Q and A on the new FEI prohibited substances list

December 2, 2009

What are the origins of the proposed new approach to the FEI Equine Prohibited Substance List?

The existing FEI Equine Prohibited Substance List ("the List") can be found within Annex II of the Veterinary Regulations (11th edition). The approach to date has been to collectively describe categories and cocktails of Prohibited Substances and to name some examples, but not to actually list out the specific substances prohibited by the rules. The current approach is described in Annex II in the Veterinary Regulations (11th Edition). Experience over time has shown that athletes and their advisers have been confused about exactly what is and what is not prohibited since this category approach is not immediately obvious to non-veterinarians. The FEI Clean Sport Commission (Chaired by Prof Ljungqvist) reported earlier this year, and amongst several recommendations, the Commission proposed that a detailed approach be taken to the List. Within the List it was felt that there should be a clear distinction expressed between doping substances and commonly used medications. A list approach is also in line with the FEI Code of Conduct for the Welfare of the Horse and WADA principles.

After feedback two versions of this new approach to a Prohibited List were offered for a decision at the General Assembly in Copenhagen, Denmark on 19 November 2009.

At the 2009 FEI General Assembly in Copenhagen on 19 November, the Progressive list was accepted by a vote of 53 to 48. This version of the Prohibited List was therefore adopted as the future FEI Prohibited Substance List and is scheduled to come into force on 1 January 2010.

Why is the FEI moving towards the approach and terminology used by the World Anti-Doping Agency (www.wada-ama.org)?

WADA serves as the independent international body responsible for coordinating and monitoring the global fight against doping in sport. It promotes coordinated and effective anti-doping programs at the international level, but also at the national level through national anti-doping organizations.

WADA also allows some medications during competition, in recognition that this still allows a level playing field and does not enhance performance unfairly.

As one of the core principles WADA seeks to achieve is clarity in the presentation and execution of its rules and as clarity is precisely the FEI's objective, the approaches are immediately aligned. By adopting similar language to that used in many other worldwide sports, the FEI will over time change many of its previously unique terms to those used by WADA i.e. Medication Forms will become Equine Therapeutic Use Exemption (ETUE) forms etc. Moving towards the WADA model was also a clear recommendation of the Clean Sport Commission.

Why do there appear to be so many individual substances in the adopted FEI Prohibited Substances List?

Over time a large number of substances which could influence the performance of the competition horse have emerged from the pharmaceutical industry. All the substances listed have been viewed as prohibited by the FEI for some time and modern instruments in laboratories can very easily test for thousands of substances at once. Similar lists of substances are also prohibited by other organizations monitoring equine sport, such as racing authorities.

Within the new FEI Prohibited Substances List, what are the two categories of substances?

Within the List and within the new FEI Equine Anti-Doping and Controlled Medication Regulations (EADCM) there are two main categories of substances:

- Banned substances - These are substances that have been deemed by the FEI to have no legitimate use in equine medicine and/or have a high potential for abuse i.e. human antidepressants, antipsychotics, nervous system stimulants, etc.

- Controlled Medication substances - An exhaustive list of medication that is prohibited in competition, and made up of all known substances which are recognized as therapeutic and/or commonly used, but have the potential to enhance performance at certain levels. Some examples might be anti-inflammatories (see note below about allowed levels), local anesthetics, bronchodilators, cough suppressants and other commonly and uncommonly used medications. Clearly substances on this list may also enhance performance depending on the timing and size of dose.

No matter what the circumstance, competition horses are expected to compete with no banned substances or controlled medication substances in their systems unless at a level defined and approved by FEI regulations.

The new FEI Prohibited Substances List which was selected by the General Assembly will come into effect on 1st January 2010 also allows the use of the Non Steroidal Anti-inflammatories (NSAIDs) Phenylbutazone, Flunixin (Banamine) and Salicyclic Acid, only one substance at a time, and then only up to defined initial maximal levels:

What is the intention behind highlighting banned and controlled medication substances within the List?

The intention is for complete transparency so that athletes and their advisers will know which type of substance is in which category of the list, and what can and cannot be used. Thereby any required enforcement sanctions can be applied appropriately with the knowledge that there is complete clarity as to the agreed FEI view on a substance that has been detected. Clearly the sanctions available for the detection of a banned substance will in most situations be more severe than for a controlled medication substance, but the sanctions for using controlled medication substances could still be up to 2 years.

The three NSAID substances are allowed up to certain levels and only one of these substances would be permitted in the horse's system at any time. Detection of levels above those specified would lead to sanctions under the new EADCM regulations.

Why are three NSAIDs allowed up to certain levels?

