Supplemented foods are everywhere: caffeinated energy drinks, snack bars with added vitamins, and hydrating drinks with added minerals, all fall into this category. To date, however no regulatory framework for supplemented foods exists in Canada. On June 25, 2021, Health Canada published a proposal for the creation of a comprehensive regulatory framework for supplemented foods. Through an amendment to the Food and Drug Regulations (“FDRs”), the proposed framework would establish detailed requirements for the use of supplemental ingredients in food.
The Temporary Marketing Authorizations Regime
As defined by Health Canada, supplemented foods include “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.”
Since 2012, Health Canada has been authorizing the sale of supplemented food products only on a case-by-case basis by issuing Temporary Marketing Authorizations (“TMAs”). Under the TMAs regime, a manufacturer or distributer who wishes to sell a food product containing supplemental ingredients must apply for an authorization to Health Canada and demonstrate the safety of the product. If an authorization is granted, it is valid for a specified period of time and provides the conditions under which the supplemented food can be sold, e.g. manufacturers and/or distributers must regularly provide research, sales data, and incident reports on their product to Health Canada.
Over time, concerns developed with the regime’s negative impact on innovation in the industry and the significant administrative burden it places upon applicants.
The Proposed Amendments
As a long-term solution, Health Canada therefore developed a proposal for the integration of a regulatory framework for supplemented foods into the FDRs. The proposed amendments are aimed at providing a predictable regulatory environment while simultaneously ensuring that the health and safety of Canadians are adequately protected.
Below we highlight some of the key proposed amendments:
- Lists of Permitted Foods & Ingredients
To begin, the proposed amendments are to be accompanied by the incorporation of several documents into the FDRs. These notably include the List of Permitted Supplemented Food Categories, which will detail the foods that can contain supplemental ingredients, and the List of Permitted Supplemental Ingredients, which will enumerate the permitted supplemental ingredients and the conditions under which a particular supplemental ingredient can be used.
Note however that some specific food categories would be prohibited from ever being added to the List of Permitted Supplemented Food Categories due to the high risk that they pose to health and safety, e.g.: alcohol beverages, fortified foods, products intended for consumption by infants or women who are breastfeeding or pregnant, some special dietary products, unprocessed or minimally processed foods.
To ensure that innovation is not impeded, the proposed amendments include a submission process through which changes to the lists may be requested. Through this process, it would be possible to add new supplemental ingredients or new food categories as well as to remove or modify the conditions of use associated with a particular ingredient. A request for a change to either list would have to describe the reason for the request and provide supporting information demonstrating that the change would be safe.
The proposal also details the applicable labelling requirements for supplemented foods. The current requirements in relation to the labelling of prepackaged foods would generally apply because supplemented foods are a subcategory of prepackaged foods. In addition, the amendments propose certain additional labelling requirements, including, e.g. that the list of ingredients appearing on the product’s label would have to detail all supplemental ingredients.
The proposed amendments would further impose the display of a standardized Supplemented Food Facts table (SFFt) on the label of any supplemented food product with the exception of those sold in small packages. In particular, a SFFt would have to list the name and absolute amount of each supplemental ingredient, including any vitamin or mineral, under a “Supplemented with” heading.
Cautionary Statements and Supplemented Food Caution Identifiers
The addition of certain supplemental ingredients or specific quantities of such ingredients would trigger a further requirement: the presence of a cautionary statement on the product label designed to alert consumers and ensure that they make informed and safe choices. For example, supplemented foods containing high caffeine levels would need to carry a cautionary statement directed at children under 14 years of age and women who are breastfeeding or pregnant. Similarly, all caffeine energy drinks will need to specifically indicate that consumers should not mix them with alcohol.
These products would also need carry a Supplemented food caution identifier (“SFCI”) :
According to the proposal, a SFCI must be a prominently placed. It is a visual cue inviting consumers to refer to the cautionary statements in order to determine whether consuming the product in question is safe given their particular circumstances.
The FDRs impose restrictions on the claims that can be made on food product labels. In addition to these general representation requirements, the proposed amendments would add further restrictions for supplemented foods. For instance, no claims about the supplemental ingredient that triggered a cautionary statement could appear on the product label. Additionally, supplemented foods with a high caffeine content statement would be prohibited from displaying representations regarding the vitamins or minerals in the product, hydration, electrolyte replacement, and physical performance.
Transition and Implementation
In order to ensure a smooth transition from the TMAs regime to the new regulatory framework, the proposed amendments would allow supplemented foods having TMAs to remain on the market for three years following the coming into force of the amendments. All approved authorization requests would be enumerated in a List of Foods Having Received Temporary Marketing Authorization Letters. In addition, all applications filed prior to the adoption of the proposed amendments would benefit from this transition period. Yet, such products would nonetheless have to comply with the conditions set out in their respective TMAs.
The proposed amendments to the FDRs are presently open for consultation until August 25, 2021. Fasken’s food and beverage team would be pleased to advise on submissions during the consultation.
Special thanks to Paolina Tosheva for her contributions to this article.