Meeting May 13 to 14, 2019: Scientific Advisory Board on Vaping Products

Meeting Summary - May 13-14, 2019: Meeting of the Scientific Advisory Board on Vaping Products

1. On May 13th and 14th, 2019, members of the Scientific Advisory Board on Vaping Products (SAB) met in Ottawa for the Board's fourth meeting. The agenda is attached in Appendix I.
2. On the first day, Dr. Steven Hoffman welcomed participants and provided context for the theme of the meeting, which was to be the role of vaping in smoking cessation. Dr. Hoffman noted the high degree of activity since the board had last met, and advised the SAB of two guests (Dr. Neal Benowitz and Dr. Nancy Rigotti) that would be participating in the meeting. He noted two Best Brains Exchange events being held in Ottawa in May 2019 on topics related to the mandate of the SAB. The introduction was followed by a brief roundtable for members to provide comments and updates.
3. Health Canada provided an update to the SAB on recent activities and developments, with Mr. Van Loon beginning by highlighting that since the last SAB meeting Health Canada announced new regulations for plain and standardized appearance for tobacco packaging and products that will come into effect on November 9, 2019 for most tobacco products. He summarized recent activities related to youth vaping, including the pending release of draft packaging and labelling regulations and the recent publication of the Notice of Intent - Potential Measures to Reduce the Impact of Vaping Products Advertising on Youth and Non-users of Tobacco Products, which will inform the development of regulations of vaping product promotions. Mr. Van Loon presented Health Canada's forward regulatory plan, a summary of recent compliance actions, and provided the board with the latest national vaping surveillance and market data. He also presented the SAB with the timeline of upcoming research and surveillance projects related to tobacco and vaping products. The SAB expressed interest in the timelines for the development and publication of regulations, and discussed the scope of activities that are considered as promotion (e.g., broadcast, social media).
4. Health Canada presented on policy and program measures which complement the regulatory actions that had been described by Mr. Van Loon, with a recent focus on addressing youth vaping. Health Canada shared information on a large scale, national youth vaping prevention public education campaign which incorporated recommendations previously made by the SAB, including the types of devices depicted in the ads and the descriptions of potential risks to youth. Health Canada also invited SAB members to participate in a consultation that was open at the time, entitled Reducing Youth Access and Appeal of Vaping Products, which sought input on a range of additional measures that might limit the appeal of vaping products to youth. Health Canada described new funding being distributed through the Substance Use and Addictions Program to support innovative projects related to vaping and nicotine, with one example being the development of lower-risk nicotine use guidelines. The presentation closed with the SAB making suggestions about the evaluation of the media campaign, and recommending that tools like mass media be incorporated into a comprehensive and integrated strategy. The SAB emphasized the importance of reaching out to healthcare providers and health organizations on projects like guidelines, as well as engaging other levels of government on multi-jurisdictional aspects.
5. Dr. Lorraine Greaves provided an update on the findings of a recent scoping review. During a prior meeting, Dr. Greaves shared her expertise and findings of ongoing research into the relationship between sex, gender and vaping. Dr. Greaves summarized the findings of the review, which examined the impact of sex and gender in substance use and vaping from biological and behavioural perspectives. She highlighted the dearth of studies focusing on sex and gender in the context of vaping, and noted that historically policies in tobacco control have too often been gender blind. Dr. Greaves concluded that although gaps exist in the literature, Health Canada should consider developing vaping policies using an equity framework. The SAB thanked Dr. Greaves for her presentation and reaffirmed the importance of applying a sex and gender- based analysis framework in nicotine and vaping research, policies and campaigns.
6. Representatives of Health Canada's cannabis program presented on the proposed amendments to the Cannabis Regulations. The presentation summarized Health Canada's work in developing regulations governing the production and sale of new classes of cannabis products, namely edible cannabis, cannabis extracts and cannabis topicals, including regulatory controls to address the public health and safety risks posed by these new products. The SAB discussed various intersections with nicotine and cannabis vaping products, including the robustness of evidence to inform health warnings, the framing of messages for public education, and the regulation of devices that could potentially be used with different substances.
