Monday 31 October 2022

Recent reports on the North American vaping market

This post reports on five recent events relevant to regulating vaping products in Canada. 

1) Health Canada inspectors find vape shops are still not following federal law.

This week, Health Canada  released the results of its fourth wave of inspections, finding that 60% of the specialist retail vaping outlets were not obeying the Tobacco and Vaping Products Act.  This report focused on inspections of brick-and-mortar stores conducted between August 2021 and March 2022.

This industry's socks are still around its ankles. In the first two inspection reports (235 stores between July-September 2019 and 845 stores between October and December 2029), Health Canada found more than 8 in 10 stores were breaking the law. During the COVID period (July 2020 to March 2021), inspections were focused on 304 social media accounts, of which more than half displayed illegal promotions. 

Gas and Convenience stores continue to be more compliant than specialist stores, with 11% failing the most recent test, compared with 12% and 14% three years ago.

2) University of Waterloo researchers report on what vape shops are selling

Last week, researchers from the University of Waterloo released their report on the vaping liquids offered for sale in Canada. (Vaping Products in Canada: A Market Scan of E-liquid products, flavours and nicotine content (2021)). 

Their review of bricks-and-mortar shops was conducted between April and May 2021 and the on-line survey was done in January to May 2021. This was a moment in time before federal restrictions on  nicotine content were in place, although they were established in two provinces (British Columbia and Nova Scotia). During this review, a ban on flavours was only in place in one province (Nova Scotia), but two others (British Columbia and Ontario) did not permit the sale in places where young people could enter.

This survey also found high levels of non-compliance. "Many online retailers did not comply with provincial nicotine limits and/or flavour bans. For example, 76% of e-liquids identified online in provinces with a full ban on fruit flavours contained a fruit flavour."

The researchers propose that age verification processes were needed to protect young people from accessing these web-sites in provinces where sales are limited to age-restricted venues.  Health Canada first indicated its intention to establish regulations on age-verification in February 2021, but has not disclosed further details since that time. 

3) Environics finds vapers do not have difficulty overcoming flavour restrictions 

Better age-gating does not address the range of concerns about vaping flavours. The focus of many regulators has now moved from putting in adult-only stores to broader restrictions on flavourings, as the governments of Nova Scotia, Prince Edward Island, Newfoundland, Northwest Territories have alrady done. Other options include prohibiting internet sales of vaping products, as Quebec does. 

Another recently-released report shows that supplier behaviour undermines these regulations. In early 2022, on behalf of Health Canada, Environics Research asked Canadian vapers about the products they used and whether they accessed flavours that were prohibited by provincial regulations. (POR 024-21, Factors Associated with changes in vaping behaviour during 2020). 

They found that adult vapers had little difficulty overcoming the restrictions if they wished to: 

"Youth and, to a lesser extent young adults, in Nova Scotia were most likely to report having been affected by the ban on flavours. Most of them found other ways to get flavours, such as homemade flavours being sold at school, or buying flavours from people at school who ordered them online. Some also reported they would buy flavours from stores that still sold them under the table.

"Adults in Nova Scotia were less affected by the restrictions, since many had previously smoked and preferred tobacco vaping flavour and others procured flavoured products online or by driving to a neighbouring province."

4. U.S. Food and Drug Administration does not yet see a public health benefit to menthol e-cigarettes

Another significant event last week was the announcement by the U.S. Food and Drug Administration that it would not allow the sale of menthol-flavoured Logic vapes. (The Logic device was marketed in Canada, but withdrawn in the summer of 2021 after Canada imposed restrictions on nicotine concentration.)

This was the first decision by the FDA regarding menthol flavourings. Under U.S. law, since September 2020, each product has been separately evaluated before being authorized for sale (although unauthorized products remain widely available). Authorization can only be issued if evidence is provided to the FDA that the product will protect public health - in effect that it will support smoking cessation and will not increase youth use. 

