Who should regulate vaping? (Hint: not the TGA)
Posted on December 18, 2018
The current requirement for nicotine vaporisers (e-cigarettes) to be approved by Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), is misguided and unworkable. TGA regulation amounts to de facto prohibition. Not a single vaping product globally has been assessed by a national regulator and gone to market in any country.
The TGA is responsible for regulating medicines and medical devices which make therapeutic (medicinal) claims, such as 'this product can help you quit smoking'. Nicotine vaporisers are consumer products used almost exclusively as a less harmful substitute by smokers who can’t or won’t quit smoking or consuming nicotine. They allow ex-smokers to enjoy an experience like smoking, with substantially reduced risk and at far less cost.
The TGA should not have a mandate over vaping products as they do not make therapeutic or medicinal claims
Vaporisers are low-risk alternatives to another consumer product, just as Diet Coke is a healthier alternative to Coke. It does not make sense to require the highest standards of research and quality for nicotine vaporisers when they are replacing a far more harmful product, lethal cigarettes, which are virtually unregulated.
The practical outcome of TGA regulation would be the decimation of the vaping market. Every device and e-liquid and every future modification would require a detailed, costly and onerous application that only tobacco companies could afford. Most small to medium companies would be driven out of business.
Currently, there is no vaping device available in Australia which is made or sold by a tobacco company. The vaping industry in Australia and globally is dominated by many small companies able to rapidly follow the fickle fads and fashions of the vaping market. Tobacco companies account for less than 20% of the world vaping market.
We would be very surprised if health policymakers would like to see tobacco companies take over the vaping market. However, that is the almost certain outcome of TGA regulation.
In this fast-evolving field, vaping devices are being rapidly replaced by newer models. If and when the regulator approves a product, it would already be obsolete. There would be substantial cost increases to consumers, reduced innovation and safety improvements and less diversity in the market.
Access to consumers would also be greatly reduced if products could only be accessed by a medical prescription and sold through pharmacies. This pathway would also add substantial costs for consumers and Medicare and is highly unlikely to be accepted by a majority of smokers.
Vaping products should be at least as accessible as cigarettes. Allowing widespread access to cigarettes at petrol stations, supermarkets and corner stores, while compelling vapers to get a prescription from a doctor and go to a pharmacy is clearly unworkable.
Vaporisers are consumer products
Consumer products are regulated by the Australian Competition and Consumer Commission (ACCC) which provide strong protection for consumers. The ACCC ensures that products are safe, fit for purpose and comply with all legal requirements, in particular under the Competition and Consumer Act 2010.
Quality, safety and performance standards specifically for vaping devices and liquids are urgently needed for products used in Australia and can be based on standards already available in the UK (BSI), France (AFNOR), Europe (CEN), US (AEMSA), and internationally (ISO).
Safety standards cover three key areas: the composition of e-liquids and other consumables, the safety of the devices and emissions from those devices.
Australian state and territory laws complement ACCC regulation of vaping products. They address the sale and supply of nicotine, the sale of vaporisers, minimum age of sale, sale in vending machines, use in smoke-free areas, advertising and display. However, state laws are not uniform and a consistent national approach would be more effective.
Additional regulatory requirements will be needed such as post-market monitoring and surveillance and product recall procedures.
Vapes are not tobacco products
Vaporisers are incorrectly regulated under most state laws as tobacco products, despite the fact that they do not contain tobacco, do not combust, do not produce smoke and are substantially less harmful.
They contain nicotine which is usually derived from tobacco. However, the presence of nicotine does not make them tobacco products, just like nicotine replacement therapies and tomatoes (which contain nicotine) are not tobacco products.
Vaporisers carry only a small fraction of the risk to health compared to tobacco products. Classifying them as tobacco products sends a misleading message to smokers that vaping is just as harmful as smoking. Classifying vaporisers under tobacco laws subjects them to restrictions that are excessive for the level of risk involved. We argue that regulation of vaping should be proportionate to risk.
A compromise solution?
The UK, EU, Canada and New Zealand use a hybrid system of regulation. Vaporisers are primarily a consumer product, but a therapeutic pathway is also available:
- Products which do not make therapeutic claims are classified as consumer products and managed under consumer law.
- Products which wish to make therapeutic claims can apply for a medicines licence and are regulated by the medicines regulator. These products need to meet a higher standard of evidence and quality. Doctors can prescribe them and some patients may have more confidence in their use.
Getting the regulation right is critical in making this life-saving technology available to smokers while ensuring the safety, quality and protection to users and minimising uptake by non-smokers.
Posted by Colin Mendelsohn, email@example.com