1.  INTRODUCTION

  1.1  The European Specialist Sports Nutrition Alliance (ESSNA) represents the interests of the manufacturers and distributors of specialist sports nutrition products in Europe. Its members include most of the major brands in the sector. Member companies are committed to adopting high standards in manufacturing processes and delivering high quality products. ESSNA members also commit to compliance with all relevant regulations. ESSNA is in regular dialogue with the European Commission and with Member State Competent Authorities, including the UK Food Standards Agency. Contact details are in Annex 1 (not printed); membership is listed in Annex 2, and the biography of our Chair, Dr Adam Carey, is given in Annex 3.

  1.2  We welcome the inquiry by the Committee into human enhancement technologies and are grateful for the opportunity to submit written evidence.

  1.3  This short introductory memorandum can be no more than a very brief overview of a number of key areas, but we hope that it is helpful as an indication of our willingness to provide further information or more detailed comment should the Committee wish to explore further any particular issue.

2.  CREDIBLE PRODUCTS

  2.1  Good basic nutrition is an absolute essential for athletes, yet all too often lifestyles and sometimes training regimes make it difficult to achieve this goal. Sports nutrition products and other specialist food products can provide a convenient form of nutrient intake. More specialist products can help build on good basic nutrition to enable athletes to achieve their maximum potential.

  2.2  Sports nutrition products include basic food supplements (vitamins and minerals), specially formulated snack bars, re-hydration drinks, sources of concentrated energy, and more specialist products to help with recovery and muscle development after intense physical exercise.

  2.3  The majority of consumers of specialist sports nutrition products today are not elite athletes, but "ordinary" consumers or recreational sportspersons who take part in often low-level sporting events, personal exercise, or gymn-based fitness regimes. Our members' products today are widely available on general retail sale, many in high-street outlets, as well as through mail order, the internet and centres of sporting activity such as sports centres and gymnasia.

  2.4  In the United Kingdom, food law requires products to be safe and appropriately labelled, and also to comply where appropriate with the compositional and other requirements of the European Union legislation which regulates food supplements (Directive 2002/46/EC) and food for "particular nutritional purposes" (Council Directive 89/398/EEC). The legislation is rigorously enforced through the work of the Food Standards Agency, the Medicines and Healthcare Products Regulatory Agency, Trading Standards Officers, and a responsible industry approach to maintaining high manufacturing standards.

  2.5  Many international competitors now take the issue of basic nutrition and enhanced nutrition very seriously because it can make a significant difference to performance as demonstrated in numerous published studies and anecdotal reports.

  2.6  The products of our members are based upon sound science. In many cases that science is well-established and widely accepted. Should the Committee find it helpful, we would be pleased to submit scientific evidence to demonstrate this.

  2.7  It is, however, in the nature of the sports nutrition sector that emerging science can contribute to product innovation and development. Sometimes, the effect of nutritional products on performance is difficult to "quantify" in the traditional sense since the number of elite athletes involved in any study would inevitably be small; other differences, for example, in training and diet, may be potentially substantial and the difference between first and second place in elite international competition is sometimes so small as to be almost immeasurable (eg hundredths of a second), and certainly below the tolerances of error in a traditional scientific study.

  2.8  We hope that your committee might recommend that those responsible for high-level, elite and international sport in the United Kingdom ensure that sportsmen and women have access throughout their careers to sound nutritional advice from experts in the field of specialist sports nutrition who can guide them not only on basic nutrition, but also on how best to maximise their potential through optimal nutritional intake.

  2.9  Such a strategy could contribute significantly to improved performance by British competitors at international level.

3.  USE OF ILLEGAL SUBSTANCES BY ELITE ATHLETES

  3.1  It is acknowledged and regretted by ESSNA members that some elite athletes seek to achieve competitive advantage by breaking the rules of their own sports and by using illegal substances. This is deplorable and is an issue rightly taken seriously by sports governing bodies and by the British Government, particularly in the run up to the 2012 Olympic Games in London.

  3.2  It is important to appreciate, however, that the term "illegal" has two different meanings in this context. For example, a substance may be "illegal" for sale for human consumption under food or medicines legislation. In such cases criminal prosecutions can, and should, be considered for those marketing or possessing such products. In relation to elite sport, however, the term "illegal" is sometimes used to describe products that contain substances which are perfectly legal for general sale to ordinary consumers (for example over the counter medicines, herbal remedies etc) but which are specifically banned by the governing bodies of sport for elite competitive athletes. Confusion over the use of these different meanings of the term "illegal" should be avoided.

