Monday 23 December 2019

Newly-released Health Canada research provides insight into young vapers

Last week, Health Canada made public its plans to ban advertising of vaping products wherever they can be seen or heard by youth. At the same time, they also released two surveys that provide information and insight into young people's vaping behaviours.

These surveys are:
  • Environics. Vapers Panel Survey to Measure Attitudes and Behaviours Regarding Vaping Products June 2019. POR 141-18
    This is an on-line survey conducted semi-annually of Canadian regular vapers (people who have vaped in the past month). The latest results can be found at:
Here are 5 take-away messages from these reports

1. Youth vaping has doubled in the past 2 years (and tripled in the past 4).

Canadian Student Tobacco
Alcohol and Drug Survey
This year's CSTADS survey was the first major representative Canadian survey of youth vaping since the federal government legalized the commercial sale of recreational nictoine. Prior to that date, vaping products were available in the grey-market of vape stores and on-line retailing.

The number of grade 10 and 11 students who had ever tried an e-cigarette jumped from one-third (33%) to almost one half (47%). The number of current users (those who have vaped in the past 30 days) doubled from 15% to 30%.

This increase has been seen across all provinces, but at different levels. The largest central Canadian provinces have lower rates of use than do the eastern or western regions, although the growth in Ontario (a 270% increase in 2 years) was one of the highest. New Brunswick did not participate in this survey in 2014-2017.

Canadian Student Tobacco Alcohol and Drug Survey

2. E-cigarettes seem more powerful than cigarettes at recruiting daily users.

Canadian Student Tobacco 
Alcohol and Drug Survey, 2018-2019
Although the proportion of children in grades 10 to 12 who have ever tried a cigarette (34.4%) is almost as high as those who have tried vaping (46.8%), a much higher proportion of vapers become regular users. Among this age group 25% of those who have ever tried vaping are now doing so daily with nicotine-based vapes, compared with 5% of those who have ever tried smoking.
The CSTADS results provided by Health Canada do not present information on dual users (those who both smoke and vape) or the relationship between past use of tobacco and e-cigarettes.

3. For young people, vaping is an on ramp to nicotine use, not an off-ramp for smoking.

Environics, POR 141-18
More than one half (56%) of young vapers (age 15-19) and almost one-third (29%) of young adult vapers (age 20-24) are non smokers (have never tried a cigarette, or smoked fewer than 100 in their lifetime). The  proportion of young people who had never smoked grew between February and June, 2019.

Even among the one-third (34%) of teenage vapers who also smoke cigarettes, only a minority (32% of dual smokers or 14% of all vapers aged 15-19) say they are trying to quit smoking. Among young adults (aged 20-24), 25% of regular vapers say the main reason they vape is to quit smoking.

4. Flavours are the "main reason" given by half of young people for vaping 

Environics, POR 141-18
(compiled from banner tables)
The most frequently-cited "main reason" of teenagers and young adults for vaping is because they "like the flaours and/or smell." Other key reasons are that "it is fun and exciting" and belief that these products are less harmful than cigarettes.

One-third of teenagers and young adult vapers say the main reason they vape is their belief that this is less harmful than smoking.

One-third of young adults say they now are using or have used e-cigarettes to help quit smoking.

5. Age-gating is not working very well.

In all provinces specialty vape shops have fewer restrictions on displaying products and promotions, and these stores are expected to be age-restricted. Nonetheless, the Environics report suggests that large numbers of underage vapers are given access to these places.

Vape shops are among the most frequently-cited place where under age regular vapers buy their devices (39% of underage vapers) and liquids (31%). One in 7 (14%-15%) of underage vapers reports they usually buy their own products on-line, with a comparable  number reporting purchases in convenence stores (10% for devices, 16% for liquids).

Children's use of vape shops is also reflected in their recall of seeing promotions in these stores. One in 5 teenage vapers (age 15-19) recalls seeing advertisement sin vape shops (33% of the 63% of this age group who recall ads).

