The question of why and how clenbuterol appeared in Jessica Hardy’s sample remains a mystery. Was Hardy simply caught doping? Or were the “dietary supplements” used by Hardy contaminated or spiked with the banned substance clenbuterol? The supplement company Advocare was cited as one of the brands of dietary supplements used by Jessica Hardy.

Intentional doping

Why would Jessica Hardy take clenbuterol when drugs with similar performance-enhancing effects were legally available to her and all other swimmers with therapeutic use exemptions for asthma medications?

The performance enhancing effects of clenbuterol are not significantly different from those of other beta-2 agonists like albuterol, formoterol, salbutamol, salmeterol and terbutaline that are used by other Olympic swimmers. Swimming phenom Dara Torres uses the two legal beta-2 agonists (LABAs) Proventil (albuterol) and Symbicort (formoterol) and seems to be doing pretty well. Why would Hardy use an illegal drug when the legal PEDs are just as good?

Accidental doping

The quality control problems of dietary supplements are well known. Over the past several years, several reports have revealed that a significant percentage of supplements were contaminated with steroidal ingredients and/or stimulants. The U.S. Drug Enforcement Agency (DEA) recently identified 22 supplements sold over the counter that contain anabolic steroids. Last month, a British study found that 1 in 10 supplements contain ingredients banned by the World Anti-Doping Agency (WADA). A brief review of these reports did not find any evidence of dietary supplements showing cross-contamination with clenbuterol.

Most sports nutrition supplement companies have an official or unofficial disclaimer stating that their products are not intended for athletes competing in organizations subject to anti-doping procedures. The Dietary Supplement Health and Education (DSHEA) permits several products that are not permitted by WADA and other professional sports organizations. As a result, most supplement companies created products for the mass market of fitness enthusiasts, recreational athletes and bodybuilders rather than create WADA/IOC approved supplements for an infinitesimally small number of elite athletes.

Jessica Hardy publicly acknowledged using several supplements from Advocare. In fact, she endorsed the Advocare product line. Advocare listed the products used by Hardy on the “Our Endorsers” page for Jessica Hardy (which has been removed in the past week but is still cached by Google).

O₂ GOLD™
Rehydrate Electrolyte Replacement Drink
Arginine Extreme
AdvoCare® Muscle Fuel Pre-Workout Drink
Muscle Gain™ Protein Shake
Muscle Strength™
Nighttime Recovery
Post-Workout Recovery Sports Drink
Catalyst™
Amplify A.T.

Advocare is a multi-level marketing company who actively recruits professional athletes to endorse and use their products. As such, we would expect Advocare to spare no expense assuring drug-test athletes that their products contain no banned substances.

Unfortunately, Advocare ONLY obtained independent certification for ONE of the ten products used by Jessica Hardy (Advocare Muscle Fuel) by a leading supplement testing organization. The Banned Substances Control Group (BSCG) requires that each and every batch of Advocare Muscle Fuel is analyzed and certified to be free of more than 80 banned substances including clenbuterol. Failure to do so results in the immediate disqualification of the company from the BSCG program. Advocare advertises its current participation in the BSCG certification program on its website.

AdvoCare® has obtained independent certification of AdvoCare Muscle Fuel™ Pre-Workout Drink through the Banned Substances Control Group (BSCG™). With this certification you can be assured that this revolutionary performance supplement is free of substances including anabolic agents and stimulants banned by major athletic associations. In addition to the power of the AdvoCare Scientific & Medical Advisory Board and the Sports Advisory Council, the BSCG certification brings confidence that Muscle Fuel not only works but it’s safe.

The Banned Substances Control Group uses a World Anti Doping Agency accredited laboratory to analyze dietary supplements for substances banned by the International Olympic Committee (IOC), the World Anti-Doping Agency (WADA), National Collegiate Athletic Association (NCAA), National Football League (NFL), and other drug-tested sports leagues.

Is it possible that the Advocare supplements used by Jessica Hardy contained clenbuterol?

