The emergence of heated tobacco products (HTPs) has seen a growing number of organisations release position statements on their use and regulation. The major agencies that have issued information or expressed concerns regarding the risk of HTPs to individual and public health have advocated caution, as outlined below.
For further reading on position statements related to e-cigarettes, see Section 18.15.
18B.11.1 Australian Government agencies
The Australian Government Department of Health and Aged Care
The Australian Government Department of Health and Aged Care , in its 2017 inquiry into e-cigarettes and personal vaporisers, stated that:
“There are concerns about the marketing and use of heat not burn tobacco products, because of the limited evidence on their ability to reduce the risk associated with conventional tobacco products and the risks they may pose to population health, such as their potential to disrupt the decline in tobacco use in Australia. The most reliable epidemiological evidence shows that the best way to avoid tobacco-related premature death and disease is to prevent exposure or to cease the use of tobacco products entirely. There is no safe level of tobacco consumption.” 1
In 2024, the Australian Government Department of Health and Aged Care released a fact sheet on tobacco product safety, which stated that:
“There is no evidence that heated tobacco products are safe or less harmful than other tobacco products. All heated tobacco products contain nicotine, an addictive and toxic drug, and other toxic chemicals.” 2
The Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Aged Care and is responsible for regulating therapeutic goods and prescription medicines. This includes regulating supply, import, manufacturing, and advertising of therapeutic goods; and ensuring that therapeutic products meet the required standards of safety, quality, and efficacy. 3
In 2019, Philip Morris International (PMI) submitted an application to the TGA to amend the scheduling of nicotine in the Poisons Standard to include “tobacco prepared and packed for heating” under Schedule 7. 4 This proposed amendment would have authorised the sale of IQOS, a heated tobacco product produced by PMI, in Australia. However, the TGA rejected the application, with the Delegate stating:
“I am not satisfied that there is a net public health benefit from wider availability of HTPs. I do not consider that HTPs would make a significant contribution to population harm reduction if I agreed to amend the Poisons Standard as proposed in the application. I consider that maintaining the current scheduling for HTPs is necessary to protect the public health from the risks of introducing a new nicotine product for non-therapeutic use.” 5
18B.11.2 Australian non-government agencies
Australian Council on Smoking and Health, Cancer Council Australia, the Heart Foundation
The Australian Council on Smoking and Health, Cancer Council Australia, and the Heart Foundation made a joint submission to the TGA in response to PMI’s application to amend the scheduling of nicotine in the Poisons Standard. The organisations stated that:
“In view of the evidence, the proposal carries a significant risk to public health in Australia and is inconsistent with longstanding, effective, evidence-based public policy positions which have significantly reduced the health harms of tobacco use driven substantially by nicotine addiction in Australia over the past several decades. There is now evidence of heated tobacco products (HTPs) conferring any public health benefit; there are, however, significant risks of harm, as supported by the evidence.” 6
The Royal Australian College of General Practitioners
The Royal Australian College of General Practitioners, in its comment on the Public Health (Tobacco and Other Products) Legislation 2023, made two recommendations regarding the regulation of heated tobacco products. The recommendations state:
- Heated tobacco products must be included among the defined tobacco products under this legislation.
