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[updated 4 Sep 2025]

In the June 2024 Senate vote on the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024, the Greens party introduced a significant amendment which required that, instead of vapes being obtained only via a doctor’s prescription (the Government’s intention), they would be instead scheduled S3 (ie over-the-counter, non-prescription sales with advice on use from a pharmacist to customers aged 18 and over). Vapes available this way would have nicotine concentrations with a maximum of 20mg/mL.

The Labor government accepted the amendment, allowing the amended Bill to pass through the Senate vote and onto its subsequent passage through the House of Representatives into law on June 27. To have rejected the amendment would have likely seen the entire Bill sunk. So the government understandingly accepted the compromise which will be implemented in less than a month from  Oct 1, 2024.

In the few weeks remaining, those wanting to buy vapes from a pharmacy (now the only legal source for vapes), will still be required to get a doctor’s prescription and have this dispensed at a pharmacy.

But what seems to have flown way under the public awareness radar here is that these changes do not mean that after Oct 1, there will be no longer be the need for anyone to get a prescription for vapes. Anyone wanting a nicotine vape with more than the 20mg/mL will still be able to access these from a pharmacy, but only with a prescription.

This is all set out in the TGA’s Requirements for unapproved therapeutic vapes for smoking cessation and the management of nicotine dependence Guidance on the Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) where a maximum concentration of 100mg/mL is currently specified.

[update: The TGA revised the upper limit for prescription-required vapes to 50mg/mL from July 2025]

So importantly, prescription access is far from dead in Australia. The intriguing question here is whether the Greens knew this all along.  Or did their inexperience blindside them to the detail of the TGA’s regulations, with their amendment unwittingly preserving  prescription access for the higher nicotine concentrations that exasperated vaping advocates have insisted are essential in minimising vapers’ abandoning vaping and resuming smoking?

Two critical concerns about low nicotine delivery devices

The preservation of prescribed access to higher nicotine concentration vapes is a very important part of Australia’s new vaping laws. Here’s why.

First, there is a huge body of evidence that low yielding nicotine delivery devices (nicotine replacement therapy) have been abandoned by millions of smokers across over 30 years as unsatisfying, and so have very poor success rates under real world conditions of use, with smoking typically being resumed (my 2022 open access Sydney University Press book Quit Smoking Weapons of  Mass Distraction documents this in detail)

The same concerns may exist about low-nicotine concentration vapes. If this is the case, then clearly low nicotine vapes will be hamstrung in their utility in assisting hardened  smokers to remain off cigarettes.

Second, when nicotine-dependent smokers use so-called low nicotine delivery cigarettes, many change the way they smoke to try and get more nicotine to their brains to satisfy subtle craving cues. As we will see below, this causes increased exposure to other toxic components of cigarette smoke or vaping aerosol, as the case may be. This collateral toxicity is a serious argument for allowing heavy smokers prescription controlled access to higher nicotine concentrated vapes.

Here’s how these problems happen.

The way smokers inhale has long been studied by researchers inside and outside the tobacco industry. This research shows that smokers “titrate” or adjust the way they smoke to obtain a dose of nicotine that their brain signals to them that they need.

It is fundamental to the understanding of both smoking and vaping behaviour that those with nicotine dependence change their puff parameters (puff frequency, puff volume, between-puff intervals) to obtain the nicotine dose that satisfies or quells their cravings.

This evidence was at the heart of the 2005 action by the Australian Competition and Consumer Commission (ACCC) to ban the use of ‘light’, ‘mild’ and similar descriptors because the terms falsely implied that smoking machine-measured nicotine yields were a reasonable guide to the nicotine actually inhaled by smokers using these products.  Smokers thought they were getting “lighter” exposure to nasties when they bought products thus labelled. However these products changed the way they smoked to obtain more nicotine. “Lights” were nothing but a deceptive commercial practice which saw the tobacco industry pinged for millions of dollars in corrective advertising and the terms outlawed.

Many studies show that a majority of people who vape, continue to smoke (dual users) – often for years (see chapter 5 of my 2022 book). Some of these are people who have no interest in quitting smoking. However many dual users do want to stop smoking but find that vapes alone do not satisfy their nicotine craving and supplement their vaping by also smoking. This is harm increasing, not harm reducing.

NRT nicotine limits produce dismal cessation rates

For decades, it has been widely acknowledged that nicotine replacement therapy’s  (NRT) dismal effectiveness in smoking cessation under conditions of real-world use is in large part due to its poor ability to successfully satisfy nicotine cravings exhibited by smokers. Even under the highly artificial conditions in which RCTs are conducted, some 95% of smokers using NRT in RCTs are smoking at post six month follow-up. Many smokers find NRT unsatisfying, with the nicotine “grunt” being a pale shadow of that inhaled from cigarettes, In this 2021 systematic review, 61% of smokers  allocated to NRT in RCTs adhered to the recommended use throughout trials, compared to only 26% in longitudinal population (real world) studies. Randomised trials see participants subjected to many influences from their research participation which enhance compliance to recommended use. But most of these influences do not exist in real world use (see chapter 2 of my 2022 book).

The research literature on NRT contains many recommendations about contemporaneous multiple modes of NRT use. This points further to the recognition that NRT in the limited very low nicotine dose of single NRT products that have been approved by governments around the world perform very poorly in cessation under conditions of real world use.

