Summary of Submissions on the Policy Options Consultation Paper on the Regulation of Caffeine in Foods Contents1 Overview of submissions received: 2 Executive Summary 3 Summary of Submissions by Question 6 Annex 1 Question 5 − Detailed summary of evidence provided by submitters 20 Annex 2 Relevant documents, reports, guidelines, and standards suggested by submitters 31 Annex 3 List of Submitters 43 ___________________________________________________________________________ 1 Overview of submissions received: The public consultation period on the Food Regulation Policy Options Paper for the Regulation of Caffeine in Foods commenced on 4 September 2013 and closed on 18 October 2013. Total number of submissions 32 Numbers of submitters by country Total from Australia Total from New Zealand Total from joint Australia and New Zealand Total from overseas (other than Australia and New Zealand) 19 8 5 0 Numbers of submitters by type Food Industry and Business Consumers Public Health Government 14 1 10 7 Opinions expressed in this summary are those of the submitters and do not necessarily reflect those of the Food Regulation Standing Committee (FRSC). A full list of submitters is provided at Annex 3. ___________________________________________________________________________ 2 Executive Summary Introduction The purpose of the Policy Options Consultation Paper for the Regulation of Caffeine in Foods was to establish if the Ministerial Council Policy Guideline needs to be updated, maintained or rescinded in order to provide Food Standards Australia New Zealand (FSANZ) with appropriate guidance to assist in the development or review of food regulatory measures relating to caffeine in food. To that end, the document provided a background to the regulation of caffeine products in Australia, New Zealand and overseas; a discussion of key issues and trends; definitions of the identified problems, three policy options and a draft policy guideline. The key problems identified by submitters with the current Policy Guideline are that: It does not meet stated objectives; it reflects current practice rather than providing guidance to FSANZ; and lacks clarity in relation to addition of caffeine to foods other than kola drinks, formulated caffeinated beverages (FCBs) and formulated beverages. It does not provide a framework for reviewing the regulation of caffeine in Australia and New Zealand with the objective of trans-Tasman Harmonisation. By seeking to maintain the status quo, the Policy Guideline may be hindering the consideration of risks to vulnerable population groups, and restricting new products without reference to a risk-based approach. It does not adequately reflect best practice regulation principles. International regulation of caffeine is currently under review in Europe, the United States and Canada, meaning the guideline may not reflect current international best practice. In order to resolve the problems the review outlined the following objectives: Determine whether the Ministerial Council Policy Guideline provides an effective framework to guide a review of regulation applying to caffeine in the food supply in light of the range of products currently on the market and potential future developments; Provide clear and unambiguous policy guidance, for example providing clarity around the treatment of caffeine-rich ingredients in food and managing risks to vulnerable population groups; Identify opportunities to harmonise the regulation of caffeine containing foods currently regulated under the Australia New Zealand Food Standards Code (Food Code) or under the New Zealand Food (Supplemented Food) Standard 2010; Ensure that the Ministerial Council Policy Guideline is in line with the current requirements for food policy guidelines as set out in the Principles and Protocols for the Development of Food Regulation Policy Guidelines. The three policy options were identified by the FRSC Caffeine Working Group to meet these objectives: Option 1: Make no changes to the Ministerial Council Policy Guideline on the Addition of Caffeine to Foods. Option 2: Amend the Ministerial Council Policy Guideline to address the issues raised in the problem definition. Option 3: Rescind the Ministerial Council Policy Guideline. ___________________________________________________________________________ 3 Responses Twelve questions on various elements in the Consultation document were proposed to submitters. The level of detail in the received submissions demonstrated considerable stakeholder engagement with the issues. This summary of submissions is therefore arranged relative to the 12 questions, and responses to each question are summarised by submitter type. Of the three policy options presented in the Consultation Paper, 88% of submitters who responded to question 12 were in favour of Option 2. Eight percent favoured Option 1 and no submitters favoured Option 3. Of those that favoured Option 1, one preferred the status quo but called for increased legislation on product sizing and labelling, while the other cited concerns over lack of data. There was consensus from all submitters around some elements. The first was that any action which may result from a change of the guidelines should incorporate a risk-based approach, and employ robust scientific evidence. Moreover, submitters agreed (as proposed in the draft Policy Guideline) that such action should take into account international best practice and emerging evidence to remain informed. All submitters that favoured option 2 welcomed a broadened scope and the inclusion of all sources of caffeine stressing that this would allow for a greater understanding of risk across a broader spectrum of the food supply. It was highlighted that targeted attention is also important in certain areas, particularly: Natural and synthetic caffeine; Products where caffeine is added; Products available in overseas markets; Novel products such as sports supplements; and Emerging markets and evidentiary trends. Submitters also stressed that, in line with the ‘high order policy principles’, the regulatory management of risks should be applicable to the wider Australia and New Zealand population. This is in addition to focusing solely on vulnerable groups. Most submitters stressed that greater attention should be given to developing consumer awareness and education, particularly through labelling. More information should be made available to consumers about safe levels of consumption, the risks and symptoms of caffeine toxicity, recommended daily intakes, and the unsuitability of certain beverages for vulnerable populations. All submitters called for greater regulatory guidance in this area, and some offered examples e.g. that labels should include information on recommended daily intake, statements about safe level of consumption, the unsuitability of certain beverages for children, and the risks and symptoms of caffeine toxicity. Industry codes were a point of discussion for most submitters. Industry and Public Health submitters hold differing views on effectiveness of the codes and whether they help to regulate caffeine in food. Industry submitters generally believed that voluntary and selfregulatory initiatives were effective with good or high compliance. Three codes in particular were highlighted: Australian Beverages Council ‘Industry Commitments on Energy Drinks’; the New Zealand Juice and Beverage Association (NZJBA) ‘Voluntary Code of Practice’; and the NZJBA ‘Industry Code – Manufacturing and Marketing of Energy Shots’. Public health groups believed that current industry self-regulation was inadequate and ineffective due to lack of monitoring and enforcement of industry codes. Government responses were divided. ___________________________________________________________________________ 4 The majority of submitters agreed that the review could support better harmonisation of standards between Australia and New Zealand, and with international best practice. Many submitters highlighted that stronger action should be taken against combined alcohol and energy drink consumption. This issue falls outside the scope of this review and it is currently being considered in a separate process by the joint FRSC-AHMC (Australian Health Ministers’ Advisory Council) committee. A range of detailed evidence and peer reviewed papers were also submitted to provide additional information about recent scientific findings; market trends associated with products containing caffeine; the use of caffeine as an ingredient in foods; and the risks and benefits associated with caffeine consumption. A full reference list can be found in Annex 2. ___________________________________________________________________________ 5 Summary of Submissions by Question Question 1: Can you provide any evidence about the level of compliance with and/or effectiveness of these industry codes? (refer chapter 4.4) Submitters were divided as to whether industry initiatives can control caffeine in the food supply. Industry The majority of submitters agreed that industry codes are an effective means of intervention. A range of best practice standards, voluntary undertakings, self-regulatory initiatives and ‘Industry Commitments’ have been established by manufacturers and industry bodies. Some referenced standards include the Australian Beverages Council ‘Industry Commitments on Energy Drinks’, the NZJBA ‘Voluntary Code of Practice’, and the NZJBA ‘Industry Code – Manufacturing and Marketing of Energy Shots’. Compliance levels were considered by industry to be “good” or “high”. They are non-binding and have not been adopted by all producers. Considered extremely effective at discouraging younger children from purchasing FCBs. With respect to the tea and coffee sector, one submitter noted that it was unclear whether industry codes to manage caffeine levels in the sector “would result in a product which would deliver an outcome whilst better serving consumer needs”. Public Health Uniformly agreed that industry codes are ineffective as they are rarely monitored by either industry or government. Overseen by the same industry they seek to govern. Evidence includes: current labelling practice for FCBs, product sizing, easy availability, frequent discounting and marketing which appeals to children, and adolescents. They have ambiguous definitions and standards leading to inconsistent claims and marketing. Difficult to evaluate effectiveness. Non-compliance penalties not being sufficiently punitive. Any reliance on industry codes should be supported by industry-funded, independent assessment of effectiveness and compliance, with significant penalties for noncompliance. Governments should be the key stakeholders in the development of policy and provide leadership through a multi-stakeholder process. Government Governments were divided with one noting a positive experience with industry codes, while one other felt that current industry self-regulation is inadequate for regulating the control of caffeine in the food supply. Mandatory healthy food and drink supply policies in the school are more effective measures than self-regulation. Definitions in voluntary codes for advertising directed at children are too narrow still resulting in exposure. One noted that they had a favourable experience working with key industry bodies and the use of non-regulatory measures such as educational tools and industry codes of practice. ___________________________________________________________________________ 6 Questions 2: Are there any international regulations of relevance that have not been provided here or in Appendix 3 (Overseas Regulation)? If so, please provide references. (refer chapter 4.5) There was general consensus from industry, public health and government submitters