Caffeinated energy drinks

An increasing number of caffeinated beverages have been introduced into the Canadian marketplace. Some of these products are known as "Energy Drinks" and usually contain a variety of unique ingredients and may feature health claims related to their capacity to restore energy and alertness.

A common substance found in most Energy Drinks is caffeine at levels ranging from those found in a weak cup of coffee to much higher levels. These products also generally contain other ingredients such as vitamins and minerals, and may also contain various herbs.

Health Canada has determined, based on consumption patterns, history of use, representation to consumers, and in accordance with its guidance document on "Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats", that products known as Energy Drinks fit the regulatory definition of a food. Health Canada's intent to assess and regulate the availability of caffeinated energy drinks on the Canadian marketplace in the context of their use as a food was announced by the Minister of Health on October 6, 2011.

Features

Transition of caffeinated energy drinks to food regulatory framework
List of foods transitioned from Natural Health Products Regulations to the Food and Drug Regulations
Supporting documents
Related information

Transition of caffeinated energy drinks to food regulatory framework

Health Canada is committed to the health and safety of Canadians and takes the concerns expressed seriously regarding caffeinated energy drinks, particularly their use by young people. As such, an independent Expert Advisory Panel on Caffeinated Energy Drinks (the Panel) was convened in fall 2010 to review scientific literature, data, and adverse reaction reports associated with these beverages. Health Canada analyzed the Panel's recommendations, completed a health risk assessment, and continued its information gathering and exchange with major food safety regulators in Canada and internationally. The information gathered helped shape their proposed management approach for products known as "Energy Drinks".

This approach included the decision to classify Energy Drinks as foods. Health Canada has set further safety requirements to account for the way these products are perceived and consumed by Canadians. The Department will also collect additional information through data submitted by industry in order to assess the effectiveness of the risk management approaches. For answers to commonly asked questions regarding the transition of caffeinated energy drinks, please visit Questions and Answers: Caffeinated energy drinks.

Under the new measures, Heath Canada:

Established minimum and maximum limits for caffeine content from all sources;
Set limits on other ingredients such as vitamins and minerals and develop a list of accepted and unaccepted ingredients;
Prohibits the use of Energy Drinks as an ingredient in pre-mixed alcoholic beverages;
Requires statements on the label indicating that the product is "not recommended for children, pregnant/breastfeeding women, individuals sensitive to caffeine", and "do not mix with alcohol";
Requires a statement on the label identifying the product as being a "High source of caffeine";
Requires the labelling of the amount of caffeine from all sources be shown in mg per container or per serving size;
Requires that all general food labelling provisions apply (e.g., nutrition facts table, ingredient labelling, allergen labelling etc).

Note: Depending on the formulation of the product, additional labelling requirements may also be required.

In addition, Health Canada will ensure that only products meeting the formulation and labelling requirements described above be eligible to be sold in Canada. Should a product not comply with the requirements, enforcement action by the Canadian Food Inspection Agency (CFIA) or revocation of the product's Temporary Marketing Authorization Letter (TMAL) may occur.

Eligible products will gain market access for a specified time period through the issuance of a TMAL to generate information needed to finalize the new regulatory framework for this category of products. TMALs will be issued for products that meet the compositional requirements, which include conditions for total level of caffeine from all sources, levels of added vitamins, minerals, and amino acids, and for novel ingredients and food additives. For additional information, please refer to the Category Specific Guidance for Temporary Marketing Authorization: Caffeinated Energy Drinks

In concert with a product receiving a TMAL, a revocation of the product's status within the Natural Health Product (NHP) queue and a classification decision that the product is considered a food will be issued. From that point onwards, the product will be considered a food and manufacturers will be required to comply with food advertising requirements which limit the advertising of caffeinated energy drinks to children.

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 aspects that are subject of the TMA. Specific conditions may apply depending on the type of product. For instance, 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 once the TMAL is issued. This includes not providing samples of the product to children.

Timeline

A transition period of up to 18 months (no later than December 2013) has been provided for industry to bring affected products into compliance with the applicable food labelling requirements. Only new or reformulated caffeinated energy products will be required to immediately meet all food labelling requirements.

List of foods transitioned from Natural Health Products Regulations to the Food and Drug Regulations

Supporting documents

Related information

News release: New approach on Energy Drinks (Oct 2011)
Caffeine in Foods
Questions and Answers: Foods marketed as Natural Health Products
General Guidance Document for Temporary Marketing Authorization for Foods
Frequently asked questions - Information for Parents on Caffeine in Energy Drinks
To obtain an electronic copy of the 2014 assessment document Energy Drinks: An Assessment of the Potential Health Risks in the Canadian Context, please contact our publications office or send an e-mail to publications@hc-sc.gc.ca with the subject heading "HPFB BCS Energy Drinks: An Assessment of the Potential Health Risks in the Canadian Context-eng".

SMIU-UGDI@hc-sc.gc.ca

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