  3.3  ESSNA welcomes moves by the UK Government, WADA and UNESCO to highlight the issue of doping in sport and to seek ways of addressing this problem. We remain committed to playing a part in this process and would hope that those stakeholders taking the lead in developing kite-marking and voluntary codes will ensure our members are fully consulted and that their views are taken on board.

  3.4  We hope that your Committee will recommend that the specialist sports nutrition sector represented by ESSNA is indeed fully involved by those agencies in developing their approach.

4.  CURRENT DIFFICULTIES

  4.1  ESSNA notes that it has been alleged that there are unscrupulous manufacturers who place on the market products that contain prohibited and sometimes dangerous ingredients and that there are also manufacturers who market products to elite athletes but who mislabel their products. We have seen no substantive evidence to support the assertion that such practices are common and can see no commercial benefit to a company from adopting such behaviour. Indeed, there would be absolutely no commercial advantage to be gained by our members deliberately contaminating, mislabelling or otherwise allowing products to go to market without full compliance with regulation. Damage to our members' brands would be considerable were they to do so.

  4.2  We deeply regret the unjustified manner in which the responsible specialist sports nutrition sector is unfairly blamed for deliberate substance abuse by individual athletes or as a result of those tests for banned substances which are in fact "false positives" (see below).

  4.3  Furthermore, the scale of positive testing for banned substances has been grossly exaggerated because of both media sensationalism and flawed interpretation of the results of the Geyer study[8].

  4.4  If there were indeed widespread contamination then many more athletes would be caught by positive tests. This is simply not happening. Tests by WADA, the IOC and other governing bodies suggest that only a very small fraction of athletes in fact test positive.

  4.5  Our members, therefore, clearly share with regulators and the sporting community a powerful incentive to see that the issue of substance abuse in sport is addressed.

  4.6  We are committed to promoting best manufacturing practice and accept that manufacturers must take full responsibility for the quality, composition and correct labelling of their products. However, individual elite athletes must also take responsibility for the substances they consume, taking professional advice before using specialist products, and they should cease blaming industry as an easy scapegoat to hide their own transgressions.

  4.7  We hope that your Committee might promote acceptance of the different but equally important responsibilities of athletes and of industry.

5.  FALSE POSITIVES

  5.1  There is one specific area to which we also feel that elite sport might pay close attention in the future. That is the area of "false positives" which can arise in cases of alleged doping or substance abuse. By this we mean that there are certain situations in which a test might indicate that an athlete has consumed a banned substance when in fact this may not be the case. False positives may arise for a variety of different reasons.

  5.2  For example, 22% of women have or may have polycystic ovarian syndrome—this could cause naturally high levels of nandralone which would cause a positive test. Individuals with naturally elevated nandralone levels are more likely to be elite athletes because they may be stronger and able to build muscle faster.

  5.3  Nandrolone is an andogenic anabolic steroid, produced naturally by the body and ingestion or injection is considered a doping offence by WADA. Intense training can increase endogenous nandrolone production in the absence of oral consumption, with the possibility of a false positive (Kohler et al 2002[9]). Sports supplements are often used to help athletes increase training intensity and volume. This could lead to an athlete testing positive, even though nandrolone (and/or its precursors) have not been consumed (Kohler et al. 2002). It is also possible that consumption of some mineral supplements such as zinc could optimise the body's natural production of nandrolone also resulting in a false positive (Kohler et al. 2002). In these examples it could be argued that the use of sports supplements resulted in positive test, even though the products were devoid of nandrolone or its precursors or any other banned compounds. This presents a difficult situation for the athlete who tests positive, the companies who supply supplements that are free of steroid contaminants and WADA.

  5.4  Athletes can also test positive through inadvertent consumption of foods or supplements containing banned substances. Under well-controlled laboratory conditions consumption of boar meat produces a positive for nandrolone, as meat naturally contains nandrolone and its precursors (Le Bizec et al. 2000[10]). The consumption of poppy seed bagels (which naturally contain opiates) could also result in an athlete testing positive for morphine (Rohrig and Moore 2003[11]). Under strict liability the athlete is responsible for anything that is present in his body and would face a ban even though the positive test arose from consumption of common food products.

  5.5  It is clear that WADA testing laboratories need to work with athletes, supplement companies and food manufacturers to gain a clearer understanding of the physiological and biochemical conditions that increase nandrolone excretion. Without this understanding athletes will be falsely accused of doping and supplement manufacturers will be falsely accused of supplying contaminated products.

  5.6  So, false positives may again suggest that the problem of doping is in fact greater than is actually the case. Certainly, if such false positives do arise, they do a grave injustice to the individual athletes involved whose careers may be destroyed, as well as being damaging to the reputation of sport and of sports nutrition manufacturers.

