1. Background
On October 6, 2011, Health Canada announced its proposed approach to managing caffeinated energy drinks. This proposed approach included new measures such as the classification of caffeinated energy drinks as foods, the establishment of caffeine limits and enhanced labelling requirements. The new measures should help Canadians make more informed decisions about these products, and reduce the risk of over consumption of caffeine and other ingredients such as vitamins and minerals. The new measures would also make it easier for parents to monitor the caffeine intake of their children and teens.
The proposed approach was posted on Health Canada's website for the purposes of stakeholder consultation. Stakeholders were invited to provide their comments to Health Canada from October 6, 2011 to November 15, 2011.
The purpose of this consultation report is to provide a summary of the comments received during the consultation and Health Canada's response including any possible change to Health Canada's proposed approach to managing caffeinated energy drinks as a result of stakeholder comments.
2. Summary of Consultation
2.1 Participation
Health Canada received seventy one (71) responses during the consultation period from 14 types of stakeholder groups. While most stakeholders provided comments or sought clarification on elements of the proposed approach to managing caffeinated energy drinks, others provided comments that were beyond the scope of this approach and of Health Canada's mandate and authority.
The largest number of responses received came from the general public (19), followed by provincial governments (14) and public health organizations (11). The remaining responses were provided by groups such as industry associations, health professionals, and academia (see Annex 1).
2.2. General Comments
Overall, the vast majority of stakeholders, in particular provincial governments, community organizations, public health organizations, school districts and the general public were supportive of Health Canada's proposed approach to managing caffeinated energy drinks. These stakeholders viewed the proposed classification of caffeinated energy drinks as food as a good way to align the regulation of caffeinated energy drinks with other food products and provide consumers with the information they need to make informed decisions about the consumption of these products.
However, some stakeholders disagreed with certain elements of the proposed approach to managing caffeinated energy drinks, particularly regarding the established limit for caffeine, measures or lack thereof related to sale, marketing and advertising, the addition of other ingredients (e.g. vitamins, minerals, guarana, taurine and herbal extracts) and labelling requirements. A small minority of stakeholders thought that caffeinated energy drinks were unfairly targeted as opposed to other caffeine containing beverages.
2.3 Comments and Health Canada Responses
The following table summarizes the comments received from stakeholders during the consultation and Health Canada's response to these comments. Comments were grouped into key themes.
1) General
| Comments |
Health Canada's Response |
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- Strong support was expressed for aligning the regulation of caffeinated energy drinks with other food products. Stakeholders in general were supportive of the classification of caffeinated energy drinks as foods.
- Others felt that more stringent measures were needed in order to mitigate potential risks associated with caffeinated energy drinks.
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- The new measures proposed by the Department will help Canadians make informed decisions about these products, reducing the chances of over consumption of caffeine and other ingredients such as vitamins and minerals.
- Health Canada will monitor the effectiveness of the proposed approach for caffeinated energy drinks and will identify any additional measures required to protect Canadians and enable consumers to make informed decisions regarding these products.
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Scope of proposed approach
- Some stakeholders raised concerns that other energy products, such as shots, pills, powders and gels, were not captured within the scope of the proposal.
- Other stakeholders expressed their disagreement with the decision taken to single out caffeinated energy drinks from other caffeine beverages and foods.
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- Health Canada will apply the principles outlined in the Guidance Document on the Classification of Products at the Food-Natural Health Product Interface: Products in Food Format to decide whether a product is classified as food or a natural health product. Products that are clearly in dosage form and in a format that may be easily distinguished from a food format will likely be considered natural health products.
- The Department will communicate classification decisions regarding other products categories in a timely manner.
- The growth of energy drink in recent years has resulted in higher levels of caffeine consumption by young people. This has raised concerns among parents, healthcare professionals about potential health risks to vulnerable populations such as children and teens and the need to introduce new measures to help Canadians make informed decisions about these product, and to reduce the chances of over consumption of caffeine and other ingredients such as vitamins.
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| Comments |
Health Canada's Response |
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Use of Term " Energy Drinks"
- Some stakeholders thought that the term "stimulant drink" or "stimulant drug containing drinks" should be used instead of energy drink, as recommended by the Expert Panel commissioned by Health Canada.
