|  | Current Issues | No.53 May 2008 |
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Supplements and Banned Substance Contamination: Offering Athletes an Informed Choice Catherine Judkins & David J. Hall |
Supplements and Contamination – A Problem for Elite Athletes? Elite athletes of all types are routinely subjected to drug-testing, regulated by sports organisations across the world in line with WADA (World Anti Doping Agency) guidelines. Any test results that indicate the presence of prohibited (performance enhancing) substances can lead to major suspensions, fines, loss of income and reputation, and potentially the ending of a career. A defining piece of research was undertaken by the Anti Doping Laboratory in Cologne (then accredited by the International Olympic Committee, IOC) in 2001/2002. This piece of research was carried out to investigate claims that supplement products could give rise to a failed drugs test for an athlete. A selection of 634 supplements were purchased from retail outlets in 13 different countries and tested for the presence of steroids considered prohibited by the sports authorities (Geyer et al., 2004). Almost 15% of these were found to contain banned steroids, none of which were declared on the label. Since that time, sports authorities around the world are hugely cautious in their advice regarding the use of nutritional supplements. Whilst it is clear that a number of supplements explicitly contain banned substances (as declared on the label), it is also clear that a number of supposedly “clean” supplements may also be inadvertently contaminated with substances that could lead to a positive drugs test. Inadvertent contamination can typically occur via the supply of raw materials, the use of ill-defined herbal-based materials, cross-contamination within the manufacturing or packaging processes, or even the use of second-hand equipment of unknown history. As a result, WADA and the majority of National Anti Doping Organisations recommend that athletes do not take any supplements, suggesting that a suitably balanced diet will suffice for top level competition. Whether true or not, there can be few elite athletes that compete without using supplementation of one form or another - whether it be a multivitamin, a recovery aid, an endurance product, etc. There is a general view that much work has been conducted since 2004 to improve Quality Assurance in the supplement industry. However, recent research undertaken in 2007 by the Informed-Choice organisation has indicated that the issue of supplements and contamination still remains among some products. In this survey, a selection of 58 US-based supplement products was purchased from standard retail channels: 25% contained steroids/pro-hormones that were not declared on the label and 11% contained stimulants (Judkins et al, 2007). None of these contaminants were disclosed on the label. There is clearly still a risk associated with taking supplements. However, athletes do continue to use them. Strict liability rules demand that athletes take responsibility for what goes into their bodies, so how can they manage the risk? Source of the Problem - Inadvertent Contamination Raw materials are sourced on a global basis, and the vast majority are never tested for the presence of banned substances. Suppliers in the Far East may commonly supply the full breadth of the supplements industry, and prohibited substances can be manufactured and stored alongside the base materials destined for products supplied to elite athletes. The opportunity for inadvertent contamination is obvious. Herbal materials are often associated with health and fitness claims that cannot be attributed to any particular substance, so complex are the materials themselves in terms of their make-up. A simple rule: if a product genuinely enhances performance but the active ingredient cannot be specifically identified, then the product should be considered a higher risk for elite athletes. Third Party Manufacturers are a feature of the supplement industry, offering manufacturing facilities on a contract basis to companies who otherwise have no such capability of their own. Such manufacturers may handle products from many companies, and the opportunities for cross contamination (from inadequate cleaning and segregation practices) are considerable. One case found in Germany involved a manufacturer of a children’s Vitamin C tablet, who also made product for a UK-based company that focused on the “high-end gym market.” The children’s Vitamin C tablets were systematically contaminated by alarming levels of steroids and prohormones as shared equipment was used to make both products, presumably with insufficient cleaning between the manufacturing runs. The levels of contamination in this instance represented a risk to health. Inadequate cleaning of equipment must be understood in context. So low are the relevant detection limits used in sports regulatory testing - typically in the low part per billion (ppb) region - that cleanliness is a real problem. Even trace levels of contamination trapped in a piece of manufacturing equipment can have significant consequences for products made using that equipment. A number of cases of inadvertent contamination have been ultimately traced to second-hand equipment, with lingering levels of prohibited substances within the mechanisms. Reducing the Risk – Supplement Testing Analytical techniques have been developed by the very best laboratories within doping control (i.e. those that have been through the WADA accreditation process) to determine the presence or otherwise of substances that are banned by WADA. These analytical techniques can be used as part of a manufacturer’s Quality Control (QC) processes to screen supplement products for the presence of trace levels of banned substances. The key laboratory accreditation for carrying out supplement testing is ISO 17025 – an international standard for testing labs which demands dependable analysis against defined detection limits for defined substances in a defined matrix (in the case of supplements the matrix can be liquid, powder, capsule, tablet, bar, etc.). Without