title: Regulatory issues concerning the development and circulation of nicotine-containing products: a qualitative study.
abstract: BACKGROUND
  This paper explores perceptions of how the regulation of nicotine-containing products (NCPs) impacts the development and availability of more effective cigarette substitutes.
  
  
  METHODS
  Qualitative study using semistructured interviews with 20 key stakeholders (7 academic experts in tobacco control, 5 representatives of 3 pharmaceutical companies, and 8 representatives of organizations involved in tobacco-control policy making) and documentary analysis.
  
  
  RESULTS
  Four main themes were identified. In general, currently available nicotine replacement therapies (NRTs) were considered to be relatively unsuccessful as substitutes because they deliver insufficient nicotine too slowly. Stronger, faster-acting nicotine products were deemed necessary. However, issues were raised about how smokers may perceive stronger, faster-acting products linked to misunderstandings about nicotine. Pharmaceutical companies have shown reluctance to pursue NRT development; discussions around harm reduction are shifting company attitudes, although concerns remain about the impact of developing more addictive products on company image and whether such products would be problematic to license. The greater cost of producing an NCP within the medical regulatory regime, compared with cigarettes, was underlined. Recreational NCPs were considered problematic as they do not currently need to meet the high regulatory standards required for medications.
  
  
  CONCLUSIONS
  Although experts generally agreed that NRT development ought to focus on stronger and faster-acting products, questions were raised over whether this aligns with smokers' understandings and requirements. A more nuanced grasp of how smokers understand harm-reduction approaches and products is required. Pharmaceutical companies may not be best placed to innovate, indicating that the market may well be left to other actors including the tobacco industry.
authors.affiliation: Centre for Population Health Sciences, University of Edinburgh, Medical School, Edinburgh, UK. catriona.rooke@ed.ac.uk
authors.forename: Catriona
authors.initials: C
authors.lastname: Rooke
authors.forename: Ann
authors.initials: A
authors.lastname: McNeill
authors.forename: Deborah
authors.initials: D
authors.lastname: Arnott
mesh_terms: D004345:Drug Industry; D040261:Harm Reduction; D006801:Humans; D009538:Nicotine / Q000008:administration & dosage*; D010465:Perception; D036301:Qualitative Research; D012907:Smoking / Q000331:legislation & jurisprudence*; D016540:Smoking Cessation / Q000331:legislation & jurisprudence*; D000074606:Smoking Prevention; D019460:Tobacco Industry; D061485:Tobacco Use Cessation Devices / Q000592:standards*; D006113:United Kingdom
chemical_list: D009538:Nicotine