Australia’s TGA Updates Review of Proposed Reforms to Nicotine E-Cigarette Regulation

According to foreign reports today, last Friday, the Therapeutic Goods Administration (TGA) of Australia updated its review of proposed reforms to the regulation of nicotine e-cigarette products.

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

The TGA's recommendations have not yet been published, but a top summary of the review consultation has been released. It reiterates the scope of the review, focusing on changes to the border control of nicotine e-cigarette products, minimum quality and safety standards—including the idea of classifying nicotine e-cigarette products as therapeutic goods.

This update emphasizes enforcement and safety, supporting the goal of ensuring that nicotine e-cigarette products are only used by those attempting to quit smoking.

Three weeks ago, all Australian health ministers agreed to establish a working group to consider solutions to all e-cigarette supply issues, including both nicotine and non-nicotine devices.

Since then, Federal Health Minister Mark Butler has increasingly called for improved border controls to enforce Australian laws that require nicotine e-cigarettes to be obtained only by prescription.

Butler stated that nothing is impossible—except allowing nicotine e-cigarettes to be sold at retailers like convenience stores without a doctor's prescription. Currently, the illegal sale of nicotine e-cigarette products is growing, with hundreds of retail stores openly violating public health laws by selling nicotine e-cigarettes.

The TGA has received nearly 4,000 submissions.

They mainly come from two perspectives. On one hand, most public health stakeholders (including NGOs and health and education agencies from states and territories) are calling for stricter border controls. On the other hand, those aligned with commercial interests are advocating for the legal sale of nicotine e-cigarettes over the counter.

The TGA noted that a large number of public submissions seem to be a coordinated response, calling for the removal of vaporizer nicotine from poison standards so that any retailer can sell it.

This is an outdated strategy used by the tobacco industry and its retail allies—carefully orchestrating responses to public consultations, claiming to represent community voices. In reality, these represent the interests of commercial entities. Regardless, the removal of vaporizer nicotine as a prescription-only substance is not within the scope of the review.

Despite the unanimous call from health and education agencies in states and territories for stricter border controls, there are differing views on how to achieve this goal.

Some have proposed introducing import licenses. Others have suggested amending customs regulations managed by the Department of Home Affairs, which would require the Australian Border Force to seize nicotine e-cigarette products imported without medical authorization. Many submissions suggested extending this to non-nicotine e-cigarette products.

Independent health groups—especially the Cancer Council, National Heart Foundation, and Australian Council on Smoking and Health, which have previously participated in landmark policy achievements like plain packaging for tobacco—support customs seizures.

Based on all evidence, including the harms of e-cigarettes, usage patterns, and current policies, this option would close the tap on border imports. State and territory governments must also terminate illegal retail sales within their jurisdictions. This would end the current exemption for non-nicotine e-cigarette products and ensure that all e-cigarette products, regardless of claimed nicotine content, can only be obtained through prescription.

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

Now is the time for strengthened enforcement and regulatory reform actions—not just postponing to working groups, consultations, and investigations. The Queensland Parliament has just begun another inquiry into e-cigarettes, marking at least the fourth inquiry in Australia since 2017.

We will soon hear what the government plans to prioritize. If the federal response to the TGA review ultimately results in issuing import licenses instead of banning imports, it must be supported by effective enforcement. Retailers have been flouting federal laws (including poison standards and therapeutic goods orders) and state/territory public health laws by importing and selling nicotine e-cigarette products. Without enforcement, import licenses will merely be another ignored policy tool.

Nothing profits more than commercialized addiction. E-cigarette manufacturers and retailers know this and seem determined to hook as many users as possible through increased illegal activities while the Australian government "considers its options." Since the mass marketing of cigarettes began in the 19th century, no population has faced such a significant risk of nicotine addiction and health hazards on an industrial scale.

The evidence is clear. E-cigarettes are harmful to health, and non-smokers face three times the risk of addiction compared to smokers, with the largest user group being young adults under 25, while only a few have successfully used e-cigarettes to quit smoking.

The Australian government has made it clear that they are committed to restricting nicotine vapor products to prescription access. Now they need to take action—seizing all imported e-cigarette products not destined for pharmacies and expanding current restrictions and enforcement to all e-cigarette products.