The United States Government recently mandated that a sports nutrition company comply with aspects of the WADA Prohibited List as part of a criminal plea agreement.

The government did not simply require that the company produce dietary supplements compliant with the Dietary Supplement Health and Education Act (DSHEA), the Anabolic Steroid Control Acts or any other relevant local, state and federal laws affecting the dietary supplement industry. The United States felt it necessary to incorporate a moral agenda above and beyond existing law into the plea agreement.

WADA supposedly exists to keep athletes in sports from doping. However, WADA’s dangerous influence threatens to influence laws that will affect tens of millions of ordinary people around the world who are not competitive athletes and have no aspirations of sports competition. They are simply individuals who are looking to feel better, to look better and to perform better with the help of supplements.

The requirement that any dietary supplement company follow the WADA code represents a disturbing trend in which WADA (and national anti-doping agencies operating under its directive) have aggressively sought to change international laws related to dietary supplements, anabolic steroids and performance-enhancing substances.

WADA has failed miserably at keeping steroids out of sports but they could have considerable success in influencing legislation affecting choice and freedom of ordinary consumers.

WADA has explicitly stated their desire for ALL national governments to criminalize the personal use of anabolic steroids and other performance enhancing drugs as defined in the WADA code – for athletes and non-athletes alike.

The UNESCO International Convention against Doping in Sport has a stated objective of criminalizing personal non-medical steroid use by applying the force of international law behind the anti-doping WADA code. The Convention also calls for increased regulation of dietary supplement (ideally to be compliant with the WADA Prohibited List).

The biggest problems caused by using the WADA code as the basis for international law is the fact that the overwhelming majority of dietary/sports nutrition supplement users and non-medical steroid users are NOT athletes. They are simply ordinary responsible, law-abiding adults who use these substances as a tool to feel better, to increase muscle size and strength, to reduce bodyfat, and/or to enhance physical attractiveness.

If WADA succeeds in the moralization of international laws related to dietary supplements and performance-enhancing substances, we may soon see laws that mirror the moralistic WADA Code. Non-athletes will be they ones that suffer while doping in sport continues unfettered.

“GNC does not sell illegal anabolic steroids. GNC is always troubled when an athlete who cheats himself and his profession attempts to implicitly or explicitly scapegoat another person or organization for his gross lapses in judgment, even if he was ‘young and stupid’ when it happened. GNC is confident that the public understands the difference between unlawful drugs that one’s cousin has to inject into the body and the legal, safe products for sale in its stores.”

спалниAlex Rodriguez referenced GNC in an interview with ESPN’s Peter Gammon where he admitted his own use of prohibited substances. Rodriguez never claimed GNC sold “illegal anabolic steroids”. Many statements made by A-Rod regarding his own use of anabolic steroids may not have been true, but everything he said about GNC was true. The only unfair characterization of GNC was any implication that dietary supplements caused A-Rod’s own positive steroid tests. mach zehnder modulator

• 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.

LG Sciences markets Methyl 1-D as an “AAS (anabolic/androgenic steroid) hormone” on their website and on their blog.

METHYL 1-D™ may be one of the most potent androgens since the prohormone ban in January 2005. With METHYL-1D, you get an AAS (anabolic/androgenic steroid) hormone that’s a chemical cousin to Testosterone. METHYL 1-D converts easily into TEST and also has an estrogen blocker to prevent bloat and bitch tits along with a 5aR inhibitor, so you can keep your hair.

LG Sciences is minimizing the significance of the FDA raid involving U.S. Marshalls and maintains that their products are DSHEA compliant.

In response to recent action taken by the FDA, LG Sciences wishes to clarify that we contend that all of its products are completely legal and safe. The FDA’s detainment is merely a preliminary step in determining compliance with food regulations. LG Sciences wishes to specifically note that no court has made any determination as to the correctness of FDA’s allegations. Although LG Sciences feels that the temporary restraint of its product by the FDA is inappropriate, the company appreciates that the FDA wishes to protect the public and will cooperate in every possible way.

Unfortunately, the Dietary Supplement Health Education Act (DSHEA) of 1994 is ambiguous and unclear in determining what substances are considered new dietary ingredients (NDI). An NDI requires data be submitted to the FDA regarding safety for human consumption prior to its introduction into the market. Due to a lack of a definitive list of approved dietary ingredients, the FDA mistakenly asserts that the products seized contain substances that are either not dietary ingredients, as defined in the Federal Food, Drug, and Cosmetic Act or that the substances are NDI. However, the substances are not NDI because these ingredients are naturally occurring, with confirmed studies over 25 years ago, and have been on the market in competitors products for several years. Thus, the ingredients have empirically been shown to be safe to consumers.