This is the result of a key policy decision taken by the General Assembly when it voted to accept the new FEI Prohibited Substance List. During early consultation, debate revolved around a few key substances, that the removal of these substances from the Prohibited List below certain levels represented a policy change, and that there were welfare arguments in support of both approaches (inclusion or exclusion from the list). As a result, the matter of the policy change was put to FEI members to vote upon, resulting in the presentation of the two alternative lists, with the rationale for each. The electorate chose the list which allows the use of these substances below certain levels.

One of the reasons why the World Anti-Doping Agency approach, which the FEI has adopted, is based on an ongoing review of the Prohibited List is that there is naturally a debate as to whether substances are "performance-enhancing" or "performance-restoring". It is however noteworthy that, while certain substances are the subject of debate, on the WADA list non-steroidal anti-inflammatories are not considered to be problematic in human athletes. In equestrian sport, the predominant argument in recent years justifying a complete ban on the use of these substances close to competition has been that the horse cannot choose for itself, and that therefore only such an approach can guarantee horse welfare. There are, however, arguments that, just as in human athletes, the use of NSAIDs is acceptable to the extent it does not exceed certain levels (in humans, there is no limit), and is in fact more humane as it allows for very basic treatment close to competition that could be required to treat, for example, simple travel related stiffness. There is also the argument that the banning of such substances is unrealistic as, a ban creates a situation that does not allow for legitimate treatment by penalizing it.

The voice of our member National Federations on this issue clearly demonstrates that there is not a universal belief that the use of such substances below defined limits is performance-enhancing, and that there is a significant body of opinion that permitting the use of certain substances, in certain cases with prescribed limits, is compatible with protecting horse welfare.

The sport has clamoured for clarity on the issue of the difference between medication and doping, and a debate as to where exactly the line should be drawn can therefore be expected. What is paramount is that policies and any changes thereto should be based on maintaining the health and well-being of horses through humane and strictly controlled veterinary practices. Imposing sanctions for the abuse of substances provides a high deterrence value. These were very much the considerations when two alternative lists were put forward for a vote, with awareness of the compelling arguments for both.

Is it true that some national laws prevent the use of some NSAIDs in competition and what does that mean for FEI competitions?

We understand that some European countries currently prohibit the use of certain NSAIDs in horses and we are currently identifying those countries and studying the applicable laws to construct an appropriate implementation plan come January 1, 2010. However, whatever implementation plan the FEI puts forward will respect the national laws of the jurisdictions in which FEI competitions are held.

Who will decide which substances should be included in the List?

The Prohibited Substances List has been drafted by the FEI List Advisory Group as an outcome of the Clean Sport Commissions. The List will be reviewed at least annually by this group, for approval by the FEI Bureau. This group is composed of a variety of stakeholders - riders, experts in pharmacology, veterinarians and chemists.

The purpose of the List Advisory group is to ensure that the correct substances are identified and placed in the appropriate List category. For example, some substances could be moved between categories in the light of new evidence, research, or emerging practices. The allowed levels of any substance is also subject to revision over time. Such an approach is in line with the practices of WADA. When the principle of the allowed use of NSAIDs up to certain limits was proposed during feedback, it was decided to put the choice to the General Assembly.

Why have the limits for the three NSAIDs been initially set at where they are?

Supportive therapy should not be performance enhancing. Therefore those who supported the viewpoint that such supportive therapy should be available available for the horse suggested a dosage regime for both Phenylbutazone and Flunixin (Banamine) that would be subclinical, and provide only a mild anti-inflammatory relief, in the way that is allowed for humans.

This regime was checked against existing data resulting from medication control requirements. This led to the establishment of the initial levels for these substances, which will continually be reviewed by the FEI List Advisory Group in light of any new information that becomes available.

The proposed maximum dosage regimes to be permitted are:

Only one of these substances is permitted at any one time and all treatment must be only be permitted by the FEI veterinary delegate in a strictly supervised manner. The current levels allowed have a slight safety margin at this dosage to allow for individual variation, but if these levels are exceeded, on purpose or by accident, sanctions will be imposed. The FEI is in regular consultation with various experts and studies are ongoing as part of a continual review as to the effect of these substances at different levels.

What is the FEI doing to ensure that commonly used controlled medication substances do not lead to accidental positive tests at competitions? What was the "Medicine Box" (FEI list of Detection Times)?

The FEI has produced a list of medications with detection times - previously known as the "medicine box": These have known time periods after which they will fall below certain detection levels. The cost of undertaking the research to provide this information this is high, but the FEI is fully committed to that investment in the future. This list of medications with known detection times can be found at the following on the FEI website at fei.org. Having access to more medications with published detection times will also assist stakeholders in making important decisions about the treatment of their horses in preparation for competition.

