Today the TGA announced an interim decision that, if made final, would clarify the regulation of e-cigarettes containing nicotine, and nicotine fluids for vaping. The proposed changes would mean that certain nicotine containing products could only be supplied with a doctor’s prescription.
This is consistent with existing state and territory laws which make the sale of nicotine e-cigarettes / fluids (except for prescription medical use) illegal throughout Australia and its possession or use illegal everywhere but in South Australia. The main impact of the decision, if confirmed through a final decision, is that importing these products purchased from overseas internet sites without a valid prescription would be illegal, and subject to impounding by the Australian Border Force. Personal imports under the TGA Personal Importation Scheme, with a valid prescription, are permitted.
To support smoking cessation, the requirement for a prescription would provide an opportunity for patients to consult with their medical practitioner as to whether e-cigarettes or other products containing nicotine are right for you as an aid to stop smoking. Medical practitioners are well placed to support smoking cessation and advise on how to reduce the risks associated with nicotine use. It is anticipated that nicotine e-cigarette products for smoking cessation will be available from both community pharmacies and appropriate Australian online pharmacies.
The requirement for a prescription will also prevent the rapid growth of youth uptake in vaping seen in Australia and overseas, and a potential pathway to cigarette smoking by young people. Between 2015 and 2019, e-cigarette use by young people increased by 72% in the US, 150% in Canada and 96% in Australia.
The proposed changes would also not affect access to registered products to help smokers quit such as gums, sprays and patches.
The interim decision will be open for public consultation until 6 November 2020, with a final decision expected in mid-December, with an implementation date of either 1 April or 1 June 2021. The public can sign up to webinars explaining the interim decision on 8 and 9 October 2020.