Assessment of industry data on pulmonary and immunosuppressive effects of IQOS

IntroductionHeated tobacco products are being touted as novel reduced-harm tobacco products by tobacco companies. In the USA, Philip Morris International submitted a modified risk tobacco product (MRTP) application to the US Food and Drug Administration in 2016 in which it purports that its heated tobacco product, I-Quit-Ordinary-Smoking (IQOS), is associated with reduced harm compared with conventional cigarettes.MethodsWe reviewed Philip Morris International’s MRTP application to assess the pulmonary and immune toxicities associated with IQOS use in both animal and human studies.ResultsAmong rats exposed to IQOS, there was evidence of pulmonary inflammation and immunomodulation. In human users, there was no evidence of improvement in pulmonary inflammation or pulmonary function in cigarette smokers who were switched to IQOS.ConclusionIQOS is associated with significant pulmonary and immunomodulatory toxicities with no detectable differences between conventional cigarette smokers and those who were switched to IQOS in Philip Morris International’s studies. Philip Morris International also failed to consider how dual use and secondhand aerosol exposure may further impact, and likely increase, the harms associated with these products.

Download Full-text

FDA’s reduced exposure marketing order for IQOS: why it is not a reliable global model

Tobacco Control ◽

10.1136/tobaccocontrol-2020-056316 ◽

2021 ◽

pp. tobaccocontrol-2020-056316

Author(s):

Lauren Kass Lempert ◽

Stella Bialous ◽

Stanton Glantz

Keyword(s):

Public Relations ◽

Tobacco Control ◽

Scientific Evidence ◽

Tobacco Product ◽

Tobacco Products ◽

Sales And Marketing ◽

Philip Morris ◽

The Us ◽

The Usa ◽

The Difference

The US Food and Drug Administration (FDA) issued orders in July 2020 authorising Philip Morris Products S.A. to market its heated tobacco product (HTP) IQOS inside the USA with claims that it reduces exposure to some dangerous substances. FDA’s ‘reduced-exposure’ orders explicitly prohibit the marketing of IQOS with claims that IQOS will reduce harm or the risk of tobacco-related diseases. Under US law, FDA’s IQOS orders are problematic because FDA disregarded valid scientific evidence that IQOS increases exposure to other dangerous toxins and that Philip Morris Products S.A. failed to demonstrate that consumers understand the difference between reduced-exposure and reduced-harm claims. Unfortunately, both ‘reduced-exposure’ and ‘reduced-harm’ are classified as ‘modified risk tobacco products’ under US law. Exploiting this confusion, Philip Morris International used the FDA decision as the basis for marketing and public relations campaigns outside the USA to press governments to reverse policies that ban or regulate the sales and marketing of HTPs, including IQOS. Parties to the WHO Framework Convention on Tobacco Control should reject tobacco companies’ unsubstantiated explicit or implied claims of reduced harm associated with HTPs and resist Philip Morris International’s and other companies’ calls to relax HTP regulations based on the FDA’s actions. Instead, parties should adopt policies aligned with the Framework Convention on Tobacco Control when dealing with HTPs and other novel tobacco products.

Download Full-text

Heated tobacco products likely appeal to adolescents and young adults

Tobacco Control ◽

10.1136/tobaccocontrol-2018-054596 ◽

2018 ◽

Vol 27 (Suppl 1) ◽

pp. s41-s47 ◽

Cited By ~ 29

Author(s):

Karma McKelvey ◽

Lucy Popova ◽

Minji Kim ◽

Benjamin W Chaffee ◽

Maya Vijayaraghavan ◽

...

Keyword(s):

Health Risks ◽

Tobacco Industry ◽

Tobacco Product ◽

Adolescent And Young Adult ◽

Tobacco Products ◽

Design And Implementation ◽

Philip Morris ◽

The Us ◽

The Usa ◽

The 1960S

BackgroundBeginning in the 1960s in the USA and globally since 1998, tobacco companies have beenaggressively promoting heated tobacco products (HTP). In 2016, Philip Morris International (PMI) applied to the US Food and Drug Administration (FDA) seeking authorisation to market their IQOS HTP system and flavoured ‘HeatSticks’ in the USA as a modified-risk tobacco product (MRTP).MethodsWe systematically evaluated the publicly available data PMI submitted to FDA in its MRTP application to determine whether PMI’s IQOS product meets the US Tobacco Control Act’s standard for MRTP claims. We examined whether PMI provided sufficient data showing tobacco users will not initiate with IQOS, that youth will not misperceive the MRTP-related claims being made concerning IQOS, and how youth perceive health risks associated with IQOS.ResultsPMI’s own studies failed to provide evidence that youth, including non-users and former users, will not find IQOS appealing, will not initiate use of IQOS and will not perceive these products as risk-free. Further, PMI did not refer to independent studies conducted among adolescents which could influence their conclusions. Finally, their studies suffered from design and implementation flaws and cannot be relied on to support the proffered claims.ConclusionPMI’s own data and available evidence from scientific studies conducted independent of the tobacco industry regarding how novel tobacco products are currently being marketed suggest that introduction of IQOS will result in adolescent and young adult non-users initiating tobacco use with IQOS and could also increase poly-use of IQOS along with other tobacco products.

