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Nicotine vaping product access
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 no changes to the availability of vaping products (including e-cigarettes) and vaping devices that do not contain nicotine.
Heat-not-burn tobacco, and many other tobacco products, 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. These products cannot be imported via the international mail under the Personal Importation Scheme. A valid doctor's prescription will continue to be required to access these products domestically via one of the established access schemes for unapproved goods. 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 here.
Review of the decision
A review of the decision will commence in the second half of 2022. More information about the review, including the terms of reference and the reviewer, will be released in early-2022.
Further information about importing, supplying, prescribing, dispensing and accessing nicotine vaping products can be found on the following pages: