Category Specific Guidance for Temporary Marketing Authorization - Caffeinated Energy Drinks

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Table of Contents

• 1.0 Introduction
  • 1.1 Scope
  • 1.2 Administrative Matters
    • 1.2.1 Transition Process
    • 1.2.2 TMA Application Process
• 2.0 Guidance on Eligibility for a TMA for Caffeinated Energy Drinks
  • 2.1 Caffeine and Alcohol
  • 2.2 Vitamins, Mineral Nutrients, and Amino Acids
    • 2.2.1 Minimum Levels
    • 2.2.2 Maximum Levels
    • 2.2.3 Maximum Levels not Specified
    • 2.2.4 Vitamins or Mineral Nutrients not Acceptable for Addition
• 3.0 Labelling, Advertising and Claims
  • 3.1 Advertising
  • 3.2 Reference Amount, Serving Size and Container Size
  • 3.3 Required Statements
    • 3.3.1 Quantitative Declaration of Caffeine Content
    • 3.3.2 Qualitative Declaration of Caffeine
    • 3.3.3 Caution Statements
    • 3.3.4 Quantitative Declaration of Ingredients Other than Caffeine
    • 3.3.5 Other Required Information
    • 3.3.6 Placement of Required Statements
    • 3.3.7 Legibility and Prominence of Required Statements
  • 3.4 Priority Allergens, Gluten Sources, and Sulphites
  • 3.5 Voluntary Statements
    • 3.5.1 Claims Related to Physical Performance.
    • 3.5.2 Claims Related to General or Specific Health Benefits
    • 3.5.3 Calorie-Free and Sugar-Free Claims
    • 3.5.4 Placement and Prominence of Voluntary Statements
  • 3.6 Sample Label
• 4.0 TMA Research
  • 4.1 Research
  • 4.2 Reporting Consumption Incidents
• 5.0 Food Additives, Flavours, Herbal Ingredients and Novel Foods as Ingredients
  • 5.1 Food Additives
  • 5.2 Other Food Ingredients
    • 5.2.1 Food Flavours
    • 5.2.2 Herbal Ingredients
    • 5.2.3 Novel Foods
• Appendix: Reference List of Ingredients

1.0 Introduction

In recent years, an increasing number of caffeinated energy drinks have been introduced into the Canadian marketplace. Although Health Canada does not have a standard for caffeinated energy drinks, these products typically refer to beverages containing caffeine in combination with other ingredients such as taurine, glucuronolactone and B vitamins. These products may also contain minerals, various herbal ingredients and other bioactive ingredients. Caffeinated energy drinks generally feature health claims related to their capacity to restore energy and alertness in the individual consuming the product. There are specific provisions limiting the addition of caffeine, vitamins, mineral nutrients and amino acids to foods outlined in the Food and Drug Regulations (FDR), and as a result manufacturers and distributors of caffeinated energy drinks sought and gained market access as natural health products (NHPs).

Health Canada has determined, based on public perception and history of use, product representation to consumers and product format, in accordance with its guidance document on Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats, that caffeinated energy drinks fit the definition of a food. As a result, in October 2011, the Minister of Health announced the intention to assess and manage the potential risks associated with these products, and regulate their availability in the Canadian marketplace in the context of their use as a food (beverage).

However, there are a number of information gaps that need to be addressed in order to finalize the regulatory amendments required to allow the safe marketing of these products under the FDR, for example consumption patterns of caffeinated energy drinks in the dietary context as food, and the effectiveness of labelling as a risk mitigation tool. A Temporary Marketing Authorization (sections B.01.054, B.01.055 of the FDR) has been determined to be the most appropriate tool to gather information in support of a final regulatory amendment.

The purpose of this document is to outline the eligibility criteria for Temporary Marketing Authorizations (TMA) in regards to caffeinated energy drinks. It is also designed to detail the transition process of those eligible products currently marketed under the NHP regime, to the food regulatory regime. This document should be read together with the General Guidance Document for Temporary Marketing Authorization for Foods and other applicable provisions of the Food and Drugs Act and the Food and Drug Regulations, along with all other legislation and regulations applicable to food.

1.1 Scope

Products included for the purposes of this guidance document

Energy drink products eligible for a TMA are pre-packaged; ready to consume water based caffeinated beverages with caffeine from all sources between 200 and 400 ppm (mg/L). They may also be non-compliant with the current FDR with regard to vitamin and mineral fortification, novel ingredients, labels or claims.

Caffeinated products that are not consumed or perceived as foods are not included. For example, many products termed "Energy Shots" are distinguished from foods by their smaller volumes and product representation, and thus would not be perceived as traditional foods. Health Canada will apply the classification principles outlined in the guidance document on the Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats on a product by product basis to determine product classification.

Other products at the Food-NHP interface, including non-caffeinated beverages, beverages with caffeine levels below 200ppm, along with other products with added vitamins and mineral nutrients not in compliance with the FDR will be the subject of a transition process managed in parallel to the caffeinated energy drinks transition.

1.2 Administrative Matters

1.2.1 Transition Process

Health Canada has adopted the three following principles when managing the transition of caffeinated energy drinks:

1. Review of Products Against Currently Established Safety Requirements
2. Operational and Procedural Fairness
3. Minimum Disturbance to the Stream of Commerce

Caffeinated energy drinks are subject to all relevant requirements applicable to food products, including the provisions of the Food and Drugs Act and Food and Drug Regulations and the Consumer Packaging and Labelling Act and Regulations. It is the responsibility of the manufacturer or distributor to ensure that marketed food products are in compliance with all applicable statutory and regulatory requirements other than those which are the specific subject of the TMA. Additional restrictions have been set to alert the consumer to the uniqueness of these products and to help ensure their safe use as foods. These include:

• Compositional requirements;
• Labelling, advertising and marketing requirements;
• Prohibition of alcoholic content; and
• Consumption incident reporting.

The specifics of these restrictions are outlined in the following sections of this guidance document.

In order to enable the transition of caffeinated energy drinks to the food regulatory framework, products that meet these requirements will be issued a Temporary Marketing Authorization Letter (TMAL). The purpose of the TMA is to gather specific data that will support an amendment to the FDR. Therefore, as a condition of the TMA, the manufacturer or distributor is required to gather such data, in a manner agreed upon with Health Canada in advance, and submit the data to Health Canada within a specified period of time. The specific details of the research protocol required for the TMAL do not necessarily need to be finalized before the TMAL is issued, and can be appended to the TMAL at a later date, once an agreement is reached with Health Canada. Should a manufacturer or distributor be unwilling to supply Health Canada with the data required to address the identified knowledge gaps associated with the research protocol, Health Canada may revoke the corresponding TMA.

TMALs will be issued for products that meet the compositional requirements, which include conditions for the level of caffeine from all sources, for levels of added vitamins, minerals and amino acids, and for novel ingredients and food additives. The product must then comply with advertising requirements when the TMAL is issued, which limit the advertising of caffeinated energy drinks to children. Products with Natural Product Numbers (NPNs), products with Exemption Numbers (ENs) meeting compositional requirements, and products with Product Licence Applications (PLAs) submitted prior to October 6, 2011 meeting compositional requirements must comply with food labelling requirements by December 2013. Products with ENs not meeting compositional requirements and products with PLAs prior to October 6, 2011 not meeting compositional requirements must comply with food labelling requirements by December 2012. Products with PLAs submitted after October 6, 2011, products with PLAs submitted before October 6, 2011 but over 180 days that did not receive an EN, and new products must comply with food labelling requirements before they will be issued a TMAL and be able to gain market access.

A list of products that have received TMAs will be posted on Health Canada's website. This posting will be done in accordance with the Privacy Act.

Along with standard requirements for TMAs, companies with a TMA for caffeinated energy drinks will be required to report data on consumption incidents and withdraw the product if requested.

With respect to the transition process, a caffeinated energy drink falls into one of the following categories:

1. Licensed products - in other words, Products with a Natural Product Number
2. Products with an Exemption Number
3. Products with a Product Licence Application
4. New Products (products seeking market access after October 6, 2011)

i) Products with a Natural Product Number (NPN)

It has been determined that all products that currently have a valid NPN meet the compositional requirements for caffeinated energy drinks and thus warrant the issuance of a TMAL. As such, manufacturers and distributors were contacted by Health Canada's Food Directorate in regards to starting the transition process, which entails a request for updated formulation data and seeking agreement with the terms of the TMAL. As part of the TMA issuance, these products will be granted a transition period until December 2013 to meet all food labelling requirements.

Once the TMAL has been finalized, manufacturers and distributors can expect to receive simultaneously from the Department by June 30, 2012: (1) a confirmation of the classification of the product as a food subject to all legislation and regulations applicable to food products; (2) a TMAL; and (3) a notice of the cancellation of their product's NPN.

ii) Products with an Exemption Number (EN)

Products with an EN currently have legal market access but their safety assessments as NHPs have not been fully completed by Health Canada. The Department will determine the eligibility of these products for a TMA, based in large part on the product meeting the composition requirements. In order to demonstrate eligibility, manufacturers and distributors will need to submit information in accordance with section B.01.054 of the Food and Drug Regulations to the Food Directorate by April 30, 2012.

Should the product be eligible for a TMA without reformulation, manufacturers and distributors can expect to receive simultaneously from the Department by June 30, 2012: (1) a confirmation of the classification of the product as a food subject to all legislation and regulations applicable to food products (2) a TMAL; and (3) a notice of the revocation of their product's EN. As part of this process, a transition period is planned for labelling. Specifically, by December 2013, the product will need to meet all food labelling requirements. However, manufacturers and distributors are encouraged to bring the labelling into compliance as quickly as possible so that Canadians will have the information they need to make informed and appropriate decisions on their use of this product.

