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ARCHIVED - Notice: Section 2.21 (risk information) of the Consumer Advertising Guidelines for Marketed Health Products

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Contact: RARC-RPCR

March 30, 2007

Further to the posting of the Consumer Advertising Guidelines for Marketed Health Products (for Nonprescription Drugs including Natural Health Products) on the Health Canada website on October 18, 2006, this is to remind you that the requirements of Section 2.21 related to the inclusion of risk information are effective April 1, 2007. Additional discussions occurred between Health Canada, consumer advertising preclearance agencies and industry associations to discuss Section 2.21 of the Guidelines, and more specifically the technical requirement to communicate verbally the general cautionary statement in TV advertisements for products that have known risks. While stakeholders in general, support the view of providing balanced information in nonprescription drug and natural health product advertising, divergent opinions exist as to how this information should be conveyed to consumers (either through the use of a super or a verbal communication).

While Health Canada still recommends that the general cautionary statement in TV advertising be communicated verbally, the use of visual disclosures ("supers") will be permitted as long as the "supers" are clear, visible and of a sufficient duration to be effectively read and understood by consumers. Advertising preclearance agencies will play a key role in the preclearance of advertising material to ensure the prominent disclosure of general cautionary statements, when required.

Therefore, to address these concerns and to ultimately put in place a system that enables consumer awareness about the importance of considering the risk/benefit profile of such products prior to their use, consensus has been reached to initiate a research-based approach to measure baseline levels with regards to population awareness in order to determine the impact of the prominent inclusion of the "general cautionary statement" in health product advertising. Health Canada will be a participant in the research project team. This study will be repeated after a certain period of time to measure progress. Health Canada will use the study results to re-evaluate its position on the need to have the general cautionary statement communicated verbally.

The technical requirement for verbal communication of the risk information described in Section 2.21 of the Guidelines will remain as posted on October 18, 2006. Editorial changes to Section 2.21 as well as any other potential regulatory amendments will be reflected once evaluations are completed. Updates will be communicated to stakeholders in a timely fashion.

All parties will be monitoring the application of Section 2.21 of the Guidelines to achieve the mutual goal of increasing consumer awareness with regard to the safety profile of nonprescription drugs and natural health products. Health Canada will focus its compliance and enforcement activities using an educational approach with respect to the application of this Section during 2007.

Health Canada continues to recommend that the consumer health product industry utilize the services of the advertising preclearance agencies to ensure that advertising materials are in accordance with the federal regulatory requirements. Advertising preclearance agencies and regulatory advertising guidance are available on the Health Canada website.