric company, where customers can find and discover anything they might want to buy online.”  Steroids, stimulants, drugs not approved for human consumption, and other potentially dangerous drugs, we hope, were not the intended aim of that mission.  Providing a marketplace for illegal compounds masquerading as dietary supplements in the face of international attention, consumer health concerns, and serious adverse events seems contrary to the customer-centric focus.  At the very least it is dangerous and irresponsible.

Global marketplaces like Amazon.com help set preferences across a variety of products, including dietary supplements.  We hope that Amazon becomes a real part of the solution by making the choice to eliminate these dangerous products instead of continuing to perpetuate their distribution.

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Athletes, Drug Testing, and Deer Antler – The Real Story

The sporting media is up in antlers with reports that allege Ray Lewis used a deer antler spray in his injury comeback.  The questions as to whether deer antler is banned and whether its use could lead to a doping violation are indeed complex.  We felt it was time to peel back the velvet to answer those questions and review the facts on deer antler.

Deer antler has a long history of use in Chinese medicine and is used ‘to decrease fatigue and improve sleep and appetite. In animal tests, deer antler has been shown to increase oxygen uptake in the brain, liver and kidneys, and increase red and white blood cell production.’  Traditionally it is available in the form of antler slices, powders, and extracts.  In its natural form, it is likely a legal dietary ingredient under the 1994 Dietary Supplement Health and Education Act (DSHEA); it has been sold at herbologists and various natural product stores for some time.

Deer antler has gained popularity as a dietary supplement over the last few years.  Some manufacturers, like LuRong Living Essential, grind the actual antler into powder form and encapsulate it in ingestible capsules.  (For the record, our company Banned Substances Control Group has certified LuRong Living Essential to be free of methyltestosterone [see below] and other contaminants.)

Other manufacturers sell the deer antler as a concentrated extract in a spray form.  The sprays, often with names like IGF-1+, are marketed as anti-aging and/or performance-enhancing agents and are offered with different dosages of IGF-1.  The sprays carry claims that the IGF-1 is delivered to the body through liposomal absorption, meaning it would be absorbed through membranes, such as those in the mouth, as opposed to having to enter the body through digestion.

Whether the spray forms are legal under U.S. law is unclear.  If deer antler is chemically altered to standardize the amount of IGF-1 present or to make it absorbable, then the spray form of deer antler is likely illegal under DSHEA.  However, we will let the FDA sort that out; we are here to examine issues related to drugs in sport.

In the realm ofSWATS spray pic sport, the hoopla started with a spray form of deer antler called The Ultimate Spray, marketed by Sports with Alternative to Steroids (SWATS), that was involved in David Vobora’s NFL positive drug test for the steroid methyltestosterone in 2009.  During the course of the civil action following Vobora’s suspension, Vobora had the spray he used tested and it was found to be contaminated with methyltestosterone.  Vobora won a $5.4 million ruling as a result.

As the article notes, we tested the spray at our nonprofit/NGO Anti-Doping Research for The Post Game in 2011 and did not find methyltestosterone.  This highlights an important point: that one batch of a product can be contaminated and another batch clean, something that athletes need to consider.

All this attention prompted MLB and NFL to issue warnings to players regarding the use of deer antler.  Interestingly, the MLB warning did not focus on the IGF-1 issue but rather on the issue of methyltestosterone contamination.  The NFL warning meanwhile concentrated more on the IGF-1 issue and questioned the appropriateness of its players or coaches representing such a product.

Confusion has swirled ever since culminating in Super Bowl fashion with allegations that Ray Lewis used the very same SWATS spray in his triceps recovery.  ESPN ticker reports are now alleging that the Alabama football team may have used the spray as well.

Whether deer antler is banned in sport and whether its use would be considered a doping violation comes down to whether it is ingested or absorbed and whether it has been certified to be free of potential contaminants like methyltestosterone.

Is deer antler a banned substance?

No, deer antler is not listed as a banned substance today in any sport.  It is true that deer antler naturally contains IGF-1, a substance banned in sport.  However, so do animal food products like red meat, eggs or milk and other common dietary supplement ingredients like colostrum.  Many food products contain IGF-1 or other growth factors that are banned in sport yet consuming them does not constitute or lead to doping violations.  The World Anti-Doping Agency (WADA) supports this notion but does not exactly provide clarity with their confusing note on colostrum: “Colostrum is not prohibited per se, however it contains certain quantities of IGF-1 and other growth factors which are prohibited and can influence the outcome of anti-doping tests. Therefore WADA does not recommend the ingestion of this product.”

Would using deer antler be considered use of a banned substance in sport?

In our opinion, the answer comes down to the form used.  Scientific publications agree that when IGF-1 is ingested in the form of colostrum it is not absorbed by the body and would ‘not elicit positive results on drug tests.’  Assuming the same is true of the IGF-1 in deer antler or other food products, ingesting the IGF-1 is unlikely to be construed as a violation of drug testing regulations since no banned substance is absorbed by the body.  Therefore, ingestible deer antler products should be acceptable for athletes to use under current rules.  Conversely, using a spray form of deer antler concentrated to contain certain amounts of IGF-1 that is delivered through liposomal absorption would likely constitute a doping violation, because if the product works as claimed the banned substance IGF-1 would be absorbed by the body.

Is IGF-1 detectable in the current sport drug testing system?

As the abstract of a recent publication states: “Currently, there is no test for the detection of IGF-1 introduced worldwide”.  This is not to say that the anti-doping community can not detect it as there are numerous publications that demonstrate the ability to do so.  IGF-1 is used as an important marker in the Sonksen test for human growth hormone that has been slowly gaining traction in the WADA community.  That said, we are not aware of a complete detection method for IGF-1 in use in sport drug testing today that can unequivocally determine if exogenous, or foreign, IGF-1 has entered the body.  So, if the deer antler sprays work as intended and IGF-1 is actually absorbed by the body, that may be a violation of drug testing policies but we do not believe it would result in a positive drug test in the current system.  Unfortunately, IGF-1 in general remains a major challenge for anti-doping authorities and is a huge potential loophole in the current doping control system.

Is there a way for athletes to protect themselves against the potential for methyltestosterone or other contamination to occur in deer antler products?

As with all dietary supplements, we would recommend that athletes only use batches or lots of products that have been certified by a reputable independent testing body to be free of banned substances.  We operate a program called BSCG Certified Drug Free® that offers testing services to manufacturers, teams and athletes to ensure that products are safe and free of banned and dangerous substances.

It is our view that if you are an athlete using a spray form of deer antler be aware that you are likely in violation of drug-testing rules even though the IGF-1 at issue may not be detectable currently.  If you want to use deer antler without violating drug-testing policies, you should be careful to use only an ingestible product that has been tested for potential contaminants like methyltestosterone.

This is a perfect example of the extremely complex issues we all face when considering the connections between dietary supplements and banned substances in sport.  We feel it is the responsibility of the leagues, the players associations, the anti-doping authorities, the FDA, supplement industry representatives, and scientific organizations like ours to come together to address the broader issues in some fashion.  As deer antler does not wander the forests alone, we owe it to the athletes to provide a concrete yes or no as to whether something is prohibited, as their careers and reputations are at stake.  We have the ability and the knowledge; we just need to make the effort.

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