In the case where the product does not meet the composition requirements, it will need to be reformulated to meet those requirements and obtain a TMAL, otherwise the product will be considered a non-compliant food. If manufacturers and distributors choose not to submit the information required for a TMA to Health Canada's Food Directorate, or elect not to reformulate their product as deemed necessary by the Department, they can expect to receive a notice of the upcoming issuance of (1) a classification decision letter confirming the product is subject to all legislation, including Part B of the Food and Drug Regulations, that apply to it as a food product; and (2) an EN revocation letter. These regulatory decisions will be issued by September 30, 2012. In this scenario, and as of September 30, 2012 manufacturers and distributors will no longer be able to market their product and the product will be considered a non-compliant food subject to enforcement action by the Canadian Food Inspection Agency (CFIA).

If, however, manufacturers and distributors submit the information required for the issuance of a TMAL and indicate their intent to reformulate the product as required, they will have until December 2012 to work with the Department to complete the reformulation process and comply with food labelling requirements, at which time they will receive from the Department (1) a confirmation of the classification of the product as a food subject to all legislation and regulations applicable to food products; (2) a TMAL; and (3) a notice of the revocation of their product's EN.

iii) Products with Only a Product Licence Application (PLA)

Products with a product licence application that have not received an exemption number are not legally allowed to be on the market, and have not been fully assessed for safety by Health Canada. However, these products can receive market access by way of an "EN" after 180 days of the date of submission according to the Natural Health Products Unprocessed Products Licence Application Regulations (UPLAR). As a result, there are three (3) subcategories of products with a PLA:

1. Product licence applications submitted after October 6, 2011: The manufacturer or distributor can expect to receive from the Department a PLA refusal letter for their product as a natural health product, confirming that the product is subject to all legislation and regulations applicable to food products. In order for the product to be legally marketed as a food, it will require a TMA. The manufacturer or distributor will need to submit information in accordance with the requirements for a TMAL 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 compositional and labelling requirements, the manufacturer or distributor can expect a TMAL to be issued, permitting the marketing of the product subject to the conditions stipulated in the TMAL. These products are not expected to be on the market unless they have been issued a TMA and comply with the conditions stipulated within.
2. Product licence applications submitted before October 6, 2011 but not eligible for an EN: These products have been in the queue for more than 180 days and the manufacturer or distributor has chosen to not receive an EN, therefore they do not have legal access to market their products. The Department will determine the eligibility of the product for a TMA, based in large part on the product's composition. Health Canada has already contacted / notified these applicants (February 2012). Manufacturers or distributors will need to submit information in accordance with the requirements for a TMAL stated under Section B.01.054 of the Food and Drug Regulations to Health Canada's Food Directorate by April 30, 2012.

   Should the product be eligible for a TMA, having met the necessary composition and labelling requirements, manufacturers or distributors can expect to receive simultaneously from the Department by June 30, 2012: (1) a confirmation of the classification of the product as a food subject to all legislation and regulations applicable to food products; (2) a TMAL; and (3) a notice of the refusal of the PLA.

   In the case where the product does not meet the composition requirements, the product will need to be reformulated to meet those requirements and comply with food labelling requirements before issuance of a TMAL and gaining market access.

   If a manufacturer or distributor choose not to submit the information required for a TMAL to the Food Directorate, or indicate they will elect not to reformulate their product as deemed necessary by the Department, by June 30, 2012 they can expect to receive from the Department a PLA refusal letter for this product as a natural health product along with confirmation that the product is a food, subject to all legislation, including Part B of the Food and Drug Regulations, that apply to it as a food product. These products are not expected to be in the market given that they are non-compliant with the Natural Health Products Regulations and UPLAR. Should these products be marketed, they would be considered non-compliant foods and subject to enforcement action by the CFIA.

3. Product licence applications submitted before October 6, 2011, in the process of receiving an EN after the 180 days in accordance to the UPLAR. Some of these manufacturers or distributors are ready to market their products as NHPs in anticipation of receiving an EN. Therefore, the manufacturer or distributor was contacted to advise them of the possible options. They have been invited to send updated information and to seek a TMAL, which will only be valid until June 30, 2012 so that they can market their product as planned. During this period they will also need to update their TMA request based on the product formulation requirements stipulated in this document in order to remain legally in the market after June 30, 2012.

   Should the product be eligible for a TMA without reformulation, manufacturers and distributors can expect to receive a TMAL from the Department by June 30, 2012. As part of this process, a transition period is planned for labelling. Specifically, by December 2013, the product will need to meet all food labelling requirements. However, manufacturers and distributors are encouraged to bring the labelling into compliance as quickly as possible so that Canadians will have the information they need to make informed and appropriate decisions on their use of this product.

   In the case where the product does not meet the composition requirements, it will need to be reformulated to meet those requirements and obtain a TMAL or it will become a non-compliant food. If manufacturers and distributors choose not to submit the information required for a TMA to the Food Directorate, or elect not to reformulate their product as deemed necessary by the Department, they will not receive a TMAL from the Department by June 30, 2012. In this scenario, manufacturers and distributors will not be able to market their product after June 30, 2012 and the product will be considered a non-compliant food subject to enforcement action by the CFIA.

