REVIEW OF EVIDENCE ON THE EFFECTS AND INTERNATIONAL REGULATION OF CAFFEINATED ENERGY DRINKS

Developed on behalf of Department of Health and Ageing by

ZEST Health Strategies

Final report

23 September 2011

CONTENTS

EXECUTIVE SUMMARY ...... 4 INTRODUCTION ...... 11 1.1 Caffeinated energy drinks and energy shots...... 11 1.2 Regulation of CEDs in Australia and New Zealand ...... 12 1.3 Regulation of energy shots in Australia and New Zealand ...... 13 1.4 Review of evidence about CEDs ...... 14 2. KEY DEFINITIONS ...... 16 3. METHODOLOGY ...... 18 3.1 Scope and key questions ...... 18 3.2 Information sources used in this review ...... 20 3.3 Search terms ...... 21 3.4 Appraisal of identified articles...... 21 4. IDENTIFIED LITERATURE ...... 23 4.1 Overview of identified literature ...... 23 5. Q1: NEGATIVE EFFECTS OF CAFFEINE IN CHILDREN, ADOLESCENTS AND ADULTS ...... 26 5.1 Summary of number and type of articles included ...... 26 5.2 Exposure to caffeine ...... 27 5.3 Exposure to caffeine from CEDs ...... 29 5.4 Effects of caffeine ...... 30 5.5 Incidence of negative effects of caffeine in children, adolescents and adults ...... 41 6. Q2: NEGATIVE EFFECTS OF OTHER COMMON INGREDIENTS OF CEDs ON CHILDREN, ADOLESCENTS AND ADULTS ...... 42 6.1 Summary of number and type of articles included ...... 42 6.2 Effects of individual ingredients CEDs ...... 43 6.3 Synergistic effects of caffeine with other ingredients in CEDs ...... 46 7. Q3: NEGATIVE EFFECTS OF CEDs ON CHILDREN, ADOLESCENTS AND ADULTS ...... 48 7.1 Summary of number and type of articles included ...... 48 7.2 Effects of CEDs ...... 49 7.3 CED overconsumption in Australia, New Zealand and overseas ...... 51 7.4 Issues/unanswered questions ...... 57 8. Q4: CHANGES IN CONSUMPTION OF CEDs AND DRIVERS OF CONSUMPTION ...... 59 8.1 Summary of number and type of articles included ...... 59 8.2 CED market worldwide ...... 60 8.3 CED market in Australia and New Zealand ...... 60 8.4 CED consumption patterns in Australia and New Zealand ...... 62 8.5 Reasons for consumption of CEDs ...... 64 8.6 Marketing strategies ...... 65

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9. Q5: CURRENT BI-NATIONAL AND INTERNATIONAL REGULATIONS REGARDING CEDs ...... 67 9.1 Summary of number and type of articles included ...... 67 9.2 Regulatory/self-regulatory approaches in Australia and New Zealand ...... 68 9.3 Regulatory approaches worldwide ...... 70 9.4 Self-regulation ...... 81 9.5 Company initiatives ...... 84 10. ISSUES AND UNANSWERED QUESTIONS ...... 85 11. CONCLUSIONS ...... 89 REFERENCES ...... 91 APPENDIX I: STANDARD 2.6.4 FORMULATED CAFFEINATED BEVERAGES ...... 99 APPENDIX II: MINISTERIAL POLICY GUIDELINE ON THE ADDITION OF CAFFEINE TO FOODS ...... 103 APPENDIX III: ABBREVIATIONS ...... 104 APPENDIX IV: SEARCH STRATEGY ...... 106 APPENDIX V: STAKEHOLDERS CONSULTED ...... 113 APPENDIX VI: CLAIMED CAFFEINE CONTENT OF ENERGY DRINKS AND ENERGY SHOTS AVAILABLE IN NEW ZEALAND, FEBRUARY 2010 ...... 114 APPENDIX VII: REGULATORY AND SELF-REGULATORY APPROACHES TO CEDs ...... 117 APPENDIX VIII: AUSTRALIAN AND NEW ZEALAND SELF-REGULATION GUIDELINES ...... 123

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EXECUTIVE SUMMARY This report provides a summary of available evidence to July 2011 relating to the effect of caffeinated energy drinks (CEDs) on children, adolescents and adults. The report also describes regulatory frameworks relating to CEDs in Australia and New Zealand and overseas. The report will be used to inform a review by the Australia and New Zealand Food Regulation Ministerial Council of the policy guideline that outlines principles and policy guidance for the addition of caffeine to food.

CEDs are non-alcoholic beverages that may contain ingredients such as water-soluble B vitamins, amino acids, glucuronolactone and caffeine and may enhance mental performance. They are regulated in Australia and New Zealand as formulated caffeinated beverages (FCBs) under Standard 2.6.4 of the Australia New Zealand Food Standards Code (the Code). Also discussed in this review are energy shots, which are small volume ‘energy’ liquid preparations with a higher per volume concentration of caffeine and other substances compared with CEDs.

Scope of review This review gathered evidence relating to five key questions. 1. What is the current state of evidence as to the negative effects of caffeine on children, adolescents and adults? 2. What is the current state of evidence as to the negative effects of ingredients such as taurine, ginseng, guarana, glucuronolactone and sugar that are commonly added to CEDs on children, adolescents and adults? 3. What is the current state of evidence as to the negative effects of CEDs on children, adolescents and adults? 4. How is consumption of CEDs changing, and what drivers influence consumption? 5. What are the current bi-national and international and regulations regarding CEDs?

The scope of the review did not extend to the issue of mixing alcohol and CEDs or vitamins as ingredients of CEDs. The search periods for the review varied according to the different questions. The review aimed to capture data from Australia, New Zealand and overseas; this was deemed particularly pertinent for questions relating to CED consumption patterns, the drivers behind increasing consumption, and international regulation of CEDs.

Identified literature – overview and limitations The literature search (which addressed questions 1 to 4) identified 127 articles; an additional search identified 11 articles related to caffeine and adverse pregnancy outcomes. Of these, 106 articles have been included in this review. These articles included government reports (n=10), review articles (n=21), original research articles (n=49), case reports (n=15) and other articles such as editorials and conference abstracts (n=7). In addition, information about regulations was sourced through personal communications with regulatory partners and key industry representatives, and via web-based portals for relevant agencies.

A limitation of this review is the variable quality of the available evidence. Only three meta- analyses/systematic reviews were identified, with six additional review articles providing only some detail regarding the methodology used and a further 12 reviews providing no information about the search strategies and selection criteria used (‘narrative reviews’). Although obvious shortfalls in methodology have been noted in the data extraction tables, a full critical appraisal of all articles was beyond the scope of this review. Several of the narrative reviews and commentaries commented on the same research articles and case reports.

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The original research articles typically reported on experimental studies (predominantly pre– post studies with either a randomised or non-randomised design). Several had small sample sizes (fewer than 50 subjects) or methodological limitations, thereby limiting their validity and potential for generalisation. The majority of reports of adverse effects relating to CEDs were based on case reports or cross-sectional surveys. While these are useful for generating hypotheses and identifying areas of concern, case reports and cross-sectional surveys cannot be used to establish causality.

In reviewing this report, it is also important to note that there are no universally accepted definitions for energy drinks, reflecting the considerable variation in the composition and regulation of these products around the world. This report uses the term ‘CEDs’ as an overarching term to describe these products, with the term ‘FCBs’ used to refer to products manufactured to Standard 2.6.4 Formulated Caffeinated Beverages in Australia and New Zealand. Moreover, a number of the review articles identified relating to CEDs were written from a US perspective. Differences in the regulatory environment between the US and Australia and New Zealand should be considered when interpreting the conclusions of the US-based reviews.

Effects of caffeine on children, adolescents and adults

Data on the physiological and psychological effects of caffeine suggest that caffeine is relatively safe in adults; however, it is unclear whether the data can be extrapolated from adults to children.

Caffeine occurs naturally in coffee, tea, cocoa, foods containing these ingredients and some medications. Caffeine may also be added to a range of beverages, including energy drinks, energy shots, cola-/kola-type soft drinks and alcoholic beverages.

Reports about safe limits of caffeine vary according to different authors and organisations. The European Commission Scientific Committee on Food stated in 1999 (and reaffirmed in 2003) that the contribution of ‘energy’ drinks to overall caffeine intake does not appear to be a matter of concern for non-pregnant adults.1,2 For children who do not normally consume much caffeine, the European Commission Scientific Committee on Food concluded that a caffeine dose of 5 mg/kg body weight/day could result in transient behavioural changes.1,2

There is currently no recognised reference health standard established for caffeine exposure, such as an Acceptable Daily Intake (ADI). No ADI has been established for caffeine because there is a lack of evidence of toxicity from relevant studies. Many of the effects from caffeine consumption would not be classed as adverse in a toxicological sense.

The New Zealand Food Safety Authority suggests an upper exposure of:  3 mg/kg bw/day (mg per kg of body weight per day) for adults as a conservative reference level based on limited evidence of acute anxiety effects;  2.5 mg/kg bw/day as a cautious toxicological limit on which to base risk assessments for children, based on limited evidence; and  200 mg/day for pregnant women based on recent evidence of foetal growth restriction.

A number of negative effects associated with caffeine were identified through this review. Some positive effects were also identified, although as this was not the primary focus of the current review and definitive conclusions cannot be made on the basis of the information identified.

The majority of literature suggests that in low-to-moderate amounts (60–400 mg/day), taken for example as repeated low doses in the diet during the day, caffeine ingestion can increase alertness and reduce fatigue and can improve performance on vigilance tasks and simple

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tasks requiring sustained response.3 Effects on more complex tasks appear to be more difficult to assess and probably involve interactions between caffeine and other variables that increase alertness, such as personality and time of day.

Regular consumption of caffeine has been shown to improve cognitive performance (i.e., simple reaction times, choice reaction time, incidental verbal memory and visuo-spatial reasoning).

Data on the physiological and neurobehavioural effects of caffeine suggest that caffeine is relatively safe in adults at moderate levels of consumption (300–400 mg/day).

A range of negative effects of caffeine were identified through this review. Common acute negative effects associated with stimulation of the central nervous system following caffeine ingestion include:  dizziness;  rapid heartbeat (tachycardia);  irritability;  anxiety;  tremors; and  insomnia.

The Food Standards Australia and New Zealand (FSANZ) Expert Working Group for Caffeine reported negative effects when very large amounts of caffeine are given or when caffeine exposure was investigated in sensitive groups (e.g. patients with anxiety disorders). Negative effects of caffeine at high doses (≥ 500 mg/day) are reported to include increased anxiety, impaired sleep and impaired fine motor control.3 Unfavourable subjective and somatic effects (e.g. tension, nervousness, anxiety, excitement, irritability, nausea, palpitations and restlessness) and performance disruption have been observed at caffeine doses of 500 mg/day.

However, the Expert Working Group reported that large population studies have failed to find a significant relationship between caffeine intake and anxiety disorders, possibly because people who suffer from anxiety may reduce their caffeine intake of their own volition. Moreover, anxiety in patients with anxiety disorders has not been demonstrated to be related to caffeine intake.

While information about effects of caffeine in pregnancy appears to be inconclusive, current guidelines recommend limiting intake to between 200 and 300 mg/day (exact amount varies depending on guidelines) due to the potential risk of restricted foetal growth, pre-term birth and miscarriage.4-6

Few studies of caffeine were identified that have been conducted in children older than one year or in adolescents.

Effects of individual ingredients of caffeinated energy drinks The identified reviews report that exposure to taurine, D-glucurono-ã-lactone, ginseng and guarana at the levels found in CEDs is not a safety concern.

Common ingredients of CEDs include taurine, D-glucurono-ã-lactone, ginseng, guarana and sugar.

A Scientific Opinion paper on the use of taurine and D-glucurono-ã-lactone as constituents of the so-called ‘energy’ drinks published by the European Food Safety Authority (EFSA)

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Panel on Food Additives and Nutrient Sources added to Food7 concluded that exposure to taurine and D-glucurono-ã-lactone at high exposure levels of 1.4 x 250mL cans per day for a 60 kg person is not a safety concern.

A systematic review of the effects of Panax ginseng as a supplement identified the most common side effects as being gastrointestinal or sleep-related but noted that monopreparations are rarely associated with adverse events or drug interactions and those documented are usually mild and reversible.8 The review identified that interactions between Panax ginseng and alcohol, warfarin and phenelzine may be possible. However, it is reported that the amounts of ginseng found in energy beverages are far below the amounts expected to deliver therapeutic benefits or cause adverse events.9

Little evidence was identified relating to the effects of guarana (or of the caffeine component of guarana specifically) in CEDs. One review9 reported that the amounts of guarana found in popular CEDs are below the amounts expected to deliver therapeutic benefits or cause adverse events. Although the review reported that some young adults have been admitted to emergency departments with overdoses of caffeine after overindulging in guarana-based energy beverages, it does not cite the original research for this claim or indicate whether the overdose was due to the additional caffeine in the guarana.

Concerns about the sugar content of CEDs stem from long-term health effects, such as development of obesity and insulin resistance. Few articles were identified that specifically discussed the effects of sugar as a component of CEDs, more commonly discussing the effects of sugar as a component of soda. For example, the FSANZ Expert Working Group for Caffeine report identified that excess consumption of soda is associated with poor diet, excess weight and dental caries.3

Effects of caffeinated energy drinks Limited comprehensive information, risk assessment data and peer-reviewed scientific research are available about the effects of CEDs.

While a number of review articles and case studies report on side effects of CEDs, uncertainty surrounding actual levels of caffeine in CEDs makes it difficult to interpret data on exposure to caffeine from CED consumption in articles reporting from overseas. Several of the reviews and articles identified in the literature review report cases of overconsumption and adverse reactions, as well as alleged fatalities related to CEDs. However, no high-quality scientific studies exist that clearly demonstrate a link between CED exposure and fatalities. Those that have been reported should be viewed with caution. A full critical appraisal is required before a judgement can be made on the quality of these reviews and articles.

Interpretation of the available data is complicated further by the fact that the stringency of regulations for CEDs in different countries varies and therefore the caffeine content of CEDs referred to in different reports may not be consistent or entirely clear.

Regardless of these findings, preliminary data from calls to poisons information centres in Australia and New Zealand indicate that reports of CED overconsumption are increasing, particularly in adolescents.

A number of the articles identified in this review call for further research into the effects of CEDs, including effects in populations such as children and adolescents and pregnant women, as well as research about effects of CEDs when consumed with alcohol and recreational drugs. It is apparent from the literature reviewed that a full risk assessment of the ingredients of CEDs and their interactions is likely to require a concerted international approach.

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Consumption patterns and drivers of consumption Consumption of CEDs is increasing. Globally, sales of CEDs (by volume) almost doubled between 2003 and 2008, with growth averaging 14% per year. In 2008, CED sales were 3.9 billion litres per year.

In Australia, CED sales were 157.7 million litres in 2010. This is forecast to increase by 52% in the next 5 years to 240.3 million litres in 2015 (ABC, personal communication, September 2011).

Drivers for consumption of caffeinated energy drinks Limited up-to-date data on CED consumption and patterns of consumption are available for Australia and New Zealand. Information from industry suggests that:  the majority of CED consumption occurs during the day;  CEDs are consumed primarily as a ‘pick me up’ or energy boost to help people stay focused and achieve during the day; and  historically, use of sports drinks and CEDs has been quite different, with sports drinks chosen for hydration and consumed before or after sports/activity, whereas CEDs have been selected for an energy boost and to improve focus; this distinction may be changing. Many beverage manufacturers appear to use cross-promotional tactics to reach consumers, integrating their product with extreme sporting events and advertising with music icons. Products are often given names that are defiant to appeal to their young market.

Information about drivers for consumption appears to be drawn mainly from self-report surveys, typically of college students in the US. One survey of 253 US college students showed that insufficient sleep (67%), increased energy (65%), and drinking with alcohol while partying (54%) were the main reasons for consuming CEDs.

The regulatory environment The key characteristic of the regulatory environment for CEDs is its global variability with varying degrees of specificity and prescription. A continuum exists from minimalist requirements through to dedicated and detailed legislation; there is no apparent determinant as to where various countries may sit along this continuum.

This variability is reflected amongst our regulatory partners of the UK, the US and Canada, and in the EU. The Australia New Zealand joint standard is seen as one of the most restrictive regimes in the world, whereas the EU and US provide far more lenient arrangements. Canada is currently conducting a review of energy drinks and has yet to announce its final recommendations and legislative approach.

With respect to labelling, the requirement for declaration of caffeine presence is almost universal but does not always require quantitative declaration. The requirement for advisory statements varies considerably. However, the advice provided does not. Marked similarities are found in the type of advice being given, in particular in respect of unsuitability for pregnant women, persons sensitive to caffeine, and children (although ages for suitability vary from 12 to 18 years, or are not stipulated). Such labelling requirements are sometimes found in legislation, but more typically in voluntary guidance either from governments or industry.

Energy drinks and/or energy shots may be deemed to be foods (beverages), drugs, or what is effectively an intermediary group such as dietary supplements or natural health products. While caffeine is always covered by the respective legislation, most typically in its chemical

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form as a food additive, herbal sources of caffeine such as guarana or yerba mate are not always explicitly addressed. Most typically, energy drinks are regulated as foods, whereas energy shots may come under dietary supplement type laws.

Underpinning this variability lies the lack of a globally recognised definition for ‘energy drinks’. As there is also no set definition for a ‘beverage’, it is not always clear in the literature whether energy shots are included as energy drinks or treated differently. Whilst Australia and New Zealand have, by virtue of Standard 2.6.4, a definition for FCBs, this term or definition is not universal.

One commonality exists in respect to cola beverages versus energy drinks and the caffeine limits used as regulatory differentiators. Typically, cola beverages (or other caffeinated non- alcoholic carbonated beverages if permitted) contain up to 145 or 150 mg caffeine/L, whereas CEDs contain caffeine in excess of this. Some countries then provide upper caffeine limits for CEDs (e.g. 320 mg/L) whereas many do not. Industry also provides a commitment to an upper limit of 160 mg caffeine/shot. This therefore identifies energy ‘shots’ as more concentrated than energy ‘drinks’.

Management of CEDs appears to have emerged, and be emerging, in an ad hoc way. It is difficult to identify the pre-determining risk assessments and/or policies that may have guided regulators’ decisions. Governments have instituted a variety of laws or other provisions; whilst industry, as represented here by beverage manufacturers and/or their umbrella organisations, has responded with significant self-regulatory activity in this space, which often goes above and beyond domestic legislation.

The material covered is not exhaustive, but is sufficiently comprehensive to draw a picture of approaches being taken globally for the risk-management of CEDs including energy shots. There are a number of areas that would benefit from further investigation, specifically, government policies, regulatory approaches to guarana, definitions for CEDs and consumer perceptions and uses of ‘shots’, other novel dietary sources of caffeine, and the contribution of self-regulatory initiatives by industry to the overall risk management of CEDs.

Issues/unanswered questions Many issues and unanswered questions relating to effects of CEDs and their ingredients, consumption patterns, marketing, and regulatory frameworks have been identified throughout this review. Some of these issues reflect evidence gaps; others are areas where conflicting opinions and data exist.

There is currently a lack of comprehensive information, risk-assessment data and peer- reviewed scientific research relating to the alleged negative (and positive) effects of CEDs.4 Research is needed to establish an adverse effect level for CEDs.6

In order to establish CED exposure, more information is needed about the levels of caffeine in CEDs. Limited independently verified data exist relating to the caffeine levels in both energy drinks and energy shots for sale in Australia and New Zealand.6 Moreover, only limited data exist on the physiological and behavioural effects of the combined ingredients of CEDs. Further information is needed to determine whether ingredients have synergistic effects.4

Information and data relating to effects of caffeine in children is inadequate and firm conclusions cannot be made about caffeine’s potential to produce long-term negative health effects at different dose levels.3

Further research is also warranted into the effects of chronic use and chronic overconsumption, and effects in at-risk populations (e.g. children, those with pre-existing medical conditions, and those who consume CEDs during and after exercise).

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The lack of quantitative and qualitative data about CED consumption patterns makes interpretation of levels of risk at a population level difficult. Further information about consumption patterns (e.g. who is consuming CEDs, at what time of day are CEDs being consumed, where are CEDs being consumed) would be useful.6

Tracking of negative health effects related to CED exposure is currently difficult owing to the lack of a specific code for CEDs. Calls to poisons information centres reporting overconsumption of CEDs are currently coded under caffeine.

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INTRODUCTION

Key points

 Caffeinated energy drinks (CEDs) are non-alcoholic beverages that contain caffeine and other ingredients such as water-soluble B vitamins, amino acids, glucuronolactone and caffeine; some of these ingredients are claimed to enhance mental performance.  Energy shots are small volume energy liquid preparations with a higher per volume concentration of caffeine and other substances compared with CEDs.  CEDs are regulated in Australia and New Zealand as formulated caffeinated beverages (FCBs) under Standard 2.6.4 of the Australia New Zealand Food Standards Code.  Regulations relating to production of energy shots differ between Australia and New Zealand.  There are no universally accepted definitions for energy drinks, shots and beverages. This reflects the considerable variation in the composition and regulation of CEDs around the world. This report uses the term ‘CEDs’ as an overarching term to describe both energy drinks and energy shots as a category. The term energy drink or energy shot has been retained when this term was used specifically by the author of a review or report.  Consumption of CEDs has increased in recent years in Australia and New Zealand, mirroring worldwide trends.  This report provides a summary of available evidence to July 2011 relating to the effect of CEDs on children, adolescents and adults. It also describes regulatory frameworks relating to CEDs in Australia, New Zealand and overseas.  This report will be used to inform a review by the Australia and New Zealand Food Regulation Ministerial Council of the guidelines that outline principles and policy guidance for the addition of caffeine to food.

1.1 Caffeinated energy drinks and energy shots Caffeinated energy drinks (CEDs) are non-alcoholic beverages that contain caffeine and other ingredients such as water-soluble B vitamins, amino acids, glucuronolactone and caffeine; some of these ingredients are claimed to enhance mental performance.

CEDs are commonly referred to as ‘energy drinks’. The main active ingredient of CEDs is caffeine, which is added as pure caffeine and/or as guarana, a herbal source of caffeine.

Energy shots are small volume ‘energy’ liquid preparations with a higher per volume concentration of caffeine and other substances compared with CEDs.

Consumption of CEDs has increased in recent years in Australia and New Zealand, mirroring worldwide trends. Nearly 500 new brands were launched worldwide in 2006. Since 2006, the CED market has grown by an estimated 32% worldwide, bringing the value of the market to $36 billion in 2010. The growth in CED sales is reported to be due to targeted marketing and to consumers being attracted to the various health benefit claims made by many of the CEDs.10

Although the full impact of the rise in popularity of CEDs has yet to be realised, the potential for adverse health consequences with excessive consumption, long-term chronic

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consumption, and consumption by certain at-risk populations should be considered and may be cause for preemptive action. Concern surrounding the caffeine content of CEDs relates to the potential adverse consequences of caffeine use. Adverse effects of caffeine are described in Section 5 of this report. Deaths, allegedly due to CED ingestion, have been reported in Australia, Ireland and Sweden.11-13 However, there has been debate as to whether these fatalities can be attributed to CED consumption.14

Caffeine content of CEDs According to the current Australian and New Zealand Standard, formulated caffeinated beverages (FCBs) must contain no less than 145 mg/L and no more than 320 mg/L of caffeine.15 Most domestic product contains the maximum permitted amount of 80 mg in 250mL cans.

Energy shots are marketed as dietary supplements and not as refreshment beverages. These small-volume products (usually up to 100 mL) typically contain the same amount of caffeine as up to two standard FCBs (i.e. a single energy shot contains the same amount of caffeine as 2 x 250 mL cans of an FCB or 1 x 500 mL can of FCB containing 80 mg caffeine/250 mL). The Australian Beverages Council Energy Shot Code recommends its members limit the quantity of caffeine per single shot serve to these levels, with a daily maximum of 200 mg caffeine.16

1.2 Regulation of CEDs in Australia and New Zealand In Australia and New Zealand, CEDs are regulated as formulated caffeinated beverages (FCBs) under Standard 2.6.4 (Formulated Caffeinated Beverages) of the Australia New Zealand Food Standards Code.15 Enforcement and interpretation of the Food Standards Code is the responsibility of state/territory departments and food agencies within Australia and New Zealand.

Food-related regulatory framework in Australia and New Zealand  Policy o The Australia and New Zealand Food Regulation Ministerial Council (the Ministerial Council), is responsible for development of domestic food regulatory policy and policy guidelines for setting domestic food standards. The Ministerial Council has the capacity to adopt, amend or reject standards and to request that standards be reviewed. o The Food Regulation Standing Committee (FRSC) is responsible for coordinating policy advice to the Ministerial Council.

 Standards setting o Food Standards Australia and New Zealand (FSANZ) is a bi-national government agency whose primary responsibility is to develop and administer the Australia New Zealand Food Standards Code (the Code), which lists requirements for foods such as additives, food safety, labelling and genetically modified foods.

 Regulation o Regulation is the responsibility of various state and territory agencies in Australia and New Zealand.

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Standard 2.6.4 was introduced in 2001 by the Australia and New Zealand Food Authority (ANZFA, now known as Food Standards Australia and New Zealand (FSANZ)) following an application from Red Bull to ANZFA to develop appropriate regulatory provisions for CEDs within the Food Standards Code. At the time, few CEDs were on the market.

In setting Standard 2.6.4, the maximum one-day quantities for substances such as caffeine and taurine were based on a safety assessment and the composition of the product to which the application was referring, that is, Red Bull (see Appendix I for full details of Standard 2.6.4). Further details on the regulatory environment for CEDs in Australia and New Zealand are provided in Section 9.

In 2003, the Australia and New Zealand Food Regulation Ministerial Council (the Ministerial Council) issued a Policy Guideline on the Addition of Caffeine to Foods.17 (Appendix II) The purpose of the guideline was to ensure that FSANZ considers the principle of limiting exposure of vulnerable individuals to foods containing caffeine when considering issues relating to the addition of caffeine to foods.

1.3 Regulation of energy shots in Australia and New Zealand Regulations relating to production of energy shots differ between Australia and New Zealand. There are currently no specific provisions in the Code for energy shots. However, energy shots are for sale in Australia having been imported from New Zealand as dietary supplements. A brief overview is provided below; the specific regulatory arrangements are discussed in detail in Section 9.

