Monday, 25 May 2020

Does vaping lead to smoking? Accumulating evidence of a gateway effect

Science marches on.
Four years ago, there was uncertain evidence that e-cigarette use by adolescents might lead to more smoking later on. Since then, a number of additional studies have been done. While the resutls vary, the evidence now consistently shows that early e-cigarette use is associated with subsequent uptake of smoking.

This post highlights four studies that show how evidence of a "gateway" effect has become progressively stronger over four years.

2016: Slower declines in youth smoking linked to e-cigarettes.

Jessica Barrington-Trimis and her colleagues analyzed data from grade 11 and 12 students, taken from a longitudinal study of children's health that was conducted in California in 1995, 1998, 2001, 2004 and 2014. Before e-cigarettes became available, smoking among California adolescents had been declining. Then in 2014, combined current e-cigarette use and cigarette use among Grade 12 students reached 13.7%. This was substantially greater than cigarette use in 2004 (9%) and only a little less than Grade 12 smoking prevalence in 2001 -- 14.7%.

These results suggested that e-cigarette use was occurring in adolescents who would not have otherwise used tobacco products.




2018: Young e-cigarette users much more likely to smoke cigarettes

The 2016 results were suggestive of an association between e-cigarette use and later smoking, but stronger evidence was needed. Dr. Barrington-Trimis and her colleagues pooled data from three similar prospective studies of high school students -- two in California and one in Connecticut. E-cigarette users were 4.6 times more like to become experimental cigarette smokers, 4.3 times more likely to become occasional cigarette smokers and 3.5 times more likely to become frequent cigarette users,

2017: E-cigarette users 4 times more likely to smoke.

While Dr. Barrington-Trimis were conducting their pooled analysis of data from three high school surveys, other researchers were conducting a meta-analysis.

(This type of pooled analysis treats the data from several sources as one larger data set. It is appropriate when the data sets are similar, as they were in the work of Dr. Barrington-Trimis and her colleagues -- data from three similarly-conducted prospective surveys of high school students. When data from different sources are more heterogeneous, meta-analysis is the preferred analytical procedure. Weighting procedures are used to adjust for differences among data sources.)

Dr Samir Soneji and his colleagues performed such a meta-analysis and published their results in 2017. Their results were similar to the results of the pooled analysis discussed above. Based on the combined results of nine studies they found that adolescents who had ever used e-cigarettes were 4.3 time more likely to become cigarette smokers.

2020: A bigger, more definitive meta-analysis provides more evidence for concern.

Science marches on and studies accumulate. By 2020, more studies on the relationship between vaping and youth smoking had been done and a larger meta-analysis was possible.

In March 2020, Jasmine Kouja and her colleagues published a meta-analysis of 17 studies of e-cigarette use and later smoking among youth, Their results were remarkably similar to earlier results from a pooled analysis and the previous meta-analysis.. E-cigarette users were 4.6 times more likely to become cigarette smokers later on. Results differed among the 17 studies in the meta-analysis, but all showed e-cigarette users more likely to become cigarette smokers, with findings ranging from 2.5 times more likely to 12.3 times more likely.


From less certain to more certain

In just four years, through repeated observations, we have moved from a tentative conclusion that e-cigarette use by adolescents might be associated with subsequent cigarette use to very strong evidence in support of a gateway effect. Seventeen studies from several different countries (including one from Canada) all found a relationship between e-cigarette use and subsequent uptake of smoking. 

While alternatives to this being a causal relationship still cannot be completely dismissed, it is now increasingly unlikely that the relationship is not one of cause and effect.

The studies cited above:

Barrington-Trimis, JL et al. E-cigarettes, Cigarettes, and the Prevalence of Adolescent Tobacco Use. Pediatrics August 2016, 138 (2) e20153983; DOI: https://doi.org/10.1542/peds.2015-3983

Barrington-Trimis, JL et al. E-cigarette Use and Subsequent Smoking Frequency Among Adolescents. November 2018 Pediatrics 142(6):e20180486

Soneji, S et al. Association Between Initial Use of e-Cigarettes and Subsequent Cigarette Smoking Among Adolescents and Young Adults. A Systematic Review and Meta-analysis. JAMA Pediatrics. 2017; 171 (8)

Khouja, JUN et al. Is e-cigarette use in non-smoking young adults associated with later smoking? A systematic review and meta-analysis. Tobacco Control. March 2020.