  5.7  We hope that your Committee might consider recommending further research into the area of "false positives".

6.  WHAT CAN COMPANIES DO?

  6.1  Whilst we would stress the point that the problem of doping in elite sport must not be overblown, it is clear that there are issues, and any case of doping is a case too many.

  6.2  Cross-contamination and accidental contamination are sometimes cited as reasons why banned substances may be present in sports supplement products. ESSNA believes however that this is not the case today if it ever was. Indeed, it is possible for manufacturers to reduce the risk of cross-contamination to an almost incidental level by establishing rigorous control mechanisms into the supply chain and ensuring that reputable suppliers are used at all times.

  6.3  The Committee may wish to consider recommending that further studies be conducted in this area to ascertain whether such contamination does in fact really occur.

  6.4  With regard to contamination more broadly, companies that produce under FDA/HFMA Good Manufacturing Practice backed up by ISO 9001/2 are at much reduced risk of contamination. Accidental contamination is more likely to occur if companies do not follow these strict guidelines or production lines are not isolated or cleaned properly in-between batches. It is never possible to eliminate all risk but these and other similar steps can reduce it substantially.

  6.5  For those manufacturers who wish to market specifically to elite athletes there is always the option of introducing pharmaceutical standard batch testing, though this is not generally considered appropriate for food products aimed at the general market.

  6.6  ESSNA accepts that sports nutrition companies should adhere to codes of manufacturing practice. Our members are already working with individual Member States regulatory bodies, trade associations, and national governing bodies of sport as they develop their own guidance in this area. Such dialogue between industry, sporting bodies and regulators is vital in terms of identifying and examining practical solutions to this problem.

  6.7  Annex 4 to this paper includes examples of good manufacturing and testing practice used by some of our members.

  6.8  We hope that your Committee might feel able to commend the responsible steps that our members have taken.

7.  DIALOGUE WITH REGULATORS

  7.1  There is a tendency on the part of regulators to deal only with the larger trade bodies representing less specialist food product categories and which are not truly representative of the specialist sector.

  7.2  Whilst such trade associations clearly should be considered as stakeholders, the sports nutrition industry cannot be represented only by such large generalist trade associations (which tend to be dominated by soft drinks manufacturers). This is one of the reasons why ESSNA was set up, and in terms of communicating with the specialist market, engaging ESSNA from the outset must be seen as a priority. The solution to this problem lies in reaching out to the small and medium sized enterprises that may not have the resources to batch test all products and to apply the most stringent monitoring regimes. ESSNA acts as an important conduit to this group.

  7.3  Regulation has a key role to play. It can punish transgression and cajole businesses. However, the leadership which ESSNA and its member companies are showing can change cultures, bring about paradigm shifts, and develop a real commitment to improvements in practices throughout the specialist sector. Indeed, the specialist sector is uniquely positioned to help lead the development of solutions to doping issues. In this regard, we look forward to assessing the proposals that result from the current IADSA/IDSI project initiated at the 2005 Leipzig Conference.

  7.4  Industry has already done much by way of self-regulation, with examples highlighted in the short case studies appended to this statement. However, ESSNA does recognise that more can be done and we very much look forward to working with government, regulators and sports bodies who are taking this process forward.

  7.5  We hope that your Committee might feel able to acknowledge the role that ESSNA can play and encourage others fully to involve our members in their work to address problems of doping and/or contamination.

8.  FUTURE LEGISLATION

  8.1  The European Commission is committed in principle to bring forward more detailed legislation to regulate still further sports nutrition products, and it produced (20 April 2004) a Working Document of a Draft Commission Directive on Foods Intended to Meet the Expenditure of Intense Muscular Effort, Especially for Sports People (SANCO D4/HL/mm/D440182).

  8.2  ESSNA is not opposed in principle to additional proportionate legislation to create a harmonised market in sports nutrition products. However, we have registered with the European Commission a number of fundamental concerns about the proposed direction of this measure.

  8.3  The proposed legislation is based upon a review of specific areas of the science of sports nutrition which was included in a report by the Scientific Committee for Foods (SCF) in 2000. That report was some time in preparation, therefore the work that led to its publication was inevitably the review of scientific papers published sometime earlier and therefore relying on studies that are now several years old. The Committee may wish to consult with the scientists involved in preparing that SCF report to see if they themselves would consider it appropriate to revisit the project prior to the Commission bringing forward legislation.

  8.4  Furthermore, the sports nutrition market has developed substantially in recent years and some of the product categories that now exist, and for which there is strong evidence of safety and efficacy, were simply not envisaged at the time this work was undertaken.

