The Ministry of Health in British Columbia is proposing new regulations under the Tobacco and Vapour Products Control Act (TVPCA) and the Public Health Act (PHA) with the proposed regulations under the TVPCA and the PHA to be enacted on April 1, 2020. The Vaping Industry Trade Association (VITA)’s response to the comments on the proposed regulatory changes are below. For ease of review, we have structured our comments to map to the sections of the Vapour Product Intentions Paper.
Impact of the Vaping Products Labelling and Packaging Regulations (SOR/2019-353)
VITA recognizes the laudable objectives of the proposed BC regulations. However, subsequent to the publication of the Vapour Products Intentions Paper, the regulatory landscape for vaping products in Canada has changed. As we are sure you are aware, on December 19, 2019, the federal government registered new regulations to the Tobacco and Vaping Products Act, Vaping Products Labelling and Packaging Regulations: SOR/2019-353 (“VPLPR”). These regulations fill much of the regulatory gap that we understand BC’s proposed regulations intend to address.
As a result of the VPLPR, some of the proposed BC regulations may be redundant and would impose confusing and contradictory requirements on manufacturers and retailers.
We assume that the release of the VPLPR has required the BC Ministry of Health to revisit some of the proposed regulations listed in the Intentions Paper. VITA would welcome a revised Intentions Paper and, if such a document is drafted, the opportunity to offer supplementary comments.
Summary of VITA’s Position
As explained in greater detail below, VITA offers the following suggestions in response to the proposed regulatory changes:
Prescribing Nicotine, Non-Cannabis/Nicotine E-Liquids as Health Hazards
- VITA opposes the intention to designate vapour products that do not contain nicotine or cannabis as a “health hazard” due to a lack of supporting evidence. Such a designation runs contrary to guidance and scientific information published by Health Canada.
- VITA does not understand the purpose of designating nicotine “unless it is authorized under other legislation” as a “health hazard” given that nicotine use is authorized and highly regulated by several provincial and federal statutes. A desire to impose stricter regulations relating to locations of consumption, or advertising, can be addressed without resort to the “health hazard” regime established under the BC Public Health Act and its associated regulations.
Prohibition on Non-Nicotine and Non-Cannabis E-Liquids
- VITA opposes the proposed ban on the sale of all non-cannabis and non-nicotine e-liquids. Use of non-nicotine e-liquids is an essential part of a smoker’s journey to beat their nicotine addiction and smoking habit. Preventing sale of these products would significantly undermine the harm-reduction potential of vaping products for smokers. Moreover, Health Canada has found that available evidence does not support the conclusion that non-nicotine e-liquids pose a health risk.
Nicotine Concentration in Vapour Products:
- The nicotine concentration limit of 66 mg/mL in vapour products imposed by Health Canada in the VPLPR is appropriate and evidence based. Heath Canada is most suited to determine and regulate the content of vapour products.
- In the event that the BC government decides to prescribe a nicotine limit, the limit should not be less than 35 mg/mL.
Restricting the Sale of Flavoured Vapour Products
- VITA opposes the proposed restrictions of flavoured vapour products. Health Canada’s existing restrictions on promotion of certain flavours that may apply to young people, and the robust labelling and advertising requirements, render the need for further restriction on flavours for the purpose of protecting young people unnecessary. Further restricting access to non-tobacco flavours, according to third-party research, would reduce the likelihood of smokers making the harm-reducing decision to switch to vaping as part of their journey to stop smoking.
Labelling, Packaging and Health Warning Requirements
- As a result of the detailed labelling, packaging and health warning requirements prescribed in the VPLPR, VITA opposes the proposed BC regulations. The proposed regulations would make it difficult or impossible for manufacturers to comply with provincial and federal requirements. The VPLPR is a sufficient and appropriate regime for labelling, packaging and health warnings.
Strengthen Restrictions on Public Advertising
- VITA believes that adult smokers should know about vaping as an alternative and communication freedoms are critical to building this awareness.
1. Prescribe Nicotine as a “Health Hazard”
Designation as a “Health Hazard”
In the Intentions Paper, BC proposes to designate two items as “health hazards”: nicotine and non-nicotine/non-cannabis e-liquids.
VITA opposes designating nicotine as a “health hazard”, and notes that nicotine is already highly regulated, at both the provincial and federal level, through specific statutes and regulations. VITA does not understand the advantage of introducing an additional regime to regulate nicotine. Further, VITA is concerned that the proposed language will create confusion and may ultimately make the designation of little effect. BC proposes that nicotine, “unless authorized under other legislation” be designated as a “health hazard”. Nicotine is a legal and heavily regulated by legislative schemes. VITA requests clarification on the scope of this proposal and, upon receipt of such clarification, the opportunity to make further comments on this issue.