   If, however, manufacturers and distributors submit the information required for the issuance of a longer-term TMAL and indicate their intent to reformulate the product as required, Health Canada will be open to the extension of the TMAL beyond June 30, 2012, to support product reformulation, they will have until December 2012 to work with the Department to complete the reformulation process and comply with food labeling requirements.

iv) New products

New products are caffeinated energy drinks that are not currently on the market and for which no PLA has been submitted to Natural Health Products Directorate. New caffeinated energy drinks meeting the conditions described in the Scope section above will not be allowed to be marketed as NHPs. These products will be required to apply for a TMA and must meet all other requirements under the FDR that are not the subject of the TMA. These products will be required to meet compositional and labelling requirements before they gain market access through the issuance of a TMA.

Enforcement

Until TMALs are issued to affected products any enforcement issues will remain under the responsibility of the Health Products and Food Branch's Inspectorate (the Inspectorate). Once TMALs are issued they will be classified as foods and will be subject to enforcement by the CFIA. The CFIA will be informed of products that have received TMALs as well as those products that were ineligible or did not pursue the receipt of a TMAL, in order to assist them in their enforcement activities.

1.2.2 TMA Application Process

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 laid out in the sections below.

Submissions may be sent electronically as outlined in the General Guidance Document for Temporary Marketing Authorization for Foods 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.

Should there be any questions regarding TMAs please contact the Department at the email address indicated above, using "Caffeinated Energy Drinks" as the subject.

Guidance on Eligibility for a TMA for Caffeinated Energy Drinks

2.1 Caffeine and Alcohol

To be eligible for a TMA, caffeinated energy drinks must meet the following criteria:

• Shall contain a concentration of caffeine no less than 200 ppm (mg/L) and no more than 400 ppm.
• For a single-serving container, the maximum amount of caffeine shall not exceed 180 mg, per container. Similarly, for a multi-serving container, the maximum level of caffeine shall not exceed 180 mg per serving (500 mL). See section 3.2 regarding serving size and container size.
• Shall not contain alcohol.

2.2 Vitamins, Mineral Nutrients, and Amino Acids

Outlined below are the minimum and maximum levels of vitamins, minerals and amino acids in caffeinated energy drinks that would be considered eligible for a TMA. At the present time, these levels are established as daily maximums and, as stated in section 3.3.3, below, companies are required to state on the label the maximum number of containers/servings that should not be exceeded daily. It should be noted that these maximums are not intended as recommended levels for addition. The reference amount used for caffeinated energy drinks under the TMA (see section 3.2) was established based on the fact that many caffeinated energy drinks are sold in single serving containers approximating this amount. It is important that companies take into account any data they have on typical patterns of consumption of caffeinated energy drink products and use that information to decide whether and to what levels to add vitamins, mineral nutrients or amino acids to their products to further reduce the likelihood that the consumer will have intakes above the daily maximum levels.

The research conducted through the TMA is expected to help determine with greater certainty the usual and upper levels of intake of these products as well as the effectiveness of the label caution statement. Once the data are available, maximum levels of addition may be set on a per reference amount or per "reasonable daily intake" basis. The research will also inform a decision about the need to retain this caution statement. In addition, the maximum levels and the nutrients in the list are subject to change based on future review as new evidence becomes available. If a petitioner wishes to pursue a TMA for a caffeinated energy drink including nutrients not identified in this guidance, a strong rationale for its composition must be provided.

2.2.1 Minimum Levels

Caffeinated energy drinks should contain a minimum of 5% of the Daily Value (DV) per reference amount and per serving of stated size of an added vitamin or mineral. This is to ensure that a sufficient amount has been provided so as not to be misleading when the product is consumed as a food.

2.2.2 Maximum Levels

Caffeinated energy drinks should contain no more than the daily maximum levels for the ingredients outlined in the table below to be considered eligible for a TMA. These maximum levels have been established to ensure that the addition of these ingredients is safe and appropriate.

Maximum Levels

Vitamin/ Mineral	Daily maximum level from Caffeinated Energy Drinks
Niacinamide	450 mg
Riboflavin	27 mg
Thiamine	5 mg
Vitamin B6	14 mg
Vitamin B12	25 mcg
Vitamin C	276 mg
Vitamin E	141 mg
Calcium	225 mg
Magnesium	25 mg
Phosphorus	364 mg
Potassium	350 mg
Other ingredients
Taurine	3000 mg

In order to determine the recommended consumption limit in terms of the number of containers or servings to be shown on product labels (see section 3.3.3), the above daily maximum levels should be taken into consideration.

2.2.3 Maximum Levels not Specified

Pantothenic acid

Given the limited scientific data available, a formal maximum level for pantothenic acid has yet to be set by the Department. However, Health Canada does not have any health and safety concerns with the addition of pantothenic acid in caffeinated energy drinks at levels up to 60 mg/day.

L-Arginine, L-Isoleucine L-Leucine, L-Lysine, L-Theanine and L-Valine

Given the limited scientific data available, a formal maximum level for these amino acids has yet to be set by the Department. However, Health Canada does not have any health and safety concerns with the addition of these amino acids in caffeinated energy drinks at levels up to 300 mg/day.

