Australia’s vaping train wreck: The Butler Plan to fix it and the devil in the detail

This post was written by Neil Francey, Research Affiliate, Sydney Health Law

Australia’s Vaping Train Wreck

Commonwealth Health Minister, Mark Butler MP, has announced that the Albanese Government is taking strong action to reduce smoking and stamp out vaping – particularly among young Australians – through stronger legislation, enforcement, education and support.

This follows public consultation over December 2022 – January 2023 led by the Therapeutic Goods Administration (TGA) seeking comment on potential reforms to the regulation of nicotine vaping products in Australia. The consultation resulted in 3896 published responses, doubtless reflecting concern over the parlous state of vaping in Australia, especially amongst youth.

Speaking at the National Press Club on 2 May 2023, Minister Butler said: “Vaping was sold to governments and communities around the world as a therapeutic product to help long-term smokers quit,” “It was not sold as a recreational product — especially not one for our kids. But that is what it has become: the biggest loophole in Australian history.”

A 2022 study of vaping product access and use among 14-17-year-olds in New South Wales found almost one-third of the sample reported being an ever-vaper, of which more than half had never smoked prior to starting vaping.   Also, more than half of ever-vapers had used a vape that they knew contained nicotine and more than half of ever-vapers reported getting the last vape they used from their friends.

Several authorities have highlighted that e-cigarette batteries are liable to explode, and produce aerosol containing hundreds of chemicals, many of which are toxic with risks including addiction, poisoning, seizures, burns and lung damage.

Currently, although nicotine e-cigarettes are unapproved medicines in Australia, pathways exist for consumers to lawfully access them via prescription.  In 2021, the Therapeutic Goods Administration (TGA) released a federal standard (the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 (TGO 110)) that applies to nicotine vaping products only and provides that they may be obtained only on prescription from an Australian medical practitioner. TGO 110 also requires child-resistant packaging, includes labelling requirements, a prohibition on certain additives, and a maximum concentration for nicotine in base or salt form of 100mg/mL.

In the 2021 process leading to TGO 110 coming into effect, the TGA invited submissions on a draft to which the ACCC sent a submission by way of a letter to the TGA dated 29 March 2021. In that letter the ACCC recommended expanding the scope of the draft TGO 110 to include all personal vaporiser products, not just those containing nicotine.  However, this recommendation was not accepted and TGO 110 in its final form bolstered an artificial divide between nicotine and non-nicotine e-cigarettes, thereby creating an enormous enforcement loophole.

Had the ACCC  engaged in a collaborative approach with the TGA in the regulation of e-cigarettes at that time, the vaping catastrophe we are now facing largely may have been avoided.

Unfortunately, and contrary to its obligation to enforce the Australian Consumer Law, the ACCC persists with its 2021 view that “… vaporiser products require ‘a tailored regulatory approach … best managed by the Department of Health and Aged Care under the Therapeutic Goods Administration regime’”.

The Butler Plan and the Devil in the Detail

Minister Butler’s Plan is to make the medical access model work and to get rid of all the vaping products that are not part of that pathway.

The Butler Plan provides for minimum quality standards for vapes comprising the following elements:

• Restricting flavours, colours and other ingredients.
• Requiring pharmaceutical-like packaging.
• Allowed nicotine concentrations and volumes will be reduced.

Also, disposable, single use, vapes will be prohibited.

Critically, the Plan depends on import restrictions being imposed on vapes not complying with such criteria.

For the moment, the proposal has the cautious support of Opposition Leader Peter Dutton but he has said he wants to see more detail.

Also, it would only take opposition to legislative changes, or a change of government at the state or federal level for things to start to unravel, and already Victorian Premier Daniel Andrews is reported as expressing some reservations about the federal government pushing the costs of enforcement on to the states.

Doubtless the Government will move quickly to amend customs regulations to prohibit everything except prescribed products coming to pharmacy wholesalers, but these could be disallowed or, worse, manufacturers may come onshore as occurred with making cigarettes.

Removing the red tape that stops a lot of doctors prescribing should be easy to do, as will amending the Therapeutic Goods (Standard for Nicotine Vaping Products) Order (TGO 110) to include a fuller list of prohibited constituents, and to allow prescription only of products with pharmaceutical-style design and packaging.

This will make branded vaping products highly visible and – with nicotine status now irrelevant – presumably make it easier to confiscate non-compliant products and easier to take action against vendors. Again, this is good as far as it goes but it depends on supply of “counterfeit nicotine vaping products“ being enforced.