VITA opposes the designation of non-nicotine and non-cannabis e-liquids as “health hazards”. We do not believe that there is evidence to support a claim that using non-nicotine vapour products poses risk to public health that supports its inclusion on the small list of designated “health hazards”.
The BC “health hazard” designation, as we understand it, is intended to be used to classify “a condition, thing or activity that:
(i) endangers, or is likely to endanger, public health, or
(ii) interferes, or is likely to interfere, with the suppression of infectious agents or hazardous agents” We understand that it is important to BC’s approach to public health to take measures to prevent health hazards, respond to health hazards and regulate the operations, activities or conditions that could pose a health hazard.
In the Regulatory Impact Analysis Statement published in the Gazette upon release of the VPLPR, Health Canada makes several comments about the safety and risk of non-nicotine vapour products that informed the final version of the regulations. As we read Health Canada’s statements, it appears that Health Canada, after reviewing all available evidence, has determined that non-nicotine vapour products do not pose a significant risk to health. We excerpt certain key passages and positions for your review:
- “there is a consensus in the scientific community that for people who smoke, completely switching to vaping is less harmful than smoking conventional cigarettes.” Vaping products may bring “public health benefits”.
- “Health Canada has identified nicotine to be the only known ingredient of concern in vaping substances, related to toxicity by ingestion.”
- Health Canada was asked by certain stakeholders to require a health warning for non-nicotine vapour products and declined to do so after extensive consultations and review of all available scientific evidence.
From the literature and studies that we have reviewed – consistent with the position taken by Health Canada after a multi-year consultation – we are not aware of any pressing health concerns posed from use of properly regulated, non-nicotine e-liquids.
Absent evidence to support claims that non-nicotine substances pose a health risk, VITA opposes the proposal to designate these products as a “health hazard”. We believe in evidence-based decision making, While BC has a mandate to take preventative measures to ensure public health, we do not believe that non-nicotine e-liquids – largely comprised of commonly available non-toxic ingredients – mandate special designation at this time.
Proposed Ban on Non-Nicotine and Non-Cannabis E-Liquids
VITA’s comments in this section respond to the proposals on this issue set out in both Section 1 and Section 4 of the Intentions Paper.
VITA opposes the proposed restriction of sale of non-nicotine and non-cannabis e-liquids. The proposed ban will likely have minimal impacts on youth vaping rates and seems counterproductive to the advocacy efforts for harm-reduction; where nicotine-free products are one of the final stages for customers to quit their addiction to nicotine. One of the many advantages of vaping technology – when compared to combustible tobacco cigarettes – is the ability for adult users to gradually reduce their nicotine consumption to zero.
Use of 0 mg/mL products is the final step in quitting all together. 0 mg/mL satisfies the hand to mouth habit. The physical and visual portion of the habit is a crucial part of why vaping is so successful compared to any other cessation method. A study published in The New England Journal of Medicine called “A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy” depicts clearly how E-Cigs are more effective than NRT products. In this study 866 participants underwent randomization. The 1yr abstinence rate for e-cigarettes was 18% and 9.9% for NRT. The study concludes with:
“E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy, when both products were accompanied by behavioural support.”
In the typical ex-smoker’s “vaping journey”, a new user will convert to vaping technology from combustible tobacco by selecting a high-nicotine e-liquids and gradually progress to a low-nicotine or nicotine-free product. The latter are the final stage before fully quitting the addiction and habit. For many adult consumers, these nicotine-free e-liquids provide them with the ability to continue their smoking-cessation journey without inhaling any nicotine. Addiction to combustible tobacco cigarettes is one of the most difficult to quit, but the nicotine-free e-liquids are the final stage in Canadians’ desire to break their nicotine addiction altogether; and thus, fully carrying out the end goal of harm reduction.
Banning the legal sale of nicotine-free e-liquids will only increase the users’ risk by pushing them to prepare their own solutions or leading them to the black market to make their purchases. Nicotine-free e-liquids contain USP-grade Propylene Glycol, USP-grade Glycerin and food-grade (GRAS) flavourings. These ingredients are readily available for consumers on the shelves of everyday stores. For example, these items can be purchased at Bulk Barn (see Appendix 1 and Appendix 2). Consumers may also be exposed to non-USP-grade Propylene Glycol which may contain Diethylene Glycol resulting in an enhanced exposure to a known toxicant prohibited by Health Canada. The resulting flavours will also not be tested for contaminants so unknown compounds may be inhaled.