Download Full-text

Light and mild redux: heated tobacco products’ reduced exposure claims are likely to be misunderstood as reduced risk claims

Tobacco Control ◽

10.1136/tobaccocontrol-2018-054324 ◽

2018 ◽

Vol 27 (Suppl 1) ◽

pp. s87-s95 ◽

Cited By ~ 17

Author(s):

Lucy Popova ◽

Lauren Kass Lempert ◽

Stanton A Glantz

Keyword(s):

Tobacco Product ◽

Tobacco Products ◽

Qualitative And Quantitative ◽

Quantitative Studies ◽

Philip Morris ◽

The Us ◽

The World ◽

The Usa ◽

And Behavior ◽

Reduced Risk

IntroductionHeated tobacco products (HTPs) are being marketed in several countries around the world with claims that they are less harmful than combusted cigarettes, based on assertions that they expose users to lower levels of toxicants. In the USA, Philip Morris International (PMI) has submitted an application to the Food and Drug Administration (FDA) in 2016 seeking authorisation to market its HTPs, IQOS, with reduced risk and reduced exposure claims.MethodsWe examined the PMI’s Perception and Behavior Assessment Studies evaluating perceptions of reduced risk claims that were submitted to the FDA and made publicly available.ResultsQualitative and quantitative studies conducted by PMI demonstrate that adult consumers in the USA perceive reduced exposure claims as reduced risk claims.ConclusionThe data in the PMI modified risk tobacco product IQOS application do not support reduced risk claims and the reduced exposure claims are perceived as reduced risk claims, which is explicitly prohibited by the FDA. Allowing PMI to promote IQOS as reduced exposure would amount to a legally sanctioned repeat of the ‘light’ and ‘mild’ fraud which, for conventional cigarettes, is prohibited by the US law and the WHO Framework Convention on Tobacco Control.

Download Full-text

Awareness, trial and use of heated tobacco products among adult cigarette smokers and e-cigarette users: findings from the 2018 ITC Four Country Smoking and Vaping Survey

Tobacco Control ◽

10.1136/tobaccocontrol-2020-055985 ◽

2020 ◽

pp. tobaccocontrol-2020-055985

Author(s):

Connor R Miller ◽

Edward Sutanto ◽

Danielle M Smith ◽

Sara C Hitchman ◽

Shannon Gravely ◽

...

Keyword(s):

Tobacco Product ◽

Regulatory Environment ◽

Cigarette Smokers ◽

Tobacco Products ◽

The Usa ◽

Multivariable Analyses ◽

Former Smokers ◽

Use Categories

ObjectiveTo evaluate heated tobacco product (HTP) awareness, trial and current use among adult cigarette smokers and vaping product users in four countries with varying regulations governing HTP sales.DesignData came from Wave 2 of the ITC Four Country Smoking and Vaping Survey, collected from February to July 2018. Respondents were current and former smokers and/or users of vaping products (18 years or older) from Canada (CA; n=3778), England (EN; n=4848), the USA (US; n=2846) and Australia (AU; n=1515). At the time of the survey, only Canada and England permitted the sale of contemporary HTPs (eg, IQOS).ResultsOverall, 30.2% of respondents reported being aware of HTPs (CA=30.4%; EN=31.0%; US=30.2%; AU=27.4%; p=0.346), 2.4% had ever tried HTPs (CA=3.3%; EN=2.4%; US=2.0%; AU=0.9%; p=0.001) and 0.9% currently used HTPs at least monthly (CA=0.8%; EN=1.2%; US=0.7%; AU=0.2%; p<0.001). Trial and current use were higher among those who concurrently smoked and vaped (at least monthly) versus other nicotine use categories (trial: 10.9% v. 1.2%–2.0%, p<0.001; current use: 8.4% v. 0.1%–1.0%, p<0.001). In multivariable analyses, HTP awareness did not differ across countries, whereas odds of trial and current use were lower where HTPs were unavailable. Odds of HTP trial did not differ by regulatory environment when restricting analysis to HTP-aware concurrent smokers–vapers.ConclusionApproximately one third of respondents were aware of HTPs, even in the USA and Australia, where contemporary HTPs were not yet on the market. Trial and use were uncommon, except among concurrent smokers–vapers. Restrictions on availability may have limited HTP use generally, but less so for concurrent smokers–vapers.

