Record of proceedings for the Science Advisory Committee on Health Products Containing Cannabis (SAC-HPCC): October 4, 2021

List of acronyms

Health Canada Directorates and Branches

• CSCB: Controlled Substances and Cannabis Branch
• HPFB: Health Products and Food Branch
• NNHPD: Natural and Non-prescription Health Products Directorate, HPFB
• PPIAD: Policy, Planning and International Affairs Directorate, HPFB
• TPD: Therapeutic Products Directorate, HPFB
• VDD: Veterinary Drugs Directorate, HPFB

October 4, 2021, 2:00pm-5:00pm Eastern Time

Welcome and introductory remarks

The Committee Co-Chairs, Dr. Paula Brown and Dr. Richard Huntsman, welcomed members to the meeting. The Committee Secretariat from the Policy, Planning and International Affairs Directorate (PPIAD) and representatives from the Therapeutic Products Directorate (TPD), Veterinary Drugs Directorate (VDD) and Natural and Non-prescription Health Products Directorate (NNHPD) of the Health Products and Food Branch (HPFB) were in attendance, as well as members from the Controlled Substances and Cannabis Branch (CSCB). The Committee’s external writer was also in attendance.

Administrative items

The Secretariat sought member updates to Conflict of Interest (COI) declarations ahead of the meeting and, as an additional reminder, the Co-Chairs invited members to provide any new declarations of affiliations and interests to the external COI advisor. No new declarations were received.

The Co-Chairs sought approval of the Record of Proceedings (RoPs) from the Committee’s September 2^nd meeting, as well as the agenda for the present meeting. Members approved both documents with no objections.

Presentation

The objective of the presentation at this meeting was to answer Committee members’ questions regarding the regulatory context for natural and non-prescription health products and to support Committee deliberations regarding the efficacy and quality considerations of CBD use in humans.

Presentation from the Natural and Non-prescription Health Products Directorate (NNHPD) on current requirements for Natural and Non-prescription Health Products

Presenter: Matt Bown, Associate Director in the Bureau of Policy, Risk Management and Stakeholder Engagement, NNHPD

The Committee members received a presentation from the Natural and Non-prescription Health Products Directorate (NNHPD). This presentation provided an overview of current requirements for natural and non-prescription health products, including:

• labelling requirements, such as considerations for front-of-pack, inner and outer labels;
• quality standards, such as pre-market specifications, site licensing requirements and good manufacturing requirements for manufacturers, packager or labellers and importers;
• evidence or information required to support assessments of potential drug-drug interactions during the product review process;
• post-market requirements such as adverse drug reaction reporting; and
• considerations for the determination of point of sale oversight.

Following the presentation, the Co-Chairs facilitated a discussion period between Committee members and NNHPD representatives. Committee members sought clarifications on labelling requirements and discussed approaches to communicate key safety information, including cautionary or risk statements, to the consumer.  To address questions from members, NNHPD noted current mechanisms in place to support adverse reaction reporting, such as data monitoring and the implementation of risk management plans. A member also asked for clarification on examples for the different evidentiary standards for safety and efficacy of traditional natural health products, compared to modern natural health products or homeopathic products. 

Committee discussion on CBD efficacy

Presenter: Dr. Richard Huntsman

Dr. Huntsman guided the next portion of the meeting, which focused on discussing considerations related to the efficacy of CBD when used for therapeutic purposes in humans. The Committee first reviewed and discussed the information provided by the Australian Therapeutic Goods Administration (TGA) during the previous Committee meeting regarding the TGA’s recent work on CBD.

Members discussed the quality of available evidence regarding the efficacy of CBD, and considerations from specific research studies and clinical trials. The Co-Chair then reviewed promising areas of related research, for which members indicated at least some evidence was available. Indications for which there is currently insufficient scientific evidence were also identified. Based on their review of evidence,  the Committee deliberated on a maximum daily dose of CBD that may be appropriate for use without a prescription and which demonstrated some evidence of potential therapeutic effects, as well as an absence of data on acute harms. Members also noted that dosing would be dependent on a number of factors, including indication and product-specific considerations.

The Committee then discussed post-market considerations and agreed on the importance of supporting informed decision-making through various accessible channels. In particular, they discussed labelling requirements and conditions of sale that could support adverse event reporting and provide consumers with educational resources and other key information pertaining to CBD.  Members also noted initial considerations related to the appropriate level of oversight for potential health products containing CBD, based on the dosage ranges discussed and the current level of related evidence.

Committee discussion on quality considerations

Presenter: Dr. Paula Brown

Dr. Brown guided the next portion of the discussion, which focused on reviewing initial quality considerations for CBD. Members confirmed that a key consideration for CBD products is the proportion of the total phytocannabinoid content that is comprised of CBD, and noted safety considerations associated with synthetically produced cannabinoids. In addition to the requirements of the current quality frameworks, members agreed on key cannabis and phytocannabinoid-specific quality-related elements that should be considered when establishing quality requirements for potential health products containing CBD. They also shared the related information that should be included on the labels of these potential products.

Members discussed differences in current quality requirements for cannabis products compared to health products, and were in agreement that alignment in quality requirements would facilitate research and ensure products of consistent quality for all consumers.

Wrap up and next steps

Presenter: Dr. Richard Huntsman

Dr. Huntsman informed members that the next meeting would provide time to reflect on feedback received from external experts, and discuss considerations related to evidence requirements and suitability for use without practitioner oversight, as well as priorities of the research and medical community. Dr. Huntsman thanked members for their active participation, and adjourned the meeting.