Health Canada published amendments to the Food and Drug Regulations ("FDR") on July 20, 2022, adding supplemented foods as a category of food that can be legally sold in Canada. The new provisions come into force July 21, 2022. The regulatory regime is the culmination of over 10 years of stakeholder and government contributions that began in 2011 when Health Canada announced its intent to transition energy drinks from the natural health products regulatory framework to the food regulatory framework.
These amendments provide a food regulatory framework for the sale of supplemented foods - prepackaged foods containing one or more added supplemental ingredients, such as vitamins, minerals, amino acids, caffeine, and herbal ingredients, which have historically been marketed as providing specific physiological or health effects. Supplemented foods previously fell between the space of food and drugs; the amended regulations seek to bridge that gap, carving out a legal category specific to the sale of supplemented foods in Canada.
Prior to these regulations, supplemented foods had a complex and evolving path to market. Since 2012, Health Canada permitted the sale of certain supplemented foods via an interim measure known as a temporary market authorization ("TMA"). Gowling WLG's Food and Beverage Group has been involved in the transition since its inception and has written extensively about the TMA regime (for more background see Supplemented Foods, A New Framework and Act Now, Supplement Later: New Draft Guidance for Supplemented Foods).
The administrative burdens and regulatory uncertainty of the temporary regime threatened to stifle innovation within the supplemented foods industry. These amendments provide that regulatory certainty to the industry, while the limitations prescribed by the added provisions strive to address Health Canada's safety and policy concerns around food fortification. Although supplemented foods are now no longer required to go through the TMA process, there will continue to be certain products that require TMA s.
Limitations on representations
The framework includes prohibitions and limitations on representations with the stated intent to prevent claims that may overshadow the risks of the supplemented food or that may be vague or misleading for the consumer (e.g. claims about any nutrient contributing to growth and development are prohibited when that supplemented food carries a cautionary statement indicating that it is not recommended for any age group under the age of 18).
These limitations could pose significant challenges for brand owners and may impact marketing and advertising for supplemented foods. At this time, there remains a number of open questions as to how these provisions will be enforced and interpreted. It is important brand owners seek advice as early as possible with respect to marketing strategies.
Supplemented food facts table ("SFFt")
Supplemented foods are now required to carry a SFFt that replaces the Nutrition Facts table but looks similar and requires the same information about serving size, calories, and the core nutrients to be declared, as well as the percent Daily Value interpretative statement. The "Directory of SFFT Formats," incorporated by reference into the FDR, describes the acceptable display formats.
The SFFt requires the name and absolute amount of each supplemental ingredient to be declared under a mandatory "Supplemented with" heading. When vitamins and mineral nutrients that are added as supplemental ingredients and naturally occurring amounts of the same vitamin or mineral nutrient are present, the amount will be declared as a total under the "Supplemented with" heading. An interpretative statement following the "Supplemented with" heading will be mandatory on supplemented foods to explain that the amounts of supplemental ingredients declared in the SFFt include both naturally occurring and supplemental amounts.
List of cautionary statements and identifier
The addition of certain supplemental ingredients or certain levels of supplemental ingredients triggers a requirement that the label include cautionary statements. The cautionary statements must be in both English and French, must appear clearly separated from other information on the label, and must be shown according to font and type size requirements to ensure legibility of the information.
When a supplemented food is required to carry cautionary statements, it is also required to 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" – see below example for one of many possible formats.
Permitted categories and ingredients
Health Canada has used incorporation by reference to publish lists of permitted supplemented food categories and ingredients.
- "List of Permitted Supplemented Food Categories" captures the specific categories of food to which supplemental ingredients may be added. Certain categories of food are excluded from the category, such as fortified foods and alcoholic beverages.
- "List of Permitted Supplemental Ingredients" captures all of the substances that may be added to a specified food as a supplemental ingredient grouped by vitamins, mineral nutrients, amino acids, and other supplemental ingredients (including caffeine). This list also sets out the detailed conditions of use for each supplemental ingredient, such as maximum levels of use in a product and whether that ingredient triggers the requirement for a cautionary statement and a SFCI .
These lists can be updated by Health Canada and can be modified by stakeholders through a premarket submission process to request any changes, including additions, removals or modifications. This submission must be accompanied by supporting information to demonstrate that the proposed change would be safe for Canadians.
Transition timeline: Jan 1, 2026
As of July 21, 2022, all TMA s for existing supplemented foods on the market will expire. Health Canada will continue to process TMA applications that have already been submitted. Under certain conditions, existing supplemented foods on the market approved under the TMA framework will have until Jan 1, 2026 to become compliant with the new regulations.
Consultation on Declaration of Supplemental Ingredients
On the same day as these regulatory amendments, Health Canada also launched a key consultation on its proposed approach for the compliance of supplemental ingredients declared on the labels of supplemented foods. This consultation is open until Aug 12, 2022.
The consultation proposes compliance criteria for supplemental ingredients declared in the SFFt – which is different from the CFIA's Nutrition Labelling Compliance Test used for conventional foods. This is an important consultation for industry as the outcome will affect the manufacturing, testing and labelling of supplemented foods.
Gowling WLG's Food and Beverage Group is reviewing these new developments closely and there is more to follow. In the meantime, please contact us with any questions or concerns with respect to how these changes may impact your business or how they can be leveraged to bring new products to market in Canada.
The authors would like to thank Priya Szymanski, Summer Law Student, and Victoria Asikis, Associate, for their assistance in publishing this article.