Meeting on November 20-21, 2017: Scientific Advisory Board on Vaping Products

Ottawa, ON

List of participants

Attendees

• Dr. Steven Hoffman (Chair)
• Mr. James Van Loon (Executive Secretary)
• Dr. Carolyn Baglole
• Dr. Geoffrey Fong
• Dr. Maciej Goniewicz
• Dr. Lorraine Greaves
• Dr. David Hammond
• Dr. Kenneth Warner

Regrets

• Dr. Linda Bauld
• Dr. Andrew Pipe
• Dr. Rachel Tyndale

Secretariat

• Dana Beaton
• Rachael Dillman
• Adam Doane
• Fatima Mussa
• Tushar Shakya

Observers

• Mathew Cook
• Genevieve Gareau-Lavoie

Meeting Summary

1. The first meeting of the Scientific Advisory Board on Vaping Products (SAB) was held in Ottawa on November 20-21, 2017. The agenda is attached in Appendix I.

2. The meeting opened on Day 1 with remarks from the Chair, Dr. Steven Hoffman, Scientific Director of the Canadian Institutes of Health Research's Institute of Population and Public Health (CIHR-IPPH). Dr. Hoffman welcomed participants and provided an overview of the board meeting agenda and objectives:

• To review important issues on vaping products
• To provide evidence-informed advice on regulations
• To identify key research evidence, gaps in research, and share recommendations

3. The Executive Secretary, Mr. James Van Loon, Director General of the Tobacco Control Directorate at Health Canada, provided a scene-setting presentation. Mr. Van Loon explained the purpose of the board, and highlighted that the board is governed by the Health Canada Policy on External Advisory Bodies. He provided an overview of vaping product use patterns in Canada, and then described the current and proposed federal legislative frameworks for vaping products. He continued with an overview of Health Canada's objectives for the first SAB meeting, and for the SAB in general, and concluded with a brief discussion on future topics and issues that might be brought in front of the board.

4. The SAB engaged in a roundtable discussion about the mission and mandate of the SAB. Members expressed excitement about the objectives of the SAB, the collaboration between Health Canada and CIHR, and the opportunities to incorporate evidence in policymaking. It was further noted that the SAB has an opportunity to advise on the integration of sex- and gender-based analysis (SGBA+), harm reduction, and substance co-use into Canada's framework for vaping products. Furthermore, members noted that the SAB provides an opportunity to advise on a topic that could potentially have serious public health implications for youth, and also provides a chance to use emerging evidence to avoid what happened with tobacco, where it took decades to identify and characterize health risks. Board members reflected on the rapidly changing landscape of vaping and the need for flexibility and adaptation in response to new evidence.

5. The SAB was invited to consider foreseeable topics and issues that the board might be able to review and provide evidence on. Building on an initial list from the scene-setting discussion, the list of topics included:

• "Gateway" (i.e., youth vaping and smoking initiation)
• Product substitution/smoking cessation
• Individual health risks
• Population health impacts
• Monitoring of international developments
• Knowledge synthesis, translation and dissemination
• Recommendations or advice relating to regulatory proposals
• Review of comparative/relative risk statements
• Harm reduction
• Equity (e.g., socio-economic status, stigma)
• Sex- and gender-related factors, and applications of SGBA+
• Balancing regulation of product trade-offs vs. aspects of products that are not trade-offs
• Promotion and marketing restrictions (e.g. flavours)
• Basic product and safety standards; and testing measures
• Identification of ethical issues and considerations
• Co-use of other substances

6. The SAB was led through the proposed Terms of Reference. Members were reminded that they are required to declare any changes to their affiliations and interests. The board was made aware that documents and materials related to the board and the meetings will be shared on Health Canada's website.

The SAB agreed that terms should be at least 3 years, followed by staggered renewal (e.g. 6 months, 18 months, etc.) to create systematic rotation of membership following the inaugural board term. Board members also discussed termination and modified the terms to refer to participation rather than attendance.

Meeting frequency and advance scheduling was discussed. The board members agreed to settle the dates for every upcoming meeting in six months, and set tentative dates for meetings upcoming within one year.

Areas of expertise, membership and ad hoc presentations were discussed. The SAB identified additional areas that might be relevant and that could be filled through additional members and/or invited speakers. The list of topics and areas for which the SAB felt it might require additional expertise included:

• Indigenous perspectives
• Individuals with lived experience
• Harm reduction specialists
• Researchers specializing in youth issues
• Non-governmental organizations and advocacy groups

7. Dr. Maciej Goniewicz presented on the biological dimensions of vaping products, with a particular focus on toxicity. The presentation provided an overview of the variables that may contribute to the toxicity of vaping products, including product type, solvent base, nicotine concentration, voltage and flavourings.