Of those products that have received marketing authorization from the FDA, the only flavour permitted has been tobacco-flavour.  Last year, the FDA recently explained its rationale: "For flavored ENDS (i.e., ENDS with e-liquid flavors other than tobacco or menthol, such as fruit), there is a known and substantial risk of youth initiation and use; accordingly, an applicant has a higher burden to establish that the likely benefits to adult smokers outweigh that risk. For tobacco-flavored ENDS the risk to youth is lower; accordingly, a lesser showing of benefit may suffice. Assessments for menthol flavored ENDS will be addressed separately. When it comes to evaluating the risks and benefits of a marketing authorization, the assessment for menthol ENDS, as compared to other flavored ENDS, raises unique considerations."

In its first decision on menthol, the regulator explained that it was not convinced that the potential benefits of menthol Logic e-cigarettes were greater than those for tobacco-flavoured ones: "the evidence provided within the application does not demonstrate that these menthol-flavored e-cigarettes are more effective in promoting complete switching or significant cigarette use reduction relative to tobacco-flavored e-cigarettes among adult smokers." 

Moreover, it found that menthol presented a higher risk for young people than did tobacco-flavoured: "For non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, existing evidence demonstrates a known and substantial risk with regard to youth appeal, uptake and use. "

Seventeen months ago, Health Canada took a different view on menthol, concluding that the potential risks to youth could be offset (balanced) by potential benefits for smoking cessation. In the June 2021 Proposed Order Amending Schedules 2 and 3 to the Tobacco and Vaping Products Act the department explained "by prohibiting all flavours with the exception of tobacco and mint/menthol, Health Canada aims to strike a balance between reducing the appeal of vaping products, to protect youth from inducements to use vaping products, and leaving some flavour options for adults who smoke and who have transitioned, or wish to transition, to vaping."  

The consultation period on Health Canada's proposed flavour restrictions ended in early September 2021. The department has not provided an update on its intentions since then.

5. Quebec government survey confirms young people are highly vulnerable to vaping.

Last week the results of the Quebec government's first survey focused on vaping were released. The survey was conducted between July and November 2020 by Quebec's statistical agency. The data were analyzed by the province's public health agency (Institut national de santé publique du Québec, INSPQ), and the results presented in the report l’Enquête québécoise sur le tabac et les produits de vapotage 2020. (The report is available only in French, and a translation of the main conclusions are presented at the end of this post.)

The survey confirms key findings from other survey on smoking and vaping in Canada: vaping has emerged as a nicotine-delivery system with widespread use among youth while cigarettes remain the preferred source by older Canadians. Although young people tend to be exclusive vapers, almost one-third also smoke cigareattes. Vapers older than 25 are as likely as not to continue smoking.  (Translated figure shown below)

Translation of the INSPQ's release "Vaping among Quebecers: data from the 2020 Quebec Survey on Tobacco and Vaping Products"

"Since they appeared on the Quebec market more than a decade ago, vaping products have experienced a dramatic increase in their use among adolescents and young adults. Faced with the emergence of this new mode of nicotine consumption, the Ministry of Health and Social Services mandated the Statistical Institute of Quebec to conduct the Quebec Survey on Tobacco and Vaping Products 2020 This is the first cross-sectional survey of vaping products in Quebec to be conducted among people aged 15 and over, with a second edition scheduled for 2023. Although the survey focused more broadly on the use of tobacco products (cigarettes, cigarillos, cigars, pipes, hookahs, chewing tobacco, heated tobacco), the objective of this document is to describe the use of vaping products and the behaviors associated with them, as well than the perceptions of Quebecers aged 15 and over with regard to the consumption of these products.

Here are the main findings that emerge from the analysis of data from the 2020 Quebec Survey on Tobacco and Vaping Products:

* The prevalence of vaping in the 30 days preceding the survey is 4%. It is higher among adolescents (18%) and young adults (15%) than among those aged 25 and over (2%).

* Among Quebecers who had smoked cigarettes or vaped in the previous 30 days, 11% reported using both traditional cigarettes and electronic cigarettes. This proportion is also higher among those aged 15-24 (21%) than among those aged 25 and over (8%).

* Vaping products are used daily by around one in two vapers (48%), with this frequency of use being more common among vapers aged 25 and over (59%) than among the youngest (37%).

* Less than half (43%) of vapers use liquids whose nicotine concentration exceeds 20 mg/ml, although this practice is much more common among 15‑24 year olds (63%) than among those 25 and over (24 %).

