TGA confirms nicotine e-cigarette access is by prescription only

From 1 October 2021, the law for consumers to import nicotine e-cigarettes and liquid nicotine will align with the law for them to buy such products domestically. Closing a gap between Commonwealth and state and territory law, the decision announced by the Therapeutic Goods Administration (the TGA) today, clarifies that consumers will require a doctor's prescription to legally access nicotine e-cigarettes and liquid nicotine in Australia.

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, announced by the Therapeutic Goods Administration (TGA) today, aims to prevent adolescents and young adults from taking-up nicotine e-cigarettes while allowing current smokers to access these products for smoking cessation on their doctor's advice.

There has been a significant increase in the use of nicotine e-cigarettes by young people in Australia and in many overseas countries. There is evidence that nicotine e-cigarettes act as a 'gateway' to smoking in youth and exposure to nicotine in adolescents can have long-term consequences for brain development.

Consumers can continue to import nicotine e-cigarettes to assist with smoking cessation with a doctor's prescription. Consumers will also be able to obtain nicotine e-cigarettes from local pharmacies and Australian based on-line pharmacies, with a prescription from an Authorised Prescriber or under the TGA Special Access Scheme. The requirement for a prescription will provide an opportunity for consumers to receive advice from their doctor on smoking cessation in the context of their overall health management.

The decision follows two rounds of public consultation during 2020. As for all decisions of this type, 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.

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 today means that importing nicotine e-cigarette products from overseas websites without a valid doctor's prescription will be illegal.

There are currently no TGA approved nicotine e-cigarettes in the Australian Register of Therapeutic Goods (ARTG). Medicines not included in the ARTG are able to be accessed on prescription from any doctor through the TGA personal import scheme, or on prescription from a doctor who has received an authorisation under the TGA Authorised Prescriber or Special Access Scheme B.

In response to concerns regarding the safety and quality of some nicotine e-cigarettes and e-cigarette fluids, a public consultation will be undertaken in February 2021 on product safety and quality standards. The consultation will be informed by existing international standards for nicotine e-cigarettes. Child resistant closures for liquid nicotine will also become mandatory to reduce the risk to children of accidental ingestion. This is consistent with many other countries.

In the coming months there will be a wide range of educational and communication resources to support health professionals and consumers on the changes. The TGA website, which will be updated regularly, includes more information for consumers and health professionals about the changes.

Consumers who may be affected by these changes are encouraged to speak to their medical practitioner regarding potential options ahead of the 1 October 2021 implementation date.

Consumers are reminded that while importation may be permitted until 1 October 2021, possession in most States and Territories without a prescription is currently illegal.

Individuals attempting to import commercial quantities of nicotine e-cigarettes and liquid nicotine may be subject to importation and seizure of products and potential fines under existing regulation.