Meeting between Health Canada and Nuvona Ltd. – July 19, 2024

Subject(s):

The proposed Order Amending Schedules 2 and 3 to the Tobacco and Vaping Products Act (Flavours)

Date:

July 19, 2024

Participants:

Tobacco Control Directorate

• Sonia Johnson, Director General (Chair)
• Manager, Vaping Regulations, Tobacco Products Regulatory Office
• Policy Analyst, Regulatory and International Policy Unit, Office of Policy and Strategic Planning

Nuvona Ltd.

• Jasmine Odlin, Director, Government and Corporate Affairs
• Adam Taylor, Regulatory Consultant, NorthStar Public Affairs

Introduction:

A meeting was held at the request of Nuvona Ltd. to discuss the proposed Order Amending Schedules 2 and 3 to the Tobacco and Vaping Products Act (Flavours), published in the Canada Gazette, Part I, in June 2021, as Nuvona was not producing vaping products at the time and therefore did not participate in the public consultation.

The Chair started the meeting with introductions.

The Chair read the transparency and disclosure statement. She reminded participants that this meeting is subject to disclosure as per Health Canada's Openness and Transparency policies. The handling of information and privacy notice was outlined and acknowledged. Health Canada also referred to Article 5.3 of the World Health Organization Framework Convention on Tobacco Control (WHO FCTC), its international obligation to protect tobacco control policies from the vested interests of the tobacco industry. It was acknowledged by Nuvona participants.

Subjects:

Nuvona (previously National Smokeless Tobacco Company) provided an overview of their business since their corporate rebrand in February 2024. Nuvona mentioned that:

• The company now seeks to diversify outside of traditional tobacco products, in line with their parent company, Altria Group;
• Nuvona is working to create conditions for harm reduction to succeed and provide an alternative for people who smoke to switch to less harmful products; and
• Altria's NJOY vape product has received 10 market authorizations from the U.S. Food and Drug Administration (FDA) and is the only product to receive such authorization to date.

In regards to the proposed Order Amending Schedules 2 and 3 to the Tobacco and Vaping Products Act (Flavours), Nuvona mentioned the following concerns:

• Following a similar prohibition on flavours made in Quebec, there has been an increase in sales for illegal products;
• Most products on the Canadian vaping market today, even those that are tobacco, mint, or menthol flavoured, would be rendered non-compliant under the current proposal;
• Nuvona does not believe it would be possible to make vaping products that are appealing to adult consumers under the proposed requirements and that the proposed ingredient list is highly restrictive; and
• Nuvona stated that data shows that flavours are critical to help people who smoke to switch, and the proposal may cause adult consumers to continue to smoke or turn to illegal vaping products to obtain flavoured products.

Nuvona recommended that Health Canada (HC) take a characterizing flavour approach, or another approach that balances the need for products that appeal to adult smokers while preventing appeal to youth.

Nuvona asked HC the following questions:

• Is Health Canada intending to publish a list of ingredients that are permitted to use as sugars or sweeteners?
  • HC firstly reminded Nuvona that the proposal is a three-ponged approach, including: limiting the promotion of flavours to only tobacco, mint and menthol; standards for sensory attributes; the list of permitted ingredients. In response to the ingredient list, HC responded that the intent of the proposal was to prohibit the addition of all sugars and sweeteners.
• Was the list of permitted ingredients consulted on as part of the proposal?
  • HC responded that it was.
• How did HC establish the proposed list of permitted ingredients?
  • HC responded that the Tobacco Control Directorate sampled nearly 1,000 products available on the Canadian vaping market. HC then analyzed these products, looking at which ingredients were more often used in sweet flavours (e.g. fruit flavours) and which ingredients were used in tobacco, mint and menthol flavours. This approach determined that it would be possible to make tobacco, mint and menthol vaping products with the proposed ingredient list.
  • In response, Nuvona commented that because it would be possible under the proposal to create tobacco, mint and menthol flavours with the proposed ingredient list, does not mean that the product would be appealing to consumers.
  • HC asked if Nuvona has compared the list of ingredients of the NJOY product to the proposed list of ingredients.
  • Nuvona responded that approximately half of the ingredients of the NJOY product would not be permitted under the proposal.
• Can HC provide any clarity regarding the status of the proposal?
  • HC responded that following the publication in the Canada Gazette, Part I, and the public consultation, comments received are carefully considered in preparation of the publication of the final regulations in the Canada Gazette, Part II. This item is on Health Canada's Forward Regulatory Plan for this year, however this is only an estimate.
• Which Minister is responsible for the proposal?
  • HC confirmed that it is the Ministerof Mental Health and Addictions and Associate Minister of Health.
• Did HC hear concerns about the proposed list of ingredients from other industry stakeholders during the public consultation?
  • HC confirmed that the department did receive feedback on this aspect of the proposal, and an overview of the feedback received would be included in the Regulatory Impact Analysis Statement of the final regulations.
• Would it have any impact on the proposal to submit comments at this point?
  • HC stated that Nuvona may provide their comments in writing if they wish.

In closing, Nuvona reiterated that they understand the objective of the proposal is to limit the flavours of vaping products, and that their concern is that these products remain appealing to adults who smoke. Additionally, Nuvona feels that products that have been permitted by the U.S. FDA under the U.S. premarket approval process should also be permitted in Canada.

Conclusion:

The meeting was then concluded.

Documents:

• Agenda as provided by Nuvona