August 30, 2018

Stanton A. Glantz, PhD

Four independent studies reinforce the conclusion, based on PMI data, that marketing IQOS will not promote complete switching from cigarettes.

Karma KcKelvey and colleagues’ paper “IQOS labelling will mislead consumers” presents the results of a close analysis of the information on consumer perceptions of IQOS that PMI presents in its modified risk tobacco product (MRTP) application to the FDA to market IQOS as a reduced risk and reduced exposure product.  They conclude that PMI’s studies did not provide sufficient evidence that IQOS users will completely switch from cigarettes to IOQS (the assumed behavior that the whole application hinges on) or that consumers will understand PMI’s proposed claims regarding exposure, harm and “switching completely.”  They go on to conclude that PMI’s MRTP application does not satisfy FDA requirements that consumers will not be misled by PMI’s proposed marketing; therefore, HTP should not be allowed to be marketed with reduced risk claims.

Independent research has confirmed the evidence in PMIs MRTP application that IQOS advertising will mislead consumers.  In their paper“Impact of modified risk tobacco product claims on beliefs of US adults and adolescents" Sherine El-Toukhy and colleagues report the results of a national study of US adults and adolescents that found that claims of lower exposure and lower risk acted similarly, with both leading to lower perceived quantity of harmful chemicals and lower perceived risk of health harm.  This means that, given that PMI’s claims of reduced risk are not supported even by their own data, if the FDA allowed PMI to market IQOS with claims of lower exposure are intrinsically misleading, they would be complicit in helping PMI perpetuate a fraud on the public similar to the historic frauds of “light and mild.” 

Despite the fact that marketing IQOS is not legal in the United States, Amy Nyman and her colleagues found that from 2016 to 2017, awareness of heated tobacco products increased and current use of heated tobacco products doubled.  Their paper,  “Awareness and use of heated tobacco products among US adults, 2016–2017,” also reports that these products are more familiar to men and younger adults and may be being used disproportionately by racial/ethnic minorities.

There is also much to learn from how PMI is marketing IQOS in other countries.  In their paper “Examining perceptions about IQOS heated tobacco product: consumer studies in Japan and Switzerland” Elizabeth Hair and colleagues report that IQOS is being marketed as a clean, chic and pure product, which resonated very well in Japan given the strong cultural values of order, cleanliness, quality and respect for others, where IQOS users are using it for socialising with nonsmokers.  Interestingly, participants in both Japan and Switzerland reported lower levels of satisfaction with the product relative to combustible cigarettes and did not see much health benefit in using IQOS, although many found the product packaging to be appealing. They note that youth and young adults are more interested in such product positioning.

Finally, in Korea, Jinyoung Kim and colleagues’ paper “Awareness, experience and prevalence of heated tobacco product, IQOS, among young Korean adults” found that awareness, experience and use of IQOS among young Korean adults were relatively higher than among their Japanese counterparts.  Significantly, all the current IQOS users in their sample were triple users of conventional cigarettes and electronic cigarettes, which contradicts PMI’s claims that conventional cigarette smokers would switch to heated tobacco products.

These studies, taken together, provide strong evidence against PMI’s claims, being made to the FDA here in the USA and to other authorities all over the world, that IQOS will lead to less smoking.  The available evidence, including from PMI itself, shows that even being allowed to make a reduced exposure claim will be misunderstood as a reduced risk claim.

The overall effect of allowing IQOS on the market appears to be to reinforce tobacco use and extend the epidemic.

 

McKelvey K, Popova L, Kim M, et al IQOS labelling will mislead consumers.  Tobacco Control Published Online First: 29 August 2018. doi: 10.1136/tobaccocontrol-2018-054333.  It is available open access here.

Background Philip Morris International (PMI) continually expands and diversifies their nicotine product portfolio, which includes IQOS, a heated tobacco product. In December 2016, PMI filed a modified risk tobacco product (MRTP) application with the US Food and Drug Administration (FDA), seeking authorisation to market IQOS in USA with three claims of reduced harm: ‘switching completely from conventional cigarettes to the IQOS system…’ (1) ‘can reduce the risks of tobacco-related diseases;’ (2) ‘significantly reduce[s] your body’s exposure to harmful or potentially harmful chemicals;’ and (3) ‘presents less risk of harm than continuing to smoke cigarettes.’ Consumers may misunderstand what is meant by ‘switching completely'.

Methods We critically reviewed study reports submitted to FDA by PMI in support of proposed marketing claims in its MRTP application for IQOS and focused on the statement that switching completely to IQOS reduces risk.

Results We found deficiencies with evidence provided by PMI supporting their assertions that: current smokers will understand what is meant by the phrase ‘switching completely'; the proposed claims will not decrease smokers’ intentions to quit; and IQOS users will in fact ‘switch completely’ from smoking cigarettes to using IQOS. The studies and measurement instruments employed by PMI suffer from design flaws and their reporting of associated findings is misleading.

Conclusion Consumers will not understand the condition of the claims—that they must quit using cigarettes completely to achieve the inferred health benefits of IQOS. Rather, they are likely to misunderstand the unsupported claims of reduced risks to mean IQOS are harm-free.

 

El-Toukhy S, Baig SA, Jeong M, et al.  Impact of modified risk tobacco product claims on beliefs of US adults and adolescents.  Tobacco Control Published Online First: 29 August 2018. doi: 10.1136/tobaccocontrol-2018-054315.  The paper is open access and available here.