7. Representatives of Health Canada's Health Products and Foods Branch presented on the regulation of vaping products with health claims under the Food and Drugs Act. For products with health claims, pre-market authorization is required from Health Canada. At this time vaping products containing nicotine and represented for use with a health claim are considered to be prescription drugs. The regulation of vaping products without nicotine and with health claims depends on the medicinal ingredient(s). The ensuing discussion explored the boundaries between health claims regulated by the Food and Drugs Act (e.g. smoking cessation), and other claims that do not require pre-market authorization (but which cannot be false or misleading, or convey health benefits). The SAB discussed implications of products with and without claims, and potential impacts in the clinical environment, including aspects like off-label use.
8. Dr. Ken Warner began the afternoon session with a presentation on recent findings from population studies which have, with few exceptions, suggested that vaping may be having a positive influence on smoking cessation at the population level. Dr. Warner noted that in countries where vaping products are available, the decline in smoking rates have tended to accelerate, in contrast to countries with prohibitive policies on vaping where declines in smoking seem to have stalled. Dr. Warner described the beginnings of a research agenda to more fully elucidate the impact of vaping on cessation, as well the trajectories of people who smoke and/or vape. The SAB discussed the relationship between vaping frequency and cessation outcomes, the role of confounders and variables such as age and socioeconomic status, patterns of use including dual use, and identifying aspects of the proposed research agenda that are context dependent and would need to be studied in Canada.
9. Dr. Maciej Goniewicz presented the results of a recent randomized trial of e-cigarettes and nicotine-replacement therapy (NRT). The study found that e-cigarettes were almost twice as effective as NRT at supporting smoking cessation under the conditions of the trial. The study recruited smokers seeking help for quitting, and both products were provided with behavioural support. This presentation was a catalyst for a thorough discussion of vaping and cessation, including the role of nicotine, the perceptions of healthcare professionals of the quality of vaping products and the companies that sell them, and the regulatory pathways that exist in different countries. The Chair asked the SAB how this technology might be channelled to the benefit of Canadians. The SAB agreed that in the current model with two ways to enter the market (i.e., as either a consumer or therapeutic product), manufacturers are less likely to choose the therapeutic product route due to the burden of the application, and suggested that the United Kingdom (UK) could serve as an example on this topic. The SAB agreed that vaping products have the potential to be beneficial for the Canadian population, however if regulations and policies are not properly developed, the country will not be able to realize these potential benefits. The SAB then had a wide-ranging roundtable discussion on the current evidence relating to vaping and smoking cessation, global perspectives on vaping product design and vaping product marketing, and the advantages and challenges associated with each of the two regulatory pathways that exist in Canada.
10. The second day of the meeting opened with a Health Canada presentation, outlining the current landscape, and the challenge that needs to be met in order to achieve the Government of Canada's goal of reducing the rate of tobacco use to less than 5 percent by 2035. The presentation summarized recent trends in smoking cessation, and emphasized that the cessation rate needs to approximately double in order to achieve the government's goal. This was followed by a discussion about the federal role in smoking cessation, the barriers and challenges that people who smoke are facing, and the levers and mechanisms available to Health Canada. The SAB raised the following ideas to consider:
    • Develop systematic approaches with provincial and territorial governments, for example incorporating smoking cessation targets into hospital funding, evaluation or quality control reviews;
    • Identify and reduce barriers to clinical research in Canada, with an aim to increase the number of smoking cessation clinical trials which assess the effectiveness of vaping products;
    • Ensure an equity framework is applied to all vaping and tobacco policies, regulations and research;
    • Further regulate the manufacturing of vaping products to ensure quality, reliable products are developed; and,
    • Provide accurate information on vaping as a smoking cessation method.
11. Dr. Linda Bauld presented on patterns, trends and policies in the UK, and explained that the UK has tightly regulated e-cigarettes in line with World Health Organization recommendations, and has promoted vaping as a smoking cessation tool. She noted the differences in regulatory restrictions for medicinal licensed products including:
    • Lower sales taxes;
    • Products available through prescription;
    • Allowing advertising;
    • Allowing health claims on products;
    • No upper limits on nicotine content; and,
    • No health warnings on packages.