* Nearly two-thirds of vapers (66%) perceive themselves to be slightly or not at all dependent on vaping products, including a higher proportion of 15-24 year olds (75%) than 25 and over (58%).

* Specialty shops are the main source of vaping devices or liquids for about six in ten vapers.

Several events that occurred in 2020 and 2021, such as the various measures put in place to fight the COVID-19 pandemic or the new legislative measures governing the use of vaping products in Canada, could have contributed to changing the portrait of the situation of vaping in Quebec. In this sense, the next cycle of the EQTPV will make it possible to follow the evolution of the use of vaping products within the Quebec population following these changes."

Wednesday 19 October 2022

BAT's disposable "VUSE GO" arrives in Canada.

This post provides background to development in the Canadian e-cigarette market.

Introducing Vuse Go. 
Last week BAT/Imperial Tobacco Canada  began selling the disposable vaping device Vuse Go in Canada. 

From the advertising copy on its website, it appears that this new product is being used to recruit new users:  "Whether you are new to vaping, want to try some new flavours without committing, or simply aren’t sure which device is right for you, disposable vapes could be the option for you!"  (The launch is also supported by a Youtube advertisement.) 

Vuse Go is available in 9 flavours, each with a distinct device colour. Each device contains 2 ml of liquid and 40 mg of nicotine altered with benzoic acid (20 mg/ml). Each device is expected to deliver 500 puffs, and is intended to be thrown out when used up. The lithium battery capacity is 370mAh, and it is not rechargeable. A larger device - the Vuse Go XL - is "coming soon". 

BAT sells the device directly to consumers in provinces where the internet sale of flavoured e-cigarettes is legal. The price is $12.99 per single unit, and less if bought in quantities ($11 per unit for 2 and $10 per unit for 5). Shipping is free. 

No surprises here. 

Although PMI's move to disposable vapes this summer took some by surprises, the launch of Vuse Go in Canada has been foreshadowed for months. 

* This summer, BAT's largest competitor - Philip Morris International - had chosen Canada as the first market for its disposable, Veeba. 

* BAT had already introduced disposable vapes to its other top vaping markets: beginning in May in the United Kingdom, quickly spreading to France (as Vuse PUFF), Germany , Greece , New Zealand, Spain and likely other places. (The product will not likely be sold in the USA in the near future, as the U.S. Food and Drug Authority requires new brands of e-cigarettes to be inspected and authorized before being allowed on the market.)

* BAT had registered 6 versions of the Vuse Go trademark in Canada in the spring (Vuse GO, Vuse GO XL, Vuse GO Pro, Vuse GO UltraVuse Go Max, Vuse Go Extra.

* BAT's CEO had informed investors this summer that the marketing of disposable vapes was being done at an accelerated pace: "We launched Vuse Go our new disposable product in the UK in May. Taking just six months, this is our fastest speed to market launch yet and a great example of our increased speed and agility."

Move over, JUUL. Disposables are the next big thing.

Over the past year, disposable e-cigarettes have rocked the British and American vaping markets - so much so, that even the investment reporters are paying attention. Earlier this month, the Financial Times noted the impact of disposable vapes on the value of the former vape-giant, JUUL: "Disposable vapes are to Juul what TikTok is to Vine: wildly more successful despite being virtually the same in every way. And like Vines, Juuls could be about to go the way of the dinosaurs."

Reuters data cited in the Financial Times

Recent reports from Great Britain and the United States have tracked a dramatic increase in the use of disposable cigarettes by younger people. 

As U.S. state governments describe it, the wave of youth vaping that started in 2017 was a result of the product design and marketing of JUUL. Facing lawsuits and regulatory pressure, JUUL was forced to modify its business practices. The JUUL wave, from an investor's perspective at least, has crashed - but not before it mapped out a path to profits for its imitators.

Just as the first generation of youth vapers were drawn in by JUUL and its imitators, their younger siblings are being hooked by disposable vapes. This next generation product is even more youth-friendly than JUUL: no-charging means greater convenience and no incriminating paraphernalia, low-price means less pain if confiscated and more ability to share with friend. Like JUUL before them - and unlike previous cig-a-like disposables -  these new vapes have the cachet of being the latest teen fad. But like JUUL -- and unlike fidget spinners -- this is a teen fad that can leave lifelong consequences. 