Teenagers vapers are frequently not asked to show proof of age. Only one-quarter of teenage vapers (aged 15-19) are "always" asked to prove their age when buying vaping products, with another quarter "often" asked and another quarter asked "rarely or never". Teenagers report that when ID is required for on-line purchases, four times in ten (37%), they do not have to prove they are old enough other than by clicking a button

Thursday 19 December 2019

Response to Health Canada's proposals to protect children from vaping promotions

We welcome the steps taken today by Health Canada to restrict e-cigarette promotions as an important initial step towards the comprehensive measures that are needed to protect children from vaping. We are especially pleased to see the Hon. Patty Hajdu make these proposals so quickly after she assumed responsibilities as the federal Minister of Health.

Protecting children from tobacco and nicotine marketing is a core public health measure, which is why we and other health groups, and parliamentarians have called on Health Canada to include these types of promotional restrictions since they first proposed legalizing vaping in 2016.

Tragically, this measure will not by itself be strong enough or fast enough to adequately address the crisis of youth vaping. We know from decades of experience with youth smoking that comprehensive protective measures are needed.  Urgently needed is a wide range of regulatory and programmatic activities at the federal level, such as:
  • effective and meaningful restrictions on flavours,
  • bans on additives that make it easier to become addicted to nicotine,
  • an end to promotional pricing (including taxes)
  • strong graphic health warnings,
  • controls on the ornamental design of packaging and devices (plain packaging)
  • public education,
  • research and surveillance,
  • industry reporting, including testing of emissions
  • support for cessation,
  • enforcement and industry accountability for the harms it causes.
The evidence of the government's failure to protect children when it opened the commercial market for recreational nicotine can be found in the results of Health Canada's survey of students smoking behaviour. The number of high school children using e-cigarettes has doubled since these products were marketed and promoted by big tobacco companies and large convenience chain stores. More than 1 in 10 (13%) of  children in grades 10 to 12 are vaping daily.

The vaping experience of the past months have highlighted the weaknesses of Canada's regulatory system to respond to market-driven problems. The measures proposed today were promised by Health Canada last February, and several more months will pass before they will finally be in place.  We look forward to working with Minister Hajdu and with parliamentarians to accelerate the implementation of these and other urgently-needed controls on the vaping market.


October 14, 2019:  Statement from the Council of Chief Medical Officers of Health calling for comprehensive vaping controls:
"We reiterate our call from April: We need to create environments that prevent youth vaping by strengthening regulatory frameworks and policies that restrict the accessibility and availability of vaping products and reduce the appeal of such products to youth. This includes plain packaging, health warnings and regulating the sale and marketing of vaping products and flavourings, and putting in place school and community policies that reduce use and encourage positive youth development."

"E-cigarette prevalence rates have doubled among students in 2018-19 since the last survey in 2016-17. Twenty percent (20%) of students (approximately 418,000) had used an e-cigarette (with or without nicotine) in the past 30 days, an increase from 10% in 2016-17. Prevalence of past-30-day use of e-cigarettes was not different between male (21%) and female (19%) students, but higher among students in grades 10 to 12 (29%) than those in grades 7 to 9 (11%). Students who have used an e-cigarette (with or without nicotine) in the past 30 days, are vaping frequently, with 40% (approximately 165,000 students) reporting daily or almost daily use."

Sunday 15 December 2019

Canadian government revenues from tobacco taxes: an update

Every year federal and provincial governments provide the public with financial reports, including information on how much revenue the have collected in tobacco taxes.  The last of these 'Public Accounts' for the last fiscal year (April 1 2018 to March 31 2019) was tabled in the House of Commons last week. Time for an update on tobacco tax revenues!

Last year, Canadian governments collected more than $8 billion in tobacco taxes
Total tobacco tax revenue received by Canadian governments this year was $8.3 billion, of which $3.4 billion (41%) was collected by the federal government and $4.9 billion collectively received by the provinces. Almost all of this revenue results from the sale of cigarettes. Only the federal government provides details on the amount of tax received from taxes on different types of tobacco products. In the case of federal revenues, 94% cames from cigarette sales, 2% from cigars and 4% from all other tobacco products, including oral tobacco and heat not burn sticks.

