Over the last few months, the Canadian Food Inspection Agency and the Food Directorate at Health Canada have taken a fundamental shift in their approach to permitted claims for food products. Previously, they had taken the position that foods could only make claims that had been specifically approved under the Food and Drug Regulations (the “Regulations”). They have now recognized that there is nothing in the Regulations that requires this. Under the new approach, food products are permitted to make health claims that are true and not false or misleading, with the exception of claims directly related to Schedule A diseases as set out in the Regulations.
As this is a recent development, we are not aware of any enforcement activity under the new approach. Food Directorate has not stated what standard of evidence will be necessary to support health claims on foods when they are challenged, but it is likely that they will apply the same standard as was previously required for pre-approval of food health claims. This standard is set out in the Guidance Document for Preparing a Submission for Food Health Claims and uses the guiding principles of: systemic approach, transparency, comprehensiveness, human evidence, high level of certainty, demonstration of causality, biological relevance, and feasibility of effective dose consumption.
Note this is a change in interpretation/approach to enforcement, not a regulatory change. It came about through the need to accommodate the transition of food-like natural health products (NHP) from NHP category to Food category through a Temporary Marketing Authorization process. Dr. Samuel Godefroy, Director General of the Food Directorate, identified the need for a re-evaluation of the food health claims approach at the CHFA West Conference & Trade Show in April 2012. The NHP-food transition, including the newly developed approach to food health claims, was also recently discussed at the IFT Food Policy Impact event in Washington, DC. Videos from that event are available at the links below: