TGA interim decision tightens e-cigarette regulations

Morgan Liotta

24/09/2020 1:03:57 PM

The final outcome of the decision will ascertain whether nicotine-containing products are supplied with a doctor’s prescription.

Man using e-cigarette
The RACGP cautions that e-cigarettes only be considered as a second-line intervention in limited circumstances.

The RACGP has welcomed the Therapeutic Goods Administration’s (TGA) interim decision to regulate the sale and use of e-cigarettes containing nicotine and nicotine fluids for vaping.
This follows the TGA’s interim decision in June to ban the sale of heat-not-burn tobacco products in Australia, after the RACGP – along with other key health organisations – put forward a submission opposing the approval of these products as part of its high-profile stance against ‘big tobacco’.
Consistent with existing state and territory laws, the sale, possession and use of nicotine e-cigarettes and fluids – except for prescription medical use – is illegal throughout Australia, with the exception of South Australia.
If confirmed through a final TGA decision, the importing of these products for personal use purchased from overseas websites without a valid prescription would be deemed illegal.
Personal imports under the TGA Personal Importation Scheme with a valid prescription are permitted.
Supply will only be authorised with a valid doctor’s prescription, which will be provided only to assist with smoking cessation where other measures, such as nicotine replacement therapy (NRT), have proved unsuccessful.
The proposed changes would not affect the current scheduling exemption for tobacco prepared and packed for smoking. The changes would also not affect access to registered products to help people who smoke to quit, such as gums, sprays and patches.
The TGA states that doctors are well placed to support smoking cessation and advise on how to reduce the risks associated with nicotine use.
RACGP Acting President Associate Professor Ayman Shenouda praised the TGA’s decision.
‘This is a sound decision from the TGA, because we need to be very cautious when it comes e-cigarettes or vaping,’ he said.
‘Some pro-vaping organisations claim that these products cause less harm and constitute an effective harm-reduction approach. However, we simply do not know the long-term health effects of using e-cigarettes.
‘We must be guided by the evidence.’
The RACGP’s Supporting smoking cessation: A guide for health professionals recommends that nicotine-containing e-cigarettes are not first-line treatments, but may be a second-line intervention for people in limited circumstances, such as those who have attempted to quit and raised e-cigarette usage with their healthcare practitioner.
Associate Professor Shenouda said that although quitting smoking is not easy, GPs are there to provide the ‘right kind’ of support and strategies for people wanting to quit smoking.
The Australian Medical Association (AMA) has also welcomed the TGA decision, saying it will ‘protect Australians’ lungs’.
‘Young Australians will be protected by the interim decision of the TGA to ensure that e-cigarettes and vaping fluids containing nicotine are only available on prescription,’ AMA President Dr Omar Khorshid said.
The interim decision will be open for public consultation until 6 November, with a final decision expected in mid-December and an implementation date anticipated mid-2021.
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