In real terms, tobacco tax revenues have not really increased  - or decreased - by very much over the past decade
Although tax rates have moved up (with the expected decrease in cigarette sales), the amount of taxes received has hardly budged in this decade once revenues are adjusted to reflect the impact of inflation.

Last year, the average Canadian smoker paid $1,680 in tobacco taxes
The federal government receives an average of $690 each year from each of Canada's estimated 4.9 million smokers. The amount received by each province ranges from $665 (Ontario) to $1,674 (Newfoundland and Labrador) per smoker. The combined average federal and provincial tax burden for each smoker is $1,682, reflecting the fact that most smokers (63%) live in the provinces with the lowest taxes.

Tobacco taxes represent about 1.5% of Canadian tax revenues and about 1.1% of total government revenues.  
The contribution of tobacco tax revenues to the treasury of federal and provincial governments ranges from a low of 0.8% in Ontario to a high of 1.8% in Alberta. Expressed as a percentage of tax revenues, the contribution of tobacco taxes ranges from a low of 1.2% in Ontario to 3.8% in Alberta.

Links to Fact Sheets: 

Tax Revenues from Tobacco Sales. December 2019.

Taxes on cigarettes in Canadian jurisdictions. October 2019.

Tobacco taxes paid by smokers. December 2019.

Thursday 12 December 2019

What research tells us about young people and e-cigarette flavours

Many researchers are focusing on the role played by e-cigarette flavourings in encouraging young non-smokers to use these products.

Earlier this year, the Nordic Welfare Council produced a report intended to inform public health efforts by governments in the Nordic Region (Iceland, Sweden, Denmark, Norway, Faroe Islands, Finland, Aland, and Greenland).

Their report - The significance of flavour additives in the use of moist snuff and e-cigarettes – with a focus on young people and the Nordic region - provides a readable summary of the evidence as well as a summary of e-cigarette and oral tobacco (snus) use in those countries.

Their conclusions are pasted below, with links to the research on which they based their findings. Because this report is already 11 months old, further studies are also identified at the end of this blog post.


  • "Flavour additives are a leading cause of young people trying tobacco products or e-cigarettes."
  • "New users have a preference for the particularly sweet flavours, such as those of sweets, fruit, chewing gum, soft drinks, etc."
  • "Young people also have a perception that e-cigarettes with the flavour of fruit, for example, are less harmful to health than e-cigarettes with the flavour of tobacco."
  • " If the product also contains nicotine, this may lead to dependence and potentially interest in trying other, more harmful tobacco products."
  • "Restrictions and regulations on flavour additives in e-cigarettes and e-liquids will therefore most likely have an impact on the use of these products by young people."


Never, current, and former smokers had distinct reasons for e-cigarette use and discontinued use and differed in flavor preferences.
Never, current, and former smokers (n=1,567; age 18-34)

Several reasons for first trying e-cigarettes predicted continued e-cigarette use, including good flavors, does not smell bad, can hide from adults, low cost, friends use, can use anywhere, to quit smoking regular cigarettes, and because they are healthier than cigarettes.
Longitudinal surveys. Middle and high school students (n=340)

Smokeless tobacco susceptibility was greatest among tobacco never-users who perceived flavored ST as easier to use.
2013-2014 Population Assessment of Tobacco and Health study (PATH) Tobacco never-users (n=7,718; age 12-17)

Ever and current e-cigarette users had higher odds of reporting that flavored ecigarettes were "less harmful" than nonflavored e-cigarettes, compared to youth who did not use e-cigarettes.
Data from a rapid response surveillance system. Students (sample [n]=3,704 from a population of students [N]=434,601; grade 6, 8, and 10)

The popularity of flavors across the range of tobacco products e.g. e-cigarettes and hookah suggest that flavoring might have broad appeal to young tobacco users.
2014 National Youth Tobacco Survey (NYTS). Middle and high school students (n=22,007).

Participants associated flavored smokeless tobacco with appealing non-tobacco products, such as chewing gum and alcohol. Availability of different varieties and flavors stimulated interest and curiosity in sampling or switching between smokeless tobacco products.
Interview. Adolescent males and smokeless tobacco users (n=23)

Dai, 2016 Flavored Electronic Cigarette Use and Smoking Among Youth.
Use of flavored e-cigarettes was associated with higher odds of intention to initiate cigarette use, lower odds of intention to quit tobacco use, and a lower prevalence of perception of tobacco's danger.
2014 National Youth Tobacco Survey (NYTS). Middle and high school students (n=21,491).

