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A new approach to tobacco control is emerging. This approach, known as Tobacco Harm Reduction, aims to prevent or reduce the damage caused by toxins generated during the process or tobacco combustion by switching current adult smokers who would otherwise continue smoking to products that have significantly reduced levels of toxic and harmful compounds than cigarettes. Some countries, like the US and the UK, are applying Tobacco Harm Reduction strategies in conjunction with existing tobacco control strategies to reduce smoking. A report from the UK Royal College of Physicians1 notes that
“The ideal harm-reduction device should therefore deliver nicotine in a manner as similar as possible to cigarettes, while at the same time maximizing palatability and nicotine delivery to approximate the experience of cigarette smoking more closely”.
In recent years, science, innovation and technology have allowed for the development of products (both tobacco and non-tobacco, nicotine-containing products) that meet these criteria – products that can fully replace cigarettes. Unfortunately, in Australia, adult smokers are unable to buy such products and are increasingly being prevented from accessing them through other means as public health authorities take an overly cautious approach to tobacco harm reduction. In an environment where smoking rates have remained relatively similar in recent years2 and existing public health strategies no longer seem to be making a difference, it is critical that the Australian Government consider the positive impact that tobacco harm reduction could have on public health in Australia.
So, what is the difference between cigarettes and these novel, science-based products and how are they assessed?
In a cigarette, combustion occurs when the tobacco is ignited by a heat source, such as the flame from a match or a lighter. Once lit, the temperature of the tobacco in a burning cigarette reaches temperatures above 850 °C3. The heat released by the combustion process breaks down tobacco leaf components generating smoke and ash. The cigarette smoke formed contains more than 6000 chemicals, some of which have been classified by public health authorities as likely causes of smoking-related diseases, such as lung cancer, heart disease and emphysema. Smoke-free products release nicotine without combustion by ensuring that the temperatures are kept at a level below the onset of combustion. Due to the absence of combustion, the aerosol formed from such products has lower levels of chemicals compared to the smoke of a standard reference cigarette.
Many countries have regulations to ensure that products that are introduced into the market to replace cigarettes are scientifically substantiated and meet relevant criteria. For example, in the United States, the Food and Drug Administration (FDA) established the first regulatory procedure for reviewing and authorising reduced-risk tobacco products, (referred to in the U.S. law as a ‘Modified Risk Tobacco Product,’ or MRTP). The FDA “Modified Risk Tobacco Product Applications: Draft Guidance for Industry” requires applicants to demonstrate that the product, as actually used, will4:
- significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and
- benefit the health of the population as a whole, taking into account both the users of tobacco products and persons who do not currently use tobacco products.
The European Union5 has a different approach which requires manufacturers and importers to submit a notification to the competent authorities of Member States for any novel tobacco product (defined as one that does not fall into any of the existing categories of tobacco products and is placed on the market after 19 May 2014) they intend to market. The notification should include available scientific studies on toxicity, addictiveness and attractiveness of the novel tobacco product, in particular as regards its ingredients and emissions; studies and market research on the preferences of various consumer groups, including young people and current smokers, and other available and relevant information, including a risk/benefit analysis of the product, its expected effects on initiation and cessation of tobacco consumption and predicted consumer perception.
Regardless of an individual country’s regulatory approach to tobacco harm reduction, it is important that before novel products are introduced into a market, they are thoroughly evaluated as an appropriate tool to reduce smoking-related harm in accordance with relevant international standards and practices, such as those released by the FDA as well as internationally accepted Good Laboratory Practices and Good Clinical Practices. Scientific studies conducted by manufacturers should also be rigorously assessed by independent experts and qualified third parties.
Due to advances in science, technology and innovation, meaningful change is possible for existing adult smokers and public health systems around the world, including in Australia. These advances enable real-world solutions that are better than the status quo. There’s no question that never starting smoking or quitting are the best options. But for those adult smokers who would otherwise continue to smoke, a continued focus on science-based innovation is an important step in the right direction.
A group of long-standing specialists in public health and tobacco control highlight the need for risk-proportionate regulation by urging regulators to review such products and the technology underpinning them, where the
“strength of regulation should be proportionate to the risk the product poses to users, with the aim of encouraging migration from high-risk to low-risk products”.6
It is no longer appropriate for Australian regulators to ignore the rapidly growing database of scientific evidence on smoke-free alternatives to cigarettes and to deny the opportunity that these products could afford to both adult smokers and our public health system. With smoking rates remaining relatively flat in recent years, there is a real need for a different, evidence-based policy and regulatory approach in Australia.
Is it possible to replace cigarettes?
Yes. It is possible to replace cigarettes – one of the most harmful ways to consume nicotine. The options already exist thanks to developments in science and technology. Australia, it’s time to make that option a reality and legalise the sale of smoke-free products.
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1 Royal College of Physicians (2016) Nicotine without smoke: Tobacco harm reduction. London: RCP.
2 Australian Bureau of Statistics https://www.abs.gov.au/ausstats/abs@.nsf/mf/4364.0.55.001
3 Baker, R.R., (1975) Temperature variation within a cigarette combustion coal during the smoking cycle; High-Temperature Science 7: 236—247
4 FDA: Modified Risk Tobacco Product Applications: Draft Guidance for Industry, March 2012.
5 European Parliament and Council, 2014. Directive 2014/40/EU on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products. Official J. Eur. Union (L127/1 – 38).