18C.6 International regulatory overview

Last updated: April 2019            

Suggested citation: Greenhalgh, EM. 18C. Heated tobacco (‘heat-not-burn’) products. In Scollo, MM and Winstanley, MH [editors]. Tobacco in Australia: Facts and issues. Melbourne: Cancer Council Victoria; 2019. Available from: http://www.tobaccoinaustralia.org.au/chapter-18-harm-reduction/indepth-18c-non-combustible-cigarettes/18c-6-international-regulatory-overview

Regulatory treatment of heated tobacco products varies across countries, with some treating them as cigarettes under the relevant legislation, others treating them more favourably, and a number of jurisdictions banning them altogether. 

In the European Union, heated tobacco products are treated as other tobacco products with regard to their sale, presentation and manufacturing. That is, the relevant provisions of the Tobacco Products Directive (TPD—see Section 18.2.2) apply and should be enforced. This includes prohibiting suggestions that a particular tobacco product is less harmful than others. However, in Italy, heated tobacco products receive the same tax reduction as applied to e-cigarettes (i.e., 50% lower as compared with conventional cigarettes), and they are subject to less stringent tobacco control policies related to health warnings, smokefree environments, and advertising.1

The UK Treasury has recently announced that it will create a new tax category for heated tobacco products. The duties imposed on the products will be determined by the weight of the tobacco used in the devices.2

In April 2019, the US Food and Drug Administration (FDA) approved Philip Morris International’s (PMI) application to sell the IQOS in the US, noting that it was appropriate for the protection of the public health because, among several key considerations, the products produce fewer or lower levels of some toxins than combustible cigarettes.3, 4 The FDA has not yet ruled on PMI’s application to market the IQOS as a Modified Risk Tobacco Product. The IQOS is treated as a tobacco product and so the packaging, labelling, advertising, promotion and sale of the IQOS is regulated under the Family Smoking Prevention and Tobacco Control Act (2009).3 The Act restricts tobacco marketing and sales to minors,  requires warning labels for smokeless tobacco products, ensures “Modified Risk” claims are supported by scientific evidence, and requires disclosure of ingredients in tobacco products. In addition, the IQOS must also include a label warning that nicotine is addictive.5  

In Japan—the largest market for the products to date—heated tobacco products are sold as tobacco products and regulated by the Tobacco Business Act.6 The Japanese government has announced plans to restrict use of heated tobacco products in certain public places; however, the restrictions will be less stringent than those on cigarettes ’because the risk to health posed by secondhand smoking of such products remains unclear’.7

In Canada, heated tobacco products are regulated under the Tobacco and Vaping Products Act.8 They are categorised as a tobacco product, and as such are regulated in the same way as conventional cigarettes. 

In 2017 the New Zealand government laid charges against Philip Morris for importing and selling iQOS, which it alleged breached 1990 legislation banning the sale of tobacco products intended for oral use. 9, 10, 11, 12  In its defence of this legal action, PMI argued successfully that the ban in s29(2) was originally enacted to control the sale of chewing and other forms of tobacco that are placed in the users’ mouth, and that it was never meant to capture inhalation‐based products.9 Further, the company provided expert testimony that its products were safer than conventional cigarettes.  The Judge applied the legal rule ejusdem generis (i.e., if particular words describe a class of things, then the general words that follow are limited to the same class of things), resulting in a narrow interpretation of the ban. The judge ruled that the ban did not apply to heated tobacco products and that the heated tobacco products could be lawfully imported, sold and distributed under the Smoke-Free Environment Act of 1990 (SFEA) and dismissed the Government’s charge against Philip Morris International (PMI). Based on that Court’s ruling, the same regulatory controls placed on smoked tobacco products under the SFEA also apply to heat-not-burn tobacco products.13 These controls include a ban on sales of heated tobacco products to minors, restrictions on promotion and advertising, a ban on sales displays, and mandatory point of sale health warnings.



 

Relevant news and research

For recent news items and research on this topic, click here.(Last updated May 2019)

References

1. Utsunomiya A. Tobacco in Japan: Shifting preferences. Tobacco Asia, 2017. Available from: http://www.tobaccoasia.com/features/tobacco-in-japan-shifting-preferences/

1. Liu X, Lugo A, Spizzichino L, Tabuchi T, Pacifici R, et al. Heat-not-burn tobacco products: Concerns from the Italian experience. Tobacco Control, 2019; 28(1):113–4. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29374094

2. Her Majesty's Treasury. Tax treatment of heated tobacco products: Response to the consultation. UK Government, London, UK 2018. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/688858/heated_tobacco_consultation_response_web.pdf.

3. Food and Drug Administration (FDA). 2019 premarket tobacco product marketing orders. 2019. Available from: https://www.fda.gov/tobacco-products/premarket-tobacco-product-applications/premarket-tobacco-product-marketing-orders.

4. LaVito A. FDA clears Philip Morris’ IQOS, Altria plans to start selling heated tobacco device in the US this summer. CNBC, 2019. Available from: https://www.cnbc.com/2019/04/30/fda-clears-iqos-philip-morris-heated-tobacco-device.html

5. Food and Drug Administration (FDA). FDA permits sale of IQOS tobacco heating system through premarket tobacco product application pathway.  Available from: https://www.fda.gov/news-events/press-announcements/fda-permits-sale-iqos-tobacco-heating-system-through-premarket-tobacco-product-application-pathway

6. Tabuchi T, Gallus S, Shinozaki T, Nakaya T, Kunugita N, et al. Heat-not-burn tobacco product use in Japan: Its prevalence, predictors and perceived symptoms from exposure to secondhand heat-not-burn tobacco aerosol. Tobacco Control, 2018; 27(e1):e25–e33. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29248896

7. No authors listed. Japan to restrict heated tobacco use but give up on indoor smoking ban ahead of 2020 Tokyo olympics. Japan Times,  2018. Available from: https://www.japantimes.co.jp/news/2018/01/30/national/science-health/japan-restrict-heated-tobacco-use-give-indoor-smoking-ban-ahead-2020-tokyo-olympics/#.WnE2WrllKUm

8. Yuen J. Health Canada orders IQOS tobacco storefront to remove its signs. Toronto Sun,  2018. Available from: https://torontosun.com/news/local-news/health-canada-orders-iqos-tobacco-storefront-to-remove-its-signs

9. Rychert M. New Zealand court dismisses ministry of health case against 'heat-not-burn' tobacco products, highlighting the need to future-proof tobacco control laws. Addiction, 2018. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29972623

10. Utsunomiya A. Tobacco in Japan: Shifting preferences. Tobacco Asia, 2017. Available from: http://www.tobaccoasia.com/features/tobacco-in-japan-shifting-preferences/

11. Rychert M. New zealand's legal action against IQOS postponed, consultation with big tobacco follows. New Zealand Medical Journal, 2017; 130(1465):109–11. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29121631

12. Cook F. Ministry of health takes tobacco giant to court over tobacco stick device. New Zealand Herald,  2018. Available from: http://www.nzherald.co.nz/health/news/article.cfm?c_id=204&objectid=12006626

13. No author listed. Vaping and smokeless tobacco.  Available from: https://www.health.govt.nz/our-work/preventative-health-wellness/tobacco-control/vaping-and-smokeless-tobacco .