As affordable as fast-food.

These disposable devices are as affordable to young people as a meal at a fast food restaurant: the Vuse GO costs about the same as a McDonald's Big Mac Meal ($12.19). 

The price of PMI's VEEBA
was cut at 180Smoke
the week after
ITL introduced VUSE GO.
The $12.99 price includes the federal excise tax of $1.00, which took effect at the beginning of October. This tax was intended to help curb youth vaping, but without any complementary price regulations to ensure a minimum price or to prevent the manufacturers from altering prices to diminish the effect of the tax.

Other tobacco companies are disposable vapes at even lower prices. The introductory price of PMI's Veeba was $9.99 - but this week -  perhaps in response to the introduction of Vuse GO - the price was lowered to $5.99.

As tasty as food treats

The new disposable vapes are sold in kid-friendly flavours.  Other than one tobacco flavour, most of the other 8 are the "ice" variants of fruit flavourings that have been shown to be particularly popular with young people. (The flavour profile of PMI's Veeba is similar).

But with harms that could go beyond addiction

One of the challenges of establishing the impact of vaping products has been the range of devices and liquids that are used, and the absence of a standardized dose that can be analyzed. Disposable vapes, however, are a standardized product and allow reliable analysis to indicate the chemicals to which a vaper is exposed. Studies of popular American disposable products (Puff Bar) have found excessive levels of  harmful chemicals, particularly those used to produce ice flavours and have raised concerns about respiratory cancer risks

The chemical profile of Vuse Go aerosols is not public. Tobacco companies are required by Canadian law to report on the quantities of certain toxins in the emissions from cigarettes, but the government has decided against imposing this requirement for electronic cigarettes. 

Disposable toxic waste.
The US FDA recommends
that e-cigarette devices
and pods be disposed of as 
toxic waste. 

Disposable vaping products intensify concerns about the environmental damage of tobacco and nicotine products. Because of the harmful chemicals in the batteries and liquids, U.S. government agencies urge vaping devices and equipment  to be treated as toxic waste.

A recent investigation by British journalists concluded that the quantity of disposable vapes thrown away in the UK each year contained enough lithium to make roughly 1,200 electric car batteries.

Sensitive to these concerns, BAT/Imperial promotes its "Vuse Take Back" system, and encourages disposable products to be discarded through a "responsible disposal program." To participate in this program, consumers are told they can return their Vuse ePod devices in person to one of two stores (Toronto and Edmonton). As for the disposables -- that is not yet in place ("coming soon".)

In the case of VEEBA, a disposal system for returned products has been implemented by RBH, albeit one that requires some organization and effort by consumers. To participate in this system, consumers must order and print a shipping label, package the used products and schedule a pick up for shipment.

New challenges for health regulators ...

In some countries, disposables have entered the market through cracks in health regulations or weaknesses in enforcement systems. 

It was the U.S. ban on flavourings in JUUL-style products (and uncertainties about the status of synthetic nicotine) that became a springboard for disposable products like Puff Bar.  In the United Kingdom, enforcement did not prevent the marketing of vaping products which broke U.K. regulations on maximum levels for nicotine and liquid volume. Denmark has also found that disposable vapes are being sold in defiance of its ban on flavoured liquids. 

These experiences demonstrate new challenges facing health regulators as a result of increasing innovation in the nicotine market.  A recent review of market trends concluded . The author of a recent review of market trends concluded "These challenges will increase as the tobacco industry continues to diversify its product portfolio, and weaponises ’tobacco harm reduction’ rhetoric to undermine policies limiting marketing, promotion and taxation of tobacco, nicotine and related products."

... Prompting new regulatory actions 

A number of governments have moved to better protect young people and the environment from the marketing of disposable vaping products.

* Last year, the Belgian government indicated its intention to ban disposable vaping products. In the face of trade challenges, the measure has been deferred, but the government says it intends to pursue it

* Last week, the Irish Minister of State proposed a ban on disposable vaping devices, possibly as a component of bans on single-use plastics.

