Upper limit of the doping risk linked to sports supplements Study of the presence of prohibited substances in high-risk sports supplements available from Dutch web shops Anti-Doping Authority Netherlands Erik Duiven Olivier de Hon Laila Spruijt Bart Coumans 20 November 2015 2 Acknowledgements The Doping Authority (Anti-Doping Authority Netherlands) would like to thank Paul Beck, Paul Brown and the other LGC staff for their outstanding contribution to the design and implementation of the laboratory tests. Without them, this report could never had reached the high analytical standard it deserved. This study was made possible by a financial contribution from the Ministry of Health, Welfare and Sports. 3 Contents Summary 5 Glossary 6 1. Introduction 10 1.1. NZVT 10 1.2. Lower limit of 1.6% 11 1.3. Use of unverified dietary supplements 11 1.4. Deliberate addition of prohibited substances 12 1.5. Upper limit unknown 12 1.6. Research area 13 1.7. Anonymity 13 2. Selection process for dietary supplements 14 2.1. Selection of web shops 14 2.2. Selection of brands 14 2.3. Selection of products 15 3. Laboratory analysis 16 3.1. Product assessment 16 3.2. Analysis of high concentrations 17 3.3. Analysis of low concentrations 17 3.4. Overall report on products 19 3.5. Overall report on brands 19 3.6. Additional: analysis of PEA-labelled products 20 4. Analysis of prohibited substances found 21 4.1 Anabolic steroids found 21 4.2 Discussion of anabolic steroids 22 4.3 'Other substances' found 22 4.4 Discussion of 'other substances' 23 5. Conclusion 25 6. Recommendations 27 References 28 Annex 1: overview of declared prohibited substances 30 Annex 2: prohibited substances analysed by LGC for the purposes of this study 31 Annex 3: result of analysis for anabolic steroids 36 Annex 4: result of analysis of other substances 37 Annex 5: result of analysis by sample / product 38 Annex 6: result of analysis by brand 40 Annex 7: prohibited substances found (at product level) 43 4 Summary Various studies have shown that dietary supplements can contain prohibited substances without this being stated clearly on the label. In response to this risk for elite athletes, the Doping Authority established the Dutch Safeguards System for Dietary Supplements in Elite Sport (NZVT). It is reasonable to assume that prohibited substances will seldom or never be added deliberately to dietary supplements submitted for analysis under the NZVT system. Nevertheless, between 2003 and 2014, eighteen of the product-batch combinations submitted (1.6%) were found to contain prohibited substances. This percentage is considered to be the lower limit for the prevalence of prohibited substances in dietary supplements. Little or nothing is known about where the upper limit is to be found. International studies have reported maximum upper limits of around 25%. However, the actual upper limit was actually expected to be much higher, especially in a group of high- risk sports supplements specifically targeting hormone regulation, strengthening muscle, weight loss/burning fat, or raising energy levels. This study focused on the question of what percentage of these high-risk sports supplements contain prohibited substances. After a selection was made from seventeen different web shops, 66 products from 21 different brands were submitted for analysis to the LGC research laboratory (United Kingdom). Twenty-five (38%) of the high-risk sports supplements tested ‘positive’ and 30 (45%) tested ‘negative’. Eight products (12%) were found to contain ‘concentrations below the adopted threshold value’. In these cases, the detection of doping substances may be explained by their natural presence in certain ingredients, such as botanical components. However, this cannot be stated with certainty. Specific research in this area is therefore required. Three of the 66 products (5%) were 'not analysable/not fully analysable'. Three of the 25 'positive' products (5% of the total sample analysed) were found to contain prohibited substances in high concentrations. In addition to the real risk these products pose for athletes in terms of doping violations, there is also a genuine health risk. Given the public health implications, these findings were therefore reported to the Netherlands Food and Consumer Product Safety Authority (NVWA). This study shows that Dutch elite athletes continue to be exposed to risks if they use product-batch combinations of dietary supplements that have not been tested for the presence of doping substances by the NZVT (or any other recognised system). At the same time, the NZVT is not used by large proportion - or even a majority - of Dutch elite athletes. This is an undesirable situation. It will therefore be important to boost the promotion of the NZVT among these elite athletes. 