In the absence of independent, third-party certification of 9 of the 10 Advocare products used by Hardy, clenbuterol cross-contamination is possible although unlikely. Clenbuterol contamination of dietary supplements is not known to be a problem; also it seems extremely unlikely that a company recruiting so many elite athletes would intentionally spike their supplements with banned substances. So, there is a good chance that Advocare is being unfairly maligned with Jessica Hardy’s misfortunes.

Advocare has strongly denied implications that any of their products ever contained clenbuterol or have caused Jessica Hardy or any other athlete to test positive for a banned substance due to ingesting their supplements.

Contrary to any false and misleading reports, AdvoCare products contain no ingredients banned by the United States Anti-Doping Agency (USADA) or the World Anti-Doping Agency (WADA) which monitor Olympic and amateur sports, or by the NCAA, NFL, MLB, NBA, NHL, MLS, or NASCAR. AdvoCare is aware of recent information about AdvoCare and some of the company’s athletic endorsers in regard to our products and remains completely confident that all of our products contain only approved substances.

In the company’s 15-year history, AdvoCare products have never tested positive for banned substances of any kind with any of our athletic endorsers.

The good news is that there should be plenty of evidence (in the form of product lab anaylses) available in the foreseeable future that will fully exonerate either Jessica Hardy or Advocare.

• Boldione (aka androsta-1,4-diene-3,17-dione)
• Desoxymethyltestosterone (aka DMT and 17a-methyl-5a-androst-2-en-17b-ol)
• 19-nor-4,9(10)-androstadienedione (aka 19-norandrosta-4,9(10)-diene-3,17-dione and esta-4,9(10)-diene-3,17-dione)

Apparently, this is a shocking surprise to supplement industry lobbyist Loren Israelsen. Israelsen recently forwarded the following remarks (written by Rob Eder) to members of the United Natural Products Alliance.

“As I have previously suggested, perhaps the Congress should examine whether the Dietary Supplement Health and Education Act–DSHEA, as it is commonly known–is being adequately enforced,” Fehr said […]

I have got some news for Donald Fehr: They don’t sell steroids in the supplement aisle. They don’t sell the “cream” or the “clear,” either. That’s because this industry does a better job of policing itself than Major League Baseball ever could.

It’s a sad and unfortunate day for the supplement industry when Major League Baseball has more credibility than supplement industry leaders. The DEA has news for Loren Israelsen – YES, they do sell steroids in the supplement aisle and the supplement industry is no better at self-regulating than MLB; at least the MLB finally acknowledged they have a steroid problem.

Obviously, this is bad news for the future of the supplement industry. Deserusan of Gaspari does a good job at summarizing the risks to the future of the industry (“The DEA Has Their Eye on Online Supplement Retailers,” April 30).

It’s no myth that physique enhancement often points one down paths which lead them to “illegal” compounds after unsuccessful trials with legal OTC supplements. However, there are numerous “grey area” supplements which are in clear violation of FDA policies that are still sold as legal supplements. My issue with these grey market compounds is that they indeed put the full spectrum of OTC supplements at risk of being banned.

We all know the FDA has been a sleeping monster for quite a few years when it comes to this, but now the supplement industry has caught the eye of the DEA.

Deserusan appeals to the industry to take “proactive” steps in light of the news.

I guess the question is, since the DEA is now looking into these compounds, what proactive steps will supplement distributors take in order to see that the DEA doesn’t crack down on more “grey area” or even perfectly legal OTC supplements? [...]

My message to them is, don’t get greedy on a few flagged steroids which puts everything else OTC on the market in harms way as well. Uncle Sam is not ****ing around anymore when it comes to steroids and that cat is out of the bag regarding these three compounds.

