On 12 June 2015 the French Federation of Weightlifting, Fitness, Powerlifting and Bodybuilding (FFHMFAC) decided to impose a 4 month period of ineligibility on the Athlete after he tested positive for the prohibited substance Oxilofrine (Methylsynephrine).

Hereafter the case against the Athlete was reopened by the AFLD. Following notification the Athlete filed a statement in his defence.

The Athlete admitted the violation, denied the intentional use of the substance and explained that the source was a supplement he had used. He acknowledged that he acted negligently as he had not checked this supplement before using.

The AFLD determines that:

• The Athlete had committed an anti-doping rule violation;
• He failed to check the ingredients on the label of this supplement;
• He did not mention the supplement on the Doping Control Form;
• He established how the substance had entered his system;
• He acted with siginificant fault or negligece.

Therefore the AFLD decides on 21 January 2016 to impose a 2 year period of ineligibility on the Athlete, starting on the date of the provisional suspension, i.e. on 12 June 2015.

On 26 June 2015 the French Federation for Kick Boxing, Muay Thai and Associated Disciplines (FFKMDA) decided to impose a 1 year period of ineligibility on the Athlete after he tested positive for the prohibited substance Oxilofrine (Methylsynephrine).

Hereafter the case against the Athlete was reopened by the AFLD. Following notification the Athlete filed a statement in his defence and he was heard.

The Athlete admitted the violation and denied the intentional use of the substance. He explained that he had used a supplement Lipo-6 Black, recommended by a person he knew, in order to to lose weight.

The AFLD determines that:

• The Athlete had committed an anti-doping rule violation;
• He had used the prohibited substance without a medical justification;
• He failed to check the ingredients on the label of this supplement;
• He did not mention the supplement on the Doping Control Form;
• He established how the substance had entered his system;
• He acted negligently and failed to demonstrate that the violation was not intentional.

Therefore the AFLD decides on 21 January 2016 to impose a 2 year period of ineligibility on the Athlete, starting on the date of the provisional suspension, i.e. on 11 June 2015.

Nine prohibited stimulants found in sports and weight loss supplements: deterenol, phenpromethamine (Vonedrine), oxilofrine, octodrine, beta-methylphenylethylamine (BMPEA), 1,3-dimethylamylamine (1,3-DMAA), 1,4-dimethylamylamine (1,4-DMAA), 1,3-dimethylbutylamine (1,3-DMBA) and higenamine /  Pieter A. Cohen, John C. Travis, Céline Vanhee, Dana Ohana, Bastiaan J. Venhuis. - (Clinical Toxicology (2021, 23 March; p. 1-8)

• PMID: 33755516
• DOI: 10.1080/15563650.2021.1894333

Abstract

Background: Weight loss and sports supplements containing deterenol have been associated with serious adverse events including cardiac arrest.

Objective: To determine the presence and quantity of experimental stimulants in dietary supplements labeled as containing deterenol sold in the United States.

Methods: Dietary supplements available for sale in the US and labeled as containing deterenol or one of its synonyms (e.g., isopropylnorsynephrine and isopropyloctopamine) were purchased online. For each brand, one container or subsample was analyzed by NSF International (Ann Arbor, MI) and one container or subsample by the Netherland's National Institute for Public Health and the Environment (RIVM, Bilthoven, The Netherlands). When differences existed between the two containers or subsamples of the same brand, both products were reanalyzed by Sciensano (Brussels, Belgium). NSF International carried out qualitative and quantitative analyses using ultra-high-performance liquid chromatography (UHPLC) quadrupole-Orbitrap mass spectrometry. RIVM performed qualitative and quantitative analysis using UHPLC quadrupole time-of-flight mass spectrometry. Sciensano carried out qualitative analysis using UHPLC quadrupole-Orbitrap mass spectrometry.

Results: Seventeen brands of supplements were analyzed. Many brands included more than one prohibited stimulant in the same product: 4 brands (24%, 4/17) included 2 stimulants, 2 (12%, 2/17) combined 3 stimulants, and 2 (12%, 2/17) combined 4 stimulants. The range of quantities per recommended serving size of the 9 stimulants detected were 2.7 mg to 17 mg of deterenol; 1.3 mg to 20 mg of phenpromethamine (Vonedrine); 5.7 mg to 92 mg of beta-methylphenylethylamine (BMPEA); 18 mg to 73 mg of octodrine; 18 mg to 55 mg of oxilofrine; 48 mg of higenamine; 17 mg of 1,3-dimethylamylamine (1,3-DMAA); 1.8 mg to 6.6 mg of 1,3-dimethylbutylamine (1,3-DMBA); and 5.3 mg of 1,4-dimethylamylamine (1,4-DMAA).