Tuesday, 19 May 2020

Banning menthol and other flavourings in cigarettes

"Menthol use is likely associated with increased smoking initiation by youth and young adults. Further, the data indicate that menthol in cigarettes is likely associated with greater addiction. Menthol smokers show greater signs of nicotine dependence and are less likely to successfully quit smoking. These findings, combined with the evidence indicating that menthol’s cooling and anesthetic properties can reduce the harshness of cigarette smoke and the evidence indicating that menthol cigarettes are marketed as a smoother alternative to nonmenthol cigarettes, make it likely that menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes."
U.S. Food and Drug Administration2013
Despite an international scientific consensus in favour of banning menthol in tobacco products, the vast majority of countries continue to permit tobacco companies to add menthol to cigarettes.

The number which do will grow dramatically this week. On Wednesday (May 20th) the sale of menthol cigarettes will be banned in the 27 member states of European Union and also the United Kingdom.

Outside of Canada (and now Europe), only a handful of countries - Turkey, Moldova, Uganda and a few others - have ordered tobacco companies to stop adding menthol flavours to cigaretes. Some countries have tried and failed: tobacco companies used challenges (eg Brazil) or intensive lobbying (eg the USA) to prevent health authorities from taking this step.

All the more reason that Canadians should be proud and appreciative of the efforts of federal and health ministries for succeeding where others have failed or not ventured. This month we celebrate the 5th anniversary of Nova Scotia becoming the world's first jurisdiction to ban menthol in cigarettes. It was that province's strengthening of its Tobacco Access Act in May 2015 that set the stage for a now Canada-wide ban on flavoured cigarettes.

This post reviews the Canadian experience of restricting menthol and other flavouring additives in cigarettes, and some assessments of the benefits of such regulations. (A chronology of events is available on a downloadable fact sheet.)

------------------------------------------------------------------------------

IMPLEMENTING FLAVOUR BANS IN CANADA

From the "candy coated" cigarillos of the early 2000s ...

Regulatory controls on cigarettes are stronger than those on cigars and other tobacco products. In the early 2000s, some tobacco manufacturers began to exploit that difference, introducing individually-packaged fruit- and candy- flavoured little cigars on to the market. These 'little cigars' were the same size and shape as cigarettes, and were sold with cigarette-type filters. Buy because the wrapping paper was made with tobacco leaves, they met the legal definition of cigars.

The strong appeal of these products to young Canadians was soon recognized, and in 2009 the federal government introduced the first law banning flavouring ingredients in some Canadian tobacco products. Menthol was exempted from these flavour restrictions, as were larger cigars and other tobacco products.

Sadly, this law was soon circumvented by companies which redesigned their products to take advantage of the remaining loopholes. Young people continued to be the primary market for this sweeter tasting smoking experience.

Quickly, both provincial and federal governments were encouraged to adopt more powerful restrictions, and to also ban menthol in cigarettes

... to more comprehensive bans on flavourings ...

Over the last half-decade, provincial, federal and territorial governments greatly strengthened restrictions on tobacco flavourings. Two approaches have been adopted:

1. Banning the use of additives, including flavouring agents. This is the approach taken by the federal government.

2. Banning the sale of cigarettes or other tobacco products which have a “characterizing flavour”. This is the approach generally taken by Canadian provinces.

Seven Canadian provinces and two territories have implemented bans on flavoured tobacco, including a ban on menthol cigarettes.

Nova Scotia was the first province to ban menthol in Canada (and one of the first in the world), a measure it introduced in the spring of 2015. Nova Scotia exempted some products from its ban, as did three other provinces and one territory which have adopted flavour restrictions. These are Alberta (2015), Ontario (2016), Newfoundland and Labrador (2017) and Northwest Territories (2020).

Three provinces and one territory have implemented comprehensive bans on flavours in all tobacco products: Quebec (2016), New Brunswick (2016), Prince Edward Island (2017) and Yukon (2020). 

In November 2018, a federal ban on the sale of menthol cigarettes came into force. 

.... although holes remain ....


