Image by Kjerstin Michaela Noomi Sakura Gihle Martinsen Haraldsen from Pixabay

Australia will soon fully implement its new vaping regulations. The twin pillars of these are :

(1) that nicotine vaping products will only be legally available to those with a doctor’s prescription. As prescribed substances can only be sold by registered pharmacists, all other retailing will be illegal. Flavoured, disposable vapes will be banned. The Therapeutic Goods Administration and state and territory governments are empowered to penalise anyone unauthorised who sells or advertises vapes. Very recently, the Federal Court ordered a vaping company to pay a penalty of $4.9 million plus the legal costs of the Commonwealth for advertising vapes. Such penalties are likely to have a major deterrent effect on illegal retailing.

(2) vapes (both with nicotine and without) will be illegal to manufacture or import into Australia unless these products are intended for sale to pharmacists who will dispense them to those with prescriptions. Seizures weighing 32 tonnes and valued at $11 million have recently been made as police and customs surveillance increases.

The TGA recently invited responses to its proposed regulations. Below is my brief submission. It recommends three amendments that I believe would sharpen the Government’s regulatory intent.

Responses to Proposed Reforms to the Regulation of Vapes

Thank you for the opportunity to respond to the proposed reforms to the regulation of vapes. Overall, the proposed reforms are quite outstanding. They are likely to attract international attention as a template for international Nicotine Vaping Products (NVP) regulation. I am in strong support of all proposals with the exception of those set out below.

Tank systems

On page 6, the document specifies that refillable tank systems are included in the definition of permitted vapes.

This is concerning as it will circumvent the regulatory intent to greatly limit the use of flavours in prescription-accessible vaping products. While only two permissible flavours are prescribed (tobacco and mint), many tank system users will undoubtedly add flavours not intended for vaping (aromatics, essential oils etc) to their tanks. It will be impossible to regulate the availability of such flavours as they are widely used in cooking, air freshening and perfumery.  Vaping chat rooms have long had extensive discussions about flavouring ingredients which participants have been using. This may well greatly accelerate with the proscriptions on all but two flavours.

The document also states early that:

“Vaping devices are currently excluded from regulation under the TG Act unless they are intended exclusively for the vaporisation and administration by inhalation of a medicine. It is proposed that the exclusion is revisited in the context of these reforms to ensure that proper controls and oversight are applied to device components of vapes moving forward.”

This looks like the door could be closed on legal sale of mods and tanks, with all that goes along with user adjustable coil temperature settings and adding non prescribed liquid flavours.

The exclusion of tank systems seems ripe to foment a whole new rise in tank use and the commerce that supports it. I would urge the TGA  to revisit the exclusion of vaping devices from the TG Act and advise the government that only closed pod system NVPs should be legal in Australia and that for ex-prescription sales of mod and tank vaping devices to remain legal would threaten the integrity of the proposed NVP regulations.

Collateral uses of vaping devices

An outstanding concern here is also that mod/tank vaping apparatus can be used to vapourise other drugs which according to this San Diego drug treatment centre can include cannabis. LSD, GHB (gamma hydroxybutyrate) and ketamine.  This is far from rare. A 2022 Kings College London survey found that 14.7% of people aged 18+ in the UK had ever vaped a non-nicotine drug, with nearly 1 in 56 (1.8%) currently doing it. In 2019, 3.9% of 19-24 Americans (1 in 26) had vaped cannabis in the last 30 days. I’ve found no data on other drug vaping by under 18s, which of course does not mean it is not happening.

As of February 18, 2020 a total of 2,807  people had been hospitalised in the USA for vaping product use-associated lung injury (EVALI). 68 people died. Of these:

• 82% reported using THC-containing products; 33% reported exclusive use of THC-containing products.
• 57% reported using nicotine-containing products; 14% reported exclusive use of nicotine-containing products.

No data appear to be available on the incidence of health incidents following vaping other drugs, but  the World Drug Survey included questions on it in a recent survey..

Mod/tank systems were invented and marketed to facilitate nicotine vaping. But like a Trojan horse, they have also enabled widespread vaping of non-nicotine drugs which have killed and seriously harmed thousands in the US alone.

Collateral damage (negative externalities) from intended use is routinely considered in all formal risk assessments in health and community safety.  For example, gun control policy considers gun misuse, not just approved uses in hunting and target shooting; DDT was widely used in Australia in agriculture and termite control where it was extremely effective, but banned in 1987 because of its collateral residual health risks to humans.  

There are many mods and tanks now in the community. If the Act disallows nicotine e-juice intended to be decanted into tanks, these mods and tanks will sit in drawers as useless without the legal availability of nicotine e-juice essential to nicotine vaping.  I strongly urge you to reconsider allowing prescription supply of nicotine e-juice for tanks and also to prohibit the sale of mods and tanks vaping apparatus for the reasons I have outlined.