Download Full-text

Heated tobacco product regulation under US law and the FCTC

Tobacco Control ◽

10.1136/tobaccocontrol-2018-054560 ◽

2018 ◽

Vol 27 (Suppl 1) ◽

pp. s118-s125 ◽

Cited By ~ 7

Author(s):

Lauren Kass Lempert ◽

Stanton A Glantz

Keyword(s):

Tobacco Control ◽

Scientific Evidence ◽

Tobacco Product ◽

Product Labelling ◽

Tobacco Products ◽

Control Laws ◽

The Public ◽

Philip Morris ◽

Product Regulation ◽

The Usa

Tobacco companies are marketing new ‘heated tobacco products’ (HTPs) composed of battery-powered holders, chargers and tobacco plugs or sticks. The non-tobacco HTP components have escaped effective regulation under many countries’ tobacco control laws because they are packaged and sold separately from the tobacco-containing components. In the USA, HTPs cannot be marketed unless the Food and Drug Administration determines that allowing their sale would be ‘appropriate for the protection of the public health’. Philip Morris International (PMI) is seeking permission to market its IQOS HTP in the USA with ‘modified risk tobacco product’ (MRTP) claims that it reduces exposure to harmful substances and is less harmful than other tobacco products. However, PMI has not submitted adequate scientific evidence required by US law to demonstrate that the product is significantly less harmful to users than other tobacco products, that its labelling would not mislead consumers, or that its marketing—with or without MRTP claims—would benefit the health of the population as a whole. Parties to the WHO Framework Convention on Tobacco Control (FCTC) must take measures to reduce tobacco use and nicotine addiction, and prevent false or misleading tobacco product labelling, advertising and promotions; the introduction of new HTPs must be assessed according to these goals. All components of HTPs should be regulated at least as stringently as existing tobacco products, including restrictions on labelling, advertising, promotion and sponsorship, sales to minors, price and taxation policies and smokefree measures. There is nothing in US law or the FCTC that prevents authorities from prohibiting HTPs.

Download Full-text

Awareness, experience and prevalence of heated tobacco product, IQOS, among young Korean adults

Tobacco Control ◽

10.1136/tobaccocontrol-2018-054390 ◽

2018 ◽

Vol 27 (Suppl 1) ◽

pp. s74-s77 ◽

Cited By ~ 27

Author(s):

Jinyoung Kim ◽

Hyunjae Yu ◽

Sungkyu Lee ◽

Yu-Jin Paek

Keyword(s):

Online Survey ◽

Electronic Cigarettes ◽

Tobacco Product ◽

Health Claims ◽

Cigarette Smokers ◽

Tobacco Products ◽

Korean Adults ◽

Philip Morris ◽

The Government ◽

Korean Market

IntroductionPhilip Morris International introduced ‘IQOS’ to the Korean market in June 2017. To monitor the use of IQOS among young Korean adults, we identified their awareness, experience and current use of IQOS.MethodsThree months after the introduction of IQOS in Korea, we conducted an online survey with 228 general young adults, aged 19–24 years.Results87 participants (38.1%) were aware of IQOS, 13 (5.7%) were IQOS ever users and 8 (3.5%) were current IQOS users. All the current IQOS users were triple users of conventional cigarettes and electronic cigarettes (e-cigarettes). There were no IQOS-only users and one IQOS ever user was a non-cigarette smoker. Among the eight current IQOS users who smoked 9.1 conventional cigarettes a day on average, four smoked 10–20 HEETS sticks a day. The current IQOS users decided to use IQOS because they believed it was less harmful or to stop smoking. The current conventional cigarette smokers were much more likely to be aware of IQOS (OR 4.496; 95% CI 2.185 to 9.250) and to be IQOS ever users (OR 11.649; 95% CI 1.024 to 132.564).ConclusionAwareness, experience and use of IQOS among young Korean adults were relatively higher than among their Japanese counterparts. Current IQOS users were more likely to smoke conventional cigarettes and/or e-cigarettes, which contradicts the tobacco industry’s claims that conventional cigarette smokers will switch to heated tobacco products. Until obtaining robust evidence concerning heated tobacco products, the government should regulate the tobacco industry’s marketing tactics and health claims.