The federal government has comprehensive restrictions on flavourings in cigarerettes, certain small cigars and blunts. There is an exemption for some alcohol-flavoured small cigars. Health Canada currently does not restrict the use of menthol or other flavour additives in large cigars, pipe tobacco, kreteks, waterpipe tobacco, snuff, chewing tobacco, roll your own tobacco or heated tobacco. These are, however, banned in some provinces, as shown below. 




.... and tobacco companies continue to exploit remaining loopholes.   

There is growing public concern about the role that flavours play in inducing young people to use vaping products and Canadian regulators are now grappling with regulating this new candy-coated addiction.

Again, Nova Scotia is providing leadership. It is the first Canadian province to take action on this issue - its ban on flavourings in e-cigarettes came into force on April 1.

Additional challenges are on the horizon. BAT has developed flavoured nicotine pouches (made without tobacco, and thus exempt from tobacco regulation). These are currently in sale in the UK and in the USA - where they are sold in a variety of flavours.  (These 'modern oral' products were discussed here earlier).

------------------------------------------------------------------------------

HISTORIC NOTES ON THE CANADIAN MENTHOL MARKET

Menthol cigarettes have been successfully phased out 


Traditional menthol cigarettes have historically represented about 5% of the Canadian cigarette market. Capsule menthol products, highly popular in some countries, were sold only briefly here before the menthol ban came into force in November 2018. But with menthol bans in place in the most populous provinces by 2017, menthol products had already largely disappeared from the Canadian market the previous year.

Health Canada - Tobacco Sales in Canada: Key Trends. June 2018

Menthol bans have reduced smoking in Canada.

To date, public studies suggest that the menthol ban in Canada reduced the number of smokers. These include reviews of the Canadian experience by health researchers and also by British American Tobacco. Industry analysts have also predicted that menthol bans will reduce cigarette consumption.

Researchers at the University of Toronto and Health Canada recently published a review of the impact of the Canadian menthol ban. Michael Chaiton and his research partners compared data on cigarette sales from 2012 to 2017 from a Canadian province which did not ban menthol (British Columbia) with one that did (Ontario). The Ontario ban on menthol cigarettes came into force at the beginning of 2017. They found that in British Colmbia there were no significant changes in cigarette sales in 2017, but there were sharp declines in Ontario. "This suggests that menthol regulations in jurisdictions with a larger percentage of menthol smokers are likely to be highly effective."  

Another study led by Michael Chaiton followed a group of Ontario smokers before and after the ban on menthol. It found that those who had smoked menthol cigarettes regularly were more likely to have quit than were those who smoked regular cigarettes. Banning this additive resulted in an increased overall rate of quitting 1 year later.

British American Tobacco's report on events is consistent with the evidence that a ban on menthol will reduce cigarette smoking.  In a presentation to investors last year, it reported that while traditional menthol cigarettes had a market share of 4% (as Health Canada reported), the capsule market picked up an additional 10% of the market-share. BAT also reported on the impact of the menthol ban on smokers in Alberta. (slide 32), on whom it had hired Kantar to do follow-up surveys. One percent of all smokers (equal to 17% of menthol smokers) had stopped smoking cigarettes after the ban was in place. With Canada's low prevalence of menthol use, however, BAT found there was "no material industry impact post ban."

Industry trade analysts agreed. "The recent ban on menthol tobacco products, such as cigarettes, is likely to make it even harder for tobacco suppliers to recruit new young customers." Euromonitor wrote in its 2018 (not public) Report on Canada. Two years earlier, in another (subscription-based) review of the global tobaco market, it had predicted that the ban on menthol in Europe would reduce the number of cigarettes smoked by 25 billion.

Tuesday, 12 May 2020

The PATH that leads to understanding the vaping epidemic

Finding the PATH

Since 2013, there has been a remarkable survey operating in the United States that has deepened our understanding of tobacco and e-cigarettes use and consequences. It is the Population Assessment of Tobacco and Health Survey (PATH) - a longitudinal, nationally representative survey of 46000 Americans. This survey generates information on tobacco and e-cigarette use behaviours, and with its longitudinal design it interviews the same individuals every year. It is planned that the survey will continue at least until 2024.

Exploring the PATH

Data from this survey has already been analyzed and there at least 104 publications using PATH data. From these studies we have learned, for example, that e-cigarette users are more likely to progress to becoming combustible cigarette users, and that, in a longitudinal analysis, e-cigarettes use was associated with lung disease.

