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.

#####

 

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.

#####

Amazon steroids not on Texas high school steroid testing lists

Many people have been discussing high school steroid testing and the effectiveness of the programs to control steroid use.  The largest such example, in fact one of the largest drug- testing programs in the world, is the University Interscholastic League (UIL) testing program in Texas.  

According to Jeff Miller’s article in the Dallas Morning News, “the Legislature initially funded the effort in 2007 with an annual budget of $3 million, but the allotment for the current school year is $750,000 – after a cut to $1 million a year earlier.” The statistics show 51,635 tests conducted from February 2008 through May 2010 with 21 positives for a positive rate of less than 0.0005% of the total.  The discussion over effectiveness, and indeed the utility of the money, rages and rightfully so. 

As the discussion continues, we reviewed the policies and the testing menu for potential sources of the issue and in hopes of addressing the problem that many believe remains.  Surprisingly, there are only ten steroids included in the testing panel according to information we reviewed from an Open Records Request, we will not list them here as we do not want to deleteriously impact the program.  Meanwhile, the UIL Anabolic Steroid List for 2010-11 is posted on its website and contains 36 anabolic steroids (33 actually as two are duplicate listings and one is not a known steroid under the name listed).  It lists those compounds “contained in section 481.104 of the Texas Health and Safety Code.”  

Unfortunately and of significant concern is that neither of these lists include steroids that until recently were available on Amazon.com.  A drug like methasterone, otherwise known as Superdrol, is not on either list.  It was for sale under the name CEL M-Drol on Amazon.com until we exposed it early this year.  After we helped break the story with Amy Shipley in the Washington Post on January 19, the product was removed from the site.  So too were CEL’s X-Tren and P-Plex, which contain the steroids ‘Tren’ and Madol as we described in our post on the topic.  Again, neither appears to be included on the lists governing UIL testing.  

For a program to be effective, it needs to test for the steroids that remain widely available, as they are one click away from the students.  If we are correct in our analysis of the lists and the program coverage then you could take any of the three products above and not test positive in the UIL program, and that is simply not acceptable.  Unfortunately, the options do not end with the CEL products.  Many other steroids remain for sale on Amazon.com and other online retailers today with names that are not included in the UIL program or other high school testing programs.  

We are certainly supporters of high school drug-testing programs and believe that they can be effective, even given the more limited per person high school testing budget.  The first step to that aim is to ensure the menu covers the new steroid options that continue to appear online daily.

Amazon sellers trafficking steroids, some classified as Schedule III Controlled Substances

With the attention paid to anabolic steroids and the threat they pose to sport and public health, it is amazing to discover that such products are for sale today at Amazon.com.  We focus here on Amazon.com and on methasterone and madol, two drugs that appear in two products for sale there, but it is important to realize this marketplace is only the tip of the iceberg.  Although some suggest that we should continue to allow free access to these products, our contention is that products like these that can cause liver failure and other significant harm should not be a mouseclick away from unsuspecting consumers, especially our youth where the harm can be greatly magnified.

The first drug is methasterone, otherwise known as methyldrostanolone, which became known under the name Superdrol in late 2005. Don helped expose it as a new designer steroid in an article by Amy Shipley published by the Washington Post Nov. 2005. Methasterone has been connected to cases of liver failure in several publications.  The chat rooms on the topic provide the user accounts and hammer home the issue; check out this graphic example, if you want.  The FDA issued a warning and took action against marketers of the product in March 2006.  The World Anti-Doping Agency added the compound to the Prohibited List for 2006.

Despite inclusion on the FDA and WADA lists, the DEA does not yet have methasterone on its list of Controlled Substances as of Sept. 15. M-Drol caught the eye of the FDA in late 2009 when the product was included on a list of 65 steroid products that Bodybuilding.com was distributing.  The FDA took action against some of the products and against Bodybuilding.com resulting in voluntary recall of the products from the site.  Nonetheless, methasterone appears to be widely available in the marketplace today in many forms including Competitive Edge Labs M-Drol.

This dangerous non-FDA approved drug can still be purchased from many mainstream retailers including through 7 Amazon Sellers at Amazon.com, as of Jan. 17.  Included in the marketing heading for the product is, “M-Drol-Anabolic Muscle Building Formula, 90ct (Compare To Superdrol).”  We decided to go ahead and do the comparison.

