Title: Effects of reduced-risk nicotine delivery products on smoking prevalence, cigarette sales and health inequalities: Regulatory implications (GIRO - Gateway into or out of smoking?)
Funder: Department of Health and Social Care

Abstract: Smoking is one of the main preventable causes of ill health and early death. Although smokers smoke to get nicotine, other chemicals in tobacco smoke are responsible for the health risks._x000D_ _x000D_ Over the years, several alternative nicotine delivery products have appeared that provide smokers with nicotine while greatly reducing the hazardous chemicals. These include Swedish snus (oral tobacco prepared in a way that minimises health risks), tobacco products which release nicotine in a vapour by heating tobacco rather than burning it, and e-cigarettes, that contain no tobacco._x000D_ _x000D_ These products have caused controversy. There is concern that they attract young people to smoking who would otherwise have never smoked and deter smokers from quitting, and so promote smoking. On the other hand, the opposite effects are possible, i.e. these products may help smokers quit and may also steer young people who find nicotine attractive away from smoking, so that they use these less risky alternatives instead._x000D_ _x000D_ The World Health Organization believes in the first set of arguments and is against these products, and on its advice some countries are banning them. Other countries, including the UK, believe that these products can reduce the harms from smoking and in the UK smokers are encouraged to switch to them._x000D_ _x000D_ Evidence for either view is currently weak. Data are urgently needed to clarify whether having these products available to buy is reducing cigarette smoking, especially among young people (which would mean that they provide a gateway out of smoking), or encourages cigarette use and smoking (which would mean that they provide a gateway into smoking). This information is important in deciding which policies and regulations regarding these products are best for public health._x000D_ _x000D_ We believe that the information on how these products affect smoking already exist, hidden in surveys carried out in different countries. Several countries that differ in how they regulate these products collect statistics on smoking in the population and also on use of these products. Such data can be analysed to see whether and in what way increases in the use of these products have changed the number of people who smoke. There are also data on sales of cigarettes and these products, which can be examined to see if sales of these products are linked to increased or decreased sales of cigarettes. Finally, changes over time in the number of people who smoke and in how many cigarettes are sold can be compared in countries that allow and countries that ban alternative nicotine products. This can show whether the different policies are having a positive or negative effect on how many people smoke._x000D_ _x000D_ The results can tell us which type of policies are more likely to help with reducing smoking in the population (and in that way also help to reduce smoking-related illness and death), i.e. whether the use of these products should be allowed and smokers encouraged to use them, or whether they should be restricted or even banned. This information will be useful in guiding future policies in the UK and also in other countries.

Lay abstract: Research question_x000D_ Does access to alternative nicotine delivery products (ANDs) promote smoking in the population?_x000D_ _x000D_ Background_x000D_ The key current controversy surrounding ANDs concerns their effects on smoking prevalence. It is currently not clear whether ANDs promote smoking among adolescents and/or detract smokers from quitting, i.e. provide a gateway into smoking, or deflect young nicotine seekers from cigarettes and/or promote smoking cessation among established smokers, i.e. provide a gateway away from smoking._x000D_ _x000D_ ANDs have been around for long enough and are used on a large enough scale for the relevant information to already exist, hidden in data on smoking and AND use and sales of cigarettes and ANDs. If in countries with policies that allow AND use, the trends in the historical decline in smoking rates have slowed down or reversed (overall and in young people in particular), this would support the ‘gateway into smoking’ hypothesis and justify restrictive policies – especially if such impact was avoided in countries that ban ANDs. The opposite finding would suggest that these products are replacing rather than promoting smoking (‘gateway out of smoking’) and justify policies that allow or even encourage their use. A finding that ANDs have no net effect on smoking prevalence and cigarette sales would also have policy implications. Existing data should also allow exploration of ANDs’ effects in different socioeconomic groups. Only modest funding is needed for this work. There are few more important questions in tobacco control that can be resolved using data that already exist._x000D_ _x000D_ Aims and objectives_x000D_ We will examine relevant datasets for links between AND use and smoking rates and between AND sales and cigarette sales. We will also compare trajectories of smoking prevalence over time in countries with contrasting legislative and policy frameworks concerning ANDs. The results of these analyses will be used to assess the likely impact of different AND policies on rates of smoking._x000D_ _x000D_ Methods_x000D_ Regarding e-cigarettes, UK, USA and Australia have a broadly similar history and formats of tobacco control but different regulatory frameworks concerning e-cigarettes. We will also review data from the Eurobarometer, a pan-European dataset._x000D_ _x000D_ Regarding heat-not-burn (HNB) products, in Japan and South Korea the state operates tobacco monopolies and publishes domestic sales data and HNB sales data are available as well. We did not find such data for any other countries._x000D_ _x000D_ Regarding snus, we will use data from Sweden, the only EU country where snus is legally available._x000D_ _x000D_ Variables concerning each country’s legislative and policy frameworks regarding tobacco and ANDs and a statistical analysis plan will be pre-registered before any analyses are undertaken. Data will be analysed using modelling techniques described in the Detailed Plan._x000D_ _x000D_ Timelines_x000D_ Months 1-3: Setting up the project; Months 4-6: UK, USA and other EC data; Months 7-9. Comparing UK/US/Australia; Months 10-12: South Korea and Japan HNB data; Months 13-15: Sweden snus data; Month 16-18: ANDs regulations and smoking rates, synthesis, final report._x000D_ _x000D_ Anticipated impact_x000D_ We expect that the project will identify AND policies that are most favourable to public health and that the results will inform future UK regulatory frameworks and may provide evidence base for relevant policies globally.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;RESPIRATORY;STROKE