Notice of intent to extend the transition for certain labelling provisions of the Supplementary Rules Respecting Nicotine Replacement Therapies Order: SOR/2024-169

Notice is hereby given that Health Canada intends to amend certain transition provisions under the Supplementary Rules Respecting Nicotine Replacement Therapies Order (the Order) - related to packaging and labelling requirements. Health Canada is proposing to extend the transition of the nicotine addiction warning statement, and provisions regarding flavour names on the label, so that industry will have more time to produce compliant labels for marketed nicotine replacement therapies (NRTs).

The Order includes a transition period of six months, ending on February 28, 2025, for NRT manufacturers to comply with the packaging and labelling provisions. Further, an additional sell-through provision was set out for NRTs that were labelled or both imported and labelled before the Order’s coming into force. However, industry feedback has shown that manufacturers require additional time to ensure sufficient supply of compliant products at the end of the transition period.

This Notice is to inform the public of the measures to address the lack of NRTs with compliant labels. These measures are being implemented to prevent a lack of supply of compliant-labelled NRTs so that smoking cessation products are available for adults wishing to quit smoking. It is important that Canadians have access to smoking cessation products and that those products are safe and effective.

The Minister of Health intends to make targeted regulatory changes that would provide more time for all manufacturers to come into compliance with specific packaging and labelling requirements. This will help ensure the availability of products for those that need to access them as a smoking cessation aid.

Key provisions, such as the transition period of the advertising and promotion requirements and packaging and labelling requirements focused on statements or graphic design elements, including brand elements that appeal to youth, will not be impacted. The prohibition on direct public access (i.e., by self-selection) to NRTs that have a limited history of appropriate use in Canada (i.e., new and emerging dosage forms) will also be maintained. As such, the measures to mitigate youth appeal of NRTs will be largely unaffected.

Background

The Order was published on August 28, 2024 with the objectives to: mitigate the risk of harm to health associated with the unintended use of NRTs by young people and those who are not using such products for smoking cessation; contribute to the prevention of nicotine exposure and dependence among young people through measures that reduce access and appeal of these products: and avoid creating significant barriers for the access to safe and effective treatments by adults trying to quit smoking.

Some of the new rules set out in the Order, such as packaging and labelling requirements, impact all NRTs on the market (except for transdermal patches to which the Order does not apply). For example, all NRTs subject to the Order require label changes to include a nicotine warning statement in accordance with the Order.  

Proposed approach

Health Canada intends to extend the transition for certain packaging and labelling provisions by an additional 6 months. This measure intends to ensure a sufficient supply of NRTs for adults who want to quit smoking, while continuing to move forward on labelling requirements for these products that impact youth appeal. The department will consult with industry and health stakeholders before amending the Ministerial Order.