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ASC Clearance Services Drug Complaint Procedure re Therapeutic Claims

Pursuant to the Health Canada (HC) Guidance Document Health Canada and Advertising Preclearance Agencies' Roles Related to Health Product Advertising, a consumer, competitor, health professional or any other organization or person concerned with health-related matters, may file a complaint with ASC Clearance Services about a consumer-directed advertisement for a natural health product or a nonprescription drug as seen, read or heard in a Canadian advertising medium1. The complaint should be based on an alleged violation of the Food and Drugs Act, Regulations, Natural Health Products Regulations or other relevant HC or ASC policies and guidelines.

Procedure Summary:

1. The complainant sends a written complaint to ASC's Clearance Services.

  1. 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.
  2. In the case of all other advertising, the complainant should send, together with the written complaint, a copy of the advertisement in question, or a hyperlink, if the advertisement is on the internet.
  3. In the case of complaints from competitors, health professionals or organizations, the written complaint must be signed by the health professional or by the CEO or a senior officer of the entity lodging the complaint.
  4. In the case of complaints lodged by an individual or organization acting not exclusively as a principal on their own behalf but rather jointly with or exclusively on behalf of another individual or organization, the written complaint must be signed by the individual or senior officer of the organization lodging the complaint and be accompanied by an attestation, using ASC’s prescribed form, that the written complaint has been authorized by such other individual who (or organization which) must also be clearly identified in the complaint when lodged with ASC’s Clearance Services.
  5. All other complaints must be personally signed by the consumer or other individual.

2. ASC Clearance Services will determine:

  1. whether the advertisement has been previously approved by ASC2; and
  2. whether there is merit to the complaint

3. For complaints that are not accepted, ASC Clearance Services will write to the complainant to explain why the complaint was not accepted.

4. For complaints that are accepted, ASC Clearance Services will advise the complainant that the complaint has been accepted and take the following next steps:

  1. ASC Clearance Services will, in writing, 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 ASC Clearance Services notification to the representative is more appropriate) that a complaint has been received.
    1. For complaints lodged by any entity or individual other than a consumer, ASC Clearance Services will provide to 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 or account the complaint was lodged [see paragraph 1. Above].
    2. For complaints lodged by consumers, ASC Clearance Services will provide to the defendant advertiser a copy of the complaint without disclosing the identity of the complainant, unless the complainant has given express permission to disclose his or her identity.
  2. In its notification, ASC Clearance Services will detail the elements of the advertisement that appear not to be in compliance with the Food and Drugs Act, Regulations, Natural Health Products Regulations and other relevant HC or ASC policies and guidelines.
  3. ASC Clearance Services will request that the defendant advertiser (or its representative):
    1. immediately cease distributing, or publicizing, or allowing to be publicized, the advertisement in question until it is brought into compliance; and
    2. confirm in writing within two weeks that the requested action has been undertaken.
  4. ASC Clearance Services will inform the defendant advertiser (or its representative):
    1. that if no reply, or a negative response, is received within the two weeks referenced in 4 c.ii. above, ASC Clearance Services will conclude that ASC is unable to adjudicate the complaint and for that reason will, without delay, forward the complaint to HC for its consideration and action, in accordance with established HC procedures;
    2. when, pursuant to 4 d)(i) above, the complaint was forwarded to HC.

5. The defendant advertiser (or its representative) may:

  1. choose to comply with ASC Clearance Services' request for corrective action;
  2. negotiate and implement an alternative corrective action acceptable to ASC Clearance Services; or
  3. request that the complaint be redirected to HC for its sole consideration and adjudication.

6. ASC Clearance Services will communicate the outcome to the complainant.

ASC Clearance Services Drug Complaints Procedure
Revised July, 2017

1. HC remains exclusively responsible for dealing with complaints about advertisements for non-NPN/non-DIN products that include therapeutic claims, as per the HC Guidance Document. Please note that complaints involving health and safety issues are forwarded directly to HC.
2. Under this procedure, ASC only accepts complaints about advertisements that were not previously approved by ASC Clearance Services. Complaints about advertising previously approved by ASC Clearance Services must proceed, if at all, under ASC’s Trade Dispute Procedure.