Section 2.21 of the Health Canada Advertising Guidelines is in effect as of April 1, 2007

Effective April 1, 2007, Section 2.21 “Risk/Safety Information Communication” of the Health Canada Guidance Document: Consumer Advertising Guidelines for Marketed Health Products for Nonprescription Drugs including Natural Health Products (Advertising Guidelines) is in effect.

  1. What does this mean to nonprescription drug and natural health product advertisers?
    Nonprescription drug and natural health product advertisers are required to include specific additional information in their advertising.


  2. Do these new Health Canada requirements apply to all nonprescription drug and natural health product advertising?
    No. Products without specific directions for use or label instructions and, that have no known risks are exempt from this requirement (e.g. SPF lip balms, toothpastes, antiperspirants etc.).


  3. 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
    235 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:
    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.


  4. How must the required information be communicated in the various media?
    1. 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
    2. Radio: In a clear, distinct and understandable manner
    3. Television:
      • Audio: In a clear, distinct and understandable manner,
        and/or
      • Video Super: Type size, font, contrast and copy placement that are sufficiently prominent, and on screen for sufficient duration for an average consumer to read and comprehend

  5. Am I required to use prescribed language to meet Health Canada requirements?
    No. There is no prescribed language, as long as the required information is clearly communicated. Statements will be evaluated in a case-by-case basis to ensure that the requirements are met. The following are examples of statements that would be evaluated to meet the Health Canada requirements.

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

  6. By when must I comply with the new requirement?
    1. Starting April 1, 2007, all advertisements submitted for Clearance, including resubmissions and renewals, must include this information
    2. All advertising is expected to be in compliance with these requirements by March 31, 2008.