Heat-not-BurnBrian P. Jenssen, MD, MSHP,​a Susan C. Walley, TobaccoMD,​b Sharon A. McGrath-Morrow, Products: MDc Industry Claims No Substitute for Science Background on Heat-not-Burn

In the wake of the rapid rise of e- over the past decade, the has launched its latest response to the documented harms of : heat-not-burn (HNB) tobacco products. aDepartment of Pediatrics and PolicyLab, The Children’s Hospital of Philip Morris International created and is heavily marketing their version Philadelphia, Philadelphia, Pennsylvania; bDepartment of Pediatrics, of these products, called the IQOS (I Quit Ordinary Smoking), which University of Alabama, Birmingham, Alabama; and cDepartment of involves disposable tobacco sticks soaked in propylene glycol that are Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, “ inserted into a holder in the HNB cigarette. Philip Morris markets these Maryland ” products as being designed to create a flavorful and satisfying1 - Dr Jenssen drafted the initial manuscript and reviewed containing vapor, without burning and without smoke. ‍ Advertisements and revised the manuscript; Drs McGrath-Morrow and claim this product releases no smoke because the tobacco leaves are Walley reviewed and revised the manuscript; and all authors conceptualized the manuscript, approved the final heated rather than burned, with no tobacco combustion. Claims and manuscript as submitted, and agree to be accountable for all distracting wording, however, are no substitute for science. The authors aspects of the work. of a recent report have2 shown that these tobacco products release cancer- DOI: https://​doi.​org/​10.​1542/​peds.​2017-​2383 causing chemicals. Accepted for publication Sep 19, 2017 The IQOS is not yet sold in the , but in December 2016, Philip Address correspondence to Brian P. Jenssen, MD, MSHP, Morris submitted a modified risk tobacco product application to the Department of Pediatrics, PolicyLab, The Children’s Hospital US Food and Drug Administration (FDA). If its application is successful, of Philadelphia, 2716 South St, Philadelphia, PA 19146. E-mail: Philip Morris will face looser restrictions in marketing HNB tobacco [email protected] products than it does for conventional tobacco cigarettes. Moreover, PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098- “ Philip Morris seeks to make affirmative safety statements on packaging 4275). and advertising for IQOS, including Scientific studies have shown that Copyright 2018 by the American Academy of Pediatrics ” © switching completely from conventional cigarettes3 to the IQOS system FINANCIAL DISCLOSURE: The authors have indicated they can reduce the risks of tobacco-related diseases. ‍ The public needs have no financial relationships relevant to this article to more accurate and unbiased information about the potential harms of disclose. these products. The FDA, public health officials, physicians and health FUNDING: No external funding. care providers, children and parents, and current tobacco users must POTENTIAL CONFLICT OF INTEREST: The authors have understand these products and take an evidence-based approach to their indicated they have no potential conflicts of interest to regulation. disclose. Increasing Awareness and Use To cite: Jenssen BP, Walley SC, McGrath-Morrow SA. Heat- not-Burn Tobacco Products: Tobacco Industry Claims No HNB tobacco products were released in sleek, futuristic IQOS flagship Substitute for Science. Pediatrics. 2018;141(1):e20172383 stores across Japan in 2014 and across Italy and Switzerland in 2015, with awareness and use of these products increasing dramatically.

Downloaded from www.aappublications.org/news by guest on September 25, 2021 PEDIATRICS Volume 141, number 1, January 2018:e20172383 Pediatrics Perspectives In February 2016, Philip Morris ranges, and carbon monoxide. All burgeoning evidence base reveals executives revealed that their HNB of these elements, on the basis of that nonusers of tobacco products, ’ tobacco product quickly captured extensive research of cigarette particularly children and adolescents,

2.4% of Tokyo s market share for smoke, have been shown to cause6 could be drawn to new products and tobacco over 6 months. According to serious harms to human health. that this could lead to a subsequent10 a recent internet survey of Japanese Additionally, the IQOS smoke had transition to traditional cigarettes. adolescents and adults, 48.0% of nicotine levels similar to levels2 in Characterizing flavors, which appeal respondents were aware of HNB conventional cigarette smoke. to youth, should be banned, and HNB tobacco products and 19.8% of 15-4 to Nicotine, the highly addictive tobacco products should be included 19-year-olds had tried the IQOS. substance found in tobacco, is in age of tobacco use purchase Tobacco Industry–Sponsored unsafe to youth and harms infant laws. The American Academy of Publications and adolescent brain development, Pediatrics supports raising the legal