2.2.4 Vitamins or Mineral Nutrients not Acceptable for Addition

The addition of vitamin A (in the form of retinol) and folic acid is not permitted to caffeinated energy drinks.

Folic acid

The addition of folic acid is not permitted in caffeinated energy drinks. The 90th percentile of folic acid intake is above the tolerable upper limit (UL) established by the Institute of Medicine of the National Academies for adolescent boys without consideration of vitamin supplement intake. Also, folate status data from the Canadian Health Measures Survey also indicates that a significant proportion of the population (40-60%) have intakes above the UL. The UL for folic acid was set due to its potential to mask vitamin B12-dependent anemia.

Vitamin A

The addition of vitamin A (in the form of retinol) is not permitted in caffeinated energy drinks. Vitamin A is a nutrient with a narrow margin of safety and with serious side effects associated with intakes above the UL (liver toxicity, teratogenicity and increased risk of fracture).

3.0 Labelling^{Footnote 1}, Advertising and Claims

In general, all requirements for labelling and advertising for food in the Food and Drugs Act, Part B of the FDR and in the Consumer Packaging and Labelling Act and Regulations will apply, other than those aspects that are the subject of the TMA. See section 3.0 of the General Guidance Document for Temporary Marketing Authorization for Foods.

The following section describes additional labelling and advertising requirements specific to caffeinated energy drinks. The basis for assessing certain claims with respect to reference amount and serving size is also described.

3.1 Advertising

Under the Food and Drugs Act, "advertisement" includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of a product. Therefore, all statements designed to promote the consumption or sale of a food are considered to be advertising. In order to make informed decisions about their health, consumers should also be provided with fair and balanced information about the benefits and the risks associated with the use of the advertised product. Unacceptable label information is also unacceptable in advertising. Please refer to sections 3.3.3 (caution statements related to product use by children) and 3.5 (principles governing the acceptability of voluntary statements) for further information.

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 TMAL is issued. This includes not providing samples of the product to children.

3.2 Reference Amount, Serving Size and Container Size

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. These two parameters provide the basis of compositional criteria for certain claims for foods. Reference amount and serving size may be subject to change as new consumption data become available, including from the TMA research.

Based on the net quantity of caffeinated energy drinks that is typically sold per container for single serving consumption, the reference amount for caffeinated energy drinks has been established at 500 mL. This amount will be used for the purposes of the TMA.

In accordance with B.01.002A of the FDR, a serving of stated size of a caffeinated energy drink shall be based on the food as offered for sale and expressed in millilitres. Where the container of the product contains 150% or less of the reference amount, a serving of stated size shall be the net quantity of the food in the container (B.01.002A(2)(c)). This means that 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.

Re-sealable containers for caffeinated energy drinks above 750 mL are considered multi-serving containers for which the serving size (500 mL) will be the same as the reference amount.

All declarations of content made on the label of a caffeinated energy drink container must be made using the same serving of stated size.

3.3 Required Statements

3.3.1 Quantitative Declaration of Caffeine Content

Caffeine content includes all sources of caffeine in the product. 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. See 3.2 above for when a container is considered to be a single-serving container.

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.

3.3.2 Qualitative Declaration of Caffeine

All caffeinated energy drinks eligible for TMA 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").

3.3.3 Caution Statements

The following caution statements should be grouped together, without any intervening material, preferably under a standardized bolded heading "Caution/Mise en garde" or "Caution/Attention". A distinct heading that stands out from other information on a label makes the information more noticeable by consumers. Alternatively, these statements may be presented in bold text.

• "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"
• "Do not mix with alcohol"

In addition, the recommended maximum number of containers or servings must not result in the daily maximum limit being exceeded for any added vitamins, minerals or amino acids set out in section 2.2.2.

3.3.4 Quantitative Declaration of Ingredients Other than Caffeine

Certain natural health product ingredients, such as herbal ingredients and their derivatives, have pharmacological effects when consumed at therapeutic levels. Although many of these ingredients have been determined to be safe for use as natural health products, their use in food presents a different context. The consumption of a natural health product is limited by a recommended dose per day and generally used for a limited period of time. In contrast, foods are consumed ad libitum, daily and over a lifetime. Due to the potential health implications of selected bioactive ingredients for some consumers, they need to be alerted to their presence as well as their levels in food products. This will help consumers adjust their intake of a given ingredient from different sources and assist them and their health care providers to assess the potential for contraindications or interactions with medications. This approach is consistent for the one followed for the declaration of caffeine levels.

When added to caffeinated energy drinks, a declaration of the level of select bioactive ingredients per serving of stated size will be required if the ingredient does not have an accepted food purpose and meets one of the following conditions:

• A limit of addition is specified for the ingredient by Health Canada's Food Directorate (see table in section 2.2.2, for example, taurine), or
• A dosage is established in the  monographs of the Natural Health Product Directorate (NHPD), or an authoritative source, such as the  European Medicine Agency (EMA), and when an individual consumes the caffeinated energy drink within the limit recommended in the Caution statement on the product label, s/he will reach or exceed the dosage in the monograph or the authoritative source.

