Dietary Supplement Certification – BSCG Certified Drug Free®

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

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

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

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

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

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

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

Sincerely,
Oliver Catlin
BSCG President

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

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

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

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

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

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

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

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

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

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

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

Is deer antler a banned substance?

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

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

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

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

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

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

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

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

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

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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.

Anti-Doping Research and Don Catlin pursue support for new Dietary Supplement Survey initiative

Dear Friends and Colleagues,

Anti-Doping Research (ADR) has been working in and around the realm of dietary supplements for some time.  Over the course of our history, we have worked on product contamination cases, medical issues stemming from dietary supplement use, characterization of new ingredients that have doping potential, media projects exposing new concerns, product testing for the Banned Substances Control Group Certification Program and more.  Our activities to date have dealt effectively with specific issues yet we have always sought a broader mechanism for evaluating the industry and the potential for controlled substances to contaminate dietary supplements.

There have been a few isolated studies on contamination in dietary supplements, but there has never been a fair and impartial industry-wide survey that examines this issue on an ongoing basis.  Surprisingly, there are no requirements today for the supplement industry to test raw materials or finished products for controlled substances, so the scope of the issue is unknown.  Through random sampling of dietary supplement products, analytical testing, and information dissemination, our Dietary Supplement Survey aims to differentiate the reputable players in the supplement industry from those that continue to introduce nefarious products, and to provide a network of information to consumers and athletes who seek safe supplementation.

Please take a few moments to explore our Dietary Supplement Survey.  We have announced the project in a recent press release and are currently in the process of generating the support and resources necessary to move forward.  Please contact us if you would like further information or if you are interested in supporting the project in some way.

Thank you kindly for your consideration.

Don & Oliver

About Anti-Doping Research, Inc.: Founded in 2005, Anti-Doping Research, Inc. (ADR) is a world-class center of analytical excellence and knowledge.  ADR’s mission is to utilize research, analytical services and education to identify dangerous and banned substances wherever they may be found and help halt their use.  ADR’s laboratory is an ISO 17025-accredited facility with a broad range of analytical capabilities.  ADR is a 501(c)(3) public charity/nonprofit/NGO; donations are most welcomed and are fully tax deductible.

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/.