Dai, 2018 Single, Dual, and Poly Use of Flavored Tobacco Products Among Youths.
Use of flavored tobacco products is prevalent among youths. E-cigarettes were the leading flavored product and often concurrently used with other flavored tobacco products.
2014 National Youth Tobacco Survey (NYTS). (n=21,926)

Evans-Polce, 2018 Reasons for Vaping Among U.S. 12th Graders.
Three distinct classes of vapers were identified: adolescents who were Vaping for Taste + Entertainment, Vaping to Experiment, and Vaping to Replace Cigarettes.
2015 and 2016 Monitoring the Future study. Students, 12th graders.

Harrell, 2017 Flavored Tobacco Product Use among Youth and Young Adults: What if Flavors Didn't Exist?
 Most of the youth and young adult tobacco users reported using flavored tobacco. Three-fourths of flavored product users said they would no longer use the product if it was not flavored. This was highest for e-cigarettes and hookah and lowest for cigarettes.
Texas Adolescent Tobacco and Marketing Surveillance System (TATAMS). Youth (n=2,483) and Marketing and Promotions across Colleges in Texas (MPACT). Young adults (n=4,326)

Hoffmann, 2016 Flavour preferences in youth versus adults: a review.
Tobacco products in flavours preferred by young people may impact tobacco use and initiation, while flavours preferred by adults may impact product switching or dual use.
Review study. (n=59 studies)

 Kong, 2015 Reasons for Electronic Cigarette Experimentation and Discontinuation Among Adolescents and Young Adults.
The top reasons for experimentation with e-cigarettes were curiosity, appealing flavors, and peer influences.
Focus group and survey. Students (n=1,302; age 12- 22)

Kowitt, 2017 Perceptions and Experiences with Flavored NonMenthol Tobacco Products: A Systematic Review of Qualitative Studies.
Positive perceptions of flavored tobacco products and flavors led to experimentation and/or initiation of flavored tobacco products.
Review study. (n=20 studies)

Miech, 2017 What are kids vaping? Results from a national survey of US adolescents.
Among students who had ever used a vaporiser, 65-66% last used 'just flavouring' in 12th, in 10th and in 8th grade, more than all other responses combined. Nicotine use came in a distant second, at about 20% in 12th and 10th grade and 13% in 8th grade.
Survey. Students (n=44,892; grade 8, 10, and 12)

ModestoLowe, 2017 E-cigs . . . Are They Cool? Talking to Teens About E-Cigarettes.
Electronic cigarettes have gained wide acceptance among adolescents, especially those with sweet flavors such as bubble gum and cheesecake. This article outlines the basics of e-cigarettes and potential health hazards.
Motivational interviewing

Morean, 2018 Preferring more e-cigarette flavors is associated with e-cigarette use frequency among adolescents but not adults.
Compared to adults, a larger proportion of adolescents preferred fruit, alcohol, and "other"-flavored e-liquids, whereas adults disproportionately preferred tobacco, menthol, mint, coffee, and spiceflavored e-liquids.
School-based survey. Adolescents (n=396), and MTurk survey. Adults (n=590). 25

Patrick, 2016 Self-reported reasons for vaping among 8th, 10th, and 12th graders in the US: Nationally-representative results.
Overall, results suggest that decisions to vape are based on curiosity, taste, and pleasure, rather than for reasons such as quitting regular cigarettes or substituting for regular cigarette smoking.
2015 Monitoring the Future study. Students (n=4,066; grade 8, 10, and 12)

Pepper, 2016 Adolescents' interest in trying flavoured e-cigarettes.
 Adolescents were more likely to report interest in trying an e-cigarette offered by a friend if it were flavoured like menthol, candy or fruit compared with tobacco. Adolescents believed that fruitflavoured e-cigarettes were less harmful to health than tobacco-flavoured e-cigarettes. Perceived harm mediated the relationship between some flavours and interest in trying e-cigarettes.
Phone survey. Adolescents (n=1,125; ages 13-17)