as has been summarized in a recent 7 minimum sales age to 21 for all report from the US Surgeon General. tobacco products. Tobacco 21 laws Although information regarding A second study revealed that the have been adopted in over 260 cities health harms and benefits should aerosol from HNB tobacco products and counties in 18 states across the come from sources independent contains nicotine and cancer-causing United States, including statewide of the tobacco industry, the vast chemicals similar to those found in policies in Hawaii, California, New “ 8 majority of currently PubMed- traditional cigarettes. Jersey, Maine, and Oregon. ” indexed publications on heat-not- Approach to Protecting Public burn are published by Philip Morris Health Finally, because of the high public or other tobacco industry companies health stakes and potential for (19 out of 27, asRegulatory of September Toxicology 7, unintended consequences, sound 2017).and Pharmacology These publications include a There is no reliable evidence scientific evidence should drive 7-part series in regarding the risk reduction or decision-making regarding these , a journal partially health benefits of tobacco products products. Tobacco, when used as financed by the tobacco industry with that purport to heat rather than intended, causes disease, disability, a history of concealed proindustry burn tobacco. Although the tobacco and death. It is the only consumer bias and an editor-in-chief previously industry claims these products are product regulated by the FDA to paid $30000 by the Tobacco Institute fall in this ignominious category. safer than cigarettes, these claims “ ” to publish an article in the journal Rather than the typical standard are not supported as of 2017. Three ’ dismissing the scientifically proven5 major approaches to these products of approving safe and effective health risks of secondhand smoke. products, the FDA s regulatory should be undertaken. “ ” Secondhand Smoke Exposure From approach to tobacco products is First, any tobacco product that HNB Products based on a public health standard. produces a smoke, aerosol, vapor, This standard, specified in the and/or emission should fall under Family Smoking Prevention and the same comprehensive smoke- – The authors of independent studies Act, Public Law free policies applied to conventional “ have identified cancer-causing 111 31 (2009), section 906(d), tobacco cigarettes. Scientific evidence chemicals in the smoke emitted by applies to the risks and benefits to has unequivocally revealed that there HNB tobacco products. In 1 study, the population as a whole, including is no risk-free level of exposure to ” “ the authors compared the contents users and nonusers of the tobacco tobacco smoke. The World Health of the IQOS with the contents of product and accounts for (1) the Organization convention on tobacco conventional cigarettes by using increased or decreased likelihood control emphasizes rejecting a a smoking device designed to that existing users of tobacco threshold value for toxic effects from ” “ capture the mainstream aerosol and 9 products will stop using such secondhand smoke. Smoke-free developed to meet the standards ’ products and (2) the increased 2 policies protect public health and for common cigarettes. The smoke or decreased likelihood that those protect tobacco nonusers rights to ” released by the IQOS contains who do not use tobacco products clean, smoke-free environments. 11 the same harmful constituents of will start using such products. ‍ cigarette smoke. These elements Second, because almost all tobacco In July 2017, the FDA articulated include volatile organic compounds use starts during childhood and a new harm control approach to near the levels found in cigarette adolescence, it is essential to prevent tobacco regulation, with emphasis smoke, polycyclic aromatic access and promotion of HNB tobacco placed on noncombustible tobacco hydrocarbons at wide comparative products to youth. A consistent and products because they may be less Downloaded from www.aappublications.org/news by guest on September 25, 2021 2 Jenssen et al 6. US Department of Health and Human Services; Centers for Disease Control dangerous than cigarettes. Thus, setting a research agenda for child and Prevention; National Center for it is critical that regulation of new and adolescent tobacco prevention Chronic Disease Prevention and Health products is based on a dispassionate and cessation) for their general Promotion; Office on Smoking and evaluation of the evidence base, not contributions to this piece. Health. The health consequences of on industry statements or purported Abbreviations smoking—50 years of progress: a science. Accordingly, all new tobacco report of the surgeon general. 2014. Available at: www.​surgeongeneral.​gov/​ products, including HNB products, library/​reports/​50-​years-​of-​progress/​. should be independently evaluated FDA: US Food and Drug Accessed February 11, 2016 on their potential to entice tobacco Administration nonusers, especially children and HNB: heat-not-burn 7. US Department of Health and Human Services. E-Cigarette Use Among adolescents, and on health-related IQOS: I Quit Ordinary Smoking Youth and Young Adults. A Report of outcomes for current tobacco the Surgeon General. Atlanta, GA: US users, including health harms and References Department of Health and Human conventional cigarette quit rates, 1. Phillip Morris International. Services, Centers for Disease Control before approving their use and Alternatives to smoking: our smoke- and Prevention, National Center for marketing them to consumers. free products. Available at: https://​ Chronic Disease Prevention and Health Tobacco use is the leading www.​pmi.​com/​smoke-​free-​products. Promotion, Office on Smoking and Health; 2016 preventable cause of disease and Accessed November 4, 2017 death in the United States. Until 2. Auer R, Concha-Lozano N, Jacot- 8. Forster M, Liu C, Duke MG, McAdam KG, product approval and advertising are Sadowski I, Cornuz J, Berthet A. Heat- Proctor CJ. An experimental method to based on the results of independent not-burn tobacco cigarettes: smoke study emissions from heated tobacco evaluations, we cannot allow the by any other name. JAMA Intern Med. between 100-200°C. Chem Cent J. 2015;9:20 tobacco industry to target cigarette 2017;177(7):1050–1052 smokers or the general public with 3. US Food and Drug Administration. 9. World Health Organization. WHO misleading claims about the safety Phillip Morris products S.A. modified Framework Convention on Tobacco of HNB tobacco products. We cannot risk tobacco product (MRTP) Control. Geneva, Switzerland: World allow the tobacco industry, whose applications. Available at: https://​www.​ Health Organization; 2005. Available at: http://​www.​who.​int/​tobacco/​ core strategy remains the sale of fda.​gov/​TobaccoProducts/​Labeling/​ MarketingandAdver​tising/​ucm546281.​ framework/​WHO_​FCTC_​english.​pdf. traditional cigarettes, to put their htm. Accessed November 4, 2017 Accessed November 4, 2017 success above the lives of individuals and public health. 4. Tabuchi T, Kiyohara K, Hoshino T, Bekki 10. Soneji S, Barrington-Trimis JL, Wills Acknowledgments K, Inaba Y, Kunugita N. Awareness and TA, et al. Association between initial use of electronic cigarettes and heat- use of e-cigarettes and subsequent not-burn tobacco products in Japan. cigarette smoking among adolescents Addiction. 2016;111(4):706–713 and young adults: a systematic review Thank you to Robert McMillen, Julie and meta-analysis. JAMA Pediatr. 5. Drope J, Bialous SA, Glantz SA. Tobacco Gorzkowski, and Mark Gottlieb for 2017;171(8):788 797 industry efforts to present ventilation – their review of this manuscript and as an alternative to smoke-free 11. The Family Smoking Prevention and to the members of the American environments in North America. Tob Tobacco Control Act. Pub L No. 111–31, Academy of Pediatrics Tobacco Control. 2004;13(suppl 1):i41–i47 123 Stat. 1776 (2009) Consortium (a group of scientists and pediatricians dedicated to

