ARCHIVED - Interim Guidance Document - Preparing a Submission for Foods with Health Claims: Incorporating Standards of Evidence for Evaluating Foods with Health Claims


This interim guidance document has been replaced by the Guidance Document for Preparing a Submission for Food Health Claims (March 2009).


The purpose of this document is to provide guidance with respect to the principles and criteria by which health claims for foods offered or advertised for sale in Canada will be evaluated and details on the types of information to be submitted for health claim approvals.

In June 2000, Health Canada published a consultation document on Standards of Evidence for Evaluating Foods with Health Claims (PDF Version). The document outlined a proposal for ensuring that foods bearing health claims are supported by appropriate evidence with respect to product safety and claim validity, as well as quality assurance of the product and of the procedures and methods for testing the product.

No alternative suggestions to the proposal outlined in the June 2000 document were provided by respondents. Therefore, no major changes to the fundamental aspects of the standards proposed in June 2000 are being made in this document.

Since the June 2000 publication of the proposed standards for evaluating foods with health claims, proposals on two approaches to regulating health claims on foods have been published. Briefly, the two approaches are: generic authorization and product-specific authorization.

To ensure the usefulness and clarity of the Interim Guidance Document, we welcome questions and comments that would help us identify specific aspects of this document that require elaboration and clarification. These comments may be sent to:

Project Coordinator,
Standards of Evidence for Foods with Health Claims
Nutrition Evaluation Division
Health Canada
Banting Research Centre, Ross Ave., PL 2203A
Ottawa, Ontario K1A 0L2

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