Is Health Canada Shooting Down My Red Bull® Wings?

That 3 o’clock caffeine boost has just gotten a little weaker. Health Canada has recently capped the caffeine content in drinks sold in Canada, forcing more than 28 products currently on the market to reformulate. These products, known as “energy drinks”, contain caffeine at levels ranging from those found in a weak cup of coffee to significantly higher levels. Originally approved for sale on the Canadian market as natural health products, Health Canada has changed its philosophy and has decided to reclassify these products as foods.

Based on consumption patterns and history of use, Health Canada has decided that these caffeinated drinks fit the regulatory definition of a food (see guidance document on “Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats”). This now brings energy drinks under the purview of additional regulations of the Food and Drug Act. The practical effect is that manufacturers of energy drinks are now permitted no more than 180 mg of caffeine per can or single-serving bottle. This is about the same as a filter drip 8 oz. (237 mL) coffee from Tim Hortons. Larger re-sealable bottles are also being capped at 400 mg of caffeine per litre.

The purpose behind the reclassification of these drinks as food products is the increased use of these caffeinated beverages by young children and teenagers. Due to the high levels of caffeine found in most of these beverages, concerns were raised over the potential to exceed the maximum caffeine intake levels recommended by Health Canada for susceptible subgroups. Children and adolescents less than 18 years of age were found to be the most at risk of exceeding Health Canada’s Recommended Maximum Daily Intakes (RMDI) for caffeine in light of the volumes reportedly consumed by this group and the lower RMDI established for this population, in comparison to adults.

Equipped with these new regulations, Health Canada intends to assess and manage the potential risks associated with these products for the next five years. They have required that manufacturers of these products report data every six months on any consumption incidents received through consumer complaints. For the time being, products currently on the market will be issued a Temporary Marketing Authorization (TMA) and will be subjected to these more stringent reporting obligations. The hope is that the current information gap on how these products are currently being used can be closed and safer products for consumption by adults and adolescents alike can be approved for sale on the Canadian market.

Author Credit Line: Cristelle Gedeon is an associate at Fasken Martineau LLP’s Life Science Industry Group specializing in regulatory affairs and intellectual property. Contact Christelle at: [email protected] or http://www.fasken.com/en/christell-gedeon/.