Supplemented foods, which are packaged food products containing one or more added supplemental ingredients such as vitamins, minerals, amino acids, and caffeine now have a distinct set of regulatory requirements. These regulatory requirements can be found in the Health Canada publication found here and are further explained in our Supplemented Foods Education information here.
Between 2012 and July 2022, products containing supplemental ingredients were authorized for sale through Temporary Marketing Authorizations (TMA) under the Food and Drug Regulations (FDR). Prior to 2012, foods containing supplemented ingredients were not permitted for sale under the Food and Drug Regulations (FDR). Instead, they were considered as Natural Health Products (NHPs). In 2011/2012, Health Canada initiated the transition of hundreds of NHPs to the food regulatory framework and issued Temporary Marketing Authorizations Letters (TMAL) for these products with the intention of developing a regulatory framework specific to these products, which granted market access. The TMA framework, though enabling market access, imposed a considerable administrative burden and was regarded as a barrier to innovation.
In 2021, Health Canada proposed the Supplemented Foods regulatory framework, presenting compliance limits for supplemental ingredients that were notably more restrictive compared to products currently available in the market under TMA’s. This proposed framework deviated significantly from initial expectations. It was a significant departure from the previous TMA processes and forced reformulation of products already in the market.
To account for reformulations and new labelling requirements, food products with supplemental ingredients and a valid TMAL as of July 21, 2022, are eligible for transition to the supplemented foods regulatory framework. The transition period to adopt the new labelling requirements ends on January 1, 2026.
Any new Supplemented Food coming onto the market will be required to comply immediately with the new regulations.
Since Health Canada's proposal, CHFA has voiced its concerns about supplemental ingredients that have minimum compliance limits.
Current Advocacy Efforts
- CHFA continues to advocate for a reasonable upper tolerance limit for certain supplemental ingredients found in Part IV of the List of Permitted Supplemental Ingredients. In September 2022, CHFA submitted Feedback on the Consultation for the Compliance of Supplemental Ingredients Declared on the Labels of Supplemented Foods.
- Health Canada will lead an awareness campaign that will be released leading up to the Supplemented Foods label changes coming into force, with specific attention to at risk populations such as pregnant/breastfeeding women and youth. CHFA will be an active participant throughout this consultation. On May 18, 2023, CHFA submitted Feedback on the Strategy for Awareness on Supplemented Food Labelling.