Abstract

Vaporised nicotine products (VNPs) that are not approved as therapeutic goods are banned in some countries, including Australia, Singapore, and Thailand. We reviewed two non-profit regulatory options, private clubs and the Australian Therapeutic Goods Administration Special Access Scheme (SAS) that have been applied to other controlled substances (such as cannabis) as a potential model for regulating VNPs as an alternative to prohibition. The legal status of private cannabis clubs varies between the United States, Canada, Belgium, Spain, and Uruguay. Legal frameworks exist for cannabis clubs in some countries, but most operate in a legal grey area. Kava social clubs existed in the Northern Territory, Australia, until the federal government banned importation of kava. Access to medical cannabis in Australia is allowed as an unapproved therapeutic good via the SAS. In Australia, the SAS Category C appears to be the most feasible option to widen access to VNPs, but it may have limited acceptability to vapers and smokers. The private club model would require new legislation but could be potentially more acceptable if clubs were permitted to operate outside a medical framework. Consumer and regulator support for these models is currently unknown. Without similar restrictions applied to smoked tobacco products, these models may have only a limited impact on smoking prevalence. Further research could explore whether these models could be options for regulating smoked tobacco products.

Highlights

  • Vaporised nicotine products (VNPs), known as e-cigarettes, have presented a regulatory challenge to policy makers because they do not neatly fit the existing regulatory frameworks for nicotine products [1]

  • We explored whether two different non-profit models

  • The Special Access Scheme (SAS) offers only marginal benefits over existing pathways for accessing unapproved therapeutic goods and may be unacceptable to many vapers and smokers who oppose the medicalisation of VNPs

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Summary

Introduction

Vaporised nicotine products (VNPs), known as e-cigarettes, have presented a regulatory challenge to policy makers because they do not neatly fit the existing regulatory frameworks for nicotine products [1]. We consider two non-profit models that have been applied to two controlled substances (cannabis and kava) as a potential model for VNP regulation in countries that prohibit their sale, possession, and use: (1) compassionate/social clubs and (2) the Australian Therapeutic Goods Administration’s Special Access Scheme (SAS). CSCs in Spain rely on the notion that the possession and distribution of cannabis would not constitute an offence under the criminal code, so long as the operation occurs solely for personal use within a closed circuit of adults [36] This code only bans commercial sale and production, and possession and use in public places [36]. Taxes are collected from sales to fund public health campaigns [40]

Kava Social Clubs
Application of Non-Profit Club or SAS Regulatory Models to VNPs
Limitations
Conclusions
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