Journal of Epidemiology Short Communication J Epidemiol 2022;32(3):139-144 Use and Awareness of Heated Tobacco Products in Europe Silvano Gallus1,+, Alessandra Lugo1, Xiaoqiu Liu1,2, Elisa Borroni1, Luke Clancy3, Giuseppe Gorini4, Maria José Lopez5,6,7, Anna Odone8,9, Krzysztof Przewozniak10,11,12, Olena Tigova13,14,15,16, Piet A. van den Brandt17,18, Constantine Vardavas19, Esteve Fernandez13,14,15,16, and the TackSHS Project Investigators+ 1 Department of Environmental Health Sciences, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy 2 The George Institute for Global Health, Sydney, Australia 3 TobaccoFree Research Institute Ireland, TU Dublin, Ireland 4 Istituto per lo Studio, la Prevenzione e la Rete Oncologica, Florence, Italy 5 Agència de Salut Pública de Barcelona, Barcelona, Spain 6 CIBER en Epidemiología y Salud Pública (CIBERESP) (Biomedical Research Centre Network for Epidemiology and Public Health), Spain 7 Institut d’investigació Biomèdica Sant Pau (IIB St. Pau), Barcelona, Spain 8 Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Pavia, Italy 9 IRCCS San Raffaele Scientific Institute, Milan, Italy 10 The Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland 11 Collegium Civitas, Warsaw, Poland 12 Foundation “Smart Health - Health in 3D”, Warsaw, Poland 13 Tobacco Control Unit, Institut Català d’Oncologia, L’Hospitalet de Llobregat, Spain 14 Tobacco Control Research Group, Institut d’Investigació Biomèdica de Bellvitge, L’Hospitalet de Llobregat, Spain 15 Biomedical Research Centre Network for Respiratory Diseases for Respiratory Diseases (Centro de Investigación Biomédica en Red en Enfermedades respiratorias, CIBERES), Madrid, Spain 16 School of Medicine and Health Sciences, Universitat de Barcelona, L’Hospitalet de Llobregat, Spain 17 Department of Epidemiology, CAPHRI-School for Public Health and Primary Care, Maastricht University Medical Centre, Maastricht, The Netherlands 18 Department of Epidemiology, GROW-School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands 19 Hellenic Cancer Society, Athens, Greece Received June 4, 2020; accepted October 26, 2020; released online January 16, 2021 ABSTRACT Background: Heated tobacco products (HTP) are new forms of tobacco consumption with limited information available on their use among the general population. Our objective was to analyze the prevalence and associations of use of HTP across 11 countries in Europe. Methods: Within the TackSHS Project, in 2017–2018 we conducted a cross-sectional study with information on HTP use in the following countries: Bulgaria, England, France, Germany, Greece, Italy, Latvia, Poland, Portugal, Romania and Spain. In each country, face-to-face interviews were performed on a representative sample of around 1,000 subjects aged ≥15 years, for a total of 10,839 subjects. Results: Overall, 27.8% of study participants were aware of HTPs, 1.8% were ever HTP users (ranging from 0.6% in Spain to 8.3% in Greece), and 0.1% were current users. Men were more frequently HTP ever users than women (adjusted odds ratio [aOR] 1.47; 95% confidence interval [CI], 1.11–1.95). Ever HTP use was inversely related to age (P for trend <0.001) and more frequent in ex-smokers (compared with never smokers, aOR 4.32; 95% CI, 2.69–6.95) and current smokers (aOR 8.35; 95% CI, 5.67–12.28), and in electronic cigarette past users (compared with never users, aOR 5.48; 95% CI, 3.46–8.68) and current users (aOR 5.92; 95% CI, 3.73–9.40). Conclusions: In 2017–2018, HTP use was still limited in Europe among the general population; however, the dual use of these products, their high use among younger generations, and the interest of non-smokers in these products are worrying and indicate the need for close monitoring in terms of prevalence and the characteristics of users. Key words: heated tobacco products; heat-not-burn tobacco products; IQOS; survey; Europe Copyright © 2021 Silvano Gallus et al. This is an open access article distributed under the terms of Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Address for correspondence. Silvano Gallus, ScD, Department of Environmental Health Sciences, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2; 20156 Milan, Italy (e-mail: silvano.gallus@marionegri.it). + The full list of TackSHS investigators is provided at the end of the manuscript DOI https://doi.org/10.2188/jea.JE20200248 HOMEPAGE http://jeaweb.jp/english/journal/index.html 139 Heated Tobacco Products in Europe After providing their consent to participate, all subjects were INTRODUCTION interviewed by ad hoc trained interviewers using computer- Heated tobacco products (HTP) are electronic devices heating a assisted personal interviewing (CAPI). The survey used a tobacco stick to generate an inhalable aerosol containing nicotine standardized questionnaire including information on demographic (and other toxicants).1 In December 2014, Phillip Morris and socioeconomic characteristics, cigarette smoking and International (PMI) launched in Italy and Japan its first HTP, electronic cigarette use.23,24 The questionnaire was first developed named IQOS.2–4 This product is now in commerce in most high- in English and subsequently translated in country-specific income countries, including the majority of European Union (EU) languages by bilingual (ie, local language and English language) Member States (MSs). Meanwhile, HTPs from other tobacco tobacco control experts. Thus, questions were asked in companies (eg, Glo by the British American Tobacco and Ploom participants’ primary languages. TECH by Japan Tobacco International) are also available in some Level of education was categorized as country-specific tertiles EU MSs. of schooling years. Self-assessment of household family These products raise concerns about their safety.3,5–7 In fact, economic status relative to the country-specific population was although HTPs produce lower levels of some carcinogens and toxic classified into three levels (higher than average, average, and chemicals compared to conventional cigarettes, they are not risk- lower than average). All subjects were asked to answer the free.5,8,9 Moreover, they produce new substances not generated by following question: “Have you ever heard about IQOS (the heat- conventional cigarettes,7 having uncertain impact on health.10 In not-burn tobacco cigarette by Philip Morris International); do you addition, long-term effects of HTPs are still unknown.8 use or did you use it?” (in England, where both IQOS and glo Besides safety problems, HTPs raise serious public health were in the market: “Have you ever heard about heat-not-burn concerns, similar to those of electronic cigarettes. These include tobacco products; do you use or did you use it?”). Possible the dual use with other traditional tobacco products and electronic answers were: 1) “I have never heard about it”; 2) “I heard about cigarettes of the majority of HTP users, the lack of evidence on it but I never used it”; 3) “I have just tried it a couple of times”; 4) the effectiveness of HTPs in assisting smokers to quit, and the “I used it in the past (not over the last 30 days)”; 5) “I use it possible “gateway effect” due to the use of these products also by occasionally (5 days or less in the last 30 days)”; 6) “I use it non-smokers and young adults who are the target of the tobacco regularly (more than 5 days in the last 30 days)”. Subjects industry and can become addicted to nicotine through HTPs.11–17 answering options 3–6 were classified as “ever HTP users”, those Only a few independent studies, mostly from Japan where HTPs answering options 5–6 as “current HTP users”. are substantially prevalent4,8,18 and the United States,19 have eTable 1 shows selected country-specific information regard- investigated the diffusion and=or the public health consequences of ing the commercialization of HTPs (eg, month of debut in the HTPs. To our knowledge, data from Europe are limited to three local market). In five countries the survey was conducted less representative national-based surveys from Italy and United than 12 months after HTP introduction (Bulgaria, England, Kingdom showing a limited but increasing prevalence of France, Italy, and Spain) while in six countries it was conducted use,2,3,20 and the interest in use by non-smokers3 and adolescents.21 at least 12 months after HTP introduction in local markets One recent study based on smokers only has identified factors (Germany, Greece, Latvia, Poland, Portugal, and Romania). related to product use from six European countries.22 Moreover, by the time of the survey, no HTP was marketed in The objective of this study was to evaluate HTP spread in Ireland, thus the question on HTPs was not asked in Ireland. Europe, providing the first measure of prevalence and associated Excluding Ireland, the survey included a sample of 10,961 factors related to awareness and use of HTPs in 11 European subjects from 11 European countries. countries. Adjusted odds ratios (aORs) and their corresponding 95% confidence intervals (CIs) for ever HTP use were estimated using unconditional multiple logistic regression models after adjusting METHODS for sex, age, level of education, and country. To compute Within the Horizon2020 - TackSHS