that the summary of international regulations in Chapter 4.5 and Annex 3 adequately reflected global variations. In addition to those mentioned in the original text, the following regulatory restrictions were provided: South Korea: recommended upper daily levels have been set by the Korean Food and Drug Administration; for adults is <400mg of caffeine per day, for pregnant women <300mg per day and for children <2.5mg/kg of body weight. Taiwan: Upper limit of in 320mg/L for beverages other than tea and coffee. Mexico: Flavoured non-alcoholic beverages containing >20mg/100mL are considered ‘beverages with added caffeine’, and must be labelled as such. Brazil: Beverages containing 80mg of caffeine are considered ‘liquid compounds ready for consumption’ and the regulations set an upper limit of 350mg/L. Chile: Beverages containing 80mg of caffeine (320mg/L) are classified as sports drinks and the regulation does not impose an upper limit but rather states that producers should not recommend on their labels a daily consumption higher than 500mg of caffeine. Two particular articles were referenced as source materials for these submissions: Heckman MA et al. 2010, ‘Caffeine (1, 3, 7-trimethylxanthine) in Foods: A comprehensive review on consumption, functionality, safety and regulatory matters’, Journal of Food Science, Vol.75, no.3, pp.R77-R87 Seifert, S. M., Schaechter, J. L, et al. (2011). Health effects of energy drinks on children, adolescents, and young adults. Pediatrics: Official Journal of the American Academy of Pediatrics 127(3): 511-528. Additionally, one submitter referenced the Food Standards Agency United Kingdom (FSAUK) ‘high caffeine’ labelling requirements. These outline that drinks containing more than 150mg/L must be labelled with the term ‘high caffeine content’ in the same field of vision as the name of the food. A public health submitter also highlighted that certain countries have prohibited or restricted the sale of some FCB variants (Uruguay, Turkey German states, Sweden and Norway) or legislated stricter labelling about the unsuitability of such products for children and limited certain promotional activities (Ireland). Question 3: Are there any other relevant data not provided here? If so, please provide details and references. (refer chapter 4.7) The general consensus from submitters was that regulators should consider latest available scientific evidence (for both added and naturally occurring caffeine in foods), the relative risks posed to any vulnerable populations and consumer behaviour, and levels of caffeine exposure (as opposed to culture changes or sales volumes). ___________________________________________________________________________ 7 Industry Points for consideration: One submitter highlighted their research, which concluded that in both Australia and New Zealand, kola beverages account for approximately six per cent of all beverages consumed (including water and alcoholic beverages). The increase of energy drink consumption can be explained by virtue of it being a new product, and that the proportion of energy drinks to the non-alcoholic beverage industry is not provided in the Consultation Paper. Referenced data source material ‘Convenience & Impulse Retailing’ and ‘Palmer 2009’ are not primary source materials and contained reporting inconsistencies. Energy Shot products are not significant in the Australian or New Zealand markets, and that manufacturers and distributors are ceasing sales of certain products, or are in the process of removing them from the market. Greater detail is needed in the tables to aid comparability i.e. ‘real serving size’ in addition to caffeine levels per 100mL. Other relevant data: The Australian Health Survey (due the first half of 2014) which is expected to offer caffeine intake data across population groups. The Implementation Sub Committee for Food Regulation’s (ISFR) analytical survey work in relation to the caffeine content of guarana-containing foods. A study by Desbrow et al. (2007)1 on consumer exposure to caffeine from retail coffee outlets which concludes that consumers experience high caffeine dose variation for similar Espresso/short black serving sizes. A study by Desbrow et al. (2012)2 on consumer exposure to caffeine from commercial coffee and coffee flavoured milk which concludes that the probability of consumer exposure to high caffeine doses from popular coffee beverages in Australia is greater than previously reported. Public Health Points for consideration: Broader data sets should be integrated into the tables, particularly on flavoured milk drinks i.e. chocolate or iced coffee, but also frozen coffee products, ‘Frappucinos’ and sports supplements (i.e. caffeine capsules, powders, pre-workout formulas, gels etc.). Tables should be organised in different way i.e. to assume that the standard takeaway coffee size (Table 1D) should be by a single shot of coffee, or to include caffeine per serving of the beverage, or average daily consumptions. The monitoring of caffeine-containing foods and of new products coming to market. Caffeine is a mildly addictive chemical at low doses which creates physiological and psychological modifications in adults, and it is not required in our food supply. Disappointed that the issue of combining FCBs with alcohol has been specifically excluded from the scope of this review – it is increasingly recognised to be a source of significant harm. 1 Desbrow, B. et al (2007) An examination of consumer exposure to caffeine from retail coffee outlets. Food and Chemical Toxicology 45 [pp.1588–1592] 2 Desbrow, B., Henry, M., and Scheelings, P. (2012). An examination of consumer exposure to caffeine from commercial coffee and coffee-flavoured milk. Journal of Food Composition and Analysis, pp1-20 ___________________________________________________________________________ 8 Caffeine is becoming increasingly prevalent with larger coffee servings becoming commonly available in cafes, FCB sales between 2001-2010 quadrupling, and caffeine increasingly being added to sport foods. Other relevant data: Kole, J. and Barnhill, A. Caffeine Content Labelling: a missed opportunity for promoting personal and public health. Journal of Caffeine Research. 2013; 3(3), 108 – 113, The upcoming Australian Health Survey. Government More consumer awareness, education or knowledge about the probable safe levels of consumption, or the risks and symptoms of caffeine toxicity is needed, especially as it poses a potential risk to vulnerable groups. Addition of caffeine to novel products is considered unnecessary and that a revised Policy Guideline should continue to restrict the addition of caffeine rich ingredients to boost caffeine content in other foods beyond current provisions. The data presented in the current Policy Guideline does not address the need to manage the food supply and the composition of foods with a risk-based approach (as opposed to ‘dietary exposure’). The proposed Policy Guideline should acknowledge the need for regulatory management of caffeine in the food supply to align with Australian and New Zealand nutrition guidelines. Data for consideration: One government submitter referenced their cross-sectional, population-health measurement survey on mean daily caffeine consumption of adults over 18 years of age. ___________________________________________________________________________ 9 Question 4: Can you provide any additional information about the use of caffeine as an ingredient in foods and/or the formulation of products using caffeine or caffeine containing ingredients. (refer chapter 4.9) Many submitters raised points for consideration about the combination of sugar and caffeine in foods, and the differences between natural and synthetic caffeine in food production. Industry submitters highlighted the role synthetic and naturally sourced caffeine plays as a flavouring agent, and as an additive: Submitters highlighted that while there is no chemical difference between synthetic and naturally sourced caffeine, there is an important considerations in terms of cost, flavour and consistency of quality. Taking these into account, industry submitters favoured synthetic caffeine. An example given to demonstrate this was coffee flavoured milk; it can use flavours to mimic coffee – saving cost and providing consistent flavours with reduced bitterness. Other submissions highlighted the variable amount of caffeine which is present in coffee and tea. One submitter commented that the addition of caffeine to sports foods at an appropriate level is a means of product innovation. Submissions also highlighted that there is a lack of clarity in current policy regarding the presence of caffeine in formulated supplementary sports foods and electrolyte drinks. Industry submissions highlighted that sugar is used to develop taste profiles for beverages (not to hide the bitterness of the caffeine), and to provide additional energy to consumers: While chapter 4.9 refers to sugar in foods, only beverages have been considered in the text. Caffeine containing foods specifically mentioned include confectionery, supplemented sports foods and beverages, breakfast cereals, baked goods, snack foods, sports/weight loss supplements, meal replacements, supplemented foods, chewing gums and breath mints. One submitter argued that claims, such as those incorporating the term “Energy” are sufficient with consumers’ knowledge to suggest the presence of caffeine and its perceived effects/benefits. The consumer submitter highlighted that the natural caffeine found in coffee and tea is better metabolised by the body than synthetic versions as it is consumed with bioactives and polyphenols – naturally occurring elements in the plant leaf it is derived from. Additionally they noted that sports performance supplements typically contain over 300mg per serve; this is above the minimum adverse effect levels for individuals under 100kg. Public health submitters expressed concern in relation to both the caffeine and sugar content of FCBs: In some cases a 0.5 litre serving can contain more than half the recommended total daily intake of sugar. There are known links between excessive consumption of energy, sugar, acidic foods with chronic health consequences. Sugar is often used to mask the bitterness of coffee. Papers referenced concluded that the removal of caffeine from sugar sweetened beverages can allow for a significant reduction in sugar content without any perceived taste difference. Comparisons of sugar content should only be made between caffeinated sugar sweetened drinks and their non-caffeinated alternatives. ___________________________________________________________________________ 10 Public health support for a broader scope is due to: Naturally occurring sources of caffeine, i.e. guarana, are also added to products (some of which may already contain caffeine). Caffeine is in other foods which are likely to be consumed by children and young people such as chocolate, corn chips, chewing gum and other types of confectionary, muffins, flavoured milks and breakfast cereals. There is a proliferation of substances marketed as formulated supplementary sports foods, gums, gels and dietary supplements, which are using caffeine as an additive. An additional point was that FCBs should be considered in terms of potential risk – such as large volumes and other ingredients which are included i.e. niacin. One government submitter noted the need to ensure the scope of the Policy Guideline includes all foods, including those naturally containing caffeine, added ingredients, and products available on overseas markets. Furthermore they noted the existence of caffeine in novel products, which needs to be taken into account. Concerns were also raised over the