New Zealand In New Zealand, energy shots had up until 2010 been manufactured under the New Zealand Dietary Supplement Regulations 1985 (NZDSR) and marketed as ‘dietary supplements’. The NZDSR required products to be labelled as such. Since 31 March 2010 energy shots have been regulated under the new New Zealand Supplemented Food Standard 2010,18 which seeks to align requirements for supplemented foods with the requirements of the Standard 2.6.4, where possible. The Supplemented Food Standard has a 2-year transition period to allow manufacturers and suppliers to comply with the new requirements.

Prior to the introduction of the Supplemented Food Standard, energy shots marketed as ‘dietary supplements’ were required to include caffeine in the ingredient list. However, the amount of caffeine did not have to be listed and advisory statements were not required.6 Since the introduction of the Supplemented Food Standard on in 2010, caffeine must be listed in the ingredient list and, if the energy shot contains more than 145 mg/L of added caffeine, the level of caffeine and the advisory statements that apply to FCBs under Standard 2.6.4 of the Code must be included on the label.

Australia In Australia, energy shots manufactured under the NZDSR have been imported from New Zealand by way of the Trans-Tasman Mutual Recognition Arrangement (TTMRA) and marketed as dietary supplements.

The regulatory status of energy shots manufactured in Australia is less clear than in New Zealand. Some products listed previously on the Australian Register of Therapeutic Goods (ARTG) and marketed as therapeutic goods have been de-listed by the Therapeutic Goods Administration (TGA). De-listing from the ARTG does not necessarily mean that these energy shots revert to a food and are covered by Standard 2.6.4.

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1.4 Review of evidence about CEDs The aim of this review is to summarise the evidence and regulations about CEDs in Australia and New Zealand to inform a review by the Australia and New Zealand Food Regulation Ministerial Council of the policy guideline that outlines principles and policy guidance for the addition of caffeine to food.

Aims of the review Since the release of the Policy Guideline on the Addition of Caffeine to Foods in 2003,17 the presence of caffeine in the food supply has changed substantially. The number of products containing caffeine, and in some cases the level of caffeine in products, has increased.

In December 2010, in response to community concern about CEDs, the Ministerial Council tasked the FRSC with scoping activity to be used to provide advice to the Ministerial Council on areas for action with regard to CEDs.19 In May 2011, the Ministerial Council requested the FRSC undertake a review of the Policy Guideline on the addition of caffeine to food.

In June 2011, the Department of Health and Ageing, on behalf of FRSC, commissioned a consolidated report into the evidence surrounding CEDs, including:  effects of caffeine on children, adolescents and adults, the levels at which consumption becomes harmful, and the potential harms associated with caffeine  the incidence of negative effects of caffeine in children, adolescents and adults  the effects on children, adolescents and adults of ingredients such as sugar, taurine, guarana, glucuronolactone and ginseng that are commonly added to CEDs, and the levels at which they become harmful, and any synergistic effects  reports of potential harms associated with CEDs  demographic trend data, consumption patterns and social drivers for use of CEDs, including effects of marketing of CEDs  a review of current international regulatory frameworks relating to CEDs.

Project team This review was commissioned and overseen by the Food Policy Section of the Research, Regulation and Food Branch of the Australian Government Department of Health and Ageing.

Content for the review was developed by:  ZEST Health Strategies: a healthcare communications agency working with Government and non-profit healthcare groups in Australia.  Food Standards Australia New Zealand (FSANZ).

A multidisciplinary Project Reference Group, consisting of representatives from a number of jurisdictions including New Zealand, as well as FSANZ and the National Health and Medical Research Council (NHMRC), was convened to provide feedback and comment at key stages during the development of the review. In particular, the group provided input into the preliminary assessment of the literature and external review of the draft report.

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Organisation of the review This report describes the methods used to gather, review and synthesise literature on the effect of CEDs in children, adolescents and adults. It starts by establishing what is known about the risks associated with caffeine (the main active ingredient in CEDs), and describes CEDs and their ingredients. The report also reviews and summarises the international regulations and self-regulatory activities by industry relating to CEDs.

Additional information is provided in the appendices. Appendix III lists all abbreviations used in the report; Appendix IV details the full search strategy used to develop the report.

Notes on interpretation of this review

Terminology The terms ‘energy drinks’, ‘energy shots’, ‘energy beverages’ and ‘caffeinated energy drinks’ are used indiscriminately by different authors. There are no universally accepted definitions for these terms. This reflects the considerable variation in the composition and regulation of CEDs around the world. This report uses the term ‘caffeinated energy drinks’ as an overarching term to describe both energy drinks and energy shots as a category. The term energy drink or energy shot has been retained when this term was used specifically by the author of a review or report.

‘Formulated caffeinated beverages’ is a specific term used in Australia and New Zealand to refer to products manufactured to Standard 2.6.4 Formulated Caffeinated Beverages. This report uses the term ‘formulated caffeinated beverages’ when describing products in relation to Standard 2.6.4. The term formulated caffeinated beverages, and Standard 2.6.4, do not cover energy shots.

Caffeine doses and standard body weights for adults and children Recommendations on caffeine doses are often specified for a particular body weight, for example a 60 kg adult or a 30 kg child. This review reports the doses and body weights as specified in the original research articles or guidelines.

Quality of evidence The quality of evidence identified through this review is variable. A note on how the quality of the information identified has been assessed is provided in Section 4.

Regulatory environment

A number of the review articles identified relating to CEDs were written from a US perspective. Differences in the regulatory environment between the US and Australia and New Zealand should be considered when interpreting the conclusions of the US-based reviews.

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2. KEY DEFINITIONS

Term Definition

Caffeine An adenosine receptor antagonist that acts as a stimulant that can influence the activity of neuronal control pathways in the central and peripheral nervous systems. Caffeine is naturally found in tea and coffee and is added to other beverages and foods. It is produced commercially either by extraction from plant material or by synthesis.

Energy drink* A beverage containing added caffeine, vitamins and other bioactive substances marketed in retail units typically between 250 mL and 600 mL.*

Energy shot* A small-volume (typically 60–100 mL) liquid product containing added caffeine, vitamins and other bioactive substances.*

Formulated A non-alcoholic water-based flavoured beverage which contains caffeinated caffeine and may contain carbohydrates, amino acids, vitamins and beverage (FCB) other substances, including other foods, for the purpose of enhancing mental performance.

Ginseng Panax ginseng is a perennial herb native to Korea and China that has been used as a herbal remedy in eastern Asia for thousands of years. It is a popular dietary supplement purported to have a number of health benefits.

Glucuronolactone D-glucurono-γ-lactone is a normal human metabolite formed from glucose. It is a naturally occurring substance produced in small amounts within the body. Dietary supplementation with D-glucarates, including glucuronolactone, is popular owing to the belief that it may aid the body’s natural defence mechanism for eliminating carcinogens.

Guarana Guarana (also known as guaranine, Paullinia cupana and Sapindaceae) is a rainforest vine domesticated in the Amazon for its caffeine-rich fruits and used by the Amazonians to increase awareness and energy. Its seeds contain more caffeine than any other plant, with levels ranging from 2% to 8%; guarana also contains the stimulants theobromine and theophylline.

Sports drink* A non-alcoholic beverage especially formulated to meet the nutritional needs of sports people. Sports drinks may contain carbohydrates, minerals, electrolytes and flavoring. Traditionally they have not contained caffeine, although this situation may be changing. Composition may vary significantly according to brand. Their purpose is to replenish water and electrolytes lost through sweating during exercise.*

Stimulant drink The Safefood Ireland 2002 report defines ‘stimulant drinks’ as ‘beverages, which typically contain caffeine, taurine and vitamin(s), and may contain an energy source (e.g. carbohydrate), and/or other substance(s), marketed for the specific purpose of providing real or perceived enhanced physiological and/or performance effects’.4

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Term Definition

Taurine Taurine is the most abundant intracellular amino acid in humans. It is involved in neuromodulation and modulation of intracellular calcium levels. Taurine occurs naturally in food, especially in seafood and meat, and it is a normal metabolite in humans. Taurine has been seen to enhance endurance performance and to aid in reduction of lactic acid build up after exercise.

* Definition used for the purpose of this report.

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3. METHODOLOGY

Key points  The scope of this review, including key questions and the approach to sourcing information, was agreed in consultation with the Food Policy Section of the Research, Regulation and Food Branch of the Australian Government Department of Health and Ageing.  This report gathered evidence relating to five key questions: 1. What is the current state of evidence as to the negative effects of caffeine on children, adolescents and adults? 2. What is the current state of evidence as to the negative effects of ingredients such as taurine, ginseng, guarana, glucuronolactone and sugar that are commonly added to CEDs on children, adolescents and adults? 3. What is the current state of evidence as to the negative effects of CEDs on children, adolescents and adults? 4. How is consumption of CEDs changing, and what drivers influence consumption? 5. What are the current international regulations regarding CEDs?  The scope of the review did not extend to the issue of mixing alcohol and CEDs.  The search periods for the review varied according to the different questions.

3.1 Scope and key questions This review gathered evidence relating to five key questions and aimed to capture data from Australia, New Zealand and overseas. Overseas data were considered particularly pertinent for questions relating to CED consumption patterns, drivers behind increasing consumption, and international regulation of CEDs.

The rationale and potential implications for each question are provided in Table 1. The scope of the review did not extend to mixing alcohol and CEDs. The issue of mixing CEDs with alcohol has been referred to the Ministerial Council on Drug Strategy, which tasked the Intergovernmental Committee on Drugs (IGCD) with developing a plan for responding to the issue of mixing alcohol with CEDs.

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Table 1: Rationale and potential implications for research questions

Question Rationale Section of report Q1. What is the current  Provides background and contextual information. Section 5 state of evidence as to  The 2003 Policy Guideline on the Addition of the negative effects of Caffeine to Food17 aims to limit exposure of caffeine? vulnerable individuals to food containing caffeine. The guideline states that, until further evidence is available, the current status quo regarding caffeine regulation in Australia and New Zealand should be maintained.  The current report will be considered by the FRSC in reviewing the Policy Guideline; any draft changes to the Policy Guideline will be presented to the Ministerial Council for possible endorsement. Q2. What is the current  Standard 2.6.4 sets the standards on composition Section 6 state of evidence as to and labelling of FCBs. The Standard was drafted the negative effects of in 2001 at a time when there were relatively few ingredients (such as FCBs on the market. taurine, ginseng,  The current report may assist in determining guarana, whether Standard 2.6.4 needs to be revised. glucuronolactone and sugar) that are  The report may also highlight a need to improve commonly added to consumer awareness of these ingredients and of CEDs on children, the benefits or harms associated with them. adolescents and adults? Q3. What is the current  The Policy Guideline on the Addition of Caffeine Section 7 state of evidence as to to Food endeavours to limit the possible adverse the negative effects of effects of caffeine containing foods on vulnerable CEDs on children, populations. adolescents and adults?  The information gathered may help the FRSC assess whether the current Policy Guideline’s advisory statements on FCBs are in alignment with scientifically substantiated risk to vulnerable sub-groups of the population.  The current report may assist the FRSC in the review of the Policy Guideline and its advice to the Ministerial Council. Q4. How is consumption  The Policy Guideline on the Addition of Caffeine Section 8 of CEDs changing, and to Food states that caffeine additions to individual what drivers influence foods need to be viewed in the context of the total consumption? diet and that possible adverse effects of caffeine- containing foods should endeavour to be limited in vulnerable sub-groups of the population.  The current report may help the FRSC in determining whether there is a need for specific population groups to have access to information that will allow them to make informed choices with regard to CEDs.

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Question Rationale Section of report  The information gathered may also assist the Ministerial Council in deciding whether the drivers influencing consumption need to be more closely monitored and taken into account when setting policy. Q5. What are the current  Regulation of CEDs varies internationally. This Section 9 bi-national and may or may not impact on CED consumption in international regulations different populations. regarding CEDs?  Comparable markets internationally have adopted different approaches to regulating CEDs, and the CED industry has adopted various self- regulatory approaches towards responsible marketing and management of CEDs.  The 2003 Policy Guideline on the Addition of Caffeine to Food aims to ensure that industry innovation and competitiveness is supported, except where public health and safety are affected.  The current report may assist the FRSC in their review of the Policy Guideline and whether current domestic regulation needs to be revised.

3.2 Information sources used in this review

Databases Databases searched included:  MEDLINE (via Ovid);  PsycINFO;  Google Scholar; and  Cochrane Database of Systematic Reviews.

Grey literature Database searches were supplemented by searching of national and international food regulation websites, conference websites, Australian and New Zealand national and jurisdictional health departments, services and organisations such as FSANZ, NSW Food Authority, and the NHMRC. Full details of the websites searched are provided in Appendix IV.

Government databases Government databases containing information such as hospital presentations and state poisons information were accessed where possible.

Consultation In addition to the searches, discussions were held with representatives from Poisons Information Centres in New South Wales, Queensland, Western Australia and Victoria, as well as the NHMRC, FSANZ, jurisdictional contacts from Australia and New Zealand and industry representatives (see Appendix V for a list of jurisdictional contacts consulted).

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3.3 Search terms For reference databases, Medical Subject Heading (MeSH) terms were used where available, or key words when appropriate. Search terms included: energy drink; energy beverage; formulated caffeinated energy beverage; caffeinated energy drink; energy shot; caffeine; ginseng; taurine; guarana; glucuronolactone; sugar; pregnancy; adverse effects; contraindications; pharmacology; psychology; physiology; behavior; and consumption.

The search periods and rationale for these timeframes are detailed in Table 2. The full search strategy of exact search strings is detailed in Appendix IV.

Table 2: Search periods used in this review

Question Search Rationale period Q1. What is the current state of evidence as to the negative effects of caffeine?  General search January 2010 Aim to identify key publications to June 2011 since the FSANZ Expert Working Group for Caffeine report into the safety aspects of dietary caffeine 3 in 2000)

 Caffeine and adverse effects in January 2008 Aim to identify key publications pregnancy to August since the 2008 Foods Standards 2011 Agency COT Statement of the reproductive effects of caffeine Q2. What is the current state of January 1990 No key publications for additional evidence as to the negative effects of to June 2011 ingredients were identified as ingredients (such as taurine, ginseng, having been published in the last guarana, glucuronolactone and sugar) 2–3 years and so it was decided to that are commonly added to CEDs on extend the search back to 1990. children, adolescents and adults? Q3. What is the current state of January 2001 2001 was when Standard 2.6.4 evidence as to the negative effects of to June 2011 was introduced in 2001 following CEDs on children, adolescents and an application from Red Bull to adults? ANZFA Q4. How is consumption of CEDs changing, and what drivers influence consumption? Q5. What are the current bi-national and international regulations regarding CEDs?

3.4 Appraisal of identified articles The initial literature selection was based on the paper title. If this was deemed relevant, the abstract or full paper was reviewed.

Publications were considered for inclusion if they addressed at least one of the research questions. Articles addressing community concerns regarding CEDs were also included.

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Papers had to be in English and a full paper available. Conference abstracts were followed up but only included if a full report was found.

Publications that dealt specifically with sports drinks (as opposed to CEDs) were excluded, as were those into the effects of CEDs in combination with alcohol.

Electronic searches were supplemented with hand searches of the reference lists of included articles where necessary.

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4. IDENTIFIED LITERATURE

Key points

 The literature review identified 127 articles relevant to questions 1–4; an additional search relating to effects of caffeine in pregnancy identified an additional 11 references. Of these, 106 articles were included in this review.  Identified articles included government reports (n=10), review articles (n=21), original research articles (n=53), case reports (n=15) and other articles such as editorials and conference abstracts (n=7). In addition, information about regulations was sourced through personal communications with regulatory partners and key industry representatives, and via web-based portals for relevant agencies.  Only three meta-analyses/systematic reviews were identified, with six additional review articles providing only some detail regarding the methodology used and a further 12 reviews providing no information about the search strategies and selection criteria used (‘narrative reviews’). The lack of information relating to the methodology used in these reviews limits their use.  Although any obvious shortfalls in methodology have been noted in the data extraction tables, a full critical appraisal of all articles was beyond the scope of this review. In addition it should be noted that several of the narrative reviews and commentaries commented on the same research articles and case reports.  Fifteen case studies reporting individual responses to caffeine, CEDs or their ingredients were also identified. A number of these were also referred to within the identified reviews.  Information relating to question 5 on current bi-national and international regulation s was sourced primarily from personal communications with regulatory partners and key industry representatives, and through web-based portals for relevant agencies in Australia, New Zealand, the EU, US and Canada. See Section 9 for further information.

4.1 Overview of identified literature The literature review identified 127 articles relevant to questions 1–4; an additional search relating to effects of caffeine in pregnancy identified an additional 11 references. Of these, 106 articles were included in this review.

Review of the articles After an initial review of the identified articles, the articles were grouped according to relevance to the research question and the quality of evidence that could be ascribed to each study type. The most commonly identified study types are described in Table 3, grouped by article type and listed in order of the quality of evidence attributed to the study. Results for each of the key questions are described in Sections 5–9 of the report.

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Table 3: Study/article types identified in the review, listed in order of attributed quality of evidence within study type categories

Study/article type Description No. of articles Review articles Systematic review A literature review focused on a single question that aims to identify, appraise, select and synthesis all high-quality evidence relevant to that question. 2 Systematic reviews use explicit methods to identify, select, and critically evaluate relevant research. Meta-analysis A systematic review that combines the results of 1 several studies using quantitative statistics. Review A review of literature that has been undertaken systematically (for example the search criteria, 6 search period and selection criteria have been explicitly specified). Narrative review A review of literature that has not been undertaken systematically (for example the search criteria, 12 search period and selection criteria may not be explicitly specified). Their use is therefore limited. Editorial/opinion Commentary from an expert regarding a particular pieces topic. May include reference to published literature 5 but typically represents an individual viewpoint. Government report Government report While government reports used a range of methods to identify and appraise evidence, it is assumed that some degree of rigour and consensus review was 10 applied to the appraisal process in order to make policy recommendations. The quality of evidence in such documents has therefore been rated highly. Original research articles

Randomised A study in which subjects are randomly assigned to controlled trial a control or experimental group, with a comparison 0 (RCT) made at the end of the study. An RCT is considered the ‘gold standard’ of clinical research.

Cohort study A cohort study is an analytical study in which individuals with differing exposures to a suspected factor are identified and then observed for the 6 occurrence of certain health effects over some period.

Case control study A study in which the risk factors of people with a certain disease (cases) are compared with those 1 without the disease (controls).

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Study/article type Description No. of articles

Pre–post study A study that examines whether participants in an intervention improve or become worse-off during the course of the intervention, and then attributes any such improvement or deterioration to the intervention. Pre–post studies can be controlled (i.e. 36 a control group is included in the study) or uncontrolled. Such studies may be useful in hypothesis generation but have limited use in ascribing causality.

Cross-sectional Studies that collect data on one occasion only from a 10 surveys single population.

Case study/case report/case series

Case reports and A description of a single case or groups of cases. case series When higher level of evidence is absent, findings of case series studies can be used to generate 15 hypotheses for further research. Little consensus exists as to how to appraise the quality of case series and reports.

Review articles Of the 106 articles included in the data extraction tables, 21 were review articles. If no methodology was given, the reviews were classified as being narrative reviews, i.e. the conclusions drawn may be based on the opinions of the authors rather than from a systematic appraisal and synthesis of the evidence. Although any obvious shortfalls in the authors’ methodology were noted in the data extraction tables, a full critical appraisal of all articles was beyond the scope of this review.

Of the reviews identified, one was a meta-analysis (into caffeine and the adverse effects in pregnancy,20 one was a Cochrane Review into caffeine and pregnancy outcomes, and one a systematic review of ginseng.8

The remaining review articles were either reviews (methodology stated) or narrative reviews that did not explicitly report on the search strategies and selection criteria used. Several of the narrative reviews and commentaries commented on the same research articles and case reports.

Original research articles Of the experimental studies (RCTs and pre–post studies), several had small sample sizes (fewer than 50 subjects) or methodological limitations, thereby limiting their generalisability and validity.

The majority of the reports of adverse effects relating to CEDs were based on case reports or cross-sectional surveys. While these are useful for hypothesis generation and for identifying areas of concern, case reports and cross-sectional surveys cannot usually be used to establish causality.

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5. Q1: NEGATIVE EFFECTS OF CAFFEINE IN CHILDREN, ADOLESCENTS AND ADULTS

Key points

 This review identified little high-quality evidence in addition to that summarised in the FSANZ Expert Working Group for Caffeine report into the safety aspects of dietary caffeine and 2010 New Zealand Food Safety Authority document Risk Profile: Caffeine in Energy Drinks and Energy Shots.3,6  There is currently no recognised reference health standard established for caffeine exposure, such as an Acceptable Daily Intake (ADI).  Caffeine intake has been associated with a range of positive and negative effects, with stimulant effects seen at low–moderate doses (60–400 mg/day) and more pronounced effects (e.g. increased anxiety, impaired sleep) seen at doses above 500 mg/day.  While both negative and positive effects of caffeine have been reported; the positive effects of caffeine were not the primary focus of the current review and therefore definitive conclusions cannot be made on the basis of the information identified.  Information about effects of caffeine in pregnancy are inconclusive; current guidelines recommend limiting intake to between 200 and 300 mg/day (exact amount varies depending on guidelines) due to the potential risk of restricted foetal growth, pre-term birth and miscarriage.4-6  Data on the physiological and neurobehavioural effects of caffeine suggest that caffeine is relatively safe in at moderate levels of consumption (300–400 mg/day);3,6 however, it is unclear whether the data can be extrapolated from adults to children. Few studies of caffeine have been conducted in children older than one year or in adolescents.3

5.1 Summary of number and type of articles included

Key articles Evidence in this section is drawn predominantly from six reports that include information about the effects of caffeine:  FSANZ Expert Working Group for Caffeine report into the safety aspects of dietary caffeine;3  2010 New Zealand Food Safety Authority document Risk Profile: Caffeine in Energy Drinks and Energy Shots;6  a report by the Stimulant Drinks Committee established by the Food Safety Promotion Board in Ireland in response to a request from the Minister of State at the Department of Health and Children for external research into the health effects of CEDs;4 and  reports from the European Commission Scientific Committee on Food about caffeine, in CEDs.1,2,7

These reviews provide evidence relating to the physiological and psychological effects of caffeine in adults, including its effects on cognitive function, mood and physical performance.

In addition, information about exposure to caffeine in Australia was drawn from the 2007 Australian National Children’s Nutrition and Physical Activity Survey.21

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Other relevant articles A further 10 articles were identified that provide information about effects of caffeine:  five original research articles describe physiological effects of caffeine;22-27 these studies typically involved fewer than 20 people;  one case report by the Adverse Drug Reactions Advisory Committee (ADRAC) reported on the possible contribution caffeine played in the death of a 25-year-old female with valvular heart disease;27  one narrative review investigated caffeine use in children;28 the methodology and search criteria for this review were not reported;  two reviews provided information about side effects of caffeine;9,29 these reviews provided no new information and only one (Higgins) provided details about the search methodology and criteria used; and  one review discussed the effect of ginseng, ephedrine and caffeine on cognitive performance, mood and energy;30 this review did not describe the search methodology and criteria used.

An additional literature search produced 11 articles relevant to caffeine and adverse pregnancy outcomes:  one meta-analysis;20  one government report;5  one Cochrane review;31  one review article;32 and  seven original research articles.33-39

5.2 Exposure to caffeine Caffeine occurs naturally in coffee, tea, cocoa, foods containing these ingredients and some medications.

Key information sources  Data on exposure to caffeine is taken from the New Zealand Risk Profile: caffeine in energy drinks and energy shots.6  Information about dose response and safe limits of caffeine exposure is from the Expert Working Group for Caffeine report.3

Mechanism of action Caffeine acts as an adenosine receptor blocker in the brain. Caffeine has a similar chemical structure to adenosine allowing caffeine to attach to the adenosine receptors. Blockage of adenosine to the neurons causes the sleep promoting effects of adenosine to stop, resulting in the neurons speeding up instead of slowing down. Caffeine is also known to increase the secretion of epinephrine, which can lead to a variety of secondary metabolic changes that can positively affect physical or mental performance.

Caffeine content of different food groups The New Zealand Risk Profile grouped caffeine-containing foods into nine categories. Major contributing foods for each population group were calculated by summing the caffeine exposure (mg/day) from each food across all consumers in each population group and

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expressing that sum as a percentage of total caffeine exposure for that population group. The relative contributions of these food groups are shown in Table 4.6

Table 4: Percentage contributions of caffeine-containing foods to caffeine dietary exposure for different population groups6

% contribution by age group Young Older Children Teenager males Adults people Females 16–44 Food 5–12 13–15 15–19 19–24 20–64* 65+ 16–44* pregnant Biscuits, cakes, 11 6 1 <1 <1 <1 <1 1 pastries Cereal <1 <1 <1 <1 <1 <1 <1 <1 Chocolate 1 <1 <1 <1 <1 <1 <1 <1 desserts Chocolate confect- 6 4 1 <1 <1 <1 <1 1 ionery Cocoa & chocolate 7 4 1 1 <1 <1 1 <1 drinks Coffee 10 23 73 83 75 61 76 57 Energy 2 3 <1 1 <1 <1 <1 <1 drinks Soft drinks 30 32 13 10 3 0 3 2 Tea 32 29 10 5 20 38 19 39 Food groups contributing 10 or more percent to total caffeine exposure are bolded; * excluding pregnant women. Caffeine may also be added to a range of beverages including energy drinks, energy shots, cola/kola-type soft drinks and alcoholic beverages.

The New Zealand Risk Profile identified that:6  for children (aged 5–12 years) and younger teenagers (aged 13–15 years), caffeine exposure was mostly from tea and kola-type soft drinks with a lesser contribution from coffee; and  for older teenagers (aged 15–19 years) and adults, coffee was the major contributor to caffeine exposure followed by tea.

The FSANZ Expert Working Group for Caffeine report provided definitions of ‘low’, ‘medium’ and ‘high’ doses of caffeine (Table 5).

Table 5: FSANZ Expert Working Group for Caffeine report’s definitions of low, moderate and high doses of caffeine3

Dose level Intake range Dose for a 70 kg adult Low 80–250 mg/day 1.1–3.5 mg/kg bw/day Medium 300–400 mg/day 4–6 mg/kg bw/day High >500 mg/day 7 mg/kg bw/day

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The Expert Working Group for Caffeine report identified that, generally, individuals consume caffeine in a small dose range over the course of a day, with caffeine predominately consumed early in the day and consumption reducing later in the day. In addition, adults often self-regulate their caffeine intake according to its effect on their sleep patterns.3

5.3 Exposure to caffeine from CEDs Some information about caffeine exposure from CEDs is available for Australia and New Zealand. Some information is also available relating to caffeine exposure from overseas. However, owing to the different regulatory environments overseas (with regard to placing limits on levels of caffeine, labelling information, and enforcing any regulations) a level of uncertainty exists as to the actual levels of caffeine in CEDs. This makes it difficult to interpret data on exposure to caffeine from CED consumption in articles reporting from overseas.