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- Health Canada's role is not to decide what products should be called. It is the Department's responsibility to ensure it uses the most appropriate tools to manage the safety of products within Health Canada's mandate.
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Product Classification
- Overall, stakeholders supported Health Canada's proposal to regulate caffeinated energy drinks as food.
- Some stakeholders expressed concern that regulating caffeinated energy drinks as food (as opposed to natural health products) could result in consumers perceiving these products as lower risk, hence consuming these products rather than healthier beverages.
- Some stakeholders were not clear on the decision-making process (or decision tree) used by Health Canada to classify caffeinated energy drinks as foods and inquired about the possibility for these products to remain natural health products.
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| Comments |
Health Canada's Response |
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Surveillance / Compliance
- Some stakeholders recommended that appropriate surveillance mechanisms be established to ensure continued safe use.
- Some stakeholders also suggested strong compliance and enforcement measures for instances of non compliance.
- Other stakeholders inquired about the development of a specific compliance and enforcement policy by the Canadian Food Inspection Agency (CFIA).
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- Health Canada will require companies to provide the department with the outcomes of a research protocol aimed at investigating consumption patterns of energy drinks including reports of consumption incidents associated with their products. In addition, companies will be required to gather and provide detailed information on the consumption patterns and sales of their products.
- This information will be used by Health Canada to support further assessments and, if necessary, to update risk management decisions related to these products.
- Health Canada will work with its partners at the CFIA to address the incidence of non compliance with the new requirements for caffeinated energy drinks. As is current practice, compliance and enforcement actions will be based on risk.
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Transition Plan
- Several stakeholders sought clarification on the transition plan for affected products (i.e. caffeinated energy drink products with a Natural Product Number (NPN), Exemption Number (EN), and new Product Licence Applications (PLAs)). In particular, some stakeholders inquired about the submission process during the transition period.
- Other stakeholders have inquired about the process to obtain market authorization under the Food and Drug Regulations.
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- In order to assist industry with the transition of eligible caffeinated energy drinks, Health Canada's Food Directorate has developed the following guidance documents:
- Requests for Temporary Marketing Authorization, or any questions regarding the transition of these products to the food regulatory framework, should be sent Health Canada's Food Directorate through the Submission Management Information Unit at the following address: SMIU-UGDI@hc-sc.gc.ca.
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| Comments |
Health Canada's Response |
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Trade
- Some stakeholders raised concerns that this approach may cause trade barriers with the United States due to a lack of harmonization with regulatory requirements for these products.
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- Given that caffeinated energy drinks are classified as foods in the United States and other key regulatory jurisdictions, Health Canada does not anticipate any trade barriers resulting from this proposed approach.
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Expert Panel on Caffeinated Energy Drinks
- One stakeholder strongly recommended that Health Canada implement the five priority recommendations made by the Expert Panel commissioned by Health Canada.
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2) Assessment of Potential Health Risks
| Comments |
Health Canada's Response |
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Access to additional documents/information
- Some stakeholders requested various documents supporting the development of the proposed approach such as the Health Risk Assessment (HRA) conducted by Health Canada and the report from the Expert Panel on Caffeinated Energy Drinks.
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- Health Canada has published on its website:
- Health Canada's HRA is currently being peer reviewed in anticipation of publication in an international peer-reviewed scientific journal.
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Regulatory Measures - Temporary Marketing Authorization (TMA)
3) Composition Requirements
| Comments |
Health Canada's Response |
Caffeine limit
- Overall, stakeholders supported the establishment of an upper limit for the total amount of caffeine in caffeinated energy drinks, including caffeine from natural sources.
- However, several stakeholders did express concerns with the proposed limit of 400 mg/Lwhichwas considered too high for certain sub populations such as adolescents and young adults considering that they may consume other caffeine-containing products. Some suggested that the upper limits be lowered, particularly for these vulnerable groups.
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- Health Canada will continue to assess the safety of these products within the context of their use by Canadian consumers (i.e. as beverages). Given that the effects of caffeine can be greater for individuals of a lighter weight, Health Canada will continue to advise consumers to limit their caffeine consumption in general and to parents to limit/monitor the caffeine consumption by their children.
