WHILE tobacco smoking has declined substantially in recent decades, it remains the leading risk factor for disease in Australia. More than 2.7 million Australians smoke daily, and tobacco smoking harms disproportionally impact those in socio-economically disadvantaged populations, Aboriginal and Torres Strait Islander peoples, and those living with mental illness. Yet there is very little regulation of the constituents that make tobacco smoking addictive, harmful and palatable.

Australia is a signatory to the World Health Organization Framework Convention of Tobacco Control (FCTC), an international treaty that aims to reduce demand for, and supply of, tobacco products worldwide. Australia has led the way in implementing some of the provisions of the FCTC, such as price and tax measures (Article 6) and packaging and labelling of tobacco products (Article 11). However, there are two articles of the FCTC where Australia has made little progress: Article 9 requires the regulation of the contents of tobacco products and Article 10 requires the regulation of tobacco product disclosures.

Regulating the contents of tobacco products to make them less attractive, toxic and/or addictive could have substantial public health benefits. There are a number of ways that tobacco products could be regulated.

Regulating flavours and additives

Additives and flavours added to cigarettes include menthol, cocoa powder, carob bean extract, fig juice concentrate and liquorice. Additives may be added in order to reduce perceptions of the harshness of cigarette smoke (eg, humectants such as glycerol), to make the flavour of tobacco more appealing, or to increase palatability. Up to 10% of the weight of cigarettes available in the US is made up of additives, but little is known about the health effects of many of these additives or how they influence the addictiveness of tobacco products. While additives are likely to contribute only a small amount of the health harms of tobacco smoking, their masking of unpleasant sensory experiences associated with smoking may increase uptake and reduce quitting.

Research has shown that flavoured tobacco products are especially appealing to youth and young adults. In the 2000s, fruit and candy flavoured cigarettes such as “strawberry and green apple” began to be sold in Australia, raising concerns about the use of these products by adolescents and young adults. In 2008, Australian Health Ministers agreed to ban the sale of flavoured cigarettes. However, the state and territory legislation that implemented this ban focused only on overtly fruit-and confectionary-flavoured cigarettes. It did not address the other additives and cigarette design features that can make cigarettes more palatable.

Worldwide, progress is being made in this area. Brazil, Canada, Chile, Ethiopia, Turkey and the European Union have banned the sale of all cigarettes with “characterising flavours”. These are flavours which are likely to be obvious to the consumer, rather than more subtle flavours introduced in small amounts to increase the palatability of tobacco products. Data are beginning to emerge about the effects of these policies. For example, the province of Ontario in Canada banned menthol cigarettes at the beginning of 2017. One year later, quit rates were significantly higher among those who smoked menthol cigarettes than those who did not. This measure could have important equity-promoting impacts as some populations, such as African Americans, have a higher use of menthol cigarettes.

Regulating cigarette filters

Filters are a design feature of cigarettes that were initially marketed to smokers purportedly as a means of reducing the harm of smoking cigarettes. In the 1950s and 1960s, tobacco companies added ventilation holes in the filters that diluted the smoke to produce lower measurements of tar and nicotine when the cigarette was smoked with a machine. They marketed these as “light” or “mild” cigarettes. However, subsequent research revealed that machine yields did not accurately reflect the exposure of smokers to toxicants because smokers engage in “compensatory smoking” by taking deeper or more puffs, and by blocking tiny venting holes in the tipping paper that encloses the filter. While these ventilated filters did not reduce the harms of smoking, they reduced the experience of harshness of inhaling cigarette smoke and led consumers to believe they were using less harmful products.

