The evolution of regulatory strategies in relation to nicotine products and their implications for product innovation and harm reduction

The current "smoking epidemic" is a global problem for governments and organisations concerned with public health. Recently, this problem has been conceptualised as one of regulation. Within the tobacco control community, there has been growing concern that the division of regulatory responsibility for conventional tobacco products (i.e. cigarettes, cigars, pipe tobacco) and alternative modes of nicotine delivery (nicotine replacement therapy products such as gums, patches and inhalers) is having adverse effects on the innovation of new medicinal products and on providing smokers with acceptable alternatives to cigarettes, the most harmful and widely used nicotine product. The 'alternatives' are mainly regulated as pharmaceuticals; therefore, must reach safety standards comparable with those required for medications rather than being compared with the known harm caused by tobacco smoking. Whilst a number of commentary and position pieces have discussed this problem, there has been little empirical work on how the current UK regulatory set-up evolved and what impacts it has. This research gap is addressed using semi-structured interviews and documentary analysis to analyse empirically the evolution and implications of divided regulatory responsibility for nicotine products in England. Adopting an actor-network theory approach, I investigate the actor-networks assembled around key non-human actors - tobacco and nicotine - focussing on developments from the 1970s until the present. In particular, I investigate the relationship between the regulatory regime and harm reduction ideas, and how they impact on the development of new medicinal nicotine products within the pharmaceutical industry. I underline the way that the regulatory regimes both shape and are shaped by the heterogeneous networks in which they are enmeshed. The thesis concludes by considering whether there are alternative approaches to regulation that would be more efficient and effective. I suggest that the regulation of recreational drug use is underpinned by 'deep conflicts in values' (Prosser 2006) and propose that further debate over the aims and limits of nicotine regulation is needed. The thesis deals with developments up until and including the 30th of November 2010