June 30 - July 20, 2024: Issue 630

 

Vapes reform Bill Passes: pharmacies to sell them over the counter from october 1 without a prescription

The Australian Government’s vaping reforms will become a reality from this Monday 1 July, after the passage of the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 through Parliament.


The Bill is part of a wider set of reforms being implemented by the Australian Government to prevent and reduce the use of vapes in Australia unless clinically appropriate for smoking cessation or the management of nicotine dependence.   

From 1 January 2024, the importation of all disposable vapes, irrespective of nicotine content, is banned. Disposable vapes that were lawfully imported into Australia before 1 January 2024 may continue to be supplied by tobacconists, vape shops and convenience stores if they do not contain nicotine or any other medicine and do not make therapeutic claims, subject to state or territory law. This allows tobacconists, vape shops and convenience stores to run down their stocks of imported disposable nicotine-free vapes. 

From 1 March 2024, the importation or manufacture of all vapes, irrespective of nicotine content, is banned unless those vapes are therapeutic vapes for supply in pharmacy settings. This includes cannabis vaping devices, such as 'dry-herb vaporisers', that may have been sold in other retail settings.

This means that from 1 March 2024, tobacconists, vape shops and convenience stores cannot supply vapes imported or manufactured on or after that date (irrespective of nicotine content). Vapes that do not contain nicotine, or any other medicine, and do not make therapeutic claims that were lawfully imported or manufacture prior to 1 March 2024 may continue to be supplied in non-pharmacy settings, subject to state or territory law. This allowed tobacconists, vape shops and convenience stores to run down their stocks prior to the passage of proposed amendments to the Therapeutic Goods Act 1989. The amendments prohibit the importation, domestic manufacture, supply, commercial possession and advertisement of non-therapeutic and disposable vaping goods. 

However late amendments to the bill, negotiated by the Greens, change how people will be able to access vapes in the future. For the first three months people will need a prescription from a medical practitioner to access vapes from their local pharmacy.

Then, from October 1 2024, people who wish to use a vape for therapeutic purposes will no longer require a prescription. Instead, they will be able to directly purchase a vape from a pharmacy. Vaping products will be kept behind the counter and only available for purchase with identification to show users are aged over 18.

The removal of the requirement for a prescription has disappointed health - the changes essentially have simply shifted the sale of vapes from vape shops to pharmacies.

The changes will mean disposal of used vapes will be done via pharmacies.

The Pharmacy Guild of Australia, in a press release titled 'Not Tobacconists or Garbologists' stated on June 24, the day the amendments were secured;

'A Bill is currently before Parliament to change the current medicines schedule for nicotine-containing vapes from Schedule 4 (Prescription Only) to Schedule 3 (Pharmacist Only).

The result of the proposed change is that nicotine-containing vapes could be available for purchase through a community pharmacy without the requirement for a valid prescription.'

The Guild strongly opposes this proposal.

Pharmacists are healthcare professionals who dispense medication that provides a proven therapeutic benefit. No vaping product has been approved by the Therapeutic Goods Administration based on its safety, efficacy or performance. No vaping product is listed on the Australian Register of Therapeutic Goods.

Vaping has long-term patient harms, including cancer, lung-scarring and nicotine addiction. There is limited evidence to support the use of vaping products for smoking cessation and nicotine dependence.

The Senate’s expectation that community pharmacies become vape retailers, and vape garbage collectors, is insulting. The Senate is about to make a bad decision. We urge the Senate to change course..''

Senator Jordon Steele-John, Greens spokesperson for health, stated;

“The Australian Greens are deeply concerned about increasing rates of vaping amongst children and see increasing nicotine dependence rates as a significant public health problem.

“The status quo in Australia is far from ideal. It’s unacceptable that children have access to flavoured vapes, and vaping products that have been entering Australia are unsafe, falsely labelled and have dangerous unknown ingredients.

''As a result of Greens negotiations, we have secured significant changes to the government's prescription only legislation that risked criminalising people for possessing vapes for personal use. 

“We need to ensure that disposable vapes are no longer littering our streets and waterways, and we need to reduce lithium battery fires. That’s why the Greens have pushed this government to commit to action on a vaping products amnesty and ensure there are convenient and safe disposal locations.''

The government did not intend to criminalise personal possession, but agreed to add further detail to the bill to clarify that offence provisions only apply "in a retail setting".

A statutory review of the world-first laws will be held in three years' time.

The Bill passed on Wednesday June 26. 

The Pharmacy Guild stating then:

''Legislation passed in the Senate today will see expanded access to nicotine-containing vapes, putting a new generation of young people in harm's way.