Competitive Edge Labs M-Drol was purchased through Amazon.com on Nov. 15 in an order fulfilled by Amazon Seller Surplus-Supplements.  We analyzed it in our ISO 17025-accredited lab and compared it to a reference standard of methasterone, or Superdrol, and in fact M-Drol does still contain methasterone.  The sale of methasterone or a drug like it would likely qualify as sale of an unapproved new drug, according to the FDA’s recent letter to industry from Dec. 15: “These products are illegal because they are unapproved new drugs under 21 U.S.C. §§ 321(p) and 355(a) and/or adulterated dietary supplements under 21 U.S.C. § 342.”

There is more clarity in the case of the second product, Competitive Edge Labs P-Plex, which contains the anabolic steroid Madol.   Madol is classified as a schedule III controlled substance by the DEA under the name desoxymethyltestosterone (no other names listed).

Madol was the second of two designer steroids discovered during the BALCO doping scandal in 2003. During the federal BALCO investigation, vials of the seized drugs were analyzed and characterized by Don and his team, then at the UCLA Olympic Analytical Laboratory.  The drug that received the most notoriety was THG, short for tetrahydrogestrinone, a modified version of the already prohibited anabolic steroid gestrinone.  Madol was characterized later in 2004 and received much less publicity.  Madol was added to the Controlled Substance list Jan. 4. 2010 after a nearly two year process.

Madol has a proper scientific name of 17α-methyl-5α-androst-2-en-17β-ol.  The compound can be found under the following names; Madol, DMT, desoxymethyltestosterone, 17a-methyl-5a-androst-2-ene-17b-ol, 17a-methyl-etioallocholan-2-ene-17b-ol and other variations.

Despite its involvement in a high-profile case such as the BALCO investigation and inclusion on the controlled substance list, Madol appears in the dietary supplement marketplace in many forms.  It became popular under the name Phera-Plex and continues to be marketed in many products today.  Numerous options can be easily purchased on the Internet, including through Amazon.com.

Today at Amazon.com you will find Competitive Edge Labs P-Plex.  P-Plex was also included in the FDA action against Bodybuilding.com, yet it remains in stock and available through two Amazon Sellers as of Jan. 17. The marketing headline for P-Plex on Amazon.com reads, “P-Plex-Anabolic Muscle Building Formula 10mg, 90ct (Compare To Phera-Plex).”  We purchased the product on Jan. 6 through Amazon.com in an order fulfilled by Amazon Seller MMMPower and have identified Madol in the product.

The FDA considers this a serious matter and in a powerful letter to industry on December 15, 2010 wrote, “Responsible individuals and companies should be aware that the government may initiate criminal investigations to hold accountable those who violate the Federal Food, Drug, and Cosmetic Act (the Act) and endanger the public health. Responsible individuals, even if the individual did not participate in, encourage, or have personal knowledge of the violation, can be criminally prosecuted under the Act, pursuant to 21 U.S.C. § 331. See United States v. Park, 421 U.S. 658 (1975). When the evidence warrants, felony charges may be appropriate.”

Knowingly or not, Amazon does appear to be providing a marketplace for selling steroids, some classified as controlled substances.  Amazon was willing to withdraw the pedophile’s guide in three weeks, as we pointed out in our blog post Nov. 12.  Hopefully, Amazon will hear the FDA on this matter and also voluntarily withdraw these steroid products from their website, sooner rather than later.  We stand ready to help Amazon or other retailers in maintaining a safe marketplace for dietary supplements in the future.  ##

FDA’s significant action is already reducing the number of steroids at some retailers

The Food and Drug Administration’s letter to industry sent Dec. 15 is one of the most important and commendable actions against the proliferation of anabolic steroids in the United States since the Anabolic Steroid Control Act of 2004, as it comes with the promise of significant enforcement action.  Unfortunately, the Anabolic Steroid Control Act did not stem the widespread availability of steroids it merely ushered in a new era of designer steroids.  By providing a list of those that were “illegal,” it pushed the prohormone manufacturers to find new compounds or name old ones using obscure nomenclature to confuse the authorities.  This recent forceful FDA action has the potential to change the landscape and it is already seeing evidence of its effect, but there is a great deal of work to do.