inclusion of various cafe styles analysed in New Zealand as these may not reflect FSANZ food composition data. Other submitters raised points which fall outside the scope of this question, including the question of labelling and consumer education. Question 5: Is there any other relevant evidence relating to the risks associated with consuming caffeine not provided here or in the listed references? If so please provide details and references? (refer chapter 4.13.4) Extensive evidence was submitted to this question and a detailed analysis can be found in Annex 1. A summary of the responses can be found below: Industry There were no high-quality scientific studies that clearly demonstrated a causal link between energy drink exposure and serious adverse health effects (see the findings of the Review of the Evidence of the Effects and International Regulation of Caffeinated Energy Drinks (the CED Review). Submissions challenged the use of data from the New South Wales (NSW) Poisons Centre where caffeine was ingested along with other intoxicating substances. Submissions noted that when a New Zealand woman consumed a high volume of CocaCola which may have been a cause of her death, the Coroner’s report acknowledged there were a number of possible causes. Two industry submitters noted that fatalities associated with caffeine were in those consuming caffeine from powders/tablets. Public Health Submissions noted that there is an extensive range of adverse effects associated with chronic caffeine consumption. Symptoms include; irritability, tremulousness, occasional muscle twitching, sensory disturbances, tachypnoea, palpitation, flushing, arrhythmias, diuresis and gastrointestinal disturbance. Excessive caffeine consumption affects the central nervous system, cardiovascular system, gastrointestinal, neuromuscular, bronchial and the skeletal systems. Symptoms of excess intake include insomnia and sleep disturbance. Two public health submitters were concerned about the addictive nature of caffeine. ___________________________________________________________________________ 11 One submitter was puzzled as to why FRSC would take note of the "insufficient evidence to confirm or refute the effectiveness of caffeine avoidance on birth weight or other pregnancy outcomes” given the inclusion criteria of the relevant study. In adolescents, adverse effects were reported to include jitteriness, nervousness, dizziness, an inability to focus, difficulty concentrating, gastrointestinal upsets and insomnia. Concerns regarding the adverse effects on oral health in relation to the low pH of caffeine containing drinks and the sugar content of beverages. Concerns surrounding the impact on bone health and increased risk of osteoporosis due to declining consumption of calcium from milk. Sweetened beverages containing caffeine play a role in obesity, and when combined with caffeine synergistically increases post-prandial hyperglycaemia. Governments The literature review from the European Food Safety Authority (EFSA) on the safety of caffeine and the American Food and Drug Administration (FDA) investigation into the safety of caffeine should be included in the Working Group’s final deliberations. An extensive literature review was presented by one submitter which also takes into account new research post July 2011. Question 6: Is there any other relevant evidence relating to the positive effects of caffeine not provided here or in the listed references? If so, please provide details and references. (refer chapter 4.13.6) There was general consensus that caffeine does offer a number of positive effects when consumed. Industry Increased alertness, increased attention, endurance performance and endurance capacity. Specific studies submitted highlighted secondary benefits such as a reduced risk of crashing for commercial motor vehicle drivers, and reduced driver sleepiness during prolonged highway driving. One submitter noted a 2009 meta-analysis of 18 studies which found that drinking 3-4 cups of coffee per day was associated with a 25% reduction in the risk of developing type 2 diabetes compared to drinking <2 cups of coffee per day. Foods and beverages which contain natural sources of caffeine also contain other components such as polyphenols and magnesium which may be associated independently or in combination with caffeine on positive health outcomes. Increased athletic performance in sport, some research shows up to 3% enhanced performance after consumption of caffeinated sports drink (as opposed to 1% with coffee consumption). The consumption of chocolate, tea and coffee are part of cultural tradition. In contrast, one industry submitter stated that there were few if any positive effects of caffeine. Public Health Caffeine enhances the exercise capacity and performance of a wide variety of sports, as reported in the EFSA opinions. There are potential benefits in cognitive performance, alertness and fatigue reduction. Observational data show that coffee consumption up to 400mg per day may be associated with decreased cognitive decline in healthy older adults, without dementia. ___________________________________________________________________________ 12 Governments Consumption can occur via foods and drinks which contain other beneficial compounds; for example, tea, coffee and cocoa contain antioxidants. These have some beneficial effects on various cardiovascular indicators. Question 7: Are there any other problems that should be considered here? If so, please provide details and justification. (refer chapter 5) In addition to the problems already defined in the Policy Options Paper, industry submissions highlighted the following aspects: There is a lack of clarity in the Policy Guideline in respect to: − The addition of caffeine to foods other than kola drinks, − It does not resolve the issue of vulnerable population groups, particularly with respect to the appeal of certain products e.g. pre-packaged coffee-flavoured milks, − It excludes foods which naturally contain caffeine (apart from guarana), and − It does not differentiate between natural and synthetic forms of caffeine. The Policy Guideline should be updated employing the new FRSC policy guideline template. This will ensure alignment with best regulatory practice guidelines in both countries, with a view to harmonisation. Polls of caffeinated drink consumers show that a large proportion of the population is unaware of the caffeine content of popular beverages. This does not allow for an informed choice of purchase. While the regulatory standards for caffeine are outside the scope of this review, a change to this policy may likely trigger regulatory changes. Therefore a holistic view must be taken in this review process. The consumer submitter highlighted that the medical impact of long term caffeine consumption differs in people, meaning it is difficult to measure acute effects. ___________________________________________________________________________ 13 Public health submitters highlighted that: Current guidelines do not offer regulatory guidance to the mandatory labelling of caffeine and non-caffeine containing flavours, particularly in relation to those products “likely” to be consumed by children. Greater consumer awareness of caffeine in foods is needed through improved labelling, particularly on new products such as sports foods, bars, gels etc. Work on caffeine and alcohol should be integrated and made complementary. Government submitters recommended that: Greater efforts should be made to capture the concerns of the general population, in addition to the emphasis on vulnerable population group risk management. Foods containing naturally occurring caffeine should be included within the scope of the guideline. Labelling of caffeine content levels across all caffeine containing foods should be considered. Question 8: Are there any other objectives that should be considered here? If so, please provide details and justification. (refer chapter 6) On the whole submitters considered the objectives as adequate, but raised additional points for consideration: Industry A level playing field for all caffeine foods should be established: There is no difference between synthetic and naturally occurring caffeine and the regulatory distinction should be removed (a comparison was made of the caffeine content of energy drinks to commercial coffee products). No unnecessary regulatory burden or bias to be placed on any one industry or manufacturing sector (particularly that which may stifle innovation). Public Health The protection of public health and safety (which includes the promotion of health and prevention of illness) should be afforded the highest priority. The Policy Guideline should not be beholden to products already on the market and that products which are brought to market should conform to established food regulation policy and standards, not vice versa. There is a need to avoid lowest common denominator approaches and that a broader scope is needed, including caffeine in sports supplements, and the inclusion of naturally occurring caffeine products. FRSC should make it clear who, and by what criteria, will determine whether the Policy Guideline provides an effective framework to guide a review of the caffeine regulations. Governments Greater emphasis on the protection of general public health and safety (particularly in objective one), and the addition of vulnerable population groups into the second objective. There are no criteria to determine whether the Policy Guideline provides an effective framework to guide a review of regulation applying to caffeine in the food supply in light of the range of products currently on the market and potential future developments. The scope of the Guideline should be broadened to include foods containing naturally occurring caffeine such as tea, coffee and cocoa. ___________________________________________________________________________ 14 Question 9: Are there any other feasible options in relation to the Ministerial Council Policy Guideline on the Addition of Caffeine to Foods which have not been listed here? If so, please provide details and justification. (refer chapter 7) There was general consensus that the options presented were a good starting point. Other areas where there was consensus include fostering greater consumer awareness and education, and the need for regulatory management of caffeine to be informed by emerging evidence from Australia, New Zealand and overseas jurisdictions. Additional points for consideration are: Industry A number of submitters felt that more consideration should be given to the role of selfregulation as well as consumer awareness/education campaigns. It was argued that a multi-layered escalation process which is enforced when required by Government bodies would prove more effective than an adequately funded enforcement agency. FRSC should consider a risk-based and more targeted approach. One submitter proposed a policy option to amend the current policy paper and remove the exemption for restricting the use of new products containing non-traditional caffeine-rich ingredients. They argued that this would ensure consistent application caffeine requirements across different food categories in the Food Code. More rigorous data or ‘sufficient evidence’ must be provided to ensure that decisions are informed. The importation of caffeine containing beverages from New Zealand into Australia which conform to the New Zealand Food (Supplemented Food) Standard 2010 is not prevented by any of the options presented. Public Health The Policy Guideline should be complemented by consumer risk education, specifically on recommended daily intake, statements about safe levels of consumption, and the unsuitability of