The Pharmacy Guild of Australia (the Guild) strongly opposed the amendments, which make vapes available for purchase over the counter in community pharmacies. The amendments were also opposed by the Pharmaceutical Society of Australia, TerryWhite Chemmart, Priceline, National Pharmacies, Blooms and Pharmacy 777 pharmacy groups alongside thousands of independent pharmacies.''

National Vice President of the Guild Anthony Tassone said the amendments compromise community health and do not take into consideration the safety or efficacy of vapes as a smoking cessation device.

“Pharmacists are healthcare professionals and community pharmacies do not want to supply this potentially harmful, highly addictive product without a prescription.

“Thanks to this Greens-led deal, community pharmacies across Australia are being asked to supply nicotine-containing vapes without a prescription,” Mr Tassone said.

Vaping products have not been approved by the Therapeutic Goods Administration (TGA) and no nicotine-containing vape is listed on the Australian Register of Therapeutic Goods.- the Guild stated

“Pharmacists can only supply a schedule 3 medicine if there is an established therapeutic need. When we don’t know the long-term effects of vapes on patient safety, how can a pharmacist make an informed decision?

“We are deeply disappointed that public policy has been developed in a vacuum without consultation prior to these amendments being passed,” Mr Tassone said.

'Significant questions remain about the impact the amendments will have on pharmacy insurance premiums, business risks and regulatory compliance. It is also unclear how this change will address concerns around availability of black-market vapes and organised crime. No guidance or protocol exists for pharmacies to stock unregulated substances with no established therapeutic benefit.'

Changes to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 will come into effect as early as October this year.

Vapes sold in pharmacies will be subject to quality and product standards including plain packaging, maximum nicotine concentration levels, and will continue to only be available in mint/menthol and tobacco favours.

The crystal clear message is that vaping products cannot be sold as a consumer good for recreational purposes. Instead, they are a tightly regulated therapeutic product available only under strict conditions.

The law does not criminalise individual vape users, but instead includes heavy penalties for sellers of illegal vapes. Any retailer found to be illegally selling vapes from July 1 will be heavily fined and could face jail time.

The Hon Mark Butler MP, Minister for Health and Aged Care, said in a statement;

“Recreational vaping is a scourge. It is a public health menace, particularly for children and for young people. 

“A product that was presented as a therapeutic good that would help hardened smokers kick the habit finally, has actually been deployed by Big Tobacco as a tool to recruit a new generation to nicotine addiction. 

“Every now and then, the Parliament has a real opportunity to do something meaningful and lasting for the health of young Australians and today was one of those days.” 

“The best time to have done this was five years ago. The second-best time is right now.”

Associate Professor Emily Stockings from the University of Sydney’s Matilda Centre and lead of the program 'Smoking, Vaping and Mental Health', with a focus on e-cigarette use in young people and vulnerable populations, says the vaping ‘epidemic’ among young people has been driven by the ease of access to these products and their sheer abundance on the market.

“The new vaping reform bill passed in parliament is, unfortunately, unlikely to stem this supply: adults will be able to buy vapes through pharmacies without a GP prescription, which essentially opens a door for continued supply to young people.”

“Even if young people can only access via prescription (when clinically appropriate), we already know that young people access vapes via older siblings or friends who on-sell them via social media platforms such as Snapchat. This new regulation will essentially allow the illicit supply of vapes to young people to continue.’’

“Striking the balance between prevention of youth uptake and reduction of smoking harms via vaping is challenging. We do appreciate that for an important minority of smokers - many of whom already experience significant health, social and financial disadvantage - access to vapes via pharmacies without the additional financial and logistical burden of a GP visit is a win. However, when accessing smoking cessation treatment, discussion with a trained health professional and provision of brief advice is the gold standard, and it remains to be seen if this is going to be feasible in busy community pharmacies.”

As this Issue goes to press 'nicotine free' vapes are still being sold online on Australian sites with New Zealand versions stating they will ship these to Australia, despite the TGA stating that from 1 March 2024, 'the personal importation of vapes is banned. Australian Border Force will seize and destroy all vapes imported by customers in Australia from 1 March 2024. Fines may also be payable.'

Pittwater Online will check whether they are still offering these in July 2024, they certainly were from March 2 to June 30.

What’s really inside vapes? We pulled them apart to find out

Christopher Kidall Park
Miles Park, UNSW Sydney

While vapes or e-cigarettes first appeared around 20 years ago as an alternative to smoking, their prevalence and use have increasingly become problematic.

Governments and regulators are now catching up to what is widely seen as an addictive and unsafe product. Australia has just passed a world-first bill that will ban all vapes from general retail later this year.