Key information sources  Information about baseline exposure to caffeine, estimated caffeine exposure from consuming CEDs in New Zealand, and the impact of CED consumption on caffeine exposure is drawn from the comprehensive 2010 New Zealand Risk Profile.6  Information about exposure in Australia is from the 2007 Australian National Children’s Nutrition and Physical Activity Survey.21

Baseline exposure to caffeine The New Zealand Risk Profile estimated baseline dietary exposure to caffeine (including coffee, tea, chocolate, kola-type soft drinks and any foods containing these ingredients) for seven New Zealand population groups.

About 2–38% of New Zealand caffeine consumers were estimated to have a baseline dietary caffeine exposure above an effect level of 3 mg/kg bw/day, depending on population group.

The 2007 Australian National Children’s Nutrition and Physical Activity Survey found that estimated caffeine intake was low in the youngest children (those aged 2–8 years) but increased in the 14–16 year olds to a mean of 47 mg for boys and 36 mg for girls.

Caffeine exposure from CEDs The New Zealand Risk Profile identified that retail units of energy drink range from 250 to 600 mL, resulting in caffeine exposures of 75–240 mg caffeine per retail unit consumed.6

The document also identified that energy shots range from 30 to 120 mL, resulting in exposures of 10–300 mg caffeine per retail unit consumed.6

Estimated caffeine exposure following consumption of energy drinks or energy shots was calculated for New Zealand children (5–12 yrs), teenagers (13–19 yrs) and young males (19– 24 yrs). It was found that approximately 70% of children and 40% of teenagers who consume caffeine may exceed an effect level of 3 mg/kg bw/day after consuming a single retail unit of an energy drink or energy shot.6

The authors note that that the effect level identified is based on limited studies. The risk profile notes that negative effects (e.g. headaches and irritability) are relatively quick to subside. There was no suggestion of long-term problems.6 In presenting their findings, the authors noted significant areas of uncertainty and gaps in available data.

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Issues/unanswered questions  Data from the New Zealand NNS Survey (1997) and the Australian National Nutrition Survey (1995) are now dated. Consumption choices, amounts and available products are likely to have changed over this period, introducing a level of uncertainty in the baseline dietary exposure assessments.6  In 2009 a survey of CEDs in NSW by the NSW Food Authority found that of the 70 CEDs identified as being subject to Standard 2.6.4, 77% had caffeine levels above the maximum set by the Standard.40 A follow-up survey in 2010 found that the majority of these CEDs were now compliant or had been taken off the market. Many countries have less stringent regulations than Australia and New Zealand, and in countries that do have regulations, it is unclear how stringently these are enforced. The uncertainty that exists as to the actual levels of caffeine in CEDs should be borne in mind when interpreting data on exposure to caffeine from CED consumption in articles reporting from overseas.

5.4 Effects of caffeine Caffeine intake has been associated with a range of negative and positive effects and benefits.

Key information sources  Much of the recent data on effects of caffeine is taken from the New Zealand Risk Profile: caffeine in energy drinks and energy shots6 and the Expert Working Group for Caffeine report.3

A number of negative effects associated with caffeine were identified through this review. Some positive effects were also identified, although as this was not the primary focus of the current review and definitive conclusions cannot be made on the basis of such information.

Information about effects of caffeine in pregnancy is inconclusive; however a number of countries have issued advice to pregnant women to limit their caffeine intake.

Furthermore, few studies of caffeine have been conducted in children older than one year or in adolescents.

Safe limits of caffeine No ADI has been established for caffeine because there is a lack of evidence of toxicity from relevant studies. Many of the effects from caffeine consumption would not be classed as adverse in a toxicological sense.

Reports about safe limits of caffeine vary according to different authors and organisations. A summary of safe limits listed in reports identified in this review is provided in Table 6.

The European Commission Scientific Committee on Food stated in 1999 (and reaffirmed in 2003) that the contribution of energy drinks to overall caffeine intake does not appear to be a matter of concern for non-pregnant adults.1,2

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Table 6: Summary of findings in relation to safe limits of caffeine exposure

Population Safe limit Author Adults ≤ 400 mg/day Heckman (2010) citing 2003 Equivalent to 6 mg/kg bw/day for a review by Bureau of Chemical 65 kg person Safety, Food Directorate, Health Canada29,41 3 mg/kg bw/day New Zealand Risk Profile6 (conservative reference based on limited evidence of acute anxiety effects) Children Upper exposure of 2.5 mg/kg bw/day as New Zealand Risk Profile6 a cautious toxicological limit on which to base risk assessments (based on limited evidence) <5 mg/kg bw/day European Commission Scientific 1,2,7 (based on dose found to increase Committee on Food arousal, irritability, nervousness or anxiety in some children, particularly low consumers of caffeine) Pregnant 200 mg/day New Zealand Risk Profile6 women (based on recent evidence of foetal UK Committee On Toxicity Of growth restriction) Chemicals In Food, Consumer Products And The Environment (COT) Statement on the Reproductive Effects of Caffeine5

Dose response to caffeine Dose–response effects of caffeine are described in the FSANZ Expert Working Group for Caffeine report,3 which concluded that:  the relationship between caffeine dose and physiological response is continuous down to the lowest levels studied (although these effects are increasingly subtle as dosage is reduced); and  it is likely that caffeine causes subtle effects even at very low dose levels.

A ‘no effect’ level was not identified. The effects of caffeine identified at different low doses included:  enhancement of performance and mood effects at doses of 37.5 mg (0.54 mg/kg bw/day in 70 kg adults);  increased anxiety levels at 210 mg in adults (3 mg/kg bw/day in 70 kg adults); and  reduced ability to sleep at doses of 100 mg (1.4 mg/kg bw/day in 70 kg adults) at bedtime.

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Positive effects of caffeine

Key information sources  Positive effects of caffeine are taken from the 2000 Expert Working Group for Caffeine report.3  Information about benefits of caffeine has been taken from a narrative review by Heckman et al. (2010).29 The Heckman narrative review focuses on the positive effects of caffeine and the methodology and search criteria for this article are not presented.

Note: This current review did not seek explicitly to identify benefits of caffeine exposure and therefore definitive conclusions cannot be drawn.

The majority of literature suggests that in adults caffeine has stimulant effects at low-to- moderate amounts (e.g. 60–400 mg/day) (assuming repeated, low doses in the diet during the day).3 Stimulant effects include:  increased alertness and reduced fatigue (as defined by measurable behavioural effects); and  improved performance on vigilance tasks and simple tasks that require sustained response.

Effects on more complex tasks appear to be more difficult to assess and probably involve interactions between the caffeine and other variables that increase alertness, such as personality and time of day.

Regular consumption of caffeine has been shown to improve cognitive performance (i.e. reaction times, incidental verbal memory and visuo-spatial reasoning).

The narrative review by Heckman also reported that:29  caffeine has been shown to reduce some of the negative side effects associated with sleep loss;  some studies suggest that caffeine can contribute to improved alertness and performance at doses of 75 to 150 mg after acute sleep loss and doses of 200 to 600 mg after a night or more without sleep; and  caffeine has a stimulatory effect on thermogenesis and caffeine consumption has been linked to reduced food intake and to promote lipolysis in both animals and humans.

Negative effects of caffeine

Key information sources  The New Zealand Risk Profile: caffeine in energy drinks and energy shots.6  A review in 2008 by Clauson et al. 2008 published by the American Pharmacists Association.14,42  The Safefood review conducted for the Food Safety Promotion Board in Ireland.4

A range of negative effects of caffeine were identified through this review.

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Common acute negative effects associated with stimulation of the central nervous system following caffeine ingestion include:  dizziness;  rapid heartbeat (tachycardia);  irritability;  anxiety;  tremors; and  insomnia.

The review by Clauson et al. in 2008 reports that a number of these effects (insomnia, nervousness, headache and tachycardia) are the most commonly reported events seen following ingestion of caffeine at the quantities present in most CEDs.42 Further information about some of the negative effects that have been associated with caffeine is provided in Table 7. It is important to note that this table reflects information identified through this review only and should not be interpreted as a definitive list of all negative effects of caffeine.

Table 7: Summary of negative effects associated with caffeine ingestion identified through this review

Negative Detail Source effect Gastrointestinal  Diarrhoea New Zealand Risk 6 system  Nausea Profile dysfunction  Vomiting Cardiovascular  Single high doses of caffeine can affect the FSANZ Expert system cardiovascular system causing rapid heartbeat Working Group for dysfunctions and high blood pressure Caffeine3  Little evidence that caffeine in typical dosages consumed in the diet contributes to hypertensive disease  Precise link between caffeine contributing to cardiovascular disease has not been established  Risk of high blood pressure associated with caffeine consumption may be higher in certain genotypes and in individuals with reduced liver function  Tolerance to effects on blood pressure and heart rate (but not to sleep disturbance) develop quickly and virtually completely  High acute intakes of caffeine (4–6 mg/kg body Safefood review4 mass, or 300–400 mg for average 70 kg male) are associated with tachycardia and acute increases in blood pressure  Longer-term risks of caffeine in relation to cardiovascular disease are less clear and evidence for an association of habitual caffeine intake with increased blood pressure is conflicting

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Negative Detail Source effect  Given that increased blood pressure is a known risk factor for heart disease and stroke, they report that individuals with high blood pressure are generally advised to reduce their caffeine consumption Calcium  Caffeine intake is associated with a slight FSANZ Expert balance deterioration in calcium balance, particularly if Working Group for calcium intake is low. Caffeine3 Cancer  Limited evidence for caffeine as a carcinogen, FSANZ Expert but results are inconsistent and not conclusive Working Group for Caffeine3

Negative effects of higher doses of caffeine (≥ 500 mg/day) in sensitive groups The FSANZ Expert Working Group for Caffeine reported negative effects when very large amounts of caffeine are given or when caffeine exposure was investigated in sensitive groups (e.g. patients with anxiety disorders).

Negative effects of caffeine at high doses (≥ 500 mg/day) are reported to include:3  increased anxiety;  impaired sleep;  impaired fine motor control (may be related to increased anxiety); and  unfavourable subjective and somatic effects (such as tension, nervousness, anxiety, excitement, irritability, nausea, palpitations and restlessness) and performance.

However, the Expert Working Group for Caffeine reported that large population studies have failed to find a significant relationship between caffeine intake and anxiety disorders, possibly because people who suffer from anxiety may reduce their caffeine intake of their own volition. Moreover, anxiety in patients with anxiety disorders has not been demonstrated to be related to caffeine intake.

Withdrawal and dependency in adults The FSANZ Expert Working Group for Caffeine3 concluded that:  caffeine withdrawal has few effects on performance;  at doses typically consumed in the diet, caffeine withdrawal may lead to withdrawal effects and some physical dependence in adults; the prevalence of such effects is variable, and the intensity of withdrawal effects is minimal in most individuals;  there is often an increase in negative mood following withdrawal of caffeine but such effects may largely reflect the expectancies of the volunteers and the lack of blinded studies; and  withdrawal symptoms usually include tiredness, weakness, headaches, nausea and flu-like feelings; even short periods of caffeine deprivation have been associated with decreased vigour, increased fatigue, increased sleepiness and yawning and lower blood pressure and unpleasant effects by the middle of the day.

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Issues/unanswered questions  The basis for observed positive effects of caffeine when consumed regularly/habitually at low doses is controversial; some reports suggest that caffeine merely removes negative effects associated with caffeine withdrawal.3 Recent studies have failed to resolve this issue. Further studies are needed in caffeine naïve individuals to clarify the effects of caffeine at low doses.

Pregnancy and caffeine

Key information sources  The UK Committee On Toxicity Of Chemicals In Food, Consumer Products And The Environment (COT) Statement on the Reproductive Effects of Caffeine (2008).5  A 2010 meta-analysis by Maslova into caffeine consumption during pregnancy and risk of preterm birth.20  A 2010 Cochrane Review into the effects of restricted caffeine intake by mother on foetal, neonatal and pregnancy outcomes.14 31

Methylxanthines such as caffeine readily pass through the placenta barrier and enter all tissues. Caffeine may therefore affect the foetus/newborn at any time during pregnancy.

Some authors of observational studies have concluded that caffeine intake is harmful to the foetus, causing growth restriction, reduced birth weight, preterm birth or stillbirth. These reports have led to the conclusion that pregnant women are an ‘at risk’ subgroup of the population who may require specific advice on moderating their daily caffeine intake.

A 2010 Cochrane review into the effects of restricted caffeine intake by mothers on foetal, neonatal and pregnancy outcome31 found insufficient evidence to confirm or refute the effectiveness of caffeine avoidance on birth weight or other pregnancy outcomes, including foetal hypoxia, foetal tachycardia and arrhythmias, foetal growth restriction, stillbirth and miscarriage. Findings from the Cochrane review were based on only one randomised controlled trial that met the inclusion criteria. The authors concluded that there is a need to conduct high-quality, double-blinded RCTs to determine whether caffeine has any effect on pregnancy outcome.31

Specific pregnancy outcomes In 2008, the UK Foods Standards Agency Committee On Toxicity Of Chemicals In Food, Consumer Products And The Environment (COT) Statement on the Reproductive Effects of Caffeine stated that it is not possible to identify a threshold level of caffeine intake below which there is no elevation of risk, although it is likely that risk increases with intakes of about 200 mg/day.5

The COT statement concluded that caffeine intake during pregnancy is associated with an increased risk of foetal growth restriction (FGR), and that there was a positive association between caffeine intake and miscarriage. However, it concluded that data on caffeine consumption during pregnancy and association with other adverse effects such as pre-term birth and congenital malformations are inconclusive.

Further evidence relating to the effects of caffeine on adverse pregnancy outcomes is provided by several large cohort studies and a meta-analysis.

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 In 2010, a meta-analysis by Maslova and colleagues into caffeine and pre-term birth found no important association between caffeine intake during pregnancy and the risk of preterm birth.20  In 2010, a large cohort study (n=2643)concluded that greater caffeine intake is associated with increases in late miscarriage and stillbirth.35 In contrast, a smaller cohort study (n=113) concluded caffeine consumption did not increase the risk of miscarriage even after adjusting for confounders.36  Two large cohort studies in 2008 (n=2635) and 2010 (n=7346) concluded that caffeine consumption during pregnancy was associated with an increased risk of FGR.

In 2011, a risk analysis of in utero caffeine exposure using human epidemiological studies and animal studies dealing with congenital malformation, pregnancy loss, and weight reduction concluded that dietary exposures of caffeine are not teratogenic nor are they directly responsible for an increased risk of miscarriage or FGR restriction. The authors concluded that major advances in risk estimates have not been made and confounding phenomena continue to be present in caffeine studies. It is still not known whether the increased risk estimates for some developmental and reproductive effects at higher exposures are due to caffeine or are due to other confounding factors.32

A summary of the evidence identified through the current review relating to specific pregnancy outcomes is summarised in Table 8.

Table 8: Summary of effects of caffeine ingestion on pregnancy identified through this review

Effect Detail Author Pre-term birth  A 2010 meta-analysis of cohort and case control Maslova et al., studies published between 1966 and 2010. The 201020 meta-analysis concluded that no important association existed between caffeine intake during pregnancy and the risk of preterm birth for either the cohort or the case-control studies.  UK Committee On Toxicity Of Chemicals In Food, Foods Standards Consumer Products And The Environment (COT) Agency Statement on the Reproductive Effects of Committee on Caffeine (2008) concluded that data on caffeine Toxicity of consumption during pregnancy and associations Chemicals in with other adverse effects such as pre-term birth Food Consumer are inconclusive. Products and the Environment, 20085 Miscarriage and  UK Committee On Toxicity Of Chemicals In Food, Foods Standards stillbirth Consumer Products And The Environment (COT) Agency Statement on the Reproductive Effects of Committee on Caffeine (2008) concluded a positive association Toxicity of of caffeine intake with miscarriage. Chemicals in  Flagged uncertainties about possible recall bias Food Consumer and confounding factors. Products and the Environment, 20085

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Effect Detail Author Miscarriage and  Cohort study 2003–2006 (n=2643) concluded Greenwood et al., stillbirth (cont’d) greater caffeine intake is associated with 201035 increases in late miscarriage and stillbirth.  Women whose pregnancies resulted in late miscarriage or stillbirth had higher caffeine intakes (geometric mean = 145 mg/day; 95% CI: 85–249) than those with live births (103 mg/day; 95% CI: 98–108). Compared to those consuming <100 mg/day, odds ratios increased to 2.2 (95% CI: 0.7–7.1) for 100–199 mg/day, 1.7 (0.4–7.1) for 200–299 mg/day, and 5.1 (1.6–16.4) for 300+ mg/day (Ptrend = 0.004).  Prospective cohort study (n=113) concluded Pollack et al. caffeine consumption did not increase the risk of 201036 miscarriage even after adjusting for confounders.

Foetal growth  UK Committee On Toxicity Of Chemicals In Food, Foods Standards restriction (FGR) Consumer Products And The Environment (COT) Agency Statement on the Reproductive Effects of Committee on Caffeine (2008) concluded that caffeine intake Toxicity of during pregnancy is associated with an increased Chemicals in risk of foetal growth restriction and that, despite Food Consumer some uncertainty, it was prudent to assume this Products and the relationship was causal. Environment, 20085  Population-based prospective cohort study 2001– Bakker et al., 2005 in the Netherlands (n=7346) concluded that 201033 caffeine intake of ≥ 6 units/day (1 unit = 90 mg caffeine) during pregnancy is associated with impaired foetal length growth.  Caffeine exposure might preferentially adversely affect foetal skeletal growth.  Prospective longitudinal observational study CARE Study (n=2635) concluded that caffeine consumption Group, 200838 during pregnancy was associated with an increased risk of foetal growth restriction, which continued throughout pregnancy (OR 1.2 (95% CI 0.9 to 1.6) for 100–199 mg/day, 1.5 (1.1–2.1) for 200–299 mg/day, and 1.4 (1.0–2.0) for >300 mg/day compared with <100 mg/day; test for trend P<0.001). High blood  Population-based prospective cohort study 2001– Bakker et al., pressure 2005 in the Netherlands (n=7890) concluded no 201134 evidence of significant adverse association of caffeine intake on maternal cardiovascular adaptations during pregnancy.

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Effect Detail Author Teratogenic  UK Committee On Toxicity Of Chemicals In Food, Foods Standards effects Consumer Products And The Environment (COT) Agency Statement on the Reproductive Effects of Committee on Caffeine (2008) concluded that data on caffeine Toxicity of consumption during pregnancy and associations Chemicals in with other adverse effects such as congenital Food Consumer malformations are inconclusive. Products and the Environment, 20085 Inattention/  The Norwegian Mother and Child Cohort Study Bekkhus et al. overactivity (MoBa), a prospective cohort study (n= 25,343) 201037 investigated the association between intrauterine exposure to caffeine and subsequent inattention/overactivity in children at age 18 months. The study concluded there was a small effect of caffeine intake at 17th week of gestation on inattention/overactivity combined, and both 17th and 30th week of gestation on overactivity, when investigated separately from inattention. Surprisingly, the caffeine effect was only found for soft drinks, not with tea or coffee. General  2011 risk analysis of in utero caffeine exposure Brent et al. pregnancy using human epidemiological studies and animal 201132 outcomes studies dealing with congenital malformation, pregnancy loss, and weight reduction concluded that dietary exposures of caffeine are not teratogenic nor are they directly responsible for an increased risk of miscarriage or foetal growth restriction.  Major advances in risk estimates have not been made and confounding phenomena continue to be present in caffeine studies. It is still not known whether the increased risk estimates for some developmental and reproductive effects at higher exposures are due to caffeine or are due to other confounding factors.

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Guidelines for caffeine use in pregnancy The review identified a number of different guidelines and recommendations relating to caffeine use in pregnancy.  UK Committee On Toxicity Of Chemicals In Food, Consumer Products And The Environment (COT) Statement on the Reproductive Effects of Caffeine (2008) concluded that, based on current evidence, it is not possible to identify a threshold level of caffeine intake below which there is no elevation of risk, although it is likely that risk increases with intakes of about 200 mg/day (perhaps lower).5 The committee advised pregnant women to limit their daily caffeine intake to 200 mg/day.  Health Canada recommends a maximum caffeine exposure of 300 mg, or a little more than two cups of coffee per day.43  The New Zealand Ministry of Health Food and Nutrition Guidelines for Healthy Pregnant and Breastfeeding Women advises pregnant and breastfeeding women to limit caffeine consumption to 300 mg per day. Breastfeeding women should consider their caffeine intake if the infant is irritable or wakeful.44  In the Republic of Ireland the Food Safety Authority of Ireland (FSAI) recommends that excess consumption of caffeine (in excess of 300 mg per day) during pregnancy should be discouraged.4  The American College of Obstetricians and Gynaecologists (ACOG) stated in 2010 that moderate caffeine consumption (<200 mg/day) does not appear to be a major contributing factor in miscarriage or preterm birth and that a final conclusion could not be made at this time as to whether there is a correlation between high caffeine intake and miscarriage.45

Effects of caffeine in children and adolescents

Key information sources  Data on effects of caffeine in children is drawn from the FSANZ Expert Working Group for Caffeine report.3  Some information has also been drawn from the Safefood 2002 report.4

Few studies have been performed into the effects of caffeine in children and adolescents, resulting in insufficient evidence from which to draw conclusions. Reports identified through this review highlight that it is unclear whether data from adults can be extrapolated to children.

In addition to children having lower body weights, childhood and adolescence are periods of rapid growth and brain development. It is therefore unclear what the physiological and psychological effects of caffeine may be in children and adolescents.

Negative effects of caffeine in children Very few studies of caffeine have been conducted in children older than 1 year or in adolescents.3 The FSANZ Expert Working Group for Caffeine reported that:  caffeine increases anxiety levels in children at doses of 95 mg (3 mg/kg bw/day in children aged 5–12 years with a mean bodyweight of 32 kg);  caffeine use disrupts sleep patterns in children; and  moderate to high doses of caffeine (approximately 100–400 mg for a child) increase nervousness, jitteriness and fidgetiness in children and adolescents.3

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The Safefood review stated that there are conflicting data on the effects of caffeine in children:4  one study found that single doses of caffeine up to 10 mg/kg body mass in children have been shown to have either no effect or small, inconsistent effects on mood, behavioural, cognitive and motor functions; and  other studies indicate that a dose of 5 mg/kg body mass (equivalent to 150 mg caffeine per day, or 4–5 cans of a cola drink for a 10-year-old, 30 kg child) can increase arousal, irritability, nervousness or anxiety in some children, particularly low consumers of caffeine.

Long-term health effects of caffeine during childhood The FSANZ Expert Working Group for Caffeine3 stated that at the time of publishing the report in 2000, it was not possible to conclude that patterns of caffeine consumption established early in life can contribute to negative long-term health outcomes in children. However, the report postulated that:  childhood and adolescence may be a critical period for the establishment of eating patterns and taste preferences;  if caffeine (in combination with sugar) enhances preferences for sweet foods and beverages, this may contribute to excess energy intake and increased risk for overweight and obesity in adulthood (see Section 6 for more information on effects of caffeine in combination with sugar); and  if it is assumed that caffeine use in childhood lays the foundations for life-long use, there may be some grounds for concern that the consumption of caffeine-containing substances by children could be considered undesirable.

The narrative review by Temple discussed evidence from animal studies that indicate that caffeine can prime the brain to increase its responsiveness to subsequent drug exposure, thereby potentiating the reinforcing effects of drugs, such as tobacco. It has been suggested that children and adolescents may be particularly vulnerable to these effects, as their brains are still undergoing development; in particular areas of the brain involved in executive function, impulsivity control, and planning.28

Issues/unanswered questions  Chronic effects in children: No studies have been reported for potential chronic effects of caffeine consumption by children.  Threshold dose for behavioural effects in children: The FSANZ Expert Working Group for Caffeine concluded that the threshold dose for possible behavioural effects in children was unclear and that further studies are needed to elucidate the potential effects of caffeine in children at doses that may be ingested from dietary sources.3  Effects on behaviour and health: The FSANZ Expert Working Group for Caffeine concluded that the literature relating to effects of caffeine in children was inadequate to provide firm conclusions about the effects of caffeine on behaviour in children and its potential to produce long term adverse health effects at different dose levels.3  Withdrawal and dependency: The FSANZ Expert Working Group for Caffeine concluded that further research will be required at doses typically consumed in the diet to examine whether withdrawal effects and physical dependency occurs in children.3  Addiction: If early caffeine use is a significant risk factor for later drug use (e.g. tobacco), there is a need to better understand this relationship in order to increase

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awareness of long-term consequences of early caffeine use.28  Conditioning: It is unclear whether the relatively moderate amount of caffeine consumed by most children and adolescents is sufficient to condition a taste preference for novel-flavoured beverages and, if a taste preference is conditioned for beverages containing added sugar, whether children also prefer foods with added sugar.28 o Studies are needed examining whether early childhood consumption of sodas containing caffeine conditions a taste preference for sugary foods and/or promotes the combination of sugar and caffeine in adulthood.  Reinforcing: In addition, it has been suggested that caffeine in combination with high levels of sugar in beverages may act synergistically to release dopamine, increasing the reinforcing properties of sweetened beverages. o Research is needed in adults and in children to assess reinforcing properties of caffeine.28

5.5 Incidence of negative effects of caffeine in children, adolescents and adults Information about the incidence of negative effects of caffeine in children, adolescents and adults is limited.

Data from the US indicate that in 2008 there were 4852 calls to Poison Control Centers relating to caffeine toxicity. Of these, 49% occurred in people younger than 19 years of age, 26% required treatment, 10% reported moderately severe symptoms, 0.2% (11 people) reported life-threatening effects and 0.02% (one person) died.46

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6. Q2: NEGATIVE EFFECTS OF OTHER COMMON INGREDIENTS OF CEDs ON CHILDREN, ADOLESCENTS AND ADULTS

Key points  Common ingredients of CEDs include taurine, D-glucurono-ã-lactone, ginseng, guarana and sugar.  There have been case reports of people experiencing symptoms of caffeine overdose that have been attributed to drinking large volumes of CEDs containing caffeine and guarana.  The identified articles report that exposure to taurine, D-glucurono-ã-lactone, ginseng and guarana at the levels found in CEDs is not a safety concern.  The European Food Safety Authority (EFSA) Panel on Food Additives and Nutrient Sources added to Food found no evidence for synergistic effects between caffeine and taurine or D-glucurono-ã-lactone, although two research articles suggested that there may be synergistic effects between caffeine and taurine, including effects on cortical programming in physical stress and changes in heart rate and blood pressure.7-9 42  A synergistic effect between caffeine and glucose on performance has been suggested. Research suggests that a combination of caffeine and glucose had beneficial effects on attention (sequential reaction time tasks) and on learning and consolidation of verbal memory.  Vitamins were not included in the scope of this review.