Schiffman, 2015 The Impact of Flavor Descriptors on Nonsmoking Teens' and Adult Smokers' Interest in Electronic Cigarettes.
The e-cigarette flavors tested appealed more to adult smokers than to nonsmoking teens, but interest in flavors was low for both groups. Online survey. Non-smoking teens and adult smokers (n=648; age 13-80)

Shang, 2018 The impact of flavour, device type and warning messages on youth preferences for electronic nicotine delivery systems: evidence from an online discrete choice experiment. Fruit/sweets/beverage flavours significantly increase the probability of choosing ENDS among youth and flavour has the most pronounced impact among three attributes.
Online survey.

Tsai, 2016 Reasons for Electronic Cigarette Use Among Middle and High School Students - National Youth Tobacco Survey, United States, 2016.
Among students who reported ever using e-cigarettes, the most commonly selected reasons for use were use by "friend or family member", availability of "flavors such as mint, candy, fruit, or chocolate"; and the belief that "they are less harmful than other forms of tobacco such as cigarettes". Availability of flavors as a reason for use was more commonly selected by high school users than by middle school users.
2016 National Youth Tobacco Survey (NYTS). Student U.S. middle school (grades 6-8) and high school (grades 9-12).

Villanti, 2017 Flavored Tobacco Product Use in Youth and Adults: Findings From the First Wave of the PATH Study (2013-2014).
Flavor was a primary reason for using a given tobacco product, particularly among youth. Eighty-one percent of youth and 86% of young adult ever tobacco users reported that their first product was flavored versus 54% of adults aged ≥25 years.
2013-2014 Population Assessment of Tobacco and Health study (PATH) Adults and youth (n=45,971; age >12)

Zare, 2018 A systematic review of consumer preference for ecigarette attributes: Flavor, nicotine strength, and type.
Consumers preferred flavored e-cigarettes, and preference varied with age groups and smoking status. Several flavors were associated with decreased harm perception while tobacco flavor was associated with increased harm perception.
Review study. (n=66 studies)


Chen-Sankey, 2019. Perceived ease of flavored e-cigarette use and e-cigarette use progression among youth never tobacco users,
Perceiving flavored e-cigarettes as easier to use than unflavored e-cigarettes may lead to e-cigarette use progression among youth never tobacco users.
Path Study 2013-2014 and 2014-2015 (n=6,983).

Goldenson 2019 A Review of the Use and Appeal of Flavored Electronic Cigarettes
Nontraditional-flavored e-cigarettes are popular among youth, but may be less common among older adults and combustible cigarette smokers. Further research is needed to determine whether use of e-cigarettes in nontraditional flavors affects smoking cessation.
Review study

Meernick. Impact of non-menthol flavours in e-cigarettes on perceptions and use: an updated systematic review
Non-menthol flavours in e-cigarettes decrease harm perceptions (five studies) and increase willingness to try and initiation of e-cigarettes (six studies). Among adults, e-cigarette flavours increase product appeal (seven studies) and are a primary reason many adults use the product (five studies). The role of flavoured e-cigarettes on smoking cessation remains unclear (six studies).
Review Study (n=51 studies)

Schneller 2019. Use of Flavored E-Cigarettes and the Type of  E-Cigarette Devices Used among Adults and Youth in the US—Results fromWave 3 of the Population Assessment of Tobacco and Health Study (2015–2016)
Adults were far more likely to report using tobacco flavor alone, compared to any other individual flavor category or flavor category combinations (OR: 21.08, 95%CI: 5.92, 75.12). Whereas, youth were more likely to report using multiple flavor categories (OR: 2.03, 95%CI: 1.55, 2.65), with the most reported pairing being fruit and candy (36%).
Path Study (n=28,148 adults, 11,814 youth)

Soneji 2019. Use of Flavored E-Cigarettes Among Adolescents, Young Adults, and Older Adults: Findings From the Population Assessment for Tobacco and Health Study
The leading e-cigarette flavor types among adolescents were fruit, candy, and other flavors; among young adults were fruit, candy, and mint/menthol; and among older adults were tobacco or other flavors, fruit, and mint/menthol.
Path Study 2014-2015 (n=3086)

Monday 2 December 2019

The FDA's ground rules for IQOS may have lessons for Canada

Last month, Philip Morris began selling the heated tobacco IQOS devices and sticks in the United States. This is almost 3 years after they were marketed in Canada.