Download Full-text

Correlates of tobacco product cessation among youth and adults in the USA: findings from the PATH Study Waves 1–3 (2013–2016)

Tobacco Control ◽

10.1136/tobaccocontrol-2019-055255 ◽

2020 ◽

Vol 29 (Suppl 3) ◽

pp. s203-s215 ◽

Cited By ~ 8

Author(s):

Karin A Kasza ◽

Kathryn C Edwards ◽

Zhiqun Tang ◽

Cassandra A Stanton ◽

Eva Sharma ◽

...

Keyword(s):

Tobacco Use ◽

Smokeless Tobacco ◽

Tobacco Dependence ◽

Tobacco Product ◽

Health Study ◽

Cigarette Smokers ◽

Tobacco Products ◽

Negatively Associated ◽

Quit Attempts ◽

The Usa

ObjectiveTo report on demographic and tobacco use correlates of cessation behaviours across tobacco products (cigarettes, electronic nicotine delivery systems (ENDS), cigars, hookah and smokeless tobacco) among the US population.DesignData were drawn from the first three waves (2013–2016) of the Population Assessment of Tobacco and Health Study, a nationally representative, longitudinal cohort study of US youth (ages 12–17) and adults (ages 18+) . Past 30-day (P30D) tobacco users at Wave 1 (W1) or Wave 2 (W2) were included (n=1374 youth; n=14 389 adults). Generalised estimating equations were used to evaluate the association between demographic and tobacco use characteristics at baseline, with cessation behaviours at follow-up (discontinuing use, attempting to quit, quitting), over two 1-year periods (W1–W2, W2–Wave 3).ResultsAmong adult users of each type of tobacco product, frequency of use was negatively associated with discontinuing use. Among adult cigarette smokers, non-Hispanic white smokers, those with lower educational attainment and those with lower household income were less likely to discontinue cigarette use; ENDS use was positively associated with making quit attempts but was not associated with cigarette quitting among attempters; smokeless tobacco use was positively associated with quitting among attempters; tobacco dependence was negatively associated with quitting among attempters. Among youth cigarette smokers, tobacco dependence was negatively associated with making quit attempts.DiscussionDemographic correlates of tobacco cessation behaviours underscore tobacco use disparities in the USA. Use of ENDS and use of smokeless tobacco products are positively associated with some adult cigarette cessation behaviours.

Download Full-text

PMI’s own in vivo clinical data on biomarkers of potential harm in Americans show that IQOS is not detectably different from conventional cigarettes

Tobacco Control ◽

10.1136/tobaccocontrol-2018-054413 ◽

2018 ◽

Vol 27 (Suppl 1) ◽

pp. s9-s12 ◽

Cited By ~ 24

Author(s):

Stanton A Glantz

Keyword(s):

Drug Administration ◽

Clinical Data ◽

Tobacco Product ◽

Tobacco Products ◽

Potential Harm ◽

Philip Morris ◽

Detectable Difference ◽

The Usa ◽

Reduced Risk

IntroductionNew ‘heated tobacco products’ are being marketed in several countries with claims that they expose users to lower levels of toxins than conventional cigarettes which could be read as being less likely to cause health problems than conventional cigarettes. In the USA, Philip Morris International (PMI) has submitted an application to the Food and Drug Administration for permission to market its heated tobacco product, IQOS, with reduced exposure and reduced risk claims.MethodsAnalysis of detailed results on 24 biomarkers of potential harm in PMI studies of humans using IQOS compared with humans using conventional cigarettes.ResultsAmong American adults, there is no statistically detectable difference between IQOS and conventional cigarette users for 23 of the 24 biomarkers of potential harm in PMI’s studies. In Japan, there were no significant differences between people using IQOS and conventional cigarettes in 10 of 13 biomarkers of potential harm. It is likely that some of the significant differences are false positives.ConclusionDespite delivering lower levels of some toxins than conventional cigarettes, PMI’s own data fail to show consistently lower risks of harm in humans using its heated tobacco product, IQOS, than conventional cigarettes.

Download Full-text

Polytobacco product use among current cigarette smokers in Hong Kong, China: results from population surveys (2015–17)

BMC Public Health ◽

10.1186/s12889-021-10341-7 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

S. L. Chau ◽

M. P. Wang ◽

Y. Wu ◽

D. Y. T. Cheung ◽

A. Kong ◽

...