Conclusion: Weight loss and sports supplements listing deterenol as an ingredient contained 9 prohibited stimulants and 8 different mixtures of stimulants, with as many as 4 experimental stimulants per product. These cocktails of stimulants have never been tested in humans and their safety is unknown.

Pharmaceutical doses of the banned stimulant oxilofrine found in dietary supplements sold in the USA / Pieter A. Cohen, Bharathi Avula, Bastiaan Venhuis, John C. Travis, Yan-Hong Wang, Ikhlas A. Khan. - (Drug Testing and Analysis 9 (2017) 1 (January); p. 135-142)

• PMID: 27062112
• DOI: 10.1002/dta.1976

Abstract

Oxilofrine (4-[1-hydroxy-2-(methylamino)propyl]phenol) is a pharmaceutical stimulant prescribed in dosages of 16 to 40 mg to stimulate the heart and increase blood pressure. It has never been approved for use in the USA as a prescription drug or as a dietary supplement. Several athletes, however, have been banned from sport for testing positive for oxilofrine and have claimed that they inadvertently consumed oxilofrine in sports supplements. Consumption of supplements containing oxilofrine may also pose serious health risks. For example, one brand of supplements containing oxilofrine has been linked to serious adverse events including vomiting, agitation, and cardiac arrest. We designed our study to determine the presence and quantity of oxilofrine in dietary supplements sold in the USA. A validated ultra-high performance liquid chromatography-quadrupole time of flight-mass spectrometry method was developed for the identification and quantification of oxilofrine. The separation was achieved using a reversed phase column, mass spectrometry detection, and a water/acetonitrile gradient as the mobile phase. The presence of oxilofrine was confirmed using a reference standard. We analyzed 27 brands of supplements labelled as containing a synonym of oxilofrine ('methylsynephrine') and found that oxilofrine was present in 14 different brands (52%) at dosages ranging from 0.0003 to 75 mg per individual serving. Of the supplements containing oxilofrine, 43% (6/14) contained pharmaceutical or greater dosages of oxilofrine. Following instructions on the label, consumers could ingest as much as 250 mg of oxilofrine per day. The drug oxilofrine was found in pharmacological and greater dosages in supplements labelled as containing methylsynephrine.

In May 2016 the World Archery Federation (WA) has reported an anti-doping rule violation against the Canadian archer Jason Lyon after his A and B sample tested positive for the prohibited substance Oxilofrine in a low concentration.

After notification a provisional suspension was ordered. The Athlete filed a statement with evidence in his defence and he was heard for the WA Anti-Doping Panel. The Athlete accepted the test results, denied the intentional use of the substance and argued that he was tested before without issues.

The Athlete had conducted an investigation into the source of the positive test and established which food, supplements and medication he had used prior to the competition in Phoenix in April 2016 where he provided a sample for drug testing. 

The Athlete asserted that certain oranges he had consumed could be the likely source of the Oxilofrine while he was unaware that these oranges might contain Oxilofrine. For analysis in a Laboratory the Athlete had purchased Satsuma oranges from a local Wal-Mart in Canada. These were the same oranges he had purchased from a Wal-Mart in Phoenix and consumed on the day of the competition.

Supported by an expert witness the Athlete demonstrated, with Lab analysis of these Satsuma oranges, the presence of Oxilofrine in a concentration to be consistent with the low concentrations found in his A and B samples. Analysis in this Lab of the supplements and medication he had used had revealed no prohibited substances. 

On the other hand the expert witness of the Lausanne Lab was very skeptical regarding the Athlete’s claims of the presence of Oxilofrine in oranges since he was was unaware of any publication which addresses the question whether gas of liquid chromatography performed on fruits or vegetables has detected the presence of Oxilofrine. 

Considering the test results the Anti-Doping Panel finds that the presence of the prohibited substance Oxilofrine had been established in the Athlete's samples and accordingly that he had committed an anti-doping rule violation. 

In view of the pleadings and the testimony provided both by the Athlete himself and his expert witness, the Panel remains unpersuaded, based on the balance of probability, that the oranges purchased at a Wal-Mart, of which he alleges to have consumed up to six in the hours leading up to the competition and the sample collection, are the source of the Oxilofrine. 

Considering the missing proof of purchase and chain of custody, the preponderance of scientific opinion that Oxilofrine is not a natural substance which develops organically in oranges and the misdirected and unsubstantiated testimony of the Athlete’s expert witness with regard to his laboratory methodology, the Panel is forced to conclude that the Athlete has not met his burden of proof regarding the source of the Oxilofrine. Consequently the Panel finds that the Athlete failed to establish that he bears No Significant Fault or Negligence. 