Taking away 0 mg/mL would eliminate the final step for vapers who sometimes crave a cigarette because of the habit but have finally outlasted their nicotine dependency. The only option left for these people would be to either use combustible tobacco products or vapour products that contain nicotine that do as well.
In Section 1 of the Intentions Paper, it is stated that research suggests youth start vaping by using flavoured e-liquids that do not contain nicotine or cannabis. VITA would like to better understand if this information is based on credible evidence brought to light by a respected authority. In absence of such evidence, the purpose of banning non-nicotine e-liquids is not evidence-based. It is therefore difficult to support the validity of this approach.
The absence of nicotine in nicotine-free e-liquids raises the question as to why those products would be considered as a health hazard. We request further elaboration on the rationale for these products being deemed health hazards, and thus, completely banned.
As government there is a responsibility to ensure these products are never targeted towards youth or non-smokers; however, there is also a responsibility to ensure adult smokers have the right to choose a less harmful product that allows for the eradication of combustible tobacco in their lives. Combustible tobacco cigarettes are the leading cause of preventable death in Canada.
2. Restrict Nicotine Concentration in Vapour Products
Nicotine Concentration Limits
As an industry, we oppose lowering the maximum nicotine concentration in e-liquids to less than the level prescribed by the TVPA (66 mg/mL) as we strongly believe that this will limit the harm reduction potential of vaping products for smokers. It should be noted that certain stakeholders suggested a 20 mg/mL nicotine limit to Health Canada during their consultations on the VPLPR. Health Canada rejected this position and chose to maintain the same limit established under the previous regulations.
Vaping devices need to deliver sufficient nicotine to have smokers satisfied with a vaping product and encourage them to switch to vaping. Like smoking cigarettes, different adult consumers prefer a range of nicotine concentrations when vaping. We believe that e-liquids with various nicotine levels have the potential to deliver to adult smokers an experience closely mirroring smoking a cigarette, thereby allowing consumers to choose the e-liquid that provides the best vaping experience for them, assisting adult smokers’ switch to e-cigarettes.
Should the government of B.C. place further restrictions on the concentration and/or delivery of nicotine in vaping products, a significant portion of adult smokers will not find vaping products to be a satisfying alternative to cigarettes and may continue to smoke.
The proposed nicotine ceiling is based on the current ceiling of 20 mg/mL imposed in Europe by the DIRECTIVE 2014/40/EU of the European parliament. Vaping has been found to be effective at helping smoking cessation and, considering the smoking decline in Europe, some would argue that the EU nicotine ceiling of 20 mg/mL is perfectly suitable for Canadian smokers wanting to stop smoking. However, the nicotine level of Canadian cigarettes is significantly higher than the ones from the EU market. DIRECTIVE 2001/37/EC of the European parliament limits nicotine emission to 1 mg per cigarette. In Canada, emission data of 236 Canadian cigarette brands indicate that nicotine emission of Canadian cigarettes can reach up to about 1.4 mg per cigarette, a 40% difference with the mandatory EU ceiling.
This difference indicates that the amount of nicotine delivered by vaping products should be higher in Canada than in Europe to reflect the specificity of the Canadian tobacco market and to maximize chances that smokers adhere to an alternative safer than tobacco. Having an insufficient level of nicotine driven by a lower nicotine ceiling could result in a compensatory behavior which could translate to longer and deeper puffs or use of a higher power device. In fact, it has been reported that the use of a lower nicotine concentration e-liquid may be associated with compensatory behaviors, increases in negative effects, urges to vape and formaldehyde exposure. This is without considering that many smokers would simply keep smoking if not satisfied with a vaping product.
It should also be considered that the EU nicotine concentration ceiling of 20 mg/mL was based on limited evidence justifying its relevance to smokers wanting to use vaping as a way to stop smoking. The EU Commission’s justification for the 20 mg/mL ratio was based on the current strength of e-cigarettes sold at the time and on a paper published by Farsalinos et al. in 2013. That paper was based on the study of a small sample of only 111 subjects having substituted smoking for vaping for at least 1 month. In addition, in a letter sent by multiple credible scientists to the commission (including Dr. Farsalinos himself) which highlighted the scientific errors in the EU Tobacco Products Directive, it is indicated that e-liquid containing 20 mg/mL provides less than 1/3 of the nicotine delivered by one EU cigarette. It is also mentioned in the same letter that 50 mg/mL is needed to roughly match a EU tobacco cigarette and that most heavy smokers need more than 20 mg/mL to switch from smoking to vaping.