- [Policy makers need to] ensure heated tobacco products are covered by the proposed plain packaging and product requirement legislation. 7
Royal Australasian College of Physicians
The Royal Australasian College of Physicians, in its 2020 submission to the Select Committee on Tobacco Harm Reduction, stated:
“Tobacco companies have no genuine interest and motive in pursuing harm reduction. Their discourse in harm reduction is an opportunistic tactic in response to policy change and to be involved in the development of next generation products such as heated tobacco products and e-cigarettes, instead of a genuine interest and motive in pursuing harm reduction.” 8
Lung Foundation Australia
Similarly, the Australian Lung Foundation, in its submission to the Select Committee on Tobacco Harm Reduction, stated:
“In accordance with strong, well-established, credible evidence, we do not support the sale of combustible cigarettes, e-cigarettes (flavoured or nicotine), snuff, heat-not-burn, or chewing tobacco as consumer products in Australia.” 9
18B.11.3 Global agencies
The World Health Organization and the WHO Framework Convention on Tobacco Control
At the eighth session of the Conference of the Parties to the World Health Organization Framework Convention on Tobacco Control (WHO FCTC) in 2018, the decision was made to recognise HTPs as tobacco products. The decision stated that:
“Heated tobacco products are tobacco products and are therefore subject to the provisions of the WHO FCTC… also that the properties of certain novel and emerging tobacco products such as heated tobacco products may pose regulatory challenges regarding their definition and classification.” 10
In 2020, the WHO released an updated version of its HTPs information sheet, which stated that:
“All forms of tobacco use are harmful, including HTPs. Tobacco is inherently toxic and contains carcinogens, even in its natural form. Therefore, HTPs should be subject to policy and regulatory measures applied to all other products, in line with the WHO Framework Convention on Tobacco Control.” 11
The International Union Against Tuberculosis and Lung Disease
In 2018, the International Union Against Tuberculosis and Lung Disease released a position statement concluding that:
- The potential benefits and risks from HTP to the public health remain undetermined but early independent research indicates that the tobacco companies are understating the risks. The Union recommends that governments apply the precautionary principle to the regulation of HTP. Countries should wait for independent assessment of the health effects of HTP and not simply take industry assertions at face value before allowing the sale of these products.
- Governments should ban indoor HTP use because the aerosol released from HTP contain many of the harmful constituents found in cigarette smoke. There are likely health risks from being exposed to second-hand aerosol of HTP.
- Advertising, promotion, and sponsorship activities of HTP should be banned as they have the potential to glamorise cigarette smoking. Children and adult non-smokers are at the risk of being led into nicotine addiction and subsequently smoking cigarettes or using other tobacco products.
- HTP should be incorporated in the regular monitoring framework of tobacco use in the country.
- In countries where HTP are already available, governments should also prohibit claims that these products assist in smoking cessation until independent evidence at both individual and population levels is available that this claim is accurate. The potential of HTP to reduce willingness to quit smoking and the impact of dual use with cigarettes should also be independently assessed.
- The tobacco industry should not be involved in the discussions of HTP policies or any other tobacco control policies. Such involvement is a violation of the WHO FCTC Article 5.3 and its Guidelines. 12
18B.11.4 Overseas government and non-government agencies
US Centers for Disease Control and Prevention
In a 2023 fact sheet, the US Centers for Disease Control and Prevention noted that:
- The emissions created from heated tobacco products generally contain lower levels of harmful ingredients than the smoke from regular cigarettes. However, that does not mean heated tobacco products are safe.
- Research suggests that heated tobacco products and their emissions contain many of the same harmful ingredients as regular cigarettes, as well as other harmful ingredients not present in regular cigarettes.
- Additional research is needed to determine whether adult cigarette smokers who completely switch to heated tobacco products might reduce their risks of tobacco related disease. 13
American Cancer Society Action Network, the American Heart Association, the American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative
In 2020, the US Food and Drug Administration (FDA) authorised the marketing of IQOS (a HTP produced by Philip Morris International (PMI)) as a modified risk tobacco product. Prior to the authorisation, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative, made the following recommendations to the US FDA:
- The applications should be denied for insufficient evidence on the impact of the marketing of IQOS with modified risk claims on the increased likelihood of initiation of tobacco use by non-users, particularly youth.
- PMI has submitted insufficient evidence that its marketing will target only adult smokers, particularly in light of its marketing of IQOS abroad, which reaches youth.
- The applications should be denied because PMI did not provide research on the impact of marketing menthol IQOS products with the proposed modified risk claims on the African-American population and youth.
- The applications should be denied because the evidence indicates that the marketing of IQOS with modified risk claims will lead to greater dual use with cigarettes instead of leading substantial members of smokers to switch completely to IQOS.
