Health Canada and JTI-MacDonald Corp. meeting: August 27, 2019
Meeting to discuss the proposed Vaping Products Labelling and Packaging Regulations
August 27, 2019
Health Canada (HC):
- Mathew Cook
- Acting Director, Tobacco Products Regulatory Office, Tobacco Control Directorate (TCD) (Chair)
- Senior Policy Analyst, Office of Policy and Strategic Planning, TCD
- Manager, Risk Management Strategies Division, Risk Management Bureau, Consumer and Hazardous Products Safety Directorate (CHPSD)
- Unit Head, Risk Management Strategies Division, Risk Management Bureau, CHPSD
Name of Industry Association:
- Caroline Evans
- Head of Corporate Affairs & Communications
- Paisley Cameron
- Regional Director, Scientific & Regulatory Affairs, Americas
A meeting was held at the request of JTI to discuss the proposed Vaping Products Labelling and Packaging Regulations. More specifically, JTI requested a meeting to discuss the proposed requirements for: the ingredient listing; test methodologies and tolerances; and the transition period.
The Chair opened the meeting by doing round table introductions.
The Chair reminded participants that this meeting is subject to disclosure as per HC’s Openness and Transparency policies. In the interest of transparency, the department stated that it would be making a record of the meeting publicly available. A copy of the handling of information and privacy notice was mentioned, circulated and acknowledged.
HC also referred to Article 5.3 of the World Health Organization Framework Convention on Tobacco Control, its international obligation to protect tobacco control policies from the vested interests of the tobacco industry.
Test methods and tolerances
JTI stated that it has concerns about Method C57.1, entitled Determination of Nicotine at Low Concentration in Liquids used in Electronic Nicotine Devices by GC-MSD/FID with respect to precision and repeatability. JTI also stated that this method was designed for low concentrations of nicotine or products without nicotine.
HC clarified that Method C57.1 was incorporated in the proposed regulation to specify a method that could be used to determine whether a vaping substance contained nicotine. The method was not prescribed to determine the accuracy of nicotine concentration that would be required to be displayed on the labels.
JTI recommended that the recently published ISO 20714:2019 method, entitled Determination of Nicotine, Propylene Glycol and Glycerol in Liquids Used in Electronic Nicotine Delivery Devices -- Gas Chromatographic Method be incorporated in the proposed regulations and used to determine the concentration of nicotine that must be displayed on vaping product labels. JTI stated that it preferred to have a prescribed test method for repeatability and precision and noted that the ISO method is internationally recognized, would provide greater consistency through industry and would offer more precision which is necessary as the nicotine concentration approaches the upper threshold of 66 mg/mL.
JTI also recommended including a tolerance limit around the nicotine concentration measurements. JTI pointed to the acceptable tolerance limits for natural health products and indicated that a 20% tolerance is used. JTI indicated that it would recommend a minimum tolerance limit of ±20%.
HC asked whether the ISO method is sensitive to detect both low and high (above 66 mg/mL) levels of nicotine. JTI indicated that the method was sensitive but would confirm for low levels and provide more information in its written submission.
JTI stated that the list of ingredients with respect to flavours is ambiguous and could be clarified to include “anything intended to add a flavour” since most ingredients have a flavour already. HC noted that the definition of “vaping substance” as defined by the Tobacco and Vaping Products Act should be considered in understanding the requirement.
JTI expressed concern regarding the proposed placement requirement for the list of ingredients. JTI showed its Logic product refills and indicated that it was unsure of whether the statement was required on the capsule itself or whether it was required on the blister pack. JTI recommended having the statement appear on the exterior packaging, similar to the placement of the nicotine concentration statement. JTI noted that the list of ingredients would not be legible due to the size and other requirements that are to appear on the blister pack. JTI noted its recommendation that the priorities for information to appear on the blister pack be the health warning and nicotine concentration statement and that the list of ingredients could either appear on the exterior package or a leaflet.
JTI noted that the proposed Coming into Force period does not include a transition period for retailers. JTI indicated that manufacturers would need a minimum of 6 months but that retailers would require additional time for sell-through. JTI noted that its products have a shelf life of over 12 months and that its inventory moves at a much slower rate. JTI also noted that tobacco regulations typically provide retailers with an additional 3-6 months to transition.
HC concluded the discussion on this topic by asking JTI to address this issue in its formal submission by providing a detailed description of the supply chain and an indication of how much time is required at each step of the process in order to better understand its concerns.
JTI discussed its estimated vaping product market share and presence at retail. JTI noted that there is wide price variability on its products despite recommending a selling price since it is ultimately at the retailers’ discretion to set prices on the products.
The meeting was then concluded.
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