certain beverages for children and adolescents. Need for additional scrutiny on highly-caffeinated beverages being mixed with alcohol. No changes should be made to current additive permission for caffeine (Standard 1.3.1). New products containing caffeine rich ingredients, from whatever source, should be subject to pre-market risk assessment on a case by case basis. Option 2 does not identify specific risk management tools such as labelling. Targeted action for novel products and FCBs including regulation of the maximum caffeine content of FCBs and sports supplements, greater restrictions on the marketing, promotion, and sale of FCBs to children, and measures to ensure the accuracy of any FCB health and nutrition claims. Governments Option 2 should be modified to take into account the issues raised in this public consultation. Risk assessment of the dietary exposure to caffeine from current and future foods should assess the whole population not just vulnerable populations Reiterated that FSANZ should work with health research agencies to monitor caffeine consumption across the population as indicated in the draft Policy Guideline ___________________________________________________________________________ 15 Question 10: Are there any impacts (advantages or disadvantages) on consumers, industry or government which have not been considered here? If so, please provide details (noting the impacts assume that a review of regulatory standards would have reference to the Policy Guideline described in the options). (refer chapter 8.3) While all submitter types offered general comments about the various advantages and disadvantages, specific comments relating to one of the three options were submitted only by Industry and Public Health groups. Option 1 There were no specific comments received. Option 2 One specific comment was received from a public health submitter on advantages to consumers noting: “Improved transparency about the major sources of caffeine in our food supply, and in correcting misinformation and myths about all sources of caffeine.” Option 3 One industry submitter provided comments as to the advantages and disadvantages for consumers, industry and government. Advantages highlighted the ability to have a greater purely science led decision making process, removing government responsibility for unpopular decision making and instilling FSANZ with greater trust. Moreover, industry would be able to operate more freely within the market and employ self regulatory approaches. Disadvantages include the removal of democratic oversight, ambiguity across the spectrum of issues, and duplication of functions. General remarks were also offered by all submitter types: Industry General disadvantages: Consumers are not aware or informed of their total caffeine dietary intake. Industry will be required to start testing caffeine levels, which will cause an increased cost of caffeine testing, and subsequent increased product costs. Additional remarks: Disagreement with some of the advantages/disadvantages listed in other options, i.e. Government Option 2: Amend the Guideline, refers to the review, maintenance or rescinding of the Guideline rather than amendment. There is a lack of consistency around the application of requirements for caffeine across different food categories in the Australia New Zealand Food Standards Code, both for the identification of naturally occurring caffeine and around the levels of caffeine added to food from naturally occurring sources. All of the options do not prevent the importation of caffeine containing beverages from New Zealand conforming to the New Zealand Food (Supplemented Food) Standard 2010, via the provisions of the Trans-Tasman Mutual Recognition Arrangement. Public Health General advantages: Increased regulatory action on labelling may be able to reduce public health costs. ___________________________________________________________________________ 16 General disadvantages: Caffeine can increase the risk of type 2 diabetes related complications, as well as obesity. Possibly limiting innovation in the range of sport foods and sports supplements which benefit athletic performance. Government General remarks: The impacts have been assessed adequately for this purpose. A more comprehensive cost/benefit analysis should be undertaken if relevant standards are reviewed. If the draft Policy Guideline is amended, these impacts will need to be amended in kind. ___________________________________________________________________________ 17 Question 11: Can you provide data to support the potential costs and/or benefits of impacts of policy options? If so, please provide details. (refer chapter 8.3) While all submitter types provided comments about potential costs and benefits, there was no supporting quantitative data submitted. One industry submitter noted that Option 1 will continue to exclude the main sources of dietary intake of caffeine from any form of control or open disclosure to consumers. Industry submitters note that Option 2 could potentially lead to downstream changes to caffeine labelling with the potential to impact on production costs. One submitter noted that at this stage, it is not possible to quantify these costs but pointed to potential updating of labels, testing and/or the re-formulation of products. Others noted the potential for existing label write-offs or ‘softer’ costs associated with resources and changeovers i.e. ongoing monitoring, compliance, editing of websites, consumer print media and communications (with two submitters providing estimated costs of testing and change over). Another noted that regulatory measures in the area may involve considerable costs across the supply chain (specifically on downstream food supply and service sectors) and non-regulatory measures should be seriously considered to reduce that impact. Appropriate lead in times for change over where also mentioned as being important particularly to small and medium manufacturers. Public health submitters suggested that better labelling would minimise the risks associated with excessive caffeine consumption and therefore reduce associated healthcare costs. Another suggested there was a potential for increased demands on pharmaceutical options. Governments offered no additional data. Question 12: Please indicate your preferred option (as stated or otherwise) and provide details as to why you consider this option suitable. Eighty eight per cent of submitters who responded to this question were in favour of Option 2. There was consensus that any review of the standard should be based on ‘best scientific evidence’ and be ‘risk-based’, that it should address specific areas of concern as identified in the Policy Options Paper, and that it allows for greater harmonisation of Australia New Zealand standards in this area. Submitters provided comments and indicated additional areas that should also be taken into account as follows: Industry The potential role for industry self-regulation efforts through codes and consumer awareness/education. The inclusion of naturally occurring caffeine products creates a level playing field for all industry sectors (i.e. novelty products vs. traditional) and allows for consideration of other caffeinated products consumed by vulnerable groups, and products that consumers do not traditionally consider to contain caffeine i.e. corn chips and chewing gum. One submitter argued that coffee, tea and hot chocolate should be exempt from caffeine content labelling. A need to have a clearer allocation of responsibilities for the determination and collection of emerging evidence, with time frames and guidance for reviewing it. This should include more information gathering on dietary intake estimates. ___________________________________________________________________________ 18 Consumer Option 2 is supported as it provides for a risk based review and risk management tools, while also focusing on vulnerable populations and increased scope to include all dietary sources of caffeine. Public Health It is essential to empower FSANZ to give effect to the objectives of the FSANZ Act i.e. the protection of public health and safety Endorsed the paragraph which encourages FSANZ to work with health research agencies to monitor caffeine consumption (especially by vulnerable populaces). They believed that this would allow FSANZ to consider emerging market and evidentiary trends into the future, undertake proactive information-gathering and develop understanding of the nature and scope of risks posed to young people. The terms ‘best scientific evidence’ and be ‘risk-based’ should be integrated into the specific policy standards. The Ministerial Council Policy Guideline should clearly identify appropriate tools for the regulatory management of caffeine i.e. improved FCB labelling similar to caffeine tablets, maximum caffeine contents of FCBs and sports supplements, assessment of health claims, and distinct labelling for caffeine from natural vs. other sources. Premarket risk assessment on a case by case basis for any additional new products containing caffeine rich ingredients, and No changes should be made to the current additive permissions (i.e. Standard 1.3.1). Stronger regulatory action on the labelling, promotion and advertising of caffeine products “likely” to be consumed by children. Governments Welcomed the ability to focus on the most vulnerable groups, but suggested expanding to include the general population. Eliminates the exclusion of foods containing naturally occurring caffeine. Advice was also needed for additional scrutiny of those highly-caffeinated beverages that are likely to be mixed with alcohol. There was a need for greater dietary exposure data to allow regulatory management to be informed by scientific evidence and international regulatory approaches. ___________________________________________________________________________ 19 Annex 1 Question 5 − Detailed summary of evidence provided by submitters Many public health submitters noted an extensive range of adverse effects associated with caffeine consumption. Symptoms of chronic consumption include irritability, tremulousness, occasional muscle twitching, sensory disturbances, tachypnoea, palpitation, flushing, arrhythmias, diuresis and gastrointestinal disturbance. Excessive caffeine consumption affects the central nervous system, cardiovascular system, gastrointestinal, neuromuscular, bronchial and the skeletal systems. Symptoms of excess intake include insomnia and sleep disturbance. Two public health submitters were concerned about the addictive nature of caffeine and one submitter was puzzled as to why FRSC would take note of the "insufficient evidence to confirm or refute the effectiveness of caffeine avoidance on birth weight or other pregnancy outcomes” given the inclusion criteria of the relevant study. In adolescents adverse effects were reported to include jitteriness, nervousness, dizziness, an inability to focus, difficulty concentrating, gastrointestinal upsets and insomnia. Public health submitters raised concerns regarding the adverse effects on oral health in relation to the low pH of caffeine containing drinks and the sugar content of beverages, as well as the impact on bone health and risk of osteoporosis due to associated declining consumption of calcium from milk. Public health submitters also noted that sweetened beverages containing caffeine play a role in obesity, and when combined with caffeine, synergistically increase post-prandial hyperglycaemia. One submitter noted that the literature review from the EFSA on the safety of caffeine and the American FDA investigation into the safety of caffeine should be included in the Working Group’s final deliberations. As per the CED Review Report3 some industry submitters reiterated that there were no highquality scientific studies that clearly demonstrated a causal link between energy drink exposure and serious adverse health effects. One industry association challenged the use of data from the New South Wales Poisons Centre where caffeine was ingested along with other intoxicating substances, and two industry submitters noted that the Coroner’s report related to the NZ woman consuming a high volume of Coca-Cola, acknowledged there were a number of possible causes of death. Two industry submitters noted that fatalities associated with caffeine were in those consuming caffeine from powders / tablets. One government submitter provided an extensive literature review, taking into account new research post July 2011. Food and Industry Businesses: Three industry submitters reiterated that the CED Review Report4 found no high-quality scientific studies that clearly demonstrated a causal link between energy drink exposure and serious adverse health effects. Two of these submitters note that that the paper by Gunja et al (2012)5, states that there is no evidence that 80 mg of caffeine consumed from an energy drink is any different from 80mg consumed from a cup of coffee. They therefore question why the CED Review Report does not take a similar approach to coffee. Furthermore, they 3 Department of Health and Ageing (2011) Review of the Evidence on the effects and international regulation of caffeinated energy drinks, The CED Review. Available on request from the Department of Health and Ageing, Canberra. 