Following the PATH to more new discoveries

Recently, a multidisciplinary, multi-agency team of scientists has taken a deep dive into the PATH longitudinal data to explore the process of becoming a tobacco or e-cigarette user. Their findings were published this month in 10 papers in a special supplement to the journal Tobacco Control.

From cross-sectional data we can count the numbers of smokers, former smokers and never smokers, but we cannot discover how one moves from one behaviour to another. That can be learned from longitudinal data and that was the focus of this recently published work. Researchers studied the movements from one state to another as shown here: 




This diagram is actually a simplified depiction of the number of changes of state that can occur, as as it does not show movement from one product category to another. British American Tobacco also pays attention to how people move into and out of tobacco use and how they move from one product to another. Their diagrammatic representation of this process is considerably more complicated.



The simplified model of transitions shown in the Figure "Behavioral Transitions" can be applied to each product -- e-cigarettes, combustible cigarettes, cigars, hookah and smokeless tobacco. Further complication can be added by studying multiple use of products and movement from one product to another.

The papers in the Tobacco Control supplement address all these subjects, although the results are not presented in the most accessible style. However, the most widely used products are e-cigarettes and combustible cigarettes, so we will examine the findings concerning these products more closely.

Cigarette Smoking

Most of those who had smoked a cigarette in the past month in 2013-14 had done so again two years later. Fewer than one-third (29%) of youth, one-quarter (25%) of young adults and one-seventh (15%) of adults had quit smoking two years later. Among those who had stopped in the year between, one-tenth of youth (11%) and one-thirtieth of adults (3%) had returned to smoking the following year.




E-cigarettes (ENDS)

It should be kept in mind that these papers study the first three waves of the PATH study, ending in 2016. The rise of closed-pod systems such as JUUL and other copycat brands that have grown to epidemic proportions among our youth has occurred since that date.

Still, trends up to 2016 show that there was already a developing youth epidemic of e-cigarette use. From Wave 1 to Wave 3 (2013 to 2016), use by youth (12-17) of e-cigarettes in the past 30 days grew from 3% to 4%. Among young adults (18-24), past 30-day use grew from 13% to 17%. Some of this e-cigarette use was experimental.

By Wave 3 (2016), 54% of the youth that had been using e-cigarettes at Wave 1 had discontinued e-cigarette use. The corresponding figure for young adults was 62%.




Poly-tobacco use 

The diagrams from the papers shown above do not capture the degree to which young people and adults use both cigarettes and e-cigarettes, although this PATH study confirms that most of those who used e-cigarettes were also smoking.

Among young adults, almost half of those who only used e-cigarettes at Wave 1 had stopped using any tobacco product over the two study waves (46%). Among those who used both e-cigarettes and combustible cigarettes, the proportion who ceased use of all nicotine products was much lower -- slightly more than 1 in 10 (12%). (Table 1)

Stanton et al, the authors of another study of PATH data similarly concluded:
"The majority of ENDS use is polytobacco use, and ENDS polytobacco users who also use cigarettes are less likely to stop using tobacco 2 or 3 years later compared with exclusive ENDS users."

PATH-type studies in Canada?

There is currently no direct equivalent to the PATH study in Canada.

Previous longitudinal surveys involving smokers included the Survey on Smoking in Canada, which was launched in 1994 to assess the impact after the federal government cut tobacco taxes; the National Population Health Survey, which was in the field for more than a decade and the Ontario Tobacco Survey  which collected data from 2005 to 2011.

The COMPASS survey, managed through the University of Waterloo, is an ongoing longitudinal survey of school children across Canada.

Saturday, 9 May 2020

Nova Scotia and Ontario move to curb high-nicotine vaping products

While the world and public health systems have been gripped with managing COVID-19, a number of regulatory changes have nonetheless been put in place with respect to vaping products.

This post provides an update on some noteworthy Canadian policy decisions in 2020.

Dialing down the nicotine:

Last Tuesday, Nova Scotia adopted regulations "to add restrictions respecting nicotine potency ... effective on and after September 1, 2020". It is believed that the limit set will be 20 mg/ml. Nova Scotia is the first province to adopt this ceiling.

