Big Question 1 - What is Tobacco Harm Reduction?

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17 September 2024

CHAPTER 2 . THE BIG QUESTIONS

Big Question 1 - What is Tobacco Harm Reduction?

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KEY SUMMARY POINTS

1

Tobacco Harm Reduction (THR) is a public health policy first described by the U.S. Institute of Medicine.

2

THR is achieved through adult smokers who would otherwise continue to smoke switching from harmful cigarettes to lower risk profile tobacco and nicotine products.

3

It is expected this reduction in, or elimination of, smoking will have a beneficial public health impact.


"A product is harm reducing if it lowers total tobacco-related mortality and morbidity even though use of that product may involve continued exposure to tobacco-related toxicants."

 

U.S. Institute of Medicine
(2001)[1]

Harm reduction, in general, refers to health policies, strategies and programmes that aim to reduce the harms and negative impacts (social and/or physical) associated with what are deemed ‘risky’ behaviours.

 

These approaches are founded on improving individual and public health and are supported by science and a strong body of evidence demonstrating that the interventions and practices are safe, practical and effective (economically, socially and culturally).

 

We also have harm reduction aims, programmes and strategies. The first is aligned with globally recognised public health authorities that the safest thing for a smoker is to quit.

 

However, as many people enjoy smoking and will not switch without a substitute alternative tobacco or nicotine product, the concept of Tobacco Harm Reduction (THR) was conceived. THR is a public health policy that aims to minimise the population level harm associated with using tobacco. Its purpose is to enable adult consumers who would otherwise continue to smoke to switch to alternative forms of tobacco and nicotine products that have a lower profile of risk as compared to cigarettes. (Figure 1).[2]

Figure 1. Tobacco Harm Reduction Equation

Tobacco Harm Reduction


=

 

Scientifically Substantiated Reduced-Risk*† Products

 

X

 

The Number of Consumers Using Reduced-Risk*† Products

Who Would Otherwise Smoke Cigarettes

The history of THR

Efforts to reduce the risk of harm from combusted tobacco products date back to the 1950s. The concept of Tobacco Harm Reduction was first articulated by Professor Michael J. Russell, who advocated for the reduction of tar in cigarettes while maintaining levels of nicotine, as “[p]eople smoke for nicotine but they die from the tar.”[3]

In 2001 the U.S. Institute of Medicine (IoM) - a governmental advisory body now called the National Academy of Science, Engineering and Medicine (NASEM) - outlined the principles behind THR in a publication called Clearing the Smoke. The IoM defined THR as: “decreasing total morbidity and mortality, without completely eliminating tobacco and nicotine use.”[1]

The leading public health benefits of THR were realised in Sweden, where smoking has been largely replaced by Oral Tobacco Products for the last 70 years, which has resulted in the lowest smoking rates in Europe (5.6% relative to the EU average of 23% in 2023) and as a result has the lowest incidence of lung cancer mortality in Europe (29.1 deaths in 100,000 people relative to the EU average of 66.7 deaths in 100,000 people).[4]

Composite image showing large tobacco leaves in a field juxtaposed with a close-up of precision technology with lasers and sensors

THR today

It is now widely acknowledged that the cause of most of the serious health risks associated with conventional cigarettes is the exposure to toxicants in the smoke produced when tobacco is burned – and not the nicotine.[5,6] There exist today four global categories of Reduced-Risk*† Products (RRPs): Heated Products, Vapour Products, Oral Tobacco Products and Oral Nicotine Pouches. Organisations such as Public Health England** (PHE) are clear that vaping is likely to be much less risky than smoking traditional cigarettes when used as a complete substitute for continued cigarette smoking.[7] Similarly, Balfour et al. stated that: “vaping can benefit public health, given substantial evidence supporting the potential of vaping to reduce smoking’s [death] toll.”[8]

Today, it is estimated that there are more than 115 million Smokeless Product adult consumers, with around 10 million[9] adult consumers using Oral Nicotine Pouches, 40 million[10] using Heated Products, and 65 million[11] using the largest category, Vapour Products.

Our role in THR

Our role is to develop and market responsibly innovative products that support THR, propose solutions to address underage access to tobacco and nicotine products, and engage with regulators and policy makers to facilitate THR.

The U.S. Food and Drug Administration[12] and other leading public health scientists[13] have considered the role of THR and its potential benefit to society, as they believe that the risk of underage use of Smokeless Products must be balanced against the substantial THR benefit offered by these products.

In 2019, the Greek ‘Ministry of Health’*** established a mechanism (Law 4715/2020) for the communication of risk related messages subject to a strict procedure of scientific assessment led by a specialised Committee.[14] Through this mechanism claims relating to a reduction in “[t]he concentration of chemical substances with known toxicity […] compared to conventional smoking.” were issued for Heated Products glo (BAT) and IQOS (Philip Morris International [PMI]).[15,16] These claims further emphasise that regulatory bodies are recognising the importance of informing adult smokers, who choose to continue to smoke, about alternative products that can benefit THR.

