By Dr. Elena Atienza Macias

In the field of doping suppression, there is a tenuous division between nutritional supplements and drugs. In this regard, it is especially alarming that supplements may contain substances that are potentially dangerous to the health of the athletes, and contain components that are prohibited under anti-doping regulations either by themselves, as prohormones or as metabolic products. In fact, a large percentage of positive results in doping controls* are due to the presence in, or contamination of supplements with substances listed in the well-known “Prohibited Substances and Methods List“.

On the other hand, I should point out that it is not only high-level athletes who use this type of substance to compete more effectively: their use is widespread in all levels of society, such as bodybuilders who use protein supplements to increase muscle growth or women who take fat-burners to lose weight. In these cases, we often find people who do not practice a sport purely for “leisure” but rather, to achieve certain ideals of beauty through the design of their body shapes, practices specifically aimed at the cultivation of the body, in gyms, fitness rooms and the like. Not only are supplements being used more widely, they are highly available, and several studies have revealed that there is a lack of security and quality control.

In this blog post, I intend to set forth, briefly but rigorously, the mix of legal issues around the extended use of (incorrectly) so-called “food supplements”, trying to express in full the complex inventory of problems arising from the ad hoc regulation in the field of doping in sport. I will do this by specifically looking at the Spanish situation.

Nutritional supplements as doping substances?

Stating the problem

Nutritional supplements (also known as “dietary supplements” or “food supplements”) are defined legally in Spain — by the Royal Decree 1487/2009, of 26 September, on food supplements — as food products consisting of concentrated sources of nutrients and presented with the aim of complementing the intake of such nutrients in the normal diet. In light of this Royal Decree, there is a wide range of nutrients and other elements that may be present in food supplements including, among others, vitamins, minerals, amino acids, essential fatty acids, fibre, various plants and herbal extracts.

There is no doubt that an athlete must take special caution when consuming supplements, as they could contain substances that are banned in professional sport. It is, therefore, recommended that athletes evaluate the need for their consumption with the help of dietician or nutrition professional. If they are deemed necessary, athletes should avoid buying products labelled in foreign languages, purchased through third parties or over the Internet without knowing their origin and level of confidence, as this could increase chances of buying ‘contaminated’ supplements.

Source: UK Anti-Doping (UKAD)

An issue which relates to this is that the vast majority of substances banned in sport are found in drugs coming to the athlete from clandestine markets. The “Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health” (MEDICRIME Convention) applies. In this regard, the Council of Europe created the so-called MEDICRIME Convention in December 2010, which constitutes, for the first time, an international treaty in the field of criminal law on counterfeiting of medical products that pose a threat to public health. Spain is the second country that has ratified the Convention. MEDICRIME gives States a powerful tool to combat this issue: the introduction of common minimum standards on criminal law and litigation among all subscribers of the Treaty countries. It also provides contact points in national health systems, reference laboratories, the police and the Customs authorities to ensure the exchange of information and cross-border cooperation. So the ratification of this Convention and its entry into force is an important step in the pursuit of the illegal trafficking of medical products from the international point of view, including the substances and methods prohibited in sport.

Following this line, recently the Director of the mentioned “Spanish Agency for Health Protection in Sport” (popularly known in Spain as AEPSAD) —Enrique Gómez Bastida—, and the Director of the “Spanish Agency for Medicines and Health Products” (also known as AEMPS) —Belen Crespo Sanchez-Eznarriaga—, have signed a framework collaboration agreement—the Collaboration Agreement between the AEPSAD and the Spanish Agency for Medicines and Health Products, Madrid, Spain, May 26, 2015 —whose objective is to articulate lines of cooperation, collaboration, coordination and communication between the two agencies in the protection of athletes’ health through the prevention of and fight against doping in sport. In this sense the AEPSAD had detected that some violations of the anti-doping regulations were derived from, among others things, the proliferation of illegal drugs that contain substances whose consumption can pose a risk to the health of athletes, including substances banned in sport or the acquisition of drugs outside the channels legally established for their custody, preservation and dispensation.

