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Approval of Advertising Materials for Exempt Natural Health Products

In July 2004, Advertising Standards Canada’s (ASC) mandate was extended to include the preclearance of consumer-directed advertising of natural health products (NHPs). Until recently, NHPs were prohibited from sale until they had been granted a Product Licence (PL) by the Natural Health Product’s Directorate (NHPD). ASC’s preclearance review is based on a product’s terms of market authorization (TMA) which in the case of NHPs is the PL.

On August 4, 2010 the Natural Health Products (Unprocessed Product Licence Application) Regulations (UPLAR) came into force. UPLAR allows for NHPs to obtain exemptions from Section 4(1) of the Natural Health Product Regulations (NHPR), against the sale of the NHP without a PL. Based on this change in the NHPR, ASC Clearance Services is accepting for review, advertising for NHPs that have received an Exemption Number from (NHPD). As per Health Canada’s Annex to the Natural Health Products Compliance and Enforcement Policy for Exempt NHPs under UPLAR, the product licence application (PLA) form submitted to Health Canada will be accepted as a temporary Terms of Market Authorization. Thus all claims made within an advertisement must be consistent with the information submitted in the PLA form. ASC’s approval number will be granted on condition that the PLA form submitted to ASC is identical to the PLA form for which an EN was granted by NHPD.

Clearance Process
  1. Submit the following to ASC:
    • Advertising copy and visuals;
    • Completed ASC Clearance Submission Form;
    • Copy of the Product Licence Application;
    • Natural Health Product Exemption Number;
    • Written attestation from the advertiser confirming that the PLA form submitted to ASC is identical to the PLA form for which the EN was granted by NHPD.
  2. ASC’s approval will be valid for twelve months. Renewals will be available at no charge.
  3. ASC’s approval number and the approved Exempt Natural Health Product advertising will be withdrawn prior to Expiry Date if and when:
    • Exempt Natural Health Product is granted a Product Licence by NHPD
    • Exempt Natural Health Product is refused a Product Licence by NHPD
    • Product Licence Application is withdrawn
  4. ASC will provide a copy of the approved advertising to Health Canada as is requested in Health Canada’s Position Statement on the Preclearance and Complaint Adjudication of Exempted Natural Health Product Advertising Materials.

As always, ASC reserves the right to immediately withdraw its acceptance of an advertisement upon the advice of Health Canada or any other Canadian regulatory authority.