The States and Territories have evidently agreed to amend each of the pieces of state tobacco control legislation to make it an offence to sell any vaping products apart from those prescribed and sold through pharmacies but at present there is no coherence in legislation and this will be a sizable task needing to be addressed in a form binding on the states and territories.

Likewise, the Commonwealth, States and Territories will need to work out how they’re going to fund enforcement.  It seems doing so through licence fees on retailers is undesirable for e-cigarettes and vaping components will only be lawfully available through pharmacies.

And enforcement will need to be comprehensive, co-ordinated and co-operative. For example, many claims made about vapes sold as not containing nicotine contravene the Australian Consumer Law which, as is made clear above, is primarily the responsibility of the ACCC.

Education campaigns have proved successful with tobacco and, adapted to vaping in the new regulatory setting, should also be effective.

Similarly, quit counselling may have a role with vaping as a means to stop smoking although this has been questioned.

Focussed quit counselling services directed at vaping is a good idea given the stated objective of e-cigarettes only being available to wean smokers off cigarettes with the ultimate goal of ridding them of nicotine addiction.

Fixing Australia’s Regulation of Vaping

At present there is no coherence in legislation and no co-ordinated co-operative enforcement approach to effectively address the problem of spiralling nicotine addiction due to e-cigarettes.

Also, TGO 110 doesn’t regulate constituents of non-nicotine vaping products or the safety of e-cigarette heating elements of either nicotine or non-nicotine e-cigarette products; and, non-nicotine e-cigarettes are not specifically covered by any national regulation.  This creates an overwhelming enforcement problem for the states.

There are several pieces of legislation and twenty relevant regulatory bodies in Australia which are relevant to the regulation of e-cigarettes:

Legislative provisions

• The Therapeutic Goods Act and state/territory Drugs and Poisons legislation
• The Australian Consumer Law
• The Customs Act
• TGA special access arrangements and Medicare provisions
• State/Territory tobacco/vaping control legislation which covers and provides for the enforcement of restrictions on retail sales.

Regulatory bodies

• Commonwealth Department of Health and Ageing
• TGA
• State/Territory Health Departments
• ACCC + State & Territory consumer affairs/fair trading bodies
• Australian Border Force/Home Affairs

Short of a complete ban on the supply of e-cigarettes outside the TGA pathway, for example as unsafe products under the Australian Consumer Law, implementation of the Butler Plan  should provide for:

• an Australian Vaping Control Law to ensure clear and consistent regulation of e-cigarettes and other vaping products,
• an  Intergovernmental Agreement on the Australian Vaping Control Law to oblige the Commonwealth and all the States and Territories to provide specifically for the clear and consistent regulation of e-cigarettes and other vaping products, and finally
• a Participation Agreement for the Co-operative Enforcement of Laws Relating to Vaping in Australia (that is: the proposed Australian Vaping Control Law, the Australian Consumer Law and relevant Customs Regulations). 

The Participation Agreement would provide for the creation of an Australian E-cigarettes Commissioner supported by an Office of the Australian E-cigarettes Commissioner to co-ordinate co-operative enforcement by relevant regulatory bodies.

All elements of this proposal are modelled on successful precedents in national regulatory bodies as set out below.  So, to achieve Minister Butler’s overall goal, all these measures should be considered to ensure that sale of nicotine vaping products is restricted to those under medical care who are trying to quit smoking.

A Proposed Way to Implement the Butler Plan

Australian Vaping Control Law

After the Trade Practices Act 1974 (Cth) was passed, over time, each of the States and Territories enacted legislation largely mirroring the key consumer protection provisions: for example, Fair Trading Act 1985 (Vic).

This developed into the Australian Consumer Law, enacted as Schedule 2 to the Competition and Consumer Act 2010 (Cth) under a legislative scheme with each State and Territory enacting legislation adopting the ACL as State and Territory law for example, Australian Consumer Law and Fair Trading Act 2012 (Vic) – so, effectively, there is national consumer protection legislation.

All of this is the subject of an Intergovernmental Agreement for the Australian Consumer Law providing for a multiple‐regulator framework overseen by all State and Territory ministers responsible for consumer affairs through the Consumer Affairs Forum (CAF).

By comparison, nicotine e-cigarettes are currently controlled through State and Territory jurisdictional Poisons Acts.  The federal Poisons Standard (made under Part 6-3 of the Therapeutic Goods Act 1989 (Cth) classifies poisons, including nicotine, into 10 schedules.  The Standard functions as a recommendation only to the States and Territories leaving them to implement these scheduling decisions through State/Territory laws.

Implementation and enforcement of the Poisons Standard is the responsibility of each State and Territory government. And, State and Territory governments can choose to vary their own legislation to classify substances differently to the Poisons Standard, although they do classify the majority of substances in accordance with the Poisons Standard.

