Title: Impacts of e-cigarette regulation via the EU Tobacco Products Directive on young people’s use of e-cigarettes : a natural experiment
Funder: Health and Care Research Wales (Welsh Government)

Abstract: Ecigarettes are a polarising issue in contemporary public health, with some arguing that the public health community should embrace them as a safer alternative to smoking, while others are concerned that they may "renormalise" smoking. These divergent views on e-cigarettes, which are to date informed by limited evidence on both sides, have led to growing public confusion in relation to the harms of e-cigarettes, and divergence in policy responses. Until recently, young people's use of e-cigarettes remained low, and almost exclusively confined to smokers. However, there is some evidence that regular use of e-cigarettes is now beginning to increase among non-smokers. There is to date, no evidence that this has led to increased smoking uptake among young people. However, even if this does not lead to increased smoking, the percentage of young people using some form of nicotine regularly appears to have increased for the first time since the turn of the century. While nicotine in itself carries few potential risks for adults, there is evidence that it can have harmful effects on emotional and cognitive functions in adult life if used regularly during adolescence, when the young person's brain is still developing. Hence, were young people who would not otherwise have smoked to become regular users of nicotine via e-cigarettes, this carries some risks to public health. Debates regarding how to limit young people's use of e-cigarettes have to date largely ignored these issues, and focused predominantly on perceived links to smoking uptake. The recent EU Tobacco Products Directive (TPD) has introduced a number of new restrictions on e-cigarettes in the UK. Much advertising is now banned. By May 2017, all products containing nicotine must now carry health warnings on 30% of the surface of the packet. Any product with a nicotine concentration above 20mg/ml will need to be licensed as a medicine. Although following the recent referendum, the UK is likely to leave the EU in the coming months or years, this legislation will remain in place for the forseeable future. The proposed study aims primarily to investigate the role of e-cigarette regulation via the TPD in influencing trajectories in young people’s use of e-cigarettes. That is, does the legislation interrupt or reverse current upward trends in young people's use of e-cigarettes? As the TPD will be implemented alongside legislation regulating tobacco even further (e.g. Plain Packaging) we will examine changes in smoking trajectories, but will not be able to disentangle impacts of e-cigarette regulation from other components. We will test the renormalisation hypothesis which provides the theoretical basis stated within the TPD documentation, by analysing whether the decline in young people's smoking rates since 1998 has been interrupted by the growing presence of e-cigarettes. We will combine secondary quantitative datasets to compare youth e-cigarette and smoking trajectories (the Health Behaviour in School Aged Children/School Health Research Network survey in Wales, SALSUS in Scotland and the Smoking, Drinking and Drug Use survey in England), to address the above aims. In addition, we will explore the implementation and context of TPD regulation via observations and stakeholder interviews, and will use qualitative interviews, before and after full implementation of TPD, to understand the processes through which legsilation impacts on young people's perceptions of e-cigarettes.

Lay abstract: In May 2016, new European Union rules about the sale of e-cigarettes came into effect in the UK. By May 2017, all e-cigarettes sales will be expected to follow these rules. This study will look at whether or not these rules bring about any changes to e-cigarette use by young people. It will also look at other health issues connected to young people’s use of e-cigarettes. There is a popular idea that e-cigarettes provide a safer alternative to smoking and that we should encourage people who smoke to use e-cigarettes instead. There is also concern that using e-cigarettes might encourage young people to start smoking because the idea of smoking becomes normal to them. The new European Union rules arose out of a concern that young people would start to see smoking as normal. The rules (the EU Tobacco Products Directive) are about advertising, labelling, health warnings on products containing nicotine, and allowing sale of very strong e-cigarettes only as medicines. While there is some evidence that experimental use and regular, weekly use of e-cigarettes are beginning to increase among young people, there is no evidence yet that this has led to an increase in smoking. The number of young people who smoke has been falling steadily since the millenium. Some people think that young people who now try e-cigarettes might have smoked tobacco otherwise, and that e-cigarettes may stop some young people from trying cigarettes. So there is a range of opinion on whether e-cigarettes might increase young people's smoking, decrease it, or have no effect. E-cigarettes may carry risks to young people other than their potential effect on smoking. Nicotine is not very harmful to adults, but there is evidence that nicotine can damage young people’s brain development. In debates about young people and e-cigarettes, this sort of direct harm from using e-cigarettes gets less attention than the risk of starting to smoke does. Rules about the sale and use of e-cigarettes vary around the world. In Australia, for example, there is a complete ban, while in the UK they are on sale in lots of places. So it is important to understand how rules about e-cigarettes might affect the health of young people. It is also important to understand whether e-cigarettes do lead young people to see smoking as normal again. This study will do this in three ways: • Using routinely collected survey data from England, Scotland and Wales to test whether the new European Union rules might reduce, or prevent further increase, in the use of e-cigarettes by young people. • Testing whether e-cigarette use leads young people to think of smoking as normal, by using historical survey data to test if e-cigarette use has begun to affect the numbers of young people who smoke. • Looking at how changes in the marketing and labelling of e-cigarettes, and how well producers and retailers carry this out, affects how young people see e-cigarettes. This will include speaking to young people, retailers and other interested parties before and after the rules come in to effect in May 2017. This part of the study will also provide a more detailed understanding of how e-cigarette use might lead to, or prevent smoking, and give a broad insight into how young people see e-cigarettes.

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