4 Ibid 5 Gunja, N. and Brown J. (2012). Energy drinks: health risks and toxicity. Medical Journal of Australia, 196(1): 46-49. ___________________________________________________________________________ 20 note that the symptoms recorded (gastrointestinal upset, and sympathetic overdrive) are the well-known side effects related to over-consumption of caffeine generally, regardless of source. Overall, these submitters considered that the risks and benefits of caffeine consumption outlined in the consultation paper are not based on a thorough review of the available evidence of caffeine. One submitter provided details of a 2013 Beverage Survey6, reporting that the average number of drinks in last seven days was: kola beverages (3.2) drink, instant coffee (3.1), green or black tea (2.9) and cafe styled coffee (1.9). Least of all was energy drinks (0.7). One drink manufacturer noted that it has been estimated that the acute lethal dose of caffeine is 10,000 mg in adults7. In order to ingest this much caffeine from their energy drink, one would need to ingest 125 cans, or over 31.25 litres. They acknowledged this volume is far in excess of the quantity that a person could reasonably drink. They also noted that there is speculation that some chilled and palatable caffeinated beverages (like energy drinks) are consumed faster than hot beverages therefore providing a greater ingestion of caffeine in a shorter time period. They noted that there are pharmacokinetic models demonstrating that whether a given caffeine dose is consumed within minutes (as energy drinks are purported to be consumed) or over 30-45 minutes (as coffee is purported to be consumed), there is no clinically significant difference. They also considered that adolescents experience no unique adverse effects from caffeine as caffeine safety is a function of body weight, not age, and that any effects adolescents may experience from caffeine are the same as those experienced by adults. Two submitters noted that in reference to a Coroner’s report suggesting that consumption of the caffeine containing kola drink was associated with a New Zealand woman’s death, the Coroner also acknowledged that there were a number of possible causes of the women’s death8. Furthermore, the experts / pathologists that reviewed the case could not agree on the most likely cause of her death. Two submitters considered that there were a number of gaps in the Consultation Paper in terms of risk: Reproductive-aged women and children are “at risk” subgroups who may require specific advice on moderating their caffeine intake. i.e. to consume less than 300mg caffeine per day (equivalent to 4.6mg/kg body wt in a 65kg person), while children should consume less than 2.5 mg/kg body wt per day9 Although coffee intake slightly increases blood pressure and plasma concentrations of homocysteine and cholesterol, there is no association with the incidence of hypertension or promoting the development of atherosclerosis in the general population10 One submitter noted that as a category, the voluminous nature of beverages means that intake of caffeine is dose-limiting, compared to products that offer direct caffeine delivery such as caffeine inhalers, caffeinated dissolvable strips, caffeine pills, caffeinated gum, and caffeinated mints. Two submitters noted that the fatalities reported associated with high levels Australian Beverages Council: Caffeine consumption – Australia, August 2013. Nawrot, P. et al. Effects of caffeine on human health. Food Additives and Contaminants, 2003: 20, 1-30. 8 Crerar, D. O. An Inquiry in to the death of Natasha Marie Harris, Findings of Coroner D. O. Crerar, New Zealand Coroner’s Court at Invercargill. 2013. 9 See note 5 10 Heckman, M.A. et al. Caffeine in Foods: A comprehensive review on consumption, functionality, safety and regulatory matters. Journal of Food Science. 2010: 77 – 87. 6 7 ___________________________________________________________________________ 21 of caffeine are related to intakes of tablets or powders containing caffeine (i.e. therapeutic products rather than foods). One submitter noted that media reports in relation to behavioural effects on children, junior sport, energy drinks and mixing of energy drinks with alcohol do not usually balance the concerns raised with information about actual intakes or the effects of caffeine. This submitter noted that in the paper by Nawrot et al 11 it was concluded that for the healthy adult population, moderate daily caffeine intake at up to 400 mg per day for a 65 kg person, is not associated with adverse effects such as general toxicity, cardiovascular effects, effects on bone status and calcium balance (with consumption of adequate calcium), changes in adult behaviour, increased incidence of cancer and effects on male fertility. However, some regulatory agencies are using this figure (400 mg per day) as a basis for regulatory concern for all adults, without clarifying that it is from a review of data or that it is for a 65 kg person. One industry association noted that data from calls to poisons information centres in Australia indicate that reports of adverse reactions allegedly caused by overconsumption of energy drinks are increasing. They noted that these calls do not provide evidence of energy drinks causing adverse reactions as more than half of the reports of hospitalisation over a six-year period involved co-ingestion of caffeine tablets, alcohol, amphetamines and other substances. They therefore challenge whether these call centre reports are a legitimate basis for regulatory concern. It considers that as crowd-sourced data it is by definition unverified, and FRSC should not rely on or cite such unverified data. One submitter noted that risks for vulnerable population groups appear ambivalent; that is, there appears to be inconclusive evidence for any specific risks to exist. Nonetheless, we note some countries take precautionary and mainly educational measures to address any such potential risks. One submitter noted that the paper should also refer to 2013 Australian Dietary Guidelines in evaluating risk management solutions.12 Consumers: One submitter who is a PhD candidate researching “Lipogenesis biomarker profiles after caffeine with sugar ingestion amongst human caffeine phenotypes", has identified in their research that there is preliminary evidence to suggest some vulnerable individuals have synergistically increased de novo lipogenesis upon consumption of caffeine with sugar compared to caffeine or sugar only.13 Public Health: Two submitters considered there is evidence that sugar sweetened beverages are associated with adult and child weight gain. One submitter referred to systematic reviews and metaanalyses of research supporting the view that sugar sweetened beverages play a causative role in obesity and other negative health impacts. One further submitter noted a study on the ‘caffeine calorie effect’ which states caffeine in sugar-sweetened beverages is contributing to 11 See note 5 National Health and Medical Research Council, Australian Dietary Guidelines (2013) 13 Ding, J., Rush, E. Using de novo lipogenisis biomarkers to study the influence of caffeine in combination with sugar on the energy metabolism of humans with different caffeine metabolic phenotypes and activity levels. Obesity Research & Clinical Practice. 2012; Vol 6; Suppl 1, 1-92. 12 ___________________________________________________________________________ 22 the obesity epidemic14. Two submitters noted research that suggests sugar and caffeine may synergistically increase postprandial hyperglycemia.15 One of these submitters recommended that in light of this finding, the draft Policy Guidelines should state that people with gestational and type 2 diabetes are a vulnerable group. One submitter considered it important that the amended Ministerial Council Policy Guideline specifically recognises that many caffeinated products also contain high levels of sugar. One submitter also notes that research suggests that caffeine may affect future preferences by acting on a developing child's brain reward-and-addiction centre. A study of 12-17 year-olds suggest that boys may be more susceptible to the reinforcing effects of caffeine than girls, regardless of usual caffeine consumption.16 This submitter notes that the American Academy of Paediatrics’ position17 is that energy drinks have no place in the diet of children, noting dietary intake of caffeine can produce harmful adverse effects in children; and that the effects of caffeine consumption can include disturbed sleep, gastric and cardiovascular problems, as well as a risk of addiction, which are particularly concerning for children. They also noted that a systematic review of literature commissioned by the World Health Organization (WHO)18 has found consistent evidence of a causal relationship between children’s exposure to food promotion material, and their behaviour and diet-related health outcomes. The WHO has recommended that States take active steps to reduce the exposure of children to marketing for unhealthy products, as a risk factor for weight gain and obesity. Two further pieces of evidence include a paper by Seifert et al (2011)19 which reviews literature around the effects, adverse consequences and extent of energy drink consumption among children, adolescents and young adults; and a paper by Temple et al (2009)20 which tested the hypothesis that adolescents find caffeinated soda more reinforcing than non-caffeinated soda and that this would relate to consumption of caffeinated products. Data gathered suggested that boys may be more susceptible to the reinforcing effects of caffeine. One submitter provided a copy of a letter written to the US FDA by a number of concerned scientists, regarding the dangers of caffeinated beverages21. Other references include Thomson and Schiess (2010)22 and Zucconi et al (2013).23 They, and another submitter, noted 14 Keast, R.S.J., Sayompark, D., Sacks, G., Swinburn B.A. and Riddell L.J. The influence of caffeine on energy content of sugar-sweetened beverages: the caffeine–calorie effect, European Journal of Clinical Nutrition; 2011: Issue number 65, 1338–1344. 