However, the Poisons Acts of the States should be much clearer and much more consistent than they currently are, at least in implementing a uniform national approach to nicotine control. 

That is, much clearer legislative provisions are needed for control of nicotine, especially vaping products, and they should be uniform.  This could be achieved in the same manner as how the ACL came into existence:

• A Health Ministers’ Meeting (HMM) could resolve to have the Commonwealth enact an Australian Vaping Control Law setting out clear and consistent legislative provisions for e-cigarettes and other vaping products.
• States and Territories would then enact uniformly consistent Acts adopting the AECL.
• Separately, the  Minister for Home Affairs (MHA) could tighten customs regulations regarding the importation of e-cigarettes and other vaping products.

This could be achieved by States referring power to the Commonwealth under s 51 (xxxvii) which would be easier to achieve with Labor in power at the Commonwealth level and in all mainland States:

(xxxvii.)  Matters referred to the Parliament of the Commonwealth by the Parliament or Parliaments of any State or States, but so that the law shall extend only to States by whose Parliaments the matter is referred, or which afterwards adopt the law.

The ban on disposable, single use vapes presumably could be based on the Commonwealth’s power on environmental grounds under international treaties.

Intergovernmental Agreement on the Australian Vaping Control Law

Such an Agreement, signed on behalf of the Commonwealth, States and Territories prior to the commencement of the Australian Vaping Control Law, would be similar to the Intergovernmental Agreement for the Australian Consumer Law.

However, the Agreement would be administered jointly by the TGA, Commonwealth, State & Territory Health Departments/Agencies and, separately, the Department of Home Affairs’ relevant customs body: Australian Border Force.

Participation Agreement for the Co-operative Enforcement of Laws Relating to Vaping in Australia

Whilst the proposed Vaping Control Law would deal specifically with the control of e-cigarettes and other vaping products, the Australian Consumer Law already has a role to play and the ACCC has already taken some enforcement action over the supply of e-cigarettes. Examples include: The Joystick Company Pty Ltd (Joystick); Social-Lites Pty Ltd (Social-Lites); Elusion Australia Limited (in liquidation) (Elusion).

There may be merit in maintaining a residual role for the ACCC since other possible ACL contraventions, outside the scope of the TGA, have been identified: “Contraventions of the Australian Consumer Law in the promotion of E-cigarettes” Sydney Health Law blog 2023; and the current lack of co-operation in enforcement has been demonstrated above.

This also anticipates the likelihood that vape manufacture is brought onshore thereby circumventing import restrictions.

The Vaping Control Law Participation Agreement, entered into between the ministers represented on the Health Ministers’ Meeting, the Consumer Affairs Forum, and the relevant Minister for Home Affairs, would provide for the appointment of an Australian E-cigarettes Commissioner supported by an Office of the Australian E-cigarettes Commissioner to co-ordinate a co-operative enforcement approach by relevant regulatory bodies.

A Participation Agreement of this kind operated successfully in relation to the uniform national regulation of the financial viability of travel agents in Australia for sixteen years from 1986 to 2014.

Australian E-cigarettes Commissioner

Once a clear and consistent national legislative approach for vaping control  is achieved, an E-cigarettes Commissioner could then play a coordinating role in the enforcement of all relevant legislative provisions by all relevant regulatory bodies: Australian Border Force (Customs), Australian Federal Police, and health and consumer affairs agencies of the Commonwealth, States and Territories (including the TGA and ACCC), all under the Vaping Control Co-operative Law Enforcement Participation Agreement.

This would require joint action by the Health Ministers’ Meeting, the Consumer Affairs Forum and by the relevant Minister for Home Affairs.

Office of the Australian E-cigarettes Commissioner

The E-cigarettes Commissioner would be a person with specialist knowledge in at least one of the fields of Health or Consumer Affairs, and with a working knowledge of any non-specialist area plus the area of Home Affairs.

The Assistant Commissioners would be:

• Health Departments: Commonwealth Health Department Secretary or nominee
• ACCC: Chair or nominee
• Home Affairs (Australian Border Force): Secretary of the Department of Home Affairs or nominee.

The E-cigarettes Commissioner would meet periodically (say, monthly) with one or more of the Assistant Commissioners to ensure a co-operative enforcement approach is being followed by relevant regulatory bodies and report (say, quarterly) to the Health Ministers’ Meeting, Consumer Affairs Forum, and the relevant Minister for Home Affairs.

The Commissioner would be given an initial three year term at which time, if real progress was being made, the term could be extended (or another person appointed) and the Office extended or the Office could be disbanded.