5 Glossary Batch See Product-batch combination. Cologne List Dietary supplements control system from Germany. Concealed declaration The prohibited substances are listed on the label using a non-standard name or as part of a non-standard name. Concentrations under the adopted threshold value Term used in the report. One or more prohibited substances were found, but only in concentrations below the adopted threshold values (reporting level compounds only – see Annex 2). In this case, the detection of prohibited substances may be explained by their natural presence in certain ingredients such as botanical and animal-derived ingredients. The low levels observed do not, in principle, involve a risk of a positive doping test for elite athletes. The supplement would therefore have passed the NZVT screening. Contamination The prohibited substance has been included in a product inadvertently. Cross-contamination The substances have been used deliberately in certain products but have also ended up inadvertently in other products. Declared The prohibited substances are listed on the label using a widespread, often generic, name. Designer amphetamines Designer compounds structurally similar to amphetamine. Designer steroids Designer compounds structurally similar to anabolic steroids. Dietary supplements Food or drink - intended to supplement a normal diet; - that acts as a concentrated source of one or more micronutrients or of other substances with a nutritional or physiological effect; - that are marketed in small unit quantities destined for consumption. Dietary Supplements (Commodities Act) Decree Legislation stating requirements applying to dietary supplements. For example, there are requirements for the preparation, composition and labelling of dietary supplements. 6 Elite athlete An athlete with a realistic probability of qualifying for a doping control. HACCP - Plus / NZVT system The risk assessment system used by participating manufacturers in the NZVT. High-Risk Dietary Supplement List Overview released by USADA of dietary supplements that: - list prohibited substances on the label; or - turn out to contain prohibited substances after additional research; or - list ingredients on the label that are often linked to prohibited substances (such as certain herbal ingredients). Informed-Choice Dietary supplements control system from the United States. Informed-Sport Dietary supplements control system from the United Kingdom. Negative Term used in the report. One or more prohibited substances were not found. The supplement would therefore have passed the NZVT screening. NOC*NSF Netherlands Olympic Committee*Netherlands Sports Confederation. NOC * NSF is therefore the Dutch Olympic Committee and the Dutch organisation representing the interests of organised sports. Not analysable/ not fully analysable Term used in the report. The analysis could (often due to the complex herbal ingredients present) not be completed in full. It was therefore not possible to determine whether one or more prohibited substances were present or absent using the defined method specification. Because of the incomplete test result, the dietary supplement in question would not have passed the NZVT screening. NZVT Abbreviation for ‘Dutch Safeguards System for Dietary Supplements in Elite Sport’. The NZVT is a system involving the Doping Authority, NPN and NOC*NSF. The system allows manufacturers of dietary supplements to have batches of their supplements checked in exchange for payment. Phytochemical Relating to the constituent components of plants. Prohibited list The list of prohibited substances and methods. 7 Positive Term used in the report. One or more prohibited substances were found. This means that the dietary supplement in question would not have been approved during the NZVT screening process. Product-batch combination Dietary supplements are made in 'charges' or 'batches'. Every so often, producers mix the ingredients to form a finished product that is then packaged. The products packaged during a given uninterrupted period are part of the same product-batch combination. Each batch of a product can be identified on the basis of an identical shelf life (often referred to as 'best before'), generally accompanied by an identical batch number or production number. Proprietary blend A mixture of ingredients that is not specified on the label except for a statement that it is a proprietary blend. RIVM Abbreviation for ‘National Institute of Public Health and Environmental Protection’. The RIVM's mission is the promotion of public health and a clean and safe environment. Spiked The prohibited substances are not listed on the label but they have been deliberately included in the supplement. Sports supplements Dietary supplements