The letter began as follows: “This letter addresses the significant public health problems posed by products that are marketed as dietary supplements but that contain the same active ingredients as FDA-approved drugs, analogs of the active ingredients in FDA-approved drugs, or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.”

It goes on to commit to serious enforcement. “Manufacturers, ingredient suppliers and distributors should not expect that a warning letter will be issued if FDA discovers potentially harmful violative ingredients in products marketed as dietary supplements. FDA recognizes that active ingredients at meaningful levels do not appear by accident in a product marketed as a dietary supplement – somewhere in the supply chain, the active ingredient is incorporated into the ingredient or the finished product. Actions that pose a risk to public health should expect a swift and strong agency response.”

The threat of significant and immediate action without any warning is what is needed to finally control the flow of these dangerous products.  This action is just in time as the situation was truly getting out of control.  An example using one retailer of such products demonstrates the problem and the effect of the FDA action.

When we first mentioned nutritionarsenal.com on Sept. 15 in our blog post, Despite numerous efforts to the contrary, prohormones remain widely available today, we found 84 products listed as prohormones.  As we noted on Dec. 12 in our blog post, New designer steroids appearing at an alarming rate, 15 new products in two months!, the explosion of such products was astounding as the number of prohormones listed had ballooned to 99!  We visited nutritionarsenal.com again today and were quite pleased to see the evidence of the FDA activity.  Today the number of prohormones offered is at 75 and dropping three weeks after the FDA letter, a clear sign that it is being taken seriously.

As we say, however, much work remains.  One of the most blatant examples comes in Competitive Edge Labs M-Drol product.  Although it was included in the FDA’s action against Bodybuilding.com in late 2009, it has remained for sale at a number of retailers since that time.  At nutritionarsenal.com, a new label has been added on the sales page for M-drol: “This item has been discontinued. All sales are FINAL,” another sign that the FDA letter, and perhaps our posts, have been effective.

FDA warns that tainted products marketed as dietary supplements are potentially dangerous – Anti-Doping Research’s Dietary Supplement Survey – A strategy in response

The Good, the Bad, and the Dirty in the Dietary Supplement Industry – Anti-Doping Research’s (ADR) Dietary Supplement Survey

Despite being widely available today, dietary supplements can contain unsafe and illegal substances that pose significant health risks to consumers.  Novel designer steroids, stimulants like ephedrine, pharmaceutically active ingredients like sibutramine, and other untested or unsafe ingredients continue to slip into the dietary supplement marketplace.  The FDA has responded with a significant and laudable new effort to work with the industry to combat the issue as described in, “FDA: Tainted Products Marketed as Dietary Supplements Potentially Dangerous.”  We would like to assist the effort through ADR’s Dietary Supplement Survey, for which we are currently raising financial support.

In ‘Tainted Body Building Products,” the FDA issued a warning that, “FDA cannot test all products on the market that contain potentially hidden ingredients.  Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.”  The numbers of tainted products are vast and the problems real.  According to the press release, “In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.”  Yet this is just a small fraction.  We would like to use our experience to help test and expose more, one of the primary goals of our Dietary Supplement Survey.

In the words of the FDA Commissioner, Margaret A. Hamburg, “These tainted products can cause serious adverse effects, including strokes, organ failure, and death.”  The dangers, as we know first-hand, are all too real, as we have dealt with numerous cases of acute liver injury in young adults who have used such products.  Colleagues such as Don Hooton have had lives forever changed by the suicide of a son using steroids to pursue athletic advancement.  Unfortunately, the issues are not isolated to body-building products as they span other categories like weight loss and sexual enhancement as well.  If such products are manufactured in the same facilities as legitimate supplements, the potential for contamination is also a concern.

In the FDA Letter to Industry, a fine point is made. “These products not only pose risks to consumers,” it states, “but undermine confidence in legitimately marketed dietary supplements in these and other categories.”  The majority of the dietary supplement industry produces products that do not contain illicit ingredients or contaminants and that should also be showcased.  In the letter, the “FDA is also seeking continued input and collaboration from the trade associations to educate the industry about this problem and to develop strategies to combat it.”

We believe that ADR’s Dietary Supplement Survey initiative could be such a strategy.  To sum up our goals:  We aim to explore which products are good, which products are bad, and which products exhibit contamination with low but potentially harmful levels of illicit ingredients.