Currently, the most predominant vapes on the market are single-use, disposable products designed to appeal to younger people. Despite their short lifespan, vapes are complex products that contain several valuable resources.

However, there are no practical means to collect or recycle vapes. Most end up as electronic waste or e-waste in landfill. Some are simply thrown on the street as litter. So what’s really inside vapes?

How do vapes work?

Vapes can be categorised as either reusable or disposable (single use), the more prevalent option.

Reusable vapes have a rechargeable battery and cartridge or liquid refills offered in a bewildering selection of flavours. More elaborate vapes contain microprocessors that offer customisable features, coloured LEDs and even small coloured screens.

In their simplest configuration, single-use disposables have the common components found in all e-cigarette types. Vapes contain a battery, a pressure sensor (like a modified microphone), an LED light, a heating element and a reservoir with e-liquid (the “juice”).

When the sensor is activated by taking a drag on the device, the battery provides power to a heating element that vaporises or atomises the liquid.

Tearing down a single-use vape

Analogous to the study of anatomy, teardowns are a technique used by industrial designers and design engineers to systematically disassemble a product.

This allows us to identify and describe the internal components and their relationships within a product. It can provide useful information about materials, manufacturing processes, assembly and technology.

Equally, it can provide insights into repairability, upgradability and ease of disassembly for end-of-life recovery for potentially valuable or harmful materials.

We obtained a random selection of commonly found, depleted, single-use vapes to teardown, identify and describe what is inside.

A teardown of a vape.
A teardown of a vape. Christopher Kidall Park

Housing

Disposable vapes are not designed to be disassembled. The main housing is made out of aluminium and covered in a paint finish and graphics, closed at the ends with plastic parts.

The vape housing is aluminium with plastic caps Christopher Kidall Park

Once the housing end caps are removed, which is often not a straightforward task, the internal assembly slides out.

These internal parts are wedged or taped together within the main housing, and battery terminals are soldered to wires connecting to a pressure sensor and a heating element embedded in an e-liquid reservoir.

Battery

Despite disposable vapes being non-rechargeable, the ones we disassembled all contained a lithium battery. Although much smaller, they are not dissimilar to the bundles of batteries found in products like power drills and electric vehicles.

The 3.7V lithium battery. They should be recycled or disposed of in an electronics waste bin. Christopher Kidall Park

These cells have high-power density: they can store lots of electrical energy in a relatively small package. This is needed to supply periodic bursts of energy to the heating element, and to outlast the supply of e-liquid in the reservoir.

All the batteries we tested during the teardown of depleted single-use vapes still maintained a charge that could power a test light bulb for at least an hour.

Pressure sensor

An air pressure sensor is a semiconductor switching device. Not unlike a microphone that converts vibrations into electrical energy, the pressure sensor detects a drop in pressure and closes an electronic switch.

The pressure sensor, with a small blue dust filter. Christopher Kidall Park

This occurs during the action of taking a drag on the vape, which creates a partial vacuum within the device. When the switch is closed, a simple (short) circuit illuminates an LED and supplies current to the heating element.

Heating element: vaporiser

The heating element is embedded in a cap at one end of the e-liquid reservoir and connected to a wick. When the device is activated, an electrical current heats a metal strip that vaporises some of the volatile e-liquid.

The heating element, vaporiser. Christopher Kidall Park

The e-liquid reservoir

Disposable vapes contain an absorbent foam material saturated with e-liquid and contained in a plastic tube with silicone endcaps.

In the centre of the reservoir is a wicking material that draws in the surrounding e-liquid to be in contact with the heating element.

The e-liquid itself contains a range of ingredients such as propylene glycol, nicotine and flavourings, many of them with unknown health impacts.

The heating element is embedded in the fluid cartridge. Different vape designs have larger or smaller cartridges. Christopher Kidall Park

Designed for the dump

The consumption of vapes has been skyrocketing in recent years, and they now represent a significant proportion of an alarming new category of e-waste.

A bin full of vape parts
Christopher Kidall Park

Single-use e-waste results in a significant loss of valuable materials – notably aluminium and lithium.

Worse, when a disposable vape is thrown in the bin, the energy-dense lithium batteries pose a fire danger for waste management workers.

The materials in vapes also have toxic effects on the environment when released.

Having potentially valuable metals mixed with other, low-value materials such as plastic makes vapes difficult to separate and recycle. Overall, single-use vapes are clearly wasteful of resources and dangerous in the environment.The Conversation

Miles Park, Senior Lecturer, Industrial Design, UNSW Sydney

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