6.1 Summary of number and type of articles included

Key articles Evidence in this section is drawn predominantly from six reports that include information about the effects of common ingredients of CEDs:  2003 and 2009 Scientific Opinion papers on the use of taurine and D-glucurono-ã- lactone as constituents of the so-called ‘energy’ drinks published by the European Food Safety Authority (EFSA) Panel on Food Additives and Nutrient Sources added to Food;1,2,7  a report by the Stimulant Drinks Committee established by the Food Safety Promotion Board in Ireland in response to a request from the Minister of State at the Department of Health and Children for external research into the health effects of stimulant drinks;4  a systematic review on Panax ginseng;8 and  two reviews,9,42 (both reviews in which the methodology was stated).

Other relevant articles A further 16 articles were identified providing information about effects of CED ingredients:  eight original research articles addressed effects of: o ginseng;47,48 o sugar;24,49 o taurine;22,26,50 o guarana51

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(these original research articles typically involved small sample sizes (only two studies involved more than 30 people).  three case reports;52-54 and  five additional narrative reviews providing information about the effects of different ingredients of CEDs;29,30,55-57 these reviews did not provide details about the search methodology and criteria used.

6.2 Effects of individual ingredients CEDs Common ingredients of CEDs include taurine, D-glucurono-ã-lactone, ginseng, guarana and sugar.

The articles identified through this review report that exposure to taurine, D-glucurono-ã- lactone, ginseng and guarana at the levels found in CEDs is not a safety concern. Effects of sugar reported in the literature relate mainly to levels found in soda rather than information related specifically to CEDs with concerns relating to effects on risk of type 2 diabetes and obesity.

Key information sources  Information about the effects of taurine and D-glucurono-γ-lactone comes from two Scientific Opinion papers by the European Food Safety Authority (EFSA) Panel on Food Additives and Nutrient Sources added to Food.2,7,28  Information about Panax ginseng is predominantly from a systematic review conducted in 2002.8  Information about other ingredients has been drawn from a review on the content and safety of energy beverages published in 2010 (review methodology was stated).9  Information about sugar has been drawn from a review of epidemiologic studies on the effects of sugar sweetened beverages (including CEDs) on risk of type 2 diabetes and obesity.56

Mechanism of action Taurine is the most abundant intracellular amino acid in humans. It is involved in neuromodulation and modulation of intracellular calcium levels. Taurine has been seen to enhance endurance performance and to aid in reduction of lactic acid build-up after exercise.

D-glucurono-γ-lactone is a naturally occurring substance produced in small amounts within the body.

Ginseng is one of the most popular herbal supplements in the world and is used for treatment and prevention of many ailments.

Guarana is a rainforest vine from South America whose seeds contain more caffeine than any other plant in the world. It also contains the stimulants theobromine and theophylline.

Sugars are carbohydrates that are oxidised by skeletal muscle for production of energy in the body.

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Interpreting the EFSA results The EFSA 2009 Scientific Opinion Paper was based on a daily mean chronic consumption of 0.5 x 250 mL cans of ‘energy’ drink per person and a high chronic exposure at the 95th percentile of 1.4 cans per regular consumer.7

This would result in a mean daily exposure to:  500 mg taurine (8.3 mg taurine/kg bw/day for a 60 kg person) and a 95th percentile exposure for regular users of 1400 mg taurine/day (23.3 mg/kg bw/day for a 60 kg person)  300 mg D-glucurono-ã-lactone (5.0 mg D-glucurono-ã-lactone/kg bw/day for a 60 kg person) and a 95th percentile exposure for regular users of 840 mg D-glucurono-ã- lactone /day (14 mg/kg bw/day for a 60 kg person).

This exposure compares to a maximum estimated mean daily exposure to taurine from omnivore diets of 400 mg/day and to D-glucurono-ã-lactone from naturally occurring sources in the diet estimated to amount to 1–2 mg/day.

Effects of taurine Concerns about the effects of taurine have arisen mainly from animal studies in which rats fed taurine exhibited behaviours such as anxiety and self-mutilation.

The EFSA concluded that no negative effects were observed for taurine at levels up to 1000 mg/kg/ bw/day. Given these safety margins, and the fact that taurine is a natural body constituent, the Panel concluded that exposure to taurine at the levels mentioned above is not a safety concern.7

Reviews undertaken by Higgins et al. and Clauson et al. also concluded that the amounts of taurine found in popular ‘energy beverages’ are far below the amounts expected to deliver either therapeutic benefits or adverse events.9,42

Effects of D-glucurono-γ-lactone The EFSA concluded that no negative effects were observed for D-glucurono-ã-lactone at levels up to 1000 mg/kg/ bw/day.7 Given these safety margins, and the fact that D-glucurono- ã-lactone is a natural body constituent, the Panel concluded that exposure to D-glucurono-ã- lactone at the levels mentioned above is not a safety concern.

Effects of ginseng A 2002 systematic review developed by Coon and Ernst explored the safety of Panax ginseng as a food supplement and did not restrict searches to levels found in CEDs.8 The review identified 146 clinical trials, representing exposure of over 8500 individuals to ginseng preparations (including over 3500 to monopreparations) with relatively few adverse events reported.

The review concluded that:  the most frequent events were gastrointestinal or sleep related;  Panax ginseng monopreparations are rarely associated with adverse events or drug interactions and that documented adverse events are usually mild and reversible;  it is difficult to establish a causal relationship between ingestion of Panax ginseng and adverse effects, partly because herbal products have a much higher potential for contamination, adulteration and mislabelling;

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 combined preparations are more often associated with such events but causal attribution is usually not possible; and  interactions between Panax ginseng and alcohol, warfarin and phenelzine may be possible.

A review published in 2010 reports a number of adverse effects associated with ginseng, including hypotension, oedema, palpitations, tachycardia, cerebral arteritis, vertigo, headache, insomnia, mania, vaginal bleeding, amenorrhea, fever, appetite suppression, pruritus, cholestatic hepatitis, mastalgia, euphoria, and neonatal death.9 However, specific details of the study type and dose used were not provided.

In the same review, the authors also commented that the amount of ginseng found in energy drinks is far below the amounts expected to deliver therapeutic benefits or cause adverse events.9

Other articles identified in the current review relating to ginseng referred to its use as a food supplement rather than an ingredient in CEDs. One article into the psychological benefits of ginseng found that ginseng supplementation had no effect on positive feelings and emotions (e.g. alertness, enthusiasm) or negative feelings and emotions (e.g. nervousness, irritability), or total mood disturbance. They concluded that no evidence exists that chronic ginseng supplementation – at either its clinically recommended level or at twice that level – enhances affect or mood in healthy young adults.48

Effects of guarana A small (n=26) controlled pre–post study into the cognitive effects of guarana found that guarana improved secondary memory performance and increased alert and content mood ratings.51

Little evidence was identified relating to the effects of guarana in CEDs. A narrative review of guarana in the Australian Pharmacist in 2007 recommended that maximum safe dosage of guarana was 2.5–4 g daily (containing 250 mg caffeine), assuming do other sources of caffeine are consumed (e.g. from tea, coffee or chocolate).57 This recommendation was based on the results of one clinical trial (size and details not provided) and a case series into sudden onset seizures after heavy consumption of energy drinks.58

Effects of sugar CEDs typically contain similar amounts of sugar as soft drinks. Higgins et al. report that a 500 mL can of CED typically contains about 54 g of sugar, equating to about 13 teaspoons of sugar.9

Concerns about the sugar content of CEDs stem from the long-term health effects such as development of obesity and insulin resistance. However, few articles were identified that specifically discussed the effects of sugar as a component of CEDs. Articles more commonly discussed the effects of sugar as a component of soda. For example, the FSANZ Expert Working Group for Caffeine report identified that excess consumption of soda is associated with poor diet, excess weight and dental caries.3

It is thought that sugar sweetened beverages, including CEDs, contribute to weight gain in part by incomplete compensation for energy at subsequent meals following intake of liquid calories. Such beverages may also increase risk of type 2 diabetes and cardiovascular disease.56

Intake of glucose or other carbohydrates before, during and after prolonged exercise has been shown to improve performance and postpone fatigue. CEDs are being used before

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exercise to improve performance owing to the perceived benefits of caffeine in combination with glucose.

Issues/unanswered questions  The EFSA Panel noted that actual exposure data on ‘energy’ drink consumption may need to be collected, especially for adolescents and young adults.7

 The EFSA Panel advice is based on effects of 250 mL cans in a 60 kg person. The Australian and New Zealand body mass is on average larger than 60 kg for an adult and many products are also available in 500mL cans. Moreover, reports suggest that people may consume more than the amount considered to be the ‘average’ intake.7

 Because CEDs contain many different ingredients, it is difficult to assign cause and effect to one specific ingredient. Higgins et al. propose that it may be the combination of ingredients that augments the effect.9

6.3 Synergistic effects of caffeine with other ingredients in CEDs The EFSA Panel found no evidence for synergistic effects of taurine or D-glucurono-γ- lactone with caffeine. A synergistic effect between caffeine and glucose on performance has been suggested.

Key information sources  Data on the synergistic effects of taurine and D-glucurono-γ-lactone comes from a Scientific Opinion paper on the use of taurine and D-glucurono-γ-lactone as constituents of the so-called ‘energy’ drinks published by the European Food Safety Authority Panel on Food Additives and Nutrient Sources added to Food.7

 Data on other ingredients has been drawn mainly from a review by Higgins et al. in 2010.9

Two research articles identified through the current review suggested that there may be synergistic effects between caffeine and taurine, including effects on cortical programming in physical stress and changes in heart rate and blood pressure.

Synergistic effects of taurine and D-glucurono-γ-lactone with caffeine The EFSA Panel found no evidence for synergistic effects of caffeine and taurine or D- glucurono-ã-lactone in terms of stimulatory effects on the brain, dehydrating effects or cardiovascular effects. The panel concluded that it is unlikely that D-glucurono-γ-lactone would have any interaction with caffeine, taurine, alcohol or the effects of exercise.7

The Panel also concluded, based on the new data available, that additive interactions between taurine and caffeine on diuretic effects are unlikely.

Two prospective controlled pre–post studies suggested that there may be synergistic effects between caffeine and taurine, including effects on cortical programming in physical stress22 and changes in heart rate and blood pressure26 in healthy volunteers. However, the small sample sizes (n=14 and n=15) limit the generalisability of these findings.

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Synergistic effects of sugar and caffeine A synergistic effect between caffeine and glucose on performance has been suggested.59 It has been suggested that a combination of caffeine and glucose has beneficial effects on attention (sequential reaction time tasks) and on learning and consolidation of verbal memory, effects not being observed when either substance was administered alone.49

Issues/unanswered questions  Few peer-reviewed studies have examined the effects of the separate components of CEDs to determine which ingredients exert their behavioural and physiological effects, or to determine if the ingredients have synergistic effects.28,4  The Safefood review (2002) also highlights the need to investigate possible adverse effects of interactions between CED ingredients such as caffeine and taurine and between such ingredients and alcohol, particularly under conditions of exercise and consequent dehydration through sweating.4  Specific information relating to the effects of individual ingredients of CEDs in children and adolescents was not identified through this review.

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7. Q3: NEGATIVE EFFECTS OF CEDs ON CHILDREN, ADOLESCENTS AND ADULTS

Key points  Limited comprehensive information, risk assessment data and peer-reviewed scientific research is available about the effects of CEDs.  Preliminary data from calls to poisons information centres in Australia and New Zealand indicate that reports of CED overconsumption are increasing.  As has been highlighted by the NSW Food Authority, levels of caffeine in CEDs do not always comply with regulations; some countries do not have stringent regulations, and where regulations are in place, it is unclear how stringently these are enforced.40  Uncertainty surrounding actual levels of caffeine in CEDs makes it difficult to interpret data on exposure to caffeine from CED consumption in articles reporting from overseas.  Several of the reviews and articles identified in the literature review report cases of overconsumption and negative reactions, as well as alleged fatalities related to CEDs. However, no high-quality scientific studies exist that clearly demonstrate a link between CED exposure and fatalities. Those that have been reported should be viewed with caution. A full critical appraisal is required before a judgement can be made on the quality of these reviews and articles.  A number of the articles identified in this review call for further research into the effects of CEDs, including effects in populations such as children and adolescents and pregnant women, as well as research about effects when consumed with alcohol and recreational drugs.  A full risk assessment of the ingredients of CEDs and their interactions will require extensive research, including toxicological investigations, which would best be carried out at a concerted international level.4  CEDs may be of more concern to individuals with certain health conditions, such as high blood pressure, arrhythmias or other heart disorders, epilepsy or diabetes.  Risks may be associated with high levels of consumption of energy drinks in conjunction with extensive physical activity.

7.1 Summary of number and type of articles included

Key articles Evidence in this section is drawn predominantly from three government reports about the effects of CEDs in children, adolescents and adults:  the New Zealand Food Safety Authority Risk Profile: caffeine in energy drinks and energy shots, 2010;6 and  two reports by the Federal Institute for Risk Assessment (BfR) in Germany into human data on the possible health risks posed by the consumption of CEDs: o the first is based on case studies from around the world reporting adverse effects in people consuming CEDs;12 and o the second report investigates the health risks of excessive energy shot intake, again drawing on case studies from around the world.13

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Other relevant articles A further 54 articles were identified that provide information about the effects of ingredients of CEDs:  12 reviews reporting negative effects of CEDs were identified; several of these reviews report on the same original articles, leading to overlap in the opinions and recommendations made by some of the review authors (note several of the reviews are US focused);9,11,14,28,42,60-66  25 original research articles, typically with sample sizes (n<50) and observational methodologies;59,67-90  two conference abstracts, typically focused on cardiovascular effects of specific CEDs (such as Red Bull, Monster);68,91  11 case reports;58,92-101  three editorials;102-104 and  one letter.105

7.2 Effects of CEDs Articles identified through this review list a range of effects associated with the consumption of CEDs. The effects of individual ingredients have been discussed in Sections 5 and 6 of this report.

Key information sources  Information about negative effects of CEDs is based predominantly on two reports by the Federal Institute for Risk Assessment (BfR)12 13 into the health effects of energy drinks and energy shots.  Information has also been drawn from a number of other narrative reviews. A lack of information relating to the methodology used by the reviewers limits their use.

Effects in adults Commonly mentioned health effects relating to the consumption of CEDs include arrhythmias, headaches, anxiety, insomnia, dehydration, gastrointestinal upset, nervousness, flushed face, diuresis, seizures, acute mania, strokes, withdrawal symptoms, tooth erosion, psychiatric events, accelerated heart rates and death.61 Reports in 2008 and 2009 by the Federal Institute for Risk Assessment (BfR)12,13 documented several case reports of negative effects related to consumption of CEDs. Based on these case studies, the report recommended further research into CEDs and:  the potential health risk for people with: o high blood pressure; o arrhythmias; and o other heart disorders;  the risk of heart problems for people without known heart disorders;  the question of higher risk of seizures for people with epilepsy or people with diabetes;  the role taurine may play in hypoglycaemia that may have contributed to the onset of a seizure in a person with diabetes;58 and

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 the risk of high levels of consumption of energy drinks in conjunction with extensive physical activity.

They also stated that as the safety of CEDs for people with kidney disease, migraine or mental health conditions is not fully known, these groups should be considered highly sensitive risk groups. The report also noted concern that CEDs combined with strenuous activity or sports could amplify the negative effects of caffeine.

In contrast, a 2010 narrative review into the problematic use of energy drinks by adolescents by Kaminer concluded that consumption of CEDs does not seem to carry negative effects that are any different from drinking similar amounts of other caffeinated beverages but that frequent consumption may serve as a useful screening indicator to identify students at risk for substance use and other problem behaviours.63

Effects in adolescents In a narrative review of caffeine use in children, Temple concluded that many of the CED studies in adolescents identified were cross-sectional and correlational studies. However, the review indicates that there appears to be a growing trend in increased CED consumption and potential negative effects, particularly within younger populations.28

In their 2011 review, Seifert et al. report that potential negative effects associated with CED intake among children and adolescents include:  exacerbation of cardiac conditions for which stimulants are contraindicated (e.g. ion channelopathies, hypertrophic cardiomyopathy);  increased risk of cardiac events in individuals with attention deficit hyperactivity disorder (ADHD);  increased risk of cardiac dysrythmias and intracardiac conduction abnormalities in children with eating disorders;  increased blood pressure, blood glucose levels, body mass index, calcium deficiency, dental problems, depression, and low self-esteem; and  potential effect on bone mineralisation due to caffeine intake.11

Safe consumption level In their 2010 review, Higgins et al. make the following recommendations for safe consumption of energy drinks:9  one can (500 mL) of an energy drink per day is safe for most healthy individuals; however, excess consumption and consumption with other caffeine-containing beverages or alcohol may lead to negative effects and possibly death;  ingestion of energy drinks before exercising or during training can have serious negative effects, most notably restlessness and irritability; can increase blood pressure; and may result in dehydration; the long-term effects of energy drinks on the human body have not been established; and  patients with clinically relevant underlying medical conditions, including heart disease and hypertension, should consult with their physician before drinking energy drinks.

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Issues/unanswered questions  In reviewing the negative health effects of CEDs, the Safefood Committee stated that it was constrained by the limited amount of comprehensive information, risk assessment data and peer-reviewed scientific research in this area.4  Seifert et al. (2011) suggest that further research is needed to better define maximum safe doses, the effects of chronic use, and effects in at-risk populations (e.g. those with pre-existing medical conditions, those who consume CEDs during and after exercise, or those who consume them in combination with alcohol), and better documentation and tracking of negative health effects. They suggest that, unless research establishes CED safety in children and adolescents, regulation, as with tobacco, alcohol, and prescription medications, is prudent.11  The Federal Institute for Risk Assessment (BfR) reports expressed concern about how to communicate risk to sensitive or high-risk groups.12,13 They also expressed concerned as to whether consumers can differentiate between sports drinks and CEDs as they are sometimes categorised or referred to together.12,13

7.3 CED overconsumption in Australia, New Zealand and overseas Data on overconsumption of CEDs is limited as much of the information gathered relates to overconsumption of caffeine rather than overconsumption of CEDs per se. For example, many poison control centres do not track the prevalence of overconsumption attributed to energy drinks, because exposures are coded as ‘caffeine’ or ‘multisubstance exposures’ and combined with other caffeine sources. The US has recently given energy drinks unique reporting codes, and Germany has tracked energy-drink-related incidents since 2002.11

Key information sources  Information about CED overconsumption has been drawn from Poisons Information Centres (PICs) in Australia and New Zealand, as well as Queensland data on hospital presentations from Emergency Department Information System (EDIS) data from 1 July 2010 to 30 September 2010 for 22 hospitals in Queensland.

CED overconsumption in Australia Four poisons information centres (PICs) operate around Australia (in New South Wales, Victoria, Queensland and Western Australia). Between them they provide cover to the whole of Australia. One PIC operates in New Zealand.

Each PIC has its own procedure in place for gathering data relating to calls concerning CED poisoning which limits opportunities for data aggregation. Data provided by each centre varied in reporting approach, content and categorisation of data. Variations affected most key data variables including caller age groups, incident or exposure type, symptoms experienced, doses consumed, and advice provided to caller. Table 9 provides a summary of data provided by each of the poison information centres (NSW PIC, Vic PIC, WA PIC and SA PIC personal communication, August 2011).

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Table 9: Summary of information received from poison information centres in Australia and New Zealand

Source Information received Timeframe

NSW PIC Preliminary data supplied for 2004–2010 from NSW, 2004–2010 (covering NSW, ACT and Tas. A review is planned for symptomatic ACT and Tas) cases by an independent medical toxicologist. A total of 297 calls were received between 2004 and 2010. The most commonly reported symptoms were agitation/anxiety, tremor/shakiness, tachycardia, nausea, vomiting, palpitations and dizziness.

Vic List of calls received related to CEDs (approximately 2005–July 2011 75 calls in 6-year period). Information recorded included: jurisdiction; adult/child; age (if under 16 years); sex; substance ingested (about 70% include brand name); dose (mouthful, can (but not always size of can), mL or L); symptoms. Eight calls were from other states (after hours calls); some calls relate to use of caffeine tablets (e.g. No- Doz)

SA PIC (covering Details about calls received (approximately 101 calls 2004–July 2011 SA, WA and NT) in 7-year period). Information recorded included: jurisdiction; adult/adolescent/child/toddler; age (in approx. 70% of cases); sex; substance ingested (about 70% include brand name); dose (in mL or mg); and symptoms. Sixteen of these calls were from other states (after- hours calls). Some calls relate to use of caffeine tablets (e.g. No Doz)

Qld Summary notes from calls received. 2009–Dec 2010 2009: 17 calls related to CEDs Information recorded included: dose (no specific data; range: ‘sips to >8 cans’; one case of chronic exposure of 2 L per day for 18 months); symptoms (tremor, dizziness, chest pain, palpitations, nausea, vomiting, weakness, intoxication, slow speech, drowsiness, anxiety, fever, hyperactivity, confusion) In three calls CED consumed in combination with No-Doz (caffeine) tablets. In one call CED consumed in combination with Dozile (doxylamine) tablets. 2010: 13 calls related to CEDs Information recorded included: dose (no specific data; range: ‘sips to >20 cans’; no chronic cases); symptoms (tremor, chest pain, tachycardia, nausea, vomiting, drowsiness, dilated pupils, disorientation, headache, restlessness). In one call CED consumed

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Source Information received Timeframe in combination with Temaze (temazepam) and Zoloft (sertraline). In one call CED consumed in combination with paracetamol.

NZ Details of calls received (approximately 82 calls in 7- 2004–Dec 2010 year period). Information recorded included: incident (background information, some information on symptoms); ingredients (e.g. mg/mL of caffeine, for about 80% of cases; majority only report caffeine not other ingredients), amount (mL); adult/child; age (in approx. 80% of cases); sex; substance ingested (about 50% include brand name).

20 calls (CEDs 18 calls and energy shots two calls). 2005–2009 Minimum and maximum self-reported caffeine intakes that elicited symptoms of caffeine toxicity were 4.0 mg/kg and 35.5 mg/kg for persons 13 and 14 years of age respectively. 6

Data were available for different time periods from each of the PICs. The only year in which data were available for all centres was 2010.

In 2010, 119 calls were made to PICs in Australia and New Zealand about consumption of energy drinks, excessive caffeine and/or guarana. Table 10 summarises demographic data of callers in 2010. While there are data gaps, Table 10 shows there were more calls related to consumption by males than by females and calls related to consumption across ages, ranging from very young children to adults.

Not all 2010 callers reported symptoms or negative effects of CED consumption. Negative effects reported by those experiencing them included: tremor; chest pain; tachycardia; nausea; vomiting; drowsiness; dilated pupils; disorientation; headache; and restlessness. Many callers reported co-consumption of a range of substances in addition to CEDs, and this should be borne in mind when interpreting the data.

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Table 10: Demographic data for calls about CEDs and caffeine consumption to poison information centres in Australia and New Zealand in 2010

Poison Total Sex Age (years) information callsa M F 0–4 5–12 13–18 19+ centre NSW, ACT, 65 34b 27 b 13 c 10 c 16 c 20 c Tas b Vic 13 7 6 0 1 4 8 (54%) (46%) (8%) (31%) (61%) d d WA, SA, NT 16 10 6 3 0 4 9 (63%) (37%) (19%) (25%) (56%) Qld 13 not provided 7 not provided (54%) NZ 12 10 2 2 0 6 4 (83%) (17%) (17%) (50%) (33%) Australia & 119 – – – – – – NZ combined a Some calls are follow-up calls to provide an update on an earlier call about the same poisoning incident. The count includes incidents rather than calls. After-hours the four PICs share the call taking so will receive calls from other states as well. b Of the 65 calls to NSW PIC, information about gender was not available for four of the calls, and for age for six of the calls. c Age categories for NSW PIC were 0-4 year, 5–12 years, 13–19 years and 20–74 years. d Age categories for Vic PIC were 0–4 years, 5–12 years, 12–16 years, and 16 years and older. The number of calls to PICs about CEDs or caffeine consumption has generally increased over the last few years, although all centres received fewer calls in 2010 compared with 2009. There may be several reasons for increasing numbers of calls, including increased consumption of CEDs, increasing awareness of possible negative effects and greater community concern about CEDs. Figure 1 illustrates number of calls for each PIC. The time periods for which data were provided varied between PICs.

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Figure 1. Number of calls about CEDs and caffeine consumption to PICs in Australia and New Zealand over time

NSW, ACT, TAS

calls VIC

of WA, SA, NT QLD

Number NZ

Year

Hospital presentation data (CED exposures): Queensland During the period July 2010 to September 2010 (i.e. the cooler part of the year), there were 268,215 emergency department presentations at 22 hospitals in Queensland. Of these, 42 (0.02%) were CED-related presentations. Of the 42 presentations:  5 (12%) resulted in hospitalisation;  24 (57%) were related to only CED consumption (i.e. no other substance was listed as taken with the CED);  18 (43%) were cases in which CED was reported to have been consumed with other substances such as alcohol (6 cases), illicit drugs (1 case), prescription drugs (1 case), over-the-counter drugs (2 cases) or ‘other’ drinks, drugs (8 cases);  the highest percentage of CED related presentations were in the 13–17 and 18–22 year age groups (57%);  the minimum age was 13 years and maximum was 45 years; and  2 were listed as Aboriginal origin and 36 had non-indigenous origin; in 4 cases, origin was not stated.

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Notes on data collection  The data reflect emergency department presentations across Queensland accessed via the EDIS for 22 hospitals in Queensland.  Data for the Queensland population from 1 July to 30 September 2010 were analysed by age structure, employment status and indigenous origin.  The only applicable field used to assess the number of relevant presentations was the triage text field termed ‘Presenting problem’.  The search terms ‘energy drink’, ‘red bull’, ‘caffeine’ and ‘guarana’ were used. Each presentation with one or more of these words in the field was manually reviewed and those not relating to caffeinated or energy drinks removed from the analysis.