• However, even with these incentives, she noted there are currently no medically licensed vaping products being sold on the UK market. Dr. Bauld did note some challenges with the reach of cessation supports when delivered through the medical system, and that in the UK free, easily accessible smoking support services are used by a very small proportion of smokers. She noted part of the challenge is that people who smoke don't view themselves as ill. Dr. Bauld spoke to renormalization in the UK and discussed findings of a study in Scotland and Wales that showed continued decline in social acceptability of smoking. She also summarized research that suggests dual users are more motivated to quit smoking than experimental vapers and smokers who do not vape, and NHS data which indicated that stop smoking service clients using e-cigarettes have had better success than those using other cessation aids. She cautioned that the UK is still experiencing challenges in addressing misinformation about the relative harms of vaping and smoking. Following an extensive public education campaign on vaping as a smoking cessation method, almost one third of UK smokers have still never tried a vaping product. The SAB thanked Dr. Bauld for her presentation and reaffirmed the need for Health Canada to look at the UK experience for guidance on this topic.

12. The final presentation was by Health Canada, which provided a summary of recent qualitative public opinion research exercises (focus groups and a week-long diary). Both were focused on understanding how smoking fits into the broader context of smokers' lives and included aspects of vaping. This research was conducted to provide a deeper understanding of the experience of smokers. Findings that arose from this research, included:
    • Smoking did not appear to be salient - smokers do not discuss smoking as a part of their daily routine when unprompted;
    • Stigma of smoking is widely felt by smokers; and,
    • Many smokers hold misperceptions about vaping.

• The SAB was very interested in this research and offered suggestions for future projects and additional research questions that could be considered. Following the presentation the SAB discussed a variety of topics that had been raised over the course of the meeting, including: sex and gender aspects of vaping (and the opportunity to learn from experience with smoking), the importance of product standards and potential for performance-based regulations, the positive and negative consequences of efficient nicotine delivery, and how messaging might be crafted to speak more effectively to either youth or adults who smoke.

13. In closing, Dr. Hoffman reflected on the fourth SAB meeting, and thanked the presenters and members for their expertise. Mr. Van Loon summarized the key takeaway messages for Health Canada to consider, including:
    • Engagement with healthcare practitioners should be improved to increase their confidence in vaping products as a tool to support smoking cessation;
    • Health Canada should consider developing regulations regarding vaping product safety;
    • Additional messages directed to smokers would be helpful, such as Health Information Messages about vaping in cigarette packages;
    • There would be a benefit to increasing the number of smoking cessation clinical trials in Canada that include the use of vaping products to expand the evidence base on efficacy;
    • Studies and policies should employ an equity framework.

• The fifth SAB meeting will occur in Ottawa on November 18-19, 2019. Dr. Hoffman adjourned the meeting and thanked the board and departmental officials for their participation.

Appendix I - Meeting Agenda

Scientific Advisory Board (SAB) on Vaping Products

Meeting #4 - May 13 & 14, 2019

• Day 1
  8:30-10:00 - Introduction
  • Welcome - Chair: Dr. Steven Hoffman
  • Brief Introductions/Roundtable - All
  • Health Canada Update - James Van Loon
• 10:00-10:15 - Break
  10:15-11:00 - Presentation and Discussion
  • Canada's Policy and Program Measures to Address Vaping - Health Canada
• 11:00-12:00 Presentations and Discussion - Health Canada Regulatory
  • Consultation on Cannabis Vaping Products - Health Canada
  • Regulation of Health Claims - Health Canada
• 12:00-1:00 - Lunch
  1:00-1:30 - Presentation
  • Sex, Gender and Vaping - Dr. Lorraine Greaves
• 1:30-2:30 Presentations - Vaping Products and Tobacco Cessation
  • Does Vaping Increase Smoking Cessation? An Examination of the Population-level Evidence - Dr. Ken Warner
  • Results of a Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy - Dr. Maciej Goniewicz
• 2:30-2:45 - Break
  2:45-4:00 - Deliberation/Discussion
  • Current State of Evidence
• Day 2
  8:30 -10:00 Presentations
  • Federal Role in Tobacco Cessation - Health Canada
  • Vaping for smoking cessation as part of comprehensive tobacco control: Policy and practice update from the UK - Dr. Linda Bauld
  • Exploratory Focus Group Research on Smoking Cessation - Health Canada
• 10:00-10:15 - Break
  10:15-12:00 - Deliberation/Discussion
  • How might Health Canada use federal "levers" to support or encourage more people to discontinue smoking (including through vaping)
• 12:00-1:00 - Lunch
  1:00-1:30 - Continue Discussion and Conclusion