More specifically, we will perform focused testing on problem categories to expose dangerous new products.  We will also conduct testing on a variety of randomly selected products to evaluate the prevalence of contamination and to demonstrate that the majority of products are indeed clean.  In the process, we will help audit the current retail environment to assist with enforcement and will characterize new supplement ingredients that have the potential to cause harm or lead to a positive drug test.  The results of our work will available via an interactive website portal complete with testing data, public service announcements and more.

As a public charity, Anti-Doping Research, a leader in performance-enhancing drug and toxicology research and testing, is working to raise $1.5 million to conduct the Dietary Supplement Survey.  We hope to gain broad support from a variety of sources to provide for a collective solution.  We have reached out to our friends in the dietary supplement community, the sporting community, anti-doping, collegiate and high school athletics, sporting sponsors, pharmaceutical companies and others in pursuit of support.  We would also welcome the involvement of the general public through volunteer activity or small contributions.  All donations are tax deductible.

If you have any questions, please contact us at 310-482-6925 or by e-mail at dcatlin@antidopingresearch.org or ocatlin@antidopingresearch.org.

Consumers, athletes and other elite professionals deserve a marketplace offering legitimate and safe dietary supplements.  With your help, we are confident that we can help make this happen.   Please join us and help support this important initiative with your contribution today.

Dietary supplement manufacturing and why designer steroids should matter to the general public

Perhaps you might think that you are far removed from the issues related to designer steroids.  Some see it as a problem for professional or Olympic sport to deal with but don’t see the issue influencing their daily lives.  Well, if you take dietary supplements on a regular basis, as more than half the population of the United States does, according to a recent Nielsen survey, designer steroids should matter to you.

Why, you might ask; I only take vitamins or herbs?  Well, the answer comes from the manufacturing process, which often occurs in co-packing facilities in the case of dietary supplements.  Co-packers simply mix and package the formulas provided by various supplement manufacturers and turn them into final products.  If your vitamin, protein powder, amino acid supplement or other product is processed in the same facility as one of the many designer steroids that continue to be produced you may have a problem.

A quick tour of a co-packer manufacturing facility illustrates the potential for contamination…

First, the raw materials are obtained and are warehoused for use.

The raw materials

The ingredients for a particular formula are then gathered and sent for measuring.

Gathering raw materials on pallet

The ingredients are weighed out according to the formula for the product.

Weighing the ingredients

The ingredients are combined in a huge blender to be mixed for hours.  If the blender is not completely cleaned and sanitized between mixes of different products, one can see how cross-contamination between products can occur.

The giant blender

If your protein powder is produced just after a designer steroid, one can see how cross-contamination might occur.    Many co-packers in the industry make an ethical choice not to participate in the manufacturing of dangerous products like designer steroids, but not all.  O.K., so there are regulations in place to protect against possible contamination of the finished products with potentially harmful unlabelled ingredients right?  Wrong.  (In fairness to the many competent and capable co-packers we should mention that we test products regularly from the facility shown above and have yet to find any contamination)

Certainly dietary supplement industry regulations have come a long way.  The phase-in of the Current Good Manufacturing Practice (CGMP) for dietary supplements over the last few years is likely to significantly improve quality of products as manufacturers are held to the new standards that CGMP dictate.  All manufacturers are now subject to CGMP, although the industry recognizes that the benefits will only be as good as the enforcement and auditing of the CGMP.

The new CGMP requirements, however, DO NOT include the need to test finished goods for contaminants such as designer steroids.  This is surprising given the prevalence of such compounds still today, even though they should be illegal to put in supplements.  CGMPs do require raw materials to be tested for purity prior to being formulated in the product and they also require testing for adulterants like arsenic or lead.

Some argue that purity checks will ensure that contaminants like designer steroids do not enter the marketplace.  However, if you explore the concept of purity testing and you realize that purity checks are often done at the microgram level, the problem is exposed.  Microgram testing is done at parts per million, testing for contaminants like designer steroids is usually done at the parts per billion level (nonograms).  Say you do a purity check on an ingredient and it comes back 99% pure after testing at the microgram level.  Well, how do you know the other 1% does not contain a hidden steroid, stimulant or otherwise unlabelled pharmaceutical ingredient? 