The Panel finds no grounds to assume that the Athlete in consuming Oxilofrine acted intentionally in order to enhance his performance. This view is also shared by WA and a four year ban was not requested.

In addition the Panel holds that it has no reason to assume that the Athlete is a “cheater”. His excellent performance record and lack of any previous violations of the Rules over many years of competition speak for themselves. 

Therefore the Anti-Doping Panel decides on 5 July 2016 to impose a 2 year period of ineligibility on the Athlete starting on the date of the provisional suspension, i.e. on 19 May 2016.

In July 2013 the Jamaica Anti-Doping Commission (JADCO) reported an anti-doping rule violation against the Athlete Sherone Simpson after her A and B samples tested positive for the prohibited substance Oxilofrine. After notification a provisional suspension was ordered. The Athlete filed a statement in her defence and she was heard for the Jamaica Anti-Doping Disciplinary Panel.

The Athlete admitted the violation and stated that it was not intentional. She asserted that one of the supplements Epiphandy D1 she used was the source of the positive test recommended by her physical trainer. She stated that she researched the ingredients of all the supplements she had used. Analysis in 2 laboraties in the USA and in one laboratory in Jamaica of the batch of Epiphandy D1 used by the Athlete showed the presence of the substance Oxilofrine in supplement.

Considering the evidence in this case and the Athlete’s degree of fault the Panel accepts that the violation was not intentional and that there are grounds for a reduced sanction. The Panel deems that the Athlete failed to mention her supplement in question on the Doping Control Form and that the substantial assistance she provided was insufficient enough for a further reduction of the sanction.

Therefore the Jamaica Anti-Doping Disciplinary Panel decides on 1 May 2014 to impose a 18 month period of ineligibility on the Athlete starting on the date of the sample collection, i.e. on 21 June 2013.

In July 2015 the South African Institute for Drugfree Sport (SAIDS) has reported an anti-doping rule violation against the Athlete Sandile Ngunuza after his A and B samples tested positive for the prohibited substances Methylhexaneamine (dimethylpentylamine) and Oxilofrine (methylsynephrine).

After notification a provisional suspenstion was ordered. The Athlete filed a statement in his defence and he was heard for the SAIDS Anti-Doping Hearing Panel.

During the proceedings the charge against the Athlete was amended by SAIDS in September 2015 and Oxilofrine excluded because re-analysis in the accredited laboratory of the Athlete’s A-sample showed that the previous reported substance Oxilofrine was in fact Hydroxy-pseudoephedrine (Pseudo-oxilofrine) a metabolite of Pseudoephedrine. Also the concentration Pseudoephedrine found in the Athlete's sample was below the WADA threshold.
In this matter WADA previously had issued a Guideline on 7 May 2015. However the accredited laboratory in South-Africa failed to introduce a timely procedure in accordance with the WADA Guideline to test for Pseudo-oxilofrine.

The Athlete admitted the violation and assumed that one of the supplements he had used contained the prohibited substance. However analysis of the Athlete’s supplements in question revealed that they didn’t contain prohibited substances. Also the Athlete suggested that the fluids he ingested from the different water stations along the 89 km route of the marathon could have been the source of the positive test.

Considering the evidence and circumstances in this case the Panel concludes - as accepted by SAIDS - that the anti-doping violation was not intentional and also finds that the Athlete could not establish on a balance of probability to the satisfaction of the Panel how the prohibited substance entered his system.

Therefore the SAIDS Anti-Doping Hearing Panel decides on 26 February 2016 to impose a 2 year period of ineligibility on the Athlete starting on the date of the provisional suspension, i.e. on 2 July 2015.

Initially during the proceedings against the Athlete the SAIDS Anti-Doping Hearing Panel had already reached an unanimous decision before the charge was amended by SAIDS in September 2015 because of the new test result. For this reason the Panel renders in this case a full reasoned decision as required under the Rules. In addition the Panel notes in the Annex their concerns dealing with the possible constitutional imperatives, anomalies and unintended consequences of the application of the Rules.

In August 2017 the Canadian Centre for Ethics in Sport (CCES) has reported an anti-doping rule violation against the Athlete after his sample tested positive for the prohibited substances 1,3-Dimethylbutylamine (1,3-DMBA) and Oxilofrine (methylsynephrine).

After notification the Athlete gave a prompt admission, waived his right to be heard, accepted a provisional suspension and the sanction proposed by the CCES.

Therefore the CCES decides on 30 October 2017 to impose a 2 year period of ineligibility on the Athlete starting on the date of the sample collection, i.e. 9 july 2017.