  8.5  We would be keen to provide more detailed comment on the proposed legislation if this would be helpful. However, since the proposal is based upon an out-dated understanding of the market and upon science published now many years ago, not only is its detail in need of review, but also its scope and fundamental principles.

  8.6  We strongly believe that before the European Commission makes the mistake of bringing forward proposals based upon old science and an out-dated understanding of the marketplace, that would seriously and substantially impact upon small and medium sized enterprises as well as restricting consumer choice, it should be invited to consider:

(a)  undertaking an inventory through the Scientific Cooperation Procedure (SCOOP) of the products currently on the market; and

(b)  asking the European Food Safety Authority (EFSA) to review through its standard procedures the safety of the products identified.

  8.7  Having taken such steps, the European Commission, in order to avoid the sort of problems and controversy associated, for example, with the Food Supplements Directive, should:

(c)  ensure that any new legislation strikes the right balance between consumer safety and maintaining consumer access to safe, popular and effective products;

(d)  provide flexibility within the legislation for future product development and innovation in such a way that does not require ongoing amendments to the primary legislation; and

(e)  demonstrate an understanding of the differences between the needs of ordinary consumers and elite athletes, the latter of whom should look to their Governing bodies for detailed regulation.

  8.8  We do hope that your Committee might feel able to endorse these points if inappropriate legislation is to be avoided.

9.  CONCLUSION

  9.1  We hope that these introductory observations are helpful to you in your work and that you will not hesitate to invite us to provide further information on any of the points covered whether through further written submission or oral evidence.

ESSNA MEMBERSHIP:

Full members

EAS International

Garnell Corporation

MET RX (Europe)

Maximuscle

Twinlab Corporation

Weider Global Nutrition

CNP (UK) Ltd

Reflex Nutrition

LA Muscle

Tropicana Health and Fitness

Carbery

Associate Members

Weider Publishing (Europe)

Health Food Manufacturers Association (HFMA)

European Health Food Manufacturers Association (EHPM)

  After qualifying from medical school at Oxford, Adam when on to complete an MRC training Fellowship and become a member of the Royal College of Obstetricians and Gynaecologists. During his training he developed a sub-specialist interest in reproductive endocrinology and nutrition. He left the NHS eight years ago and for seven years was head of nutrition for the Rugby Football Union. He now manages a similar role for England Cricket and supports a number of other Olympic sports as well as having an active involvement in football. Adam has been the Chairman of ESSNA since December 2003.

  Maximuscle is Britain's largest sports nutrition brand and sell a complete range of products for serious and dedicated gym users, athletes and sports participants. Our reputation and unique range means we supply many of the biggest names in British sport across; rugby, football, cycling, bodybuilding and many more...

  With this comes an important responsibility, which is to ensure all our products are manufactured to the highest standards, whilst complying with the most stringent quality control checks. The list below provides you with a detailed summary of the processes we use to ensure our products meet the highest quality and safety:

  1.  Maximuscle tests the raw ingredients it uses in all of our products. We demand purity, authenticity and origin certificates. Where we are not 100% assured of the quality of these certificates, Maximuscle will perform independent tests on raw ingredients to confirm the above.

  2.  Maximuscle regularly visits and audits its manufacturing plants, to ensure compliance with either; HACCP, ISO9001, 9002 or GMP, whichever is most suitable for the type of products we are producing.

  3.  All finished batches are independently tested at Trading Standards approved labs, to ensure that the macro nutrients quantities (fat, carbs, protein, etc) are correct and what is on the label is in the bottle.

  4.  Every batch undergoes microbiological tests to ensure that there is no danger of heavy metal contamination or bacteria growth. All new batches of bars or perishable goods are shelf life tested before being released to the market place.

  5.  Maximuscle is the only company in the World to have each and every batch of products—  independently drug screened at HFL, (an approved WADA lab). This unique test, which Maximuscle uses, complies with ISO17025 (the same standard as used by the IOC) as well as being UKAS approved. This unique ISO17025 approved drug test screens each and every batch, to show that problematic stimulants and steroids are not present above an agreed de minimis level.

  6.  Maximuscle hold all Certificates of Analysis for all lot numbers.

  *The key to the success of Maximuscle's comprehensive drug screening is that we test each and every batch of all of our products, to ensure peace of mind for our customers. Unlike other brands we do not do random testing or use the IOC urine test. Although these are cheaper alternatives, they are not considered fool proof for the risks found within the supplement industry. The HFL tests have been developed specifically for sports nutrition products and are unique. Most importantly they are UKAS and ISO17025 approved, which is vital to ensure these tests are trusted by athletes.