Is it O.K. if your protein powder, amino acid, or vitamin contains microgram quantities of a steroid or stimulant?  How does that magnify itself in your body with daily use of a protein powder where a serving size might be 100 grams, three times daily?  We don’t think that such contamination is acceptable as it could reach levels significant enough to lead to harm for a consumer.  Certainly, such levels of contaminants could cause positive drug tests for elite professionals like athletes or police officers; in fact, even contamination in the low parts per billion can lead to positive drug tests.

We would like to evaluate how prevalent contamination is in today’s supplement marketplace.  Nobody knows the scope of the issue since there are no requirements to test.  We want to survey the industry to characterize the issue through random sampling of a variety of products.  We also want to work to expose the bad products in the industry, like the new designer steroid options that continue to pop up daily.

If you are interested in such issues and would like to support our efforts to conduct a survey of products from the industry, please reach out to us at info@antidopingresearch.org or explore our Dietary Supplement Survey concept, which we are currently raising funding to conduct.  All contributions to our 501c3 public charity Anti-Doping Research are tax deductible.  We would welcome your support of this public-health initiative as we believe it will lead to improved consumer protection, better regulations, and much-needed improved quality control of dietary supplements.

New designer steroids appearing at an alarming rate, 15 new products in two months!

First, thank you to our friends, colleagues and all of you who have been reading our new blog.  We have enjoyed writing it and sharing some of our thoughts on important topics in a new and exciting forum.  We were not sure what to expect when starting this concept but have been pleasantly surprised by the readership.  We hope to keep you interested and inspired with our thoughts, and perhaps make a small impact on the relevant issues in the process.

We have noticed that many of you appear passionate about dietary supplements as we are.  We have worked for many years on issues related to such products and continue to do so today.  While the majority of manufacturers produce reputable supplements, there is a subset that continues to work around the current regulations and produce potentially dangerous products.

We have dealt first-hand with the dangers, which include numerous cases of serious liver failure caused by the uneducated or unintended use of powerful steroids.  Most of these occur in our youth, college or high school students looking for the body beautiful quick fix who stumble upon the wrong supplement on the Internet and cause serious harm to themselves.  Many of these come from methlyated steroids, which sadly remain widely available on the Internet today, despite the fact they are well known.

We focused on the issue in a previous post, Despite numerous efforts to the contrary, prohormones remain widely available today.  At that time one of the sites we visited, http://www.nutritionarsenal.com/Search.aspx, was selling 84 products listed as prohormones.  We visited the site again recently and found 99 products now listed as prohormones.  Amazingly, 15 new products that are likely illegal steroids or aromatase inhibitors in disguise have appeared on one website in two months time.  Sure, this is the holiday season of retail but this explosion seems ridiculous.  In a quick review, at least 75% of the 99 products appear to contain active ingredients that are likely powerful steroids.  That’s right: 75% contain steroids.

Some of these appear to be new compounds altogether, which we are exploring, but others are simply old steroids with new and confusing nomenclature.  A simple example with the compound methasterone, also known under the name Superdrol and Methylmasterdrol, explains the situation well.

Methasterone became popular several years ago.  The FDA deemed the compound to be a synthetic steroid and warned one of the companies that produced it.  The following is an excerpt from the March 8, 2006 FDA warning letter:

“This letter relates to your product Anabolic Xtreme Superdrol, containing the synthetic steroid methasteron. The product label and your Internet website, http://www.anabolicx.com, state that this product is “anabolic” and list methasteron as an ingredient. Further, your website includes statements about this product such as the following:

  • “Many people have packed on pounds of lean mass and increased their strength while using this potent supplement . . . .”
  • “The average user will gain between 6-10 pounds in as little as three weeks.”

Although Anabolic Xtreme Superdrol is not currently available on your website, where it is marked “Discontinued,” it is still being distributed in interstate commerce with a label that lists your firm name and website. The product label and your website represent this product as a dietary supplement. However, the product cannot be a dietary supplement because the active ingredient used in the product, methasteron, is not a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, nor is it a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient described above. Rather, it is a synthetic steroid. Consequently, methasteron is not a “dietary ingredient” as defined in Section 201(ff)(1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 USC 321(ff)(1)], and your product is not a dietary supplement because it does not contain a dietary ingredient.”

