Nicotine vaping products with no quality assurance ‘unacceptable’

Australia’s proposal to allow personal imports of nicotine-containing vaping products without rigorous analysis of their ingredients is ‘unacceptable’, the RACGP said in a submission to the Therapeutic Goods Administration (TGA).
 
The RACGP is calling for consistent high standards and quality for liquid nicotine for e-cigarettes in its submission to the TGA’s consultation for its new standard for vaporised nicotine.
 
While noting Australia’s position as a world leader in making vaporiser nicotine a therapeutic product that is only available with a prescription, the RACGP says the health watchdog should require further checks.
 
‘The aim should be to support evidence-based use of these products and seek to ensure the products available in Australia meet standards for quality and safety,’ the submission states.
 
‘That the TGA will not require nicotine vaporiser products imported into Australia to meet good manufacturing practice standards and provide a certificate of analysis is unacceptable.’
 
Chair of the RACGP’s Expert Advisory Group for the current smoking cessation guidelines, Professor Nick Zwar, who contributed to the college’s response, says without those assurances there could be insufficient information for prescribers to determine product quality.
 
‘You don’t know how well it has been made and you don’t know exactly what is in it,’ he told newsGP.
 
‘That is really surprising, that [the TGA] would allow things to come in without those two forms of documentation being provided.’
 
Under Australia’s e-cigarette regulations, a prescription is required for nicotine-containing vaping products. But some people take advantage of the personal importation scheme and order the products from overseas to possess and use them illegally.
 
There will be options for doctors to prescribe nicotine-containing e-cigarettes for people to fill through personal importation.
 
Professor Zwar says the complexity over that importation method runs the risk of doctors shying away from prescribing them.
 
‘Things that come into Australia and are dispensed through an Australian pharmacy would need to meet the TGA standards, but scripts that are written through the personal importation scheme – there’s no way that you could know if it meets the standard or not,’ he said.
 
‘That second avenue to access is quite problematic because you can’t be sure if those standards would apply. Nowhere in the world has a nicotine e-cigarette gone through a full approval as a medicine.
 
‘These are all unapproved products but we’re making them available with a prescription, so it’s quite an unusual situation.
 
‘It’s important for prescribers to be aware that if they do prescribe something through that personal importation route, then as far as I can tell, these standards don’t necessarily apply.’
 
Despite the concern over quality assurance checks from the TGA, the RACGP broadly welcomes the standard for nicotine vaporiser products. It has also called for the standard to apply to Australian-made export-only products, and to extend to clinical trial products as a minimum standard.
 
Likewise, warning labels should be on the products or in an accompanying information sheet and active ingredients other than nicotine should be banned, the RACGP said.
 
The submission highlights that the products should be labelled with their active ingredients and nicotine concentration or content.
 
‘Prescribers will have greater confidence and consumers are better informed if all vaporiser nicotine products are labelled with the nicotine concentration,’ it stated.
 
The RACGP says nicotine concentration of the products should not be limited so doctors can scale the required dose for individual patients, but a prescription limit such as three months’ supply should be used.
 
‘The suggested level for dosing can be addressed in clinical practice guidance advice to prescribers,’ the submission stated.
 
According to Professor Zwar, the TGA is trying to strike the right balance for demand and regulation.
 
‘They’re trying to make it available enough for consumers who want to get access to vaping products to not have too much difficulty, but are they providing enough regulatory frameworks for prescribers to feel willing to be involved?’ he said.
 
‘If they don’t get that balance right then it won’t succeed because there won’t be enough doctors willing to prescribe these products to people who might benefit.’
 
e-Cigarettes continue to create controversy, amid opposing views on their efficacy to help people quit smoking.
 
The current RACGP smoking cessation guidelines suggest frontline use of nicotine replacement therapy, varenicline or bupropion, together with behaviour supports. It recommends, with high certainty, a combination of nicotine replacements such as patches and medication.
 
e-Cigarettes containing nicotine are not recommended as first-line treatments given ‘the long-term health effects of vaping are unknown’.
 
Professor Zwar says there is potential benefit for vaping for some people who have tried previously to quit.
 
‘To be able to offer another option, which might be as good or possibly even more effective, is quite important,’ he said.
 
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