specific ISO 17025 accreditation for supplement analysis, contaminated products could still pass undetected. Companies with GMP (Good Manufacturing Practice) accreditation can also offer some comfort to the end user, but GMP accreditation does not necessarily mean that products are tested for contamination with low levels of banned substances. Pharmaceutical products themselves are commonly prohibited in sport, and yet they are all made to GMP standards. Therefore, companies that manufacture products in line with good manufacturing practices, and that also carry out regular banned substance screening on their products using ISO 17025 accredited tests, are the only companies that can significantly reduce the risk of contaminated products finding their way into retail channels. Can a Contaminated Supplement Cause a Failed Drugs Test? Research has shown that tiny amounts of contamination, particularly with norsteroids such as nandrolone and norandrostenedione, can give rise to a failed drugs test (Catlin et al., 2000). An administration study in which a creatine supplement was contaminated with just 10 micrograms of norandrostenedione, and was given to 18 volunteers, showed that urinary levels of the major metabolite of this steroid (norandrosterone) was up to 14 times higher than the WADA threshold for a failed drugs test (Judkins et al., 2006). The 10 microgram level represented a contamination of just 0.0002% - demonstrating that even minute levels of steroid in a product could pose a risk to an athlete. Companies that choose to have products screened for banned substances must ensure that the analytical detection limits used for testing are in the low part per billion region if they are to offer any security to an athlete. This is typically a detection level as low as 10 nanograms per gram (10 ppb). This kind of analysis is much more sensitive that any technique commonly available as routine QC in the supplement industry. It should be noted, however, that even with GMP regulations and product screening for banned substances using ISO 17025 accredited tests, there is still no “100% guarantee” that a product is “clean.” New designer steroids regularly find their way into the market place, and it is difficult to detect these unknown compounds. Equally, the distribution of contamination is not usually even across a batch, so an analytical test on a portion of a given batch can only be taken as an assessment of the likelihood of contamination elsewhere in that batch. It is a good indication – but not a 100% assurance. Managing the Risk So, how can athletes manage the risk associated with supplementation? If they are faced with two similar products, one of which has been manufactured to high standards and that has been regularly tested by a credible lab (and no contamination found) and one that has not, the athlete can surely assume that the tested product represents a lower risk in terms of contamination. It is noteworthy to mention that WADA do not accredit any labs for supplement testing, and that there is no “WADA test” for supplements. Indeed, WADA does not permit its labs to undertake such analytical testing on behalf of supplement companies – effectively depriving the athletes and the manufacturers from access to the testing that best minimises the contamination risk. However, one lab that can offer this service is HFL: a UK-based doping control lab, which has withdrawn its WADA accreditation and continued support for the world of supplement testing, sports authorities and their athletes. Supplement Testing at HFL HFL is one of the world’s most experienced anti-doping labs and has an extensive history in the field of supplement testing. The lab analyses over 2500 products a year on behalf of reputable manufacturers that seek to ensure their products are safer for athletes to use. HFL has drawn upon its experience within the WADA community to advise on the process of product screening, and offers several screening programmes, all of which involve analysis of supplements (using ISO 17025 accredited tests) for trace levels of steroids and stimulants banned by WADA. Many of the products screened at HFL are published on a web directory on www.SupplementAware.com. In addition, HFL also carries out testing for two quality assurance programmes: Informed-Choice, which operates in North America (www.Informed-Choice.org) and Informed-Sport, which operates in Europe and Scandinavia (www.Informed-Sport.com). Both the Informed-Choice and Informed-Sport programmes include the use of a logo or “kitemark” on products, so that it is easy for athletes to see which products have undergone the additional stringent Quality testing required for elite sports. For more information about HFL testing, or advice on supplements and contamination in general, please contact Dr. Catherine Judkins (cjudkins@hfl.co.uk, tel +44 1638 720500). Alternatively, send an enquiry via the contact forms available on all of the above websites. References Catlin, D.H., Leder, Z.B., Ahrens, B., Starchevic, B., Hatton, K.H., Green, A.G., Finkelstein, J.S. (2000). Trace contamination of over-the-counter androstenedione and positive urine test results for a nandrolone metabolite. J Am Med Assoc. 284:2618-2621 Geyer, H., Parr, M.K., Mareck, U., Reinhart, U., Schrader, Y., Schanzer, W. (2004). Analysis of non-hormonal nutritional supplements for anabolic-androgenic steroids – results of an international study. Int J Sports Med. 25:124-129 Judkins, C., Hall, D., Hoffman, K., (2007). Investigation into Supplement Contamination Levels in the US Market. Retrieved from http://www.usatoday.com/sports/2007-12-05-supplement-study_n.htm Judkins, C., Watson, P., Russell, C. (2006). A crossover study of 19-nor-androstenedione contamination in sports supplements: preliminary findings. Proceedings of the 5th International Congress on Medical Polymers. Cologne, Germany. Contact Dr Catherine Judkins HFL Ltd Fordham Cambridgeshire, UK Email: CJudkins@hfl.co.uk http://www.icsspe.org/portal/index.php?w=1&z=5 Supplements and Banned Substance Contamination: Offering Athletes an Informed Choice Catherine Judkins & David J. Hall