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Health claims on food labels
Drug representations and pre-market approval

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, may be required.

Schedule A disease claims

Section 3 of the Food and Drugs Act (FDA), prohibits the sale of a food that is labelled or advertised to the general public as a treatment, preventative or cure for any of the diseases referred to in Schedule A, unless exempted within the Food and Drug Regulations (FDR).

Health Canada has authorized the use of some disease risk reduction claims through specific regulatory exemptions in the FDR (see the Table of Disease Risk Reduction Claims). This was made possible with section B.01.601 of the FDR, which exempts certain foods bearing specified disease risk reduction claims from the provisions of subsections 3(1) and 3(2) of the FDA.

In addition, B.01.601 of the FDR also maintains the food status of foods labelled with these disease risk reduction claims, by exempting them from the provisions of the FDA and FDR applicable to drugs.

The permitted disease risk reduction claims are based on sound scientific evidence that has established a relationship between certain elements of healthy diets and the reduction of the risk of developing certain diseases.

When a health claim makes reference to a Schedule A disease, a pre-market assessment of the claim by Health Canada's Food Directorate is mandatory 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.

Note: Disease risk reduction claims are not permitted on foods represented for use in very low energy diets nor are they permitted on foods that are intended solely to be consumed by children under two years of age [B.01.601(1)(c)(i), FDR].

Drug claims not listed in Schedule A

Drug claims about diseases or health conditions not listed in Schedule A are subject to the same level of standards of evidence as claims about Schedule A diseases or conditions; however, pre-market assessment of the claim is voluntary.

Health claims that have been voluntarily submitted and accepted by Health Canada's Food Directorate will be added to the list of accepted claims and may be used on all food products meeting the conditions of use for that claim. A summary of health claim assessments is published on their website for claims that have already been reviewed.

Each document contains the information concerning the scientific evidence evaluated, and also mentions:

  • Health claim statements that may be made
  • Conditions for the food to carry the claim
  • Conditions for the label and advertisement

The CFIA uses these documents and the information contained therein in order to verify the compliance of the claims used on products.

Claims that have not been reviewed must be able to disclose evidence supporting these claims upon request by the CFIA.

For information on submitting a pre-market assessment, visit Health Canada's Guidance Document for Preparing a Submission for Food Health Claims.

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