Examples of ingredients that are considered subject to quantitative declaration, pending on their levels in the caffeinated energy drink product, include: Ginseng, Ginkgo biloba, Milk thistle, Astragalus, Grape skin extract, Coenzyme Q10. Applicants of a TMA are advised to consult with Health Canada's Food Directorate if they have questions whether the level of an ingredient of interest should be declared (see contact information in section 1.2.2).

The ingredients listed below have accepted food purposes and are excluded from the above requirement.

• A vitamin, mineral nutrient
• A food additive
• A flavouring agent
• Other food ingredients with only a food purpose that provide calories and/or hydration

Note that a quantitative declaration of an amino acid outside the ingredient listing can be made only for a product that is a source of protein or that meets specified exemptions described in B.01.305(2) of the FDR. Petitioners are advised to consult with the Food Directorate regarding making quantitative declaration of amino acids, in the ingredient listing.

3.3.5 Other Required Information

The company name and identity of the principal place of business must be provided on the product label. Companies are encouraged to provide a toll-free number on the label to facilitate the reporting of consumption incidents by the public (see section 4.2).

3.3.6 Placement of Required Statements

Quantitative declarations of caffeine and other ingredients described in section 3.3.4 should be placed immediately below the Nutrition Facts table or adjacent to the ingredient listing. The same serving size must be used as in the Nutrition Facts table.

Qualitative caffeine declaration should be adjacent to the quantitative declaration or the caution statements, unless the qualitative declaration appears on the principal display panel.

Caution statements (see section 3.3.3) should be in close proximity to the Nutrition Facts table, either below or adjacent to it.

3.3.7 Legibility and Prominence of Required Statements

It is recommended that the required statements specific to caffeinated energy drinks be displayed in letters of the same size using upper and lower case letters, contrast (for example, black text on white background) and prominence, since this information is of similar public health significance to the core information in the Nutrition Facts table displayed on the label.

3.4 Priority Allergens, Gluten Sources, and Sulphites

Caffeinated energy drinks must be compliant with current allergen labelling regulations as per Section B.01.010 of the FDR. Note that Health Canada published amendments to the FDR in February 2011 to 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, cream, which could trigger allergen, gluten, or sulphite labelling requirements in a prescribed manner. Manufacturers of caffeinated energy drink products being transitioned from the Natural Health Product regulatory regime to the food regulatory regime and not required to be reformulated will be provided an additional transition period for allergen labelling rather than being immediately subject to the new regulation on August 4, 2012. These products must fully comply with the enhanced food allergen labelling requirements along with all other labelling requirements by December 2013. In the case where a product is reformulated before December 2013, then that product must be fully compliant with the enhanced allergen labelling requirements at the same time as reformulation. Product licence applications submitted after October 6, 2011 and new products must comply with all food labelling requirements before gaining market access, and at the time of issuance of a TMA. Note that manufacturers of these 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.^{Footnote 2}

Note that 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.

3.5 Voluntary Statements

As noted in section 3.2 of the General Guidance Document for Temporary Marketing Authorization for Foods, 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 and applicable guidance. Note also that when a voluntary statement or claim about an ingredient (for example, ginseng) is made on the label, other than as part of the ingredient listing, the level of the ingredient in the food should be declared in grams or milligrams per serving of stated size.

Companies marketing caffeinated energy drinks as food in Canada that are being transitioned from the natural health products to the food framework should be aware that differences exist in determining the acceptability of claims between the two frameworks.

One major difference is that nutrient content claims and health claims on food products must be linked to specific substance(s) in the product.

Health claims for food should be expressed in specific rather than general terms, such that claims are both measurable and quantifiable, and therefore allow scientific verification. This will reduce the possibility of claims being vague, uninformative and misleading. For example, a claim about "temporarily restoring alertness" is more specific than a claim about "enhancing cognitive performance".

Listed below are several principles by which the acceptability of certain claims on caffeinated energy drinks will be assessed.

3.5.1 Claims Related to Physical Performance

The use of energy drinks containing caffeine for sport performance is not supported by a recently conducted evidence-based review^{Footnote 2}. The potential ergogenic effects of caffeine appear to be more closely related to its role as a central nervous system stimulant and the associated decreased perception of physical effort^{Footnote 2}. However, the use of caffeinated energy drinks exceeding the quantity stated as part of the caution statements is not recommended especially for purposes of hydration after physical activity and for new or novice users who have had limited exposure to caffeinated energy drinks^{Footnote 2,Footnote 3}.

Health Canada's updated advice on the consumption of caffeinated energy drinks is consistent with this assessment. In this context, health claims made on these products should not contradict this advice nor should the claims be likely to convey mixed messages about the use of energy drinks containing caffeine to the general public. This directive applies in particular to any health claims (implied or explicit) making reference to physical performance (for example, physical exertion, endurance, aerobic, anaerobic, power, strength, motor performance, recovery, or sports). Modifications to the claim wording including conditions of use (amount, timing and the targeted group for use of the product) may be necessary to allow for the safe use of caffeinated energy drinks. For example, the addition of another message that would avoid confusion of the role of caffeinated energy drinks as sports drinks or for rehydration purposes could be acceptable for the duration of the TMA, such as "not intended for re-hydration". The effectiveness of the modified claim statement in mitigating the health concern will be assessed through research required to be conducted as part of the TMA.

3.5.2 Claims Related to General or Specific Health Benefits

The use of the term "energy" as part of the product name for caffeinated energy drinks or in a claim for the caffeine-related effects of these products does not refer to calories as is generally the case for other foods and beverages. In this case, the use of the term "energy" is considered an implied health claim consistent with the primary purpose of this product category, which has been represented to provide mental and physical stimulation for a short period of time. Also, claims stating or implying general or specific health benefits that result from the long term consumption of these products are not appropriate, including "source of" claims about a vitamin or mineral nutrient. The claim must not create an impression that the product can be consumed as part of a daily eating pattern. It will also be necessary to limit claims on caffeinated energy drinks to those that would not promote consumption by children or for unintended or inappropriate use.

3.5.3 Calorie-Free and Sugar-Free Claims

The reference amount of 500 mL would disqualify some products in single serving containers less than 500 mL from making calorie-free and sugar-free claims (see table following B.01.513 of the FDR). An exemption from this section of the FDR with respect to the reference amount requirement will be allowed for these claims for the duration of the TMA. Health Canada will further examine this section of the FDR to support a permanent solution for the future.

3.5.4 Placement and Prominence of Voluntary Statements

To ensure that voluntary claims do not detract consumers' attention from the caution statements, it is recommended that voluntary claims not be more prominent than the required caution statements. If a voluntary claim is made on the principal display panel, it is recommended that a statement to the effect "See caution statements below (or adjacent to) the Nutrition Facts table" in the same type size and prominence should appear on the upper right corner of the same panel.

3.6 Sample Label

To illustrate how the required statements may be displayed on product labels, two sample labels are provided for illustrative purposes only (see Exhibit 1).

Exhibit 1: Two examples are provided here for illustrative purposes only to show how the required statements for caffeinated energy drinks may be displayed on product labels.

Example A: The Nutrition Facts table does not reflect the style and format specified in the Food and Drug Regulations respecting Nutrition Labelling. Refer to the Nutrition Labelling section of the CFIA's website for more information regarding specifications for the Nutrition Facts table.

Example B: The Nutrition Facts table does not reflect the style and format specified in the Food and Drug Regulations respecting Nutrition Labelling. Refer to the Nutrition Labelling section of the CFIA's website for more information regarding specifications for the Nutrition Facts table.

4.0 TMA Research

4.1 Research

Health Canada conducted a scientific assessment of the potential hazards and exposure associated with the common ingredients found in caffeinated energy drinks such as caffeine and vitamins. Health Canada has concluded that a number of data gaps need to be addressed to support its efforts to regulate caffeinated energy drinks as food and to appropriately manage potential health risks associated with these products.

To address these gaps, Health Canada requires data on: Canadians' consumption patterns for caffeinated energy drinks in order to better estimate exposure to caffeine and other ingredients from these beverages; and data on consumer's understanding and use of label information as well as the effectiveness of product labels as a risk management tool.

As a condition of the TMA, details of the research to be conducted during the temporary marketing period must be submitted to Health Canada for review. Research and data collection for caffeinated energy drinks should be targeted to address the data gaps mentioned above, so that information can be generated that will be relevant and supportive of an amendment to the FDR. Agreement between Health Canada and the petitioner must be reached on the research protocol prior to the implementation of any studies.

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.

4.2 Reporting Consumption Incidents

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 all TMA holders and applicants in the coming weeks.

5.0 Food Additives, Flavours, Herbal Ingredients and Novel Foods as Ingredients in Caffeinated Energy Drinks

5.1 Food Additives

Permitted food additives are listed in the tables to Division 16 of Part B of the FDR. The tables are generally organized according to the functional classes of food additives. In this way, the Regulations enable the use of additives by specifying the food or foods an additive can be used in, the purpose for adding it to that food, and the maximum level of use in that food. New additives and new uses of permitted additives must undergo the premarket approval process enabled by section B.16.002 of Division 16 (in other words, the food additive submission process). In some situations, the use of an additive may be temporarily permitted under an Interim Marketing Authorization (IMA) once the safety evaluation of the food additive submission has been completed.

"Caffeinated energy drinks" will be unstandardized beverages within the food regulatory framework. Therefore, they may contain food additives that are allowed in unstandardized beverages, carbonated beverages (if the caffeinated energy drink is carbonated), or the broader category of unstandardized foods.

Some caffeinated energy drinks that are being transitioned from the natural health product regulatory framework to the food regulatory framework may not comply with one or more food additive provisions in the FDR. During the transition period, such food additives (for example, steviol glycosides at specific levels) that are part of caffeinated energy drink formulations that were originally submitted under the natural health product regulatory framework may be allowed in caffeinated energy drinks under a TMAL provided the non-compliance does not pose a public health concern.

