Questions and Answers: Caffeinated energy drinks

1. What are the steps to have a caffeinated energy drink product reviewed and approved for sale in Canada?
2. Who should I contact to have a caffeinated energy drink product reviewed and approved for sale?
3. Where can I find more information about the statutory and regulatory requirements for food?
4. Who can I contact for general questions about the regulation of caffeinated energy drinks?
5. What are the key transition dates and deadlines?
6. What are the rules around allergen labelling and these products? 
7. What are the rules around sampling and advertising to children?
8. What will be required of industry concerning the research protocol, which is a condition of the Temporary Marketing Authorization (TMA)?
9. What will be required of industry concerning consumption incident reporting?
10. To obtain a TMA, is it necessary to resubmit information that was already submitted to the Natural Health Products Directorate as part of the product license application?
11. What is required to import a caffeinated energy drink?
12. Can the products transitioned to the food regulatory framework continue to have the same claims as they had as Natural Health Products (NHPs)?  
13. What statements are required on caffeinated energy drinks as it relates to caffeine content?
14. What statements are required regarding the recommended amount for consumption per day? 
15. Are there any specific guidelines on the requirements for caffeinated energy drinks under the food regulatory regime?
16. What about NHP queue products with caffeine less than 200 ppm (mg/L)? 
17. Are caffeinated energy drinks containing alcohol allowed to be sold in Canada?
18. Will other products be transitioning from the natural health product regulatory framework to the food regulatory framework? 
19. What is the timeline for new caffeinated energy drinks that were not in the NHP queue gaining market access?
20. Stevia extract has not been approved for use in food products in Canada. Has the status of stevia extract for prepackaged foods in Canada changed? 
21. Will unapproved food additives, such as steviol glycosides, be permitted in caffeinated energy drinks eligible to be transitioned to the food regulatory framework?
22. Is there any information about the risks of consuming caffeinated energy drinks? 
23. Where can I find a list of caffeinated energy drinks that have received Temporary Marketing Authorization Letters (TMALs)?
24. Where can I report a caffeinated energy drink consumption incident? 
25. What are the required statements on caffeinated energy drink labels?

1. What are the steps to have a caffeinated energy drink product reviewed and approved for sale in Canada?

In order for such products to be legally marketed in Canada, they will require a TMA issued by Health Canada. The manufacturer or distributor of the product will need to submit information in accordance with the requirements for a TMA stated under section B.01.054 of the Food and Drug Regulations. The Department will determine the eligibility of the product for a TMA, based in large part on composition requirements. If the product meets these requirements, manufacturers or distributors can expect a TMA to be issued, permitting the marketing of the product subject to the conditions stipulated in the TMA. In the case where the product does not meet composition or labelling requirements, the product will need to be reformulated or adjusted to meet those requirements to obtain a TMA; otherwise, it will not receive a TMA and will not be able to gain market access.

Please consult the General Guidance Document for Temporary Marketing Authorization for Foods  and the Category Specific Guidance for Temporary Marketing Authorization - Caffeinated Energy Drinks for more details regarding the requirements and process.

2. Who should I contact to have a caffeinated energy drink product reviewed and approved for sale?

We encourage manufacturers and/or distributors to contact the Submission Management and Information Unit within Health Canada's Food Directorate at: SMIU-UGDI@hc-sc.gc.ca to discuss the requirements for the eligibility of products for a TMAL and the process related to the transition of caffeinated energy drinks to the food regulatory framework. Please use "Caffeinated Energy Drinks" as the subject of the email to ensure the appropriate and timely management of your correspondence.

3. Where can I find more information about the statutory and regulatory requirements for food?

For more information on statutory and regulatory requirements for food, including any questions pertaining to pre-market notification and assessment requirements or the use of health claims for food, please consult:

• The  Food and Drugs Act and its  Regulations;
• Guidelines and policies applicable to foods on the Food Directorate website;
• Guidelines and policies related to health claims for foods;
• The Canadian Food Inspection Agency's  Guide to Food Labelling and Advertising and other food-related regulations and guidelines; and
• Health Canada's Proposed Approach to Managing Caffeinated Energy Drinks.

For any general questions regarding the regulatory requirements for food, please contact Health Canada's Food Directorate at Food-Aliment@hc-sc.gc.ca.