Hospital presentation data (CED exposures): New Zealand Data provided by New Zealand show that during the period 2006–2010 there were 12 possible cases of hospitalisation due to exposure to CEDs.

CED exposures/overconsumption reported overseas As mentioned in Section 5, in the US in 2008 there were 4852 calls to Poisons Control Centers relating to caffeine toxicity. No information was available relating to toxicity due to CEDs specifically, as at that time, a separate reporting code did not exist for CEDs. Such a code has recently been introduced in the US and toxicity data specific to CEDs is now being collected.11

The literature review identified 15 case reports of overconsumption or negative effects resulting from exposure to CED. Seifert provides a representative sample of case reports documenting negative effects associated with CED consumption that have been reported in journal articles, newspaper articles and online news sources.11 The Federal Institute for Risk Assessment (BfR) reports document a range of case studies from around the world relating to negative effects relating to consumption of CEDs (2008 report) and energy shots (2009 report).12,13

Issues/unanswered questions  Several of the reviews and articles identified in the literature review report cases of overconsumption and negative reactions, as well as alleged fatalities related to CEDs. However, no high-quality scientific studies exist that clearly demonstrate a link between CED exposure and fatalities. Those that have been reported should be viewed with caution. A full critical appraisal is required before a judgement can be made on the quality of these reviews and articles.  A letter by Cassidy from the Irish National Poisons Information Centre (NPIC) in response to the review by Seifert11 and reports by the BfR,12,13 highlights the problems that exist in reiterating what has been published in various reports and reviews regarding fatalities linked to CEDs. The letter queried data quoted in the Seifert article and the BfR reports to which Seifert referred.105 and suggested that Seifert and the BfR misinterpreted the NPIC data relating to two fatalities and consumption of CEDs. No causality was established, or inferred by the NPIC between the consumption of the CED and the two fatalities. The data appear to have been misinterpreted and the wrong conclusions drawn.

 It is not possible to report whether any of the cases of adverse events/overdose

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reported in the articles can be linked conclusively to consumption of CEDs – no studies exist that clearly demonstrate causality and this will not be possible without reviewing the original data. Reissig et al. highlight clinical pharmacology and epidemiological studies that demonstrate an association of caffeine use with dependence on alcohol, nicotine, and other drugs, and one study showed that CED use predicts subsequent non-medical use of prescription stimulants.14  Thomas and Scheiss note that there are significant areas of uncertainty and data gaps relating to the negative effect level of CEDs.6

7.4 Issues/unanswered questions A number of the articles considered in this review provided recommendations for action relating to CED consumption. Many of these articles are commentaries rather than consensus guidelines or policies.

A number of the articles included in this review highlight issues and areas of uncertainty relating to interpretation of the effects of CEDs. Gaps in available information on which to base recommendations about CEDs are identified by the New Zealand Risk Profile (see Table 11).6

Table 11: Issues/unanswered questions related to CEDs and their effects for the New Zealand population6

Gap/issue Implication Information relating to health  Weak evidence of negative effects on which to base effects of CEDs is safety levels incomplete/out of date Lack of information about  Lack of information on which to base weightings for risk market share scenario modelling  Inappropriate assumptions with respect to energy drink and energy shot choices and contribution of caffeinated alcoholic beverages to caffeine exposure Lack of current information on  Current risk to New Zealanders from energy drinks and consumption of energy drinks energy shots cannot be accurately quantified and energy shots Lack of independently verified  Current risk to New Zealanders from energy drinks and caffeine levels in energy drinks energy shots cannot be accurately quantified and energy shots

Issues/unanswered questions Evidence gaps that may warrant further research:  concerted toxicological investigations at an international level;4  long-term studies to understand the effects in at-risk populations;  the possible negative effects on exercise performance and fluid balance during sport and exercise due to interaction of the principal ingredients contained in CEDs;4  the contribution of CEDs to childhood obesity and psychiatric illness, including attention deficit hyperactivity disorder;62

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 addiction research in adolescents chronically using CEDs, given the links between caffeine dependence to tobacco and alcohol use and the suggestion that CED use serves as a gateway to other forms of drug dependence;14 62 and  the possible negative effects of the interaction of CEDs with recreational drugs (e.g. Ecstasy).4

Policy suggestions that may warrant discussion:  monitoring of patterns of CED consumption;4  toxicity surveillance should be improved, and regulations surrounding CED sales and consumption should be based on appropriate research;11  encouraging clinicians to screen for CED use among their patients to identify symptoms related to toxicity and give patients greater understanding of the risks of high-dose and long-term CED use;62 103  encouraging clinicians to report all suspected cases of CED toxicity to a poison control centre to allow generation of pooled data to drive analysis and legislation on these products;62 103  educational interventions to inform adolescents of the consequences of consuming CEDs;61 and  banning CEDs in schools, and parents should limit their children’s access to high caffeine drinks.103

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8. Q4: CHANGES IN CONSUMPTION OF CEDs AND DRIVERS OF CONSUMPTION

Key points  Globally, sales of CEDs (by volume) almost doubled between 2003 and 2008, with growth averaging 14% per year. In 2008, CED sales were 3.9 billion litres per year.106  CED sales in Australia and New Zealand were 34.5 million litres in 2001, 156.6 million litres in 2010 and are forecast to be 237.6 million litres in 2015. This is a predicted 53% increase in sales over a 5-year period.107  The Australian Beverages Council has reported that a number of major brands withdrew their energy shot products from the Australian market in 2010 and 2011, and predict that the category is expected to further decrease in both volume and value (ABC, personal communication, September 2011).  Information from industry suggests that: o the majority of CED consumption occurs during the day; o CEDs are consumed primarily as a ‘pick me up’ or energy boost to help people stay focused and achieve during the day; and o historically, use of sports drinks and CEDs has been quite different, with sports drinks chosen for hydration and consumed before or after sports/activity, whereas CEDs have been selected for an energy boost and to improve focus; this distinction may be changing (ABC, personal communication, September 2011).  Many beverage manufacturers use cross-promotional tactics to reach consumers, integrating their product with extreme sporting events and advertising with music icons. Products are often given names that are defiant to appeal to their young market.29  Information about drivers for consumption comes from self-report surveys, typically of college students. One US survey of 253 college students showed that insufficient sleep (67%), increased energy (65%), and drinking with alcohol while partying (54%) were the main reasons for consuming CEDs.76

8.1 Summary of number and type of articles included

Key articles Information regarding changing trends in consumption of CEDs and drivers of consumption has been drawn primarily from a 2010 US narrative review focused on how the CED market is likely to develop in the USA in the coming years.29

Other relevant articles A further nine articles were identified that provide information about the consumption of CEDs and drivers of consumption:  eight original research articles76,108-113, including one Australian qualitative study using semi-structured focus group interviews to obtain data about the type of nutritional supplements and drinks consumed by adolescents and the reasons for consumption, with emphasis on the perceived benefits;114 and  one industry news report.106

In addition to reports and articles found through the literature search, information was obtained through consultation with CED manufacturers in Australia and New Zealand.

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8.2 CED market worldwide Globally, sales of CEDs (by volume) almost doubled between 2003 and 2008, with growth averaging 14% per year. In 2008, CED sales were 3.9 billion litres per year. North America and Australasia have the highest regional consumption at 4.2 litres per person per year.106

Key information sources  Information about the CED market comes from Canadean (a beverage market research company) and from communication from the Australian Beverages Council.  Additional information comes from AustFoodNews (AFN)106, as well as a 2010 narrative review by Heckman into the CED market in the US.29

Drivers of consumption of CEDs A key driver of increasing consumption of CEDs is said to be market diversification, including:  more private label products (such as store brands);  larger container sizes;  multi-packs;  sugar-free versions; and  juice hybrids.

These developments are said to be behind the increase in US consumption of CEDs forecast for 2007–201229. Heckman believes that in the US consumption is being driven by consumers using CEDs to help maintain their life-work balance and by the influence of CED marketing on the younger generation.29

Heckman also anticipates that the CED market will continue to diversify and expand. In addition to new product launches endorsing a new, improved and longer-lasting energy boost, new developments will be geared towards increasing the health functionality of CEDs, with drinks targeting:  women;  carbohydrate-conscious individuals;  body builders; and  extreme-sports enthusiasts.29

8.3 CED market in Australia and New Zealand CED sales in Australia and New Zealand were 155.6 million litres in 2010. This is forecast to increase by 53% in the next 5 years to 237.6 million litres in 2015.107

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Key information sources  Information about the CED market in Australia and New Zealand has been sourced from the food and beverage industry. Some of the original data are from market research reports by companies such as Canadean.  Information from New Zealand is based on a snapshot market survey that took place in February 2010.6

Australian CED market CED sales for Australia and New Zealand are listed in Table 12. Data is actual for 2001, provisional for 2010, and forecast for 2015.

Table 12: Sales of CEDs in Australia and New Zealand 107

Year CED sales (million litres) Australia New Zealand Total 2001 19.5 15.0 34.5 2010 107.9 47.7 155.6 (provisional) 2015 173.8 63.8 237.6 (forecast)

The Australian Beverages Council (ABC) has reported that a number of its members withdrew their energy shot products from the Australian market in 2010 and 2011, and predicts that the category is expected to further decrease in both volume and value in the future (ABC, personal communication, September 2011). Red Bull, which sells energy shots in 20 countries, has withdrawn them from sale in the US market, but is continuing to sell them in Australia.115

Sales forecasts for energy shots in Australia in 2011 for 150 mL containers are 100,000 litres (compared to sales of 300,000 litres in 2010); no forecast is available for 60 mL containers.

According to the Australian Beverages Council, research indicates that ‘shots with high caffeine levels have failed’ (ABC, personal communication, September 2011).

New Zealand CED market A total of 28 energy drinks and 16 energy shots were identified as available on the New Zealand market as of February 2010.6 See Appendix VI for a list of energy drinks and energy shots on sale in New Zealand in 2010.

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8.4 CED consumption patterns in Australia and New Zealand Limited up-to-date data on CED consumption are available for Australia and New Zealand.

Consumption data: Australia

Key information sources  Information about CED consumption has been provided by the Australian Beverages Council. Some of the original data came from the 2007 Australian National Children’s Nutrition and Physical Activity Survey and from Roy Morgan market research (ABC, personal communication, September 2011).

Consumption data for Australia from the Australian Beverages Council for March 2011 are provided in Table 13.

The ABC quoted data from the 2007 Australian National Children’s Nutrition and Physical Activity Survey (of children aged 2–16 years) which found that 23 out of 4400 respondents had consumed a CED on the day of the survey.116

The Roy Morgan Single Source Quarterly Report, April 2010–March 2011 found that 11% of males and 6.2% of females aged over 14 years of age had consumed a CED in the past 7 days, and 21.3% of 18–24 year olds had consumed a CED in the past 7 days (Table 13) (ABC, personal communication, September 2011).

Table 13: Australian Beverages Council data on consumption of CED in last 7 days (ABC, personal communication, September 2011)

Age group Proportion who have (n=892) consumed a CED in the past 7 days 14–17 years 18.2% 18–24 years 21.3% 25–34 years 15.2% 35–49 years 7.1% 50–64 years 2.1% 65+ years 0.6% Gender Male 11% Female 6.2%

Various sets of data from members of the ABC and the New Zealand Juice and Beverage Association (NZJBA) indicated that there is no consensus as to when CEDs are consumed. This may reflect different underlying consumption patterns for different brands of CEDs.

One manufacturer indicated that focus group surveys in Australia and New Zealand showed that CEDs are consumed primarily as a ‘pick me up’ or energy boost to help people stay focused and achieve during the day, with the majority of CED consumption occurring between 10 am and 2 pm (n = 212, male and females aged 18–35 in Sydney and Auckland) (member company of the NZJBA, personal communication, September 2011).

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Consumption data: New Zealand

Key information sources  1997 New Zealand National Nutrition Survey (NNS) and 24-hour dietary recall records.6  2002 New Zealand National Children’s Nutrition Survey (NNCNS).6

The most current data about CED consumption in New Zealand is provided by the 1997 NNS).

The 24-hour dietary recall records from the 1997 NNS found that 0.6% of respondents (3 out of 4636) consumed a CED on any one day.6

The 2002 NNCNS (children 5–15 years) asked questions related to consumption of ‘New Age Drinks’. This food description contains both caffeinated and non-caffeinated beverages, but provides some indicative information on potential frequency of consumption of caffeinated beverages.

The survey found that:  overall, 7.6% of respondents reported consuming ‘New Age Drinks’ at least once per week;  only 0.6% reported consuming these foods daily;  approximately 81% of respondents reported never consuming these beverages or consuming them less frequently than once per month; and  of the ‘New Age Drinks’ listed the most frequently consumed were E2 (39%), V (23%) and Lift (16%); of these three brands only V is caffeinated.6

Consumption data: worldwide Data from the US indicate that consumption in the US is much higher than in Australia and New Zealand. Seifert, 2011 reported that according to self-report surveys, CEDs are consumed by 30–50% of US adolescents and young adults.11

Malinauskas reported that 51% of participants in a US survey of students (n=253) reported consuming greater than one CED each month in an average month. The majority of users consumed CEDs:  to counteract insufficient sleep (67%)  to increase energy (65%)  to drink with alcohol while partying (54%).76

The majority of users consumed one CED in most situations although consuming three or more with alcohol was a common practice while partying (49%).76

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8.5 Reasons for consumption of CEDs

Key information sources  An Australian qualitative study to find out why adolescents consume CEDs.114

 An Australian study into use of CEDs to combat driver fatigue.108

 Information provided by the Australian Beverages Council (ABC, personal communication, September 2011).

Adolescents A series of semi-structured focus group interviews used to explore reasons for consumption of CEDs by Australian adolescents reported that participants:114  articulated that they had recently experienced the physiologic effects of caffeine and that was the major motivating factor behind their consumption  had deliberately sought an ‘energy boost’, and had received it in the form of a stimulant effect from consuming CEDs  incorrectly believed that CEDs ‘created’ energy (rather than the caffeine and other ingredients acting as a stimulant).

The authors reported that many of the misguided ‘energy creation’ beliefs among adolescents may be attributable to information provided to consumers in the advertising and marketing of the CEDs.

Car and truck drivers Armstrong reported on the use of CEDs to combat driver fatigue and noted that while Australians perceive that CEDs and caffeine medication may be an effective countermeasure for driver-fatigue, they are more likely to use CEDs than caffeine medication (pills).108

Sport and exercise Research undertaken in Australia in 2010 found that 24% of CED volume is consumed within a ‘physical action occasion’ (which includes sports and exercise), and of this, 71% of the volume is consumed around traditional sports. The research suggests that most CED consumption in sports occurs in pre-sport/training to avoid a slow start and to motivate (mental stimulation) and energise. However, consumers do not see current CEDs as ideal for sport (ABC member company, personal communication, September 2011).

Consumers in qualitative research groups have highlighted the need for an energy solution ‘made for sports’ or ‘designed for sport’. It is on this basis that Powerade Fuel+, a CED for sport, has recently been launched in Australia (ABC member company, personal communication, September 2011).

In contrast, other New Zealand beverage manufacturers see little overlap between sports and CEDs and state that (NZJBA member company, personal communication, September 2011):  there is only a small overlap in occasion when a consumer may want to be energised and hydrated at the same time;

 sports drinks consumers use these drinks before or after sports/activity for hydration; and

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 CED consumers are looking for an energy boost, to help them get through the day and to aid focus.

These diverse opinions may reflect the different ways in which beverage manufacturers market and promote CEDs.

CED and related behaviours Several cross-sectional studies reported on behaviours that were associated with CED consumption. As these were surveys, no conclusions could be drawn as to whether the CEDs are leading to these behaviours, or whether individuals who partake in certain activities (such as risk-taking behaviour, smoking, and drug and alcohol use) are more likely to consume CEDs.  Calamaro surveyed 100 12–18 year old high school students and found that many adolescents use multiple forms of electronic media-related technology (such as a television, computer, telephone, or music device) in their bedrooms and concurrently consumed caffeinated beverages. Their ability to stay alert and fully functional throughout the day was impaired by excessive daytime sleepiness. Thirty-three percent of the teenagers reported falling asleep during school. Caffeine consumption tended to be 76% higher by those who fell asleep during school.109  In 2008, Miller surveyed undergraduate students in the US and reported a positive association between higher CED consumption with marijuana use, sexual risk-taking, fighting, seatbelt omission and taking risks on a dare for the sample as a whole. Miller also associated CED consumption with smoking, drinking, alcohol problems and illicit prescription drug use for white students but not for black students.111  Miller concluded that sport-related identity, masculinity and risk taking are components of the emerging portrait of a ‘toxic jock’ identity, which may signal an elevated risk for health-compromising behaviours. College undergraduates' frequent consumption of Red Bull and comparable CEDs should be recognised as a potential predictor of ‘toxic jock’ identity.111,112

Issues/unanswered questions  Thomson and Schiess highlighted that the CED consumption information for New Zealand is clearly dated and represents a data gap.6

8.6 Marketing strategies Marketing of CEDs is distinctly different from that of other beverages. In the US and Canada, for example, CEDs are often targeted toward children and adolescents.102 In Australia and New Zealand, members of the ABC and NZJBC have committed to not market to children.16,117,118

Key information sources  Information about marketing strategies comes from a number of narrative reviews, including Heckman, Reissig and Temple.14  Many of these reviews represent personal rather than consensus opinions. All of the reviews are US-focused.

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Children and adolescents Several of the narrative reviews commented on the effects of marketing on children and adolescents. Marketing strategies include:  sporting event and athlete sponsorships;  promotion at extreme sporting events;  alcohol-alternative promotion;  product diversification and increased availability (in the USA the CED sector contains ready-to drink, shots and powder forms);28  product placement in media (including Facebook and video games) specifically oriented to children, adolescents, and young adults;11  use of brand names that are defiant to appeal to their young market;29 and  cross-promotional marketing targeting risk-taking youth in which cans of alcoholic CEDs resemble the non-alcoholic counterparts (in the US).11

Several of the authors proposed that preventative action is needed.63 It has been suggested that restrictions or bans be placed on advertising and aggressive marketing of CEDs to youthful and inexperienced users.14,102

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9. Q5: CURRENT BI-NATIONAL AND INTERNATIONAL REGULATIONS REGARDING CEDs

Key points  The current regulatory environment in Australia and New Zealand includes: o the joint Australia New Zealand standard for ‘formulated caffeinated beverages’; o the New Zealand Supplemented Food Standard 2010; o the New Zealand Dietary Supplement Regulations 1985; and o the Trans-Tasman Mutual Recognition Arrangement.

 The joint Australia New Zealand standard for ‘formulated caffeinated beverages’ is one of the most prescriptive in the world, and is more restrictive than those of regulatory partners such as the United States, United Kingdom and European Union. The approach being taken by Canada is still under consideration.  The regulatory approach by other governments to CEDs varies markedly around the world with respect to level of prescription, regulatory designation (e.g. as ‘foods’, ‘drugs’ or other) and labelling requirements.  There are, however, a number of common threads and similarities in approach by governments and industry, specifically in relation to delineating caffeine levels, advisory statement contents, and volumes and caffeine concentrations for ‘energy shots’. Caffeine limits in cola-/kola-based beverages are commonly linked to those of CEDs and used as a benchmark for regulatory differentiation with CEDs.  A lack of clear definition for energy drinks makes some comparison difficult, as does explicit reference, or not, to herbal sources of caffeine.  Industry worldwide has implemented self-regulatory approaches to the management of energy drinks and energy shots and provides consumer information in a number of ways. In some instances, these measures go above and beyond domestic legislative requirements.  A number of areas for further consideration are identified. These include government policies, definitions, and novel dietary sources of caffeine (for example guarana).

9.1 Summary of number and type of articles included

Key articles In order to reflect the most current information, the majority of the information provided here has been sourced primarily from personal communications with regulatory partners and key industry representatives, and national legislation was accessed through web-based portals for relevant agencies such as Australia, New Zealand, the EU, US and Canada. Web-based information was also relied on for place-in-time reports of regulatory and related activity over recent years, and for educational resources from various non-government or industry sources. Appendix VII contains summaries of the regulatory and self-regulatory approaches in tabular format.

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Articles have also been used and include two published reviews:  a 2009 narrative review by Reissig (no methodology provided);14 and  a 2010 narrative review by Heckman.29

Note: The body of this chapter outlines regulatory and guidance approaches by countries of interest and self-regulatory initiatives by industry. The material covered is not exhaustive, but is sufficiently comprehensive to draw a picture of approaches being taken globally for the risk-management of CEDs including energy shots.

9.2 Regulatory/self-regulatory approaches in Australia and New Zealand

Australia and New Zealand Australia and New Zealand share a bi-national approach to food regulation through the joint Australia New Zealand Food Standards Code. The Code is developed and maintained by FSANZ in response to policies set by the Australia New Zealand Food Regulation Ministerial Council.

Under the Code, the direct addition of caffeine to food products is restricted to kola-type soft drinks and FCBs. The Code does not prescribe limits for naturally occurring caffeine in foods such as coffee, tea and cocoa.

Under the code:  the total caffeine content of kola beverages must not exceed 145 mg/L per drink (as regulated under Standard 1.3.1 − Food additives); this maximum permitted level includes contribution of caffeine from caffeine-containing ingredients such as guarana;  an FCB must contain no less than 145 mg/L and no more than 320 mg/L of caffeine, including caffeine from guarana (as regulated under Standard 2.6.4 − Formulated caffeinated beverages);15 and  as regulated under Standard 1.2.3 − Mandatory warning and advisory statements and declarations, any non-FCB food or beverage that contains caffeine and/or guarana or its extract must have a statement on its label that the product contains caffeine; the exact source of the caffeine does not have to be specified or quantified.

In Australia and New Zealand, the demarcation of caffeine content serves as a key regulatory differentiator between cola-based beverages and FCBs. Moreover, and as outlined in Standard 2.6.4, labels on FCBs must state the quantity of caffeine in mg/100mL and mg per serving size. The label on a FCB must also include an advisory statement that: a) the food contains caffeine; and b) the food is not recommended for children, pregnant or lactating women and individuals sensitive to caffeine.

Standard 2.6.4 is seen by industry as one of the most prescriptive systems in the world, both in respect of its composition and labelling requirements (ABC, personal communication, August 2011). It is important to note the reference to composition also includes the other ingredients typically found in FCB’s; specifically, Standard 2.6.4 provides regulatory parameters around the non-caffeine ingredients found in Red Bull, as an application from Red Bull was the basis for the development of the standard in 2001. By way of comparison, the separate New Zealand arrangements (described below) are considerably more flexible, both in respect of caffeine content and the other substances contained in FCBs. Restrictions in respect of non-caffeine ingredients and the need for some advisory statements such as a ‘recommended maximum daily consumption’, and ‘not suitable for…’. are not typical of international laws for CEDs; although such statements may be recommended in guidance material.

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There are currently no specific provisions in the Code for energy shots; however, separate New Zealand regulations provide these. Energy shots are available for retail sale in Australia having been imported from New Zealand as dietary supplements or supplemented foods; the regulatory arrangements underpinning this are discussed in the following section.

In 2010, a number of energy shots were listed on the Australian Register of Therapeutic Goods and marketed as such. However, they were delisted by the TGA on the basis that the TGA considered them to be foods rather than therapeutic goods. Further to, the TGA’s electronic listing facility was modified to require applicants to consider whether their intended products were covered by a food standard (e.g. Standard 2.6.4). If they were not compliant with Standard 2.6.4 (or other), this action effectively deemed them to be non-compliant foods in Australia.

New Zealand New Zealand’s legislative framework is different to that of Australia. New Zealand currently has four separate categories of regulation:  foods;  supplemented foods;  dietary supplements; and  medicines.

By way of contrast, Australia only has two categories: foods and therapeutic products (which include medicines, and complementary medicines, akin to dietary supplements). In addition to the arrangements under the joint Code, there are three further legislative instruments that add to the complexity of regulatory arrangements across the Tasman:  the New Zealand Food (Supplemented Food) Standard 2010 (the SFS);18  the New Zealand Dietary Supplement Regulations 1985 (NZDSR);119 and  the TransTasman Mutual Recognition Arrangement (TTMRA), which is given effect under legislation in each jurisdiction.

The TTMRA came into effect in 1998 to promote trade between Australia and New Zealand, and permits the sale of any food legally able to be sold in either Australia or New Zealand to be sold in the other country (i.e. the two countries recognise each other’s laws as they relate to the regulation of goods, with some exceptions, including therapeutic goods). Under the TTMRA, compliant supplement foods can be sold in Australia.

The SFS came into force on 31 March 2010. Its purpose is to provide an interim arrangement for supplemented foods until there are appropriate permissions in the Code, and to regulate ‘food-type’ dietary supplements that were formerly regulated under the NZDSR in a way that aligns these products as closely as possible to the requirements of the Code. The SFS consists of two parts, as outlined below.  Part 1 of the SFS directly incorporates many of the labelling requirements of the Code, but excludes FCBs as defined in Standard 2.6.4 (as per Clause 6). Supplemented foods sold under Part 1 must meet various requirements including being labelled as ‘supplemented food’. With respect to caffeine, if the supplemented food contains more caffeine, including from other sources such as guarana, than is required to meet its technological function (i.e. flavouring) under the principles of good manufacturing practice (GMP), then the label must include the average quantity of caffeine present per serve and per 100mL/gm; and advisory statements concerning non-suitability for children, pregnant or lactating women and caffeine sensitive individuals. These labelling requirements, which did not exist under the old NZDSR, are similar to those

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required by Standard 2.6.4. There remains however no limits on the amount of caffeine that may be added and the SFS therefore allows for the production of energy shots.  Part 2 of the SFS is effectively the old NZDSR, which have carried over as an interim transitional arrangement for 2 years. The NZDSR will cease to exist as of 30 March 2012. Energy shots that have previously been sold under the old NZDSR are now supplemented foods. They may continue to be sold labelled as ‘dietary supplements’ while Part 2 of the SFS remains in force. After 30 March 2012, they must comply with Part 1 of the SFS. The SFS has a two-year transition period to allow manufacturers and suppliers operating under Part 2 of the SFS time to comply with the new requirements, at which point they must comply with Part 1 of the SFS, or with the joint Code.

If the Code has not introduced provisions for energy shots by that time, and assuming they are deemed to be a ‘food’, energy shots in their current form will have no regulatory basis in Australia, but may continue to be made to the SFS and imported into Australia under the TTMRA. This also includes products imported into New Zealand, compliant with and in accordance with New Zealand regulation, which are then exported from New Zealand to Australia.