Now, at this point I wonder whether nutritional supplements have the same control as drugs. The answer, as we might have expected, is no; if nutritional supplements were regulated as drugs they would not be in the legal limbo which they are in, and it would be irrelevant to talk about problems of control and regulation. In fact, food supplements do not count as medication and are not subject to the specific controls on the pharmaceutical industry; so they may be contamination with undeclared substances which are prohibited in sport. And in practice it turns out that a large percentage of positive results in doping controls** are due to the presence or contamination of food supplements with substances included in the list of substances and methods prohibited in sport.

The problem is accentuated because an athlete can be sanctioned because of a positive control due to a prohibited substance in a supplement. Thus, in connection with the sanctions regime and the fight against doping, the AEPSAD warns that the detection of the presence of a prohibited substance or its metabolites or markers in an athlete’s bodily specimen is classified as a very serious violation, punishable by a two-year suspension in accordance with article 22.1 of the Law 3/2013. In these cases, to claim lack of knowledge of their presence due to ignorance or a faulty label, is not a valid justification.

International and European Legislation

In the context of a zero-tolerance approach to doping, there was a major step forward on October 19, 2005, during the 33rd General Conference of UNESCO held in Paris, when the International Convention against Doping in Sport was approved. Once ratified by signatory countries, this permitted regulatory harmonization and the effective enforcement of the World Anti-Doping Code in the territory of the signatories. This Convention already highlighted this problem and although it pointed out that the Governments enjoy a certain degree of flexibility in terms of how they put the Convention into effect, whether by legislation, regulation, administrative policies or practices. However, the signatory States, including Spain which ratified the Convention on October 25, 2006, are required to adopt specific measures to:

“Encourage producers and distributors of nutritional supplements to set “best practice” in the labelling, marketing and distribution of products that might contain prohibited substances”.

In the European regulatory landscape, I could highlight the Regulation (EU) No. 1169 / 2011 of the European Parliament and the Council on food information to the consumer. Known as “Regulation IAC”, it entered into force December 12, 2011, being applicable from December 13, 2014, with the exception of the provisions relating to nutritional information, which shall apply from 13 December 2016. The regulation requires labelling of food supplements “in a clear and comprehensible manner” to help consumers who want to make their decisions about food and diet with greater knowledge of the facts. In addition, they “must indicate the country of origin or place of provenance of a food, given that the absence of such an indication may lead to misleading consumers as to the true country or place of origin of that product”.

Within the anti-doping agency of the United States (known as USADA), a law of great significance in this field was passed: the Designer Anabolic Steroid Control Act of December 2014, which is intended to prevent steroids being marketed as food supplements or distributed under a false labelling. The adoption of this law has been a crucial key in the protection of athletes at all levels and consumers from companies that sell designer steroids masquerading as supplements. As part of the USADA Mission for ‘clean’ (of doping) athletes, the Agency works to help athletes understand the risks associated with the use of food supplements.

The position of the Spanish Agency for Health Protection in Sport

The AEPSAD alerts athletes of the possible consequences, both for their health and in terms of possible sporting sanctions, of a lack of vigilance in the purchase and consumption of food supplements. Athletes must remain active in anti-doping in sport and should ensure that no prohibited substance enters their body, being held responsible when their presence is detected.

Among the mechanisms which they have devised, and are backed by the AEPSAD, the “absence of banned substances certification program” called Informed Sport is emphasized. The international scientific group LGC (which leads the program) has been working with the Agency in order to increase awareness of the risks associated with unintentional doping which can be derived from products contaminated with substances prohibited by WADA.

Source: Informed Sport

The AEPSAD proactively advises Spanish athletes and sports organizations on the problem of unintentional doping and refers to Informed Sport as the most effective and widely recognized way to minimize the risk. In addition to AEPSAD educational material in Spanish aimed at its stakeholders, LGC has presented its program to the leaders of the Spanish sports supplement industry, offering its advice in the area of quality assurance. As I mentioned before, this is a program of testing and certification of food supplements created by the British company LGC, endorsed and developed in conjunction with national anti-doping organizations (such as UKAD in the UK or NADA in Germany), which gives athletes access to safe purchasing of supplements.