4. Who can I contact for general questions about the regulation of caffeinated energy drinks?

For any general questions regarding the regulation of caffeinated energy drinks, you may contact the Submission Management and Information Unit within Health Canada's Food Directorate at: SMIU-UGDI@hc-sc.gc.ca.

5. What are the key transition dates and deadlines?

For caffeinated energy drinks that had submitted applications to the Natural Health Products Directorate before the October 6, 2011 announcement, the Department is asking manufacturers or distributors to submit information in accordance with the requirements for a TMA stated under section B.01.054 of the Food and Drug Regulations by April 30, 2012.The Department plans to have the majority of TMALs issued for eligible products meeting compositional requirements by June 30, 2012. However, this will be partly dependent on manufacturers and distributors providing the required information in a timely manner.

Key transition dates and timelines are set out in the tables below:

Key transition dates and timelines

	Timeline
Products not requiring reformulation
Companies must submit TMAL information by	April 30, 2012
Simultaneous issuance of TMALs and NHP status revocation by	June 30, 2012 (majority of cases)
UPLAR deadline	February 4, 2013
Companies must bring labelling into compliance by	December 2013
Products requiring reformulation
Companies must submit TMAL information by	April 30, 2012
Companies informed by FD of need to reformulate by	May 15, 2012
Companies must signal intent to reformulate to FD by	June 1, 2012
Notification to companies electing not to reformulate (PLA: companies receive refusal and classification; EN: companies advised of September 30 withdrawal date)	June 30, 2012
Deadline for product withdrawal (for products with ENs electing not to reformulate)	September 30, 2012
Company must submit new TMAL information for reformulated product by	October 15, 2012
Most TMALs for properly reformulated products issued	November-December 2012
Reformulation and re-labelling deadline	December 15, 2012
UPLAR deadline	February 4, 2013

6. What are the rules around allergen labelling and these products?

Caffeinated energy drinks must be compliant with current allergen labelling regulations as per Section B.01.010 of the Food and Drug Regulations (FDR). However, published amendments to the FDR that took place in February 2011 will further strengthen the labelling requirements for pre-packaged foods containing substances most frequently associated with food allergies and food intolerances. As of August 4, 2012, these enhanced labelling requirements for priority allergens, gluten sources, and added sulphites will be in force for pre-packaged products regulated as food, with the exception of standardized beers. Some caffeinated energy drinks may contain certain ingredients such as whey protein, soy or cream, which could trigger the new allergen, gluten, or sulphite labelling requirements.

Accordingly:

• Manufacturers of caffeinated energy drink products being transitioned to the food regulatory regime and not requiring reformulation will be provided a transition period for the new allergen labelling requirements rather than being immediately subject to the new regulations on August 4, 2012. This is consistent with the broader labelling transition period (see 5. What are the key transition dates and deadlines?). These products must fully comply with the enhanced food allergen labelling requirements along with all other labelling requirements by December 2013. Manufacturers are encouraged, however, to bring their labels into compliance as early as possible for the benefit of consumers.
• In the case where a transitioning product requires reformulation in order to be transitioned to the food regulatory framework, that product must be fully compliant with the enhanced allergen labelling requirements at the same time as its reformulation (i.e. to receive a TMA by December 2012), since re-labelling will already be required based on the product's new formulation.
• Product licence applications submitted after October 6, 2011 and all new caffeinated energy drink products must comply with all food labelling requirements before gaining market access. Manufacturers of new products will not be provided an additional transition period for allergen labelling and will be immediately subject to the new regulation on August 4, 2012.

Food manufacturers are also urged to comply with Health Canada's policy with regard to precautionary labelling where consumers may need to be warned due to the inadvertent presence of allergens, gluten source or sulphites through cross-contamination.

Should Health Canada identify a significant health risk with respect to the undeclared presence of priority food allergens, added sulphites or gluten sources in a pre-packaged caffeinated energy drink, whether label transition has occurred or not, the Canadian Food Inspection Agency will take appropriate enforcement action, which may include recall of the product.

7. What are the rules around sampling and advertising to children?

Caffeinated energy drinks are not recommended for children because of their high levels of caffeine and other ingredients. For this reason, this type of product must not be promoted to children. This requirement is effective immediately when the TMA is issued. This includes not providing samples of the product to children.

8. What will be required of industry concerning the research protocol, which is a condition of the Temporary Marketing Authorization (TMA)?