Keyword(s):

Control Policy ◽

Tobacco Product ◽

Cigarette Use ◽

Related Factors ◽

Cigarette Smokers ◽

Tobacco Products ◽

Product Use ◽

Younger Age ◽

Current Cigarette ◽

Age And Sex

Abstract Background Polytobacco product use is increasingly popular, but little is known about the prevalence, trend, and factors of such use particularly in non-western countries. Method A representative sample of 1139 current cigarette smokers aged 15+ (84.1% male) were telephone interviewed in Tobacco Control Policy-related Surveys in 2015–2017. Information collected included poly-tobacco use (PTU), smoking and socio-demographic characteristics. Associations of current PTU with related factors were analyzed using logistic regression with adjustment for confounders. Prevalence was weighted by age and sex of current cigarette users in the general population. Results Eighty-four point one percent (95% CI 81.4–86.6%) were exclusive cigarette smokers. Fifteen point nine percent (13.4–18.6%) were current polytobacco product users, 12.3% (10.2–14.8%) used one tobacco product and 2.52% (1.59–3.97%) used two tobacco products in addition to cigarette. Cigarette use with cigar was more common (6.28%, 4.75–8.27%), and the least used product with cigarette was e-cigarette (1.05%, 0.44–2.50%). The changes in overall prevalence of PTU by number of products use varied in 3 years. Current PTU was associated with being male (AOR 2.01, 95% CI 1.12–3.61), younger age (AORs range from 1.34–4.65, P for trend < .001) and less ready to quit (2.08, 1.09–3.97). Conclusions Prevalence of PTU increased slowly by year, one tobacco product use with cigarette was more common. The most used tobacco product with cigarette was cigar. Being male, younger and less ready to quit were associated with current PTU.

Download Full-text

Patterns of non-cigarette tobacco and nicotine use among current cigarette smokers and recent quitters: Findings from the 2020 ITC Four Country Smoking and Vaping Survey

Nicotine & Tobacco Research ◽

10.1093/ntr/ntab040 ◽

2021 ◽

Author(s):

Lin Li ◽

Ron Borland ◽

K Michael Cummings ◽

Shannon Gravely ◽

Anne C K Quah ◽

...

Keyword(s):

Smoking Cessation ◽

Cigarette Smoking ◽

Smoking Status ◽

Tobacco Product ◽

Cigarette Tobacco ◽

Cigarette Smokers ◽

Tobacco Products ◽

Patterns Of Use ◽

Levels Of Use ◽

Current Cigarette

Abstract Introduction This study explores patterns of use of non-cigarette tobacco and nicotine products among adult cigarette smokers and recent ex-smokers. Along with cigarette smoking status we explore differences as a function of countries with different product regulations, gender and age. Methods Data came from the ITC Four Country Smoking and Vaping Wave 3 Survey conducted between February-June 2020. The analytic sample consisted of 9112 current cigarette smokers (at least monthly) and 1184 recent ex-smokers (quit cigarettes ≤ 2 years) from Australia, Canada, England, and the US. Respondents were asked about their cigarette smoking and current use of the following non-cigarette products: combustible tobacco (cigars, cigarillos, pipe, waterpipe); non-combustible tobacco (smokeless tobacco, and heated tobacco products (HTPs)); and non-tobacco nicotine products (nicotine vaping products (NVPs), nicotine replacement therapy (NRT), and nicotine pouches)). Results Overall, NVPs (13.7%) and NRT (10.9%) were the most reported nicotine products used, followed by cigars (5.3%), cigarillos (4.2%), and HTPs (3.5%). More than 21% current and recent ex-smokers of cigarettes reported using a non-tobacco nicotine product and non-combustible product, with respondents in England reporting the highest levels of use (>26%). Males, younger respondents, and current non-daily cigarette smokers were more likely to use non-cigarette nicotine products. Notably, 11.6% of ex-cigarette smokers were using other combustible tobacco. Conclusion Considerable percentages of current cigarette smokers and ex-smokers use non-cigarette nicotine products, and there are unexpectedly high levels of use of other combustible products by those recent ex-smokers of cigarettes which is concerning and has important implications for definitions of smoking cessation. Implications The tobacco product market has evolved to include new products which add to existing non-cigarette tobacco products creating a much more diverse nicotine market. This brief report provides a snapshot of use of various combustible and non-combustible nicotine containing products among current cigarette smokers and recent ex-smokers in four western countries. Our results indicate that use of non-cigarette tobacco and nicotine products among these cigarette smokers and recent ex-smokers is not low, particularly among males, younger and non-daily cigarette smokers. Use of other combustible tobacco among respondents that recently quit cigarette smoking is concerning and has important implications for definitions of smoking cessation. Increased emphasis on researching non-cigarette nicotine product use is warranted in tobacco control generally and smoking cessation in particular.

Download Full-text