Public consultation on planned reforms to Australia’s vaping laws has further polarised positions on how to handle the habit.
Despite e-cigarettes being classified as a prescribed medication under the Poisons Standard on 1 October 2021, the TGA stated that emerging evidence suggests that these measures have not prevented children and adolescents from accessing nicotine vaping products (NVPs) and many adults are accessing them on the black market, rather than lawfully with a prescription from an Australian registered doctor.
While the AMA and the Heart Foundation have called for tighter restrictions to be implemented to address the concerningly high uptake of NVPs by young people, proponents have pointed out the benefits of using vaporisers as an effective tool to quit smoking.
The debate has gained renewed attention in the media recently thanks to a submission made by the Australian Association of Convenience Stores (AACS) on 13 January 2023, which called for NVPs to be treated in the same way as tobacco products and alcohol.
CEO Theo Foukkare said that an analysis commissioned by AACS and conducted by Roy Morgan Research and Convenience Measures Australia (CMA) in 2022, showed that the current model has regrettably resulted in the growth of a black market which targets children and bypasses any proper safety and ingredient regulations.
“We have an out-of-control black market – the government has lost control,” Mr Foukkare said, speaking with 6PR on 17 January 2023.
“We have 1.2 million adults in Australia, as confirmed by Roy Morgan, that are vaping nicotine products regularly, and with the current prescription model, of those 1.2 million, only 10% are actually going to a doctor, getting the script, and then going to a pharmacy.
“The rest of them are buying them on the black market through dodgy retailers, through social media, and in the schoolyard.
“Now our position is clear: we do not want any kids vaping, smoking, or doing anything that is bad for them – we are very supportive of that. What we need is a clear, tightly regulated consumer model like we have with traditional cigarettes that are sold by responsible retailers.”
NVPs are currently regulated through a combination of Commonwealth and State and Territory laws and can only be lawfully supplied by pharmacies in Australia.
It is illegal for other Australian retailers (such as tobacconists, ‘vape’ shops and convenience stores) to sell NVPs to consumers, even where the consumer has a valid doctor’s prescription, which can be accessed with a prescription using three established access pathways for unapproved medicines:
- Personal Importation Scheme: This scheme allows a person with a prescription from an Australian medical practitioner to directly import up to 3 months’ supply of NVPs per order for their own personal use, or the use of immediate family members who have a prescription.
- Authorised Prescriber Scheme (AP scheme): Under this scheme, a medical practitioner can apply to the TGA for approval to supply NVPs to their patients as an aid to stop smoking.
- Special Access Scheme B (SAS B): Under this scheme, a medical practitioner can apply to the TGA to supply NVPs to a single patient on a case-by-case basis.
The legislation permits the importation (by commercial suppliers or pharmacists) of NVPs for supply under the AP and SAS schemes in advance of an AP or SAS approval being granted, provided the importer believes the NVPs will be supplied to the end consumer under one of these schemes.
Retail supply is not regulated by the Therapeutic Goods Act and as there are currently no TGA-approved NVPs, the lack of import controls has been highlighted as a disincentive to companies obtaining the necessary evidence and applying to register an NVP on the Australian Register of Therapeutic Goods (ARTG).
“The current prescription-only model requires consumers to have a prescription for all purchases of nicotine vaping products, requiring a GP visit, and restricting sales to pharmacies or overseas retailers,” Mr Foukkare said.
“Many doctors do not understand how to prescribe, and many pharmacies do not supply vapes. These hurdles in obtaining vapes, particularly for people who want to quit smoking, have led to the emergence of a large-scale black market.”
The AACS’s research suggested that 88% of NVPs were being purchased through the black market and 12% only of NVP consumers were using the prescription model as intended.
“We believe there are close to 100 million nicotine vapes that are being imported into Australia and there is absolutely no regulation on what is in them, how they are packaged or who sells them, which we just think is madness.”
In its submission to the TGA’s consultation the AMA said it had repeatedly advocated for regulations to be changed to limit access to NVPs by banning the personal importation of NVPs and supported minimum safety and quality standards, pre-market assessment of NVPs, as well as registration on the ARTG.
“The Personal Importation Scheme bypasses many of the product standards outlined in regulations, such as labelling, packaging, and record-keeping requirements and it is incredibly challenging to enforce,” Professor Robson said.
“Patients with a prescription for an NVP should be able to have the confidence that they are using a product that has passed the safety, quality, and efficacy assessments of the TGA, instead of purchasing an overseas product that has not had to meet good quality and safety standards.”
While the TGA consultation focused primarily on NVPs, the AMA also advocated for introducing controls on the importation of all vaping products through customs, as well as reducing the allowed concentration of nicotine from 100mg/ml to just 20mg/ml.
“This would begin to address the public health challenge of tackling both non-nicotine vapes and nicotine products. Nicotine and non-nicotine vaping products are regulated differently which complicates and hinders progress on this issue,” Professor Robson said.
“Vaping is not harmless, it is not safe, it is not part of tobacco control. Vaping products are a gateway to smoking for young people and there are significant risks from vaping that warrant much stronger regulation.
“For example, we know many products marketed as not containing nicotine have been found to contain nicotine and products have also been found to contain prohibited chemicals that can cause serious harm, like vitamin E acetate and diacetyl, which can cause serious damage to the lungs.”
Similarly, the Heart Foundation’s submission advocated for the introduction of controls of all vaping products (both NVPs and non-nicotine products and devices) through an amendment of the Customs (Prohibited Imports) Regulations 1956, by declaring all products are included as prohibited imports.
While the Foundation fully backs establishing a regulated source of quality NVPs, by classifying them as therapeutic goods and requiring them to be registered on the ARTG, it would prefer that no changes were made to the current system if enforcing that scheme poses a threat to the current prescription pathway.
Professor Robson said the AMA also wanted improved regulation to curb the proliferation of recreational non-nicotine vaping products, including implementing similar regulation to tobacco products, such as health warnings, better labelling, plain packaging, and tobacco licences.
However, Mr Foukkare noted that the AACS was also in full support of effectively regulating product standards and maximum nicotine content, as well as eliminating the wide range of flavours that have been so appealing to children.
“We are talking about packaging requirements, health warning labels – everything that the health advocates are saying needs to happen – we are on the same page. The only difference is if the government doubles down on this prescription model, that they have already openly said has failed, we are going to continue to fail,” Mr Foukkare said.
“What we need is responsible retailers take control, as has happened in NZ, the UK, in Europe and in Canada – and that is how we have treated cigarettes and alcohol for decades.
“I am not a health advocate, I represent retailers, but I only need to look at what those other countries have done, and where the government health departments have implemented vaping as a stop smoking message – now they have the lowest smoking rates on record, and they are continuing to decline.
“We need to see that happen in Australia. “
And whilst Mr Foukkare was quick to admit that AACS members would profit from their proposal, regulating NVPs as an adult consumer good in Australia would mean the generation of at least $300 million per year or $1.2 billion over forward estimates for the Australian Government to use to fund tobacco and NVP control programs.