Health Canada has concluded that a number of data gaps need to be addressed to support its efforts to regulate caffeinated energy drinks as foods and to appropriately manage potential health risks associated with these products. The collection of data relevant to a regulatory need is a critical element of the TMA instrument.

As a result, Health Canada will require data on: Canadians' consumption patterns for caffeinated energy drinks (in order to better estimate exposure to caffeine and other ingredients from these beverages), consumer's understanding and use of label information, and the effectiveness of product labels as a risk management tool.

As a condition of the TMA, details of the research to be conducted by industry during the temporary marketing period must be submitted to Health Canada for review. The research protocol including the methodology will need to be finalized no later than September 2012.

Due to the large number of caffeinated energy drinks that may require a TMA, and the fact that many of the data gaps that need to be addressed are common to all caffeinated energy drinks, some of the research may be conducted collectively (via a trade organization representative of the sector). However, additional product-specific information may be required, and would need to be provided by individual manufacturers or distributors.

9. What will be required of industry concerning consumption incident reporting?

Manufacturers or distributors will be required to undertake consumption incident reporting as a condition of their TMAs. Consumption incident reports will need to be submitted to Health Canada annually. Health Canada is developing a form that industry can use to report information on consumption incidents. This form will be shared with TMA holders and applicants once finalized.

10. To obtain a TMA, is it necessary to resubmit information that was already submitted to the Natural Health Products Directorate as part of the product license application?

Manufacturers or distributors are advised to follow the application process outlined in the document General Guidance Document for Temporary Marketing Authorization for Foods while also making reference to the specific requirements for caffeinated energy drinks as described in the following document:

• Category Specific Guidance for Temporary Marketing Authorization - Caffeinated Energy Drinks

Submissions may be sent electronically by email to the following address: SMIU-UGDI@hc-sc.gc.ca. Please use the words "Temporary Marketing Authorization (TMA) application - Caffeinated Energy Drinks" in the subject line.

11. What is required to import a caffeinated energy drink?

There is currently no requirement to obtain an import licence for caffeinated energy drinks, however, caffeinated energy drinks will need to receive a TMAL in order to be legally marketed in Canada. For additional information on the TMA process, please see 2. Who should I contact to have a caffeinated energy drink product reviewed and approved for sale?.  

12. Can the products transitioned to the food regulatory framework continue to have the same claims as they had as Natural Health Products (NHPs)?

Certain statements, such as nutrient content claims and health claims may be made on the label or in advertisements for food products on a voluntary basis. However, when they are made, they must comply with the Food and Drugs Act and the food provisions of the FDR along with applicable guidance.

Companies with products on the market (or in queue) that are going to be transitioned from the NHP regulatory framework to the food regulatory framework should be aware that differences exist in determining the acceptability of claims between the two frameworks.

Health claims on foods are generally not subject to pre-market review. The exception is for health claims pertaining to diseases, disorders, or abnormal physical states listed in Schedule A of the Food and Drugs Act and for nutrient content claims not stipulated in the Food & Drug Regulations.

Health claims on foods must be truthful and not misleading -- per Section 5.(1) of the Food and Drugs Act -- and substantiated with appropriate scientific evidence for which documentation may be required for compliance and enforcement purposes. Health claims should be measurable and quantifiable to the extent possible, and therefore allow scientific verification. This will reduce the possibility of claims being vague, uninformative or misleading. For example, a claim about "temporarily restoring alertness" is more specific than a claim about "enhancing cognitive performance".

In addition, another difference that exists between the two frameworks for health claims is that claims on food products must be linked to a specific substance or substances in the product and not to the consumption of the product itself.

With respect to the transition of food products at the food-NHP interface to the food regulatory framework, health claims that have been used in the NHP context and that may not meet Food and Drug Regulations requirements "as is" will generally not be an impediment to the issuance of Temporary Market Authorization Letters (TMALs). In most cases, a transition period is being permitted to bring labelling and claims into compliance with the food regulatory framework. One exception is the use of explicit or implied claims about diseases, disorders, or abnormal physical states listed in Schedule A of the Food and Drugs Act. Such claims will not be permitted on foods under the TMA process.

The Food Directorate will be pleased to work with any companies interested in reviewing or assessing their claims in this context.

For more information, please consult Health Canada's current policy and guidance on health claims on foods.
                                                                                   
As a part of the food regulatory modernization work being conducted by Health Canada, the Department will review the health claims framework to develop a risk-based oversight associated with the use of health claims on food labels. In conducting this work, the Food Directorate will undertake broad consultations with stakeholders from academia, food industry, health professional organizations and international regulatory bodies.

