Thursday, 12 December 2019

What the research says 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.

CONCLUSIONS OF THE NORDIC WELFARE COUNCIL:

  • "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."

ARTICLES REVIEWED BY THE NORDIC WELFARE COUNCIL:

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)

STUDIES PUBLISHED SUBSEQUENT TO THE NORDIC COUNCIL REVIEW

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.

DIFFERENT COUNTRIES, DIFFERENT REGULATORY APPROACHES

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!