- As per the proposed management approach for caffeinated energy drinks, the product label must indicate the total amount of caffeine from all sources.
- With regards to soft drink products, Health Canada has established guidelines for the labelling of caffeine content. This information will help consumers to make informed decisions regarding the consumption of caffeine-containing beverages. These labelling practices will also help parents better identify and monitor the amount of caffeine consumed by their children.
- As part of its management approach for caffeinated energy drinks, Health Canada will require companies to provide the outcomes of a research protocol aimed at investigating consumption patterns of energy drinks including reports of consumption incidents associated with their products. In addition, companies will be required to gather detailed information on the consumption patterns and sales of their products.
- This information will be used by Health Canada to support further assessments and, if necessary, to update risk management decisions related to these products.
- For any non-re-sealable container irrespective of size, the maximum amount of caffeine shall not exceed 180 mg, per container. Also, for a multi-serving re-sealable container, the maximum level of caffeine shall not exceed 180 mg per serving (500 mL).
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| Comments |
Health Canada's Response |
Limits for vitamins, minerals and other ingredients
- Several stakeholders raised concerns regarding the absence of an upper limit for other ingredients, such as vitamins, minerals, guarana, taurine and herbal extracts, commonly found in caffeinated energy drinks. In particular, some were concerned about health risks associated with these ingredients while others suggested the addition of a warning statement for these ingredients.
- Some stakeholders suggested that Health Canada should allow fortification with vitamin/minerals similar to what is permitted under the Natural Health Products Regulations (NHPR) and inquired about other ingredients which are currently allowed under the NHPR but not under the Food and Drug Regulations (FDR).
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- Health Canada has developed measures to mitigate over exposure through the establishment of daily maximum levels for certain vitamins, minerals and amino acids. These levels may be subject to change as new evidence becomes available including from the research conducted as part of the TMA.
- With regards to herbal ingredients, those that are acceptable for general use in food would be acceptable for use in caffeinated energy drinks. A number of herbs and botanical preparations have been identified by the Food Directorate to be unacceptable for use in foods. This may change over time as new information becomes available.
- Labelling requirements for food products, such as a list of ingredients and the nutrition facts panel, will apply to these beverages and will help enhance consumers' awareness about the composition of these products.
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| Comments |
Health Canada's Response |
Single serve size
- A significant portion of stakeholders disagreed with HC's definition of a single serving size and non-resealable containers (single serve containers of 591 ml) which was considered to be a large volume, in part due to the high level of sugars found in these beverages.
- Some stakeholders suggested that the label should indicate the maximum volume per day to be consumed (dosage).
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- Reference amount and serving size refer to quantities of a type of food usually consumed by an individual at one sitting, as determined from consumption data. The quantity is not meant to indicate recommended or desirable intake.
- All declarations of content made on the label of a food product must be made using the same serving of stated size, identical to that used for declarations of nutrients in the nutrition facts panel. In the case of single-serving container, the serving size is the same as the container size.
- A statement on the label of caffeinated energy drinks to include the maximum number of container(s)/serving(s) not to be exceeded per day will be required.
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4) Labelling Requirements
| Comments |
Health Canada's Response |
Cautionary statements
- Stakeholders supported the inclusion of additional information and appropriate statements on the labels of caffeinated energy drinks.
- Some suggested the addition of statements such as:
- Expanding the proposed statement " Not recommended for children.." to specify "teenagers" or "children below 18";
- The inclusion of the recommended maximum daily caffeine limit;
- A cautionary statement regarding consumption of caffeinated energy drinks in the context of physical activity.
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- Health Canada will assess the data related to consumer response and reaction to the labelling requirements for caffeinated energy drinks in order to determine their effectiveness.
- Should it be deemed necessary, modifications or the addition of new labelling requirements will be made to the currently required statements in order to more effectively relay the information to Canadians to enable them to make informed decisions.
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| Comments |
Health Canada's Response |
Claims
- Clarifications were sought on the types of claims that would be permitted as a food product in comparison to what is currently allowed as a natural health product.
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- Several types of claim can be made on food products, including health claims and nutrient content claims.