13. What statements are required on caffeinated energy drinks as it relates to caffeine content?

In addition to a synthetic source of caffeine, natural sources, such as guarana and yerba mate, must be included in the content calculation. For single-serving containers, caffeine content will be declared on a per container basis whether or not the container is re-sealable. Containers up to 750 mL are considered as single-serving containers, whether or not they are re-sealable. In addition, a caffeinated energy drink that cannot be re-sealed will be treated as a single-serving container, regardless of container size.

For multi-serving containers, meaning a re-sealable container larger than 750 mL, caffeine content must be declared on a per serving basis of 500 mL. In addition all caffeinated energy drinks will be required to display the following statement on the product label:

• "High caffeine content"*

*It is recommended that a consistent statement be used in describing the caffeine content. However, no objection will be taken if synonyms equivalent in meaning to the above statement are used (for example, "high in caffeine").

14. What statements are required regarding the recommended amount for consumption per day?

Caffeinated energy drinks will be required to have the following statement on the label: "Do not consume more than (X) container(s)/serving(s) daily" or "Usage: (X) container(s)/serving(s) maximum daily." This limit on the number of containers or servings must not result in the daily maximum limit being exceeded for any added vitamins, minerals or amino acids. More specific information about this can be found in the Category Specific Guidance for Temporary Marketing Authorization - Caffeinated Energy Drinks.

15. Are there any specific guidelines on the requirements for caffeinated energy drinks under the food regulatory regime?

The eligibility criteria particular to caffeinated energy drinks are outlined in the document Category Specific Guidance for Temporary Marketing Authorization - Caffeinated Energy Drinks. Details on the process to apply for a Temporary Marketing Authorization can be found in the document the General Guidance Document for Temporary Marketing Authorizations for Foods.

16. What about NHP queue products with caffeine less than 200 ppm (mg/L)?

Other products at the Food-NHP interface, including non-caffeinated beverages, beverages with caffeine levels below 200 ppm, and other products with added vitamins and mineral nutrients not in compliance with the Food and Drug Regulations will be the subject of a separate transition process. Please visit the Foods Marketed as Natural Health Products website for more information on the transition of products at the food-natural health product interface.

17. Are caffeinated energy drinks containing alcohol allowed to be sold in Canada?

No. The Temporary Marketing Authorization Letters (TMAL) that permit the sale of caffeinated energy drinks as foods do not authorize the sale of alcoholic versions of these products and do not authorize their use as ingredients in other foods, including in alcoholic beverages.

Furthermore, the Food and Drug Regulations do not permit the addition of caffeine to any alcoholic beverage. However, some alcoholic beverages are allowed to have flavouring ingredients that naturally contain caffeine (e.g. guarana, coffee). They are also allowed to have as ingredients cola or other soft drinks that are themselves permitted to contain caffeine as a food additive.

Health Canada continues to advise consumers not to mix these products with alcohol and will continue to restrict their use as an ingredient in pre-mixed alcoholic beverages. In addition, Health Canada is requiring all caffeinated energy drinks to display the statement "Do not mix with alcohol" on the label.

18. Will other products be transitioning from the natural health product regulatory framework to the food regulatory framework?

Certain food products that have gained or are awaiting market access as natural health products and that are represented as and have a history of use as foods are being transitioned as part of the food-natural health product transition. Please visit the Foods Marketed as Natural Health Products website for more information on the transition of products at the food-natural health product interface.

19. What is the timeline for new caffeinated energy drinks that were not in the NHP queue gaining market access?

During the transition process, Health Canada's Food Directorate will be focused as a short term priority on those products requiring transition to the food regulatory framework, especially those products already on the market. This approach is consistent with the transition principle of "minimal disruption to the stream of commerce." In July 2012, Health Canada will develop and share performance standards for TMA submissions, explaining the commitment and timelines with respect to the processing of new submissions.

20. Stevia extract has not been approved for use in food products in Canada. Has the status of stevia extract for prepackaged foods in Canada changed?

