Health Canada's Position Statement on the Preclearance and Complaint Adjudication of Exempted Natural Health Product Advertising Materials
: On February 4, 2013, the temporary Natural Health Products (Unprocessed Product Licence Application) Regulations (NHP-UPLAR) have been repealed as planned. A Notice on the impact of the repeal of NHP-UPLAR on advertising will also be issued. Further information on the repealing of NHP-UPLAR can be found in the Frequently Asked Questions (FAQs).
Issued: September 30, 2010
File number: 10-117136-439
This statement applies to advertising of natural health products (NHPs) for which an exemption number (EN) has been issued by Health Canada under the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR). This position statement will be in effect strictly for the duration of the NHP-UPLAR and will be annulled once the NHP-UPLAR are repealed.
The NHP-UPLAR provide a temporary solution for certain NHPs for which a complete product licence application has been submitted, a submission number has been issued, and after 180 days are still awaiting a final product licensing decision (product licence or refusal). NHPs for which an EN has been issued are exempted from the current prohibition against sale without a product licence (as set out in section 4 of the Natural Health Products Regulations (NHPR)); they are therefore legal for sale. Health Canada will continue to fully assess each exempted product, resulting in either the issuance of a product licence in the form of a natural product number (NPN) or a homeopathic medicine number (DIN-HM) or a refusal. The NHP-UPLAR will be repealed 30 months after coming into force (as set out in section 8 of the NHP-UPLAR). For further information, visit the Natural Health Products Exempted Products Web page.
The advertising preclearance agencies (APAs) review and preclear advertising material to help industry ensure compliance with the regulatory provisions of the Food and Drugs Act (F&DA) and associated Regulations, and the various Health Canada guidance documents and APA codes of advertising.
The agencies also offer independent mechanisms to adjudicate complaints on advertising for authorized health products. These agencies use the terms of market authorization (TMA) of marketed health products (the product licence in the case of an NHP) as a fundamental tool for the review of advertising.
Health Canada's Position Statement on the Preclearance and Complaint Adjudication of Exempted NHP Advertising Materials:
Advertising preclearance agencies, in accordance with their established procedures, will perform the preclearance and complaint adjudication of advertising materials pertaining to exempted NHPs. In lieu of the product licence, the product licence application (PLA) form submitted to Health Canada will temporarily serve as the TMA.
In order to allow APAs to verify compliance of an advertisement with the PLA form, the exemption number holder (EN-holder) should provide the APA with a copy of the product's PLA form submitted to the Natural Health Products Directorate (NHPD) for which the EN was granted. APAs are expected to verify the consistency of advertising claims with the content of the PLA. APAs are not expected to review the scientific evidence included in the PLA. Advertising of a product in a manner consistent with that product's PLA, absent other factors, would not generally be false or misleading or likely to create an erroneous impression with respect to its character, value, quantity, composition, merit or safety.
APAs will also provide Health Canada with copies of advertising materials they have reviewed, to keep Health Canada aware of the trends in the advertising of exempt NHPs such that further guidance can be developed as warranted.
EN-holders whose product is the subject of a complaint will be requested to provide the APA with a copy of the PLA form submitted to the NHPD for which the EN was granted.
During the review of advertising or adjudication of complaints, should there be an unwillingness to comply, or a potential risk to health or non-compliance with the F&DA and/or associated Regulations, including a potential contravention of section 9(1) of the F&DA regarding false or misleading claims, these matters should be referred to Health Canada by the APAs, as per established procedures.
Health Canada's Involvement
Any matter referred to Health Canada will be reviewed in accordance with Health Canada's policies and procedures. Activities that are found to pose a risk to health and/or are in contravention of the F&DA and associated Regulations may be subject to compliance and enforcement actions. Follow up activities are prioritized based on the risk to health that the product may pose on the general public. Further information can be found in the NHP Compliance & Enforcement Policy (POL-0044) and the accompanying Annex to the NHP Compliance & Enforcement Policy for Exempt NHPs (POL-0093) in the Natural Health Products Compliance and Enforcement section of the Health Canada Web site.
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