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Interim decision of entry of nicotine in the Poisons Standard: Information for consumers
Consumers are invited to have their say on proposed changes to make certain nicotine products a prescription only medicine. To help you make an informed submission this page provides information on what making these products prescription only medicines would mean for consumers if the interim decision is made final.
The proposed changes would not affect the current exemption from scheduling for tobacco prepared and packed for smoking. The changes would also not affect access to registered products to help smokers quit such as gums, sprays and patches.
The delegate must reconsider the interim decision in light of all relevant submissions received by the notified due date before making a final decision.
The interim decision on nicotine scheduling is a separate process from the Australian Government’s proposed prohibition on the importation of e-cigarettes containing vaporiser nicotine.
What the proposed changes would mean
The proposed changes would mean that certain nicotine containing products for human use could only be supplied to you in accordance with a doctor’s prescription. Affected products containing nicotine include:
It would also affect heat-not-burn tobacco products, chewing tobacco, snuff and other novel nicotine products. The proposed changes clarify the scheduling for these products, which are currently Schedule 4 prescription medicines when for human therapeutic use.
The proposed changes would also make it illegal to possess these products without a prescription from an Australian-registered medical practitioner.
This is consistent with existing state and territory laws which make sale of nicotine e-cigarettes / e-juice illegal throughout Australia and its possession illegal everywhere but in South Australia.
So while you would still be able to use the ‘personal importation scheme’ under the Therapeutic Goods Act 1989 to order online from your usual supplier 3 months’ supply of e-cigarettes containing nicotine and a maximum amount of 15 months’ supply in 12 months, it would be clear that you would be required to have a prescription. You would also be able to fill your prescription at your local community pharmacy, however your pharmacy may have to order it in for you.
A flow chart including the steps that would lead up to dispensing the prescription is set out below.
Rationale for the proposed changes
Substances are scheduled according to the risk of harm and the level of access control required to protect consumers. In the delegate’s view, restricting the availability of nicotine containing e-cigarettes to supply in accordance with a prescription is necessary to reduce the potential uptake of e-cigarettes and smoking in young adults who would otherwise be at low risk of nicotine addiction.
The requirement for a prescription would also provide an opportunity for you to consult with your medical practitioner as to whether e-cigarettes or other products containing nicotine are right for you as an aid to stop smoking. Medical practitioners are well placed to support you to stop smoking and advise on how to reduce the risks associated with nicotine use.
Other public health concerns that informed the interim decision include:
- the potential for the delivery from an e-cigarette of very high levels of nicotine
- the risk of initiating or maintaining nicotine addiction
- the unknown long-term adverse effects.
The evidence that was considered in forming this view is provided in the Notice of an interim decision to amend the current Poisons Standard.
About e-cigarettes and nicotine
E-cigarettes are devices for making vapour for inhalation. E-cigarettes are considered by some health professionals as an option to help people quit smoking, although this view is strongly contested as the published evidence is mixed.
To date, no e-cigarette product has been approved by the Therapeutic Goods Administration (TGA) for lawful supply in Australia as a smoking cessation aid. These products are therefore considered to be 'unapproved' therapeutic goods which have not been evaluated by the TGA for quality, safety and effectiveness.
The usual nicotine replacement therapies (including sprays, patches, lozenges and chews), available without prescription from pharmacies and some retail outlets, would not be affected by the proposed decision. There are also prescription medicines that can help you quit, as well as a range of non-medicine approaches to smoking cessation.
For help with quitting, talk to your health professional or phone the Quitline on 13 7848. Alternatively, visit the Quit Now website.