Stevia extract is not currently permitted for use as a sweetener in foods available for sale in Canada nor as a tabletop sweetener. However, Health Canada's Food Directorate recently completed a detailed safety assessment of the use of steviol glycosides as a sweetener in certain food categories at various maximum levels of use, and as a table top sweetener. Since no safety concerns were identified during this assessment, the Department is proposing amendments to the Food and Drug Regulations to enable the use of steviol glycosides as a food additive. As with all regulatory proposals, stakeholders will be provided with an opportunity to provide comments once this proposal is published in Canada Gazette Part 1.

21. Will unapproved food additives, such as steviol glycosides, be permitted in caffeinated energy drinks eligible to be transitioned to the food regulatory framework?

A Temporary Marketing Authorization (TMA) has been determined to be the most appropriate tool for transitioning caffeinated energy drinks from the natural health product regulatory framework to the food regulatory framework. The only unapproved food additives that will be permitted in caffeinated energy drinks under a TMA will be those food additives that: (1) were present in caffeinated energy drink products eligible for transitioning from the natural health product regulatory framework to the food regulatory framework; and (2) do not pose an unacceptable health risk when used in caffeinated energy drinks sold as a food. Since the TMA will only temporarily permit the sale of products containing certain non-permitted food additives, manufacturers of products containing an unapproved food additive should consider submitting a food additive submission, following the food additive submission process as set out in the Food and Drug Regulations, as soon as possible. Doing so will help to ensure that transitioning products are compliant with respect to food additives by the time the applicable TMA expires.

22. Is there any information about the risks of consuming caffeinated energy drinks?

Because of their high levels of caffeine and other ingredients, it is not clear what would be the effect of these products when mixed and consumed with alcohol. Therefore, Health Canada continues to advise consumers not to mix these products with alcohol and will continue to prohibit their use as an ingredient in pre-mixed alcoholic beverages. Also caffeinated energy drinks are not recommended for certain vulnerable populations such as children, pregnant/breastfeeding women and individuals sensitive to caffeine.

In addition, caffeinated energy drinks are not recommended for children because of their high levels of caffeine and other ingredients. In some cases, one caffeinated energy drink could have more caffeine than the recommended maximum daily intake for many children.

It is difficult to link specific intake levels of caffeine with specific health effects because everybody has a different tolerance for caffeine. However, it is known that children are at an increased risk of experiencing behavioural effects from consuming caffeine. Health Canada has received a number of reports of suspected health problems associated with caffeinated energy drinks. Symptoms have included irregular heart beat and nervousness.

For more information on the risks associated with the consumption of caffeinated energy drinks, please review the "It's Your Health - Caffeine" available on Health Canada's web site.

Health Canada will also work with provinces and territories and other partners to develop educational tools and materials, particularly targeted to children and teens, which will include information on the risks associated with excessive consumption of caffeinated energy drinks. These tools will also allow parents and school teachers to educate their children and students, respectively, and raise their awareness of the potential risks associated with the overconsumption of caffeine and other ingredients such as vitamins and minerals.

23. Where can I find a list of caffeinated energy drinks that have received Temporary Marketing Authorization Letters (TMALs)?

A list of caffeinated energy drinks that have received TMALs has been posted on Health Canada's web site. This list provides details on the product name, company name, TMAL number, TMAL issuance date, and TMAL expiration date.

24. Where can I report a caffeinated energy drink consumption incident?

Consumption incidents may be reported to the  Canadian Food Inspection Agency or by telephone at 1-800-442-2342, or by TTY at 1-800-465-7735. Consumers are also encouraged to contact the caffeinated energy drink company to report any consumption incidents.

25. What are the required statements on caffeinated energy drink labels?

Caffeinated energy drink labels will be required to include:

• A Nutrition Facts Table like other prepackaged foods and beverages
• Quantitative declaration of total caffeine content from all sources;
• Qualitative declaration of caffeine ( "High caffeine content" or synonymous equivalent);
• Quantitative declaration of selected bioactive ingredients (e.g. ginseng, ginko biloba);
• The following caution statements:
  • Do not consume more than (X) container(s)/serving(s) daily" or "Usage: (X) container(s)/serving(s) maximum daily";
  • "Not recommended for children, pregnant or breastfeeding women and individuals sensitive to caffeine"; and
  • "Do not mix with alcohol"

Caffeinated energy drinks (CEDs) that do not require reformulation to receive a TMAL will have until December 2013 to meet these labelling requirements.

More detail on the labelling requirements for CEDs can be found in the guidance document for this specific product category.

Contact us: SMIU-UGDI@hc-sc.gc.ca