But sadly, I don’t think supplement retailers will heed Deserusan’s warning. When the FDA raided LG Sciences and seized over one million dollars in dietary supplements containing 1,4,6 etiocholan-dione (ATD) and 4-etioallocholen-3,6,17-trione (6-OXO-4-androstenedione), I don’t think a single supplement retailer stopped selling products containing these ingredients. Even when the owner of a supplement company brutally murdered his girlfriend with a baseball bat, I couldn’t find a single supplement retailer who had a problem continuing to sell his dietary supplements.

I am afraid that retailers don’t recognize the significant of the Dietary Health and Supplement Education Act (DSHEA) and will take it for granted until it is too late.

Former NFL running back Femi Ayanbadejo has filed a lawsuit against Author L. Rea of ALR Industries. He claims an undisclosed ingredient in ALRI Max LMG caused him to fail an NFL doping test leading to his release by the Arizona Cardinals and Chicago Bears. Ayanbadejo tested positive for a “form of nandrolone.” Ayanbadejo’s attorney is blaming the positive steroid test on the manufacturer for possibly intentionally “spiking” the supplement with banned substances or contamination from the manufacturing facility.

I have not had a chance to review legal documents in the case. The owner of ALR Industries did not seem to be aware of the lawsuit and could not provide me with any insight into the case.

But on the surface, I’m not sure it has merit from a legal standpoint. Keep in mind that substances prohibited by the NFL (or WADA) are not necessarily prohibited by DSHEA as over the counter supplements (nor should they be). It does not appear that ALR Industries is guilty of producing supplements unintentionally contaminated with steroids or supplements containing undisclosed steroidal products unless there is evidence other than the failed drug test.

It appears that the ingredient that caused Ayanbadejo to test positive on the NFL’s steroid test was clearly listed on the label and/or marketing materials and identified as a legal progestin similar to other progestin-based steroids like trenbolone and nandrolone.

The active compound in Max LMG is 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one… It is legal because it is a progestin, and before anyone thinks “birth-control”, remember that trenbolone, nandrolone, methyltrienolone and Methyl-Dien all are also progestins. I doubt anyone will disagree with the effects of these compounds upon favorable body composition.

In addition, the label warned consumers about androgenic side effects.

Possible side effects include acne, hair loss, hair growth on the face (in women), aggressiveness, irritability, and increased levels of estrogen.

When an ingredient is said to be in the same class of compounds as banned steroids “trenbolone” and “nandrolone” (legality notwithstanding) and the side effect of “hair growth on the face (in women)” is listed on the bottle, I think this would be indicative of a dietary supplement that a drug-tested athlete would be wise to avoid. In other words, Ayanbadejo made a mistake and should have known better.

My opinion is based on the following assumptions:

1. Max LMG is not contaminated with undisclosed steroidal hormones, either intentionally or unintentionally.

2. The active ingredient in Max LMG is accurately disclosed as 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one.

3. A metabolite of 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one resulted in Femi Ayanbadejo’s positive steroid test for a “form of nandrolone.”

4.  The compound 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one was legally permitted under DSHEA and the Anabolic Steroid Control Act of 2004 whereas the “term `anabolic steroid’ means any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone).”

Given these assumptions, there does not appear to be a violation of law nor a failure of enforcement (of DSHEA).  Comments are welcomed.

I do not believe that this is the case. There really isn’t any documented evidence to support such a claim. Although all anabolic steroid users I would venture to guess use sport supplements – I do not necessarily support the hypothesis that increasing supplement use would increase anabolic steroid use.

Furthermore, he told me that steroid education programs are critical in high schools address the confusion regarding steroids and supplements:

These educational programs need to first involve educating coaches and athletic directors concerning realistic expectations from training programs and the risks and benefits of anabolic steroids and when supplements could be considered (they do not go hand-in-hand with the onset of training programs that unfortunately too many uneducated coaches appear to stress) and then educating the adolescent athlete.

We need to remember that steroid education involving coaches is also important at reducing steroid use in high schools.

 Chris Connolly, the head football coach and athletic director of Dolgeville High School in Dolgeville, New York, has taken the gateway theory, as it applies to suppplements, to the extreme.

