In an announcement by the Minister of Health on October 6, 2011, Health Canada declared its intention to revise its classification of caffeinated energy drinks from natural health products to foods. Due to its public perception and history of use, product representation to consumers and product format, it was deemed by Health Canada that caffeinated energy drinks better fit the definition of a food. As a result, caffeinated energy drinks that have been granted NPNs or ENs, or products with Product Licence Applications that were submitted prior to October 6, 2011, are currently being shifted to the food regulatory framework, and this transition will be facilitated by the issuance of Temporary Marketing Authorization Letters (TMALs). TMALs will allow eligible caffeinated energy drinks to be marketed subject to specific conditions, until final regulatory requirements are put in place for these products in the Food and Drug Regulations.
In order to keep your caffeinated energy drink on the Canadian market, an application must be submitted to the Food Directorate for Temporary Marketing Authorization (TMA). In order to obtain TMA, certain eligibility criteria must be met such as restrictions on level of caffeine from all sources, levels of added vitamins, minerals and amino acids, and for novel ingredients and food additives. Additionally, the Food Directorate has put forth a series of requirements for labels, including quantitative and qualitative caffeine declarations, caution statements, quantitative declaration of other ingredients, and declaration of priority allergens.
Companies eligible to receive a TMAL must submit an application for Temporary Market Authorization of their caffeinated energy drink to the Food Directorate by April 30, 2012. Companies with products that do not meet compositional requirements are required to inform the Food Directorate no later than June 1, 2012 of their intention to reformulate the product. If you are unsure if your product is eligible to receive a TMAL based on its current formulation, please contact Source Nutraceutical for a comprehensive review of your product.
We can prepare your application for TMA of your caffeinated energy drink to help maintain your product on the Canadian market. We can also help you reformulate your product such that it meets the new composition requirements.