- All claims for food are subject to subsection 5(1) of the Food and Drugs Act, which prohibits false, misleading or deceptive food representations; however, regulatory requirements vary depending on the type and nature of the claim.
- While certain claims on natural health products are also made for food products, differences exist in determining the acceptability of claims between the two frameworks.
- For more information regarding the claims for foods, please refer to the Guide to Food Labelling and Advertising and the Category Specific Guidance for Temporary Marketing Authorization - Caffeinated Energy Drinks
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Caffeine
- Some stakeholders disagreed with the decision to require the amount of caffeine in the product to be displayed on the label. It was suggested that this information could potentially influence consumers to drink products that contain the most amount of caffeine.
- Some stakeholders felt that indicating the amount of caffeine in mg would not provide relevant information to consumers as it would not be associated to any reference amount.
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- Health Canada has decided that the amount of caffeine in mg from all sources in the product be indicated on the label. This information will help consumers to make an informed decision regarding the consumption of these beverages. This labelling requirement will also help parents better identify and monitor the amount of caffeine consumed by their children.
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Others
- Participants stated that label information should be in a large font size and visible to ensure consumers read the labels and are aware of the labelling information.
- Others recommended that a 1-800 number and contact point be clearly provided on the label for use by consumers.
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- Caffeinated energy drinks will be subject to food labelling requirements which requires labels to be legible and visible to consumers.
- A company's contact information is required to be on the product label to facilitate the reporting of consumption incidents. Companies are also encouraged to provide a toll free number on the label.
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5) Prohibition of Pre-mixed Alcoholic Beverages with Caffeinated Energy Drinks
| Comments |
Health Canada's Response |
Pre-mixed alcoholic beverages
- Participants unanimously supported prohibiting the use of caffeinated energy drink beverages as ingredients in pre-mixed alcoholic beverages.
- It was recommended that either the sale of any caffeinated alcoholic beverage be prohibited or that a discernable difference in the packaging and or claim be required to mitigate the potential confusion consumers may face as the pre-mixed alcoholic beverages and caffeinated energy drinks look similar and are using the same brand name.
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- Health Canada recognises that there are alcoholic products that, while being sold are sold using brand names associated with caffeinated energy drinks, do not contain the suite of ingredients found in caffeinated energy drinks. These alcoholic products are subject to the Food and Drug Regulations.
- Some of the ingredients contained in caffeinated energy drinks such as added vitamins and minerals are not permitted in pre-mixed alcoholic beverages or, as in the case of added caffeine are not permitted at the same levels.
- The sale of alcoholic beverages is under provincial jurisdiction. However Health Canada will work with its provincial counterparts to develop and implement appropriate risk management approaches to ensure they are aware that caffeinated energy drinks should not be mixed with alcohol.
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6) Consumption Incident Reporting
| Comments |
Health Canada's Response |
Data collection
- Some stakeholders stressed the need to share data collected on reported consumption incidents with the public and public health authorities.
- Some stakeholders questioned the need for consumption incident reporting for caffeinated energy drinks while it is currently not mandatory for other food products.
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- Health Canada will continue to collect information on potential health hazards associated with caffeine in food. Health Canada will leverage all sources of information available on potential adverse reactions or incidents reported as a result of consuming caffeinated energy drinks. Health Canada will require manufacturers and distributors to collect information and report to the Department any consumption incident reported by consumers.
- Health Canada will also partner with Provincial, Territorial and international partners to collect and assess information on the potential acute and longer term effects related to the consumption of these products by the various subsets of population.
- Should new information collected as result of these data gathering mechanisms indicate the need to update Health Canada's management approach of these products, Health Canada will adjust its regulatory requirements and limitations on these products.
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7) Market Research
| Comments |
Health Canada's Response |
Consumer use
- Stakeholders recommended that data on consumption patterns of caffeinated energy drinks as well as on the impact of marketing strategies on consumption habits be gathered in order to adapt, as needed, current and future risk mitigation strategies (e.g. awareness campaigns, requirements for labelling, cautionary statements, etc.).
- Others thought that research related to caffeine consumption should be conducted for all caffeinated products, regardless of the source/type of products.
