Proposed New Regulatory Framework for Supplemented Foods in Canada

• Prepackaged foods marketed in Canada as providing specific physiological or health effects, based on containing one or more added supplemental ingredients, e.g., vitamins, minerals, amino acids, caffeine, and herbal ingredients, are called “supplemented foods.”  Supplemented foods, including beverages with added minerals, caffeinated energy drinks, and snack bars with added vitamins, differ from fortified foods in that fortification involves adding nutrients like vitamin D for an established public health purpose (e.g., preventing rickets in children).  As Canada’s Food and Drug Regulations (FDR) currently have no specific provisions for supplemented foods, Health Canada, beginning in 2012, has issued temporary marketing authorization (TMA) letters for supplemented foods following case-by-case safety assessments.  TMA holders are required to generate and submit information on their products.

• On June 25, 2021, Health Canada announced the pending publication of proposed amendments to the FDR that would create a regulatory framework for supplemented foods that resembles a similar approach used in New Zealand.  A supplemental ingredient included in a newly created List of Permitted Supplemental Ingredients would be exempt from the prohibition under Canada’s Food and Drugs Act (FDA) on the sale of food that contains poisonous or harmful substances or that are adulterated, provided the supplemental ingredient is added according to the conditions set out in a new List of Permitted Supplemented Food Categories, including the use of a cautionary statement on the label of the product in some cases.  When a supplemented food is required to be labelled with a list of cautionary statements, the proposed regulations would also require the product to carry a supplemented food caution identifier (SFCI) on the label.  The new regulatory framework for supplemented foods would eliminate the reporting requirements that are currently required under the TMA process.  Other proposed amendments to the FDR include:

  • A submission process for requesting changes to the List of Permitted Supplemented Food Categories or the List of Permitted Supplemental Ingredients;

  • A Supplemented Food Facts table (SFFt) that would replace the Nutrition Facts table (NFt) on the label of prepackaged products;

  • New provisions allowing the use of supplemental ingredients in standardized foods under the proscribed conditions of use when the standard would not otherwise permit such use;

  • Clarification that when a supplemented food is used as an ingredient in the manufacturing of another supplemented food, the supplemental ingredient in the first food is also a supplemental ingredient in the second food and subject to the same conditions of use in the List of Permitted Supplemental Ingredients;

  • A prohibition on the sale of a prepackaged product containing an assortment of supplemented foods and regular foods of the same type;

  • An exclusion of certain food categories from ever being supplemented foods due to the higher level of risk associated with them, or because they are subject to other regulatory provisions in the FDR;

  • Different or additional labelling requirements in some cases to help consumers distinguish supplemented foods from regular food, better understand their associated risks, and make more informed decisions related to consuming these supplemented foods; and

  • Controversial proposed restrictions on representations for supplemental ingredients that trigger cautionary statements which could potentially limit industry’s ability to communicate the intended benefit of the supplemental ingredient being added to a product and the physiological function it provides to consumers.

• Existing supplemented foods on the market with TMAs would be provided a transition period of 3 years to come into compliance with the proposed regulations once they come into force.  Additionally, Health Canada would continue to accept TMA applications up until the coming into force date of the new regulations and would continue to process these applications following the coming into force date.  Comments on the proposed new regulations for supplemented food are due by August 25, 2021.