* This fall, Denmark has established an inter-ministerial “control task force” to address disposable e-cigarettes that were entering the market in defiance of the ban on flavoured vaping liquids.
* In September, Switzerland disclosed that it is considering putting a surtax on disposable devices

* Earlier this month, the U.S. FDA has increased its enforcement efforts against Puff Bar and other manufacturers of similar disposable products. 

* In April, the French territory of New Caledonia banned the importation of disposable e-cigarettes

In addition, 30 countries aim to protect public health by not permitting the sale of any vaping products, and 8 countries have moved to ban flavourings other than tobacco-flavour or tobacco and menthol.

Health Canada has signalled its intent to curtail flavourings, with draft regulations proposed in the early summer of 2021. In its forward regulatory plan of 2021, the department also identified the need to "impose restrictions on design features that are appealing to youth to prevent their use in the manufacture of vaping products."  There has been no update on the timetable for flavour restrictions, and plans for design regulations were dropped in the spring 2022. 

Will we know if disposables cause problems in Canada?

Federal government surveys of vaping behaviour (like the Canadian Student Tobacco, Alcohol and Drugs Survey, the Canadian Community Health Survey and the Canadian Tobacco and Nicotine Survey) are not designed to monitor the impact of device or brand on consumer behaviour, or to provide quantitative evidence to support policy or regulatory adjustments related to these aspects. They will not track the use of disposable vapes by Canadian youth or adults. (Health Canada's Canadian Cannabis Survey, by contrast, does ask questions about the use of disposable devices). 

Other consumer research commissioned by Health Canada has on occasion provided qualitative insights into the impact of product design. For example, a study by Environics, made public this fall, concluded that "It was notable that, among youth – many of whom were still in high school – many either used disposable vapes such as Ghosts, or would share vaping devices with friends" ... "Participants appreciated their compact nature, the variety of flavours available and their affordability compared to larger vapes, for which pods had become expensive. A few also explained that the nicotine concentration is higher in smaller devices, and they generally taste better." 

Implications for public health

Big Tobacco's involvement in the disposable vape business exposes several vulnerabilities in Canada's public health approach to nicotine. 

Canadian regulators appear unconcerned or unprepared. Although the increased use of disposable vaping products has raised concerns and prompted new actions in other countries, Canadian federal and provincial health regulators have so far been silent about this development. 

Our core health surveillance tools are not designed to assess the impact of specific products. Unlike the U.S. PATH study,  Canadian government surveys do not follow the smoking trajectories of individuals (they are not longitudinal), and they do not gather information on the products used.

Canada has no protective barriers to market access. Unlike the European Union, Canada does not require pre-notification of the introduction of vaping products. Unlike the United States, Canada does not require vaping product manufacturers to receive authorization for new devices or brands.
Canada's regulatory system does not provide a timely response to tobacco market developments. Unlike other health protective laws, the federal tobacco law does not authorize the government to implement interim regulations or otherwise reduce the time to respond to urgent concerns. (Three of the 5 tobacco- and vaping-related regulations currently in development were launched more than 5 years ago).

There are no health-protective controls on nicotine prices. Despite the evidence establishing the benefits of higher prices in reducing smoking (and other drug use), governments have been reluctant to impose price controls on tobacco or nicotine products. Taxation helps elevate prices, but does not prevent companies from selling below the cost of production to recruit new users to addictive products. 

Friday 7 October 2022

With schools 'back to normal' what has happened to youth vaping rates in Canada?

This post provides an update on surveys of tobacco and vaping behaviour of Canadian youth. 

Annual results from U.S. school surveys on tobacco use

This week, American media are reporting monitoring efforts by the Center for Disease Control, which reports 1 in 7 high-schoolers in that country (14%) used a vaping product in the last school year (January to May 2022). Most of those kids  were using disposable devices (67%) with fruit-flavoured liquids. (68.5%) 

The U.S. results are encouraging when compared with the pre-pandemic situation uncovered by the same National Youth Tobacco Survey in 2019, when almost twice as many students were vaping (27.5%). There are no statistically comparable results for the pandemic years because olf methodological changes triggered by school closures. The modified on-line survey conducted in 2021 produced lower estimates of e-cigarette use than the in-class survey in 2022. 