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- Health Canada will require, as part of the Temporary Marketing Authorization requirements, that market data on consumption and sales of caffeinated energy drinks be collected for products sold in Canada by manufacturers and distributors. Information collected will support further evaluation of the effectiveness of the various measures required by Health Canada for caffeinated energy drinks and will help the Department determine whether additional safety requirements are needed.
- Surveys to gather detailed Canadian food consumption data are carried out by Statistics Canada as part of the Canadian Community Health Survey. The most recent survey of 2004 did not include useful consumption data for caffeinated energy drinks as these products were relatively new to the Canadian market at that time. It did include consumption data for other types of caffeinated products.
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Non Regulatory Risk Management Measures
8) Consumer Education
| Comments |
Health Canada's Response |
Education and awareness
- Some stakeholders recommended a strong consumer education campaign that would describe the health risks associated with the consumption of highly caffeinated products, regardless of the type or source of products.
- Some stakeholders suggested that the education campaign should also reach significant groups able to build awareness around the consumption of caffeinated energy drinks by youth such as health professionals, school teachers, sport trainers, etc., and that communication channels used by youth such as social networks be used.
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- As part of the proposed management approach for caffeinated energy drinks, Health Canada will develop new information and tools to further inform consumers of food caffeine sources, as well as the levels not to be exceeded, to mitigate potential health effects related to the over consumption of caffeine.
- Health Canada will partner with Provincial and Territorial governments, health professional organisations to develop and disseminate education materials on this topic (e.g. through the use of social media).
- Health Canada aims to share its risk assessment on caffeinated energy drinks consumed as a beverage with its Provincial and Territorial partners so that it could be used as needed to further guide the development of management approaches under their oversight (e.g. point of sale restrictions). This HRA will also be published in an international peer-reviewed scientific journal.
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9) Research and Monitoring of Long-term Health Effects
| Comments |
Health Canada's Response |
Research and monitoring
- Some stakeholders expressed concerns regarding the possible long-term health effects of early consumption of caffeinated energy drinks, such as: bone density loss, addiction, mental health issues, migraines, gut issues, heart palpitations, etc.
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- Health Canada will continue to collect data from domestic and international sources on the potential health effects of caffeinated energy drinks and share details of its assessment. In particular, Health Canada will continue to collaborate with its partners to collect the latest scientific information, including research on potential long-term health impacts of caffeinated energy drinks and their common ingredients in order to help inform their decision making processes.
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10) Leverage Tools Developed by Stakeholders
| Comments |
Health Canada's Response |
Marketing, Advertisement and Point of Sale
- Some stakeholders felt that advertising had not been appropriately addressed in the proposed approach and recommended that a Code of Practice be developed by the Department to restrict marketing, advertising and product sampling particularly to children and adolescents.
- Some stakeholders recommended more stringent measures be implemented for the marketing and sale of caffeinated energy drinks, particularly to children and youth, such as prohibiting the sale, marketing and advertisement of caffeinated energy drinks below the age of 18 years old.
- Some stakeholders recommended that these products not be made available in bars and other places where alcohol is sold and that points of sale be restricted to limit access of these beverages to children and teenagers (e.g., school, sports arena, etc.).
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- Health Canada will work in collaboration with industry to develop a Code of Practice on labelling, advertising and sampling of these products providing the basis for responsible marketing by the beverage industry.
- While point of sale is within provincial/territorial jurisdiction, Health Canada will partner with its counterparts to develop and implement appropriate risk management approaches and support their actions limiting the advertising and sampling of these products to children.
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Conclusion/Next Steps
The online consultation was successful in providing stakeholders with the opportunity to provide their input into Health Canada's proposed approach to managing caffeinated energy drinks. The majority of the stakeholders saw this approach as a positive first step, and would like to see the proposed measures further tightened. It should be noted that some of the concerns raised, or suggestions made, by stakeholders were beyond Health Canada's regulatory mandate.
Moving forward, Health Canada will be working at finalizing the development of various aspects of the approach associated with the transition of these products to the food regulatory framework as well as future compliance and enforcement program with its federal partners.
Further stakeholder input will be sought throughout this process. Stakeholder comments will be taken into consideration as Health Canada further refines its proposed approach and next steps.
Annex 1: Stakeholder Distribution
