Important consultations on nicotine and e-cigarettes in Australia and New Zealand
Nicotine Science & Policy | updated 31 August 2016
Both Australia and New Zealand have legislation that was introduced before the introduction of e-cigarettes and which effectively makes possession of nicotine (Australia) or nicotine-containing e-cigarettes (NZ) illegal. In Australia there is a proposal to amend the scheduling of nicotine to make sale, possession and use of nicotine legal; in New Zealand the Ministry of Health proposes making nicotine e-cigarettes legal consumer products. Comments on both proposals are invited.
In New Zealand the sale and supply of nicotine e‑cigarettes is prohibited. Users obtain nicotine e‑cigarettes through importation and illegal local sales. The current regulations were in force before the emergence of e-cigarettes. The sale and supply of e‑cigarettes in New Zealand is controlled by the Medicines Act and the Smoke-free Environments Act 1990 (SFEA). They are unlawful if the product contains nicotine derived from tobacco, or the product contains nicotine and has not been approved for supply for therapeutic use. Under the Medicines Act and the SFEA, people can import nicotine-containing e‑cigarette products to use personally as a smoking cessation tool but cannot supply them, sell them or give them away to anyone else.
The New Zealand Health Ministry recognises that the legal status of e‑cigarettes is confusing, that the laws are not routinely enforced, and that ‘There is emerging evidence that e‑cigarette use may substantially reduce the burden of disease caused by smoking’. Further, the Ministry of Health ‘proposes to make legislative changes that will maximise the potential benefits of e‑cigarettes and minimise potential risks to smokers and to the wider population.’
The MoH has launched a public consultation on the policy options for regulating e-cigarettes and proposes legalising the sale of e-cigarettes as consumer products.
The proposed amendments would prohibit the sale and supply of e-cigarettes to children and young people under 18 years of age; the advertising of e-cigarettes; and the use of e-cigarettes in designated smoke free areas.
The MoH is seeking feedback on whether other controls in the SFEA with regards to smoked tobacco should also apply to e-cigarettes, such as: the requirement for graphic health warnings, the prohibition on displaying products in sales outlets, the prohibition on advertising and sponsorship, regulations concerning ingredients (eg, nicotine content and/or flavours), and the requirement for standardised packaging.
The MoH is also seeking comments on whether e-cigarette liquids containing nicotine should be subject to some form of excise or excise-equivalent duty, as a means to deter uptake.
Finally, the MioH is seeking feedback on whether e-cigarette safety and quality should be further regulated, such as the extent to which product containers are childproof, the safe disposal of e-cigarette devices and liquids and the safety of devices (eg, in terms of their ability to prevent accidental burns, explosions and spillage).
The consultation closes on 12 September 2016. Comments can be submitted here: http://www.health.govt.nz/publication/policy-options-regulation-electronic-cigarettes-consultation-document
The submission process is simple. There is an online form that can be completed which includes a number of questions – for example “do you agree that the sale and supply of nicotine e-cigarettes and nicotine liquids should be allowed on the local market, with appropriate controls?” And “do you think it is important for legislation to prohibit the sale and supply of e-cigarettes to young people and those under 18 years of age…” There are twelve questions in total. There is also an opportunity to add additional pages of text.
The deadline for initial submissions to the TGA has now passed. There will be further opportunities to comment.
Whilst e-cigarette devices are allowed in Australia, the key ingredient – nicotine - is a Schedule 7 Dangerous Poison under the Standard for the Uniform Scheduling of Medicines and Poisons. A combination of Federal and State laws effectively prohibits legal access to nicotine, its possession and use unless authorised eg by getting it on prescription. Nicotine was put into this schedule before e-cigarettes became available. Most Australian vapers are using nicotine illegally and obtain nicotine solutions on the internet from overseas or through an unregulated black market.
Despite legal prohibition of nicotine e-cigarettes are increasingly popular in Australia – by 2013 20% of smokers had tried e-cigarettes and 7% were currently using them . Current use reportedly increased to around 15% by 2014.
The current regulation of nicotine is clearly out of line with the current use of e-cigarettes and the scientific evidence of the relative safety of nicotine. Colin Mendelsohn succinctly states the case for legalising nicotine in Australia: http://www.smh.com.au/comment/smh-editorial/tobacco-treatment-specialist-nicotine-vaping-should-be-legal-20160815-gqsktg.html
The New Nicotine Alliance Australia (NNA) – a consumer advocacy group - has made a submission to the Australian Therapeutic Goods Administration (TGA) for low-strength nicotine for use in electronic cigarettes to be made legally available in Australia as a substitute for smoking. https://www.tga.gov.au/media-release/general-process-amending-poisons-standard-nicotine . The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods.
The essence of the NNA-Australia proposal is that Schedule 7 be amended to exempt nicotine in preparations for use as a substitute for tobacco in concentrations up to 3.6%.
This proposal will be strongly opposed by those in Australia who are against tobacco harm reduction and alternative safer nicotine products https://ajp.com.au/news/nicotine-vaping-reschedule-unlikely-expert .
Comments are invited on the proposal with a deadline for submission of 1 Sept 2016. NNA Australia is a small consumer group and their proposal needs support. Please consider submitting a comment. The deadline for public submissions to TGA is 1st September.
This is a link to the TGA announcement: https://www.tga.gov.au/consultation-invitation/consultation-proposed-amendments-poisons-standard-acms-meeting-november-2016
The TGA limits its information to this: ‘An applicant has proposed to exempt nicotine from Schedule 7 at concentrations of 3.6 per cent or less of nicotine for self-administration with an electronic nicotine delivery system ('personal vaporiser' or 'electronic cigarette') for the purpose of tobacco harm reduction.’ The TGA will not provide a copy of the application to anyone – which makes detailed comment on the application difficult! Please contact NNA Australia if you want further information.
This is a link to the cover page and submission requirements. If you wish to submit a comment use the first one titled “Scheduling Proposal” https://www.tga.gov.au/form/scheduling-consultation-coversheets#scheduling-proposal
This is a link to the Act that they must use when considering the application http://www.austlii.edu.au/au/legis/cth/consol_act/tga1989191/s52e.html
What happens next:
The proposal along with any public submissions will be considered at the joint meeting of the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemical Scheduling, 15-17 November 2016.
After considering advice from the advisory committees and public submissions, there will be am interim decision. The interim decision will be published on the TGA website in February 2017, inviting further submissions from the public.
After considering any further submissions, a final decision which is published on the TGA website in March 2017.
 Gravely, S., Fong, G. T., Cummings, K. M., Yan, M., Quah, A. C. K., Borland, R., Hummel, K. (2014). Awareness, trial, and current use of electronic cigarettes in 10 countries: Findings from the ITC project. International Journal of Environmental Research and Public Health, 11(11), 11691–704. doi:10.3390/ijerph111111691