Figure 2 summarises our role in Tobacco Harm Reduction and how we will focus on both encouraging adult smokers who would otherwise continue to smoke towards exclusive use of Smokeless Products instead of cigarettes, and preventing the access of these products by the underaged.

Figure 2. Our role in THR

Reducing the Number of Adult Smokers

 

Support for evidence-based and proportionate public health initiatives to reduce smoking 

 

Commitment to Smokeless Products

 

Scientific assessment and publication of risk profile of Smokeless Products

 

Legal compliance with global regulations 

 

Support for adult-orientated flavours that encourage switching by adult smokers who would otherwise continue to smoke 

Addressing Underage Access

 

Support bans on flavours that are predominantly attractive to the underaged

 

Support retail licensing and restrictions

 

Support tougher enforcements of illicit products

 

Support point of sale Underage Access Prevention (UAP) technology

 

Introduction of novel, consumer-acceptable, product-based technologies that prevent underage access

 

Adult-orientated product design and descriptions only 

Disclaimers

* Based on the weight of evidence and assuming a complete switch from cigarette smoking. These products are not risk free and are addictive.

† Our products as sold in the U.S., including Vuse, Velo, Grizzly, Kodiak, and Camel Snus, are subject to FDA regulation and no reduced-risk claims will be made as to these products without agency clearance.

** Public Health England (PHE) was replaced in Oct 2021 by the UK Health Security Agency and Office for Health Improvement and Disparities

*** Hellenic Republic Ministry of Health General Directorate of Public Health & Life Quality Directorate of Dependencies Department B - Other Dependencies

 

References

[1] Institute of Medicine Staff, Clearing the smoke: assessing the science base for tobacco harm reduction. National Academies Press, 2001. DOI: 10.17226/10029

[2] Bates, C., Regulation: Why less is more. E-cigarette summit, 2013. Available at: https://www.slideshare.net/slideshow/ecigarette-summit-12-novem/28364227#11 (Accessed: 4 July 2024)

[3] Russell, M. J., Low-tar medium nicotine cigarettes: a new approach to safer smoking. Br Med J, 1976. 1(6023): p.1430-1433. DOI: 10.1136/bmj.1.6023.1430 (Accessed: 30 July 2024)

[4] Human D., et al., The Swedish experience: a roadmap to a smoke free society. Smoke Free Sweden 2023, 2023. Available at: https://smokefreesweden.org/wp-content/themes/smokefreesweden/assets/pdf/reports/Report%20The%20Swedish%20Experience%20EN.pdf

[5] McNeill, A. and Munafò, M.R., Reducing harm from tobacco use. J Psychopharmacol, 2013. 27(1): p. 13-18. DOI: 10.1177/0269881112458731

[6] Fagerström, K.O. and Bridgman, K., Tobacco harm reduction: the need for new products that can compete with cigarettes. Addict Behav, 2014. 39(3): p. 507-511. DOI: 10.1016/j.addbeh.2013.11.002

[7] McNeill A., et al., E-cigarettes: an evidence update. Public Health England, 2015. Available at: https://www.gov.uk/government/publications/e-cigarettes-an-evidence-update

[8] Balfour, D.J., et al., Balancing consideration of the risks and benefits of e-cigarettes. Am J Public Health, 2021. 111(9): p. 1661-1672. DOI: 10.2105/AJPH.2021.306416

[9] TobaccoIntelligence, Regulatory & Market Intelligence for Alternative Tobacco & Nicotine Products, Nicotine Pouch Market Database, Quarter 1 Report. 2024.

[10] TobaccoIntelligence, Regulatory & Market Intelligence for Alternative Tobacco & Nicotine Products, Heated Tobacco Market Database, Quarter 1 Report. 2024.

[11] ECigIntelligence, Regulatory & Market Intelligence for the e-Cigarette Sector, ECigIntelligence market database, July Report. 2024.

[12] Lindblom, E.N., What Is “Appropriate for the Protection of the Public Health” Under the US Tobacco Control Act?. Food Drug Law J, 2019. 74(4): p. 523-585. Available at: https://www.jstor.org/stable/27007713

[13] Hatsukami, D.K. and Carroll, D.M., Tobacco harm reduction: past history, current controversies and a proposed approach for the future. Prev Med, 2020. 140: p.106099. DOI: 10.1016/j.ypmed.2020.106099

[14] Greek Law 4715/2020, (Article 36), Available at: https://www.kodiko.gr/nomothesia/document/634794/nomos-4715-2020

[15] BAT Announcement, Scientific Decision for glo™ neo classic tobacco. 2024. ΕΠΙΣΤΗΜΟΝΙΚΗ ΑΠΟΦΑΣΗ ΓΙΑ ΤΟ glo™ neo classic tobacco – Blog (discoverglo.gr) (Accessed: 26 July 2024)

[16] PMI Science, Greek Ministry of Health approves differentiated health claims for heated tobacco products, including THS. 2023. https://www.pmiscience.com/en/smoke-free/tobacco-regulation/greece-approves-health-claims-heated-tobacco/

 

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