Record of proceedings for the Science Advisory Committee on Health Products Containing Cannabis (SAC-HPCC): July 30, 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

July 30, 2021, 11:00am-2:00pm 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 Directorate (PPIAD) and representatives from the Therapeutic Products Directorate (TPD), Veterinary Drugs Directorate (VDD) and Natural and Non-Prescription Drugs Directorate of the Health Products and Food Branch (HPFB) were in attendance, as well as members from the Controlled Substances and Cannabis Branch (CSCB).

Prior to the meeting, members provided input to the Secretariat regarding key safety considerations related to cannabidiol (CBD), based on their expertise and the available information. The Co-Chairs thanked members for their feedback and outlined that the input provided would help to effectively guide the meeting discussion.

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 March 3 and June 17 meetings, as well as the agenda for the present meeting. These documents were approved by members with no objections.

To support subsequent discussions, Committee members considered different approaches to reaching consensus on a given statement or recommendation, in order for it to be put forward by the Committee in their reports to Health Canada.  Different options were explored, including the approach outlined in the Committee’s Terms of Reference regarding the capture of members’ advice. Through this approach, recommendations and advice from the Committee for which there is overall general consensus would be presented, and when a full consensus is not possible, the diversity of opinions of members would be reflected in the resulting documentation. Co-Chairs noted that each recommendation would be accompanied by key considerations, both in support of and in caution of the recommendations, which would ensure that the opinions of all members is reflected. Members agreed to use this approach for capturing their advice and recommendations.

Presentations

The objective of presentations at this meeting were to support Committee deliberations regarding the safety of CBD use in humans.

Discussion on potential external presenters and meeting participants

Presenter: Dr. Paula Brown

As indicated in the Committee’s Terms of Reference, consultations with experts is subject to Committee discretion. During previous Committee meetings, to address any data or expertise gaps, members identified specific areas of expertise and knowledge where they would appreciate the insights of external experts. Members noted the importance of considering perspectives from health care professionals such as pharmacists, naturopaths, or nurses to support discussions on the suitability of non-prescription CBD use.

The Committee also identified potential academic experts and additional patient advocacy groups they would like to engage with on particular issues.

Committee discussion on CBD tolerability

Presenter: Dr. Paula Brown                      

Dr. Brown led a discussion on the current level of evidence for CBD safety and tolerability, and discussed a potential daily dose limit that may be suitable for use without practitioner oversight.

Members discussed details of certain CBD safety and tolerability studies, including study length and the populations considered. They mentioned the lack of long-term studies and minimal evidence for use in a range of populations, including vulnerable populations. There was also consideration of different routes of administration and the associated bioavailability of CBD, and the need for further discussion on these factors.

Members noted concerns and uncertainties regarding potential interactions between CBD and other medications. They mentioned that while there may be data regarding the short-term safety of CBD in healthy population, many individuals who may be interested in using CBD may not fall within this healthy population category.

The Committee then discussed adverse reactions associated with CBD and which are of greatest concern. Adverse reactions discussed by members included impairments in cognition and impaired psychomotor functioning, drowsiness, potential drug-drug interactions and liver damage. Members also discussed potential dose limits at which no serious adverse reactions were noted and considered recommendations for packaging and unit purchases that reflect available safety and tolerability data.

Final points of discussion included gaps in available safety data and the robustness of clinical evidence for long-term use of CBD and potential ways to mitigate these uncertainties.

Committee discussion on CBD and Problematic Substance Use and Substance Use Disorder

Presenter: Dr. Richard Huntsman

Dr. Huntsman guided the next portion of the discussion, which focused on problematic substance use and substance use disorder. In particular, members discussed whether there is any evidence that CBD can be habit forming and if there are risks that CBD could be misused, abused or illicitly used.

Using the definition of CBD that scoped the Committee’s initial evidence review efforts, members shared that there is evidence that CBD is not habit forming.

Members also discussed the lack of psychoactive effects associated with CBD use. Members noted some ongoing research efforts aimed at investigating the effectiveness of CBD for the reduction of opioid consumption in cases of dependence, and shared that more research is needed in this area.

Committee discussion on CBD and initial public health considerations

Presenter: Dr. Paula Brown

Dr. Brown led a discussion on public health considerations associated with CBD use, and if any related risks could be mitigated by a practitioner’s supervision.

Members discussed considerations related to the lack of long-term evidence for the safety and tolerability of CBD, as well as the potential for drug-drug interactions. They also considered doses that may be suitable for use without a prescription, compared to doses that would still require practitioner oversight. Indications for which Canadians may be interested in using health products containing CBD as well as initial insights on the evidence available for the efficacy of CBD for these indications were also discussed.

The Committee agreed that should health products containing cannabis be made available without practitioner oversight, further public education would also need to be available to support informed decision-making.

Discussion on additional safety-related considerations

Facilitator: Dr. Richard Huntsman

Dr. Huntsman provided members time to discuss additional safety-related considerations that were not captured in the previous discussions. No further concerns were raised. 

Wrap up and next steps

Presenter: Dr. Richard Huntsman

Dr. Huntsman reminded members that the next meeting will focus on efficacy, and in preparation for that meeting, he asked that members provide initial efficacy-related perspectives to the Secretariat, based on their review of the existing evidence for the same scope of CBD preparations. This input will help guide the discussions at that upcoming meeting.

Dr. Huntsman thanked members for their active participation, and adjourned the meeting.