Section 3.1 Mint and tobacco flavours

Comment: No inhalable therapeutic goods contain flavouring chemicals for the very important reason that it is inadvisable to inhale chemical agents which have not been thoroughly assessed as being generally regarded as safe (GRAS) for inhalation. Asthma inhalants like salbutamol are a perfect example of this. This is particularly important with the regulation of NVPs because daily vapers typically inhale vapes some 500 times daily. The long term health consequences of this remain unknown.

I therefore strongly agree with the critical importance of strictly limiting the range of flavours in prescription accessible NVPs. I also accept that it is important that the taste of NVPs should not be so unpleasant and unpalatable to those using them for smoking cessation so as to cause many intending NVP users to rapidly abandon them.

As far as I am aware, there are no GRAS data available for the proposed mint flavour when being inhaled.  However, in the trade-off between this concern about possible long term consequences of  deeply inhaling vapourised mint some 500 times a day by daily vapers, and the concern to make NVPs not taste or smell repulsive, I believe allowing mint flavour would be a reasonable compromise.

However, I do not support the proposal to allow a flavour named “tobacco” flavour. If it is proposed that there be a specific,  standard, fully prescribed (defined)  flavour known as “tobacco” this will presumably taste and smell like the taste and smell of tobacco. This is likely to strongly remind smokers who are vaping of the taste and smell of the tobacco they had been (and for dual users) still are smoking. If we reasonably assume that for many smokers this smell and taste will evoke strong positive associations, then the availability of a tobacco vape flavour may act as “pull” factor back toward smoking which would not be sensible.

It would be far preferable to permit a flavour with an anodyne name that neither denoted or connoted any appealing associations. Examples of such names might include “standard”, “classic”, “basic” or “regular”.  Here is an example of advertising for Nicorette NRT gum using “classic”. I do not believe any NRT products are flavoured with “tobacco”.

The flavour and smell sensations delivered by such anodyne descriptors would be such that users would not instantly associate the taste or flavour with any fruit, confectionary, beverage or food. Taste panels could be used to rate taste acceptability and to ensure that candidate flavours did not evoke any proscribed associated tastes or smells.

Section 3.1.3 Lowering maximum nicotine concentration in e-liquids to 20 mg/mL in base form (or base equivalent), to align with the limits in the EU, UK and Canada.

It is critically important to note that, unlike Australia, the EU, EK and Canada do not yet have a prescription-access only NVP policy like Australia. They have set the 20 mg/mL nicotine limit to try and reduce the likelihood of nicotine naïve children becoming addicted.

Australia’s limit is not being set for prevention of regular use by children (who will rarely be prescribed NVPs) but for already addicted smokers trying to quit. This is a very important difference against which the wisdom of reducing the current limit of 100 mg/mL to 20 mg/mL needs to be considered. I believe such a large reduction is misguided.

Medicinal cannabis which has been legally prescribable in Australia for several years is not seeing diversion from prescription access to those without prescriptions. This would seem relevant to concerns about limiting prescription vapes to 20mg/mL. If there is indeed concern that major diversion might occur and therefore a  low limit justified for safety reasons, the unlikelihood of diversion occurring is a strong counterpoint to this.

NRT nicotine limits produce dismal cessation rates

For decades, it has been widely acknowledged that nicotine replacement therapy’s 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 developed 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 months follow-up. 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.

The research literature on NRT contains many recommendations about contemporaneous multiple modes of NRT use and lifetime use. This points further to recognition that NRT in the limited very low nicotine doses that have been approved performs very poorly in cessation under conditions of real world use.

It is fundamental to the understanding of 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 their cravings.  When there is a low maximum nicotine level in a vape, more dependent users will typically puff more and in larger volumes to reduce their cravings. If the nicotine level was higher, across a 24 hour period they would take less puffs from a higher yielding vape than from a much lower yielding one.

The growing research literature on airways inflammation is too immature to be certain about which components of vape emissions are likely to be of most concern. But it seems very unlikely that the normal dose-response relationship would be somehow different with vaping than it is for any other cause of lung damage, including smoking. The higher the exposure, the more likely the risk. A higher puff frequency and volume when using a low nicotine vape means users will be exposing their lungs to higher doses of excipients (propylene glycol/vegetable glycerine)  than they would if they were using a higher nicotine yielding vape.

This study notes that “in experimental animal studies, unheated PG or VG have minimal lung toxicity (14). However, when delivered from e-cigs, there are measurable increases in lung inflammatory infiltrates, cytokines, infections, reactive oxygen species, and gene expression (9, 15, 16).

By maximisng NVP nicotine concentration  at 20 mg/mL, it is 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 remain. This is obviously not the outcome being sought via prescription access to NVPs for those who are already nicotine addicted.

I would recommend a compromise here by lowering the maximum limit by half from 100 mg/mL to 50 mg/mL.

Competing interests

In July 2023 I was engaged as a temporary advisor by the World Health Organisation for a three day meeting on NVPs held in Geneva.