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ASC Application of Section 2.21 of the Health Canada Advertising Guidelines (Risk/Safety Information Communication)

Section 2.21 of Health Canada’s Guidance Document: Consumer Advertising Guidelines for Marketed Health Products for Nonprescription Drugs including Natural Health Products (Advertising Guidelines) requires risk communication in advertising of products in these categories.

  1. What does this mean to nonprescription drug and natural health product advertisers?
    Nonprescription drug and natural health product advertisers are required to include risk communication information in advertising, except for those products without specific directions for use or label instructions, and that have no known risks, e.g. SPF lip balms, toothpastes, antiperspirants.

  2. What kinds of products are subject to the requirement?
    Product Requirement in Advertising
    (see #5 for acceptable wording)
    Example
    Products with specific directions for use/label instructions Statement re Label Vitamin C
    Always read and follow the label
    Products for which some risks have been identified

    i) With up-to-date label




    ii) Without up-to-date label



    i) General Cautionary Statement plus
    Statement re Label


    ii) General Cautionary Statement
    plus
    Statement re Label
    plus
    Source of additional info (e.g. website, 1-800 #)
    Cold medicine


    i) With up-to-date label:
    This product may not be right for you. Always read and follow the label.


    ii) Without up-to-date label:
    Without up-to-date label: This product may not be right for you. Always read and follow the label. For more information visit www.coldmedicine.com.
    See Section 2.21 of the Guidelines, pages 29-30, for requirements in cases where a safety advisory has been issued.

  3. Must specific language be used for risk statements?

    No. Health Canada does not prescribe language, but the required information must be clearly communicated. ASC evaluates each statement within the context of the advertising to ensure the requirements are met.

    The following are examples of statements that generally would be evaluated to meet the Health Canada requirements.

    General Cautionary Statements:
    • This product may not be suitable/appropriate/right for you
    • Not suitable/appropriate for everyone
    Statements re Label:
    • Always read and follow the label
    • Read the label and follow directions of use
    Combined statements:
    • This product may not be suitable/right for you, please read and follow the label
    • To be sure this product is suitable/right for you always read and follow the label

  4. How must the required information be communicated in the various media?
    • Print/Out of Home/Web, etc.: Type size, font, contrast and copy placement that are sufficiently prominent for an average consumer to read and comprehend
    • Radio: In a clear, distinct and understandable manner
    • Television:
      - Audio: In a clear, distinct and understandable manner,
      and/or
      - Video Super: (see #5 below for specific requirements)

  5. What are the technical requirements for communicating risk information using video supers in television commercials for nonprescription drugs and natural health products?
    Parameter Technical Requirement
    Size In a standard definition image, the type should be a minimum of 14 scan lines.
    Duration Onscreen for a minimum of 3.5 seconds.
    Contrast The type should either be a light colour over a predominantly dark background or a dark colour over a predominantly light background. Opacity should be set at 100% and the kerning set at 0. A drop shadow could also be used to aid legibility.
    Font A sans serif font should be used for maximum legibility.