15 Whitehead, N., and White, H. Systematic review of randomised controlled trials of the effects of caffeine or caffeinated drinks on blood glucose concentrations and insulin sensitivity in people with diabetes mellitus. Journal of Human Nutrition and Dietetics. 2013: 26(2): 111-125. 16 Oddy W and O'Sullivan T.A. Energy drinks for children and adolescents, erring on the side of caution may reduce long term health risks. British Medical Journal. 2009; 339 17 Committee on Nutrition and the Council on Sports Medicine and Fitness (2011) Clinical Report – Sports drinks and energy drinks for children and adolescents: are they appropriate? Pediatrics, 127, 1182-9. 18 Cairns, G., Angus, K. & Hastings, G. (2009) The extent, nature and effects of food promotion to children: a review of the evidence to December 2008 – Prepared for the World Health Organization. 19 Seifert S.M. Schaechter J.L. Hershorin E.R., Lipshultz S. E. Health effects of energy drinks on children, adolescents, and young adults. Pediatrics. 2011: 127(3):511-28. 20 Temple et al. Sex differences in reinforcing value of caffeinated beverages in adolescents. 2009: 20(8) Behavioral Pharmacology 731–741 21 Arria A.M., O’Brien M.C., Griffiths R.R., Crawford P.B, Babu K., Goldberger B.A., Griffen W.C., Higgen J.P, Kappagoda C.T., Lipshultz S.E., Madsen K., Marczinkski C.A., Miller K.E., Olgin J., Sepkowitz K.A., Temple JL, Thombs D.L and Wibbelsman C.J. Letter to commissioner Hamburg Re: The use of caffeine in energy drinks. Sent March 19, 2013 [cited 2013 Oct 9]. Available from: http://graphics8.nytimes.com/packages/pdf/business/BestofScienceLetter_v22.pdf 22 Thomson B and Schiess S. (2010) Risk Profile: Caffeine in energy drinks and energy shots. [cited 2013 August 30]. Available from: (http://www.foodsafety.govt.nz/elibrary/industry/Risk_Profile_Caffeine-Science_Research.pdf) 23 Zucconi S., Volpato C., Adinolfi F., Gandini E., Gentile E., Loi A., Fioriti L. (2013) Gathering consumption data on specific consumer groups of energy drinks. Supporting Publications EN-394; p1-190. 2013 [cited 2013, August 30]. Available from: www.efsa.europa.eu/publication ___________________________________________________________________________ 23 they were particularly concerned about the addictive nature of caffeine, both physical and emotional, as documented in research by Pohler (2010).24 This paper also refers to a syndrome called caffeinism that results from chronic consumption of caffeine and addiction. Symptoms include nervous irritability, tremulousness, occasional muscle twitching, sensory disturbances, tachypnoea, palpitation, flushing, arrhythmias, diuresis and gastrointestinal disturbances. It was also noted that patients may present with generalised anxiety or depression, and withdrawal of caffeine can be an onerous task, taking between two days and two weeks. Two other submitters noted that the promotion of caffeine containing products is targeted at youth and adolescents, and particularly young males.25 It was noted that it is unlikely that consumption established early in life would not contribute to long-term negative health outcomes. One submitter noted that evidence suggests high intake of caffeinated beverages not only disrupts sleep patterns but can also lead to insomnia, a common feature of caffeine intoxication.26, 27 This submitter also noted they were puzzled as to why the FRSC would take note of the "insufficient evidence to confirm or refute the effectiveness of caffeine avoidance on birth weight or other pregnancy outcomes" as presented by a Cochrane review that is based on only one randomised control trial that met the inclusion criteria. This submitter also raised the issue of oral health (the risk of dental caries and dental erosion) in that caffeine is associated with salivary dysfunction secondary to the diuretic effects of caffeine.28 They also note that independent of this is the impact of erosive actions of the acids (at a low pH) contained within caffeinated drinks on oral health.29 They noted that adolescents report specific effects including jitteriness, nervousness, dizziness, an inability to focus, difficulty concentrating, gastrointestinal upsets and insomnia; and that healthcare providers have reported effects including dehydration, accelerated heart rates, anxiety, seizures, acute mania and strokes from the consumption of energy drinks. This submitter noted that according to Pohler (2010)30 excessive caffeine consumption affects virtually every organ system including the central nervous system, cardiovascular system, gastrointestinal, neuromuscular, bronchial and the skeletal systems. Caffeine consumption elicits a prolonged stress response in the body, and the clinical effects of caffeine make it particularly important for the care of persons with hypertension, diabetes mellitus, gastrooesophageal reflux disease and irritable bowel syndrome. It may also make medical management and control of such diseases more difficult to manage. Additional concerns suggested in the literature by Reissig et al. (2009)31 include a greater vulnerability to caffeine intoxication among children and adolescents, who are not habitual caffeine uses, and have not yet established a pharmacological tolerance. More alarmingly, some studies also suggest that energy drinks may provide a gateway to other forms of drug dependence.32 Finally this submitter considers that a particular concern for girls is the association between cola beverage consumption and bone fractures.33 Whilst the caffeine and orthophosphoric acid 24 Pohler, H. Caffeine Intoxication and Addiction. The Journal for Nurse Practitioners. 2010: 6(1): 49-52. Reissig, C.J. and Strain, E.C. Caffeinated Energy Drinks – A growing problem. Drug and Alcohol Dependence. 32009: 99 (1-3): 1-10. 26 Attila, S. and Cakir, B. Energy drink consumption in college students and associated factors. Nutrition. 2011: 27; 316-322. 27 See note 13 28 Walsh, L.J. Caffeine: Emerging Dental and general health Concerns. University of Queensland. 2003: 1-3. 29 Ibid 30 See note 12 31 See note 13 32 See note 13 33 See note 14. 25 ___________________________________________________________________________ 24 content in black cola drinks is linked with hypocalcaemia, there is also an associated declining consumption of milk, compared with caffeinated, carbonated beverages, which raises concerns of osteoporosis in later life. One submitter noted that the risks and benefits of caffeine consumption outlined in the Consultation Paper are not based on a thorough review of the available evidence of caffeine. As one example, the Consultation Paper mentions caffeine induces bone loss in postmenopausal women. The submitter considered that the relationship of caffeine bone health deserved more attention. For example evidence showed that large doses of caffeine increases urinary excretion of calcium for several hours after consumption.34,35,36 Intakes above 400mg/day are significantly associated with hip fracture in both men and women37 however, there are unlikely to be harmful effects on bone health in individuals who have adequate intakes of calcium and moderate caffeine intake (up to 400mg/day).38 This submitter strongly recommended revisiting the Consultation Paper post completion of the literature review from EFSA on the safety of caffeine and the American FDA investigation into the safety of caffeine. One submitter noted reports provided for the recent Institute of Medicine (IOM) two-day workshop provided an extensive review of the adverse health effects of caffeine, particularly on children.39 They also note that there is some preliminary evidence suggesting that some individuals are more susceptible to the effects of caffeine due to a genetic polymorphism associated with a slower rate of caffeine metabolism.40 Thus, identifying those at risk from caffeine within the population presents challenges. This submitter refers to a paper by Temple et al. (2010)41 noting that the rise in caffeine use among children and adolescents has lead many researchers to question the safety of caffeine use within this population, however little empirical data exist on the physiological, psychological, or behavioural effects of habitual caffeine use among children. Furthermore, further research should be conducted to better understand these effects. One submitter noted that given the growth in the number of beverages containing caffeine, it is problematic to base any conclusions on dietary exposure solely based on New Zealand children’s consumption data taken from 2002. It is highly likely that children’s exposure to caffeine-containing products has changed over time (most likely increasing). It is also important to note that parents of children may not accurately report their child’s ‘junk food consumption’, which may contain caffeinated soft drinks and FCBs. This same submitter noted the recent death of an adult male in the United Kingdom directly attributed to the consumption of highly caffeinated mints. One submitter noted a study of student athletes found misconceptions surrounding the use of energy drinks including substituting energy drinks for water when engaging in strenuous 34 Tucker, K.L. Dietary intake and bone status with ageing. Curr Pharm des. 2033 (Cite 2011 Jan 10); 9 (32):268. Brown, J.P., Josse R.G. Clinical Practice Guideline for the diagnosis and management of osteoporosis in Canada. CMAJ. 2002: S1-S34. 36 See note 5. 37 See note 23 38 See note 5 39 http://iom.edu/~/media/Files/Activity%20Files/Nutrition/PotentialEffectsofCaffeine/caffeineORNLreport.pdf 40 Cornelis & El-Sohemy. Coffee, caffeine, and coronary heart disease. Current Opinion in Lipidology 2007; 18(1):1319. 41 Temple JL, Dewey AM, and Briatico LM. Effects of acute caffeine administration on adolescents. Exp Clin Psychopharmacol. 2010; 18(6):510-520. 35 ___________________________________________________________________________ 25 physical activities.42 As a consequence the subjects were putting themselves at risk of dehydration due to the diuretic nature of caffeine. The results of the study show a degree of confusion surrounding the role of sports drinks and that of energy drinks.43 One submitter refers to the Australian Institute of Sport (AIS) advice for athletes which outlines a range of concerns associated with supplement usage. Advice includes potential reactions between caffeine and other supplements, effects on sleep, anxiety, heart rate and recovery.44 Government: One submitter noted that the National Health & Medical Research Council of Australia reviewed the literature in the development of the Australian Dietary Guidelines (2013) and evaluated evidence relating to coffee intake and gastric cancer, hepatocellular cancer, breast cancer, endometrial cancer, colorectal cancer, bladder cancer, ovarian cancer, liver cancer, cardiovascular disease, hypertension and type 2 diabetes.45 Also reviewed was the risk of tea consumption to development of breast cancer, gastric cancer, ovarian cancer, colorectal cancer, stroke, cardiovascular disease, lung cancer and the risk of alcohol and caffeine consumption on breastfeeding outcomes. This submitter noted that products containing high amounts of caffeine have been associated with serious adverse effects particularly among children, adolescents and young adults suffering from seizures, diabetes, cardiac abnormalities, mood and behavioural disorders or those on medications.46 One submitter provided a lengthy review of the evidence in relation to the risk of caffeine. A summary is provided here: Community concerns regarding caffeine consumption by vulnerable populations Consumer surveys indicate that there is a growing concern around sale of caffeinated beverages to children under the age of 12 years both in Western Australia47 and in the US.48 Group of US health professions advocating for the FDA to apply GRAS standard to energy drinks and require caffeine content labelling requirements to protect children and adolescents from the risks of energy drink consumption.49 42 Buxton, C., and J. Hagan (2012). A survey of energy drinks consumption practices among student -athletes in Ghana: lessons for developing health education intervention programmes. Journal of the International Society of Sports Nutrition 9: 1-8. 