18B.8 Public health and regulatory considerations

Last updated: May 2024
Suggested citation: Greenhalgh, EM & Hippolyte, D. 18B.8 Public health and regulatory considerations. In Greenhalgh EM, Scollo, MM and Winstanley, MH [editors]. Tobacco in Australia: Facts and issues. Melbourne: Cancer Council Victoria; 2024. Available from https://www.tobaccoinaustralia.org.au/chapter-18-e-cigarettes/indepth-18b-non-combustible-cigarettes/18b-8-public-health-and-regulatory-considerations


The introduction and growing popularity of heated tobacco products present challenges to the public health and tobacco control communities similar to those stemming from the growth of e-cigarette use. 1 As with e-cigarettes, the recency of heated tobacco products means that their long-term health effects are largely unknown 2 (see Section 18B.6). Evidence to date suggests limited usefulness of heated tobacco products as a smoking cessation aid, with the most common pattern of use among people who smoke being concurrently with cigarettes (i.e., dual use, see Section 18B.7). There is also evidence of use by young people, including never smokers, and concerns that the products could serve as a ‘gateway’ to combustible cigarettes. 3 Claims that heated tobacco products are safer than conventional cigarettes could enhance smoking appeal and initiation among young people and act as a deterrent to quit attempts among people who smoke. Given that the products deliver nicotine, they have the potential for creating and/or maintaining nicotine dependence in the user. 4

The involvement of the tobacco industry in research and regulations concerning ‘reduced-risk’ or cessation products is of concern to public health experts. Research on the health risks of the products is dominated by industry-affiliated studies, which generally report outcomes in favour of the products. 5 , 6 In Australia, Philip Morris International (PMI) made an application in 2019 to the Therapeutic Goods Administration (TGA) to amend the Poisons Standard (see Section 18B.9) to add an additional exemption for ‘tobacco prepared and packed for heating’, which would allow IQOS to be legally sold in Australia. While the company’s application was rejected in August 2020, an analysis of PMI’s tactics found that it extensively lobbied the Australian government to legalise heated tobacco products. This occurred alongside a retail strategy that involved preparing a network of youth-focused retailers such as bars, clubs and pubs, to distribute IQOS. These kinds of strategies can undermine the implementation of independent, evidence-based tobacco control policy. 7 Further, claims by the tobacco industry that its goal is for smokers to switch to ‘safer’ products have been met with scepticism. For example, Philip Morris International (PMI) claims that it wants to ‘quit smoking’ and that ‘the greatest contribution PMI can make to society is to replace cigarettes with less harmful alternatives’. 8 Despite these claims, PMI has made no active moves to cease selling cigarettes and continues to fight effective tobacco control measures. 9  

Research independent of the industry is needed to evaluate potential risks to public health and individual consumers. 10   A study by PMI modelled the potential population health impact of introducing a reduced-risk tobacco product (RRP) into Japan and concluded that the introduction would substantially reduce tobacco-related deaths. 11 However, independent research examining the PMI studies used in its application to the US Food and Drug Administration (FDA) found that the model suffered from serious methodological flaws that undermine the company’s claims of reduced risk. 12   Researchers assessed the PMI model against FDA guidelines for modified risk tobacco product (MRTP) applications along with more general criteria for evaluating reduced-risk tobacco products. The study found that the PMI model limited examination of the impact of cigarette and heated tobacco product use on mortality to only four tobacco-attributable diseases and excluded morbidity, underestimated mortality, excluded tobacco products other than cigarettes, did not include FDA-recommended impacts on non-users, and underestimated the impact on other population groups.  

Given their rapid growth in some markets, some have suggested that existing tobacco control regulations should be extended to encompass heated tobacco products, including the research and dissemination of messages regarding potential health risks, restricting advertising and promotion, and extending smokefree areas to protect bystanders from heated tobacco emissions. 1 , 13 Banning characterising flavours and including the products in minimum age of purchase laws may also help prevent vulnerable young people from taking up the products. 10 Others have suggested allowing access to the products by prescription only to people who smoke who are unable or unwilling to quit smoking using other methods. 14

The World Health Organization (WHO) recommends that when developing regulations on heated tobacco products, countries should consider: 13

  • the health risks to users and non-users;
  • the risk of tobacco use becoming renormalised;
  • the risk of uptake by non-users of tobacco products, particularly young people;
  • the possibility that smokers who would otherwise have quit tobacco products switch to heated tobacco;
  • dual/poly use of heated tobacco with other tobacco and nicotine products, and the associated health risks
  • capacity to assess industry claims regarding the relative harm of heated tobacco products, and to prevent misleading claims.

