18B.10International regulatory overview

Last updated: May 2024
Suggested citation: Cho, M & Greenhalgh, EM. 18B.10 International regulatory overview. 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-10-international-regulatory-overview

 

Regulatory treatment of heated tobacco products varies across countries, with some laws treating them as cigarettes, some treating them more favourably than cigarettes, and others banning them altogether. For instance, although heated tobacco products are often priced similarly to conventional cigarettes, they are subjected to lower excise tax and carry a lower tax burden in many countries. 1 Campaign for Tobacco-Free Kids provides an overview of heated tobacco products and cigarettes taxes and prices around the world. 2 The WHO has identified that the inconsistency amongst countries regarding heated tobacco product regulation owes to regulators being largely unprepared for the continual development of novel products by the tobacco industry. 3

European Union (EU)

In the European Union, heated tobacco products are defined by the Tobacco Products Directive (TPD) as either smokeless tobacco products or tobacco products for smoking, depending on their characteristics. 4  The TPD regulates the sale, presentation and manufacturing of heated tobacco products. 4 The TPD prohibits any suggestions that a particular tobacco product is less harmful than others. Since 2023, EU Member States must ensure the display of health warnings on heated tobacco products and ban flavoured heated tobacco products. 5

Italy

Taxation

Heated tobacco products were introduced in Italy in 2014 as a pilot country for the European market by Philip Morris International. 6 , 7 Outside of the Asia-Pacific region, Italy accounted for the largest heated tobacco product market in 2019. 3 Although categorised as tobacco products, heated tobacco products receive the same tax reduction as e-cigarettes (50% lower as compared with conventional cigarettes). 7 In 2019, Legislative Decree 119/2018 further reduced the excise duty on heated tobacco sticks from 50% to 25% of the tax on conventional cigarettes. 1 , 8 The significant tax discount resulted in the surge of the tobacco market by 30 times in 2019, 1 whilst preference for heated tobacco products led to a decrease in the cigarettes market by 10.3%. 1 , 9 In 2023, the excise duty was increased to 40% of the “equivalent” quantity of cigarettes, in response to pressure by health authorities. 1

Italy is the only country that compares quantities of heated tobacco sticks and cigarettes based on consumption time. 1 The Customs and Monopolies Agency (Agenzia delle dogane e dei Monopoli, ADM) determines the tax on the ‘equivalent’ quantity of cigarettes based on the average time required to consume a sample of best-selling brands of conventional cigarettes deemed to be similar to heated tobacco sticks. The time of consumption varies considerably between heated tobacco stick brands. Alternative methods used in other countries comparing the number of sticks or the weight of tobacco. 1

Other Regulation

Heated tobacco products are also subject to less stringent tobacco control policies related to health warnings, smokefree environments, and advertising. 6

United Kingdom (UK)

Legislation

UK legislation bans heated tobacco products with:

  • a characterising flavour,
  • a filter, paper, package, capsule or other component containing flavourings,
  • a filter paper or capsule containing tobacco or nicotine, or
  • a technical feature allowing the consumer to modify the smell, taste, or smoke intensity of the product. 10

Taxation

The Finance Act 2019 (UK) categorises heated tobacco products as “tobacco for heating”. The UK taxation rates are slightly higher than the average rate in the EU, where heated tobacco products are classified as “other tobacco products”. Prior to this enactment, heated tobacco products were often identified as “other smoking tobacco”, which allowed lower taxation rates than combustible cigarettes. Since July 2019, the UK taxes heated tobacco products based on the weight of the tobacco used.

North America

United States (US)

Authorisation to Sell

In the US, corporations must receive permission by the Food and Drug Administration (FDA)  to sell new tobacco products. 11 In April 2019, the FDA approved Philip Morris International’s (PMI) application to sell IQOS in the US. The FDA deemed that the decision was appropriate for the protection of the public health because, among other considerations, the products produce fewer or lower levels of some toxins than combustible cigarettes. 12 , 13

Legislation

Since IQOS is treated as a tobacco product, the packaging, labelling, advertising, promotion and sale of IQOS is regulated by the Family Smoking Prevention and Tobacco Control Act (2009). 12 , 14 The Act:

Modified Risk Claims

The Family Smoking Prevention and Tobacco Control Act (2009) prohibits tobacco companies from making modified risk claims without obtaining a modified risk granted order. 14

The FDA issued a modified risk granted order authorising PMI to market IQOS with the following reduced exposure information:

  • the IQOS system heats tobacco but does not burn it, which significantly reduces the production of harmful and potentially harmful chemicals; and
  • scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals. 17

Canada

In Canada, heated tobacco products are regulated under the Tobacco and Vaping Products Act. 18 , 19   The Act defines ‘tobacco product’ as a product made in whole or in part of tobacco, including tobacco leaves, as well as:

