18C.6 International regulatory overview

Last updated: March 2018         

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; 2018. Available from: http://www.tobaccoinaustralia.org.au/chapter-18-harm-reduction/indepth-18c-non-combustible-cigarettes/18c-6-international-regulatory-overview

In New Zealand, heated tobacco products are considered tobacco products for oral use, and like other tobacco products that are not smoked, their sale and distribution is prohibited.1 The New Zealand government has laid charges against Philip Morris for allegedly importing and selling iQOS, after it was banned.2, 3 In August 2017, the government announced its plan to establish a pre-market approval system for smokeless tobacco products, including heated tobacco products, to potentially allow them to be regulated as consumer products in the future.4  

Elsewhere, heated tobacco products are generally treated as cigarettes under the relevant legislation, or are treated more favourably. 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.5 However, in Italy, heated tobacco products receive the same tax reduction as 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.6 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.7

In the US, heated tobacco products are treated as cigarette products, and the Food and Drug Administration (FDA) must first approve all new tobacco products introduced to the market. In 2017, Philip Morris International applied to the FDA to be able to sell iQOS in the US, and for permission to market it as a modified-risk tobacco product.8 Regarding the latter application, in January an independent advisory committee voted against PMI’s claims that switching from cigarettes to iQOS reduces the risk of tobacco-related diseases, and that switching completely to iQOS presents less risk of harm than continuing to smoke cigarettes. The committee agreed that switching completely from cigarettes to iQOS significantly reduces exposure to harmful or potentially harmful chemicals, but did not agree that such reductions are reasonably likely to translate to a measurable and substantial reduction in morbidity and/or mortality.9 The evidence PMI used to support its claims was also criticised by public health experts for being flawed and cherry-picked.10, 11 The advisory committee’s recommendations are non-binding, and the FDA has not yet decided on either application (as at March 2018). 

In Japan—the major market for the products to date—heated tobacco products are sold as tobacco products and regulated by the Tobacco Business Act.12 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”.13


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

2. 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

3. 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

4. New Zealand Ministry of Health. Smokeless tobacco and nicotine-delivery products. 2017. Available from: https://www.health.govt.nz/our-work/preventative-health-wellness/tobacco-control/smokeless-tobacco-and-nicotine-delivery-products

5. Food and Drug Administration. 2018 TPSAC meeting materials and information. 2018. Available from: https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/ucm583080.htm

6. Liu X, Lugo A, Spizzichino L, Tabuchi T, Pacifici R, et al. Heat-not-burn tobacco products: Concerns from the Italian experience. Tobacco Control, 2018. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29374094

7. Treasury H. Tax treatment of heated tobacco products: Response to the consultation 2018. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/688858/heated_tobacco_consultation_response_web.pdf

8. European Parliament. Parliamentary questions: Subject: Marketing of a hybrid tobacco product. 2017. Available from: http://www.europarl.europa.eu/sides/getAllAnswers.do?reference=P-2016-009191&language=ES

9. Food and Drug Administration. Philip Morris products S.A. Modified risk tobacco product (MRTP) applications. FDA, 2017. Available from: https://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm546281.htm

10. Lempert LK and Glantz S. Detailed analysis of the executive summary (section 2.7) submitted by Philip Morris international in support of its MRTP application for IQOS. UCSF Center for Tobacco Control, Research and Education, 2017. Available from: https://tobacco.ucsf.edu/sites/tobacco.ucsf.edu/files/u9/Comments%20on%20Exec%20Summary%20-%20final.pdf

11. Lasseter T, Bansal P, Wilson T, Miyazaki A, Wilson D, et al. USA: Reuters special reports raise questions about the quality of Philip Morris international’s research into ‘heat not burn’ products and their interaction with governments. Reuters, 2017. Available from: https://www.reuters.com/investigates/special-report/tobacco-iqos-science/

12. 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, 2017. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29248896

13. 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  

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