- The application should be denied because there exists considerable doubt about the extent of individual health benefits from complete switching from cigarettes to IQOS. 14
Campaign for Tobacco-Free Kids
In a 2020 fact sheet on HTPs, Campaign for Tobacco-Free Kids made the following conclusions:
- Heated tobacco products carry serious health risks.
- More research is needed to understand better the specific health harms caused by heated tobacco products.
- Governments should consider banning heated tobacco products or applying tobacco control provisions to both the heated cigarettes and the heating devices that are fully compliant with the WHO Framework Convention on Tobacco Control. 15
Public Health England
In its 2018 review on e-cigarettes and HTPs, Public Health England stated that:
“…it is currently not clear whether heated tobacco products provide any advantage as an additional potential harm reduction product. Depending on emerging evidence on their relative risk to combustible tobacco and e-cigarettes, regulatory levers such as taxation and accessibility restrictions should be applied to favour the least harmful options alongside continued efforts to encourage and support complete cessation of tobacco use.” 16
European Respiratory Society
The European Respiratory Society’s (ERS) position paper on HTPs states that:
“Even though heated tobacco products may perhaps be less harmful for smokers they nevertheless remain both harmful and highly addictive, and there may be a risk that smokers will switch to heated tobacco products instead of quitting. ERS cannot recommend any product damaging the lungs and human health.” 17
European Lung Foundation
In a 2024 fact sheet, the European Lung Foundation concluded that:
“There is currently no evidence showing that these products are any less harmful than traditional cigarettes. In fact, harmful chemicals were found in heated tobacco products in higher amounts than in traditional cigarette smoke. There is some evidence of chemicals in heated tobacco products that are not present in traditional cigarettes, and which could be toxic and harmful.” 18
European Academy of Paediatrics
In 2021, the European Academy of Paediatrics released a position statement on the growing threat of e-cigarettes and novel tobacco products. The Academy stated:
“We cannot be complacent about the long-term consequences of the inhalation of e-cigarettes and heated tobacco products… It is not the role of the Academy to prove these devices are unsafe; it is up to the industry to prove they are safe, if they can .” 19
French Alliance Against Tobacco
The French Alliance Against Tobacco’s 2017 position statement on HTPs concludes that:
“Independent data on heated tobacco is insufficient; heated tobacco must be subject to the rules on smoked tobacco products; and heated tobacco is more of a problem than a solution for tobacco control.” 20
Relevant news and research
For recent news items and research on this topic, click here. (Last updated May 2024)
References
1. Australian Government Department of Health and Aged Care. Inquiry into the Use and Marketing of Electronic Cigarettes and Personal Vaporisers in Australia. 2017, Australian Government. Available from: https://www.aph.gov.au/DocumentStore.ashx?id=4f4d5093-5468-40c0-b573-986692900aad&subId=512734.
2. Australian Government Department of Health and Aged Care. Are there safe smoking and tobacco options? 2024. Available from: https://www.health.gov.au/topics/smoking-vaping-and-tobacco/about-smoking/no-safe-options.
3. Therapeutic Goods Administration. TGA Basics. Canberra: Australian Government Department of Health and Aged Care, 2015. Last update: Viewed Available from: https://www.tga.gov.au/tga-basics.
4. Therapeutic Goods Administration. Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACMS/ACCS meetings, March 2020. Australian Government Department of Health and Aged Care. 2020. Available from: https://www.tga.gov.au/resources/consultation/consultation-proposed-amendments-poisons-standard-accs-acms-and-joint-acmsaccs-meetings-march-2020.
5. Therapeutic Goods Administration. 3.3.2 Nicotine (heated tobacco products). Australian Government Department of Health and Aged Care. 2020. Available from: https://www.tga.gov.au/resources/publication/scheduling-decisions-final/public-notice-final-decisions-acms29-accs27-joint-acms-accs24-march-2020/332-nicotine-heated-tobacco-products.