A number of different brands of energy shots, for example, Frucor’s ‘Pocket Rocket’, are currently seen on the Australian market. Although these are not compliant with the Code, if produced as New Zealand dietary supplements or supplemented foods they may be legally imported into and sold in Australia under the TTMRA.

9.3 Regulatory approaches worldwide Australia and New Zealand maintain close collaborative links with other countries with similar demographics and regulatory interests in respect of food.

Australia and New Zealand also maintain active involvement internationally through the Codex Alimentarius Commission (Codex) which includes the EU and our ‘Quads’ partners Canada and the US. These countries serve as useful comparators for regulatory standards in Australia and New Zealand and facilitate leanings and understanding of food regulation globally.

Canada

Regulatory bodies in Canada Health Canada is the developer of food standards and consists of a number of directorates. Currently, the Food Directorate oversights caffeine additions to the non-alcoholic beverages, while the Natural Health Products Directorate (NHPD) oversees natural health products, including CEDs. The difference appears to be related to claims made in the context of caffeinated beverages versus caffeinated energy beverages.

The Canadian approach to energy drinks is under consideration. Three parallel processes are in effect that may influence outcomes:  development of a draft Caffeinated Energy Drinks Labelling Standard (shared with industry in July 2010 for consultation);  an Interim Marketing Authorization (IMA) IMA regarding use of caffeine in food products; and  Preliminary Guidance for Industry on the Labelling of Caffeine Content in Pre- packaged Foods) (voluntary preliminary guidance document produced by the Food Directorate).

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These draft processes have yet to be resolved and together present a complicated picture around the management of CEDs.

The purpose of the draft Caffeinated Energy Drinks Labelling Standard is to facilitate the assessment of Product License Applications, which are required for energy drinks. This draft standard may provide some indication of the direction in which regulations for CEDs in Canada may go; however, its review process is not yet complete and therefore the final outcome unknown.

As part of this process the Canadian Health Minister convened the Independent Expert Advisory Panel on Caffeinated Energy Drinks in 2010 to review the latest scientific literature, data and adverse reaction reports associated with the consumption of caffeinated energy drinks and provided a report to Health Canada. The Panel’s advice forms one part of the information being considered for assessment of caffeinated energy drinks. Based on the review of the Panel recommendations and other sources of information, changes to the labelling requirements for caffeinated energy drinks may be implemented.

Current Canadian regulations Historically, cola-type beverages have been the only food products allowed to contain caffeine (according to Part B.16.100 of the Food and Drug Regulations, administered by the Food Directorate). This is in the function of a food additive to characterise the nature of cola- type beverages and a maximum of 200ppm of caffeine is allowed in the finished product. However, in response to a submission to allow caffeine and caffeine citrate in non-alcoholic carbonated water-based flavoured beverages and sweetened beverages other than cola type drinks, an IMA has been granted to allow such use up to a level of 150ppm caffeine. The IMA process is an important initiative that was enacted in July 1997 and bridges the time between the completion of the scientific evaluation of certain enabling amendments (e.g. expansion of uses of food additives already listed under Division 16 of the Food and Drug Regulations) and publication of the approved amendments in the Canada Gazette, Part II.

In current Canadian legislation, caffeine does not have to be listed as an ingredient on the label of food products unless it has been added separately to the product as a pure substance. With caffeine that has been added to a food product as an additive, such as with cola-type beverages, there is no requirement to quantitatively state the amount of caffeine present in the product. For natural sources of caffeine such as guarana, the food label is not required to identify the presence of caffeine nor state the amount of caffeine that the product contains. However in 2010, the Canadian government published draft voluntary guidance for the labelling of pre-packaged foods containing caffeine which suggests considerably more detail.

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The 2010 document Preliminary Guidance for Industry on the Labelling of Caffeine Content in Pre-packaged Foods provides the following general labelling guidelines:  when the food additive caffeine is added to a beverage, the caffeine content of that beverage should be expressed on the product label in milligrams (mg) per serving size;  when the food additive caffeine is added to a beverage that also has added to it an ingredient that naturally contains caffeine (e.g. guarana), all sources of caffeine should be taken into account in order to express total caffeine content on the product label in mg caffeine/serving size;  if an ingredient that is a relatively unknown source of caffeine (e.g. guarana, yerba mate), is added to a food, the total caffeine content of that food should be indicated on the product label in mg of caffeine per stated serving size; and  the product’s caffeine content statement should be placed outside and directly beneath the nutrition facts panel and should read as follows: ‘Caffeine Content: __mg per stated serving size’.

Caffeinated versions of carbonated soft drinks that have not previously been permitted to contain the food additive caffeine and which consumers would not expect to contain caffeine should bear a statement ‘Contains Caffeine’ which is highly visible on the front of the package.

Natural health products under the Natural Health Product Regulations are classified as intended for therapeutic purposes due to the ingredients they contain, the ‘dosage form’, and the claims they make. Such claims would include those seen for CEDs, such as ‘increases mental and physical alertness’.

All energy drinks authorised for sale by Health Canada must state their Natural Product Number on the label. Under the regulations, the common and scientific names of all product ingredients must be present on the product’s label, as well as the quantity of each ingredient per dosage unit, recommended dose and use information, and risk information about the specific product. However, there is considerable flexibility as to CED formulations under this scheme and significant variability is seen on the market, above and beyond that found in Australia or New Zealand as FCBs.

European Union

Regulatory bodies in the EU Regulations are passed either jointly by the EU Council and European Parliament, or by the European Commission alone.

In the United Kingdom (UK) food-related matters including labelling were previously under the auspices of the UK Food Safety Authority (FSA) however, following recent restructuring of that authority, labelling legislation for England and Wales is now the responsibility of the Department for Environment, Food and Rural Affairs (DEFRA).

Laws of the European Union (EU) include regulations, directives and decisions. There are also mutual recognition arrangements that assist the flow of goods from one EU member to another.120  Regulations are the most direct form of EU law – as soon as they are passed, they have binding legal force throughout every Member State, on a par with national laws. National governments do not have to take action themselves to implement EU regulations.

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 Directives are addressed to national authorities, who must then take action to make them part of national law.  Decisions apply in specific cases only, involving particular authorities or individuals.

Commission Directives lay down certain end results that must be achieved in every Member State. National authorities have to adapt their laws to meet these goals, but are free to decide how to do so. Directives may concern one or more Member States, or all of them. Each Directive specifies the date by which the national laws must be adapted and allows national authorities some flexibility within the deadlines to take account of differing national situations.120

About mutual recognition The principle of mutual recognition has been in place in European law since 2009 and states that certain goods which are lawfully sold in one member state within the European Economic Area (EEA) should also be permitted to be sold freely anywhere else within the EEA, even though the product may not fully comply with the rules of the member state of destination. There is an exception however, insofar as the destination State may refuse the products in its current form, if it can show why this is necessary for the protection of its consumers or environment (e.g. in relation to public health and safety).

The Principle of Mutual Recognition covers all EU member states including the non-member states Iceland, Norway and Liechtenstein who have also agreed to this regulation as members of the EEA. It further requires all members to make their national technical rules regarding importing and exporting goods freely available as well as the standard procedures for enforcing the rules.

CEDs have been a good example of EU members exercising their jurisdictional rights; further detail is provided under the respective countries below.

Current EU regulations The labelling of energy drinks is specifically addressed under Commission Directive 2002/67/EC, which came into effect in 2002 and was to be fully implemented by July 2004. The opinion of the Scientific Committee in 1999 concluded that caffeine in energy drinks was generally not a cause for concern. However, it was considered an issue for pregnant women and children. This aspect, and noting that some Member States had already enacted legislation requiring labelling for caffeine, prompted the introduction of compulsory labelling requirements through EU applicable harmonised legislation.

The aim of these labelling requirements was especially to inform consumers about high levels of caffeine present in atypical foods and soft drinks (i.e. foods and soft drinks that would not normally contain caffeine). As a result a beverage that contains caffeine in excess of 150 mg/L must place the following message on its label directly under where the product name is stated: ‘High caffeine content’. This message must then be followed in brackets by the caffeine content expressed in mg/100mL.

In the case of the EU the caffeine level of 150 mg/L is used as the regulatory differentiator between other beverages and CEDs. For other beverages caffeine is permitted as a flavouring agent up to 150 mg/L. When used in this way, caffeine must be mentioned by name in the list of ingredients immediately after the word ‘flavouring’. This was brought about in 2002 by a derogation in Commission Directive 2002/67/EC, which effectively expanded on the ingredient listing requirements in the general labelling provisions, to require the specific mention of caffeine. There is, however, no requirement for quantification of the caffeine present in the foodstuff.121

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Energy shots are addressed separately through Commission Directive 2002/46/EC, which governs food supplements. Under this Directive ‘food supplements’ may contain a wide range of nutrients and other ingredients including vitamins, minerals, various plants and herbal extracts. Whilst caffeine cannot be added in its chemical form, guarana and other herbal sources of caffeine could be included. This Directive also notes that specific rules regarding other substances with nutritional or physiological effects should be laid down at a later stage. Meanwhile, national rules may be applied i.e. individual member states may apply their own requirements. Food supplements are defined in the Directive, and notes that these are concentrated sources of nutrients or other substances with nutritional or physiological effects, marketed in dosage form as liquids or powders designed to be taken in measured small unit quantities.

Under Directive 2002/46/EC, there are also specific labelling requirements. These include the names and quantities of substances (including quantity per portion), which characterise: the product; daily recommended doses and warnings against exceeding that dose; and that the products should be stored out of the reach of children.

Regulations in the UK There is no separate legislation specifically relating to CEDs in the UK rather, as a member of the EU, the UK has the same labelling requirements regarding caffeinated beverages that came into effect in July 2004 as horizontal legislation across the EU.

Prior to Commission Directive 2002/67/EC, the Food Advisory Committee of the UK Ministry of Agriculture, Food and Fisheries had recommended that stimulant drinks with caffeine levels greater than 125 mg/L carry clear statements regarding the levels of caffeine, and advisory statements regarding unsuitability for children and caffeine-sensitive individuals.4 These labelling statements are not part of the current EU regulations.

European exceptions to EU regulations Whilst all EU member states adopt horizontal labelling directives, as noted above, members can institute their own national legislation where they consider it is in the public health and safety interests of their population. With regard to CEDs this has been exemplified by the setting of upper caffeine levels, reported ‘banning’ of CEDs, or additional labelling requirements.

For example, Denmark and France had set upper statutory levels of 150 mg caffeine/L, which would rule out most CEDs regulated as ‘foods’.4 Denmark, France, and Norway (non- member of the EU) have been reported as ‘banning energy drinks’.122 While this may have been the effect at some point in time, a major supplier of energy drinks to Europe has confirmed that this is no longer the case and formulations of Red Bull energy drink in France, Denmark and Norway are now the same as in Australia and New Zealand (Red Bull, personal communication, September 2011). Finland provides an example of additional labelling requirements. Further information is provided in Table 14.

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Table 14: Exceptions to EU regulations for CEDs

Country Exception Norway  The ban on Red Bull in Norway has recently been lifted according to a private website report in May 2011.  Since then Red Bull in various sizes has been available along with a wider variety of energy drinks.123 France  France prohibited Red Bull, in its original formula, for 12 years owing to conservative policies on the fortification of foods with vitamins, minerals and other nutritive substances.  During this time, Red Bull without the addition of taurine was available.124  In July 2009 the French government was required to lift this prohibition on the basis of advice from the EFSA that there was insufficient evidence that taurine was unsafe.  European countries cannot implement bans in the absence of proven health risks. Red Bull did however agree that health warnings recommending moderate consumption and advising against consumption by pregnant women and children would feature on its cans.14 124  Other energy drinks have been available in France, including ‘Extreme Energy’, which was launched in France in 2003 and is the number one selling energy drink in France. Extreme Energy excludes taurine and glucuronolactone from its formulations, and uses guarana as its caffeine source. As such it has been promoted as the ‘natural alternative’.125 Denmark  Denmark had banned the sale of Red Bull completely according to Reissig.14 Red Bull energy drink is now available in Denmark in the same formulation as elsewhere in Europe, and Australia and New Zealand (Red Bull, personal communication, September 2011).  On the basis of national studies in Denmark, which concluded that young people consume too many energy drinks per day, the Danish Food Minister proposed to the EU in September 2010 that labelling requirements should be stricter and more informative and apply across the EU.  The labelling advice specifically suggested was: “Contains high level of caffeine. Adults should consume no more than 50cl a dy. Persons under 18 no more than 23cl a day. Not for children under 1-. Should not be consumed when pregnant. 126  In view of potential trade barriers across the EEA members that this proposal would raise it would need to firstly be further considered by EFSA and the European Community before it could be implemented. Currently, caffeine in foodstuffs in Denmark is regulated as flavouring to a maximum permitted level of 150 mg/kg. Finland  The Finnish Food Safety Authority requires the labelling of energy drinks to state that the product is not suited to children, pregnant women or persons sensitive to caffeine. The labelling also indicates the recommended daily intake (which may be a few cans a day) or a warning about the detrimental effects of excessive intake.  Finland has had its own energy drink (Battery) on the market since 1997. This product continues to be one of the Nordic countries leading energy drink brands with a caffeine content of 107 mg caffeine per can (i.e. 320 mg/L).  The label advice for Battery is: ‘Avoid drinking before bedtime. Not for children, expectant mothers or caffeine-allergics. Maximum recommended

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Country Exception consumption 3 cans per day.127  With respect to non-CED beverages, Decree 1084 of 2004 of the Finnish Ministry of Trade and Industry, requires that caffeine used in food as a flavouring substance needs to indicate this in connection with the name of the product or in the list of ingredients, after the word ‘flavour’ (or linguistic alternative). Similar to the EU, the Decree also stipulates that the labelling of any drink with a caffeine content of more than 150 mg/L state the indication ‘high caffeine content (...mg/100 ml)’ in connection with the name of the drink.128

United States of America (US)

Regulatory bodies in the US Caffeine-containing beverages are regulated as foods or dietary supplements by the US Food and Drug Administration (FDA).

In 1980, it was proposed that caffeine be banned from soft drinks in response to caffeine related health concerns. Had this been the case, caffeine may have been regarded as a psychoactive ingredient and regulated as a drug. However, the cola beverage industry (PepsiCo Inc specifically) successfully argued that it was a flavouring agent, and its use was retained.

Regulation of CEDs in the US differs considerably from those countries described above, and may be considered the least restrictive system. It has been described as a ‘mostly unregulated’ market, with Reissig et al., stating that ‘[other] manufacturers appear to be ignoring the FDA caffeine limits and FDA has not enforced the limits’.14

Reissig et al. also describe the history of the US approach to CEDs as being illustrative of ‘the complexity of the regulatory issues involved in their sale, use, and promotion’.14

Current US regulations Foods and dietary supplements in the US are under the jurisdiction of the FDA. The FDA does not have any regulations specifically addressing the labelling, ingredients or formulation of CEDs. However, there are general regulations that apply. Prior to 1994, dietary supplements were subject to the same requirements as conventional foods under the Federal Food, Drug and Cosmetic Act; the event of the Dietary Supplement Health and Education Act in 1994 (DSHEA) created a new regulatory framework for the safety and labelling of dietary supplements.

A manufacturer or distributor in the US has the prerogative to decide whether they intend to market and promote their products as a conventional food or as a dietary supplement. Energy drinks per se are seen to be conventional foods however they are not defined by the FDA. The producer can vary this product, determine its market position as a food or as a dietary supplement, then go to market with no prior approval. This is on the understanding that they need to meet the applicable requirements and are responsible for the safety of the product and labelling as to its intended use.

Use of caffeine Additives such as caffeine, whether added to a conventional food, or as an ingredient in a dietary supplement, must be used in accordance with food additive regulation which specifies the conditions under which it must be used. However, such regulation is not needed if the substance is ‘generally recognised as safe’ (GRAS) (i.e. substances generally recognised to

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be safe by qualified experts). The FDA Code of Federal Regulations, nr 21CFR182.1180 states that: caffeine is GRAS when used in cold drinks such as cola-based beverages and that the level of caffeine in these types of beverages must not exceed 0.02% (i.e. 200ppm).129

Caffeine may also be used as an ingredient in other conventional foods or dietary supplements provided the manufacturer can assure it is safe under the conditions of use that they specify in the labelling. GRAS substances, and dietary supplements, are not required to undergo pre-market assessment.

Any food product, including energy drinks, that contains caffeine must list caffeine as an ingredient on the product label. However, the actual quantity of caffeine contained in the product does not have to be stated on the label and there are no further labelling requirements.

By way of comparison, over-the-counter caffeine stimulant products in the US, for example ‘NoDoz’, must contain a range of warnings and directions around amount and use of caffeine (FDA 21CFR340.50). Information includes dosage advice and contra-indication for children under 12 years of age. This is in stark contrast to energy drinks, some of which may have much higher contents of caffeine, and furthermore, as beverages, may be consumed more frequently.

Many beverages in the US now exceed the cola caffeine limit, some quite substantially, and there appears to be little enforcement action, except in relation to the mixing of alcohol and energy drinks, which received considerable attention from the FDA in 2010.

Beverages versus dietary supplements Some years ago, the US FDA recognised an increase in the marketing of beverages as dietary supplements, despite the fact that the packaging and labelling of many liquid products represented the products as conventional foods. It was also noted that they may contain novel ingredients, such as added botanical ingredients or their extracts, which have not previously been used in conventional foods and may be unapproved food additives. In addition, ingredients that have been present in the food supply for many years were being added to beverages and other conventional foods at levels in excess of their traditional use levels or in new beverages or other conventional foods.

In response to this, the FDA released guidance in 2009 to assist dietary supplement and beverage manufacturers and distributors in determining whether a liquid product may be labelled and marketed as a dietary supplement.130

This guidance identifies that the FDA “considers a liquid product’s name, packaging, serving size, and recommended conditions of use, as well as other representations about the product, to be important determinants of whether the product is represented as a conventional food and may not be marketed as a dietary supplement”. The impact of this is also that any substance added to a beverage or other conventional food that is not GRAS for its intended use, means the food is ‘adulterated’. The information given below regarding caffeine in alcoholic beverages provides an example of where this assessment has been applied.

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CEDs and alcohol in the US In November 2009 the FDA notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intended to look into the safety and legality of their products. The FDA requested that the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or evidence of prior approval.

In November 2010, the FDA warned four companies that their caffeinated malt alcoholic beverages violate the Food, Drug, and Cosmetic Act. The FDA stated these products violated the Act because they contained caffeine, an unapproved food additive when added directly to an alcoholic beverage and packaged in this combined format. This announcement was made after 12 months of investigation by the FDA, including reviewing the responses received from the manufacturers, and consultation with experts in the field of toxicology, physiology and epidemiology. Based on the information the FDA has reviewed, the agency does not consider the use of caffeine, in the alcoholic beverages under investigation, to be GRAS.

The beverages under investigation contain high levels of alcohol (12–20% by volume), caffeine (45–185 mg) and other substances such as taurine and guarana.

State-based variation in regulations Individual states of the US can also implement local provisions that may then vary across the country. For example, Washington, Michigan, Utah and Oklahoma have all banned alcoholic energy drinks and in December 2010 a Long Island Republican legislator put forward a proposal to ban non-alcoholic energy drinks.131

Other international approaches Elsewhere around the globe, regulation of CEDs varies considerably and is in differing stages of development. Table 15 provides a snapshot of the variety in approach and some activities at a global level. Policy making and/or risk assessments behind the approaches to regulation for CEDs is not always apparent and has not been explored in this review. Further work in this area may be informative. The Middle East and Russia provide interesting examples where philosophical (rather than safety) concerns may be driving government responses.

Table 15: Examples of other global approaches to regulations for CEDs

Country Exception Thailand  Krating Daeng, which is Thai for ‘Red Bull’, has been widely consumed since the early 1970s and is produced by the TC Pharmaceutical Co. (which is now a subsidiary of Red Bull Beverage Co. Ltd); flexibility to formulations and presentation is allowed.  There are now a wide variety of Red Bull products available in different sized packaging.  In one case, Thai Red Bull is reported as being sweeter than its Western equivalents, is un-carbonated, and does not contain taurine.123

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Country Exception Japan  In Japan, energy drinks known as ‘genki’ have been used as functional beverages for a long time. They were originally bottled as ‘medicines’  ‘Lipovitan’ (a product for which there are 21 varieties in the Japanese market) is manufactured by a pharmaceutical company (Taisho) as are many other brands in Japan.132  Manufacturers of CEDs are limited as to the claims they can make on label if CEDs are marketed as foods. In order to make health-related claims, products must be categorised as Foods for Specified Health Uses (FOSHU). Such products are assessed by the Ministry of Health, Labour and Welfare (MHLW) for safety and effectiveness to approve the health-related claims.  In 2006, a new anti-fatigue/anti-stress health claims FOSHU category was proposed, with the intended inclusion of energy drinks. In 2008, it was reported the MHLW were delaying approval of this category and it was not clear when, or if, the MHLW would authorise the new claims.  Products using related ingredients are widely sold in Japan without on- label health claims and without the formal FOSHU logo confirming MHLW acceptance of the products.133 South Africa  Labelling of foods in South Africa is the responsibility of the Department of Health and is governed by the Foodstuffs, Cosmetics and Disinfectant's Act of 1972 and its regulations.  Regulations relating to caffeine-containing soft drinks, specifically those categorised as ‘formulated caffeinated beverage or cola beverage’, have recently been modified to be more stringent in an effort to enhance public awareness of possible effects and to protect consumers against misleading labels. All food labels need to comply with the new regulations by 1 March 2012.  Where ‘energy drinks’ contain more than 150 mg/L of caffeine, the amended regulations require that the containers state the quantity of caffeine per serving size and per 100 mL (expressed in mg) and state ‘high caffeine content’ on the label in a particular font and size (i.e. bold capital letters not less than 3.0 mm in height).  Advisory statements in similar font are required regarding unsuitability for children under 12 years, pregnant women and those sensitive to caffeine and note that products are not to be consumed with alcohol.134  The public had until 13 August 2011 to comment on the draft amendment.135 Middle East  According to an article from the Emirates Authority for Standardization and Metrology Agency (ESMA), 17 July 2011, the United Arab Emirates is soon to implement new requirements for warning labels for energy drinks as part of its commitment to the ‘best healthy ways’ for the consumer.136  As of the first quarter of 2012, all energy drinks for retail sale will require health warning labels, and are to be positioned on shelves that also carry bi-lingual (Arabic and English) health warning advice.  ESMA will require energy drink brands to be registered and certified to demonstrate rule compliance. ESMA describes a cooperative ‘censorship mechanism’ whereby the state authority will check the product for safety and conformity with the regulations while the local

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Country Exception censorship bodies will manage retail positioning and presence of health warnings.137  Further to, the Ministry of Economy has issued notices for supermarkets to provide warnings on supermarket shelves that energy drinks are not suitable for children under 16, pregnant women, and people sensitive to caffeine, and diabetic patients.138 Russia  In Russia, it was recently reported that the predominantly Muslim region of Chechnya is planning to ban the sale of non-alcoholic energy drinks such as Red Bull to under-18s, saying they are un-Islamic and dangerous. “Energy drinks are comparable to beer”, the Deputy Minister of Health in Chechnya, Rukman Bartiyev, told Reuters, adding that they were harmful to health.139  The more conservative sectors of Chechen society were reported as praising the proposed ban whereas, it was met with anger by the ordinary Chechens noting they are becoming increasingly frustrated at laws that only apply to Chechnya and sometimes contradict the Russian constitution.139

Codex Alimentarius Commission

About Codex Codex Alimentarius is the Latin term for ‘food code’: it is a code of food standards for all nations. It was developed by an international commission in 1962. Its purpose is to guide and promote the elaboration and establishment of definitions and requirements for foods, to assist in their harmonisation and, in doing so, to facilitate international trade.140

Codex is taken into consideration in its role of developing international food standards and guidelines under the auspices of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Australia and New Zealand are both part of the 167 country membership of Codex, and through their involvement on many Codex committees assist with the development of its standards and guidelines.

Codex does not have specific provisions for caffeinated energy drinks, although the matter has been raised through at least two Codex Committees, the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) and the Codex Committee on Food Labelling (CCFL).  The CCNFSDU considered energy (stimulant) drinks in 2000 and 2001 in conjunction with their discussions around sports drinks, and the need or not for a definition of ‘high energy’. In November 2001 the decision was made that neither a definition for high energy nor a standard for sports drinks and energy drinks was needed.141,142  At its meeting in 2010, the CCFL was due to discuss the ‘misleading name of energy drinks’. However, as an agenda paper was not presented for the item, it was subsequently deferred until such time as a discussion document becomes available.143 It remains to be seen whether Codex will instigate any further activity in respect of CEDs, but it seems unlikely at this point in time.

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Issues/unanswered questions  Not all countries that sell CEDs have developed regulation to specifically address these products, and/or the current arrangements are still in a state of development or review.  A common definition for energy drinks has not been established and the matter of what is a beverage and what is a shot remains unanswered. Such differentiation may eventually emerge by default, with most energy drinks regulated as foods, and energy shots regulated as food or health supplements or therapeutic products, and with energy shots manufactured as concentrated products of 100mL or less in volume (see Appendix VIII).  The inclusion or otherwise of guarana’s contribution to caffeine content is not always clear and has not been substantially investigated in this review. Government documents do not always explicitly mention guarana, and label information may or may not be required to quantify caffeine contribution from guarana. In any future work further consideration should be given to whether guarana and other herbal sources of caffeine are captured in requirements for caffeine analysis, declaration of presence, and quantitative contribution.  It would also be valuable to look more closely at the policies and/or risk assessments that have led to the regulatory outcomes in various countries.  The focus of this report is on beverages and shots however, recent innovations in the ‘energy’ market have led to other forms of caffeine-containing foods such as gels, concentrated powders, dissolvable ‘sheets’, and chewing gums. Regulatory approaches to these other products should also be considered if caffeine in the food supply is to be looked at more broadly.

9.4 Self-regulation The beverage industry around the world has recognised the need to take responsibility for the promotion, marketing and access to CEDs and energy shots. To this end there are a number of self-regulatory initiatives in place, either by individual companies, or by umbrella beverage associations that cover the majority of brand leaders in their market.

The beverage associations reviewed (both in Australia and New Zealand and overseas) typically provide consumer-friendly information, such as fact sheets or other statements on their websites regarding the responsible and safe use of energy drinks. These types of recommendations often go beyond the legislative requirements as outlined above in Sections 9.2 and 9.3.