  • tubes and filters intended for use with that product,
  • a device, other than a water pipe, that is necessary for the use of that product, and
  • the parts that may be used with the device. 18

Heated tobacco products are therefore categorised as tobacco products, and are regulated in the same way as conventional cigarettes. For instance, it is illegal to advertise tobacco products, including heated tobacco products. In 2018, Health Canada warned Rothmans, Benson and Hedge company (Canadian subsidiary of Philip Morris International) to remove signage advertising ICOS to the public from stores. 19

Limitation on Sales

The sale of heated tobacco products is subject to a minimum sales age and product packaging requirements. 18 All tobacco product packages must display health warnings, including information regarding toxicity, the quit line and available cessation web portal services. 20

Self-service display of tobacco products and the sales of heated tobacco products containing menthol and clove flavours are prohibited. 18

Taxation

Heated tobacco products are taxed under “other tobacco products”. 18 , 21

New Zealand

In New Zealand, heated tobacco products are treated as tobacco products (Section 2). 22 They are defined as smokeless tobacco products that have a device that uses or facilitates the use of heat to aerosolise nicotine from tobacco leaf directly (Section 2). 22 The Smokefree Environments and Regulated Products Act 1990 is the primary tobacco control law in New Zealand. 22 The Act bans the advertising, promotion and sponsorship of tobacco and tobacco devices, subject to any exemptions. 22

Ministry of Health v Philip Morris (New Zealand) Ltd [2018] NZDC 4478

In 2018, the New Zealand Ministry of Health charged Philip Morris (New Zealand) Limited with selling a tobacco product called “HEETS” labelled, or otherwise described as suitable for chewing, or for any other oral use (other than smoking) in breach of s 29(2) of the Smoke-free Environment Act 1990, which bans the sale of tobacco products intended for oral use. 23 , 24   Philip Morris argued successfully that s 29(2) was enacted to control the sale of chewing and other forms of tobacco that are placed in the users’ mouth, rather than inhalation‐based products. 25 Further, Philip Morris provided expert testimony that its products were safer than conventional cigarettes.  The District Court of New Zealand applied the legal rule ejusdem generis (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. 23 The Court dismissed the government’s charge against Philip Morris, on the basis that heated tobacco products could be lawfully imported, sold and distributed under the Smoke-free Environment Act 1990. 23

Asia

The Asia-Pacific region reported to contribute the largest share of revenue from heated tobacco products in 2021, especially amongst people aged between 18 and 39. 3 In particular, Japan and the Republic of Korea have large markets for heated tobacco products. 3 Japan accounted for 85% of the global heated tobacco product market in 2018, which was the largest share of revenue. 3 The Republic of Korea had the fastest rate of growth in heated tobacco product revenue. 3

Japan

In Japan, heated tobacco products are sold as tobacco products and regulated by the Tobacco Business Act. 26 The use of heated tobacco products increased significantly between 2015 and 2018. 27 For example, IQOS was available in 57 markets by 2020, after being launched in Japan by PMI in 2014. 3 The total number of IQOS users was estimated to be around 15.4 million in 2020. 3 The profit margins for IQOS were 30-50% higher than that of conventional cigarettes. 3 In 2020, research found that a considerable number of people used heat tobacco products in smoke-free locations, and emphasised the need for policymakers to establish explicit regulations regarding the use of heat tobacco products in smoke-free environments. 28

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 second-hand smoking of such products remains unclear’. 29

Republic of Korea

In South Korea, heated tobacco products are classified as general consumer goods rather than tobacco products. 30 Corporations are therefore not required to include health warnings or comply with tobacco regulations for heated tobacco products. 30

In Korea, heated tobacco products have both an international and domestic presence. Following the introduction of heated tobacco products by JTI in 2019, there was a rapid shift in demand from conventional cigarettes to heated tobacco products. 3 In response to the high demand for heated tobacco products, Korea Tobacco and Ginseng Corporation (KT&G), which is the country’s leading cigarette producer, launched its own heated tobacco products in 2017. In 2020, KT&G and PMI agreed to allow PMI to distribute KT&G’s heated tobacco products. 3

Research has shown that heated tobacco product retailers employed aggressive promotional strategies targeting women and young people, and making baseless health claims, due to inadequate regulations. 30 Several Departments of Family Medicine at Korea’s largest Universities have advocated for increased monitoring and regulation of heated tobacco product marketing until the issues surrounding the harm of heated tobacco products are resolved. 30

Relevant news and research

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

References

1. Tax Gap of Heated Tobacco Products in Italy. US: Campaign for Tobacco-Free Kids 2023. Available from: https://www.tobaccofreekids.org/what-we-do/global/taxation-price/tax-gap-italy#:~:text=Heated%20tobacco%20products%20were%20introduced,%E2%80%9Cequivalent%E2%80%9D%20quantity%20of%20cigarettes.

