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Clearance Services Health Product Competitive Complaint Procedure Regarding Therapeutic Claims
Updated: January 2024
Health Canada Consumer Complaint Procedure
Health Canada (HC) has developed a proactive monitoring program for the advertising of health products. A consumer, health professional, or any other organization or person concerned with health-related matters, may file a complaint directly with HC about an advertisement for a natural health product, a non-prescription drug, a medical device, a veterinary health product, a prescription drug, a biologic or biosimilar as well as any opioids or other controlled substances as seen, read or heard in a Canadian advertising medium. The Health Canada document Stop Illegal Marketing of Drugs outlines their process for submitting a complaint.
Ad Standards Competitive Complaint Procedure Summary
While HC adjudicates consumer and special-interest group complaints regarding therapeutic claims in health product advertising, Ad Standards continues to offer a competitive complaint process for non-prescription drug and natural health product advertisements that competitors believe to be not in compliance with the Food and Drugs Act, Food and Drug Regulations, Natural Health Products Regulations or other relevant HC or Ad Standards policies and guidelines. Note that this process is only available to competitors. Any consumer or special interest group must direct their complaints to HC as described above.
1. To raise a concern with an advertisement, a competitor can send a written complaint addressed to the Director, Clearance Services (Health Products Section).
In the case of broadcast advertising, the complainant should describe the advertisement, identify the advertised product and provide the date, time and station on which the advertising was seen or heard.
In the case of advertising in all other media, the complainant should send, together with the written complaint, a copy of the advertisement in question, or a hyperlink, if the advertisement is online.
Complaints must explain the basis under which the complainant alleges a violation of the regulatory framework. Please note that the written complaint must be signed by the CEO or a senior officer of the entity lodging the complaint. Where the complaint is lodged by an individual or an organization on behalf of the competitor, the written complaint must be signed by the individual or senior officer of the organization lodging the complaint and be accompanied by an attestation that the complaint has been authorized by such other individual/organization who/which is the competitor and that competitor must be clearly identified in the complaint.
2. Upon receipt of a complaint, Ad Standards Clearance Services will determine whether the advertisement has been previously approved by Ad Standards.
Under this competitive complaint procedure, Ad Standards only accepts complaints about advertisements that were not previously approved by Ad Standards Clearance Services. Complaints by a competitor about advertising previously approved by Ad Standards Clearance Services may only be raised in relation to a potential violation of the Canadian Code of Advertising Standards and must proceed under Ad Standards Advertiser Dispute Procedure.
Where the advertisement has not been previously approved by Ad Standards, Ad Standards Clearance Services will determine whether the complaint raised has merit and is therefore upheld.
3. When complaints are upheld, the following steps will be taken:
a) Ad Standards Clearance Services will notify the defendant advertiser (or its Canadian representative, such as the manufacturer under license, distributor, or importer of the advertised product, if in the opinion of Ad Standards Clearance Services, notification to the representative is more appropriate) in writing that a complaint has been received and upheld by Ad Standards. Ad Standards Clearance Services will provide the defendant advertiser a copy of the complaint, including the identity of the complainant and, where applicable, the identity of the principal on whose behalf the complaint was lodged.
b) In its notification, Ad Standards Clearance Services will detail the element(s) of the advertisement that it has determined is/are not in compliance with the Food and Drugs Act, Food and Drug Regulations, Natural Health Products Regulations, or other relevant HC or Ad Standards policies and guidelines.
c) Ad Standards Clearance Services will request that the defendant advertiser (or its representative):
- immediately cease distributing, or publicizing, or allowing to be publicized, the advertisement in question until it is brought into compliance; and
- confirm in writing within two weeks that the requested action has been undertaken.
4. The defendant advertiser (or its representative) may:
a) choose to comply with Ad Standards Clearance Services' request for corrective action;
b) implement an alternative corrective action acceptable to Ad Standards Clearance Services; or
c) request that the complaint be redirected to HC for its sole consideration and adjudication.
5. If no reply is received from the defendant advertiser (or its representative) within the two weeks referenced in paragraph 3 above or if the defendant advertiser (or its representative) refuses to comply with Ad Standards’ determination, Ad Standards Clearance Services will conclude that Ad Standards is unable to adjudicate the complaint and will, without delay, forward the complaint to HC for its consideration and action, in accordance with established HC procedures. Ad Standards will notify the defendant advertiser (or its representative) of such action.
6. Regardless of the outcome, Ad Standards will inform the complainant in writing of its decision.
Ad Standards Clearance Services Drug Complaints Procedure
Revised January 2024