Health Canada 2024 Changes for Nicotine Replacement Therapies (NRT)
On August 22, 2024, the Honourable Mark Holland, Minister of Health, announced new measures aimed at preventing youth from being harmed by nicotine replacement therapies (NRTs). The following outlines the recent updates from Health Canada concerning NRTs.
There is increasing concern that NRTs, particularly newer formats like nicotine pouches, are being used recreationally by youth under 18. To address these concerns, Health Canada has introduced new regulatory measures. Businesses involved with NRTs must comply with these updated requirements.
What Are the New Measures?
The Ministerial Order introduces the following changes:
- Prohibition on Advertising: Any advertising or promotion that could appeal to youth is now prohibited.
- Pharmacist Supervision: New and emerging NRTs can only be sold by pharmacists or under their supervision.
- Flavor Restrictions: Flavors other than mint or menthol are prohibited for new and emerging NRTs.
- Mandatory Warnings: Clear nicotine addiction warnings and indications of intended use as a smoking cessation aid are required.
- Label and Packaging Review: Manufacturers must submit label and package mock-ups for Health Canada’s review.
Implications for Your Business
Adults trying to quit smoking will continue to have access to smoking cessation aids like nicotine gums, lozenges, sprays, and inhalers at various retail locations in approved flavors. However, if you are a manufacturer or retailer of NRTs, it is essential to comply with these new measures to avoid appealing to youth and ensure adherence to Health Canada’s regulations. Non-compliance can result in your product/s becoming illegal to sell in Canada.
Legal Sale of NRTs in Canada
To legally sell NRTs in Canada, a natural health product (NHP) must have a Natural Product Number (NPN) license and bilingual labeling. If the NHP is manufactured outside of Canada, it requires a Health Canada licensed importer of record. The licensing timeline for NRTs, classified as Class 3 NHPs, typically takes approximately 210 days, although this is non-binding.
How We Can Help
At Quality Smart Solutions, we have prepared over 9,000 NPNs and possess the expertise needed to ensure compliance with Health Canada’s regulations. Navigating the complexities of NRT product licensing and preparing a comprehensive safety and efficacy report can be challenging. Our experienced and highly qualified team is here to help you achieve the best outcome for your product registration and market access strategy. Contact us today to discuss how we can support your business!
