On July 20, 2022, Health Canada published amendments to the Food and Drug Regulations (FDR), introducing new regulations for supplemented foods as a category. These new regulations continue to protect the health and safety of Canadians while providing a clear and predictable regulatory environment for supplemented foods. Supplemented foods are defined as pre-packaged foods containing one or more added ingredients, such as vitamins, minerals, amino acids, caffeine, or herbal extracts. Examples of supplemented foods are beverages with added minerals, caffeinated energy drinks, snack bars with added vitamins, etc. The amended FDR come into force as of July 21, 2022.
Supplemented foods containing added ingredients may be harmful if consumed by vulnerable populations, or if overconsumed by the general population. Therefore, under the new regulations, all supplemented foods must have a standardized Supplemented Food Facts table including information on the amount of the added ingredients, similar to the Nutrition Facts table for foods.
In addition, supplemented foods should also provide information on the cautions and directions for use if Supplemented foods should also provide information on the cautions and directions for use if containing certain ingredients, to alert the consumers about the potential risks. To further mitigate the effects of potential health risks, the new regulations impose strict compositional limits and conditions of use, as well as limits on the type of foods that can be supplemented. It also prohibits the use of supplemented foods as ingredients or as constituents of ingredients to produce edible cannabis.
Prior to the regulations, manufacturers and distributors were required to obtain a Temporary Marketing Authorization (TMA) from Health Canada to sell supplemented foods. Supplemented foods that are already on the Market with a TMA or an application that has been submitted before July 21, 2022, will have until December 31, 2025, to comply with these new regulations. All new supplemented foods will need to comply with the regulations immediately. With Health Canada no longer requiring TMA applications, supplemented foods will be able to be sold in Canada under the condition that the product’s ingredients are on the List of Permitted Supplemented Food Categories or the List of Permitted Supplemental Ingredients. If either the supplement category or ingredient is not currently on either list, manufacturers are able to petition Health Canada to amend either list mentioned above, however at the time this article was written, Health Canada has yet to reveal the process in order to do so.
If you have questions about the new regulations and how to become compliant, contact us today.