On 21 December 2020, the Therapeutic Goods Administration (TGA) announced a decision that, from 1 October 2021, consumers need a valid prescription to import nicotine vaping products, such as nicotine e-cigarettes, nicotine pods and liquid nicotine. This means that when a consumer purchases these products online from an overseas supplier, they legally require a prescription from an Australian doctor.
There has been a significant increase in the use of nicotine e-cigarettes and other nicotine vaping products by young people in Australia and in many other countries. There is evidence that nicotine vaping products act as a 'gateway' to smoking in youth and exposure to nicotine in adolescents may have long-term consequences for brain development.
This decision balances the need to prevent adolescents and young adults from taking-up nicotine vaping products while allowing current smokers to access these products for smoking cessation with appropriate medical advice.
What happened to the law regulating imports of nicotine vaping products on 1 October 2021?
On 1 October 2021, the entry for nicotine in Schedule 4 to the Poisons Standard was amended so that it now captures all nicotine vaping products as prescription only medicines.
This means that it is now illegal for consumers to import nicotine vaping products from overseas websites without a valid prescription from an Australian doctor. Consumers continue to require a valid doctor's prescription to purchase nicotine vaping products from Australian pharmacies.
It was, and remains, illegal for other Australian retailers (such as tobacconists, 'vape' shops or convenience stores) to sell nicotine vaping products to consumers, even if the consumer has a valid doctor's prescription.
There are currently no TGA approved nicotine vaping products in the Australian Register of Therapeutic Goods (ARTG). Medicines not included in the ARTG are known as 'unapproved' medicines. There are established pathways for consumers to legally access unapproved nicotine vaping products, with a valid prescription, but these medicines have not been assessed by the TGA for safety, quality and efficacy.
There are various smoking cessation aids that are registered in the ARTG, including many nicotine replacement therapies (NRTs) (such as sprays, patches, lozenges, chews and gums) and some prescription medicines. Unlike nicotine vaping products, these medicines have been assessed by the TGA for safety, quality and efficacy. There are also non-pharmaceutical approaches to smoking cessation.
What is not affected?
NRTs currently registered in the ARTG and available without prescription (from pharmacies and some retail outlets) are not affected by the changes.
There are also no changes to the availability of vaping products (including e-cigarettes) and vaping devices that do not contain nicotine.
Although heat-not-burn tobacco, and many other tobacco products, have been reclassified under the Poisons Standard from Schedule 7 to Schedule 4, they continue to be controlled as 'prohibited imports' and are only to be imported for commercial or personal use with a permit from Australian Border Force. Permits for tobacco products generally preclude importation via international mail.
In addition to permit requirements, Schedule 4 tobacco products (including heat-not-burn tobacco) are subject to the requirements of the Therapeutic Goods Act 1989. This means they can only be imported or supplied via one of the established access schemes for unapproved goods. A doctor's prescription or authorisation is required in order to import these goods under the Personal Importation Scheme, and similarly a consultation with a doctor will be necessary in order to access these goods in Australia under the Special Access Scheme or the Authorised Prescriber Scheme. The doctor would need to consider whether it is appropriate to prescribe such a product, having regard to the relevant standards of good medical practice and informed consent.
How was the decision made?
The decision followed 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 was not a decision of the Government or the Minister. Among other things, the Delegate considered:
- the 2385 public submissions received in response to the interim decision consultation
- the Report of the Senate Select Committee on Tobacco Harm Reduction released on 18 December 2020
- the submissions to the Senate Inquiry and testimony at the public hearings held on 13 November and 19 November 2020.
The Regulatory Impact Statement for the decision is available at Nicotine Scheduling Regulation Impact Statement (RIS).
Support services
Some people may find issues relating to smoking cessation distressing. If you or someone you know needs additional support, please contact any of the below crisis support helplines:
Adult
- Lifeline: 13 11 14
- Suicide Call Back Service: 1300 659 467
- Beyond Blue: 1800 512 348
- MensLine Australia: 1300 789 978
Youth
- Kids Helpline (5-25 years): 1800 551 800
- Headspace: 1800 650 890
- ReachOut
More information
More information about importing, supplying, prescribing, dispensing and accessing nicotine vaping products can be found on the following pages: