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Nicotine e-cigarette access
On 21 December 2020, the Therapeutic Goods Administration (TGA) announced a decision that from 1 October 2021, the importation of nicotine e-cigarettes and liquid nicotine for vaping will require a valid prescription.
This aligns with current domestic restrictions under State and Territory law that prohibit the supply of nicotine containing e-cigarettes in Australia without a valid medical prescription.
This decision balances the need to prevent adolescents and young adults from taking-up nicotine e-cigarettes while allowing current smokers to access these products for smoking cessation with appropriate medical advice.
There has been a significant increase in the use of nicotine e-cigarettes by young people in Australia and in many other countries. There is evidence that nicotine e-cigarettes act as a 'gateway' to smoking in youth and exposure to nicotine in adolescents may have long-term consequences for brain development.
The decision follows two rounds of public consultation on the proposed changes during 2020. The decision was made by a senior medical officer at the TGA as a Delegate of the Secretary of the Department of Health. It is not a decision of the Government or the Minister.
What is happening to the law regulating imports of nicotine e-cigarettes from 1 October 2021
Nicotine is already a Schedule 4 Prescription Only Medicine in the Poisons Standard when in preparations for human therapeutic use. The changes clarify the scheduling of nicotine and close a regulatory gap between Commonwealth and state and territory laws.
Under existing state and territory laws, the sale of nicotine e-cigarettes and liquid nicotine without a prescription, is illegal throughout Australia. Additionally, the possession or use of these products without a prescription is illegal in all states and territories except South Australia. The decision means that importing nicotine e-cigarette products from overseas websites without a valid doctor's prescription will be illegal.
Nicotine e-cigarettes will require a prescription
Consumers will need a valid Australian prescription (script) to access nicotine e-cigarettes and liquid nicotine. This will provide an opportunity for consumers to receive appropriate medical advice on options for smoking cessation.
Obtaining nicotine e-cigarettes
There are currently no TGA approved nicotine e-cigarettes in the Australian Register of Therapeutic Goods (ARTG). Medicines not included in the ARTG are known as 'unapproved' medicines. There are established pathways for legal access to unapproved nicotine e-cigarettes, with a valid prescription.
Consumers can import nicotine e-cigarettes legally through the TGA Personal Importation Scheme, with a doctor's prescription. Any medical practitioner who considers it is appropriate for their patient to use nicotine e-cigarettes for smoking cessation can prescribe nicotine e-cigarettes for personal importation. Medical practitioners do not need TGA approval to prescribe nicotine e-cigarettes for their patient when they access them through the personal importation scheme.
Supply in Australia
Consumers will also be able to obtain nicotine e-cigarettes from local pharmacies and Australian based online pharmacies, with a prescription from an Authorised Prescriber. Medical practitioners would need to apply to the TGA for authority to prescribe unapproved nicotine e-cigarettes as an aid to stop smoking through the simplified Authorised Prescriber Scheme or the Special Access Scheme (SAS). Depending on state or territory restrictions, other prescribing health practitioners may also be able to apply under the SAS.
A simplified nicotine-specific online form is available on the Authorised Prescriber dashboard of the SAS & Authorised Prescriber Online System. Once approved, the authorisation is valid for a five year period and the Authorised Prescriber may, in accordance with the RACGP guidelines to support smoking cessation, prescribe nicotine for smoking cessation to patients without any further required TGA approval.
Child resistant closures will be mandatory for liquid nicotine
From 1 October 2021, all liquid nicotine products will require child resistant closures to reduce the risk of accidental exposure to or ingestion of liquid nicotine.
This is consistent with many other countries and is also consistent with TGA-approved nicotine replacement products, which require containers with child resistant closures.
What will happen before 1 October 2021
The Delegate has considered the 2385 public submissions received in response to the interim decision consultation. The Delegate has also considered the Report of the Senate Select Committee on Tobacco Harm Reduction released on 18 December 2020, as well the submissions to the Senate Inquiry and testimony at the public hearings held on 13 November and 19 November 2020.
In response to concerns regarding the safety and quality of unapproved nicotine e-cigarettes and the need for prescribing guidance, additional resources and standards will be developed before the changes are implemented on 1 October 2021, including:
- public consultation in early 2021 on product safety and quality standards (so these standards are in effect well before 1 October 2021). The consultation will be informed by existing international standards for nicotine e-cigarettes.
- provision of educational resources to support health professionals.
- consumer education activities.
What is not affected
Nicotine products that are not affected include nicotine replacement therapies currently available without prescription (from pharmacies and some retail outlets including sprays, patches, lozenges and chews). These products have been assessed by the TGA as safe for retail sale.
There are no changes to the availability of e-cigarettes that do not contain nicotine.