While descriptions of tobacco products as “mild” or “light” are now banned in Australia, filters remain a major way for tobacco companies to innovate and differentiate their products, particularly since the introduction of plain packaging. For example, there are cigarette brands with recessed or firm filters that have “taste flow filter” or “firmer feel filter” added to their variant name. Another innovation is the addition of flavour capsules in the filter which are designed to be crushed by the consumer to release a burst of flavour, often menthol. These have been named in Australia as variants such as “ice blast” and “optimum crush”. The purchasing of products with flavour capsules is increasing in Australia, and is concerning as they are likely to be especially appealing to young people and non-smokers. Public health organisations and tobacco control experts in Australia have recommended banning cigarettes containing flavour capsules. Another recommendation is to introduce a standard filter design that all tobacco manufacturers must comply with in order for their products to be sold in Australia. This would remove the opportunity for tobacco companies to make their products more appealing through filter innovations. Some organisations and tobacco control advocates have also proposed banning cigarette filters entirely due to large environmental damage caused by discarded butts.

Reducing nicotine content to non-addictive levels

Nicotine delivered via cigarette smoking is highly addictive. Mandating a reduction of nicotine content of cigarettes to non-addictive levels was recommended by the WHO Study Group on Tobacco Product Regulation. They stated that nicotine levels would need to be reduced by at least 95% compared with typical cigarettes in order to maximise the public health gains of this policy. Reviews of randomised trials have concluded that switching to these very low nicotine cigarettes (VLNCs) leads to a reduction in the number of cigarettes smoked per day, a reduction in nicotine dependence, and are likely to increase cessation. While reducing nicotine content by a moderate amount has been shown to lead to an increase in the intensity of smoking, compensatory smoking has not been demonstrated in individuals using VLNCs. Recent research suggests that an immediate reduction to very low levels of nicotine, rather than a gradual progression to lower levels, may be more effective in reducing smoking and nicotine dependence.

Restricting the sale of tobacco products to only those with non-additive levels has not yet been implemented anywhere worldwide. However, modelling suggests that reducing nicotine in cigarettes to non-addictive levels could save millions of lives in the US and result in a gain of 157 million quality-adjusted life-years over 50 years. There are no technological barriers to implementing a VLNC standard for all cigarettes and the US Food and Drug Administration issued an advanced notice of proposed rule-making in 2018 to reduce nicotine in combustible cigarettes to “minimally or non-addictive levels”. Potential negative consequences of reducing nicotine levels would be potential fostering of mistaken beliefs among the public that VLNCs are safer than standard cigarettes, and a growth in black market tobacco products.

Another key consideration is the role that e-cigarettes, or other novel nicotine delivery devices will play in such a regulatory framework. These products can provide nicotine to those who are dependent on it in a less harmful form than combustible cigarettes. The Therapeutic Goods Administration has recently announced a framework for the regulation of vaporised nicotine products in Australia that will come into force on 21 October 2021 to provide access to these products via a medical prescription for people who have not been able to quit smoking by other methods.

Where to from here?                    

Worldwide, progress is beginning on regulating the constituents and engineering features of cigarettes to address their attractiveness, toxicity and addictiveness. While Australia has led the way in other areas of tobacco control, tobacco product regulation is an area where we are falling behind other countries.

In the most recent annual report that signatories are required to provide to the WHO, the Australian Government Department of Health stated that no progress had been made in testing or regulating the contents or emissions of tobacco products, or in requiring manufacturers or importers to disclose information about contents or emissions. However, the government stated that tobacco product regulation and constituent disclosure would be considered as part of a current review of national tobacco control legislation.

Currently, tobacco and nicotine product regulation in Australia is covered by a combination of state and commonwealth legislation, making it piecemeal and variable between state and territories. We recommend that national legislation is developed encompassing the regulation of all nicotine and tobacco products. The mandatory national standard for reduced ignition propensity cigarettes demonstrates that national product standards could be developed and implemented under current regulatory frameworks. However, research and stakeholder consultation are needed to evaluate the possible models of product regulation and regulatory targets that will be most effective at reducing smoking and will be feasible to implement in the Australian context.

Dr Kylie Morphett, University of Queensland, Faculty of Medicine, School of Public Health, National Health and Medical Research Council (NHMRC) Centre of Research Excellence on Achieving the Tobacco Endgame.

Associate Professor Coral Gartner, University of Queensland, Faculty of Medicine, School of Public Health, NHMRC Centre of Research Excellence on Achieving the Tobacco Endgame.