Relevant news and research

For recent news items and research on this topic, click here. (Last updated May 2024)  


1.  Caputi TL, Leas E, Dredze M, Cohen JE, and Ayers JW. They're heating up: Internet search query trends reveal significant public interest in heat-not-burn tobacco products. PLoS One, 2017; 12(10):e0185735. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29020019

2.  Ratajczak A, Jankowski P, Strus P, and Feleszko W. Heat Not Burn Tobacco Product-A New Global Trend: Impact of Heat-Not-Burn Tobacco Products on Public Health, a Systematic Review. International Journal of Environmental Research and Public Health, 2020; 17(2). Available from: https://www.ncbi.nlm.nih.gov/pubmed/31936252

3.  World Health Organization. Heated tobacco products information sheet. 2017. Available from: http://www.who.int/tobacco/publications/prod_regulation/heated-tobacco-products/en/

4.  Lopez AA, Hiler M, Maloney S, Eissenberg T, and Breland AB. Expanding clinical laboratory tobacco product evaluation methods to loose-leaf tobacco vaporizers. Drug and Alcohol Dependence, 2016; 169:33-40. Available from: https://www.ncbi.nlm.nih.gov/pubmed/27768968

5.  Suzuki H, Aono N, Zhang Y, Yuri K, Bassole Epse Brou MAM, et al. Comparison of Publications on Heated Tobacco Products With Conventional Cigarettes and Implied Desirability of the Products According to Tobacco Industry Affiliation: A Systematic Review. Nicotine & Tobacco Research, 2023. Available from: https://www.ncbi.nlm.nih.gov/pubmed/37950902

6.  Martin-Alvarez JM, Almeida A, Golpe AA, and Asensio E. Electronic device or regulated tobacco product? Learning from the diffusion of heated tobacco products in Spain. Public Health, 2023; 219:61-6. Available from: https://www.ncbi.nlm.nih.gov/pubmed/37119795

7.  Watts C, Burton S, and Freeman B. Creating a market for IQOS: analysis of Philip Morris' strategy to introduce heated tobacco products to the Australian consumer market. Tobacco Control, 2022; 31(3):458-63. Available from: https://www.ncbi.nlm.nih.gov/pubmed/33191270

8.  Philip Morris International. Sustainability report. 2017. Available from: https://www.pmi.com/resources/docs/default-source/pmi-sustainability/pmi_sustainability_report_2016.pdf?sfvrsn=143382b5_2

9.  Hawkes N. Big tobacco's new year's resolution to quit smoking. British Medical Journal, 2018; 360:k79. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29305417

10.Jenssen BP, Walley SC, and McGrath-Morrow SA. Heat-not-Burn Tobacco Products: Tobacco Industry Claims No Substitute for Science. Pediatrics, 2018; 141(1). Available from: https://www.ncbi.nlm.nih.gov/pubmed/29233936

11.Lee PN, Djurdjevic S, Weitkunat R, and Baker G. Estimating the population health impact of introducing a reduced-risk tobacco product into Japan. The effect of differing assumptions, and some comparisons with the U.S. Regulatory Toxicology and Pharmacology, 2018; 100:92-104. Available from: https://www.ncbi.nlm.nih.gov/pubmed/30367904

12.Max WB, Sung HY, Lightwood J, Wang Y, and Yao T. Modelling the impact of a new tobacco product: review of Philip Morris International's Population Health Impact Model as applied to the IQOS heated tobacco product. Tobacco Control, 2018; 27(Suppl 1):s82-s6. Available from: https://www.ncbi.nlm.nih.gov/pubmed/30275170

13.WHO Study Group on Tobacco Product Regulation. Report on the scientific basis of tobacco product regulation: Eighth report of a WHO study group., WHO Technical Report Series, No. 1029.Geneva, Switzerland: WHO, 2021. Available from: https://www.who.int/publications/i/item/9789240022720

14.Paumgartten FJR. A critical appraisal of the harm reduction argument for heat-not-burn tobacco products. Rev Panam Salud Publica, 2018; 42:e161. Available from: https://www.ncbi.nlm.nih.gov/pubmed/31093189