Areas of discussion following the presentation included the role of temperature in toxic emissions, the prevalence of high powered and temperature-controlled devices, testing methods and standardization, and the toxicological endpoints assessed in different kinds of studies.

8. Dr. David Hammond presented on the clinical effectiveness of vaping products, providing a summary of the findings of previous reviews, and highlighting some of the challenges in evaluating the effectiveness of vaping products for smoking cessation at the population level, including: product variety, self-selection in population studies, lack of data on reasons for use and patterns of use, and dual use with tobacco.

Areas of discussion related to clinical effectiveness included the need for more high-quality evidence (i.e., controlled trials) in order to inform clinicians and health providers and help them to be more effective risk communicators to patients and communities. The SAB discussed the role of vaping products as formal therapeutic options for cessation, and the current gaps in evidence that will have implications on messaging and practice guidelines developed for health providers.

Dr. Kenneth Warner presented on existing evidence on population-level trends and patterns of use of vaping products, focusing on youth and adults in particular. The presentation described recent trends in e-cigarette and tobacco use, which for youth have indicated that smoking has decreased while vaping has increased. Dr. Warner's views of the data were that vaping has not renormalized smoking, and that the data suggest nicotine exposure among youth is at an all-time low. In reviewing trends among adults, the presentation highlighted recent evidence suggesting that more frequent vaping has been associated with increasing cessation, emphasizing the importance of detailed patterns of use in the evaluation of outcomes. The presentation summarized recent efforts to model the population health impacts of vaping product use, and described recent studies that suggested vaping may increase smoking cessation rates by at least 8-12%.

The SAB discussed the need for the replication of population studies in different countries, and noted that many countries choose to repeat existing population-level studies for their context. Members indicated that Canada should collaborate with other regulators and organizations on product science to leverage existing resources and infrastructure. The question of cross-jurisdictional applicability of scientific evidence was proposed as an item for discussion at a future SAB meeting.

10. Dr. Geoffrey Fong presented an international picture of regulatory policies on vaping products, and provided a number of cross-country comparisons. The presentation reviewed differences in awareness, ever-use, current use, public opinion, risk perception and reasons for different beliefs. Different regulatory stances on vaping were reviewed, and a conceptual model for evaluating transitions between product use states was described.

Discussion largely centered on the impact of policies and regulations on transitions between cigarettes and vaping products, exploring issues of substitutability, advertising, taxation, and the need to situate e-cigarette policies in the context of existing tobacco policies.

11. On Day 2, the SAB was asked to provide advice to Health Canada on health benefit and comparative statements in commercial promotions of vaping products. Health Canada explained the current legislative proposal (which prohibits statements in commercial promotions, unless authorized by regulation), and requested advice and recommendations from the SAB about whether and how certain statements could be authorized. In particular, Health Canada sought the SAB members' input on processes and criteria for identifying or selecting authorized statements applied to products, and conditions that might be applied to the use of any comparative statements.

There was discussion of the role of uncertainty, standards of evidence and precaution in considering possible comparative statements. The SAB agreed they should weigh in on this matter, that these kinds of statements are in principle good, and that Health Canada should develop a system that would allow the use of comparative statements.

The SAB provided input on processes, criteria, and conditions related to comparative statements:

• Processes: SAB members agreed that a 'top-down' process (i.e. statements prepared by the regulator) for synthesizing statements is preferred and signaled that the SAB is well-placed to peer review and conduct final checks on any statements developed, and agreed that there should be a process to re-evaluate older statements. To identify possible statements, the SAB suggested that industry and public health stakeholders could be invited to offer suggestions that could be further developed and authorized.
• Criteria: Consensus among the SAB was that criteria for evaluating the accuracy of a statement should be explicit, and based on a weight of evidence, and take the totality of evidence into consideration. Throughout the meeting the SAB repeatedly and unanimously referred to a statement of "vaping is harmful, but less harmful than smoking" as an example of a statement that is supportable with the current evidence.
• Conditions: The SAB suggested that conditions for the use of comparative statements on vaping products (such as where the statement shows up on a product) be revisited at a future meeting, and requested that potential conditions be identified by Health Canada to guide the SAB on its recommendations.

The SAB also discussed and agreed on the points summarized below:

• Product standards: the SAB suggested that some form of product quality standards should be considered as a condition for use of statements.
• Relative risk: the SAB suggested that messaging should convey both that vaping is a safer alternative to smoking, and that it is harmful.
• Keep messaging simple: SAB members agreed that complex messages should be avoided and that consumer perception of messages should be assessed.
• Statements should be general: The SAB advised that statements should not be specific to any given product, and should make reference to the act of 'vaping' or the product category, and not use terms like 'this product'.
• Avoid Statements of certainty: SAB members agreed that statements should not convey certainty, given that there currently is limited epidemiological evidence available.