MET-RX

Product Quality Assurance

  MET-Rx is committed to providing high quality nutritional supplements. Our products do not contain any banned substances. We do not use any ingredient which contravenes the current anti doping recommendations of WADA or UK Sport in any of our formulas, nor do we have any of these substances on the manufacturing premises.

  MET-Rx follows strict Good Manufacturing Practices. Our Quality Control, Quality Assurance and HACCP programs are internally and independently audited to ensure top quality products and that our performance measures are continually met.

  Our Quality Assurance professionals supervise manufacturing and packaging processes to ensure product integrity, purity and accuracy of contents. In-process Quality Control checks are performed at every stage of the manufacturing and packaging process to ensure that the end product is of the highest quality.

  All raw material suppliers are required to conform to our stringent product specification protocols and each batch of material is subjected to an extensive Quality Assurance programme:

—  We endeavour to conform to the United States Pharmacopoeia and National Formulary requirements, which are the industry standard for potency, quality, purity, and strength.

—  All raw materials are tested for identity.

—  All of our raw materials and finished goods are tested by our in-house chemistry laboratory for potency and purity and by our microbiological lab for purity.

—  Our Quality Control laboratory employs degreed and qualified chemists who test our products to ensure that they meet our stringent specifications for consistency and quality of product.

—  Quality testing is performed using USP/NF procedures, where they exist.

—  If a USP/NF procedure does not exist for a product, other published referenced works are consulted, such as the European Pharmacopoeia, etc.

—  If a published method does not exist, we have method development chemists on staff that develops procedures which are then proprietary to MET-Rx.

—  Our products are subjected to rigorous laboratory testing before, during and after manufacture, including analysis by HPLC, GC, FTIR, TLC, UV/ Spectrophotometry, wet analysis and Near Infrared Spectrophotometry.

EAS INTERNATIONAL

  EAS is the world's leading provider of active lifestyle nutrition products and is dedicated to producing products that have been sufficiently backed by scientific research both in their effectiveness and safety. EAS provides products that cater for a variety of people from regular gym users to elite athletes.

  EAS have strong ethical practices which have resulted in an excellent reputation throughout the globe in more then 46 countries. Many athletes, throughout the world, use EAS products with confidence that they are effective, safe and free from any banned substances.

Scientific Research

  EAS is committed to providing the marketplace with scientifically based dietary supplements. EAS support this by fostering a strong relationship with their science board, a group of ABBOTT and ROSS scientists and health professionals from around the world.

Food Safety

  EAS International products are only manufactured in facilities with the following certified manufacturing processes:

—  EN ISO 9001:2000.

—  HACCP (Hazard analysis Critical Control Points).

—  GMP (Good Manufacturing Practice).

—  IFS (International Food Standard).

Doping Free

  EAS International products which are considered to be for professional use, are additionally production lot tested for non IOC compliant substances and are considered to be "doping-free".

  Even though EAS has never come under question regarding their products containing banned substances, ensuring the purity and quality of products has demanded increased vigilance over suppliers, ingredients, equipment and production processes. EAS has even gone so far as to have their own products tested for banned substances before they are marketed and sold.

  EAS works with the most experienced sports testing lab in the EU. The laboratory is accredited for forensic testing for the World Anti-Doping Agency (WADA), who supports the efforts of the IAAF and FINA in effort to reduce doping in sports in general and regardless of sport. This laboratory and testing service used by EAS is currently the only one of its kind in the UK to be accredited by the United Kingdom Accreditation Service (UKAS) under ISO 17025, which is an internationally recognised quality standard for analytical testing.

  Sealed batch samples of all tested products are retained for the duration of the product shelf life. In the event that an athlete who has been taking an EAS guaranteed doping-free product returns a positive conducted in accordance with the World Anti-Doping Code, these sealed batch samples will be made available for independent testing to prove that the positive test was not due to that EAS product.

  To help provide that extra confirmation to athletes, EAS can provide them with Certificates of Analysis for all batches of tested products. In addition, to make things quick and easy, athletes can cross reference their product lot numbers with our online service at www.doping-free.com.

May 2006

9   Kohler et al (2002) Urine nandrolone metabolites: false positive doping test? Br J Sports Med. 36; 325-329. Back

10   Le Bizec et al (2000) Consequence of boar edible tissue consumption on urinary profiles of nandrolone metabolites. I Mass spectrophotometric detection and quantification of 19-norandrosterone and 19-noretiocholanolone in human urine. Rapid Commun Mass Spectrom. 14; 1058-1065. Back

11   Rohrig and Moore (2003) The determination of morphine in urine and oral fluid following ingestion of poppy seeds. J Anal Toxicol. 27; 449-452. Back