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.

Pedophile’s guide and steroids at Amazon.com: The guide has been removed, what about the steroids?

Competitive Edge Labs - M-Drol

It has been hard to avoid the recent coverage regarding the sales of “The Pedophile’s Guide to Love and Pleasure” on Amazon.com.  The story has grown to some significance in the last week getting much airtime on CNN and other outlets and resulting in a litany of media articles and commentary on the topic.

According to a Los Angeles Times article, “Amazon dumps pedophile book,” on Nov. 12, “the book was published for the Kindle, Amazon’s popular e-reader device, Oct. 28.”  So, in approximately two weeks the book has garnered enough attention and resulted in enough pressure on Amazon that it has been pulled.

Now arguments abound as to whether the book should have been allowed on the site in the first place.  Amazon issued a statement Wednesday that said it “believes it is censorship not to sell certain books simply because we or others believe their message is objectionable.”  Others cite free speech right as reasons the book should remain available.  We believe, as many do, that the heinous instructions for proper pedophilia are offensive and obviously that argument won out.  Nonetheless, the book is not illegal, it is merely fiercely objectionable and that is what got it pulled.

Meanwhile, despite their being illegal, steroids remain available on Amazon.com today.  We pointed this out in a previous post, “Despite numerous efforts to the contrary, prohormones remain widely available today” (Sept. 15).

In the post, we recounted the Nov. 3, 2009 press release Bodybuilding.com voluntary recall of 65 Dietary Supplements that may contain steroids.  According to the notice, ‘the FDA has advised the Company of its concern that the Recalled Products may contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: “Superdrol,” “Madol,” “Tren,” “Androstenedione,” and/or “Turinabol.”

At the time we wrote our previous post, several of these products remained available on Amazon.com, more than a year after the recall.  Still today, Nov. 12, some of the recalled steroid products remain available on Amazon.com, including Competitive Edge Labs – M-Drol.  We searched for another of the brands that was included in the recall, Advanced Muscle Science, and did not find either of their two recalled products listed on Amazon.com.  What we did find was more than 30 new options available from Advance Muscle Science, several of which appear likely to contain steroids as well.  A glance through the “Customers Who Bought This Item Also Bought” section seems to lead to more options.

We understand how a book that is as offensive as the “Pedophile’s Guide” can be removed within two weeks, not because it is illegal, but rather because it is offensive.  We can not understand, however, why products that are likely to contain steroids, such as those included in the voluntary recall, remain available after more than a year if they are illegal to sell.

The recall should have been a road map to removal of these products from the marketplace, yet some remain on Amazon.com.  Many more remain available elsewhere, from other major retailers.  If we value the protection of our youth and the integrity of sport, we can and should work to get steroids removed from Amazon.com and other retailers as well.  Supporting our Dietary Supplement Survey, a scientific examination of dietary supplements and their ingredients with the results made public, is one way you can help.  For more information, visit the Ant-Doping Research website at http://www.antidopingresearch.org.