The reason for the delay was that the US Food and Drug Administration would not permit the sale of this or any other new tobacco product until it was satisfied that doing so was in the public interest. In granting authority, the FDA imposed market restrictions and reporting requirements that were designed to limit harmful unintended consequences - like initiating use by non-smokers or former smokers.

As the industry trade magazine Tobacco Reporter describes, the impact of FDA requirement is significant:
Access to the IQOS store is strictly controlled. Customers have to show identification and declare whether they currently smoke cigarettes. Nonsmokers and those under 21 are turned away, according to Altria.
The IQOS marketing authorization requires Altria to keep detailed records and send the FDA quarterly reports on its sales, including details like demographic data on its customers and how many have switched to IQOS from cigarettes or use both products.
The company must also send an annual report with more granular information, including any reports of adverse experiences.
In this post, we summarize some of the different regulatory approaches that have been taken with respect to next generation tobacco products and ways to prevent post-market problems.


Canada:  Post market reporting required (for tobacco)

In Canada, manufacturers can begin marketing new tobacco or vaping products without having first to seek the permission of federal or provincial governments. As long as they meet the many requirements of federal and provincial laws - taxes, packagign, ingredient restrictions, sales displays - they are allowed to be sold. After products are on the market, companies are required to file monthly or annual reports on certain marketing activities. Different types of nicotine products (eg cigarettes, e-cigarettes, oral tobacco, cigars) trigger different requirements.

Over the past decade tobacco companies have introduced Canadian consumers to new styles of cigarette filters (Aqua and Activate), oral tobacco (Snus), of heat-not-burn (IQOS, glo), of e-cigarettes (JUUL, Vype, Logic, Blu). On no occasion was Health Canada required to assess whether the marketing of these products was in the public health interest, or authorized to take action if this was not the case other than through the enforcement of pre-existing laws and regulations or the development of new ones. The structure of our tobacco regulatory system is one that leads to a perpetual game of catch-up.

The Canadian approach applies the same rules to all products within a certain category. Heat-not-burn tobacco products (like IQOS) and oral tobacco are treated as tobacco products under federal health and tax law, and subject to the same advertising restrictions as cigarettes. Vaping products and oral nicotine are subject to lesser restrictions. Reporting requirements for vaping products, for example, have not been developed although the products have been on the market now for 18 months.

European Union: Premarket notification required for e-cigarettes

In other parts of the world, rules have been put in place to limit the capacity of companies to take government by surprise when they launch new nicotine-carrying products. When the European Union Directive on tobacco was amended in 2014, it included requirements for manufacturers to give governments a six month 'heads-up' before marketing any novel tobacco product or electronic cigarettes. The directive also authorizes member states to establish authorization systems for such products. Many countries impose a notification fee to help defray the costs of processing or review.

Some of the challenges of this approach have recently been documented - including the volume of premarket authorizations that can result. Finland received more than 19,000 premarket notifications within a 3 year period. 

With this approach, governments are still playing a game of catch-up, but the industry has a little shorter head start than in Canada.

USA:  Premarket authorization required for next generation products

The U.S. has gone further than any other country in ensuring a review of products before they are marketed.

All tobacco products introduced to the market or modified after 2007 are required to submit a Premarket Tobacco Application  (PMTA) to the U.S. Food and Drug Authority. (Minor changes to cigarettes, however, can be introduced without this process if they are 'substantially equivalent' to a product already on the market).

In 2016, this requirement was extended to e-cigarettes. Those which were already on the market were given until May 2020 to submit an application for approval. (BAT's subsidiary recently did so for some of its vaping devices).  A little over a year from now, the FDA will be granting approval and setting the conditions of sale for JUUL, Logic, VYPE/VUSE and the hundreds of products sold by large and small manufacturers, or it will be ordering them them off the market.