43 Buxton C and Hagan J. A survey of energy drinks consumption practices among student athletes in Ghana: Lessons for developing health education intervention programmes. Journal of the International Society of Sports Nutrition. 2012:9; 1-8. ibid. 44 Australian Institute of Sport – Website Fact Sheet – AIS Sports Supplement Program – Caffeine. 45 National Health and Medical Research Council. A review of the evidence to address targeted questions to inform the revision of the Australian Dietary Guidelines. Canberra: National Health and Medical Research Council, 2011. 46 Seifert, S.M. and Judith, Schaechter, J, L. Hershorin E.R., Lipshultz S. E. Health effects of energy drinks on children, adolescents, and young adults. Pediatrics: Official Journal of the American Academy of Pediatrics. 2011: 127 (3): 511-528. 47 Pollard CM, Meng X, and McStay C. Community concern about the sale of high-caffeine drinks to children under 12 years of age: Western Australia population survey results. Health Promot J Austr. 2013; p. 1-2. 48 The Rudd Centre for Food Policy and Obesity. Measuring parental attitudes about energy drinks. 2012[cited 2013 August 29]. Available from: http://www.yaleruddcenter.org/resources/upload/docs/what/policy/SSBtaxes/SSB_Parent_Attitudes_Energy_Drinks.p df 49 Arria AM, O’Brien MC, Griffiths RR, Crawford PB, Babu K, Goldberger BA, Griffen WC, Higgen JP, Kappagoda CT, Lipshultz SE, Madsen K, Marczinkski CA, Miller KE, Olgin J, Sepkowitz KA, Temple JL, Thombs DL and ___________________________________________________________________________ 26 Energy drink consumption levels A 2006 Queensland dietary survey found that energy drink consumption increased with age. Of those children in year 10, 50% drank energy drinks within the past 12 months and between 5-8% had consumed two or more energy drinks per week.50 EFSA survey found that adolescents had the highest prevalence of consumption, 68% of adolescents reported consumption within the last year. 16% of children, 12% of adolescents stated that they regularly consumed 4-5 energy drinks per week.51 Average caffeine consumption per day in the US has been estimated at 60-70 mg/day.52 Public health issues regarding caffeine consumption Experts have identified evidence gaps on the impact of energy drinks and childhood obesity,53 addiction in adolescents,54 impact on flavour preferences and how this could relate to weight gain.55 2010 Expert working group postulated that caffeine intake in children can lead to dependency on caffeine and withdrawal effects on abstinence.56 Acknowledged that in adults there may be enhanced performance and mood effects at doses of 37.5 mg; but also that in children higher caffeine doses have been reported to increase anxiety (95 mg) and reduced sleep (100mg).57 A small study looking at coffee consumption in 10 consumers found increased anxiety levels after consuming ~80 mg caffeine dose compared to the control group.58 2013 study examined association of energy drink consumption with anxiety, depression and stress in young Western Australian adults.59 Findings from this study indicated that young adult males intake of energy drinks were associated with increased levels of anxiety, and further work should examine the impact of energy drinks on mental health. Dose response trial of between 0-200 mg found that heart rate decreased and diastolic blood pressure increased with increasing caffeine intakes.60 Review of evidence on safety of energy drinks conducted by the International Society of Sports Nutrition recommend that parents should thoroughly assess the potential harmful Wibbelsman CJ. Letter to commissioner Hamburg Re: The use of caffeine in energy drinks. Sent March 19, 2013 [cited 2013 Oct 9]. Available from: http://graphics8.nytimes.com/packages/pdf/business/BestofScienceLetter_v22.pdf 50 Abbott RA, Macdonald D, Mackinnon L, Stubbs CO, Lee AJ, and Davies PSW. Healthy Kids Queensland Survey 2006 – Summary Report. Brisbane: 2007. Queensland Health. 51 Zucconi S., Volpato C., Adinolfi F., Gandini E., Gentile E., Loi A., Fioriti L. Gathering consumption data on specific consumer groups of energy drinks. Supporting Publications 2013: EN-394; p1-190. 2013 [cited 2013, August 30]. Available from: www.efsa.europa.eu/publication 52 Seifert SM, Schaechter JL, Hershorin ER, and Lipshultz SE (2011) Health Effects of Energy Drinks on Children, Adolescents, and Young Adults. Pediatrics 127; 511-528. 53 Department of Health and Ageing. 2011. Review of the Evidence on the effects and international regulation of caffeinated energy drinks, The CED Review. Available on request from the Department of Health and Ageing, Canberra. 54 Ibid. 55 Keast RSJ, Sayompark D, Sacks G, Swinburn BA, and Riddell LJ. The influence of caffeine on energy content of sugar-sweetened beverages: ‘the caffeine–calorie effect’. Eur J Clin Nutr. 2011; 65:1338–1344. 56 Smith PF, Smith A, Minors J, McNeil J, and Proudfoot A Report from the Expert Working Group on the safety aspects of dietary caffeine. 2000 [cited 2013 Mar 22]. Available from: http://www.foodstandards.gov.au/_srcfiles/EWG_Dietary_caffeine.pdf 57 Ibid. 58 Vinader-Caerols C, Monleon S, Carrasco C, and Parra A (2012). Effects of alcohol, coffee, and tobacco, alone or in combination, on physiological parameters and anxiety in a young population. Journal of Caffeine Research 2(2): 7076. 59 Trapp GSA, Allen A, O’Sullivan TA, Robinson M, Jacoby P, and Oddy WH (2013). Energy drink is associated with anxiety in Australian young adult males. Depression and Anxiety 00:1-9. 60 Temple JL, Dewey AM, and Briatico LM. Effects of acute caffeine administration on adolescents. Exp Clin Psychopharmacol. 2010; 18(6):510-520. ___________________________________________________________________________ 27 effects before approving their consumption in their child or adolescent, and that those with a pre-existing medical condition may be affected by the high carbohydrate and or caffeine content and should check with their physician before consuming.61 − Another review highlighted concerns regarding caffeine toxicity. Specific health risks for children and adolescents including; potential effects on neurological development, cardiovascular systems, the risk of caffeine dependence and addiction, and risk of overweight and obesity.62 − 2012 literature review on toxic effects of energy drinks in adolescents listed physiological effects linked to caffeine consumption at therapeutic levels including: bronchodilation, increased gastric acid secretions, headache, nausea, vomiting, diuresis, tachycardia, central nervous system excitation. Whereas at toxic levels of caffeine consumption there were associations with: vomiting, tachycardia, altered mental status, arrhythmias, seizures, and hypotension in larger overdoses.63 Trials examining caffeine intake on cardiovascular outcomes: − 80 mg caffeine dose led to an increased platelet aggregation & decreased endothelial function.64 − 200 mg caffeine daily for 7 days led to increase in systolic blood pressure of 10 mm Hg, increased heart rate. 53% reported no adverse effect, 20% (n=3) reported gastrointestinal symptoms, 25% (n=4) reported feeling jittery or shaky. 1 participant reported sleep disturbance and another increased force of heart beats.65 − Caffeine during pregnancy may lead to increased exposure both in terms of amount and duration to the fetus as the placenta and fetus due to the inability of the placenta or fetus to metabolise caffeine.66,67, 68 Shown to increase accelerations in fetal heart rate and increased uterine contraction.69 Caffeine may intake may adversely affect fetal growth.70 One other submitter noted the risks associated with consuming caffeine on increasing blood pressure.71 It is noted that some of this effect may be mediated by combination with taurine and an increase in cardiac stroke volume and cardiac output.72 The increased diastolic blood pressure from caffeine can be seen even in adolescents73 and has been implicated in a case 61 Campbell B, Wilborn C, La Bounty P, Taylor L, Nelson MT, Greenwood M, Ziegenfuss TN, Lopez HL, Hoffman JR, Stout JR, Schmitz S, Collins R, Kalman DS, Antonio J, and Kreider RB. International Society of Sports Nutrition position stand: energy drinks. J Int Soc Sports Nutr. 2013; 10:1 (16 pages). 62 Committee on Nutrition, and the Council on Sports Medicine and Fitness. Sports drinks and energy drinks for children and adolescents: are they appropriate? Pediatrics 2011; 127(6): 1182-1189. 63 Wolk BJ, Ganetski M, and Babu KM. Toxicity of energy drinks. Curr Opin Pediatr. 2012; 24: 243-251. 64 Worthley MI, Prabhu A, De Sciscio P, Schultz C, Sanders P, Willoughby SR. Detrimental effects of energy drink consumption on platelet and endothelial function. The American Journal of Medicine 2010; 123:184-187. 65 Steinke L, Lanfear DE, Dhanapal V, and Kalus JS. Effects of energy drink consumption on hemodynamic and electrocardiographic parameters in healthy adults. Ann Pharmacother. 2009;43 (4):596-602. 66 Yang A, Palmer AA, and de Whit H. Genetics of caffeine consumption and responses to caffeine. Psychopharmacology 2010;211: 245-257 67 Grosso LM, Bracken MB. Caffeine metabolism, genetics, and perinatal outcomes: a review of the exposure assessment considerations during pregnancy. Ann Epidemiol 2005;15:460–466. 68 Buscicchio G, Piemontese M, Gentilucci L, Ferretti F, and Tranquilli. The effects of maternal caffeine and chocolate intake on fetal heart rate. J Matern Fetal Neonatal Med. 2012;25(5):528-530. 69 Ibid. 70 Sharmin S, Guan H, Willaims AS, and Yang K. 2012. Caffeine reduces 11ß –Hydroxysteroid Dehydrogenase type 2 expression in human trophoblast cells through the adenosine A2B receptor. PLoS ONE 7 (6): 8 pages 71 Cohen, D.L. and Townsend, R.R. Does consumption of high-caffeine energy drinks affect blood pressure? J Clin Hypertens. 2006: 8, 744-5. 72 Bichler, A et al. A combination of caffeine and taurine has no effect on short term memory but induces changes in heart rate and mean arterial blood pressure. Amino Acids. 2006: 31, 471-6 73 Temple, J.L. et al. Effects of acute caffeine administration on adolescents, Exp Clin Psychopharacol. 2010: 18, 51020. ___________________________________________________________________________ 28 report of a ruptured cerebral aneurysm in a 38 year old74). Hypertension is a significant cause of morbidity and mortality in Australia.75 This submitter also notes that independent of the direct effect of caffeine on blood pressure, FCBs also contain high levels of sodium the known leading preventable dietary cause of hypertension. This submitter noted the risk of FCBs on dental decay which is at least as bad as76,77,78and perhaps even worse than other soft drinks.79,80 They noted that FCBs have also been associated with marked dentine hypersensitivity.81 This submitter also noted reports to the poisons information line in NSW regarding caffeinated energy drinks increased by over 540% between 2004 and 2010.82 This submitter notes that although the combination of FCBs and alcohol is out of scope of the Policy Options Paper, significant harm can arise from their use, especially when FCBs are used as a way of extending a drinking session. 