Have you been anticipating the Food and Drug Regulations (FDR) adding supplemented foods as an official category of food? As a result of the July 20th amendments, these food products can now be sold in Canada as of July 21st, 2022. This has been the result of over 10 years of contributions which began when Health Canada announced their intentions to shift energy drinks from the Natural Health Products (NHP) to the food regulatory framework.
Now that these amendments are in effect there is a clear regulatory framework in place for selling supplemented foods. Supplemented Foods for those that are not familiar are prepackaged foods that contain at least one supplemental ingredient such as vitamins, minerals, amino acids, and herbal ingredients that were marketed as providing specific physiological or health benefits. The amendments will fill the gap between the food and drugs space by creating a specific category for the food products.
In our blog, we’ll outline the old regulations, their limitations, the permitted categories/ingredients, the transition timeline, and much more.
Food and Drug Regulations: Amendments Limitations:
Before these regulations, Health Canada let certain supplemented foods be sold through an interim measure known as the Temporary Marketing Authorization (TMA). These new amendments will seek to address several safety and policy concerns related to food fortification. Although the TMA process is no longer required certain products will require TMA’s.
The framework uses limitations that have the intent to prevent claims that could overemphasize the risks of supplemented food or mislead the consumer in any way. An example of this could be (claims of a nutrient that contributes to growth and development when the supplemented food has a cautionary statement that indicates it’s not recommended for anyone under the age of 18). Ultimately this could end up impacting the marketing and advertising of supplemented foods in a major way.
The Supplemented Food Facts Table (SFFT) Requirement:
Due to the new amendments, all supplemented foods are required to have an SFFT which replaces the Nutrition Facts Table (NFT) although they are still quite similar. According to the “Directory of SFFT Formats,” the SFFT requires the name and absolute amount of each supplemental ingredient under the mandatory “Supplemented with” heading. When vitamins, minerals, and nutrients are added to a product, they’ll also be included under this heading. A statement to interpret this will also be mandatory on supplemented foods to clarify that the amounts of supplemental ingredients declared by your SFFT include both supplemental and naturally occurring quantities.
Cautionary Statements & Identifier List:
Adding certain ingredients or levels of ingredients to a food product triggers a requirement that the label includes cautionary statements in both English and French. These statements must be separated from other information on the label and must be shown in a way that ensures they can be easily read. When a food product requires cautionary statements, it must also display a “Supplemented Food Caution Identifier” (SFCI) on the principal display panel. The SFCI must be black and white and include an exclamation mark, in addition to the text “Supplemented”.
Permitted Supplemented Food Categories and Ingredients by Health Canada:
List of Permitted Supplemental Ingredients: This list will capture substances that might be added to a specific food as a supplemental ingredients grouped as; mineral nutrients, amino acids, vitamins, etc. The conditions of use for each supplemental ingredient are also very detailed. Some examples of this could include the maximum levels of use in a product and ingredients that trigger an SFCI or cautionary statement.
List of Permitted Supplemented Food Categories: This list captures the various categories of food for which supplemental ingredients can be added. Various categories of food are exempt from the category like alcohol and fortified foods.
Health Canada can update these lists, and stakeholders can request changes (including additions, removals, or modifications) through a premarket submission process. This submission must be accompanied by supporting information demonstrating that the proposed change would be safe for Canadians.
Amendments Transition Timeline – Jan 1st, 2026
As of July 21, 2022, all TMA approvals for existing supplemented foods on the market will expire. Health Canada will continue to process TMA license applications that have already been submitted, but existing supplemented foods on the market approved under the TMA framework will have until Jan 1, 2026, to become compliant with the new regulations.
This consultation proposes compliance criteria for supplemental ingredients declared in the SFFT. This will affect the manufacturing, testing, and labeling of supplemented foods.