Electronic nicotine delivery systems : approach to regulation in South Africa

Abstract

Background: The explosion in the popularity and use of e- cigarettes over the last decade has raised concerns and incited intense discussions over their safety, efficacy and potential public health impact. Globally there is dramatic variation in the approach to regulation, with certain jurisdictions attempting to regulate e-cigarettes either as tobacco products, medicines, consumer products or poisons whilst others have banned their use and sale. The aim of this study was to review the e-cigarette regulatory strategies adopted by the World Health Organisation, Australia, European Union and United States in an attempt to identify feasible approaches to the regulation of e-cigarettes in South Africa within the context of existing institutional regulatory frameworks. Methods: The principles of an explorative comprehensive literature-based review using a thematic qualitative approach were employed. The primary method of data collection was documentation, collected and selected using document review and analysis. Results: The strategies between jurisdictions studied vary significantly in their approach to e-cigarette regulation with each equally facing challenges and massive criticism. The South African approach to the medicalisation of e-cigarettes when evaluated against the WHO FCTC regulatory objectives was found to be ineffective and warrants a change in strategy. Within the existing medicine and tobacco product regulatory frameworks, SA has the option to regulate e-cigarettes as: (1) medicine; (2) tobacco products; or (3) an amalgam of the two approaches. Conclusion: The most expeditious way for SA to regulate e-cigarettes immediately, in the absence of robust scientific data would be to implement a hybrid approach - regulation as a medicine when marketed for therapeutic use and as tobacco products when used recreationally.