Government regulation applies to all suppliers within the jurisdiction of the law, while industry’s self-regulation only formally captures its members, although it may also impact on the behaviours of those non-members who are aware of it. While this is an important aspect difference to note, in the interests of minimal effective regulation, industry self-regulation and provision of consumer information may be sufficiently far reaching to support a cost-effective, less prescriptive, approach to the risk management of CEDs in many circumstances.

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Self-regulation in Australia and New Zealand The umbrella beverage organisations in Australia and New Zealand are:  The Australian Beverages Council (ABC), which represents over 95% of the non- alcoholic beverage industry in Australia, and 99% by volume of CED production in Australia; and  The New Zealand Juice and Beverages Association (NZJBA), which represents the manufacturers of New Zealand's juice, carbonated drink and bottled water brands, and their suppliers; currently, NZJBA members represent over 95% of all juice and beverages sold at a retail level in New Zealand.

The NZJBA has joined with the ABC in adopting an ‘Industry Commitment’, which supports a responsible approach to the marketing, promotion and consumption of these products in order to ensure energy drinks are not available in schools, are not directed at children and are not promoted for mixing with any other beverage. The commitment also addresses further aspects in relation to energy drinks and alcohol (refer to Appendix VIII).118

Both associations also subscribe to an Industry Code for the Manufacturing and Marketing of Energy Shots (refer to Appendix VIII).16 117 This Code focuses on adults as the target market and requires that energy shots not exceed 160 mg caffeine per shot. As the typical shot size is 60mL, this means 160 mg caffeine/60mL (2667 mg/L) compared with 80 mg caffeine/ 250mL caffeine permitted in CEDs (320 mg/L). This approach was not based on shots being a comparative ‘beverage’ but rather, a dosage approach as fits within the shot concept, whereby the daily caffeine intake afforded by one shot, would be equivalent to the amount of caffeine consumed in the recommended maximum ‘daily amount’ of CEDs (e.g. 2 x 250mL cans at 80 mg caffeine per can = 160 mg caffeine). The commitment also proposes a maximum daily intake of caffeine through shots as 200 mg/day; on the basis of 160 mg/serve this would represent 1.25 serves. Random market surveillance done by FSANZ identified that some energy shots contain 200 mg caffeine as a single serve, and Appendix VI provides two examples of shots containing 250 mg or 300 mg /serve.6

The Industry Code goes on to outline advisory statements, which are in line with those required on FCBs, and to suggest that retailers ensure visibility of advisory statements and do not position products near items of interest to children e.g. confectionery.

Self regulation in Canada The Canadian Beverages Association is the national industry association in Canada representing the broad spectrum of brands and companies that manufacture and distribute the majority of non-alcoholic liquid refreshment beverages consumed in Canada.144

The Association provides a number of consumer information sources regarding energy drinks. Current examples include:  a brochure on ‘Understanding energy drinks, what are they, who are they for’;  an Energy Drinks Fact Sheet that includes; “Recommended use of Energy Drinks: As a product category energy drinks are recommended for adults and are not recommended for children, pregnant or breastfeeding women, and people who are sensitive to caffeine”; and  a link to the Health Canada ‘Safe Use of Energy Drinks’ fact sheet.

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Self-regulation in the UK

The British Soft Drinks Association (BSDA) represents the interests of producers and manufacturers of soft drinks including carbonated drinks, still and dilutable drinks, fruit juices and bottled water in Britain. BSDA members are responsible for the vast majority of products on the British soft drinks market.

In 2008, the BSDA released a press statement saying that ‘High-caffeine energy drinks are not recommended in the UK for consumption by children and it is not permitted to provide them in schools’.145

In 2010, the BSDA also published a voluntary Code of Practice for the labelling of energy drinks. It similarly recommended that all beverages classed as energy drinks carry the statement ‘Not suitable for children, pregnant women and persons sensitive to caffeine’ on their labels; and the energy drinks not be promoted to children under 16yrs.146

Self-regulation in the US The American Beverage Association (ABA) was founded in 1919 and represents hundreds of beverage producers, distributors, franchise companies and supply industries. The ABA broadly covers manufacturers and distributors of non-alcoholic energy drinks in the US and provides voluntary guidance specifically for the responsible labelling and marketing of energy drinks in the US.

Similar to other codes discussed, it addresses label information regarding caffeine content, advice against mixing with alcohol, and for avoidance by susceptible groups (children pregnant women, and caffeine-sensitive individuals). It also clarifies these are not sports drinks, not suitable for children and should not be marketed as such, nor sold in schools.147

Self-regulation in the European Union The Union of European Beverages Association (UNESDA), founded in 1958, represents a substantial portion of the European non-alcoholic beverages association. Its members are soft drinks companies who conduct their business in at least five EU Member States and include national trade associations from 25 European countries.

A revised version of the UNESDA Code of Conduct targeting the labelling and marketing of energy drinks was published in December 2010 and is due to be fully implemented by the end of 2011.148 It specifically addresses high caffeine beverages as defined by the Commission Directive 2002/67/EC.149 The guidelines include labelling recommendations such as “consume moderately” and “not recommended for children, pregnant women and persons sensitive to caffeine”. Principles for marketing include there should be no communications directed to under 12-year-olds and no promotional activities in the vicinities of schools or similar demographic institutions. These principles also identify the distinction between energy drinks and sports foods and that energy drinks should not be promoted as delivering rehydration.

Further to the above Code on energy drinks, UNESDA has also recently launched a comprehensive Code of Conduct specifically covering the responsible sales and marketing of Energy Shots150 (see Appendix VII). This Code describe energy shots as small volume liquids (no more than 100mL) for the adult market, and specifically notes them as being dietary supplements formulated to the Commission Directive 2002/64/EC.151

The voluntary Code on energy shots was launched in May 2011 with immediate effect and is to be fully implemented by UNESDA members by the end of 2012. In accordance with the requirements of Commission Directive 2002/46/EC, there are a number of required labelling statements including recommended daily dose, and warnings about exceeding that dose.

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UNESDA members are also required to declare the presence of caffeine and quantify it, and provide advisory statements regarding children, pregnant women and caffeine sensitive persons. The Code provides guidance against promoting the mixing of energy shots with alcohol, promotion to children, and suggests that retailers be encouraged to place products near counters where sales can be monitored. Interestingly, it also advises that “energy shots should not be placed next to energy drinks so that the two categories are not confused.”

In addition, the Code addresses consumer information and requires the industry to provide comprehensive information about energy shots, their responsible consumption, and the characterising ingredients and caffeine content relative to other sources.

Energy Drinks Europe is a new organisation established in December 2010. Within its role as a European association specifically representing European energy drink producers, Energy Drinks Europe is building on the work already done by UNESDA and developing a marketing code on energy drinks for its members.

9.5 Company initiatives In addition to the codes of their umbrella organisations, major companies that manufacture and supply CEDs in Australia and New Zealand also have their own internal policies and guidance, as noted here.  Frucor has an internal policy not to promote energy drinks (full sugar and sugar free) to under 18 year olds, this thereby also excludes these products from schools.  Frucor and Coca Cola Amatil engaged in a voluntary agreement in 2006 with the NZ government to withdraw all full sugar energy drinks (including shots) and soft drinks from schools by the end of 2009. At the time it was a world first agreement of its type.  Red Bull has been actively involved in the development of a number of the above codes, such as those of ABC, NZJBA, UNESDA, and Energy Drinks Europe, and commits it subsidiaries and distribution partners worldwide to use best endeavours to adhere to the marketing principles set out in those codes.

Issues/unanswered questions  The extent to which energy drinks and shots should be regulated by governments, or self- managed by industry should be considered. Different approaches have emerged in different countries potentially in response to external factors such as market supply, consumer behaviour, trade aspects and/or political interest.  Any future consideration of the regulatory management of CEDs should take into account ongoing or emerging actions by industry, and should include monitoring of activities already implemented in order to ascertain effectiveness, and coverage of the market.  A comprehensive cost–benefit analysis would be important to assist in consideration of whether risk management measures should be government or industry based, or a combination of both.

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10. ISSUES AND UNANSWERED QUESTIONS Many issues and unanswered questions relating to effects of CEDs and their ingredients, consumption patterns, marketing, and regulatory frameworks have been identified throughout this review. Some of these issues reflect evidence gaps; others areas where conflicting opinions and data exist. The key issues are summarised below by question area.

Caffeine  Currency of information: Data relating to caffeine intake from the New Zealand NNS Survey (1997) and the Australian National Nutrition Survey (1995) are now out of date. Consumption choices, amounts and types of products available have changed in the past 15 years. Up-to-date data are required if baseline dietary exposure assessments are to be accurate.6  Verification of caffeine levels in CEDs and compliance with regulations: Surveys of CEDs in NSW found that many exceeded the maximum levels of caffeine. More information is needed regarding levels of caffeine in CEDs and whether they comply with regulations, both in Australia and New Zealand.  Positive effects at low doses: The basis for observed positive effects of caffeine at low doses is controversial; some reports suggest that caffeine merely removes negative effects associated with caffeine withdrawal.3 Recent studies have failed to resolve this issue.  Threshold dose for behavioural effects in children: The threshold dose for possible behavioural effects in children is unclear and further studies are needed to elucidate the potential effects of caffeine in children at doses that may be ingested from dietary sources.3  Long-term effects on health in children: The literature relating to effects of caffeine in children is inadequate and firm conclusions cannot be made about caffeine’s potential to produce long-term negative health effects at different dose levels.3  Withdrawal and dependency: Further research is required at doses typically consumed in the diet to examine whether withdrawal effects and physical dependency occur in children.3  Addiction: It has been suggested that early caffeine use is a significant risk factor for later drug use (e.g. tobacco). There is a need to understand this relationship in order to increase awareness of the long-term consequences of early caffeine use in children and adolescents.28  Conditioning: Studies are needed to examine whether early childhood consumption of soft drinks containing caffeine conditions a taste preference for sugary foods and/or promotes a preference for the combination of sugar and caffeine in adulthood.28  Reinforcing: Research is needed in adults and in children to assess reinforcing properties of caffeine. Caffeine in combination with high levels of sugar in beverages may act synergistically to release dopamine, increasing the reinforcing properties of sweetened beverages.28

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Individual ingredients in CEDs  Consumption and dose: The EFSA Panel advice on taurine and glucuronolactone in CEDs is based on effects of 250mL cans in a 60 kg person. The Australian and New Zealand body mass is on average larger than 60 kg for an adult and many products are also available in 500mL cans. Moreover, reports suggest that people may consume more than the amount considered to be the ‘average’ intake.7  Synergistic effects: Only limited data exist from peer-reviewed studies on the physiological and behavioural effects of the combined ingredients of CEDs to determine if the ingredients have synergistic effects. This is an area that requires further study.4 28  Use during exercise: There is also a need to investigate possible negative effects of interactions between ingredients such as caffeine and taurine, particularly under conditions of exercise and consequent dehydration through sweating.4

Effects of CEDs  It is not possible to determine whether any of the cases of adverse events/overdose reported in the articles can be linked conclusively to consumption of CEDs.  Although there are many reviews of CEDs, no high-quality scientific studies exist that clearly demonstrate a link between CED exposure, negative health effects, and fatalities. A full critical appraisal is required before a judgement can be made on the quality of the reviews and articles that link CEDs with negative effects.  Further research is needed to better define maximum safe doses, the effects of chronic use and chronic overconsumption, and effects in at-risk populations (e.g. those with pre-existing medical conditions, those who consume CEDs during and after exercise), and better documentation and tracking of adverse health effects. 11  Concern has been expressed about how to communicate risk to all the possible sensitive or high-risk groups.12,13  Concern has been expressed as to whether consumers can differentiate sports drinks from CEDs when they are sometimes categorised or referred to together.12,13  Clinical pharmacology and epidemiological studies have demonstrated an association of caffeine use with dependence on alcohol, nicotine, and other drugs, and one study showed that CED use predicts subsequent non-medical use of prescription stimulants. This needs to be investigated further.14

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CED consumption and drivers of consumption  CED consumption information for New Zealand and Australia is incomplete, and the data that exists is dated. This represents a significant data gap.6  A similar data gap has been noted by the EFSA Panel, who stated that there is a particular need for consumption data for adolescents and young adults.7  CED consumption data needs to be collected regularly to establish trends in consumption.  More information is needed about the target market for CEDs, and whether marketing of CEDs is influencing consumption of CEDs by individuals who fall outside of the stated market (adolescents and young adults).

Bi-national and international regulations  Not all countries that sell CEDs have developed regulation to specifically address these products, and/or the current arrangements are still in a state of development or review.  A common definition for energy drinks has not been established and the matter of what is a beverage and what is a shot remains unanswered. Such differentiation may eventually emerge by default, with most energy drinks regulated as foods, and energy shots regulated as food or health supplements or therapeutic products, and with energy shots manufactured as concentrated products of 100mL or less in volume (see Appendix VIII).  The inclusion or otherwise of guarana’s contribution to caffeine content is not always clear and has not been substantially investigated in this review. Government documents do not always explicitly mention guarana, and label information may or may not be required to quantify caffeine contribution from guarana. In any future work further consideration should be given to whether guarana and other herbal sources of caffeine are captured in requirements for caffeine analysis, declaration of presence, and quantitative contribution.  It would also be valuable to look more closely at the policies and/or risk assessments that have led to the regulatory outcomes in various countries.  The focus of this report is on beverages and shots however, recent innovations in the ‘energy’ market have led to other forms of caffeine-containing foods such as gels, concentrated powders, dissolvable ‘sheets’, and chewing gums. Regulatory approaches to these other products should also be considered if caffeine in the food supply is to be looked at more broadly.

Industry initiatives  The extent to which energy drinks and shots should be regulated by governments, or self-managed by industry should be considered. Different approaches have emerged in different countries potentially in response to external factors such as market supply, consumer behaviour, trade aspects and/or political interest.  Any future consideration of the regulatory management of CEDs should take into account ongoing or emerging actions by industry, and should include monitoring of activities already implemented in order to ascertain effectiveness,

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and coverage of the market.  A comprehensive cost–benefit analysis would be important to assist in consideration of whether risk management measures should be government or industry based, or a combination of both.

Evidence gaps that may warrant further research:  concerted toxicological investigations at an international level;4  long-term studies to understand the effects in at-risk populations;  the possible adverse effects on exercise performance and fluid balance during sport and exercise due to interaction of the principal ingredients contained in CEDs;4  the contribution of CEDs to childhood obesity and psychiatric illness, including attention deficit / hyperactivity disorder62  addiction research in adolescents chronically using CEDs, given the links between caffeine dependence to tobacco and alcohol use and the suggestion that CED use serves as a gateway to other forms of drug dependence;14 62 and  the possible adverse effects of the interaction of CEDs with recreational drugs (e.g. Ecstasy).4

Policy suggestions that may warrant discussion:  monitoring of patterns of CED consumption;4  improvements in toxicity surveillance;11  ensuring regulations for CED sales and consumption are based on appropriate research;11  encouraging clinicians to screen for CED use among their patients to identify symptoms related to toxicity and give patients greater understanding of the risks of high-dose and long-term CED use;62,103  encouraging clinicians to report all suspected cases of CED toxicity to a poison control centre to allow generation of pooled data to drive analysis and legislation on these products;62,103  considering interventions to reduce consumption by adolescents, such as educational interventions to inform adolescents of the consequences of consuming CEDs;61banning CEDs in schools; and education for parents to limit their children’s access to high caffeine drinks.103

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11. CONCLUSIONS The growing popularity of CEDs is due in part to a range of commonly held beliefs about CEDs, that is that they can boost energy levels, improve weight loss, increase stamina, improve physical performance and increase alertness and concentration. Many people who consume CEDs believe that these drinks provide short-term physical or mental benefits. Some of the marketing strategies used to promote CEDs encourage these beliefs.

This review identified little high-quality evidence relating to the purported beneficial or negative effects of CEDs. There also appears to be little evidence that energy drinks are any more effective at improving cognitive function or increasing energy than traditional caffeinated beverages such as coffee, tea or kolas. As with coffee, tea and kolas, any beneficial mental or physical effects appear to be derived primarily from their caffeine and sugar content.

Concerns about the potential health issues associated with CEDs stem from the caffeine and sugar content of these products. Other common ingredients, such as ginseng, taurine, glucuronolactone and guarana, are reported not to be a safety concern at the levels found in CEDs. However, given the many ingredients in CEDs, synergistic effects are a possibility and further investigation appears to be warranted.

In the absence of high-quality evidence of negative effects of CEDs, consumers have generally been advised to limit their CED consumption to no more than one (500mL) can of CED per day. This may be particularly pertinent in children and adolescents in whom lower body weights and ongoing brain development may make them more susceptible to negative effects.

While CEDs appear to be safe for the majority of consumers when used in moderation, the high caffeine content may pose health risks for certain populations. Populations identified as being at potentially higher risk include pregnant or lactating women and people with pre- existing medical conditions, such as high blood pressure, arrhythmias and other heart disorders, epilepsy, diabetes, kidney disease, migraine or mental health issues. In addition, current opinion suggests that people who consume CEDs during and after exercise or sports should also be considered an at-risk population until further research demonstrates otherwise.

Many consumers are unaware that energy drinks contain large quantities of caffeine and sugar, or of the differences between CEDs and sports drinks. The need for consumer education is likely to increase given the blurring of categories and continuing product diversification by beverage manufacturers.

It appears that long-term research is needed to understand the effects in at-risk populations, to better define maximum safe doses of CEDs, and to determine whether there are any negative effects associated with chronic, long-term use of CEDs. In the meantime, it would seem appropriate for doctors to be aware of the possible effects of CEDs in at-risk populations and potentially screen for consumption to educate families and individuals.

Regulations of CED sales and consumption should be based on appropriate research and locally relevant data. However, gaps in data exist and these gaps limit the recommendations that can be made. Up-to-date consumption data are needed for Australia and New Zealand in order to establish who is consuming CEDs, when and why they are consuming these products, as well as any emerging trends. Toxicity surveillance could also be improved. Provision of a unique reporting code for CEDs would allow toxicity to be tracked more clearly.

There is considerable variation in the way in which CEDs are currently regulated around the world. The management of CEDs has emerged in an ad hoc way and it is difficult to establish

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what the pre-determining risk assessments and/or policies are that may have guided the regulators’ decisions. Governments have instituted a variety of laws or other provisions; while industry, as represented here by beverage manufacturers and/or their umbrella organisations, has responded with significant self-regulatory activity in this space, which often goes above and beyond domestic legislation.

There are, however, a number of common threads and similarities in approach by governments and industry, specifically in relation to delineating caffeine levels, advisory statement contents, and volumes and caffeine concentrations for energy shots. Caffeine limits in cola/kola- based beverages are commonly linked to those of CEDs and used as a benchmark for regulatory differentiation with CEDs.

There are a number of regulatory issues that would benefit from further investigation, specifically, government policies, regulatory approaches to guarana, definitions for CEDs and consumer perceptions and uses of ‘shots’, other novel dietary sources of caffeine, and the contribution of self-regulatory initiatives by industry to the overall risk management of CEDs.

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APPENDIX I: STANDARD 2.6.4 FORMULATED CAFFEINATED BEVERAGES

Purpose The purpose of this Standard is to regulate non-alcoholic water-based flavoured formulated caffeinated beverages that are manufactured for the purpose of enhancing mental performance.

Table of Provisions 1. Interpretation

2. Composition

3. Labelling

1 Interpretation In this Standard –

 caffeine means all caffeine present from whatever source in a formulated caffeinated beverage.

 formulated caffeinated beverage means a non-alcoholic water-based flavoured beverage which contains caffeine and may contain carbohydrates, amino acids, vitamins and other substances, including other foods, for the purpose of enhancing mental performance.

 one day quantity in relation to formulated caffeinated beverage, means the maximum amount of that food that should be consumed in one day in accordance with the directions specified in the label.

2 Composition (1) A formulated caffeinated beverage must contain no less than 145 mg/L and no more than 320 mg/L of caffeine.

Editorial note: See Standard 1.3.1 – Food Additives for the limits for food additives, other than caffeine, in formulated caffeinated beverages.

(2) A formulated caffeinated beverage may contain the substances listed in column 1 of the Table to this subclause, provided the amount of that substance present in the food is no more than the amount specified in relation to that substance in column 2 of the Table.

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Table to subclause 2(2)

Column 1 Column 2 Substance Maximum amount per one-day quantity Thiamin 40 mg Riboflavin 20 mg Niacin 40 mg Vitamin B6 10 mg Vitamin B12 10 µg Pantothenic acid 10 mg Taurine 2000 mg Glucuronolactone 1200 mg Inositol 100 mg

(3) A formulated caffeinated beverage must not be mixed with a non-alcoholic beverage as standardised under Standard 2.6.2.

Editorial note: Other foods such as herbal substances may be added to formulated caffeinated beverages unless this is proscribed elsewhere in the Australia New Zealand Food Standards Code. Standard 1.4.4 regulates prohibited and restricted plants and fungi, and Standard 1.3.1 regulates food additives.

3 Labelling (1) The label on a package of formulated caffeinated beverage must include declarations of the average quantities, per serving size and per 100 mL of –

(a) caffeine, expressed in milligrams; and

(b) the substances listed in column 1 of the Table to subclause 2(2), where present, expressed in the units included in column 2 of the Table.

(2) The declarations under subclause 3(1) may be adjacent to or follow a nutrition information panel on the label of a package of formulated caffeinated beverage, provided that the declarations are clearly distinguished from the nutrition information required by Standard 1.2.8.

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Editorial note: An example of the placement of the declarations required under subclause 3(1) adjacent to or following a nutrition information panel as permitted under subclause 3(2) is set out below.

NUTRITION INFORMATION Servings per package: (insert number of servings) Serving size: 250 mL Quantity per Quantity per 100 Serving mL Energy kJ (Cal) kJ (Cal) Protein g g Fat, total g g – saturated g g Carbohydrate, total g g – sugars g g Sodium mg (mmol) mg (mmol) COMPOSITION INFORMATION Caffeine mg mg Thiamin mg mg Riboflavin mg mg Niacin mg mg Vitamin B6 mg mg Vitamin B12 µg µg Pantothenic acid mg mg Taurine mg mg Glucuronolactone mg mg Inositol mg mg

(3) The label on a package of formulated caffeinated beverage must include advisory statements to the effect that –

(a) the food contains caffeine; and

(b) the food is not recommended for –

(i) children; and

(ii) pregnant or lactating women; and

(iii) individuals sensitive to caffeine.

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(4) The label on a package of formulated caffeinated beverage that contains one or more of the substances in the Table to subclause 2(2) must include an advisory statement to the effect that –

‘Consume no more than [amount of one-day quantity (as cans, bottles or mL )] per day’.

(5) Where a formulated caffeinated beverage is not required to bear a label pursuant to clause 2 of Standard 1.2.1, the advisory statements under subclauses 3(3) and 3(4) must be –

(a) displayed on or in connection with the display of the food; or

(b) provided to the purchaser on request.

Editorial note: The advised one-day quantity is calculated from the permissions in the Table to subclause 2(2) as it relates to the concentration of substances in the product. The substance that yields the lowest equivalent amount will determine the advised consumption limit.

For example:

Column 1 Column 2 Column 3 Column 4 Product X Concentration Maximum permitted Equivalent amount formulation (mg/L) one-day quantity of product X (mL) (refer to Table to subclause 2(2)) Riboflavin 30 20 666 Niacin 80 40 500 Pantothenic acid 15 10 666 Taurine 2000 2000 1000

The equivalent amount in Column 4 is calculated as (Column 3 x 1000) /Column 2

In this example niacin presents as the most limiting substance, and therefore, the advised consumption limit for product X would be 500 mL. If product X is packaged in 250 mL cans, the advised consumption limit may also be expressed as ‘two cans’ – for example – ‘consume no more than 500 mL per day’ or ‘consume no more than two cans per day’.

(6) A formulated caffeinated beverage is not a ‘claimable food’ in Standard 1.3.2.

(7) The label on a package of formulated caffeinated beverage must not include declarations of the quantities of vitamins present in the food expressed as a proportion or multiple of the –

(a) Recommended Dietary Intakes; or

(b) Estimated Safe and Adequate Daily Dietary Intakes; of that vitamin.

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APPENDIX II: MINISTERIAL POLICY GUIDELINE ON THE ADDITION OF CAFFEINE TO FOODS

Ministerial Council Policy Guideline on the Addition of Caffeine to Foods17 Endorsed by the Ministerial Council on 4 April 2003

Scope/aim To limit the exposure of vulnerable individuals to foods containing caffeine.

High order principles 1. Give priority to protecting public health and safety. 2. Ensure that consumers have access to sufficient information to enable informed and healthy food choices. 3. Ensure that industry innovation and competitiveness is supported, except where public health and safety is affected. 4. Be consistent with, and complement, Australia and New Zealand national policies and legislation including those relating to nutrition and health promotion, fair trading, industry growth and international trade and innovation.

Be cost-effective overall, not more trade restrictive than necessary, and comply with Australia’s and New Zealand’s obligations under the WTO Agreements.

Other principles 1. Endeavour to limit the possible adverse effect of caffeine containing foods on vulnerable sub-groups of the population. 2. Ensure that the effect of caffeine additions to individual foods is considered in the context of the total diet. 3. Ensure the appropriate use of advisory statements on caffeine-containing foods in alignment with scientifically substantiated risk to vulnerable sub-groups of the population.

Policy guidance Until further evidence becomes available, maintain the status quo (as currently in place in Australia and New Zealand) for caffeine regulation by: 1. maintaining the current additive permissions for caffeine; and 2. restricting the use of new products containing non-traditional caffeine rich ingredients (including guarana) to boost the caffeine content in other food, beyond the current provisions for caffeine.

Caffeinated kola drinks and formulated caffeinated beverages will be permitted in accordance with the current standards.

Foods, which naturally contain caffeine and have a long history of use and consumer awareness/association with caffeine, such as tea, coffee and cocoa, are to be exempt from the labelling provisions and the use of these foods naturally containing caffeine to be added to other foods will continue to be allowed. Guarana, as a non-traditional food containing caffeine, will continue to have special labelling provisions outlined in the Food Standards Code.