The problem of contamination with nutritional supplements: the controversial Contador case

A high-profile case within this problematic is that of the famous Spanish cyclist Alberto Contador. This athlete was sanctioned with a two-year suspension, including the loss of the 2010 Tour de France—in which he tested positive for Clenbuterol—and all other victories achieved until January 25, 2011,the dies a quo established for that period, considering that the positive test of the athlete for Clenbuterol was more likely to have been caused by the ingestion of a contaminated (nutritional) supplement than by a blood transfusion or by ingestion of contaminated meat (the argument was put forward by the rider). The hypothesis of contaminated food supplements was considered by Court of Arbitration for Sport as the most likely cause, although I cannot ignore the fact that the court expressly admitted that it could not be certain that this was the case. From this point of view, the Contador case is considered as archetypal as regards the rule of objective responsibility in questions of sporting disciplinary action.

On February 6, 2012 the Court of Arbitration for Sport (CAS), headquartered in Lausanne, ruled on the case of doping that surrounded the Spanish cyclist Alberto Contador. He was sentenced to pay a fine of 2.485.000 Euros to the International Cycling Union (UCI), and to be banned for two years. The cyclist tested positive in both samples A and B in a doping test carried out in September 2010, during the Tour de France. Specifically, 50 pictograms of a substance banned by both the World Anti-Doping Agency (WADA) and the UCI, called Clenbuterol, were found in his body. This substance is a drug that is known to improve athletic performance. While initially, the Competition Committee acquitted the cyclist on the grounds of lack of fault or negligence—being unable to declare him liable for violation of an anti-doping standard, under Article 296 of the anti-doping rules of the UCI, which requires voluntary ingestion of prohibited substances—the CAS, however, resolved the case using the so-called “nutritional supplement theory”.

With this theory, the CAS is saying that, although it has not determined how the banned substance entered the athlete’s body, the most likely means was via a nutritional supplement, in such a way that if the athlete fails to demonstrate that they have been completely diligent, it is enough to condemn them under a rigorous application of the principle of objective responsibility. This case is paradigmatic in that the principle in dubio pro reo, characteristic of every branch of law, falls in favour of the principle of objective responsibility, reversing the burden of proof

Opposite the case of the cyclist Contador, we could highlight that of Australian Michael Rogers. Unlike the Spaniard, Rogers did successfully use the argument about ingestion of contaminated meat to be absolved of his positive test for Clenbuterol, according to a statement from the UCI. The Australian had tested positive in the laboratory in Tokyo in a control carried out on October 20, 2013. He won the Cup of Japan and was provisionally suspended by the UCI. However, the world time trial champion claimed as the cause, the eating of contaminated meat in China during his participation in the Tour of Beijing. The UCI, after consultation with the WADA, concurred with the alleged cause and acquitted him.

In any case, I cannot talk, in purity, of a true objective responsibility, but rather of a quasi-objective responsibility, because this does not automatically impose responsibility according to the mere result, but admits the possibility of reducing or even eliminating sanctions if the accused athlete manages to prove that there has been no fault or negligence on their part, or at least that there has not been significant blame, to which end they have to demonstrate how the prohibited substance has entered their body.

Conclusions and suggestions for further research

Following on from my Ph.D. thesis main conclusions, the following statements can be drawn: the introduction of a system based on the principle of strict liability becomes one of the most legally controversial aspects, if we consider the general system of Spanish Administrative Law, which has as its starting point the principle of guilt. This principle would be totally distorted and invalidated if the strict liability is accepted: indeed, the mere occurrence of the event (i.e. the existence of a prohibited substance in the athletes` body) is sufficient to trigger the presence of an offence. The author’s intentionality and will are totally neglected. As a consequence, —and taking into account that the strict liability is not completely excluded in our legal system— the reasons for accepting a doping system governed by the strict liability should be solid, in the light of the disadvantages and negative effects that the aforementioned principle can, in our judgment, determine.

