Electronic cigarettes, also known as e-cigarettes, electronic nicotine delivery systems (ENDS) or e-cigs, are devices for making mists for inhalation, that usually simulate the act of cigarette smoking. Electronic cigarettes are sometimes marketed as an option to help people quit smoking, or as a tobacco replacement.
Unlike Nicotine Replacement Therapy (NRT) products, which have been rigorously assessed for efficacy and safety and, therefore, approved by the Therapeutic Goods Administration for use as aids in withdrawal from smoking, no assessment of electronic cigarettes has been undertaken and, therefore, the quality and safety of electronic cigarettes is not known.
The Australian Government is concerned about the use of electronic cigarettes in Australia. The impact of wide scale use of these devices on tobacco use is not known, and the outcome in the community could be harmful.
If you are considering supplying and promoting electronic cigarettes, you need to know the following information:
- Products claiming to help people quit smoking are therapeutic goods
- The importation and supply (including sale) of therapeutic goods is illegal in Australia unless authorised by the TGA.
- Nicotine is classified by law as a dangerous poison. States and territories have responsibility for regulating dangerous poisons. In all states and territories, the retail sale of nicotine is an offence unless a permit has been issued by the relevant state or territory authority. In some states and territories, obtaining, purchasing, possession and/or using nicotine without a permit is an offence. In most jurisdictions there are similar controls on manufacturing (including mixing), storage, labelling and packaging and other aspects of dangerous poisons. For details, contact the relevant state or territory health agency. These state and territory laws have not been overridden by Commonwealth legislation
- Some states and territories have legislation prohibiting the marketing of products that resemble tobacco products
- Electronic cigarettes have not been evaluated for quality, safety or performance by the TGA.
If you wish to import or supply electronic cigarettes as an aid to reducing dependence on nicotine, (e.g. as a therapeutic good) then you will need to become a sponsor and make an application to the TGA. Your application will need to include evidence of the beneficial effects of electronic cigarettes. The TGA recommends seeking the advice of a regulatory affairs consultant in this situation.
Some overseas studies suggest that electronic cigarettes containing nicotine may be dangerous, delivering unreliable doses of nicotine (above or below the stated quantity), or containing toxic chemicals or carcinogens, or leaking nicotine. Leaked nicotine is a poisoning hazard for the user of electronic cigarettes, as well as others around them, particularly children. Dangerous and lethal doses of nicotine can be absorbed through the skin. Electronic cigarettes containing substances other than nicotine have not been assessed for safety.
Importing unregistered products is illegal. Consumers may inadvertently break the law, waste their money or risk their health when buying unregistered products online. These unregistered products may be:
- fake (counterfeit)
- contaminated or not manufactured to appropriate standards;
- contain undisclosed, dangerous ingredients;
- past their use-by date;
- too strong or too weak.
- If you are worried about a medicine or medical device, and want to report the problem, please complete an online reporting form.
The Australian Government is encouraging all smokers to quit smoking. You can get help with quitting from the Quitline, telephone 13 7848, or your general practitioner. For some quitters, using a nicotine replacement therapy approved by the TGA may be an appropriate option. There are also prescription medicines to assist with quitting, subsidised by the Pharmaceutical Benefits Scheme. It is recommended that you discuss these therapies with your pharmacist, doctor or other health professional.