All the above demonstrate that the EU ceiling is too low to support sufficient nicotine delivery from many vaping devices at a level that would suit most smokers while minimizing exposure to any toxicants that could be found in vapour.
Factoring the 40% gap between the nicotine levels of EU and Canadian cigarettes, it is reasonable to consider that any nicotine ceiling should be at least 40% higher in Canada than the EU, if not much higher when taking into consideration consumer smoking or vaping behaviour, which includes sensory experience and product satisfaction such as ease of use, device power options and device design (including efficacy of the vapourization process that can all influence the nicotine delivery, just as nicotine delivery can impact sensory experience and product satisfaction).
In addition, a 20% tolerance on the nicotine concentration should be allowed, to factor the concentration variability resulting from manufacturing, measurement methods and stability of nicotine in the liquid. Such a tolerance factor is already applicable to the nicotine level of nicotine replacement therapy.
Applying the above-noted correction factors (40% and 20%) to the proposed ceiling of 20 mg/mL, the nicotine ceiling of vaping liquid should be at least 35 mg/mL, and higher if the need of smokers is considered. In this context, we strongly encourage the government of B.C. to keep the nicotine ceiling to the level set by the VPLPR (less than 66 mg/mL). Doing otherwise will severely limit the harm reduction potential of vaping products in Canada by reducing the likelihood of having smokers switching to vaping.
Nicotine-Containing E-Liquid Container Size Limit
In addition, VITA thinks that the proposed limitation on container size for nicotine-containing e-liquids will have multiple negative impacts on the effectiveness of vaping as a harm reduction tool.
- The cost to the consumer would be greatly increased under this proposal, resulting in a lower appeal for current smokers to transition away from combustible tobacco cigarettes.
- Smaller containers sizes also have a great impact on the efficacy of vapour products for senior citizens and those with physical ailments due to the small container being harder to open, close and dispense liquid from.
- Also, there would be potentially unconsidered negative environmental impacts resulting from the small container size for these single-use plastics as customers will be purchasing a larger number of containers.
Currently, the average purchase cost for a 60 mL container of e-liquid is $30.00, while the average purchase cost for a 10 mL container of e-liquid is $8.00. Under the proposed regulations, the consumer would experience an increase over 50% in additional costs over a 10-day period, without considerations for the increased 13% sales tax applied to vapour products as of January 1, 2020.
As a harm-reduction tool designed to help over 4.5 million Canadians battle their addiction to combustible tobacco cigarettes, we should make the purchasing cost for vapour products as reasonable as possible. We feel that reduction in container size for e-liquids has limited positive impacts on the availability of these products to youth.
Ten mL containers offer such limited surface area that being able to appropriately label products with warnings and all other required information contained in the VPLPR and CPLA results in confusing and difficult-to-read product labels (see Appendix 3 & 4). Small containers and closure sizes also make these products difficult for anyone with limited mobility in their hands to use these products. Negative usability impacts to consumers in the 50+ age category should be highly considered in proposed regulations as they face higher health risk as they have been smoking combustible tobacco cigarettes over an extended number of years.
3. Restrict the Sale of Flavoured Vapour Products
VITA does not support a flavour ban. Current regulations that prohibit the promotion of certain flavours are appropriate for the Canadian market and should be enforced.
We believe that Health Canada has struck the right balance between ensuring that adult smokers have access to less harmful alternatives while not promoting to young people.
Flavours are a complex issue yet play an important role for smoking reduction in adults. Many adult smokers looking for an alternative do not want a product that tastes like the cigarettes they are trying to leave behind.
Research confirms that flavours can help people to stop smoking and to avoid relapsing: A study by Tackett et al., (2015), found that flavours may be associated with higher rates of smoking cessation.
In the largest ever survey of Canadian vapers (4,000 +), Rights4Vapers concluded that:
- Adults use vaping to quit smoking.
- The vast majority (93.5%) of respondents reported quitting smoking because of vaping. Among the few respondents (112) who did not fully quit, 33 or 29.5% reported they were smoking less because of vaping.
- Adult vapers need flavours. Vapers begin using a single flavour that is almost never tobacco or menthol. As time passes, they increase the number and variety of flavours they use to remain smoke-free.