12. The SAB discussed evidence needed to increase the research community's ability to assess public health impacts of vaping in Canada. The purpose of this discussion was to identify questions that require strategic research investment to support understanding and regulatory decision-making on vaping products.

Priorities for research that were noted by board members include:

• Cohort Study: To assess transitions between non-smoking, vaping, and smoking, as well as initiation and quit rates.
• Perceptions on Vaping Products: Society responses to changes in products and product quality.
• Surveillance, Reporting and Data Collection: There is an immediate need for improvement of surveillance systems to collect rapid data, market data, and support coordination of small studies.
• Studies on Disease-Modifying Properties: Comparative studies of properties in vaping products that modify or induce health outcomes such as asthma and COPD, and whether switching between products has an effect on disease progression.
• Vaping Products and Smoking Cessation: Studies on vaping products and their effectiveness as a nicotine replacement therapy (NRT) in the Canadian context are needed.
• Issues related to Dual Use: Reasons for dual use, how people transition between products, and contextual factors for dual use through population-based studies.
• Optimization of Regulatory Model and Standards for Vaping Products: Policy research on the effectiveness of regulations for vaping products over time on population health.

SAB members agreed that the research agenda should be revisited at the next SAB meeting to generate a formal research agenda that will elevate Canada's ability to research vaping products and their impacts on health. SAB members requested that Health Canada prepare a bi-annual update in the form of a backgrounder or summary on activities of Health Canada's Tobacco Directorate on vaping products in advance of each SAB meeting.

13. The Chair provided closing remarks. Dr. Hoffman reflected on the SAB meeting, summarized key takeaway messages, and thanked the presenters. Dr. Hoffman emphasized that this is an opportunity for Canada to lead, and the imminent challenge of optimizing public health is possible with the support of the SAB to examine issues and provide recommendations.

Dr. Hoffman concluded with next steps for the SAB, proposing agenda items for the next meeting stemming from the first meeting's discussions, which include:

• Overview of the state of population studies in Canada - what are the studies that need to be repeated in the Canadian context, and what resources are needed?
• The state of surveillance of vaping in Canada, and Health Canada's existing surveillance protocols and tools
• Research agenda on Vaping Products - advise on a draft research agenda for Canada based on discussions from first SAB meeting

14. Identified actions that Health Canada will take in advance of the next SAB meeting include:

• Developing a draft of relative/comparative risk communication statements for SAB to advise on for future meeting or telephone call
• Sharing inputs that will be released ahead of the meeting (National Academies of Sciences, Engineering and Medicine (NASEM) report; Public Health England updated report)
• Preparing a summary of current market research and surveillance for future meeting

15. The SAB confirmed the second upcoming SAB Meeting on May 14 and 15, 2018 in Ottawa, ON, and tentatively set the third meeting on November 19 and 20, 2018 in Toronto, ON. The SAB Secretariat will create meeting highlights of the first SAB meeting for board members to review for additional feedback and reflections. Dr. Hoffman adjourned the meeting and thanked the board for their willingness and efforts to guide and advise on this important area.

Appendix I - Meeting Agenda

Day 1 - Mon Nov 20

8:30-10:00 - Why are we here?

• Welcome/address from the chair [Hoffman]
• Brief introductions/roundtable [All]
• Scene setting presentation [HC]
• Issues and topics the panel might be expected to weigh in on [HC]
• Presentation from CIHR [Hoffman]

10:00-10:15 - Break

10:15-12:00 - Do we have a common view of our mission and mandate?

• Roundtable on member objectives & expectations [All]
• Dialogue between HC and members on issues and topics of importance and additional priorities [All]
• Table discussion - Terms of Reference, discussion of current membership and any missing expertise [All]

12:00-13:00 Lunch (provided)

13:00-14:30 - What do we know/can we share with one another about key subject areas? PART I

• Biological dimensions (e.g., toxicity)
• Clinical dimensions (e.g., efficacy, abuse liability)

14:30-15:00 Break

15:00-16:30 - What do we know /can we share with one another about key subject areas? PART II

• Population dimensions (e.g. trends and patterns of use)
• Regulatory dimensions (e.g., varying approaches to product regulations)

Day 1 - Tues Nov 212 - Tues Nov 21

7:30-8:30 -Breakfast (provided)

8:30-10:00 - SAB Task#1 - What recommendations could we offer about the authorization of comparative statements?

• Presentation on comparative statements [HC]
  • Guided discussion [Hoffman/All]

10:00-10:15 - Break

10:15-11:00 Task #1 continued

11:00-12:30

What research would improve our ability to evaluate the public health impacts of vaping in Canada?

• Guided discussion [Hoffman/All]

12:30 - 13:00 Lunch (provided)

13:00-13:30 - Next steps and closing remarks from the chair

• Guided discussion [Hoffman/All]

13:30 - Adjourn