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The Australian Therapeutic Products Authority updates its review of proposed changes to the regulation of nicotine e-cigarettes

The Australian Therapeutic Products Authority updates its review of proposed changes to the regulation of nicotine e-cigarettes

2023-03-28

March 28 - The Australian Therapeutic Products Authority (TGA) on Friday updated its review of proposed changes to the regulation of nicotine e-cigarette products, it was reported.


The federal government is now reportedly actively considering the TGA's recommendations.


The TGA's recommendations have not been published at this time, but a top-level summary of the review's advisory opinion has been published. It reiterated the scope of the review, focusing on changes to border controls for nicotine vape products, minimum quality and safety standards - including the idea of classifying nicotine vape products as therapeutic.


The update's emphasis on law enforcement and safety supports the goal of ensuring that nicotine vape products are only available to people using them to try to quit smoking.


Three weeks ago, all Australian health ministers agreed to set up a working group to consider options to address the supply of all e-cigarettes, including nicotine and nicotine-free devices.


Since then, the federal health minister, Mark Butler, has increasingly called for improved border controls to enforce Australian laws that make nicotine e-cigarettes available only by prescription.


Butler says nothing is off the table -- except allowing nicotine e-cigarettes to be sold without a doctor's prescription at retailers such as convenience stores. The illegal sale of nicotine vape products is currently on a growing scale, with hundreds of retail outlets selling nicotine e-cigarettes in flagrant violation of public health laws.


The TGA published nearly 4,000 submissions.


They come from two main points of view. On the one hand, most public health stakeholders, including ngos and health and education agencies of state and territory governments, have called for tighter border controls. On the other side, those aligned with commercial interests are calling for legal sales of nicotine e-cigarettes over the counter.


The TGA noted that a large number of comments submitted by the public appeared to be campaign responses calling for carburetor nicotine to be removed from the poison standard so that it could be sold by any retailer.


This is an old tactic used by the tobacco industry and its retailer Allies - crafting responses to public consultations that claim to be the voice of the community. In effect, these represent the interests of business entities. In any event, the arrangement to abolish vaporized nicotine as a prescription-only substance is not within the scope of the review.


While state and territory government health and education agencies are united in calling for tighter border controls, there are different views on how to achieve this.


Some have proposed introducing import licences. Others suggested changes to customs regulations administered by the Department of the Interior, which would require the Australian Border Force to confiscate nicotine vape products imported without medical authorisation. Many submissions suggested extending it to non-nicotine vape products.


Independent health groups - notably the Cancer Council, the National Heart Foundation and the Australian Council on Smoking and Health, which has previously been involved in landmark policy achievements such as tobacco paperpackaging - have supported customs impoundment.


Based on all the evidence, including the dangers of e-cigarettes, patterns of use, and current policies, this option would turn off the spigot at the border. State and territory governments must also end illegal retail sales in their jurisdictions. This would end the current exemption for the sale of non-nicotine vape products and ensure that all vape products, regardless of the claimed nicotine content, are only available by prescription.


The proliferation of so-called non-nicotine vape products, many of which contain nicotine when tested, is disrupting enforcement efforts to make nicotine vape products prescription-only.


Now is the time to intensify enforcement and regulatory reform action - not just postpone it to working groups, consultations and investigations. The Queensland state parliament has just begun another inquiry into e-cigarettes, at least the fourth in Australia since 2017.


Soon we will hear what the government plans to prioritise. If the federal response to the TGA review is ultimately to issue import licences rather than ban them, it must be backed up by effective enforcement. Retailers have flouted federal laws (including poison standards and therapeutic products orders) and state/territory public health laws by importing and selling nicotine vape products. If not enforced, import licences will be just another neglected policy tool.


There's nothing more lucrative than a commercialized addiction. E-cigarette manufacturers and retailers know this, and seem determined to get as many users hooked as possible by increasing the illegality, while the Australian government "considers their options". Not since cigarettes were first sold on a large scale in the 19th century has an entire population been at such risk of nicotine addiction and health hazards on an industrial scale.


The evidence is clear. E-cigarettes are harmful to health. Non-smokers are three times more likely to take drugs than smokers. The largest group of users are young adults under the age of 25, teenagers and a small number of people who have successfully used e-cigarettes to quit smoking.


The Australian government has made clear its shared commitment to restricting nicotine fogging products to prescription access. Now they need to take action -- confiscating all imported vape products that are not destined for pharmacies, and extending current restrictions and enforcement to all vape products.


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