Informing iQOS Regulations in the United States: A Synthesis of What We Know

Carla J. Berg*, Yael Bar-Zeev, Hagai Levine

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

16 Scopus citations

Abstract

The tobacco industry offers various products, including heated tobacco products (HTPs). Philip Morris International’s (PMI) “iQOS” has the greatest HTP market share, as well as research on its use and impact. iQOS was released in 2014 and is now in more than 40 countries. The U.S. Food and Drug Administration announced permission for PMI to sell iQOS in the United States in April 2019, and iQOS was launched in October 2019. Decisions pending its modified risk tobacco product (MRTP) application will occur subsequently. The U.S. regulatory efforts regarding iQOS could be informed by examining (a) Philip Morris USA other product marketing efforts and (b) the iQOS market in countries where it is available. This article briefly addresses these two points with extant literature and suggests that future research should address important gaps in what is currently known, including strategic international collaborations and research, which historically has been critical for advancing tobacco control globally.

Original languageAmerican English
JournalSAGE Open
Volume10
Issue number1
DOIs
StatePublished - Jan 2020

Bibliographical note

Funding Information:
In summary, as iQOS markets in the United States begin to expand, regulatory efforts can be informed by the literature gleaned from prior “reduced harm” products marketed by PM in the United States as well as research of existing iQOS markets. First, the language and imagery used in advertising iQOS needs to be scrutinized to determine the extent to which consumers are interpreting or misinterpreting the product as less harmful, despite iQOS not currently being considered a modified risk product. Similarly, regulatory efforts must consider consumer perceptions of how and why the product should be used (e.g., to facilitate cessation of regular cigarettes, to project positive self-image) and who should use them (e.g., young people, current regular cigarette users) based on marketing materials. Relatedly, given iQOS software and the ability to collect user data ( Lasseter et al., 2018 ), regulation is needed regarding the extent to which these data are being used by PMI to monitor and/or promote iQOS use among users. In addition, regulatory efforts must also consider PMI’s interactions with policymakers, press, and merchants; prior work has documented the relevance of doing so ( Bar-Zeev et al., 2019 ; Mathers et al., 2018 ; Rosen & Kislev, 2018 ). In addition, research must strategically build on this literature. Several key strategies could advance the literature and fill gaps critical to FDA regulation. First, strategic international collaborations are needed to advance and inform regulatory efforts for the broad range of emerging tobacco products. Such research is critical before and after the introduction of new products into various markets with differing regulatory environments to advance tobacco control globally and to anticipate how PMI will market iQOS in different regulatory contexts ( O’Connor, 2012 ). Relatedly, research should compare responses to the iQOS product and its marketing channels and messaging across segments of populations in different countries to determine the extent to which similar consumer segments are being targeted in these countries, as well as the generalizability of findings across contexts. Particularly relevant to PMI’s MRTP application, research must examine consumer perceptions of harm reduction messaging in iQOS marketing. Countries with fewer advertising restrictions may be strategic settings to examine consumer reactions to actual ads in real-life settings. Finally, comprehensive case studies of iQOS marketing in countries where it is available are needed to provide in-depth information regarding the actual marketing strategies being used. Indeed, common themes across HTPs regarding their marketing and distribution channels have been identified but not fully studied within a single market ( WHO, 2018 ). Israel, for example, could be one strategically chosen country. In Israel, iQOS has and will face regulatory changes over the course of a short 4-year period. Initially, in 2016 to 2017, iQOS was not designated as a nontobacco product and thus was not subject to regulatory oversight. Then, from 2017 to 2020, it was designated as a tobacco product ( Rosen & Kislev, 2018 ) and subject to relatively weak legislation. In 2020, iQOS will face new tobacco control policies in Israel including increased restrictions on advertising and requirements on packaging ( Baumer, 2019 ; Wootliff, 2018 ). Contexts such as this offer the opportunity to see how PMI will operate and adapt within different policy contexts within a single country over time. Ultimately, several key themes regarding the marketing of novel tobacco products, particularly, iQOS, have emerged across contexts, tobacco products, and time. U.S. tobacco regulatory efforts, in general and specific to iQOS, could be advanced by considering what we know and by strategically building on the literature. Declaration of Conflicting Interests The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Y.B-Z. has received fees for lectures from Pfizer Ltd (distributor of a smoking cessation pharmacotherapy in Israel) in 2012–2015, 2017–current. She has also received fees for lectures from Novartis (past distributor of nicotine replacement therapy in Israel) in the past (2012–2015). H.L. had received fees for lectures from Pfizer Israel Ltd (distributor of a smoking cessation pharmacotherapy in Israel) in 2017. Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This manuscript was supported by the National Cancer institute (R01CA239178-01A1; MPIs: Berg, Levine). Berg is also supported by the National Cancer Institute (R01CA215155-01A1; PI: Berg; R01CA179422-01; PI: Berg), the US Fogarty International Center/National Cancer Institute (1R01TW010664-01; MPIs: Berg, Kegler), and Fogarty/NIEHS (D43ES030927-01; MPIs: Berg, Marsit, Sturua). ORCID iD Carla J. Berg https://orcid.org/0000-0001-8931-1961

Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This manuscript was supported by the National Cancer institute (R01CA239178-01A1; MPIs: Berg, Levine). Berg is also supported by the National Cancer Institute (R01CA215155-01A1; PI: Berg; R01CA179422-01; PI: Berg), the US Fogarty International Center/National Cancer Institute (1R01TW010664-01; MPIs: Berg, Kegler), and Fogarty/NIEHS (D43ES030927-01; MPIs: Berg, Marsit, Sturua).

Publisher Copyright:
© The Author(s) 2020.

Keywords

  • alternative tobacco products
  • marketing
  • tobacco control
  • tobacco industry

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