The fear that using most common and casual substances will encourage his players to use more volatile and potentially harmful drugs is what has driven Connolly to ban his Blue Devil teams from using any supplement, including legal ones.

“I don’t even like GNC or EAS,” Connolly said. “We talk about in the preseason and in spring training: eat right, work right and take absolutely no supplements. We don’t even use Gatorade, only water.”

On the one hand, I think it is good to teach young athletes to believe in intrinsic factors as responsible for their abilities and success in sports rather than external factors like supplements. 

But it is borderline irresponsible to be so anti-supplement as to ban Gatorade. I guarantee that more high school athletes die and will continue to die from dehydration and heat stroke than will likely ever die from anabolic steroid use.  Gatorade can help prevent dehydration, heat related illnesses such as heat stroke and heat exhaustion. Coach Connolly’s irrational fear of supplements places the teenage athletes playing sports for Dolgeville High School at a slightly greater risk for heat related illnesses.

Water works. But Gatorade has been documented to outperform water for various reasons detailed here, not the least of which is the flavor/taste of Gatorade.

Gatorade or Powerade – the electrolytes promote fluid retention & the carbohydrates provide energy for the brain and muscles. Electrolytes (sodium, potassium, magnesium & chloride) are necessary for maximum absorption of water. Athletes typically prefer the flavor of Gatorade or Powerade & will stay better hydrated if these products are available.

There are legitimate reasons to prohibit supplement use by teenagers e.g. problem of contaminated dietary supplements, but the gateway rationale is not one of them.

While CNN is technically inaccurate, it is closer to the truth than Levin’s advocacy would suggest. From a consumer standpoint, I feel it is safer to assume that dietary supplements are unregulated. Most regulations are actually “post-marketing” measures i.e. very little prevents a new supplement from being sold in the marketplace.

I like the Dietary Health and Supplement Education Act (DSHEA) in principle too. But the supplement industry has abused and exploited DSHEA and utterly failed to self-regulate in the face of legislative challenges to DSHEA. It remains to be seen whether DSHEA is salvaged or systematically dismantled.

There is a reason that dozens of steroids have been and continue to be sold as dietary supplements for over a decade in the U.S.; DSHEA makes it legal. As long as supplement companies avoid certain claims and meet certain criteria well-known within the industry, the steroidal supplements can be introduced to the marketplace without “burdensome” requirements that the supplement company notify the government. This is the legacy of DSHEA.

At least one of the two most infamous designer steroids in the history of sport steroid scandals could have probably been legally sold as dietary supplements if they did not become scrutinized due to the spotlight of the BALCO steroids in baseball scandal i.e. tetrahydragestrinone aka THG aka “The Clear” and desoxymethyltestosterone aka DMT aka Madol synthesized by the convicted “father of prohormones” Patrick Arnold.

Pat Arnold’s indictment didn’t identify these so-called designer steroids as “anabolic steroids” because, legally, they were not. In response to the BALCO scandal, the FDA issued a press release on THG stating it was an “unapproved new drug” and not a “dietary supplement” to stop manufacturers who felt it met DSHEA criteria from selling it. (Actually, the latter steroid DMT was introduced into the marketplace but quickly (and voluntarily) pulled by its manufacturer shortly after the press associated it with the BALCO scandal and Patrick Arnold.)

THG and DMT did not legally become “anabolic steroids” until the passage of the Anabolic Steroid Control Act of 2004.

Several new steroid products are currently sold as dietary supplements legally and others illegally. But little is done about either due to the laissez faire regulation of the industry.

Furthermore, dietary supplements contaminated with steroids and stimulants continues to be a problem; for this reason alone I would be cautious about teenagers or children using any dietary supplement. Sadly, the supplement industry (or more accurately, several companies within the industry) are giving legislators every excuse to gut DSHEA.

[T]hese health risks… generally will not deter a player from using these substances. This is because players who use or are considering using performance enhancing substances do not consider them dangerous if used properly. This view is reinforced when players see that other players who they know are using performance enhancing substances arc not experiencing the adverse health effects described in the educational materials.

