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Nicotine e-cigarettes: Questions and answers

Nicotine e-cigarette access by import is made the same as access domestically

21 December 2020

What is happening to the law regulating imports of nicotine e-cigarettes?

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. The decision closes a gap between Commonwealth and state and territory law by clarifying that consumers will require a doctor’s prescription to legally access nicotine e-cigarettes and liquid nicotine in Australia.

Child resistant closures for liquid nicotine will also become mandatory to reduce the risk to children of accidental ingestion.

Under existing state and territory laws, the sale of nicotine e-cigarettes and liquid nicotine without a prescription, is already illegal throughout Australia. Additionally, the possession or use of these products is illegal in all states and territories except South Australia, without a prescription. From 1 October 2021, importing nicotine e-cigarette products from overseas websites without a valid doctor’s prescription will be illegal.

What products are affected by the changes?

These amendments mainly affect nicotine e-cigarettes and nicotine liquid. The changes will also apply to other novel nicotine delivery products, including heat-not burn tobacco.

Nicotine replacement therapies (including sprays, patches, lozenges and chews) that do not require a prescription will continue to be available from pharmacies and some retail outlets.

Who made the changes?

A senior medical officer at the Therapeutic Goods Administration (TGA) acting as a Delegate of the Secretary of the Department of Health made the changes. In keeping with the legal requirements it is not a decision of the Minister or of Government.

What factors were considered when making these changes?

The requirement for a prescription to access nicotine e-cigarettes 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.

For more information about the factors informing the changes, please refer to the public notice of the final decision.

What are the risks with nicotine?

There are significant health risks associated with nicotine use.

Please refer to the public notice of the final decision for a review of the evidence related to nicotine e-cigarette use leading to nicotine addiction and tobacco use, particularly among adolescents.

Why can't nicotine e-cigarettes be sold in supermarkets and pharmacies like other smoking cessation products such as sprays, patches, inhalators and gums?

There are a number of differences between nicotine replacement therapies (NRT) such as sprays, patches, inhalators and gums compared to nicotine e-cigarettes. These NRT products deliver nicotine to the body through the lining of the mouth and cheeks (sprays, inhalator, gums and lozenges) or the skin (patches). Importantly, they are designed to reduce nicotine withdrawal and cravings while minimising the potential for abuse when compared with e-cigarettes that deliver rapid boluses of nicotine to the lungs. So-called "inhalers" do not deliver nicotine to the lower respiratory system in the same manner as e-cigarettes.

The safety, quality and efficacy of NRT in these sprays, patches, inhalators and gums have been assessed by the TGA and determined that they can be sold in retail outlets with reasonable safety. They deliver nicotine at much lower concentrations than many nicotine-containing e-cigarettes. NRT, such as patches, were initially approved as prescription medicines and were down-scheduled when supporting safety data became available.

Why can’t nicotine e-cigarette products be sold in supermarkets and tobacconist stores like regular cigarettes?

Nicotine is a poisonous substance. Given its toxicity and potential for serious harms to human health, including death if ingested, e-cigarette devices and liquids containing nicotine are subject to controls under the Commonwealth Standard for the Uniform Scheduling of Medicines and Poisons (Poisons Standard).Nicotine when in tobacco prepared and packed for smoking is exempt from the Poisons Standard and can therefore be sold in general retail stores. This is an historical position from when the Poisons Standard was first made some decades ago and a where a range of substances and products that were otherwise regulated through State and Territory laws were excluded from the Poisons Standard.

I currently use nicotine containing e-cigarettes to help me quit smoking, what do these changes mean for me?

You may still be able to access nicotine e-cigarettes. However, you will need to discuss your needs with a doctor first. It is important to talk to your doctor about the best treatment options available to you to help you quit smoking.

Read our information for consumers page for an overview of how consumers can access nicotine e-cigarettes where appropriate.

What is scheduling?