The statements or opinions expressed in this article reflect the views of the authors and do not represent the official policy of the AMA, the MJA or InSight+ unless so stated.


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3 thoughts on “Future of tobacco product regulation in Australia

  1. Andrew Thompson says:

    Dr. ARC says: “If we as health professionals are serious about reducing smoking in all its forms, we need the government to make the cost of smoking prohibitive for all but the most dedicated smokers who will eventually cease to exist!”

    Australia already has that. For the last years of my smoking habit, I bought black-market tobacco. And look how well prohibition worked with cannabis, amphetamines and heroin. No. If anything will make smoking obsolete, it is innovations in nicotine delivery. SLT, vaping, HTP for the win!

    If you as health professionals seriously want to reduce the disease and harm of smoking, best to work /with/ the consumer than impose ever more coercive restrictions on consumption of pleasurable substances.

  2. Dr. ARC says:

    Nicotine and alcohol addictions have been accepted since their inception hundreds of years ago. Yet cocaine, heroin, amphetamines and THC are illegal and heavy fines are imposed if you are caught using these drugs.
    One of the reasons that the former drugs are allowed is the revenue that excise provides to the government from the sale of these two drugs, and by any other standard they are both addictive drugs, both of which cause enormous expensive health issues.
    If we as health professionals are serious about reducing smoking in all its forms, we need the government to make the cost of smoking prohibitive for all but the most dedicated smokers who will eventually cease to exist!
    The increased revenue can be used to treat smoking related CVA and Myocardial infarction.

  3. Aki Nilanga Bandara says:

    Access to e cigarettes by means of strictly through the medical prescription is indeed a commendable tobacco prevention strategy.
    It is sometimes critical that we use the most recent evidence based information before making such a significant tobacco policy statement “These products can provide nicotine to those who are dependent on it in a less harmful form than combustible cigarettes”.
    It is premature to state that “e cigarettes are less harmful than combustible cigarettes”.
    Please could you consider “harm reduction” after careful consideration of known “absolute adverse effects, harm and safety of vaping”
    It is important also to consider emerging additional information of adverse effects of vaping. According to new research published in the American Heart Association’s official journal Circulation, people who smoked traditional cigarettes in addition to using e-cigarettes experienced health effects as harmful as those who smoked cigarettes exclusively; those effects are associated with a higher risk for cardiovascular disease and death (1). In a large data analysis of more than 7,100 U.S. adults, researchers examined the association of cigarette and e-cigarette use with inflammation and oxidative stress as biomarkers predicting cardiovascular disease (1).
    Most recent two systematic review findings clearly show that e-cigarette is not a promising smoking cessation tool. “There is insufficient evidence that e-cigarette are efficacious for smoking cessation compared to no intervention, placebo or NRT” (2). “Data on the effectiveness and safety of e-cigarette for smoking cessation among adults are also limited and results are inconsistent” (3).
    In addition, researchers from Stanford University show that teenagers and young adults ages 13 to 24 who use e-cigarettes are five times more likely to be diagnosed with Covid-19 than their non-vaping peers. Those who are dual users-people who smoke both traditional and electronic cigarettes-are seven times more likely to test positive for the virus, the researchers found (4).
    (1). American Heart Association. “Vaping combined with smoking is likely as harmful as smoking cigarettes alone, study finds.” ScienceDaily. ScienceDaily, 4 January 2021. .
    (2). Systematic review and meta-analysis of evidence on the efficacy of e-cigarette use for sustained smoking and nicotine cessation https://t.co/VBrtusT7y7 #medRxiv
    (3). Patnode CD, Henderson JT, Coppola EL, Melnikow J, Durbin S, Thomas RG. Interventions for Tobacco Cessation in Adults, Including Pregnant Persons: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2021;325(3):280–298. doi:10.1001/jama.2020.2354
    (4). Digitale E. Vaping linked to COVID-19 risk in teens and young adults. Stanford School of Medicine. August 11, 2020. https://med.stanford.edu/news/all-news/2020/08/vaping-linked-to-covid-19-risk-in-teens-and-young-adults.html

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