Health Canada Introduces New Regulations For Supplemented Foods

On July 20, 2022, Health Canada published amendments to the Food and Drug Regulations in the Canada Gazette Part II. The amendments add new regulations for supplemented foods.  Supplemented foods are prepackaged foods containing one or more added ingredients, such as vitamins, minerals, amino acids, or caffeine, and are marketed as providing a specific physiological or health effect. The primary target for these regulations is consumer energy-type beverages, which have been treated inconsistently and, on an ad-hoc basis for many years. The new supplemented foods regulations came into force on July 20, 2022 but have a transition period to January 1, 2026.

The new supplemented food regulations outline specific labelling and compositional requirements for supplemented foods. A summary of these requirements is outlined below.

Permitted Supplemental Food Categories and Supplemental Ingredients

Health Canada published a list of permitted Supplemented Food Categories which specifies the categories of food to which supplemental ingredients may be added, and a list of  Supplemental Ingredients which outlines the permitted supplemental ingredients and the conditions under which a particular supplemental ingredient can be used.

Supplemented Food Facts Table (SFFt)

Supplemented foods must carry a Supplemented Food Facts Table (SFFt) that replaces and contains the same information present on the Nutrition Facts Table. The SFFt must list the name and the absolute amount of each supplemental ingredient, under a “Supplemented with” heading.

Cautionary Statements and Supplemented Food Caution Identifiers

The addition of certain supplemental ingredients or specific quantities of supplemental ingredients triggers a requirement that the label include cautionary statements. The cautionary statements must appear in both English and French. The statements must inform the consumer of any risk associated with the supplemental ingredient(s) in the food.  The cautionary statements must be separated from other information on the label. Supplemented foods that are required to include cautionary statements must also display a Supplemented Food Caution Identifier (SFCI) on the label of the product. The SFCI is a black and white label that notifies the consumer that the product is supplemented.

Prior to these regulations, manufacturers and distributors had to obtain a Temporary Marketing Authorization (TMA) from Health Canada to sell supplemented food. As of July 21, 2022, all TMAs for existing supplemented foods on the market will expire. Supplemented foods on the market approved under the TMA framework will have until January 1, 2026, to comply with the new regulations. 

For questions regarding regulatory law, including questions about the new regulations for supplemented foods, please contact Gordon Jepson.

Summary By: Victoria Di Felice