Supplemented Foods

On July 21, 2022, a new set of regulations came into force for Supplemented Food products. These regulations aim to replace the previous application process used to permit the sale of supplemented foods in Canada. Manufacturers are responsible for ensuring compliance with the new regulations prior to the product’s sale.

• Previous Requirements

  Supplemented Foods were subject to market authorization on a case-by-case basis, where a Temporary Market Authorization (TMA) was required to sell the product in Canada. This process was established to provide ensure safe consumer consumption and to provide regulations for foods outside of the Food and Drug Regulations’ scope.

• New Requirements

  Supplemented Foods, supplemented with ingredients pre-approved by Health Canada under the new regulations, do not require a Temporary Market Authorization (TMA).

  Manufacturers and distributors must ensure that the products entering the market are compliant with the new set of regulations, including compliance with the following;

  • product labelling (including Supplemented Foods Facts table)

  • required cautionary statements and directions of use

  • conditions of ingredient use (approved daily amounts and amounts per serving)

  • front of packaging identifier requirements

  For foods supplemented with ingredients not outlined in the new regulations, manufacturers or distributors can submit a request to review the food and its additives.

• Timeline

  For supplemented foods with a valid TMA: Manufacturers or distributors, with a valid Temporary Market Authorization for the supplemented food, have until December 31st, 2025 to comply with the new requirements.

  For supplemented foods with an expired TMA: Manufacturers or distributors can continue selling their supplemented foods and have until December 31st, 2025 to ensure compliance with the new regulations.

  For supplemented foods entering the market after the release of the new regulations: Manufacturers or distributors must ensure that the supplemented foods are compliant with the published requirements and use proper labelling.