83,84 They also note potential confusion of FCB ‘energy drinks’ with electrolyte ‘sports drinks’ (can mean that their use with sport or dancing leaves the consumer at risk of further dehydration 85 and possibly cardiac events from caffeine toxicity, even amongst young people.86 Furthermore, caffeine’s well-known role in sleep impairment can lead to a reduction in work performance.87 One submitter notes that twenty-one per cent of calls about FCBs to the NSW Poisons Information Centre between 2004—2010 were about accidental ingestion in children with a mean age 38 months.88 Half of the cases of energy drink toxicity reported to the US National Poison Data System (NPDS) involved unintentional exposures in children less than 6 years old; importantly educational campaigns and restrictions on the sale of FCBs significantly reduced reports of FCB toxicity.89 This submitter noted that the effect of caffeine on the fetus is mentioned in the Paper, but the effect on the pregnant women themselves was not. The noted that pregnant women may be 74 Argano C. et al. Take the wind out of your sails: relationship among energy drink abuse, hypertension, and breakup of cerebral aneurysm. Intern Emerg Med. 2012: 7, Suppl 1, S9-S10. 75 National Heart Foundation of Australia (National Blood Pressure and Vascular Disease Advisory Committee), Updated December 2010. Guide to the management of hypertension. 2008. 76 Ehlen, L.A. et al. Acidic beverages increase the risk of in vitro tooth erosion, Nutr Res. 2008: 28, 299-303. 77 Kitchens, M. Effect of carbonated beverages, coffee, sports and high energy drinks, and bottle water on the invitro erosion characteristics of dental enamel. J Clin Pediatr Dent. 2007: 31, 153-9. 78 Von Fraunhofer, J.A. Effects of sports drinks and other beverages on dental enamel. 2008: 53, 28-31. 79 Cavalcanti, A.L. et al. Short communication: In vitro assessment of erosive potential of energy drinks. Eur Arch Paediatr Dent. 2010: 11, 253-5. 80 Owens, B. The erosive potential of soft drinks on enamel surface substrate: an in-vitro scanning electron microscopy investigation. J Contemp Dent Pract. 2007: 8, 11-20. 81 West, N. Prevalence of dentine hypersensitivity and study of associated factors: A European population-based crosssectional study. J Dent. 2013. 82 See note 23 83 Pennay, A et al. Combining energy drinks and alcohol – a recipe for trouble? Aust Fam Physician. 2011: 40, 104-7 84 Pennay, A et al. Alcohol and caffeinated energy drinks: a preliminary study exploring papers of consumption and associated harms. Fitzroy, Melbourne: Turning Point Alcohol and Drug Centre, 85 See notes 43 and 44 86 Berger, A.J. Cardiac arrest in a young man following excess consumption of caffeinated ‘energy drinks’. Med J Aust. 2009: 190, 41-43. 87 Centers for Disease Control and Prevention. Energy drink consumption and its association with sleep problems among U.S. service members on a combat deployment – Afghanistan, 2010. MMWR Morb Mortal Weekly Rep. 2012: 61, 895-8. 88 See note 23 89 Seifert, M.J. et al. An analysis of energy drink toxicity in the National Poison Data System. Clin Toxocol (Phila). 2013: 51, 566-74. ___________________________________________________________________________ 29 less habituated to caffeine as many women intentionally reduce their caffeine intake as a result of becoming pregnant, as well as taking longer to clear caffeine from their bodies90 increasing the risk of effects of caffeine on the women themselves. There is also no mention of the transmission of caffeine through breast milk91 and the implications for breastfed babies. This submitter also noted the vulnerability of those with psychiatric disorders where caffeine consumption may lead to the worsening of anxiety disorders,92 relapse of bipolar spectrum disorder93 or inducement of psychosis in a previously stabilised patient.94 In addition, although daily headaches are a well-known symptom of caffeine withdrawal the particular vulnerability of those who are prone to migraines was not. This group is then at risk of diagnostic confusion and what would otherwise be unnecessary medication use.95 There have been many case reports of adverse reactions involving the use of FCBs, many of which involve young people and excessive usage. These include liver toxicity,96 97 excessive intraoperative bleeding,98 anaphylaxis,99 anxiety disorders in the previously healthy100 and hallucinations. In addition to the supraventricular and ventricular tachyarrhythmias mentioned are other cardiovascular pathologies, including coronary vasospasm even leading to myocardial infarction (heart attack),101 or atrial fibrillation in young, otherwise healthy individuals 102 and aortic dissection in those with pre-existing cardiovascular disease. 103 One further submitter noted that a recent paper found that energy drink consumption was associated with increased anxiety in young adult, and that research into the contribution of energy drink used in the development of mental health problems is needed.104 This submitter also noted that the IOM provides data on Caffeine in Food and Dietary Supplements'.105 They also commented that reference to the 2013 Australian Dietary Guidelines including recommendations for children, adolescents and during pregnancy and breastfeeding regarding caffeine consumption was omitted from the Consultation Paper. 90 Gaohua, L. e al. A pregnancy physiologically based pharmacokinetic (p-PBPK) model for disposition of drugs metabolised by CYP1AA2, CYP2D6 and CYP3A4. Br J Clin Pharmacol. 2012: 74, 873-85. 91 Stavchansky, S. Pharmacokinetics of caffeine in breast milk and plasma after single oral administration of caffeine to lactating mother. Biopharm Drug Dispos. 1988: 9, 285-99. 92 Chelben, J. Effects of amino acid energy drinks leading to hospitalisation in individuals with mental illness. Gen Hosp Psychiatry. 2008: 30, 187-9. 93 Rizkallah, E. et al. Could the use of energy drinks induce manic or depressive relapse among abstinent substance use disorder patients with comorbid bipolar spectrum disorder? Bipolar Disord. 2011: 13, 578-80. 94 Cerimele, J.M. et al. Psychosis following excessive ingestion of energy drinks in a patient with schizophrenia. Am J Psychiatry. 2010: 167, 353. 95 Dees, B. et al. Managing migraine and other headache syndromes in those over 50. Maturitas, 2013. 96 Vivekanandarajah, A. et al. Acute hepatitis in a woman following excessive ingestion of an energy drink: a case report. J Med Case rep. 2011: 5, 227. 97 Apestegui, C.A. Energy drinks: another red flag for the liver allograft, Liver Transpl. 2011: 17, 1117-8 98 Foran, M. et al. Excessive intraoperative bleeding with chronic energy drink consumption. J Oral Maxillofac Surg. 2012: 70; 1439-41. 99 Lees, S. E. A case of taurine-containing drink inducted anaphylaxis. Asia Pac Allergy. 2013: 3, 70-3. 100 Berigan, T. An anxiety disorder secondary to energy drinks: a case report. Psychiatry (Edgmont). 2005; 2, 10. 101 Berger, A.J. Cardiac arrest in a young man following excess consumption of caffeinated energy drinks. Med J Aust. 2009: 190, 141-3. 102 Scott, M.J. Myocardial infarction in a young adult following the consumption of a caffeinated energy drink. BMJ Case Rep. 2011. 103 Jonjev, Z.S. High energy drinks may provoke aortic dissection. Coll Antropol. 2013: 37; Suppl 2, 227-9. 104 Trapp, G.S.A. et al. Energy drink is associated with anxiety in Australian young adult males. Depression and Anxiety. 2013:00, 1-9. 105 The Institute of Medicine (2013) Caffeine in Food and Dietary Supplements: Examining Safety. Food and Nutrition Board on Health Sciences Policy ___________________________________________________________________________ 30 Annex 2 Relevant documents, reports, guidelines, and standards suggested by submitters The following documents were referenced in submissions, in addition to those already referenced in the Food Regulation Policy Options Paper on The Regulation of Caffeine in Food. Please note that this list of references is as provided by submitters and we take no responsibility for accuracy of referencing. Abbott RA, Macdonald D, Mackinnon L, Stubbs CO, Lee AJ, and Davies PSW. Healthy Kids Queensland Survey 2006 – Summary Report. Brisbane: 2007. Queensland Health. Aranda, J. V., Collinge, J. M., Zinman, R., & Watters , G. (1979). Maturation of caffeine elimination in infancy. Arch Dis Child, 54, 946-949 American Academy Of Pediatrics Committee On Nutrition And The Council On Sports Medicine Fitness (2011). Sports drinks and energy drinks for children and adolescents: are they appropriate? Pediatrics, 127, 1182-9. ANZFA (2001) Inquiry Report – Application A394 Formulated Caffeinated Beverages, Attachment 4, Amended Regulation Impact Statement, Apestegui, C. A., Julliard, O., Ciccarelli, O., Duc, D. K. & Lerut, J. (2011) Energy drinks: another red flag for the liver allograft. Liver Transpl, 17, 1117-8. Argano, C., Colomba, D., Di Chiara, T. & La Rocca, E. (2012) Take the wind out your sails: relationship among energy drink abuse, hypertension, and break-up of cerebral aneurysm. Intern Emerg Med, 7 Suppl 1, S9-10. Arnaud, M. J. (2011). Pharmacokinetics and metabolism of natural methylxanthines in animal and man. Handbook of Experimental Pharmacology, 200, 33-91. 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Available from: http://australianbeverages.org/wpcontent/uploads/2013/04/EnergyDrinks_AnIndustryCommitment.pdf (cited 16 October 2013). Australian Government, Australian Communications and Media Authority (2008) Review of the Children’s Television Standards 2005; Report of the Review, ___________________________________________________________________________ 31 Australian Institute of Sport (20120) AIS Website Fact Sheet – AIS Sports Supplement Program – Caffeine, AIS Sports Supplement Program. Aztec Australia (2013) Total Australian Grocery & Convenience, Calendar Year 2012. Beckford K, Riddell L, Grimes C. (2013) Australian children’s consumption of caffeinatedformulated beverages – abstract submitted to Nutrition Society of Australia, Annual Conference. Berger, A. J. & Alford, K. (2009) Cardiac arrest in a young man following excess consumption of caffeinated "energy drinks". Med J Aust, 190, 41-3. Berigan, T. (2005) An anxiety disorder secondary to energy drinks: a case report. 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Available from: www.efsa.europa.eu/publication ___________________________________________________________________________ 42 Annex 3 List of Submitters Food Regulation Policy Options Paper for the Regulation of Caffeine in Foods Food Industry and Business No 14 Unique Drinks Red Bull Australia and New Zealand Australian Beverages Coca-Cola South Pacific Nestle Frucor Beverages Ltd Australian Food and Grocery Council New Zealand Food and Grocery Council Cerebos (Australia) Limited and Cerebos Gregg’s Limited New Zealand Juice and Beverage Association Unilever Ltd Australian Industry Group The Food Technology Association of Australia Nutritional Concepts Group Pty LTD Consumers Joe Ding No 1 Public Health No 10 Healthy Kids Association Obesity Policy Coalition Public Health Association of Australia Dieticians Association of Australia Australian Health Promotion Association Western Australia Deakin University's School of Exercise and Nutrition Sciences Elaine Rush, Professor of Nutrition, AUT Australian Medical Association High Performance Sports New Zealand Vic Health (Victorian Health Promotion Foundation) Government No 7 Department of Health and Human Services − Tasmania Department of Health and Environments and Primary Industries, Victoria Department of Health, Western Australia South Australia Public Health Ministry for Primary Industries NZ ACT Health Directorate Department of Health, Queensland TOTAL = 32 submissions received ___________________________________________________________________________ 43