It is our view that electronic cigarettes, supplied with an atomizer that contains either nicotine or a placebo, are therapeutic goods, more specifically a system pack comprising of both a medical device and a medicine and must be reviewed by the TGA and included on the Australian Register of Therapeutic Goods (ARTG) as a medical device prior to supply in Australia. Why are e-cigarettes therapeutic goods?
Electronic cigarettes meet the definition of a therapeutic good, in that they are likely to be taken to be for therapeutic use such as:
Electronic cigarettes are claimed to be designed to assist smoking cessation with methods such as imitating the taste, smell, feel and action of smoking that do not rely on administering nicotine. Therefore, the electronic cigarette without nicotine is likely to be taken to be a therapeutic good.
Further, the following information supports the view that the electronic cigarette, even without nicotine is a therapeutic good:
Overseas marketing material, available to Australian consumers via the internet, contains therapeutic claims regarding the electronic cigarette's function to assist smoking dependence.
What type of therapeutic good - is it a medicine o r a medical device or a combination?
Having established the electronic cigarette is a therapeutic good, the next question is whether it is regulated as a medicine, a medical device or a combination product.
The electronic cigarette consists of a battery with indicator light, battery charger, atomizer, cartridge for liquid nicotine or placebo and mouthpiece which when used together deliver the therapeutic effect.
The liquid mixture in the cartridge achieves its principle intended action by pharmacological or chemical means. Even without the nicotine, the flavour and fragrance in the liquid placebo acts on the body receptors and therefore still achieves the principle intended action by pharmacological means. Hence this component of the electronic cigarette would be regulated as a medicine.
The other components of the electronic cigarette (battery, atomizer, cartridges, mouthpiece) are essential to the delivery of the therapeutic action and achieve their principle purpose by mechanical means and hence are medical devices.
Hence the electronic cigarette, in totality is a system consisting of both a medicine and medical device.
The electronic cigarette will need to meet the regulatory requirements for both medicines and medical device and will need to be included on the Australian Register of Therapeutic Goods, before it can be lawfully supplied in Australia.
Although it is the responsibility of the manufacturer to classify the device, it is my view that the electronic cigarette system is likely to be a class IIa medical device, being an active medical device used to deliver a medicine.
Where to from here - For Sponsors wishing to import E-Cigarettes for supply to the Australian Market.
The process is complex due to the therapeutic good being a combination of both a Medicine and Medical Device.
1. Contact the medicines area of the TGA to ascertain what regulatory requirements need to be met in relation to the medicine component of the E-cigarette
2. Submit an application to the TGA for the Medicine to be evaluated.
3. If the Medicine component is approved, then obtain the appropriate certifications from the manufacturer of the E-Cigarette for the device component.
4. If the Manufacturers Certification for the device component is acceptable, then submit an application for the device.
5. There will also be fees incurred with the assessment of the medical device
There are a number of technical and regulatory requirements that need to be met and there will also be ongoing regulatory obligations.
Yours sincerely,
Medical Devices Information Line
Telephone: 1 800 141 144
Fax: 02 6232 8785
Websites:
Information www.tga.gov.au/devices/devices.htm
e-Business www.ebs.tga.gov.au
Electronic cigarettes meet the definition of a therapeutic good, in that they are likely to be taken to be for therapeutic use such as:
- alleviating or curing the disease of smoking dependence; and/or
- influencing, inhibiting or modifying a physiological process, ie nicotine dependency and associated cravings.
Electronic cigarettes are claimed to be designed to assist smoking cessation with methods such as imitating the taste, smell, feel and action of smoking that do not rely on administering nicotine. Therefore, the electronic cigarette without nicotine is likely to be taken to be a therapeutic good.
Further, the following information supports the view that the electronic cigarette, even without nicotine is a therapeutic good:
Overseas marketing material, available to Australian consumers via the internet, contains therapeutic claims regarding the electronic cigarette's function to assist smoking dependence.
- Various websites which promote electronic cigarettes for the cessation of smoking etc
- The four step program referred to in the user manual includes the atomized cartridges with high medium, low and no nicotine content
What type of therapeutic good - is it a medicine o r a medical device or a combination?
Having established the electronic cigarette is a therapeutic good, the next question is whether it is regulated as a medicine, a medical device or a combination product.
The electronic cigarette consists of a battery with indicator light, battery charger, atomizer, cartridge for liquid nicotine or placebo and mouthpiece which when used together deliver the therapeutic effect.
The liquid mixture in the cartridge achieves its principle intended action by pharmacological or chemical means. Even without the nicotine, the flavour and fragrance in the liquid placebo acts on the body receptors and therefore still achieves the principle intended action by pharmacological means. Hence this component of the electronic cigarette would be regulated as a medicine.
The other components of the electronic cigarette (battery, atomizer, cartridges, mouthpiece) are essential to the delivery of the therapeutic action and achieve their principle purpose by mechanical means and hence are medical devices.
Hence the electronic cigarette, in totality is a system consisting of both a medicine and medical device.
The electronic cigarette will need to meet the regulatory requirements for both medicines and medical device and will need to be included on the Australian Register of Therapeutic Goods, before it can be lawfully supplied in Australia.
Although it is the responsibility of the manufacturer to classify the device, it is my view that the electronic cigarette system is likely to be a class IIa medical device, being an active medical device used to deliver a medicine.
Where to from here - For Sponsors wishing to import E-Cigarettes for supply to the Australian Market.
The process is complex due to the therapeutic good being a combination of both a Medicine and Medical Device.
1. Contact the medicines area of the TGA to ascertain what regulatory requirements need to be met in relation to the medicine component of the E-cigarette
2. Submit an application to the TGA for the Medicine to be evaluated.
3. If the Medicine component is approved, then obtain the appropriate certifications from the manufacturer of the E-Cigarette for the device component.
4. If the Manufacturers Certification for the device component is acceptable, then submit an application for the device.
5. There will also be fees incurred with the assessment of the medical device
There are a number of technical and regulatory requirements that need to be met and there will also be ongoing regulatory obligations.
Yours sincerely,
Medical Devices Information Line
Telephone: 1 800 141 144
Fax: 02 6232 8785
Websites:
Information www.tga.gov.au/devices/devices.htm
e-Business www.ebs.tga.gov.au
they didn't just cross our boundries, they crossed thier own as well, of course they won't admit to that, so why lose our dignity over what is probably flogging a dead horse anyway. There's always the hope that they change thier mind and a little common sense wouldn't go astray, but I'm not holding my breath. 
40 bucks for nicorette and a license check seems a little too close to reality for my liking. Aditionally it's like admitting to being sick when your not.
