Health Canada Meeting Summary (Bill S-5)

Initially, this was only released to our membership.  However, there has been a significant amount of concerning ‘scuttlebutt’ with regard to how Bill S5, an act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other acts,  is and is not going to impact our industry. To help provide some clarity and to dull some of the more potentially damaging rumors, we are publicly publishing the meeting minutes from one of our more recent meetings with Health Canada to discuss Bill S5 and pending regulations.

On Wednesday April 25, 2018 ECTA had the opportunity for a 1 ½ hour sit-down meeting with Health Canada. This meeting took place at 3pm at the Main Statistics Canada Building in Ottawa Ontario. ECTA was represented by ECTA President Daniel David, Board of Directors member Mike Meathrel, and Compliance Officer Rachel Longwell. The total number of Health Canada representatives was 12, and included members from the Tobacco Control Directorate, Consumer Product Safety Directorate, and the Regulatory Operations and Regions Branch.

The following summery is our interpretation of the information given by Health Canada during this meeting. These notes were given verbally by the directors in attendance and taken down in writing by ECTA members.

Agenda Items & Summary

1. Opening Introduction, ECTA structure and mandate

The meeting was opened with an explanation of ECTA’s history, mission statement, and a discussion on the vaping industry as a whole to help give Health Canada representatives a better understanding of how it operates. This was accompanied by a booklet containing materials for attendees to follow along with. The Table of Contents for this document is located in Appendix A (see below).

2. Demonstration and explanation of ECTA tools and services provided to members for S5 compliance

The purpose of this agenda item was to give an overview of the additional requirements ECTA members must adhere to such as VG/PG ratios and “Made on” dates. The intent was to demonstrate how these items fit on the already compliant labels, given their likely inclusion in the regulations.

Agenda item #2 addressed the tools currently available on the ECTA webpage that center around Bill S5 compliance. These tools included the size calculator, label maps, label templates, retailer checklists, and FAQ’s. The overall consensus is that all attendees were impressed with the work ECTA has put in to ensuring their members are prepared for Royal Assent, including the extra steps taken to ensure label indelibility. They informed us that upon Royal Assent, they are prepared to start enforcement of all CCCR and CCPSA regulations shortly thereafter. They are simply waiting for the go – ahead to begin.

3. Proposed Nicotine Warning

The purpose of this agenda item was to provide examples of nicotine warnings in terms of placement and size to detail the challenges we might face trying to incorporate them into the label. We hope these challenges will be considered during regulation development and would like to collaborate on this development.

Moving on to agenda item #3, some guidance was offered to Health Canada on the proposed Nicotine warnings size and placement. These warnings have not yet been included in CCCR/CCPSA requirements, however Health Canada hinted many months ago that they would be required in time. ECTA’s main concern is the size requirements of these warnings, considering a compliant label has minimal space to begin with. ECTA offered to work with Health Canada on the preparation of these warnings and any additional warnings to ensure they fit within the label’s without diminishing branding space.

4. Industry compliance status update (CCCR/CCPSA upon royal assent)

Purpose of this section was to identify issues with compliance of imported e-Liquid, and give a general overview of the preparedness of the industry for Royal Assent with hopes of receiving further clarification on what will be required prior to and following Royal Assent.

For agenda item #4 ECTA provided a rough idea of the industry’s preparedness for Bill S5 Royal Assent in terms of compliance, comparing ECTA members with non ECTA members, where the number of compliant ECTA members is approximately 95%.  The issue concerning importation of International E-Liquids from companies that do not fall under the same regulations as Canada, and therefore would not be considered compliant upon import, was also brought to attention.

5. Industry S5 compliance misconceptions

The purpose of Agenda item #5 is similar to that of #4, where common misconceptions were brought to the attention of Health Canada in hopes that potential solutions could be discussed and guidance on requirements could be given.

Agenda item #5 focused on misconceptions that exist in the vaping industry. ECTA identified the main cause of these misconceptions as lack of understanding, grey market mentality, doubting the governments capability to enforce, and mixed messages on social media. Health Canada responded by offering to provide an updated summary of the regulations to clarify what is expected. It was pointed out by Health Canada that rarely is a new industry informed of their classification before being regulated, but an exception was made in this case allowing for companies to prepare ahead of Royal Assent.

6. Nicotine testing classification of 0.1mg/mL

This section was included to remind Health Canada of the difficulties of testing for 0.1mg/mL and to seek clarification regarding the requirements for verifying nicotine concentrations for products currently on the market.

Agenda item #6 was briefly touched on, where ECTA proposed 0.1mg/mL was too low to accurately detect during testing to be the lowest concentration required for CCCR/CCPSA hazard labelling. Health Canada representatives clarified that this concentration is being considered as a consumer threshold to be used by enforcement when inspecting Nicotine Free products to ensure they are Nicotine Free. It was noted that Health Canada was open to discussion about increasing this limit to 0.3mg/mL however no conclusions were made.

7. Questions and feedback on legislation and proposed regulation. 

• We wanted to discuss POD systems and provide examples, specifically of pre-filled systems to identify the potential issue of adding CCCR requirements on individual PODS.
• We required follow up clarification on the requirements for Child Resistant Certifications for Tanks
• We wished to get clarification of E-Liquid brand elements, including fruits on labels, illustrations, and flavor names to improve our ability to advise members during the upcoming audit.

The last item on the Agenda covered, labelling requirements for closed POD systems, child resistant certifications for Tanks, and E-Liquid brand elements and illustrations. Attendee’s were unfamiliar with the POD systems and were given samples to clarify what they are and how they are used. The main issue discussed was the labelling requirements for POD systems as they do contain hazardous liquid, however are too small to be properly labelled following CCCR/CCPSA requirements. ECTA was given verbal confirmation that upon Royal Assent the PODs themselves will not be enforced, but the packaging they come in will be. Adding to this, they have informed ECTA that child resistant tanks will not be a requirement of Bill S5.

There is currently a great deal of confusion within the vaping industry over issues such as flavour names and branding elements allowed on labels come Royal Assent. They also informed us that they will not offer any interpretations on Bill S5 phrasing in regard to flavour names and Images considered appealing to children. The regulation states:

The example given was “Unicorn Milk”, while not technically falling under one of the 5 restricted flavour categories it certainly has an element that could be considered appealing to children. The best course of action for the industry regarding this issue is to avoid, at all cost, anything that could be considered appealing to a child.

The meeting closed with a question period and a show of gratitude from Health Canada representatives for the information ECTA brought to their attention regarding the vaping industry.

8. Other Business

Time allowed for general discussion, where we attempted to get into relative risk statements, couldn’t provide clarification at this point.

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