The poor performance of NRT has been summarised by pointing out that many smokers find it too low and too slow in nicotine delivery in comparison with smoking and relapse back to smoking.

With vaping, similar concerns exist.

New JAMA paper

Of great relevance here, is a research paper recently published in JAMA Network Open. The study randomised 50 current vapers in a controlled cross-over trial to complete two sessions of using the same product (JUUL or NJOY) that differed by nicotine concentration (3% [JUUL] or 2.4% [NJOY] and 5% [JUUL or NJOY]) in random order. In each session, participants vaped up to 60 minutes ad libitum, preceded by 12 hours of nicotine abstinence.

The primary outcomes measured in each session were puffing topography parameters  (total session time, cumulative puffing time, total puff number, inter-puff interval, total inhaled volume, average puff volume) and plasma nicotine levels measured before and after each session.

They found that median topography parameters were significantly higher during the vaping sessions with the lower 3% or 2.4% nicotine concentrations compared with the higher 5% nicotine concentration for three of the measured  outcomes: puffing time (1.3 minutes vs 1.2 minutes], puff duration (2.6 seconds  vs 2.4 seconds, and total inhaled vapour volume (1990.0 mL vs 1490.0 mL. The median plasma nicotine boost observed in the 5% nicotine concentration condition (0.0060 mg/L was significantly higher than that in the 3% or 2.4% vape sessions (0.0043 mg/L.

The authors concluded that “This randomized crossover clinical trial provides direct evidence that partial nicotine reduction in salt-based e-cigarettes was associated with acute compensatory puffing and the potential for increased exposure to toxicants. These results suggest that at least for current e-cigarette users, partial nicotine reduction can lead to enhanced exposure to some toxicants in the short term” as vapers change the way they vape to get a dose that satisfies their nicotine appetite.

They referenced seven studies published between 2016 and 2021 which had reported similar compensatory vaping measures, but noted that each of these had involved older generation vapes, not the nicotine salt-based products that were used in their study and which are commonly used today.

What vapers inhale besides nicotine

When vapers inhale, it is not just vapourised nicotine they pull into their lungs. The aerosol inhaled also contains vapourised excipients (substances other than the active drug – here, nicotine – used to support the process of delivering the active substance). With vapes these include synthetic favouring chemicals, none of which have ever been tested as safe for inhalation; propylene glycol (PG) and/or vegetable glycerine (VG); and minute metallic particles sloughed off from the metal heating coils found in all vapes when these metal coils are heated.

Dow Chemical is a leading manufacturer of PG.  Here’s what it has to say about breathing it in.

“Therefore breathing spray mists of these materials should be avoided … Dow does not support or recommend glycols in applications where breathing … is likely”

Likely!? This is the understatement of understatements when it comes to vaping.  With an average ~568 puffs a day by daily vapers, that’s 568 point-blank deep lungfuls of vapourised PG – not just nicotine – that vapers are getting – a rather different exposure to the fleeting exposure to theatrical fog (also PG) that most of us have experienced occasionally when watching drama in a theatre.

This study notes that “in experimental animal studies, unheated PG or VG have minimal lung toxicity. However, when delivered from e-cigs, there are measurable increases in lung inflammatory infiltrates, cytokines, infections, reactive oxygen species, and gene expression.”

Lowering maximum nicotine concentration in e-liquids to 20 mg/mL in base form (or base equivalent), allowed Australia to align with the limits in the EU, UK and Canada.

But here, it is critically important to note that, unlike Australia, the EU, EK and Canada do not yet have a pharmacy and prescription-access only vaping access policy like Australia’s. These nations have set the 20 mg/mL nicotine limit to try and reduce the likelihood of nicotine naïve children becoming addicted when they obtain vapes under “consumer access” models of regulation favoured by the vaping industry and all tobacco companies now also selling vapes.

Australia’s 20mg/mL limit is not being set for the prevention of regular use by children (who will rarely be prescribed vapes) but for nicotine-addicted smokers using vapes to try to quit.

Had the TGA made no provision for higher nicotine concentration vape to be prescribed by doctors, it would have been highly probable that, as has long occurred with NRT, many heavily nicotine addicted users will similarly quickly desist from using prescribed vapes after finding that their cravings persist. This is obviously not the outcome being sought via prescription access to vapes for those who are already nicotine addicted.

Those pharmacy chains which have argued that they would have been happy to supply vapes only by prescription may well be happy with the realisation that they can still dispense vapes. The Royal Australian  College of GPs and the AMA which were both highly supportive of the original prescription-only policy, are likely to advise their thousands of members that the prescription route still exists for those smokers with entrenched nicotine addiction.

Pharmacists who are obligated by S3 regulations to discuss the vapes they are dispensing with purchasers, are in the perfect position to inform relevant more nicotine addicted customers about seeking a prescription from a doctor.

[added 5 Sep 2024] Here is a list of vapes (including vaping substances, vaping accessories and vaping devices) that sponsors have provided to the TGA stating that the vapes comply with applicable standards for supply in Australia for smoking cessation or the management of nicotine dependence. The listed vapes have not been assessed by the TGA for quality, safety and efficacy or performance. As of 5 Sep 2024 there are 1,472 notified products, many of which have nicotine concentrations between >20mg/mL and 100mg/mL.