These results are an important way to monitor the impact of a changing policy and evolving business practices. In 2019 and 2020, the U.S. government introduced a number of measures designed to curb youth vaping. These included raising the legal age to purchase vaping or tobacco products to 21 years, and banning the sale of certain types of flavoured products. In response to the results released yesterday, advocates are calling for more comprehesive flavour bans and the marketing of disposable products is coming under increased scrutiny.

Gaps and holes, but Canadian school survey data are on the way ...

The Canadian Student Tobacco, Alcohol and Drug Survey

The most recent national estimate of tobacco use among Canadian school students is now more than 3 years old. Results of the Canadian Student Tobacco Alcohol and Drug Survey (CSTADS) conducted in the 2018-2019 school year were made available in December 2019. The data was alarming - showing that by their senior high school years, 3 in 10 Canadian children were vaping. These results were used by Health Canada as support for its proposals to reduce nicotine levels and restrict flavours in vaping liquids.

Those results were the last assembled by a team at the University of Waterloo, which had administered the survey on behalf of Health Canada for several years. In 2020, a competitive process was launched to selecting a new agency to conduct the survey, causing an interruption to the traditional two-year cycle. No federal school surveys were taken in the 2019-2020 or 2020-2021 school years. In December 2020, a $1 million-dollar contract was awarded to CCI Research to continue the survey in the 2021-2022 school year

This cycle of the survey asks no questions about the types of vaping devices or brands that Canadian students are using, although such information had previously been sought.  No date for release of this next wave of survey data has been made public.

Other school-based surveys

Some provincial governments conduct school health surveys which include information on tobacco use:

* The bi-annual Ontario Student Drug Use and Health Survey, for example, is the longest ongoing survey of school health. In 2021 it conducted its 4th survey of e-cigarette use, finding a similar trend to that observed in the U.S: a dramatic increase in 2019, with usage falling during the pandemic. 

* B.C. runs an adolescent health survey every five years, with the next cycle in 2023. 

* Results for Quebec's school based health survey addressing tobacco and vaping, among other drug behaviours, were last released for 2019, with another survey on more comprehensive health behaviours in the field this fall.

* Compass is a school-focused health research project led by researchers at the University of Waterloo which provides longitudinal insights into local behaviours. The annual survey provides data that are used to assess factors that contribute to reduced e-cigarette use (i.e. ineffectiveness of school programming, the impact of COVID, relationship to other health behaviours, etc.)

Other (non-school surveys of adolescent health behaviours)

Other efforts to measure vaping by young Canadians include the annual Canadian Tobacco and Nicotine Survey, which was launched in 2019. The most recent results of that survey were released by Statistics Canada last April. The results, shown below, suggest some stability in past-month vaping behaviour over the past three years, but with increased daily vaping (unpublished data show that 1 in 5 Canadians aged 15-24 who had ever tried a vaping device was vaping daily in the winter of 2021-2022). 

Since 2021, the Canadian Community Health Survey includes questions on e-cigarette use. These results have not been proactively released and are not known to have been reported (other than those from a rapid-release component of the survey taken in 2020). Electronic cigarette use is not included among the standard health indicators reported by Statistics Canada from this survey. 

The ITC Youth Tobacco and Vaping Survey conducts annual national surveys in Canada and also in the US and England. This survey asks about the types of vaping products used, allowing comparison of product choices between countries and over time.

Continuing challenges

The long periods between cycles of government surveys, the preference of university-based surveyors for disseminating results through journal publications, the absence of mandatory reporting on manufacturers and the complexities of studying youth behaviours make it challenging for Canadian  health regulators to keep their finger on the pulse of youth nicotine use -- let alone to respond in a timely way.

In the meantime, the data that are available suggests that vaping remains a serious and widespread problem. 

Many upstream measures to protect youth are either not yet in effect (eg tax increases that don't hit retail until January 2023), not yet approved (eg flavour restrictions) or not even on the agenda (eg banning youth-focussed disposable products). Tobacco and nicotine companies continue to experiment: and there is nothing in place to prevent the explosion of disposable vaping products that has driven  increases in youth vaping in the United Kingdom, the United States and elsewhere. 
Until then, this health issue will likely continue to be managed as a downstream policing issue -- with the burden shifted to school administrators and sales-to-minors enforcement officials.