This makes sense. If steroid use is rampant and the clubhouse, yet no one is experiencing any of the negative side effects, then why would players give any credence to the MLB “steroid education” programs? Perhaps overstating and exaggerating the side effects and related scare tactics are not effective in a drug education program?

As a solution to the shaky credibility of current steroid education program, the Mitchell Report suggests offering “education on alternative methods to achieve the same results.”

Brilliant! Tell athletes to not use steroids because, among other reasons, success and performance should be the result of “character” and not “chemistry.” As George Will eloquently argues in the Mitchell Report:

Athletes who are chemically propelled to victory do not merely overvalue winning, they misunderstand why winning is properly valued. Professional athletes stand at an apex of achievement, but their achievements are admirable primarily because they are the products of a lonely submission to a sustained discipline of exertion. Such submission is a manifestation of good character Drugs that make sport exotic, by radical intrusions into the body, drain sport of its exemplary power by making it a display of chemistry rather than character. In fact, it becomes a display of some chemists’ virtuosity and some athletes’ bad character.

Then, at the same time tell athletes to use substances (supplements) that have the same (drug-like and performance-enhancing) results as steroids.

[W]hile it is important to educate players about the dangers of performance enhancing substances, it is just as important to educate them on how to achieve the same results through proper training, nutrition, and supplements that are legal and safe.

Of course, this will encourage knowledgeable chemists to create legal supplements with drug- and steroid-like effects that comply with current regulations (i.e. Dietary Supplement Health and Education Act); as defined by law, such supplements are assumed safe unless or until the FDA can prove otherwise! THG redux.

Brilliant!

The study was done by Informed Choice, a nonprofit coalition of dietary supplements, and the analysis was conducted by the British company, HFL, to investigate levels of steroid and stimulant contamination in popular supplements available on the US market. The names of the supplements that were tested were not identified. This is most likely out of fear of legal action against them by any company should it be named in the study results.

Of course, the results shocked Travis Tygart, the CEO of the US Anti-Doping Agency (USADA). In recent years, the USADA has asserted, even in the absence of any hard data, that contamination of dietary supplements is not a problem for drug-tested athletes. He further claimed that no American athletes has tested positive for steroids due to contaminated supplements since 2004. He has called for Informed Choice to publish the names of the implicated supplement company so the “illegal activity” can be stopped.

Of course, such assertions have been made in the self-interest of the USADA rather than out of concern for athletes. The presence of undeclared banned substances in dietary supplements could lead the way for significant doubt about the guilt of athletes who fail drug tests, thereby making the job of the US Anti-Doping Agency significantly more difficult.

The present study is only further evidence of the quality control problems in the dietary supplement industry and the risks for competitive athletes subject to doping tests. In recent years, at least one athletes has successfully sued a supplement manufacturer. The IOC conducted a similar study between 2000 and 2002 that revealed 15% of dietary supplements purchased in various countries contained undeclared steroid and/or prohormone ingredients.

There are several explanations for the high incidence of steroids and stimulants found in sports supplements:

1. Intentional contamination. There have been allegations that some supplement companies may have added some undeclared ingredients, usually by the addition of a stimulant, so that the consumer actually “feels” that the product is working. The overall success of the sports nutrition supplement industry is largely due to the “placebo effect” – if the consumer “feels” something from the supplement, they think it is working. If they think it is working, it may actually have benefit (placebo) and they will continue to buy the product.
2. Cross-contamination. Many factories manufacturer various different categories of supplements in the same facility.  For example, ephedrine products may be processed on the same equipment as vitamin and mineral products; hormonal products may be processed on same line as protein powders. If the equipment is not cleaned properly, contamination could result.
3. Contaminated raw material. Supplement manufacturers often import raw materials from Asia, India and Eastern Europe. This could be contaminated with impurities.

Informed Choice Supplement Research Report (PDF)