2. Campaign for Tobacco-Free Kids. Heated Tobacco Products and Cigarettes Taxes and Prices Around the World. US Available from: https://www.tobaccofreekids.org/what-we-do/global/taxation-price/tax-burden-htp#mapBurden.

3. World Health Organisation. 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, Geneva 2021.

4. Report from the Commission on the establishment of a substantial change of circumstances for heated tobacco products in line with Directive 2014/40/EU. European Union 2022. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52022DC0279

5. Heated tobacco flavours ban now official, and will apply throughout the EU. 2022. Available from: https://tobaccointelligence.com/heated-tobacco-flavours-ban-now-official-and-will-apply-throughout-the-eu/

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, 2019; 28(1):113-4. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29374094

7. Legislative Degree 188/2014: Italy. Available from: https://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legislativo:2014-12-15;188!vig.

8. Legislative Decree 119/2018: Italy. Available from: https://www.adm.gov.it/portale/documents/20182/527578/009+Det+-not+burn+16-1-19.pdf/bfe0025b-9d7a-48ec-9448-28edcb83350b.

9. Blue Book - Organization, Statistics and Activity - Year 2019. Italy Available from: https://www.adm.gov.it/portale/en/libro-blu-organizzazione-statistiche-e-attivita-anno-2019

10. The Tobacco and Related Products Regulations. 2016.

11. Premarket Tobacco Product Marketing Granted Orders. US: FDA, 2024. Available from: https://www.fda.gov/tobacco-products/premarket-tobacco-product-applications/premarket-tobacco-product-marketing-granted-orders.

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

13. 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

14. Family Smoking Prevention and Tobacco Control Act (US). 2009; Available from: https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/family-smoking-prevention-and-tobacco-control-act-table-contents.

15. Food and Drug Administration (FDA). FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway.  2019. Available from: https://www.fda.gov/news-events/press-announcements/fda-permits-sale-iqos-tobacco-heating-system-through-premarket-tobacco-product-application-pathway.

16. Family Smoking Prevention and Tobacco Control Act - An Overview. US 2020. Available from: https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/family-smoking-prevention-and-tobacco-control-act-overview#:~:text=To%20protect%20the%20public%20health,and%20marketing%20of%20tobacco%20products.

17. US Food & Drug Administration. Philip Morris Products S.A. Modified Risk Tobacco Product (MRTP) Applications. USA 2022. Available from: https://www.fda.gov/tobacco-products/advertising-and-promotion/philip-morris-products-sa-modified-risk-tobacco-product-mrtp-applications#:~:text=On%20March%2011%2C%202022%2C%20FDA,but%20does%20not%20burn%20it.

18. Tobacco and Vaping Products Act. 1997; Available from: https://laws.justice.gc.ca/eng/acts/T-11.5/page-1.html.

19. 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

20. Tobacco Products Appearance, Packaging and Labelling Regulations, 2023: Canada. Available from: https://laws.justice.gc.ca/eng/regulations/SOR-2019-107/rpdc.html.

21. Tax Gap of Heated Tobacco Products in Canada. Campaign for Tobacco-Free Kids, 2023. Available from: https://www.tobaccofreekids.org/what-we-do/global/taxation-price/tax-gap-canada.

22. Smokefree Environments and Regulated Products Act. 1990; Available from: https://www.legislation.govt.nz/act/public/1990/0108/latest/versions.aspx.

23. Ministry of Health v Philip Morris (New Zealand) Limited. 2018; Available from: https://www.districtcourts.govt.nz/all-judgments/2018-nzdc-4478-moh-v-morris/.

24. 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

25. 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

26. 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

27. Hori A, Tabuchi T, and Kunugita N. The spread of heated tobacco product (HTP) use across various subgroups during 2015–16 and 2017–18 in Japan. 2023. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9884561/

28. Kiyohara K and Tabuchi T. Use of heated tobacco products in smoke-free locations in Japan: the JASTIS 2019 study BMJ Journals, 2020. Available from: https://tobaccocontrol.bmj.com/content/31/1/65

29. 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

30. Ju H, Lee H, Choi J, Kim S, and Kang E. The online promotion strategies of e-cigarette and heated tobacco product retailers in South Korea following the COVID-19 pandemic: Implications for regulation. Tobacco Induced Diseases, 2024; 22. Available from: https://www.tobaccoinduceddiseases.org/The-online-promotion-strategies-of-e-cigarette-and-heated-ntobacco-product-retailers,178380,0,2.html#ungrouped