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RACGP push for stricter vaping regulatory framework

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The RACGP is calling for tighter regulations on nicotine vaping and has offered ‘cautious support’ for establishing product registration, in line with other medicines, following evaluation of quality, safety, and efficacy for smoking cessation.
 
However, while the college recognises there is an ‘urgent need’ to review existing regulation of nicotine vaping products, it also warns some proposed reforms may have ‘unintended consequences for prescribing for smoking cessation’.
 
The recommendations are contained in an RACGP submission to the Federal Government’s public consultation into proposed Therapeutic Goods Administration (TGA) reforms of the way nicotine vaping products are regulated in Australia.
 
The TGA reforms support access to products ‘of known composition and quality’ for smoking cessation with a doctor’s prescription, as well as better control over the growing black market of the products and the rise in young people accessing them.
 
RACGP President Dr Nicole Higgins says change is needed as ‘Big Tobacco’ has adapted to public health measures aimed at cigarettes by becoming ‘Big Nicotine’ and targeting younger people.
 
‘Times have changed … [but] their strategies are the same, and just as cynical as ever,’ she said.
 
‘More and more young people who have never smoked cigarettes are now vaping and this is deeply concerning.’
 
According to recent statistics, there has been a rise in young Australians aged 18–24 using e-cigarettes or vapes, with 64% of current smokers and 20% of non-smokers having tried them, compared to 49% and 13.6% three years earlier.
 
Additionally, research published last year suggests almost one in three 12–17-year-olds have tried vaping – up from 14% in 2017 – more than half of whom have never smoked. Of the cohort who had tried vaping, 30% bought the product themselves, a rate that has also more than doubled in the past five years.
 
According to the RACGP submission, flavourings ‘increase the appeal of vaping’, with fruit and sweet flavours popular among young people and potentially encouraging uptake among non-smokers.
 
Recommendations from the college’s Smoking cessation guidelines include the restriction of tobacco flavours where possible to tobacco flavour, while it is also notes that there is ‘limited evidence’ about the long-term safety of inhaled flavourings.
 
Meanwhile, ‘non-nicotine products’ are another form of vaping that Dr Higgins is concerned about.
 
‘Many vaping products sold as non-nicotine do, in fact, contain nicotine,’ she said.
 
‘This makes it clear that getting people addicted is a core part of Big Nicotine’s marketing strategy. It is also a strategy that attempts to side-step efforts to improve health through questionable and furtive marketing, such as use of influencers to create a new generation of nicotine users.
 
‘Big Nicotine has taken advantage of a lower evidence base to create an impression of a safe alternative to cigarettes and built a customer base of new users including young people.
 
‘We are at risk of trading one public health disaster for another.’
 
The potential reforms outlined by the TGA have been reviewed by the RACGP’s Smoking Cessation Expert Advisory Group (EAG) and align with recommendations in its Smoking cessation guidelines, with the college calling for:
 

• stricter border controls, including removal of the personal importation scheme for nicotine vaping products
• mandating listings of all product ingredients, with fines for incorrectly labelled products
• restricting supply of the products to three months per prescription
• restricting flavours to tobacco and pharmaceutical-like packaging with warnings about risks, such as poisoning and burns.

 
The Pharmacy Guild has backed the RACGP’s submission of recommendations, saying that flavours should be limited to ‘reduce the appeal’ and be specified on prescriptions of nicotine vaping products.
 
The Guild also supports the college’s Smoking Cessation EAG’s advice that the products are not recommended as a first-line treatment for smoking cessation.
 
Dr Higgins highlights the Smoking cessation guidelines’ advice that nicotine vaping products should only be used to aid smoking cessation under the guidance of a GP.
 
‘We believe this is the only legitimate use of these products,’ she said.
 
‘The RACGP understands that getting a prescription is harder than walking to the shop. But GPs are here to help and to work with you to improve your health, without judgement.
 
‘Your GP can work with you to take control of your health, and save you money, by helping you to access smoking cessation products and develop strategies that work for you.’
 
The recent submission advises GPs prescribing the products to use the Authorised Prescriber pathway and encourage patients to have the prescription filled locally rather than overseas via the personal importation scheme.
 
However, should the TGA remove the option of people filling prescriptions via the personal importation scheme, the college says ‘reasonable notice’ will be required to allow the community and health professionals to make the adjustment, and so that the industry can improve the currently limited range of appropriate products available via prescription domestically.
 
Under recommendations for minimum quality and safety standards for vaping products, the college is proposing to reduce the maximum nicotine concentration for both freebase nicotine and nicotine salt products to 20 mg/mL (base form or base form equivalent), stating that ‘decisions about nicotine concentration are best made by clinicians who have access to evidence-based guidance’.
 
‘The dose of nicotine received by the person can vary by the type of vaping device, concentration of nicotine and inhalation technique,’ the submission states.
 
‘Therefore, the RACGP Smoking cessation guidelines provide advice on initial dosing but note that dose titration may be needed with regular follow-up and should be discussed with the patient.’
 
The Australian Association of Convenience Stores has also backed calls to tighten regulations on the sale of nicotine vaping products, saying that ‘poorly enforced’ restrictions have led to unregulated use among young people and lost revenue for retailers and the Government.
 
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e-cigarettes nicotine vaping products smoking cessation vaping young people

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