Anticipating Change: Supplemented Foods to Amend Canada's Food Regulations
Supplemented foods currently exist in a gray area of the law – not quite health products, despite containing added ingredients that provide physiological or health effects, and not quite foods as defined by the Food and Drug Regulations (FDRs). The best example of a supplemented food is a caffeinated energy drink, but supplemented foods could also be a protein bar with added vitamins and minerals, or a tea with added Zinc, Echinacea, and Vitamin C to boost immunity against cold season. Supplemented foods are pre-packaged foods that contain supplemental ingredients, which could potentially carry health and safety risks if consumed in excess by the general population, or if consumed by vulnerable populations, such as children or pregnant women.
For the reasons stated above, supplemented foods currently require a manufacturer or distributor to apply for a Temporary Marketing Authorization (TMAs) before bringing a product to market in Canada. The manufacturer/distributor must provide Health Canada with enough research and information on its product for Health Canada to determine its safety. Following this, the product receives a TMA with conditions, and is allowed to be sold to consumers; however, the manufacturer/distributor must continue to provide Health Canada with data for the duration the product is on the market. The entire process is lengthy, labour-intensive, and subject to interpretation. And while we must commend Health Canada for ensuring the safety of Canadian consumers, it is a welcome relief to see discussions finally occur that could introduce amendments to the FDRs to allow the inclusion of supplemented foods.
The proposed amendments would provide a predictable regulatory environment for industry, and outline the conditions of the proposed supplementary ingredients, as well as labelling and advertising requirements. Health Canada would like to see all supplemented foods carry a Supplemented Food Facts table (much like the Nutrition Facts table), and cautionary statements on the Principal Display Panel of the product. Moreover, Health Canada would prohibit representations and claims on the packaging with regards to the supplemental ingredients. All of these requirements would allow consumers to distinguish supplemented foods from regular foods, understand the health effects of these products, and make informed choices. For the manufacturer/distributor, a regulatory framework would do away with the lengthy process of applying for a TMA and updating Health Canada periodically on the status of its supplemented food product.
While there is still no timeline for when we can expect these amendments to occur, Health Canada just wrapped up its consultation process with industry on September 24, 2021. Prior to the publication of the amendments, Health Canada will notify Canada Gazette of the forthcoming changes. Any manufacturer or distributor with a TMA will have three years to transition to the new regulatory framework once the proposed regulations come into force. Health Canada promises to publish a List of Foods that Have Received Temporary Marketing Authorization Letters on the day the proposed regulations come into force, which will list all supplemented foods that comply with the previous system.
If you have questions or concerns about either the current system for supplemented foods, or the proposed amendments to the FDRs, contact us at info@gsjameson.com.