6. Cancer Council Australia, National Heart Foundation of Australia, and Australian Council on Smoking and Health. Proposed amendment to the Poisons Standard - nicotine 2020. Available from: https://www.tga.gov.au/sites/default/files/public-submissions-scheduling-matters-referred-acms-29-accs-27-and-joint-acms-accs-24-meetings-held-march-2020-joint.pdf.
7. The Royal Australian College of General Practitioners. RACGP Response - Public Health (Tobacco and Other Products) Legislation 2023. 2023. Available from: https://www.racgp.org.au/advocacy/reports-and-submissions/view-all-reports-and-submissions/2023-reports-and-submissions/tobacco-and-other-products-legislation.
8. Royal Australasian College of Physicians. The Royal Australasian College of Physicians’ submission to Tobacco Harm Reduction Inquiry 2020. Available from: https://www.racp.edu.au/docs/default-source/advocacy-library/submission-to-senate-inquiry-on-tobacco-harm-reduction.pdf.
9. Lung Foundation Australia. Submission to the Senate Inquiry on Tobacco Harm Reduction. 2021. Available from: https://lungfoundation.com.au/wp-content/uploads/2020/12/Information-Paper-Submission-to-Senate-Select-Committee-on-Tobacco-Harm-Reducation-Dec2020.pdf.
10. World Health Organization. Heated tobacco products: a brief. 2020. Available from: https://www.who.int/europe/publications/i/item/WHO-EURO-2020-4571-44334-62636.
11. World Health Organization. Heated tobacco products: information sheet - 2nd edition. 2020. Available from: https://www.who.int/publications/i/item/WHO-HEP-HPR-2020.2.
12. International Union Against Tuberculosis and Lung Disease. The Union's position on heated tobacco products (HTP). 2018. Available from: https://www.theunion.org/what-we-do/publications/official/body/Heat-not-burn-Union-Position-Statement-Final.pdf.
13. Centers for Disease Control and Prevention. Heated Tobacco Products. 2023. Available from: https://www.cdc.gov/tobacco/basic_information/heated-tobacco-products/index.html#what-are-htp.
14. American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative. Comments submitted to the U.S. Food and Drug Administration. 2019. Available from: https://assets.tobaccofreekids.org/content/what_we_do/federal_issues/fda/regulatory/2019_02_11_Public_Health_Groups_Comments_IQOS_MRPTAs.pdf.
15. Campaign for Tobacco-Free Kids. Heated Tobacco Products: Evidence. 2020. Available from: https://assets.tobaccofreekids.org/global/pdfs/en/HTP_evidence_en.pdf.
16. McNeill A, Brose L, Calder R, Bauld L, and Robson D. Evidence review of e-cigarettes and heated tobacco products 2018. A report commissioned by Public Health England. London: Public Health England, 2018. Available from: https://assets.publishing.service.gov.uk/media/5a981c6740f0b67aa27253cc/Evidence_review_of_e-cigarettes_and_heated_tobacco_products_2018.pdf.
17. European Respiratory Society. ERS Position Paper on Heated Tobacco Products. 2020. Available from: https://www.ersnet.org/news-and-features/news/ers-position-paper-on-heated-tobacco-products/.
18. European Lung Foundation. E-cigarettes, heated tobacco and smokeless tobacco products. 2024. Available from: https://europeanlung.org/en/information-hub/keeping-lungs-healthy/e-cigarettes-heat-not-burn-and-smokeless-tobacco-products/.
19. Bush A, Lintowska A, Mazur A, Hadjipanayis A, Grossman Z, et al. E-Cigarettes as a Growing Threat for Children and Adolescents: Position Statement From the European Academy of Paediatrics. Front Pediatr, 2021; 9:698613. Available from: https://pubmed.ncbi.nlm.nih.gov/34737999/
20. French Alliance Against Tobacco. Heat Not Burn Tobacco & Related Products. 2017. Available from: https://ensp.network/position-paper-heat-not-burn-tobacco-related-products/