Information about the FEI approach to anti-doping and medication control has always been publicly available. However to complement the proposed new approach, the FEI is substantially increasing the accessibility to that information, which will be available in a variety of easy to use formats. These formats will also be suitable for educational and training purposes, of both competitors and the required FEI officials. A database of Prohibited Substances will also be launched shortly, available on the FEI website.

Why are "substances with a similar chemical structure or biological effect" also prohibited in addition to those individually named in the new List?<p> Every attempt has been made to keep the List comprehensive, however some substances might structurally differ by maybe only a few atoms, from those individually listed, or others might have just as potent an effect as those listed. In order to keep a proposed list sensible, there has to be a fair recognition that such substances are prohibited substances as subsets of the listed substances. This is the WADA approach.

Does the FEI check for substances that are not itemized in the List?

Yes, the FEI must be vigilant about the emergence of new substances or unusual trends. Then, if appropriate, the FEI List Advisory Group can add any substance thought to be suitable for either category of the list, giving 90 days notice before it would be considered prohibited under FEI Regulations. After the addition of the new substance to the list has come into effect, detection could lead to enforcement action.

Which substances are allowed during competition?

Knowing what is on a Prohibited List, gives a good idea of what is allowed during competition. However it is best to check for each discipline. Specifically any medications that are injectable may not be permitted to be administered whilst under FEI rules without an FEI Form 3, which must be completed by a treating veterinarian and countersigned by the FEI Veterinary Delegate present at the event. This administration while under FEI rules may require oversight or stewarding by the FEI Veterinary Delegate or designee. Treating veterinarians will be required to consult with the Veterinary Delegate.

General and specific examples of permitted medications:

  1. Antibiotics. Note - all except procaine penicillin G

  2. Antiprotozoals (i.e. specific brand names include Marquis, Navigator)

  3. Antiulcer medications. Specific generic names include Omeprazole, Ranitidine, cimetidine and sucralfate

  4. Insect repellents

  5. Anthelmintics. Note - all except Levamisole or Tetramisole.

  6. Rehydration fluid intravenously, minimum 10 litres. Note - Fluids are not allowed to be administered to horses in the eventing discipline on the morning or afternoon prior to their start on cross-country.

  7. B-vitamins, amino acids and electrolytes. These have always been allowed orally and in many cases this is still the preferred route of administration. However in some circumstances a veterinarian may prefer to administer them intravenously or intramuscularly. Note - See above procedure required

  8. Altrenogest (Regumate) for mares only so long as FEI form 2 is properly submitted.

  9. All topical wound ointments that do not contain a corticosteroid, local anesthetic or irritant (such as capsaicin) or other substances on the Prohibited List.

  10. Preventative or restorative joint therapies. Many of these products in the oral form (chondroitin, glucosamine, etc.) have always been allowed orally and in many cases this is the preferred route of administration. However in some circumstances a veterinarian may prefer to administer joint restorative therapy intravenously or intramuscularly. Specific examples of the medications used in this matter are Legend or Hyonate intravenously, Adequan intramuscularly or Pentosan polysulfate intramuscularly.

  11. Note - No intra-articular administration of any medications is allowed whilst under FEI rules.

What about the implications of the new List on Herbal, Homeopathic Products and foodstuffs?

The FEI has always cautioned athletes, trainers, grooms and veterinarians against the use of herbal medications, tonics, oral pastes and products of any kind, the ingredients and quantitative analysis of which are not known in detail. Many of these products could actually contain one or more Prohibited Substances. A similar position is taken regarding foodstuffs.

Persons administering a herbal or so called natural product to a horse or pony for health reasons or to affect its performance, having been informed that the plant origin of its ingredients do not violate the FEI regulations, may have been misinformed.

The use of any herbal or natural product to affect the performance of a horse or pony in a calming (tranquillizing) or an energizing (stimulant) manner is expressly forbidden by FEI regulations. The use of a calming product during competition may also have important safety consequences.

The FEI does not test or approve herbal or natural products to verify a possible violation of the FEI rules and regulations. Therefore a claim that the product does not violate the FEI rules or is undetectable by drug testing is the sole responsibility of the manufacturer or individual making such a claim. The use of an herbal or natural product may result in a positive test result, contrary to the claim by the manufacturer or marketing agent. Many Prohibited Substances have their origin in plants and may be regarded as serious rule violations. For example, many pharmacologically potent and readily detectable forbidden substances are obtained from plants, e.g. cocaine, heroin and marijuana all come from plants. This warning is common to all major equine regulatory authorities.

Please also keep in mind the possible contamination of feed by Prohibited Substances. Athletes and their advisors should discuss this problem with their feed supplier. Avoid buying products in retail outlets for which specifications are unclear or from retailers you do not know very well. This warning also applies to feed additives.