Essentially that means that all of the "next generation products" must eventually be approved by the FDA or removed from the market.

In the USA, the government has the power to tell the companies to wait at the starting line until the regulations are ready and to expect that some will be sent off the field - even if they are well down the track.

Getting authorization is a privilege that comes with conditions 

Unlike Europe or Canada, the U.S. health regulators are obliged to assess whether or how allowing any of these new products will contribute to the health of Americans. As the FDA describes it:
A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health. In order to reach such a decision and to authorize marketing, FDA considers, among other things:
  • Risks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as nonusers;
  • Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available;
  • Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available; and
  • The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product.
So far, the FDA has approved two products under this process: The IQOS heat not burn cigarette (2019) and Swedish Match snus (2015). It recently authorized Swedish Match to inform consumers that their products pose lower health risks than cigarettes.

FDA Permission to sell Next Generation Products comes with strings attached:

The FDA process permits the regulator to apply specific rules to specific products. It allows them to permit some vaping device designs, but not all. It allows them to put different conditions on some manufacturers than on others.

The FDA's authorization for IQOS illustrates how a product-specific, company-specific authorization can be constructed. In the 122-page review made public this spring, the FDA transparently explained its reasons for issuing the authorization, including the reasons that the advice of some its own experts were rejected and over ruled. It set the constraints that Philip Morris must follow, including the guidance that it is to take measures to prevent new uers, former smokers or dual use:
 Limiting youth exposure and initiation and use of the products as you have indicated in your PMTAs (i.e., complete switching to IQOS by adult cigarette smokers) are important components of consideration for the marketing of these products to continue to be appropriate for protection of the public health.
The level of detail in the reporting requirements greatly exceed those currently in place in Canada. Under these requirements (page 102 to 110 of the authorization decision), PMI must report on past activities and give notice of future ones. The first four (of several dozen) of these obligations reflect how much more detail is required than in Canada.
  • A summary of U.S. sales and distribution of the tobacco products, including total U.S. sales reported in dollars, units, and volume, and broken down by U.S. census region, major retail markets, and channels where the products are sold (e.g., convenience stores, food and drug markets, big box retailers, digital platforms, tobacco specialty shops, company-owned stores). 
  • Data on product purchasers. Report any data collected about new purchasers, those who have switched tobacco products, and/or multiple product users. The results must be broken down by purchaser demographics (e.g., age, gender, race/ethnicity, geographic location) and must not include personally identifiable information.
  • An analysis of the actual delivery of advertising impressions, by channel, by product, and by audience demographics (e.g., age, gender, race/ethnicity, geographic location), including a breakout by age-group (i.e., adults, ages 25+; young adults, ages 18-24; and youth, ages 12-17 and ages 11 and under). This analysis must be verified against post-launch delivery-verification reports submitted to you from an accredited source. 
  • A summary of media tracking and optimization, by channel, by product, and by audience demographics (e.g., age, gender, race/ethnicity, geographic location), including a summary of realtime digital media monitoring to identify, correct, and prevent delivery of advertising impressions to youth, ages 17 and under, and including a summary of implementation of any corrective and preventive measures. 
The cost? Born by the tobacco industry

The FDA approach comes with a cost, as it takes a large infrastructure to manage approvals and post market surveilance. The FDA's budget for its tobacco control office is more than $660 million this year.  Importantly, these activities are not funded by the general taxpayer, but through a special assesasment of "Tobacco User Fees" charged to manufacturers on the basis of their market share in certain product categories.

The benefit? Greater transparency and more science behind decision-making

The FDA review process provides a tranparency that allows for independent scientists and public health contributors to participate knowledgeably in the regulatory process. Much of the companies' application, the FDA decision and the opinion of its critics and supporters become a matter of public record. (A year ago, Tobacco Control published a supplement of independent assessments of PMI's application).

The FDA invested more than US$180 million last year to outside researchers (Tobacco Centers of Regulatory Science) to participate in building the science to inform tobacco regulation. That's more than 4 times Health Canada's entire tobacco control budget!