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APPENDIX III: ABBREVIATIONS ABA American Beverage Association ABC Australian Beverages Council ACOG American College of Obstetricians and Gynaecologists ADHD Attention deficit hyperactivity disorder ADI Acceptable Daily Intake ADRAC Adverse Drug Reactions Committee ANZFA Australia and New Zealand Food Authority (now known as Food Standards Australia and New Zealand (FSANZ)) ARTG Australian Register of Therapeutic Goods BfR Federal Institute for Risk Assessment (Germany) BSDA British Soft Drinks Association CEDs Caffeinated energy drinks CCFL Codex Committee on Food Labelling COT Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (UK) DEFRA Department for Environment, Food and Rural Affairs (UK) DSHEA Dietary Supplement Health and Education Act 1994 (USA) EDIS Emergency Department Information System EEA European Economic Area EFSA European Food Safety Authority ESMA Emirates Authority for Standardization and Metrology Agency EU European Union FAO Food and Agriculture Organization FCBs Formulated caffeinated beverages FGR Foetal growth restriction FDA US Food and Drug Administration FOSHU Foods for Specified Health Uses (Japan) FRSC Food Regulation Standing Committee FSA Food Safety Authority (UK) FSANZ Food Standards Australia New Zealand GMP Good Medical Practice GRAS Generally recognised as safe IGCD Intergovernmental Committee on Drugs IMA Interim Marketing Authorization MeSH Medical Subject Heading mg/kg bw/day mg per kg of body weight per day MLHW Ministry of Health, Labour and Welfare (Japan)

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NHMRC National Health and Medical Research Council NHPD Natural Health Products Directorate (Canada) NNCNS New Zealand National Children’s Nutrition Survey NPIC National Poisons Information Centre NZ NNS New Zealand National Nutrition Survey NZDSR New Zealand Dietary Supplement Regulations NZJBA New Zealand Juice and Beverages Association PIC Poisons information centre PPM Parts per million RCT Randomised controlled trial SFS New Zealand Food (Supplemented Food) Standard 2010 TGA Therapeutic Goods Administration TTMRA Trans-Tasman Mutual Recognition Arrangement UNESDA Union of European Beverages Association WHO World Health Organization

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APPENDIX IV: SEARCH STRATEGY

SUMMARY Searches were conducted in PubMED/MEDLINE, PsycINFO, the Cochrane Database of Systematic Reviews, Google Scholar and Google general databases during the period 23/6/2011 to 27/6/2011. For questions 1 and 2 Medical Subject Headings (MeSH) in the PubMED/MEDLINE databases were used. In PsychINFO terms were mapped to subject headings.

Summary of database searches

Total titles in Endnote library 127 By study type Clinical trials – not randomised 15 Randomised clinical trial 17 Randomised trial 21 Case report 9 Review 12 Comparative study 11 Other study type not described or no abstract 42

By topic, with overlap Caffeine 108 Taurine 23 Ginseng 11 Glucuronolactone 7 Guarana 10 Energy drink 52 Energy shot 0 Sugar or glucose or sucrose 60

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SEARCHES AND HITS

Question 1: What is the current state of evidence as to the negative effects of caffeine in children, adolescents and adults? PubMED/MEDLINE Date of search 24/6/2011 Limits: humans; search period 1/1/2010 to 22/6/2011 Search terms MeSH terms Hits Caffeine and ("Caffeine/adverse effects"[Mesh] OR 14 psychology "Caffeine/contraindications"[Mesh] OR "Caffeine/pharmacology"[Mesh] OR "Caffeine/toxicity"[Mesh]) AND "psychology"[Subheading] AND ("humans"[MeSH Terms] AND English[lang] AND ("2010/01/01"[PDAT] : "2011/06/22"[PDAT])) Caffeine and ("Caffeine/adverse effects"[Mesh] OR 2 physiology "Caffeine/contraindications"[Mesh] OR "Caffeine/pharmacology"[Mesh] OR "Caffeine/toxicity"[Mesh]) AND "Physiology"[Mesh] AND ("humans"[MeSH Terms] AND English[lang] AND ("2010/01/01"[PDAT] : "2011/06/22"[PDAT])) Subtotal for PubMED/MEDLINE* + 16 PsycINFO Date of search 23/6/2011 Limits: humans; search period 1/1/2010 to 22/6/2011 Search Q1. 1. ((caffeine and adverse effects).mp. OR 2 Caffeine and harm 2. (caffeine and toxicity).mp. OR 3. (caffeine and pharmacology).mp. OR 4. (caffeine and contraindications).mp) 5. ((caffeine and psychology).mp. OR 6. (caffeine and physiology).mp. ) For all of these [mp=title, abstract, heading word, table of contents, key concepts, original title, tests & measures] 7. 1 or 2 or 3 or 4 8. 5 or 6 9. 7 and 8 10. limit 9 to (psycarticles journals and human and english language and yr="2010 - 2011") Subtotal for PsycINFO* 2

Question 2: What is the current state of evidence as to the negative effects in children, adolescents and adults of ingredients such as taurine, ginseng, guarana, glucuronolactone and sugar that are commonly added to CEDs? PubMED/MEDLINE Date of search 24/6/2011 Hits Limits: humans; search period 1/1/1990 to 22/6/2011 Guarana ("guarana powder"[Supplementary Concept] OR 14

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"Paullinia"[Mesh]) AND ("Caffeine/adverse effects"[Mesh] OR "Caffeine/contraindications"[Mesh] OR "Caffeine/pharmacology"[Mesh] OR "Caffeine/toxicity"[Mesh]) LIMITS Humans, English, Ginseng ("Panax"[Mesh] OR "ginseng pentadecapeptide, Panax 5 ginseng"[Supplementary Concept]) AND ("Caffeine/adverse effects"[Mesh] OR "Caffeine/contraindications"[Mesh] OR "Caffeine/pharmacology"[Mesh] OR "Caffeine/toxicity"[Mesh]) AND ("humans"[MeSH Terms] AND English[lang] AND ("1990/01/01"[PDAT] : "2011/06/22"[PDAT])) Glucuronolactone ("glucuronolactone"[Supplementary Concept]) AND ("Caffeine/adverse effects"[Mesh] OR 7 "Caffeine/contraindications"[Mesh] OR "Caffeine/pharmacology"[Mesh] OR "Caffeine/toxicity"[Mesh]) Taurine ("Taurine/toxicity"[Mesh] OR ("Taurine/adverse 19 effects"[Mesh] OR "Taurine/contraindications"[Mesh] OR "Taurine/pharmacology"[Mesh])) AND ("Caffeine/adverse effects"[Mesh] OR "Caffeine/contraindications"[Mesh] OR "Caffeine/pharmacology"[Mesh] OR "Caffeine/toxicity"[Mesh]) AND ("humans"[MeSH Terms] AND English[lang] AND ("1990/01/01"[PDAT] : "2011/06/22"[PDAT])) Sugar (glucose or ("Glucose"[Majr] OR "Dietary Sucrose"[Majr]) AND 47 sucrose) and ("Caffeine/adverse effects"[Mesh] OR caffeine and "Caffeine/contraindications"[Mesh] OR psychology and/or "Caffeine/pharmacology"[Mesh] OR physiology "Caffeine/toxicity"[Mesh]) AND ( "physiology"[Subheading] OR psychology [subheading]) AND ("humans"[MeSH Terms] AND English[lang] AND ("1990/01/01"[PDAT] : "2011/06/22"[PDAT])) Subtotal for PubMED/MEDLINE* 81 PsycINFO Date of search 23/6/2011 Limits: humans; search period 1/1/1990 to 22/6/2011 Caffeine and harm 1. (caffeine and adverse effects).mp. 2 and taurine or 2. (caffeine and toxicity).mp. ginseng or guarana 3. (caffeine and pharmacology).mp. or glucuronolactone or sugar 4. (caffeine and contraindications).mp. For all of these search in [mp=title, abstract, heading word, table of contents, key concepts, original title, tests & measures] 5. 1 or 2 or 3 or 4 6. (caffeine or taurine or ginseng or guarana or glucuronolactone or sugar).id. 7. 5 and 6

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8. limit 7 to (psycarticles journals and human and english language and yr="1990 -Current") 9. limit 8 to (human and english language and "0100 journal" and yr="1990 -Current")

Subtotal for PsycINFO* 2

Question 3: What is the current state of evidence as to the negative effects of CEDs on children, adolescents and adults?

PubMED/MEDLINE Date of search 25/6/2011 Hits Search (((((((“Carbonated Beverages/adverse 150 effects”[Mesh] OR “Carbonated Beverages/poisoning”[Mesh] OR “Carbonated Beverages/toxicity”[Mesh]) OR (“Beverages/adverse effects”[Mesh] OR “Beverages/poisoning”[Mesh] OR “Beverages/supply and distribution”[Mesh] OR “Beverages/toxicity”[Mesh])) AND (“psychology”[Subheading] OR “physiology”[Subheading]))) AND (((((energy drink)) OR (energy beverage)) OR (formulated caffeinated energy beverage)) OR (caffeinated energy drink)) OR (energy shot)))) NOT alcohol[MeSH Major Topic] Limits: Humans, English, Publication Date from 1990/01/01 to 2011/06/24 Less title screening, excluding radiotherapy shot, other 137 therapy, gun shot, other beverages Subtotal for PubMED/MEDLINE* 9 PsycINFO Date of search 23/6/2011 (caffeinated energy drink or CED or energy shot or 2 formulated caffeinated beverage or energy beverage or energy drink).id. 2. limit 1 to (human and English language and yr=”1990 – Current”) 3. (toxicity or overdose or withdrawal or dependence).id. 4. 2 and 3 5. limit 4 to (human and”0100 journal” and yr=”1990 – Current”) Subtotal for PsycINFO* 2 Google Scholar Nil useful results 0

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Question 4: How is consumption of CEDs changing, and what drivers influence consumption? Google Scholar Date of search 25/6/2011 Hits Search in: Containing all of the words: caffeine, behavior 89 Biology, Life And exact phrase: ‘energy drink’ Sciences, and NOT alcohol, cycle, cycling, strength, endurance Environmental Science Containing all of the words: caffeine, marketing 0 and And exact phrase: ‘energy drink’ Social Sciences, NOT alcohol, cycle, cycling, strength, endurance Arts, and NB The term ‘consumption’ was too broad a for Google Humanities scholar, as was ‘trend’ and Containing caffeine 2 Medicine, And exact phrase ‘energy shot’ Pharmacology, and NOT alcohol, cycle, cycling, strength, endurance Veterinary Science

Subtotal for Google Scholar* 26 Google web Date of search 27/6/2011 Search terms 4 marketing energy drinks – hits 3,990,000. Scan of first 20 results for news items from industry publications in the first 20 results Subtotal for Google web* 4 PubMED/MEDLINE Date of search 27/6/2011 (energy[All Fields] AND drink[All Fields]) OR (energy[All 2 Fields] AND ("beverages"[MeSH Terms] OR "beverages"[All Fields] OR "beverage"[All Fields]) OR (formulated[All Fields] AND caffeinated[All Fields] AND energy[All Fields] AND ("beverages"[MeSH Terms] OR "beverages"[All Fields] OR "beverage"[All Fields]) OR (caffeinated[All Fields] AND energy[All Fields] AND drink[All Fields]) OR (energy[All Fields] AND shot[All Fields]) Hits: 453 And Marketing [All fields] to the above selection: Hits 2 (energy[All Fields] AND drink[All Fields]) OR (energy[All 29 Fields] AND ("beverages"[MeSH Terms] OR "beverages"[All Fields] OR "beverage"[All Fields]) OR (formulated[All Fields] AND caffeinated[All Fields] AND energy[All Fields] AND ("beverages"[MeSH Terms] OR "beverages"[All Fields] OR "beverage"[All Fields]) OR (caffeinated[All Fields] AND energy[All Fields] AND drink[All Fields]) OR (energy[All Fields] AND shot[All Fields]) Hits: 453 And behaviour

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Hits: 29 Excluding articles about electron spectroscopy, radiation, shot noise, gun shots, coffee consumption, dietary studies Subtotal for PubMED* 31 Cochrane Date of search 25/6/2011 Database of Term searched: Caffeine 0 Systematic Reviews Results: only caffeine as a drug therapy. Term searched: Energy drink Results: Nil. Total titles in Endnote from all searches* 127

* Minus duplicates and papers not in English. NB: At this stage we cannot confirm that full text versions of all of the 127 papers identified are available. + An additional search was carried out in PubMed to supplement the information obtained relating to caffeine and adverse pregnancy outcomes.

Search terms used for websites: Energy drinks; energy shot; formulated caffeinated beverages; energy beverage; caffeine; taurine; ginseng; guarana; glucuronolactone

Website Data sources retrieved

Food Standards Australia New  Report: Expert Working Group Safety Aspects of Zealand Dietary Caffeine, June 2000  Report: FSANZ Annual Report 2009-2010  Standard 2.6.4 Formulated Caffeinated Beverages National Health and Medical  Report: Dietary guidelines for children and adolescents Research Council in Australia, April 2003 Commonwealth Department of  Report: Investment in the Indonesian Food and Agriculture Fisheries and Agriculture Sector. Global food and beverage trends, Forestry (includes energy drinks as one of the fastest growing products) NZ Food Safety Authority  Various website pages  Document: Risk profile: Caffeine in energy drinks and energy shots, April 2010  Fact sheet: “Caffeine – information sheet” National Drug and Alcohol  N/A Research Centre National Institute on Drug  Webpage/fact sheet: “Know the Scene: Energy Drinks: Abuse for Teens A Boost in the Wrong Direction” Australian Drug Foundation  Alcohol and energy drinks

NSW Food Authority  Report: Food Authority Survey – Caffeine in Caffeine Drinks NSW Health  Report: New South Wales Centre for Public Health Soft Drinks, Weight Status and Health: A Review,

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Website Data sources retrieved

2009  Fact sheet: “Caffeine and your health”, 1998 Victoria Department of Health  Report: Healthy choices: food and drink guidelines for Victorian public hospitals, April 2010 Queensland Department of  Fact sheet: “Caffeine and your health” Health South Australia Health  N/A WA Health  MAF Food Safety factsheet. “Caffeine: The facts”, June 2010  MAF Food Safety factsheet: “The coffee chemical”  Booklet, Drug and Alcohol Office, WA Caffeine: the facts, 2006 (as part of drugaware.com.au) NT Health  N/A Tasmania Department of  N/A Health and Human Services WHO  Report: Marketing Food the children: the global regulatory environment, 2004  Report: Chapter 3, Water requirements, impinging factors, and recommended intakes, Ann Grandjean, Centre for Human Nutrition, University of Nebraska NIH  Various webpages including: “Pediatricians group raps energy and sports drinks for kids” 31 May 2011;  Links to articles in Pediatrics some with comments IARC  N/A 12th Food Regulations and  Presentation by Professor Asim K. Duttaroy, Faculty of Labelling Standards Medicine, University of Oslo “Caffeine levels in energy Conference drinks – The imperative for further regulation” European Food Safety  Scientific Opinion of ANS Panel: The use of taurine Authority and D-glucurono-gamma-lactone as constituents of the so-called “energy” drinks, 2009 Health Canada  Consumer information “It’s your health – caffeine”, 2010  Consumer information “Caffeine and carbonated soft drinks”, 2010  Consumer advice “Caffeine consumption: Caffeine advice for children, pregnant and breastfeeding women”, 2010

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APPENDIX V: STAKEHOLDERS CONSULTED

Jane Allen Food Standards Australia New Zealand (FSANZ)

Dr Kevin Buckett Director, Public Health, SA Health

Dr Donald Campbell Principal Adviser/Manager (Public Health), Science, Information and Risk Directorate, Ministry of Agriculture and Forestry, NZ

Tracey Duffy Director, Food Policy Section, Department of Health and Ageing (DoHA)

Emma Dunning Assistant Director, Food Policy Section, Department of Health and Ageing (DoHA)

Rosalind Harrison Senior Scientific Officer (Toxicology), TAS Health

Stuart Heggie State Manager, Environmental Health, Department of Health and Human Services, TAS Health

Edward Jansson Director, Science and Technical Services, NSW Food Authority

Vesna Morosin Acting Assistant Director, Emerging Issues, National Health and Medical Research Council (NHMRC)

Jenny Reid Manager Food Safety, New Zealand Food Safety Authority (NZFSA)

Xavier Schobben Director, Environmental Health Branch, NT Health

Dr Robert Solomon Manager, Food Regulation Policy Section, Department of Agriculture Fisheries and Forestry (DAFF)

Vojkan Stefanovic, Manager, Environmental Health Project Team, ACT Health

John Ward Senior Food Safety Science Officer, Food Safety & Regulation, VIC Health

Sophie Williamson Team Leader, Food Unit Environmental Health Directorate, Department of Health WA

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APPENDIX VI: CLAIMED CAFFEINE CONTENT OF ENERGY DRINKS AND ENERGY SHOTS AVAILABLE IN NEW ZEALAND, FEBRUARY 2010

Product Retail unit size Caffeine Caffeine Guarana Reference (mL) concentration per retail unit concentration (mg/100 mL) consumed (mg/100 mL) (mg) Energy Drinks Angel Energy 300 32 96 NA 1,2,3,6 Drink Big Cock 440 30 132 NA 1,2,6 Charlie’s 500 15 75 Ingredient 2 Vitamin Water, Energy Cocaine 250 32 80 Nil 2 Demon Energy 250 and 500 32 80/160 NA 1,2,3,6 Drink Demon Killa 500 32 160 NA 1,3,6 Troppo Energy Drink Hemp Huge 440 32 141 45 2,6 Ink 500 32 160 120 1,2,4 Monster 500 32 160 Ingredient 1,2,3 Original Monster Ripper 500 32 160 NA 1,2,3 Mother 500 32 160 Nil 1,2,3 Mother Inferno 500 32 160 Nil 1,2,3 NOS Liquid 500 48 240 20 2 Energy Nutrient Water - 575 14 81 25 2,3 Passionfruit Citrus Rasta Blasta 500 32 160 20 2 Red Bull 473 17 80 Nil 1,2,3 Red Bull Sugar 473 17 80 Nil 1,2,3 Free Rockstar Juice 473 32 151 Nil 1,2,3 Rockstar 473 32 151 Nil 1,2,3 Original Rockstar 500 32 151 NA 1,3,6 Punched Supplement 600 17 102 Nil 2,4 Water - Energise Supplement 600 15 90 Nil 2 Water - Revive

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Product Retail unit size Caffeine Caffeine Guarana Reference (mL) concentration per retail unit concentration (mg/100 mL) consumed (mg/100 mL) (mg) V Berry 250 31 77 120 2,3 V Black 250 and 500 31 77/155 120 1,2,3,4 V Green 250 and 500 31 77/155 120 2,3,4 V Lemon 250 31 77 500 2,3,4 V Sugarfree 250 31 77 120 2,3,4 Vitaminwater 600 16 96 Ingredient 2,4 Energy Energy shots Bacchus D 100 30 30 Nil 2,3 6 Hour Power 60 208 125 Nil 1,6 Clear Shot 60 208 125 Nil 5 Demon Citrus 60 333 200 12 2,3 Blast Demon Tropical 60 333 200 12 2,3 Punch’d Monster Hitman 89 Ingredient NA Ingredient 2 NOS Energy 60 416 250 NA 1,6 Shot NOS High 60 333 200 12 2 Octane NOS 60 333 200 12 2 Supercharged Octane 30 33 10 Nil 1,2 Octane Citrus 30 50 15 Nil 2 Reckless 70 178 125 NA 1,6 Energy Shot Red Bull 60 133 80 Nil 1,2,3 Energy Shot Top Flight 60 Ingredient NA Nil 5 V Pocket 60 267 160 Nil 1,2 Rocket Energy Shot X Shot 120 250 300 20 5 Table reproduced from the NZ Risk Profile6. NA = not available, Nil = none present, Ingredient = present, but amount not specified 1=Energy Fiend, 2009, A website run by caffeine enthusiasts James Foster and Ted Kallmyer, owned by Exis Holdings Limited, a New Zealand corporation that is neither a beverage manufacturer nor lobby group. Caffeine amounts reported on this website were obtained from brand websites, nutrition panels or directly from beverage manufacturers. The site includes links to a number of scientific papers, consumer reports, and governmental sources or reports. 2=Christchurch retail outlets 3=Included in NSW study, October 2009

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4=Alannah Steeper, Manufactured Foods Database, personal communication, identifies caffeine and guarana as ingredients but not amounts 5=Ursula Egan, NZFSA, personal communication, 9 November, 2009. 6=New Zealand company websites

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Summary of (some) government requirements for energy drinks and energy shots

Country Responsible Regulatory CED Caffeine permissions Label advice (and other) for energy agency instrument classification (mg caffeine/L i.e. ppm) from drinks and/or energy shots (energy shots caffeine and/or guarana (paraphrased) only specified Cola CEDs/shots NB: Required expression of quantity where beverages varies, e.g. mg caffeine/100mL, mg applicable) (or other caffeine per serve, or both where permitted) Australia & Food Australia New Food 145 145–320 Contains caffeine & quantity New Zealand Standards Zealand Food ‘Consume no more than’ maximum daily Australia New Standards intake Zealand Code Advisory statements about: children, pregnancy and lactation, caffeine sensitive persons New Zealand New Zealand New Zealand Supplemented GMP >GMP for Contains caffeine & quantity Ministry of Supplemented food (energy flavour, no Advisory statements about: children, Agriculture Food shots) upper limit pregnancy and lactation, caffeine sensitive and Food Standard persons 2010 New Zealand New Zealand Dietary n/a No limit Contains caffeine & quantity Ministry of Dietary supplement Agriculture Supplement (energy shots)

and Food Regulations 1985 Canada Health Draft Natural Health n/a 80–200 mg Contains caffeine & quantity Canada – Caffeinated Product per single Recommended dose and use: Natural Energy Drinks dose – ‘do not consume more than xx daily..’, Health Labelling

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Country Responsible Regulatory CED Caffeine permissions Label advice (and other) for energy agency instrument classification (mg caffeine/L i.e. ppm) from drinks and/or energy shots (energy shots caffeine and/or guarana (paraphrased) only specified Cola CEDs/shots NB: Required expression of quantity where beverages varies, e.g. mg caffeine/100mL, mg applicable) (or other caffeine per serve, or both where permitted) Product Standard 400 mg` per or if caffeine >200ppm Directorate (2010) day - Take every yy hours as needed. Do not consume more than zz daily

Advisory statements about: children (<18 years); and caffeine sensitive persons (latter may be replaced with: ‘Anxiety, irritability, insomnia and headaches have been known to occur in which case discontinue use and consult a health care practitioner’. If caffeine >300ppm, advisory statements also for pregnancy, planned pregnancy and lactation Do not mix with alcohol Package as a single dose Health Preliminary Food 150 non-cola n/a Contains caffeine (if new source) & Canada – Guidance for quantity Food Industry on 200 cola Directorate the Labelling of Caffeine Content in Pre-packaged

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Country Responsible Regulatory CED Caffeine permissions Label advice (and other) for energy agency instrument classification (mg caffeine/L i.e. ppm) from drinks and/or energy shots (energy shots caffeine and/or guarana (paraphrased) only specified Cola CEDs/shots NB: Required expression of quantity where beverages varies, e.g. mg caffeine/100mL, mg applicable) (or other caffeine per serve, or both where permitted) Foods European European Commission Food 150 <150 Ingredient listing: e.g. ‘flavour (caffeine)’ Union, incl. Commission Directive “High caffeine content” & quantity United 2002/67/EC;

Kingdom Commission Directive >150 2000/13/EC; European Commission Food n/a No limit Caffeine & quantity per portion Commission Directive supplement Daily recommended doses and warnings 2002/46/EC (energy shot) against exceeding that dose Advisory: that the product should be stored out of the reach of children. Finland Finnish Food Food 150 320 “High caffeine content” & quantity Safety Recommended daily intake , or warning Authority about excessive intake Advisory statements about: children, pregnancy and lactation, caffeine sensitive persons Sweden 135 320 Special labelling requirements for CEDs (not reviewed)

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Country Responsible Regulatory CED Caffeine permissions Label advice (and other) for energy agency instrument classification (mg caffeine/L i.e. ppm) from drinks and/or energy shots (energy shots caffeine and/or guarana (paraphrased) only specified NB: Required expression of quantity where varies, e.g. mg caffeine/100mL, mg applicable) caffeine per serve, or both South Africa South Africa Food 150 >150 Quantity of caffeine Department “High Caffeine Content” (bold, capital, of Health 3.0mm height) Advisory statements about: children under 12 years, pregnancy, caffeine sensitive persons; mixing with alcohol United Arab Censorship Food (not reviewed) (not Health warnings Emirates and reviewed) Advisory statements about: children under registration 16 years, pregnancy, caffeine sensitive mechanisms persons; diabetic patients United States US Food and FDA Code of Food 200 Not nil of America Drug Federal regulated? Administration Regulations nr 21 CFR182 US Food and Dietary Dietary n/a No limit Ingredient listing: caffeine Drug Supplement supplement Administration Health and Education Act 1994

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Summary of (some) industry guidelines for energy drinks and energy shots

Company/ Content / guidance organisation Caffeine levels (mg/L) Labelling & Advisory statements Marketing guidance Drinks Shots Australian Beverage 145–320 160 / single Contains caffeine and quantity Drinks: not available near schools; not directed Council & New shot Maximum daily consumption & at children; not promoted to mix with other Zealand Juice and daily caffeine from shots not to beverages Beverages 200 /day exceed 200 mg Alcohol and CEDs: specific guidance provided Association Advisory statements about: Shots: market to adults; avoid positioning near children, pregnancy and lactation, confectionery or child-products; position and caffeine sensitive persons monitor near counter sales American Beverage Caffeine & quantify Do not promote mixing with alcohol Association Advisory statements about: Differentiate from sports drinks children, pregnancy and lactation, Not to be sold or marketed in schools (k-12), or caffeine sensitive persons to children British Soft Drinks 150 Do not promote to children under 16 years, not Association to be sold in schools UNESDA 150 160 Drinks: consume moderately Drinks: not promote mixing with alcohol; do not Shots: contains caffeine and promote to children<12 years; do not promote quantity; recommended daily as rehydration sports drinks; not to be amount; warning not to exceed promoted near schools or other child facilities daily dose Shots: do not promote mixing with alcohol; Advisory statements about: target to adults; not to be sold in packages children, pregnancy, caffeine >100mL; position and monitor near counter sensitive persons sales; place with food supplements ( where available); do not place near energy drinks; not

to be promoted to children or near schools or other child facilities

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Company/ Content / guidance organisation Caffeine levels (mg/L) Labelling & Advisory statements Marketing guidance Drinks Shots Drinks & Shots – off label information: responsible consumption, characteristic ingredients, caffeine content relative to other sources Red Bull Has contributed to development of above guidance and subscribes to in jurisdictions of sale Frucor, Coca Cola Made commitment to removing all energy drinks from schools by 2009 Do not promote to children (under 18 years)

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 Energy shots – an industry commitment (Australian)

 Energy shots – an industry commitment (NZ)

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