The active compound present was 2a, 17a-Dimethylandrostane-3-one-17b-ol.  The compound on the label was written as 2a, 17a di methyl etiocholan-3-one-17b-ol.  The difference in terminology on the label can help to disguise the ingredient.  Interestingly, the compound does not seem to be on the DEA’s Controlled Substance list

One might think that this was the last we had seen of the compound methasterone in dietary supplements; afterall, the FDA considers it a synthetic steroid.  But, alas, this is not the case.  A quick look through the available products on nutritionarsenal.com finds many products that contain this compound on the label such as Competitive Edge Labs M-Drol, Extreme Performance Group Dianavar, Methastadrol and more.  It is rather shocking that although the FDA acted against one company in 2006 for selling the synthetic steroid methasterone, multiple other companies still appear to sell the same synthetic steroid today more than four years later.  Unfortunately, this is only the tip of the iceberg.

Sadly, although many perhaps thought the era of designer steroids was behind us, the opposite seems true as the creation of new options only seems to be gaining ground.  While some, such as methasterone products, are well known, others will require resources to explore, characterize and regulate.  We look forward to participating in that process.

More methylhexaneamine positives. Why was the compound’s presence not addressed earlier?

Methlyhexaneamine

Sadly, the rash of positive drug tests related to methylhexaneamine continues.  Yesterday, it was reported by Velonation.com that the cyclist brothers Rui and Mario Costa both tested positive for methylhexaneamine in the past year.  This is merely the latest example of a string of high-profile positive drug tests related to methylhexaneamine that have surfaced in the last two years.

Our previous blog post (of Sept. 10) explains how the many synonyms and brand names that surround methylhexaneamine create confusion and can result in inadvertent use of the drug.  We also briefly looked into the interesting history of the compound.  We posed the question, ‘why is this drug banned in sport yet legal in dietary supplements’, and that question remains.

What we did not examine is why it took so long to address this compound, as it was exposed as a potential problem in the Washington Post on May 8, 2006.   Patrick Arnold, the chemist mastermind behind the infamous BALCO steroid scandal, was awaiting his sentencing at the time.  Meanwhile, his company was marketing methylhexaneamine under the trademarked name Geranamine.  The father of designer steroids, as many consider Arnold to be, had shifted his focus to methylhexaneamine.  The writing was on the walls, or at least in the Washington Post, that this substance would become a problem in sport.

Methlyhexaneamine was added to the World-Anti-Doping Agency Prohibited List for 2010.  In the U.S. supplement industry, the argument continues as to whether or not the compound should be allowed as an ingredient.  For now, it continues to be legal to make supplements that contain the compound.

Another positive drug test related to dietary supplement contamination

Sadly, another positive drug test related to use of a dietary supplement surfaced yesterday, this time in equine sport, http://www.horseandhound.co.uk/news/397/302201.html.  Don’t let this situation happen to you; there are ways to protect yourself.

According to the story, a British endurance rider, Christine Yeoman, had her horse test positive for ractopamine, a potent beta agonist, at an event on August 9, 2009.  She had been giving the animal Neigh-Lox, used to prevent gastric ulcers.  Neigh-Lox was manufactured in the United States by Kentucky Performance Products.  Traces of ractopamine were found in the product in subsequent testing, and the company has admitted to the contamination.

For those who are not aware, drug testing usually works according to strict liability, meaning if a drug is detected resulting in a positive test, the individual is responsible for the presence of the substance in the body regardless of where it might have originated.  If the issue is related to a contaminated supplement, the athlete or rider still faces possible sanctions.  The human sport system considers supplement use to be voluntary, and thus even if supplement contamination is the source of a positive drug test the athlete is usually held responsible.

In this equine case, the rider had to spend more than €200,000 to clear her name and win an unprecedented ruling from FEI.  The ruling stated: “Even ordinary feed is often mixed and includes several additives which may be contaminated. Even feed without additives may be contaminated.  Equestrian sport on a high level can be said to require the use of feed supplements to care properly for such elite horses.  In the tribunal’s opinion, PRs [persons responsible, i.e. the rider] are not the proper party to bear the risk of supplements contaminated at the manufacturer level.”

Unfortunately, testing for banned substances in dietary supplements is not mandatory and the risk of contamination remains an issue.  Testing options that can protect against these issues are available to the general public, athletes, and the dietary supplement industry.  We operate our own such program at Banned Substances Control Group.  For more details, please explore http://www.bscg.org/.