On April 28, Ontario formalized regulations which will allow only specialty vape shops to sell vaping products that have higher nicotine levels than 20mg/ml. This will come into force on July 1.

Addressing flavours, access and price:


The regulations adopted by Ontario in late April will restrict the types of flavours that can be sold in stores other than specialty vape shop.  Convenience stores and other locations will only be able to sell tobacco, menthol and mint frlavours. This will come into force on July 1.

On April 1st, Nova Scotia became the first Canadian province to ban the sale of flavoured vaping products. Prince Edward Island has proposed draft regulations to similarly restrict flavours, for which notification was given to the World Trade Organization.

On March 1st, Prince Edward Island banned the sale of vaping products in stores other than specialty vape shops, and set the legal age for sale at 21 years.

On January 1st, British Columbia became the first province to put a specific tax on vaping products Nova Scotia's Budget promised a vaping tax to take effect on September 15. Alberta's Budget promised a 20% tax on vaping products, but did not set an implementation date.

Other provincial governments and Health Canada have indicated that they intend to strengthen other regulations on the way these products made and sold. In March, Minister Hajdu told Parliament that "nicotine concentration and flavours are two of the areas where we believe we need to take stronger and quicker action."

A brief summary of these Canadian restrictions (and the graph below) are available on a fact sheet downloadable here. A chronology of regulatory developments on e-cigarettes in Canada and elsewhere can be accessed here



Monday, 4 May 2020

New vaping promotions expose challenges to regulators.

Over the past couple of weeks, BAT (owner of Nicoventures and Imperial Tobacco Canada) has launched new promotions in Canada for its vaping products. This campaign is part of a global re-branding initiative the company shared with investors in March.

This campaign can be seen as a test run of the federal government's plans for stricter rules on vaping promotions (announced in December). While seemingly following these new rules, BAT has nonethless been able to make vaping look fun, easy, not dangerous - and eminently 'tryable'.

This post looks at how this campaign exposes some of the challenges in our current constraints on nicotine marketing.

1: The companies have plenty of creative space to make their brands look sexy and cool.
The federal law on vaping and tobacco advertising takes a different approach with respect to vaping and tobacco advertising restrictions. For tobacco, all promotions are banned except those which are specifically permitted. For vaping, all promotions are allowed except those which are specifically banned.

This law prohibits "lifestyle advertising" for vaping products (s. 30.2), and defines a lifestyle ad as one which "associates a product with, or evokes a positive or negative emotion about or image of, a way of life such as one that includes glamour, recreation, excitement, vitality, risk or daring." The narrowness of the definition is rooted in a 2007 ruling of the Supreme Court.

Despite this prohibition, last year the social media pages run by BAT in Canada were laden with lifestyle imagery, like those from 2018 shown below. This drew complaints (including our own) as well as enforcement action by Health Canada.

Once Health Canada told them to remove the lifestyle influencer ads, BAT replaced them with more static images linked to product attributes like flavours and design. As the current ads from 2019-2020 shown below demonstrate, the company continues to make vaping products look exciting and glamourous -- but not in a way that is considered by enforcement officials to go against federal law.


Vype-Vuse Canada Instagram Feed 2018





Vype-Vuse Canada Instagram Feed 2019-20.

  

Vype-Vuse video promotions - 2018 and 2020 (click to play)


2: Domestic regulation is ineffective when global social media is exempted
Government authorities have been clamping down on influencers and other social media promotions, but the industry has shown little respect for national-level regulation.

The United Kingdom advertising authority, for example, told BAT last December to stop using Instagram in ways that general audiences could access them. Health Canada sent Imperial Tobacco warning letters regarding the content on its social media accounts.

BAT's response? To set up Instagram accounts in other countries and to provide links to these sites in its domestic posts.

The most recent Instagram and Facebook posts of Vype Canada are shown below. These are informational ads -- but the hashtags within them immediately lead viewers to promotions that provide, let us say, a very different type of promotion. Note the first reference on both pages to #vusechargebeyond (which we highlighted in yellow). This term was trademarked by BAT in Canada last October.

Through its global presence, BAT manages dozens of Instagram, Facebook, Twitter, and Youtube accounts. Some of these are linked to countries (e.g. , Vypeitalia), others are stateless (e.g. vype_worldwide). The national accounts become gateways to global promotions which flaut domestic regulations.