The raison d’être of this kind of liability, supported by the majority of scholars’ positions, remains in the preventive nature that permeates the sport world: it has the aim to achieve “normalcy” in the development of sport competitions, and to obtain the least possible violation.

On the contrary, our position is strongly opposing this approach, and in the course of this study it has been proved through several arguments: a) our thesis argues that the fight against doping does not justify, in any case, the violation of rights and fundamental legal principles, as in this case the presumption of innocence, which is related here to the principle of culpability. In fact, the athlete` fault is presumed, and the burden of proof of his/her innocence is left upon him/her (probatio diabolica). Some classical criteria are completely neglected, such as the invincible error of prohibition that occurs in this case when the athlete, knowing that the action of doping is illegal, considers that his/her conduct does not infringe the law because of an error that he/she cannot avoid to commit, despite his/her diligence (e.g., the case of a mislabelling of a prohibited substance); b) we also state that the strict liability in this context must be excluded —and we advocate for the revision of this principle— as it can lead to truly unfair and disproportionate situations (e.g., the punishment of innocent athletes) and to cases in which there is no legal protection in the hands of the authority that is judging the athlete, and thus ultimately decides at its own discretion.

More information on Elena’s research and other work in this area can be found here:

Atienza Macías, E., «2015 WADA code comes into effect: significant changes in the Spanish legal arena», The International Sports Law Journal (ISLJ), Vol. 15, No.1, Asser Press — Springer, Berlin-Heidelberg, Germany, 2015, pp. 49-54.

Atienza Macías, E., «Doping and health protection: a review of the current situation in the Spanish legislation», The International Sports Law Journal (ISLJ), Vol. 14, Numbers 1-2, Asser Press — Springer, Berlin-Heidelberg, Germany, June 2014, pp. 138-142.

Gleaves, J. / Christiansen, A.V., «The Curious Cases of Clenbuterol», International Network of Humanistic Doping Research Newsletter, Editorial, June 2014, INHDR, Aarhus University — Department of Public Health, Aarhus, Denmark, 2014.

Schönfelder, M., «Nutritional Supplements – Creatine», Biomedical Side Effects of Doping, Sarikaya, H. / Peters, C. / Schulz, T. / Schönfelder, M. / Michna, H. (Eds.), Institute of Public Health Research, Technische Universität München, Munich, Germany, 2007, pp. 154-170.

WADA, Athletes must show caution due to contaminated meat, November 23, 2011.

* This information is based on facts and figures taken from the “Spanish Agency for Health Protection in Sport” (Agencia Española de Protección de la Salud en el Deporte or AEPSAD), available at: http://www.mecd.gob.es/aepsad/informed-sport.html. The Agency´s data extracted from “Informed-Sport”, which is a quality assurance program for sports nutrition products, suppliers to the sports nutrition industry, and supplement manufacturing facilities. The program certifies that all nutritional supplements and/or ingredients that bear the Informed-Sport logo have been tested for banned substances by the world class sports anti-doping laboratory, LGC. Athletes choosing to use supplements can use the search function above to find products that have been through this rigorous certification process. Information available at:  www.Informed-Sport.com.

** I would like to refer to the facts and figures taken from the presentation made by the Director of the Spanish Agency for Health Protection in Sport on the occasion of the course concerning new WADA Code, held in Santander at the Menéndez Pelayo International University. The Director of the Agency  assured that approximately 85% of all positive for doping in sport, given in Spain, are “accidental doping”; that is to say, athletes without intent to consume any medication for doping. See the data fields extracted from the presentation of AEPSAD Director, available at: http://www.uimp.es/gabinete-de-comunicacion/actualidad-uimp/andreas-krieger-el-dopaje-nos-muestra-la-cara-desconocida-del-deporte-de-elite.html.