- Adult smokers need higher nicotine levels to switch. Smokers choose high nicotine levels to begin vaping, but then dramatically decrease their nicotine strength over time
In a study on US vapers, Farsalinos et al. found that “[t]he average score for importance of flavours variability in reducing or quitting smoking was (‘very important’)” and that “the majority of participants stated that restricting variability of flavours would make the [e-cigarette] experience less enjoyable while almost half of them answered that it would increase craving for tobacco cigarettes and would make reducing or completely substituting smoking less likely.” The study concluded that “EC liquid flavourings play a major role in the overall experience of dedicated users and support the hypothesis that they are important contributors in reducing or eliminating smoking consumption.” 
Public health experts have recognized the important role that flavours can—and do—play in increasing the potential for tobacco-free vapour products to act as a satisfactory alternative to cigarette smoking: Clive Bates, ex-director of UK anti-smoking charity ASH UK has stated that “nonusers should understand that flavours are an important aspect of vaping and integral to the experience. They are also part of a migration away from tobacco. Initial switchers tend to favour tobacco flavours but gradually move on to non-tobacco flavours often as part of a permanent switch from smoking.”
Jeff Stier, Senior Fellow at the National Center for Public Policy Research in Washington “[h]umans learn by association. When we associate the pleasure of nicotine with the burnt tobacco, we think we like burnt tobacco. What flavours help us do is disassociate the pleasure of the nicotine with the burnt tobacco.”
VITA agrees that preventing young people from vaping is a pressing and critical goal. However, we are concerned that the proposed ban on e-liquid flavours will actually do more harm than good towards this goal. Banning flavoured e-liquid will remove Good Manufacturing Process Standards (GMP) and replace them with inexperienced and unqualified individuals trying to enter the black market. A flavour ban or regulatory regime that severely restricts e-liquid flavours will create a thriving black market and allow for easier access for youth.
We have already begun to witness the dangers of unregulated, black market products: serious illness. These lung issues reported by the CDC and FDA relate to the use of black market, illicit substances. When you remove access to well-regulated, legal flavours, you do not remove demand. Instead, you force smokers to resort to use of potentially harmful black-market products that could result in illness or even death.
The Tobacco and Vaping Products Act addressed flavoured e-liquid: instead of banning the agent, it restricts the promotion of the flavour. This was a responsible way to regulate. This allows smokers to use their right to choose a product that is significantly less harmful and not be reminded of cigarettes and choose a flavour they wish to use. Speaking to those who have both smoked cigarettes and moved to vapour products, tobacco e-liquid does not taste like burning tobacco and is not desirable by most vapour product users.
4. New Labelling, Packaging and Health Warning Requirements
VITA praises the British Columbia government’s actions to reduce the prevalence of teen vaping through these proposed regulations. However, many of the concerns that BC sought to address with the proposed labelling, packaging and health warning requirements have now sufficiently covered by the VPLPR. Parts 1 and 2 of the VPLPR set out, in great detail, specific labelling and packaging requirements, including requirements to display health warnings. VITA supports Health Canada’s proposed labelling, packaging and health warning regime as it is robust, detailed and provides flexibility to change or add additional health warnings, as needed.
It is VITA’s position that BC should not impose additional labelling packaging or health warning requirements on manufacturers. Additional requirements would only serve to create confusion, and potentially place manufacturers in a position where it is difficult or impossible to comply with both sets of regulations.
5. Strengthen Restrictions on Public Advertising
The prohibition of any advertising that youth could see will prevent most forms of advertising online and any form of advertising in retail establishments that youth have access to, such as convenience stores. Although these restrictions may be intended to prevent youth from becoming attracted to vaping products, they will have the unintended effect of further limiting adult smokers’ awareness and understanding of vaping products and will undermine the potential of these products to convert smokers.
Since the legalization of vaping products, vape products have entered nearly 20,000 convenience stores across Canada. As a result, vapers can access these reduced risk alternatives in areas where there are no vape shops or at times when vape shops typically are not open. Another unique advantage of the convenience distribution channel is that this is where most adult smokers purchase their cigarettes.
The increased availability of vape products in convenience channels post-legalization only supports the goals of tobacco harm reduction if adult smokers know that vape products are available and if they are aware of the reduced risks associated with switching from smoking to vaping.
Without some form of advertising and promotion beyond what is allowed for tobacco products, adult smokers may not be aware that a much less harmful alternative is available. VITA is not asking for colourful signs, lifestyle advertisement, or enticing materials to promote vapour products but the opportunity to develop, and create information targeted at the adult smoker that communicates relative risks and benefits.
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