Objective Under US law, tobacco product marketing may claim lower exposure to chemicals, or lower risk of health harms, only if these claims do not mislead the public. We sought to examine the impact of such marketing claims about potential modified risk tobacco products (MRTPs).

Methods Participants were national samples of 4797 adults and 969 adolescent US smokers and non-smokers. We provided information about a potential MRTP (heated tobacco product, electronic cigarette or snus). Experiment 1 stated that the MRTP was as harmful as cigarettes or less harmful (lower risk claim). Experiment 2 stated that the MRTP exposed users to a similar quantity of harmful chemicals as cigarettes or to fewer chemicals (lower exposure claim).

Results Claiming lower risk led to lower perceived quantity of chemicals and lower perceived risk among adults and adolescents (all p<0.05, Experiment 1). Among adults, this claim led to higher susceptibility to using the MRTP (p<0.05). Claiming lower exposure led to lower perceived chemical quantity and lower perceived risk (all p<0.05), but had no effect on use susceptibility (Experiment 2). Participants thought that snus exposed users to more chemicals and was less safe to use than heated tobacco products or electronic cigarette MRTPs (Experiments 1 and 2).

Discussion Risk and exposure claims acted similarly on MRTP beliefs. Lower exposure claims misled the public to perceive lower perceived risk even though no lower risk claim was explicitly made, which is impermissible under US law.

 

Nyman AL, Weaver SR, Popova L, et al.  Awareness and use of heated tobacco products among US adults, 2016–2017.  Tobacco Control Published Online First: 29 August 2018. doi: 10.1136/tobaccocontrol-2018-054323.  The paper is open access and available here.

Introduction Although heated tobacco products (HTP) have been on and off the commercial market for the past three decades (eg, Premier, Eclipse and Accord), they have not received widespread consumer acceptance as an alternative to combustible cigarettes. This may change with recent product innovations, shifts in consumer preferences and the tobacco market landscape and a US regulatory environment that may permit an internationally available HTP to be sold in the USA, possibly with a reduced exposure or risk statement. This study examined the extent of awareness and use of HTP in the USA and assessed the characteristics of those aware of and using these products.

Methods Data came from the 2016 and 2017 Tobacco Products and Risk Perceptions Surveys of national probability samples of US adults, conducted online during September–October 2016 (n=6014) and August–September 2017 (n=5992). Weighted χ2 tests and regression analyses examined changes in awareness and use of HTP between 2016 and 2017 and characteristics associated with awareness and use.

Results From 2016 to 2017, awareness of HTP among US adults increased from 9.3% to 12.4% (p<0.001), ever use increased from 1.4% to 2.2% (p=0.005) and current use increased two fold, from 0.5% to 1.1% (p=0.004). Men and adults under age 45 years had higher rates of awareness than women and those 45 and older, respectively. Non-white adults, cigarette smokers and both current and former users of electronic nicotine delivery systems were more likely to be using HTP.

Conclusions Awareness and use of HTP in the USA are increasing. These products are more familiar to men and younger adults and may be being used disproportionately by racial/ethnic minorities. With increases in HTP availability and the potential for reduced-risk claims ahead, surveillance of patterns and consequences of use by both smokers and non-smokers is needed.

 

Hair EC, Bennett M, Sheen E, et al.  Examining perceptions about IQOS heated tobacco product: consumer studies in Japan and Switzerland.  Tobacco Control Published Online First: 15 May 2018. doi: 10.1136/tobaccocontrol-2018-054322.  The paper is open access and available here.

Objective To examine consumer perceptions, attitudes and behaviours regarding the heated tobacco product, IQOS, as well as to document the product’s marketing strategies to determine its potential for appealing to youth and young adults.

Method Truth Initiative, in collaboration with Flamingo, collected qualitative data via: (1) expert interviews, (2) semiotic analysis of IQOS packing and marketing materials, and (3) 12 focus groups with adults in Switzerland (ages 19–44 years; June 6–9, 2016) and Japan (ages 20–39 years; June 22–24, 2016) (n=68 for both groups).

Results Expert interviews and IQOS packing and marketing analyses revealed the product is being marketed as a clean, chic and pure product, which resonated very well in Japan given the strong cultural values of order, cleanliness, quality and respect for others. Focus groups results indicated Japanese IQOS users used the product for socialising with non-smokers. Focus group participants in both Japan and Switzerland reported lower levels of satisfaction with the product relative to combustible cigarettes, although many found the product packaging to be appealing. While participants identified several benefits and barriers related to IQOS, few reported any potential health benefits of use compared with combustible tobacco products.

Conclusion IQOS was marketed as a sophisticated, high tech and aspirational product. Because youth and young adults are more interested in such product positioning, this approach raises some concern about youth appeal. This research shows cultural factors appeared to affect the appeal of this messaging, indicating that prevalence and uptake data will likely not be similar from country to country.

 

Kim J, Yu H, Lee S, et al.  Awareness, experience and prevalence of heated tobacco product, IQOS, among young Korean adults.  Tobacco Control Published Online First: 29 August 2018. doi: 10.1136/tobaccocontrol-2018-054390. The paper is open access and available here.

Introduction Philip 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.

Methods Three months after the introduction of IQOS in Korea, we conducted an online survey with 228 general young adults, aged 19–24 years.

Results 87 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).

Conclusion Awareness, 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.

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