Please make a submission to the TGA vape consultation

Posted on December 11, 2022 By Colin

VAPERS SHOULD MAKE a brief submission to the TGA consultation on Nicotine Vaping Products (NVPs). Without your input, even stricter regulations on vaping are likely to be introduced. The deadline for submissions is 16 January 2023.

You can download my final submission here (updated 3 January).

Policy makers have consulted widely with anti-vaping groups. However, vapers and pro-vaping experts have not had the opportunity to give input and the consultation document suggests that the TGA proposes to restrict vaping further and maintain the prescription requirement.

The current regulations focus on reducing youth access. However, the harm to young people from vaping is relatively minor.

Regulation should balance concerns about the potential risks to young people with the substantial and immediate health benefits for adult smokers. The TGA needs to know how important vaping is for adult smokers.

The four issues for reform are outlined below with my response, based on the UK and New Zealand models.

Border Control

The government wants to tighten controls over imported illegal vaping products and is considering removing the Personal Importation Scheme, which allows users to import personal supplies.

However, the current flood of illegal, unregulated imports has been caused by the prescription-only regulations

The need for a prescription has substantially reduced access for adult smokers and vapers and has created a high demand for illegal products from the black-market.

Increased efforts to intercept the millions of illicit imports is bound to fail. The Australian Border Force is seriously under-resourced and will be diverted from its role in detecting other more important and dangerous products.

The solution is to make vaping products readily available for adults under a tightly regulated consumer model. Illegal imports will no longer be required

Under this model, adults will be able to readily access nicotine liquid without a prescription from pharmacies, licensed specialist vape shops and licensed general retail outlets. Youth access can be restricted by strict age verification, severe penalties and loss of licence for underage sales

Pre-market assessment

All vaping products should be registered for quality and safety prior to marketing.

The best way to do this is with a streamlined pre-market notification system under which manufacturers notify the regulator that their products are compliant with Australian standards and provide confirmatory data before marketing is allowed. This is working well in the UK and New Zealand.

The alternative is a pre-market authorisation approach, under which the regulator must assess every product prior to approval.

This method is onerous, expensive and time-consuming and has been a resounding failure in the US.

Minimum quality and safety standards

The current Micky Mouse TGO 110 standards for nicotine products need to be upgraded as they provide very little protection for users.

Flavours

Flavours are an integral part of the appeal of vaping and play an important role in helping smokers switch.

Wholesale flavour bans will do more harm than good

My suggestions are

Simple descriptions of flavour profiles only eg ‘mint’, ‘blueberry’, ‘tobacco’, ‘vanilla tobacco’
Prohibit descriptive flavour names that specifically appeal to youth eg ‘dragon vomit’
Prohibit flavours found to have a material risk to health

Restricted ingredients

Restriction of ingredients that may be harmful to health should be mandatory, as in the TPD.

Plain packaging

Plain packaging sends a signal to smokers that vaping is as harmful as smoking and would reduce the appeal of the safer product. It is not appropriate for vaping products due to the low health risk.

Warning statements

Scary warnings are not appropriate and may discourage smokers from switching from deadly cigarettes. Warnings should compare the risks of vaping to smoking eg

“This product may be addictive but is a far less harmful alternative for adult smokers”
“If you are a smoker, switching completely to vaping is a much less harmful option”

Nicotine concentration

I support an upper limit of 20mg/mL for freebase nicotine and 50mg/mL for nicotine salt, as in New Zealand

The higher concentrations are needed for disposables and small pod vapes which are popular transition models. Also some heavier smokers need higher doses to satisfy their higher nicotine dependence, at least initially.

Maximum bottle size

I support a maximum amount of nicotine per container rather than a maximum bottle size. The New Zealand limit of 1800mg nicotine per container is a sensible compromise. This would be 100mL of 18mg/mL or 36mL of 50mg/mL. All containers should have child-proof caps.

Disposable vape ban

Disposable vape devices are a popular aid for adults transitioning from smoking as they are convenient, easy-to-use, require no maintenance or charging and provide good nicotine delivery. They are especially useful for elderly, disabled and non-technical users.

However disposables should not appeal to young people, for example not have bright colours or youth-appealing flavour names and images.

Are nicotine vaping products therapeutic goods?

The TGA is concerned that many illegally imported products do not list nicotine as an ingredient. This only applies to illegal products that aim to avoid detection at the border. The illegal market has been created by the harsh prescription requirements. The solution is to legalise nicotine vapes as consumer products.

Vaping products should be regulated by the Australian Competition and Consumer Commission (ACCC) which provide strong protection for consumers. They are not therapeutic goods (ie do not make medicinal claims) and should not be regulated by the TGA.