Downloaded from www.aappublications.org/news by guest on September 25, 2021 PEDIATRICS Volume 141, number 1, January 2018 3 Heat-not-Burn Tobacco Products: Tobacco Industry Claims No Substitute for Science Brian P. Jenssen, Susan C. Walley and Sharon A. McGrath-Morrow Pediatrics originally published online December 12, 2017;

Updated Information & including high resolution figures, can be found at: Services http://pediatrics.aappublications.org/content/early/2017/12/08/peds.2 017-2383 References This article cites 5 articles, 1 of which you can access for free at: http://pediatrics.aappublications.org/content/early/2017/12/08/peds.2 017-2383#BIBL Subspecialty Collections This article, along with others on similar topics, appears in the following collection(s): Substance Use http://www.aappublications.org/cgi/collection/substance_abuse_sub Smoking http://www.aappublications.org/cgi/collection/smoking_sub Public Health http://www.aappublications.org/cgi/collection/public_health_sub Permissions & Licensing Information about reproducing this article in parts (figures, tables) or in its entirety can be found online at: http://www.aappublications.org/site/misc/Permissions.xhtml Reprints Information about ordering reprints can be found online: http://www.aappublications.org/site/misc/reprints.xhtml

Downloaded from www.aappublications.org/news by guest on September 25, 2021 Heat-not-Burn Tobacco Products: Tobacco Industry Claims No Substitute for Science Brian P. Jenssen, Susan C. Walley and Sharon A. McGrath-Morrow Pediatrics originally published online December 12, 2017;

The online version of this article, along with updated information and services, is located on the World Wide Web at: http://pediatrics.aappublications.org/content/early/2017/12/08/peds.2017-2383

Pediatrics is the official journal of the American Academy of Pediatrics. A monthly publication, it has been published continuously since 1948. Pediatrics is owned, published, and trademarked by the American Academy of Pediatrics, 345 Park Avenue, Itasca, Illinois, 60143. Copyright © 2017 by the American Academy of Pediatrics. All rights reserved. Print ISSN: 1073-0397.

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