project,23 we conducted a prevalence estimates and aORs we applied a statistical weight to cross-sectional study, based on a face-to-face survey, in 12 guarantee the representativeness of the general adult population in strategically selected European countries: Bulgaria (fieldwork each country; for pooled estimates we further applied a statistical time: October 2017), England (January–February 2017), France weight with each country contributing in proportion to its (November–December 2017), Germany (June 2018), Greece population aged 15 years or over.26 Statistical analyses were (June–July 2018), Ireland (November 2017), Italy (November performed using SAS 9.4 (SAS Institute; Cary, NC, USA). 2016), Latvia (October 2018), Poland (September 2018), Portugal (November–December 2017), Romania (June–July 2017), and Spain (October 2017), representing about 80% of the whole RESULTS EU population. The detailed methods of the TackSHS survey, Of 10,961 subjects from 11 European countries, 10,839 (98.9%) including the questionnaire development, have been explained provided valid responses on HTP awareness and use, and were elsewhere.23–25 Briefly, in each country we sampled around 1,000 included in this analysis. Overall, 72.2% had never heard about subjects, representative of the general population aged 15 years or HTPs (from 53.0% in Greece to 84.6% in Spain), 26.0% had heard older in terms of age, sex, geographic area, and socioeconomic about these products but never used them (from 13.4% in characteristics. Subjects were selected mainly through a multi- Romania to 38.7% in Greece), 1.5% had tried them once or twice, stage or a stratified random sampling. We obtained the approval 0.1% were past users and 0.1% were current users (Table 1). of the protocol of the TackSHS survey from a local ethics Overall, 1.8% of respondents described themselves as ever HTP committee in each of the 12 countries, and the protocol was users (from 0.6% in Spain to 8.3% in Greece). Men were more registered inClinicalTrials.gov (ID: NCT02928536). frequently HTP ever users than women (aOR 1.47; 95% CI, 140 j J Epidemiol 2022;32(3):139-144 Gallus S, et al. Table 1. Odds ratiosa (OR) for heated tobacco product (HTP) ever vs never use and corresponding 95% confidence intervals (CI) in the European population aged ;15 years, according to selected individual-level characteristics. TackSHS, 2017–2018 Subjects aware of HTP, % Subjects Totalb unaware of HTP ever users N HTP Never tried All ever users % Just triedc Past users Current users N b (%) OR (95% CI) TOTAL 10,839 72.2 26.0 1.5 0.1 0.1 268 (1.8) Country (month of fieldwork) Bulgaria (Oct 2017) 1,050 78.7 19.3 1.5 0.2 0.3 21 (2.0) 1.68 (0.58–4.88) England (Jan–Feb 2017) 1,013 69.1 28.8 1.5 0.4 0.2 21 (2.1) 1.63 (0.92–2.86) France (Nov–Dec 2017) 1,018 79.1 19.2 1.4 0.2 0.2 18 (1.8) 1.46 (0.83–2.55) Germany (Jun 2018) 1,012 64.2 34.3 1.3 0.0 0.1 16 (1.4) 1.28 (0.73–2.23) Greece (Jun–Jul 2018) 1,000 53.0 38.7 6.8 0.5 1.0 83 (8.3) 6.61 (3.63–12.04) Italy (Nov 2016)d 1,059 74.7 24.2 1.1 0.0 0.0 10 (1.1) 1 Latvia (Oct 2018) 936 66.4 31.8 1.8 0.1 0.0 17 (1.8) 1.47 (0.19–11.53) Poland (Sep 2018) 724 63.7 34.7 1.6 0.1 0.0 11 (1.6) 1.36 (0.71–2.58) Portugal (Nov–Dec 2017) 1,000 64.5 32.5 2.5 0.0 0.5 30 (3.0) 2.57 (1.16–5.70) Romania (Jun–Jul 2017) 1,001 83.6 13.4 2.6 0.4 0.0 30 (3.0) 2.61 (1.35–5.02) Spain (Oct 2017) 1,026 84.6 14.7 0.6 0.0 0.1 11 (0.6) 0.53 (0.24–1.18) Sex Women 5,727 76.5 22.1 1.2 0.1 0.2 109 (1.4) 1 Men 5,112 67.5 30.4 1.9 0.2 0.1 159 (2.1) 1.47 (1.11–1.95) Age, yearse 15–25 1,350 69.0 28.3 2.3 0.4 0.0 42 (2.7) 1 25–44 3,699 65.9 31.8 1.9 0.1 0.2 154 (2.3) 0.84 (0.57–1.22) 45–64 3,922 71.7 26.7 1.5 0.1 0.1 66 (1.7) 0.63 (0.43–0.94) ≥65 1,838 86.8 12.9 0.2 0.0 0.1 6 (0.3) 0.14 (0.06–0.32) P for trend <0.001 Educationf Low 4,136 76.8 21.7 1.3 0.1 0.1 68 (1.5) 1 Medium 3,799 70.4 27.8 1.6 0.1 0.2 107 (1.8) 0.99 (0.70–1.40) High 2,901 67.8 30.0 1.7 0.3 0.2 93 (2.2) 1.30 (0.91–1.86) P for trend 0.166 Household economic statusf Lower than average 2,711 78.1 20.4 1.1 0.3 0.1 49 (1.5) 1 Average 5,624 74.4 23.9 1.5 0.1 0.1 150 (1.7) 0.99 (0.66–1.48) Higher than average 1,394 68.3 29.0 2.3 0.2 0.3 51 (2.8) 1.61 (0.99–2.63) P for trend 0.060 Smoking status Never smokers 5,828 76.7 22.8 0.4 0.0 0.1 26 (0.5) 1 Ex-smokers 1,886 70.8 27.2 1.8 0.1 0.1 41 (2.0) 4.32 (2.69–6.95) Current smokers 3,125 63.2 32.5 3.7 0.5 0.3 201 (4.4) 8.35 (5.67–12.28) Electronic cigarette statusf Never users 10,295 73.1 25.5 1.2 0.1 0.1 194 (1.4) 1 Past users 291 54.9 36.2 7.1 0.8 1.0 42 (8.9) 5.48 (3.46–8.68) Current users 247 56.1 34.9 6.5 0.9 1.6 32 (8.9) 5.92 (3.73–9.40) CI, confidence interval; HTP, heated tobacco products; OR, odds ratio. a ORs and their corresponding 95% CIs were estimated using unconditional multiple logistic regression models adjusting for sex, age, level of education, and country. Estimates in bold are statistically significant at 0.05 level. b Unweighted number of subjects with available information on HTP use (N = 10,839) or unweighted number of ever users of HTPs (N = 268). c Subjects reporting to have tried HTP a couple of times. d Italy was used as the pilot country, thus, its fieldwork was anticipated to November 2016. Italy has been chosen as the reference category because it is the first European country where IQOS was launched. e Participants’ age was ≥15 years in all countries, except England (≥16), Ireland (≥18), Greece (15–64), and Latvia (15–74). f The sum does not add up to the total because of few missing values. In particular, 3 subjects had missing information on level of education and 6 subjects had missing information on electronic cigarette use. Moreover, the variable on self-assessment of the household (family) economic status relative to the country- specific population was missing in all German participants (n = 1,012) plus further 98 subjects. 1.11–1.95). Ever use was inversely related to age (compared with users (compared with never users, aOR 5.48; 95% CI, 3.46–8.68) <25 years, aOR 0.84; 95% CI, 0.57–1.22 for 25–44 years; aOR and current users (aOR 5.92; 95% CI, 3.73–9.40). No statistically 0.63; 95% CI, 0.43–0.94 for 45–64 years; and aOR 0.14; 95% CI, significant relationship was observed between HTP use and 0.06–0.32 for ≥65 years of age; P for trend <0.001). Ever HTP socio-economic characteristics, including level of education and use was more frequent in ex-smokers (compared with never household economic status. smokers, aOR 4.32; 95% CI, 2.69–6.95) and current smokers In countries where HTPs were introduced less than 12 months (aOR 8.35; 95% CI, 5.67–12.28), and in electronic cigarette past before the survey conduction, the prevalence of HTP awareness J Epidemiol 2022;32(3):139-144 j 141 Heated Tobacco Products in Europe was 23.3% and that of HTP ever users was 1.4%. Corresponding HTPs quit smoking before HTPs were launched in the local estimates in countries where HTPs were introduced more than 12 markets. This supports the fact that a large proportion of ex- months before the survey conduction were 34.3% and 2.2% smokers using HTPs are not people switching to HTPs to reduce (P < 0.001 and P = 0.001 for awareness and use, respectively). their harm, but people who relapse nicotine addiction, being Among 41 HTP ever users and ex-cigarette smokers at the time attracted by this new alleged safe product. How HTPs are of the survey, 20 (49%) quit smoking before HTPs were attracting non-smokers to nicotine addiction is a matter of introduced in the local market of each country. concern that requires further research. This study has some weaknesses, mainly related to its cross- sectional design. Although the overall sample size is large, our DISCUSSION study is based on a small sample of European HTP users. In many This study provides the prevalence and factors related to the HTP countries the survey was conducted only a few months after HTP use among the general population in multiple European countries. introduction into the market, and the fieldwork was conducted in We found that the prevalence of ever HTP use (and the frequency different time periods (ranging between November 2016 and of use) was still low. Overall, almost 2% of European adults October 2018), making the comparisons of HTP use among already tried (or used) HTPs, with a wide variation between countries difficult. Furthermore, some differences in terms of countries. Young people, men, ever smokers, and electronic sampling methodology used24 add complexity to the interpreta- cigarette users were more likely to be attracted to these new tion of the results. Moreover, no pictures of heated tobacco products, in line with previous researches.21,27 The large variation products were shown to participants during the interviews. This, in HTP awareness (ranging between 15% and 47%) and use together with some possible differences in the wording of (ranging between 1% and 8%) also reflects differences in the questions asked in various countries, may have resulted in a commercialization of these products. In fact, countries with a response bias. The strengths of our survey include the shorter experience of HTPs (ie, with time since HTPs representativeness of the adult population of the included introduction in