In Australia, medicines and chemicals are classified into Schedules according to the level of regulatory control required over the access to (availability of) the substance to protect public health and safety.

The Schedules are published in the Poisons Standard and are given legal effect through state and territory legislation. Decisions on scheduling of medicines are made by a senior medical officer within the TGA following extensive public consultation and on the advice of an expert Advisory Committee.

Supplying nicotine e-cigarettes

How will pharmacies and wholesalers be authorised to import and sell nicotine?

A wholesaler licence must be obtained from the relevant State or Territory health department as requirements are governed by State and Territory legislation. The contact details for the State and Territory medicines regulation units are available on the TGA website. There is no requirement for a separate commonwealth import licence.

What are the criteria for pharmaceutical wholesalers in terms of their eligibility to become a supplier?

Applicants for a wholesale licence must meet a number of requirements, including demonstrating that they are a fit and proper person and that the premises are suitable for wholesale purposes.

The TGA publishes the Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8 (Wholesale Code), which is implemented through the States and Territories.

The Wholesale Code is applicable to wholesalers, including manufacturers, wholesalers, manufacturer's agents, importers and distributors who store and/or supply wholesale prescription and pharmacy medicines.

Can vape shops supply liquid nicotine to consumers?

No. Vape shops are currently not legally allowed to sell liquid nicotine and the final decision does not change this. This is because prescription medicines can only be supplied by pharmacies dispensing a doctor’s prescription. Vape shops can still sell non-nicotine containing vaping liquids and vaping equipment.

What is the process to register a nicotine e-cigarette product on the ARTG?

The usual prescription medicines registration process apply. A submission to register a prescription medicine consists of:

  • data that support the quality, safety and efficacy of the product for its intended use. Evidence for efficacy and safety would be required to come from clinical trials,
  • completed forms, and
  • the payment of fees.

The detailed requirements are set out on the TGA website. The TGA welcomes discussions with potential sponsors on the required data package. Sponsors can email the TGA at info@tga.gov.au

The TGA also offers a dedicated service to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations. Visit the TGA website to find out more information on how the SME Assist team can help you.

Can pharmacists send liquid nicotine products in the mail – for example to patients living in rural or remote locations who do not have access to a local pharmacy?

Yes. Many pharmacies already provide a service supplying prescription medicines through the mail, subject to the presentation of evidence of a prescription. More information is available at the Pharmacy Board Guideline for Dispensing of Medicines.

Will patients need to submit their original prescription to an overseas supplier to facilitate access under the personal importation scheme?

Patients ordering prescription medicines through the personal importation scheme usually hold the original prescription and provide a copy of the prescription to the supplier.

Prescribing nicotine e-cigarettes

What is the difference between the Authorised Prescriber (AP) and the Special Access Scheme B (SAS-B) pathway for prescribers?

The main difference is that once a doctor becomes an Authorised Prescriber (AP), they do not need to notify the TGA each time they prescribe nicotine e-cigarettes for smoking cessation. Medical practitioners are able to use the AP scheme to prescribe nicotine as an aid to stop smoking - without requirement for ethics committee approval. For the five year duration of the approval no further applications or permissions are required.

Application to become an Authorised Prescriber is free of charge and only the prescriber's name and AHPRA number is required to be filled into a simple online form which will be available on the TGA website.

The Special Access Scheme B (SAS-B) applications are approved on an individual patient basis, which means that a separate application needs to be submitted to the TGA for each patient.

Can doctors who are not Authorised Prescribers (AP) write a prescription to be supplied under the personal importation scheme?

Yes. A doctor may write a script for a single patient to access nicotine e-cigarettes through the personal importation scheme for up to 3 months’ supply.

If you wish to bring in more than 3 months' supply at the one time into Australia, an Australian-registered doctor will first need to apply to the TGA for approval through the Special Access Scheme B (SAS-B) or to become an Authorised Prescriber using the forms available on the TGA website.