Stakeholder engagement session regarding nicotine replacement therapies: December 16, 2024

Subject(s)

Health Canada hosted a stakeholder engagement session regarding the department's work to extend the transition period for certain labelling provisions of the Supplementary Rules Respecting Nicotine Replacement Therapies Order (the Order).

Date

December 16, 2024

Participants

Health Canada

• Stephen Norman, Director General, Natural and Non-Prescription Health Products Directorate (NNHPD), Health Products and Food Branch (HPFB)
• Eva McGrath, Acting Associate Director, NNHPD, HPFB

Industry representatives

• Gerry Harrington, Senior Vice-President, Consumer Health, Food, Health, and Consumer Products of Canada
• Roberta Kramchynsky, Vice President, Health Policy and Regulatory Affairs, Food, Health and Consumer Products of Canada
• Hilary Orr, Director and Health of Regulatory Affairs, Kenvue (Manufacturers with Marketed NRTs)
• Dora Oakley, Manager of Regulatory Affairs, Kenvue (Manufacturers with Marketed NRTs)
• Katherine Lal, Director, Government Affairs Canada, Kenvue (Manufacturers with Marketed NRTs)
• Chris Mascella, Kenvue (Manufacturers with Marketed NRTs)
• Éric Gagnon, Vice President, Legal and External Affairs, Imperial Tobacco (Nicoventures) (Manufacturers with Marketed NRTs)^{Footnote *}
• Steve Lamont, Senior Regulatory Counsel, Imperial Tobacco (Nicoventures) (Manufacturers with Marketed NRTs)^{Footnote *}
• Adam Miltenberger, Director, Operations, Lucy Goods, Inc. (Manufacturers with Marketed NRTs)
• Kristian Uggerhøj, Chief Executive Officer, Alkalon A/S (Manufacturers with Marketed NRTs)
• Howard Smith, Chief Scientific Officer, Alkalon A/S (Manufacturers with Marketed NRTs)
• Ali Khamessan, Vice President, Quality and Regulatory Affairs, Euro-Pharm International Canada Inc. (Manufacturers with Marketed NRTs)
• Nader Sharifi, Euro-Pharm International Canada Inc. (Manufacturers with Marketed NRTs)
• Lamia Belabbes, Euro-Pharm International Canada Inc. (Manufacturers with Marketed NRTs)
• Amanda Wong, Head, R&D, Haleon (Manufacturers with Marketed NRTs)
• Anjali Newman, Regulatory Affairs OTC & Operations Lead, Haleon (Manufacturers with Marketed NRTs)
• Raghuram Naidu Arigela, Director, Nutricede Inc. (Nutrameltz) (Manufacturers with Marketed NRTs)
• Suresh Kolla, President & Chief Executive Officer, Nutricede Inc. (Nutrameltz) (Manufacturers with Marketed NRTs)
• Denis K. Ivic, Vice President, Sales and Development, Nutricede Inc. (Nutrameltz) (Manufacturers with Marketed NRTs)
• Ram Arigela, Nutricede Inc. (Nutrameltz) (Manufacturers with Marketed NRTs)
• John Bonin, President and Chief Executive Officer, Quimica Canada Limited (Manufacturers with NRTs)
• Maxwell Cunningham, Chief Executive Officer, Sesh Products Inc. (Manufacturers with Marketed NRTs)
• Prasanth Venugopalan, Rubicon Research Canada Limited (Manufacturers with pending product or site licence applications)
• Randy Hurst, Vice President, Business Development, Juno Pharmaceuticals
• Gretchen Zimmerman, Perrigo International, Inc. (Manufacturers with Marketed NRTs)
• Sonia Parmar, Vice President, Government Relations and Regulatory Affairs, Canadian Health Food Association
• Mohit Sharma, CellChem Pharmaceuticals Inc. (Manufacturers with Marketed NRTs)

Introduction

Health Canada's Health Products and Food Branch (HPFB) held a stakeholder engagement session to seek feedback on a targeted change to the Order to mitigate a situation where there may not be sufficient supply of nicotine replacement therapies (NRTs) for adults who want to quit smoking. Participants included representatives from industry associations and natural health product licence holders.

HPFB reminded participants that this meeting is subject to disclosure as per Health Canada's Openness and Transparency policies. As per this policy, HPFB stated that it would be making a record of the meeting publicly available. The handling of information and privacy notice was outlined and acknowledged. HPFB also referred to Article 5.3 of the World Health Organization Framework Convention on Tobacco Control (PDF format) (WHO FCTC), its international obligation to protect tobacco control policies from the vested interests of the tobacco industry.

Subjects

Health Canada welcomed participants and gave a brief presentation on the issue of product availability for adults wishing to quit smoking and the extension being considered for certain transition provisions. The discussion focused on implementation, including the sell-through period and transition period outlined in the Order.

Participants were supportive of an extension and appreciated the move from compliance at the retail level to compliance at the manufacturing level. However, some participants mentioned that even a 12-month extension to the date of application of the permitted sale provisions would not be enough to maintain product availability at the retail level. Participants also signaled the urgency of getting an amendment formalized as soon as possible to allow manufacturers that may have stalled operations pending a regulatory decision to continue to manufacture and label product with their existing labels and ensure continued product availability.

Conclusion

The meeting was then concluded.