Drug Representations and Pre-market Approval
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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.
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