In 2022, Health Canada introduced the Supplemented Foods Regulations to help better safeguard consumer health and safety while also providing a clear regulatory framework for supplemented foods.
The requirements for supplemented foods, including compositional and labelling requirements, are outlined in the Supplemented Foods Regulations and the documents incorporated by reference into the Food and Drug Regulations (Canada).
What is a supplemented food?
Supplemented foods are pre-packaged foods containing one or more supplemental ingredients, such as vitamins, minerals, amino acids, caffeine, or herbal extracts. Some examples of supplemented foods include beverages with added vitamins and minerals, caffeinated energy drinks, and granola bars with added vitamins. There are a limited number of categories of foods that are permitted to have supplemental ingredients. Any other food category that is not outlined in this list is not considered a supplemented food.
The list of permitted supplemental ingredients lists all the supplemental ingredients allowed for addition to supplemented foods, along with their conditions of use.
Supplemented foods must meet specific labelling requirements, such as having a supplemented food facts table (SFFt) and including certain cautionary label statements as well as a caution identifier. These requirements will assist consumers in differentiating supplemental foods from other foods, informing them about the risks of consuming specific supplemental ingredients, and helping them make informed decisions about their health.
Supplemented food facts table
A supplemented food facts table (SFFt), which is similar to the nutrition facts table (NFt) on other foods, must be present on the labels of supplemented food products. The table must use the unique heading “Supplemented Food Facts” instead of “Nutrition Facts” but must still include the core nutrients information as normally required. In addition to the core nutrients, it must list the total amount of each supplemental ingredient in the food under the heading “Supplemented with.” As with NFts, there are different formats for SFFts that can be used which will be deemed acceptable under the new regulations.
Supplemented foods may be harmful to a person’s health if: they consume too much of an added supplement ingredient, are pregnant, a child, or belong to another vulnerable group. Accordingly, to warn consumers of any risks connected to one or more supplemental ingredients in the food product, cautionary statements on the label may be required. To establish if a caution is necessary, the total amount of each supplemental ingredient must be compared to its threshold level for cautionary labelling. Products with supplemental ingredients below the threshold amounts are not required to have cautionary statements. If the same cautionary statement is necessary for more than one supplemental ingredient, it only needs to appear once on the label.
Cautionary statements are required if the supplemental food contains any of the following:
- certain supplemental ingredients (e.g. zinc always requires cautionary statements), or
- more than a certain amount of a supplemental ingredient per serving (e.g. more than 74 mg of vitamin C)
Cautionary statements must be grouped together under a standard, bolded header “Caution” in order to make them more prominent.
Supplemented food caution identifier
Canada’s focus on ensuring that consumers are able to make informed food purchasing decisions is evidenced by the requirement for a standardized supplemented food caution identifier to be included on the product’s front panel if cautionary statements are necessary for such product. This is similar to the new requirement to include a standardized front-of-package nutrition symbol for products that are high in sodium, sugar or saturated fat. The objective is to alert consumers to review cautionary warnings to help them decide if the food is suitable for their consumption. As with the SFFt, there are various acceptable formats for the standardized caution identified that may be used.
The Canadian Food Inspection Agency (CFIA) began enforcing the Supplemented Foods Regulations immediately when the regulations came into effect on July 20, 2022 for new supplemented foods introduced to the market after that date. A transition period is available for supplemented foods that had a valid temporary marketing authorization letter (TMAL) at the time the regulations came into effect and for products that applied for a TMAL prior to that date and subsequently received a Health Canada notification. For products eligible for the transition period, the CFIA will begin enforcement on December 31, 2025.
Should you have any questions regarding product labelling for food products in Canada, please feel free to reach out to any member of Miller Thomson’s Marketing, Advertising and Product Compliance team.