While the TMA will allow such products to be temporarily marketed during the transition process, a food additive submission will be required to request regulatory approval of new food additives or new uses of already-permitted additives before the TMA expires. Caffeinated energy drinks that receive a TMAL during the transition period must be fully compliant with the FDR in order to remain on the market once the TMA expires. These products will not be eligible for a second TMA to extend the authorization of a non-permitted use of a food additive after expiry of the first one.

5.2 Other Food Ingredients

5.2.1 Food Flavours

The Regulations do not require pre-market evaluation of most food flavouring ingredients and there is no "positive" list of permitted flavours in the Regulations. However, the Food and Drugs Act prohibits the sale of adulterated foods, and section B.01.046 of the FDR lists certain food flavouring substances that would render a food adulterated. These substances are not permitted in any food; including caffeinated energy drinks (see Appendix).

Flavouring ingredients used in caffeinated energy drinks and other foods should be of food-grade quality. Flavouring preparations that meet the standards of identity and composition in Division 10 of the FDR are acceptable for use in caffeinated energy drinks. Other flavour ingredients would be considered food-grade if they meet the specifications that are prescribed in the latest edition of the Food Chemicals Codex or if they meet the most recent flavouring specifications set by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

Ultimately, the seller is responsible for ensuring that flavouring substances in their food products do not result in a violation of section 4 of the Food and Drugs Act, which essentially prohibits the sale of an unsafe food.

5.2.2 Herbal Ingredients

Herbal ingredients that are acceptable for general use in food are acceptable for use in caffeinated energy drinks. However, Health Canada's Food Directorate has previously identified a number of herbs and botanical preparations (see Appendix) that are considered inappropriate for unrestricted consumption as foods. None of these substances should be used in caffeinated energy drinks. However, Health Canada's Food Directorate will consider new information that demonstrates these substances are safe for consumption should a manufacturer or distributor wish to submit it.

5.2.3 Novel Foods

Division 28 of the FDR requires that all novel foods undergo a mandatory pre-market assessment prior to being authorized for sale in Canada. Novel foods are:

• Products and ingredients that do not have a history of safe use as a food;
• Foods resulting from a process not previously used for food, causing the food to undergo a major change;
• Foods that have been modified by genetic manipulation, also known as genetically modified foods, genetically modified foods, genetically engineered foods or biotechnology-derived foods.

The proposed food would be out of compliance with the Regulations if it contains an unauthorized novel food ingredient. In this case the novel food ingredient would require a novel food notification under Division 28 in order to be brought into compliance with the Regulations. The nature of the information required as part of a novel food notification can be found in the Guidelines for the Safety Assessment of Novel Foods.

The onus is on the proponent to be in compliance with Division 28, including for ingredients found in caffeinated energy drinks. If you are unsure about the novelty status of particular ingredients, you are encouraged to contact the Novel Foods Section to further discuss this issue before making a TMA request. If a food is deemed not to be novel, its use defaults to Section 4 of the Food and Drugs Act, and any other applicable regulations or standards.

More information about novelty determination can be found in the Guidelines for the Safety Assessment of Novel Foods. It is recommended section 4.1.1.1 of these guidelines be consulted to help determine if the ingredient is novel or not (history of safe use as a food).

Appendix: Reference List of Ingredients

Negative List of Ingredients

The ingredients found on the Negative List are divided into three categories, flavouring ingredients that are not permitted in any foods (including caffeinated energy drinks), herbal ingredients that are considered to be inappropriate for unrestricted consumption in foods, and other ingredients that are not permitted in caffeinated energy drinks. These lists of ingredients are not exhaustive and may be revised as new information becomes available.

Prohibited Flavouring Substances (Section B.01.046, Division 1 of Part B of the FDR)

• Coumarin, an extract of tonka beans, the seed of Dipteryx odorata Willd. or Dipteryx oppositifolia Willd.
• Dihydrosafrole
• Isosafrole
• Oil of American sassafras from Sassafras albidum (Nutt). Nees
• Oil of Brazilian sassafras from Ocotea cymbarum H.B.K.
• Oil of camphor sassafrassy from Cinnamomum camphorum Sieb
• Oil of micranthum from Cinnamomum micranthum Hayata
• Safrole
• Oil, extract or root of calamus from Acorus calamus L.
• Cinnamyl anthranilate

Herbs and Botanical Preparations Previously Identified as Inappropriate for Unrestricted Consumption as Foods

• Cascara sagrada
• Chaparral
• Ephedra
• Germander
• Gotu kola
• Horsetail
• Kava-kava
• Khat
• Senna
• Acorus calamus (which is prohibited under B.01.046)
• Arnica (Arnica montana, wolf's bane, leopard's bane)
• Comfrey
• Magnolia officinalis
• Pleurisy root (Asclepias tuberosa)
• Stephania tetranda
• Yellow jessamine (Gelsemium sempervirens)

Other Ingredients Not Permitted in Caffeinated Energy Drinks (see explanation in section 2.2.4)

• Folic acid
• Vitamin A (in the form of retinol)