Australian Therapeutic Goods Administration updates review of proposed reforms to nicotine e-cigarette regulation

March 27 news, according to foreign reports, on Friday, Australia's Therapeutic Goods Administration (TGA) updated its review of proposed reforms to the regulation of nicotine e-cigarette products.



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

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

The update's emphasis on enforcement and safety supports the goal of ensuring nicotine vaping products are only available to people who use them to try to quit smoking.
Three weeks ago, all Australian health ministers agreed to form a working group to consider options to address the supply of all e-cigarettes, including nicotine and nicotine-free devices.

Since then, federal Health Minister Mark Butler has increasingly called for improved border controls to enforce Australian law that nicotine e-cigarettes are only available by prescription.

Butler said nothing is out of the question -- except allowing nicotine e-cigarettes to be sold without a doctor's prescription at retailers such as convenience stores. Currently, the illegal sale of nicotine vaping products is on the rise, with hundreds of retail outlets selling nicotine vaping products in flagrant violation of public health laws.

The TGA published nearly 4,000 submissions.
They mainly come from two viewpoints. On the one hand, most public health stakeholders, including NGOs and state and territory government health and education agencies, have called for tighter border controls. On the other hand, those aligned with commercial interests have called for legal over-the-counter sales of nicotine e-cigarettes.



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

It's an age-old tactic used by the tobacco industry and its retailer allies -- orchestrating responses to public consultations, claiming to be the voice of the community. In effect, these represent the interests of commercial entities. In any event, arrangements to abolish vaporizer nicotine as a prescription-only substance were outside the scope of the review.

While state and territory government health and education agencies are united in calling for tighter border controls, there are differing views on how this can be achieved.

Some have proposed introducing import licenses. Others have suggested changes to customs regulations administered by the Department of Home Affairs, which would require the Australian Border Force to confiscate nicotine vaping products imported without medical authorization. A number of submissions suggested extending it to non-nicotine e-cigarette products.

Independent health groups - notably the Cancer Council, the National Heart Foundation and the Australian Council on Smoking and Health, who have previously been involved in landmark policy achievements such as tobacco plain packaging - have backed customs seizures.

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

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

Now is the time to step up action on enforcement and regulatory reform – not just postpone until task forces, consultations and investigations. Queensland parliament has just opened another inquiry into vaping, at least the fourth in Australia since 2017.

Soon we'll hear what the government plans to prioritize. If the federal response to TGA review is ultimately to issue import licenses rather than ban imports, it must be backed by effective enforcement. Retailers have flouted federal laws (including the Poisons Standards and Therapeutic Goods Order) and state/territory public health laws by importing and selling nicotine vaping products. If not enforced, import licenses will be just another neglected policy tool.

There is nothing more profitable than a commercialized addiction. E-cigarette makers and retailers know this and appear determined to hook as many users as possible by increasing 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. The risk of drug use for non-smokers is three times that of smokers. The largest user group is young adults under the age of 25. Teenagers and a small number of people successfully use e-cigarettes to quit smoking.

The Australian government has made it clear that they are collectively committed to restricting nicotine vaping products to the prescription route. Now they need to take action -- confiscate all imported vaping products that aren't destined for drugstores, and expand current restrictions and enforcement to all vaping products.