This guidance document is intended for stakeholders, including manufacturers and distributors of foods for sale in Canada, to facilitate the understanding of the Supplemented Foods Regulations, which came into force on July 21, 2022.

The Supplemented Foods Regulations should be read in conjunction with other provisions of the FDR applicable to pre-packaged products as well as the FDA and the documents incorporated by reference into the FDR (List of Permitted Supplemental Ingredients, List of Permitted Supplemented Food Categories, Directory of Supplemented Food Facts Table Formats, and Directory of Supplemented Food Caution Identifier Specifications), listed in Appendix 1. To account for new requirements specific to SFs in the FDR, certain consequential amendments had to be made to existing provisions in the FDR (for example, expanding labelling provisions in Part B, Division 1 applicable to the Nutrition Facts table to include the Supplemented Food Facts table). This document does not elaborate on these consequential amendments. Health Canada’s webpage on Supplemented Foods provides information and resources related to the requirements for SFs.

It is the responsibility of manufacturers and distributors to comply with all applicable legislative and regulatory requirements. In case of a discrepancy between this guidance and the provisions of the FDR or documents incorporated by reference, the regulations and the documents incorporated by reference take precedence.

In this guidance document, “must” is used to express a requirement, that is, a provision of the FDR that the manufacturer or distributor is obliged to satisfy; “should” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of this document.