This year, the Australian government will progressively ban the retail sale of all e-cigarettes, known as vapes. Vapers will only be allowed to use nicotine vapes that comply with Therapeutic Goods Administration (TGA) product requirements – and only to help them quit or manage their nicotine dependence, if prescribed by a doctor and dispensed by a pharmacy.

This will be accompanied by increased funding for law enforcement to prevent illegal importation of vapes, a public education campaign about the risks of vaping, and greater efforts to encourage smokers to only obtain their vapes on prescription.

But for the scheme to be successful, three things need to happen: vaping products that vapers will use need to be available, GPs need to be willing to write prescriptions, and pharmacies need to be able to meet the demand. None of these are guaranteed.

Failure to do so could see some people continue to use the illicit market for vapes, or to switch to traditional cigarettes.

The previous vape policy failed

The new policy tightens the enforcement of a retail sales ban on vapes containing nicotine first introduced in 2011. This only allowed smokers to use nicotine vapes if they had been approved for smoking cessation (quitting) by the TGA and were prescribed by a doctor to help them quit smoking.

The TGA’s expectation was that nicotine vapes would eventually be produced that would be approved for prescription. When no vapes had been approved by 2021, the TGA reclassified nicotine to allow doctors to prescribe unapproved nicotine vapes.

But these policies didn’t meet their objectives. Fewer than 10% of vapers obtained a prescription.

The TGA’s impact assessment of the 2021 policy shows it failed to prevent vaping among Australian youth or give smokers legal access to vapes. This was in large part because vape retailers illegally sold nicotine vapes as nicotine-free products (which were not banned) and sold colourful, flavoured disposable vapes that appealed to young people.

By the end of 2023, an estimated 1.3 million Australian adults were using vapes containing nicotine. The largest uptake was among young adults aged 18 to 24 and there was a worrying uptake among young people aged 14 to 17. More than 90% of vapes were obtained illegally from retail vape stores and via internet sales.

What are the new rules, and what are their aims?

From January 1, the importation of disposable vapes is banned.

From March, there will be a complete ban on the import of non-therapeutic vape products. Importers of therapeutic vapes will need a licence and permit from the government’s Office of Drug Control to import them.

The government will later set product standards that limit flavours, reduce permissible nicotine concentrations and require pharmaceutical packaging of therapeutic vapes.

The policy aims to reduce adolescent vaping by 2026 while allowing adult smokers to use vapes for quitting and managing nicotine dependence, by making them easier to access.

But there are major challenges in achieving these goals.

1. Enough therapeutic products

The TGA will need to ensure there are enough products that meet their product standards and that vapers will use.

It’s unclear how vape producers will be encouraged to notify the TGA that their device meets standards and whether vapers will be interested in using them.

However, vapes exist with specified nicotine levels that could be plain-packaged, if required.

2. Doctors will need to prescribe them

The new regulations allow any medical or nurse practitioner to prescribe nicotine vapes for smoking cessation and to manage nicotine addiction.

Given the existing low uptake of vape prescribing and strong discouragement from the Australian Medical Association and medical colleges, more medical practitioners will need to be persuaded to prescribe vapes.

GP guidelines for quitting recommend prescribing nicotine gum and patches, and vapes only if these products are unsuccessful. However, a Cochrane review of clinical trials found vapes were more effective for smoking cessation than nicotine gum and patches.

3. Pharmacies need to dispense them

There must be enough pharmacies prepared to dispense vapes. Pharmacy organisations are cautiously supportive of the new regulations but it’s unclear how many pharmacies will provide vapes. This may depend, in part, on demand for these products.

Risks of the illicit market

All of these challenges need to be met in two years. Failure to achieve these aims will sustain the illicit market for vapes.

Vapers who are unconcerned about the possibility of arrest for possessing vapes without a prescription (a criminal offence in most states) may continue to use the illicit market.

Australian Border Force officials have conceded they will not be able to prevent the illicit importation of vaping devices.

There is also a risk some vapers will switch to cigarettes which, while expensive, are readily available. Vapes are not without harm, but toxicological analyses conclude they are less harmful than conventional cigarettes.

What if the vape regulations fail?

If the vape laws aren’t successful, regulators must find another way to meet the policy’s goals of minimising youth vaping and reducing the size of the illicit vaping market.

One way would be to allow the sale of approved vapes to adult smokers under much tighter regulations than apply to cigarettes. This could mean banning disposable vapes and restricting sales of other vapes to licensed tobacconists on the condition that they will lose their licence if they sell to youth. This could be enforced by requiring the installation of CCTV in stores, as occurs in US cannabis retail outlets.

This alternative model could include many of the other regulations proposed: only allowing approved vaping devices, plain packaging, flavour restrictions and no advertising. But this model wouldn’t require a doctor’s prescription or restrict dispensing to pharmacies.

Wayne Hall, Emeritus Professor, The National Centre for Youth Substance Use Research, The University of Queensland

This article is republished from The Conversation under a Creative Commons license. Read the original article.