the local market lower than 12 months at the European countries in terms of age, sex and habitat, and the time of the survey) were those with a lower awareness and use of use of face-to-face interview. More importantly, this is the first these tobacco products. European study evaluating the spread of HTP among the general Subjects aged 15–24 years have more frequently tried HTPs, in population, using the same standardized questionnaire in different agreement with previous findings.15,20 This suggests that the countries. Therefore, our estimates may serve as key baseline youngest generations could be the key target subpopulation of measures for future studies. HTP marketing promotions. However, the number of current Our study shows that only 0.1% of Europeans currently use HTP users among the young is null, likely due to the relatively HTPs. Once generalized to the 28 EU MSs, our estimate is expensive device—as compared to electronic cigarette—that compatible with more than half million adults currently using discourages initiation for a regular use.17 this product. Our data show that HTPs are: i) mainly used in Although no statistically significant relationship has been combination with other products, ii) mainly used by the youngest observed between the use of HTP and socioeconomic character- generations, and iii) also used by (and likely promoted to) never istics, wealthier subjects systematically reported the highest levels smokers. These findings are worrying and indicate the need of HTP awareness and use, in line with previous studies.3,20 for close monitoring of prevalence, trends and determinants of The majority of HTP ever users were dual users (ie also HTP use. Our study could be useful to support the planning, smokers of conventional cigarettes). This raises concerns that, implementation and monitoring of targeted prevention inter- similar to what has been observed for electronic cigarettes,28–30 vention, as well as inform decision making at the normative and HTPs could also be used in places where combustible cigarettes public health level in Europe. are not permitted while HTPs are not covered by the national legislation. These findings are in line with a recent research conducted among 6,027 smokers from 6 EU MSs according to ACKNOWLEDGMENTS which ever use of HTPs was significantly higher among those who Authors would like to thank Liliane Chatenoud, Tobias Effertz, had tried to quit smoking in the last 12 months, had tried electronic Filippos T Filippidis, Gergana Geshanova, Sheila Keogan, cigarettes during their lifetime and among those that perceived Hristo Ivanov, José Precioso, Krzysztof Przewozniak, Polina HTPs as less dangerous than combustible cigarettes.22 A Starchenko, Vergina K Vyzikidou for their help in the prepara- qualitative study conducted in the United Kingdom in 2018 found tion, translation and=or submission of the study protocol to local that IQOS users mostly experimented with IQOS to reduce or ethics committees. IDIBELL group thanks CERCA Programme to stop smoking combustible cigarettes due to health risks, Generalitat de Catalunya for the institutional support. perceiving IQOS as an (healthier) alternative way to continue Conflicts of interest: KP obtained grants and personal fees smoking.17 Moreover, only a few had completely stopped from the Polish League Against Cancer (Polska Liga Walki smoking both IQOS and combustible cigarettes, as people mainly Z Rakiem) and from Start-up Helping Hand Powered by used IQOS in place of (or alongside) traditional cigarettes.17 addictions.ai, outside the submitted work. In line with the current evidence,3 our study found that a Contributors: SG and EF had the original study idea; EF, GG limited but not negligible proportion of HTP users (ie, 10% of and AL contributed to the finalization of the survey questionnaire; all HTP ever users) were never smokers, suggesting that these XL, AL and EB carried out the statistical analysis; SG drafted the products are attracting towards nicotine dependence new article in collaboration with XL, EB and AL; all other authors segments of population, with potentially different characteristics made substantial contributions to conception, design and from those known to be associated with exclusive tobacco interpretation of data; all the authors approved the final version consumption. Moreover, almost half of ex-smokers who used of the manuscript. 142 j J Epidemiol 2022;32(3):139-144 Gallus S, et al. Funding: This project has received funding from the European 15. Marynak KL, Wang TW, King BA, et al. 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