Items deemed unapproved food additives by the FDA 1,4,6 etiocholan-dione or commonly known as ATD or 1,4,6 Androstatriene3,17-dione. Additionally items alleged to require a new dietary ingredient status 4-etioallocholen-3,6,17-trione or better known by the trade name 6-OXO-4-androstenedione. LG Sciences looks forward to assisting the FDA in clarifying this matter and the prompt return of its inventory.

Legal Gear, the predecessor to LG Sciences, previously ran afoul of the FDA by selling unapproved new drugs containing synthetic anabolic steroids. Legal Gear discontinued the product after receiving a cease and desist from the FDA.

In March 2006, the FDA warned a company called Legal Gear – the predecessor to LG Sciences – to cease distribution of another product that was marketed as a dietary supplement but was actually an unapproved new drug containing synthetic steroids, the government’s statement said.

“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.

Clearly, Fehr was disingeniously trying to blame DSHEA for the problem baseball was having with anabolic steroids. He tried to use the supplement industry as a scapegoat for MLB’s problems and it deservedly failed.

But the supplement industry needs to pull their heads out of the stand, stop patting themselves on the back for a job well-done, and respond honestly to criticisms of their industry.

First, they have failed miserably at self-regulating the supplement industry. Steroids are currently sold in the supplement aisle. And they have been for over a decade. They were sold legally under DSHEA up until the loophole was closed by the Anabolic Steroid Control Act of 2004. They were even sold using pharmaceutical delivery methods most likely not permitted by DSHEA. And since 2004, supplement companies have continued to sell designer steroids. Supplement industry expert, William Llewellyn, clarified this for me in his comments to a previous post:

Designer steroids are still sold, as has been discussed above. SOmetimes they are not labeled as ingredients, but most often they are clearly listed. The fact remains, however, that synthetic designer steroids are considered unapproved new drugs, and are NOT covered by DSHEA as legal dietary supplements. Patrick Arnold was charged, and served time, for such a crime – no new law needs to be passed to address this.

Andro, norandro etc were covered by DSHEA because you could find them in most animals, and hence in the food supply. No animals, plants, etc naturally produce DMT, Epistane, methyl, 1-4ADD, etc etc.

I am sure there are only a few companies flaunting DSHEA and this doesn’t reflect the practices of the entire industry. But my point is that the industry is NOT doing a good job self-policing itself because the practice continues unabated.

Furthermore, significant percentages of dietary supplements have been reported to be contaminated with anabolic steroids and stimulants that are not disclosed in the ingredients. It would be nice to share my protein shake with my 6-year old daughter without worrying about the possibility of contamination due to poor quality control.

If the supplement industry is content to ignore the problem of poor self-regulation, then they share in the blame should a backlash against DSHEA occur as a result of the present-day steroid hysteria.

The next time you hear an “industry expert” say something like this (“Major League pain for supplements,” February 11)…

They don’t sell steroids in the supplement aisle.

Or this…

Anabolic steroids are not dietary supplements and dietary supplements are not anabolic steroids,” said Council of Responsible Nutrition president Steve Mister.

…please ask them to be honest for the sake of the future of DSHEA. Steroids and designer steroids are and have been sold, legally and illegally, as dietary supplements.

But I have to give credit to Rob Eder. In his closing comments, he sarcastically suggested that Fehr donate $20 million to help the FDA enforce DSHEA.

So where exactly did Fehr think the government would get the money to conduct that kind of an investigation? Rather than spend $20 million to pay for former Sen. Mitchell’s investigation, why not just donate the $20 million to the Food and Drug Administration whose job it is to police the dietary supplement industry? Contrary to popular belief, DSHEA absolutely grants FDA regulatory authority over the dietary supplement industry.

If MLB was really concerned about what products the FDA allows to come to market, they’d spend the $20 million to lobby Congress for a greater annual budget allocation for FDA.

Bravo. Illegal or undisclosed steroids in our dietary supplements is more important than the voluntary use of steroids by professional baseball players. It is time that Congress reevaluate their priorities. I like DSHEA. It just needs to be enforced. It is clear that the supplement industry can’t regulate itself as they are not even aware of any problems. Rather than waste money on steroids in baseball, federal money would be better spent enforcing a good law like DSHEA and making our dietary supplements safe.

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.

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)