For example, social media streams link Canadians to promotions that are banned in Canada, such as sponsored virtual concerts, race cars, and fashion.

Canadian law is poorly structured to take action against these promotions. Even though the federal law was drafted in 2017, it makes no provision for social media. The decision of previous decades to take no action against imported magazines and broadcasts has been applied to socoial media. (TVPA, s. 31). Individuals or companies based in Canada are not allowed to use that exemption -- but as long as the campaigns are run by multinational headquarters, these promotions benefit from this statutory carve-out.

Last year Instagram and Facebook's pledged to stop paid influencers promoting vaping products. BAT seems to have found a way to #chargebeyond that barrier.

Imperial Tobacco's social media pages direct viewers to trans-border advertising.

Govypeca Instagram refers viewers to #vusechargebeyond:


Vype Canada Instagram May 2020
showing link (highlighted) 
to #vusechargebeyond



#vusechargebeyond Instagram May 2020



Vypeca Facebook refers viewers to #vusechargebeyond:


Vype Canada Instagram May 2020
showing link (highlighted) 
to #vusechargebeyond

#vusechargebeyond Facebook May 2020



3: Product and packaging are used as advertising platforms
This winter plain and standardized packaging became a requirement for tobacco products sold in Canada, as plain packaging had been required for cannabis products since 2018. Soon, cigarettes will also be required to have a standardized appearance.

The federal labelling requirements for Vaping products were finalized in December and come into force on July 1. These new rules require companies to increases the size of the warnings and standardize the appearance of the nicotine concentration, as BAT has done in its new Vype-Vuse packages. They do not, however, prevent the company from using other design elements to dilute the impact of these new requirements. Their new packages, shown below, demonstrate how they have chosen to do this.

The devices themselves are increasingly decorated and image-laden, as shown below. Again, the rationale for not allowing harmful products to be enticingly designed has not been transferred to vaping devices.


Vype capsule package 2019


Vype-Vuse capsule package, 2020


Vype-Vuse decorative 'skins' - May 2020


Japan Tobacco "Crystal" Logic  May 2020



4: Candy-coated addiction can be advertised, as long as it isn't called candy
Canada's federal lawprohibits vaping products from being promoted in ways that make consumers think that they taste like candy, soft drinks, cannabis or deserts. This is why you won't find flavours like Tiramisu sold in Canada, although it is sold by BAT in other countries.

The law does not prevent vaping products from tasting like confectionery, as long as it is not promoted in that way. Nor are companies prohbited from using flavour descriptions that make the product seem as attractive as candy or deserts: promoting Creme-brulée flavoured vape is forbidden but promoting "Smooth vanilla with soft notes of cinammon" is okay.

The use of evocative flavour descritions was recently reviewed by the U.K. advertising authority, which found that Vype flavour descriptions "went further than simple factual claims and constituted descriptive, promotional language". It ordered BAT to tone down its flavour descriptions.

BAT markets Vype-Vuse flavours in Canada with descriptive, promotional language:

"explosion alive with almond notes"
"zesty, lively combination"
"deepy yet light blend of..."
"collision of cucumber freshness with an element of tanginess"
"Expertly crafted refreshing mint"
"soft notes of"





5: E-stores are excessively promotional
In 2002, Saskatchewan became the first Canadian province to ban the display of tobacco products, a measure which has been extended to the display of vaping products in all but one province (Alberta). Specialty vape shops are generally exempt from these requirements, as long as young people are not permitted in the store.

Increasingly, the preferred route to market for big nicotine companies are their own e-commerce sites and their own retail outlets - as BAT has acknowledged to its investors. (E-commerce is not allowed in Quebec, and the the companies do not accept orders from Nova Scotia, where flavours are banned).

These sites work on the honour system with respect to youth access, requesting visitors to self-identify their age. Although the federal government proposes to require meaningful age-gating, this is not currently in place.

In Canada, these sites are highly designed, rich in colour, movement and sound. The products are displayed in a showroom context -- with special effects and dramatic backdrops. This is in contrast to a few other countries -- notably Belgium -- where web-sites are staid and products cannot be shown. The contrast between BAT's e-commerce websites in Canada and Belgium is shown below.


Canada - govype.ca - May 4, 2020




Belgium - govype.com/be/be - May 4, 2020