Health Claims
Drug Representations and Pre-market Approval

This page is part of the Guidance Document Repository (GDR).

Looking for related documents?
Search for related documents in the Guidance Document Repository

When a health claim brings a food under the definition of a "drug" (definition) through the use of a disease risk reduction claim (definition) or a therapeutic claim (definition), a pre-market assessment of the claim, by the Food Directorate of Health Canada, is mandatory. Furthermore, when a health claim makes reference to a Schedule A disease, a premarket review and an amendment to the FDR is required before the use of the claim is permitted. For information on obtaining a pre-market approval, visit Health Canada's Guidance Document for Preparing a Submission for Food Health Claims.

Date modified: