If we fail now – as a matter of urgency – to push through regulations designed to promote access to prescription e-cigarettes, we will fail to protect the health of current and future generations of Australians.
In June 2022, the National Health and Medical Research Council (NHMRC) published an updated review of the evidence showing that non-smokers who use e-cigarettes are more likely to start smoking than non-smokers or vapers. A review of the evidence by the Australian National University, commissioned by the Australian government and published in April 2022, reached the same conclusion.
The health risk posed by e-cigarettes is not only an increased tendency to smoke. NHMRC’s evidence review found that e-cigarette aerosols contain dozens of chemicals known to be harmful when inhaled, causing irreversible lung damage (eg diacetyl, acetoin and acetylpropionyl) and organ damage with long-term exposure (eg manganese and nickel). . Twenty chemicals, including acrolein, formaldehyde, mercury, benzene, toluene and cadmium, were found to be harmful when inhaled and have the potential to be fatal.
Another very recent review, which did not attract media attention in Australia, was conducted by the American Heart Association and specifically assessed cardiopulmonary risks for adolescents. The authors concluded that adolescents who vape, like adolescents who smoke, are likely to have lower lung function and are particularly susceptible to any other lung damage, such as asthma or pneumonia. Similarly, the authors concluded that adolescents who vape are highly likely, like those who smoke, to have an increased risk of cardiovascular disease in later years due to damage to endovascular and myocardial cells.
From October 2021, Australia adopted a prescription model for e-cigarettes containing nicotine. The aim of this approach was to reduce the use of e-cigarettes by children and provide a pathway for adults to use e-cigarettes under the guidance of a health professional as part of a structured smoking cessation trial. The Royal Australian College of General Practitioners’ 2021 smoking cessation guideline updates recommend nicotine-containing e-cigarettes as “second-line therapy” for use when all other Therapeutic Goods Administration (TGA)-approved pharmacotherapies have failed.
However, the investigation of the ABC program Four corners (Vape Haze, which aired on June 27, 2022) showed the extent to which importers and sellers of e-cigarettes break the law. In essence, nicotine-containing e-cigarettes are highly available because individual entrepreneurs and businesses can easily import them and retailers feel able to stock and sell them with impunity. Combine high availability with attractive flavors and online marketing aimed at children, and it’s no wonder kids (and young adults) are addicted to nicotine-containing e-cigarettes.
In theory, the prescription model in Australia should work like this: liquid nicotine is a schedule 4 drug and therefore nicotine-containing e-cigarettes or electronic nicotine delivery systems (ENDS) should only be imported or sold by a domestic pharmacy with a valid prescription. ENDS should not be available as part of the consumer market.
In principle, however, the prescription model is not enforced. Australia’s border force is failing to stop the importation of hundreds of thousands of ENDS, mainly cheap disposable devices that end up in schoolyards. Retail enforcement is complicated because ENDS are subject to both jurisdictional drug and poison laws that govern the enforcement of Schedule 4 drugs and tobacco legislation that governs the advertising and sale of tobacco products but not Schedule 4 drugs. Not all states and territories have a clear path to enforce the illegal sale of ENDS in convenience stores, gas stations and newsagents.
E-cigarettes that do not contain nicotine, or electronic non-nicotine delivery systems (ENNDS), will defeat all enforcement efforts. ENNDS are legal as a consumer product, but cannot be sold to children in all states except Western Australia, where they are outright banned because they resemble a tobacco product. Since ENNDS and ENDS are identical in appearance, importers and sellers can simply claim that their products are legal ENNDS (along with the deliberate mislabeling of the device) and not illegal ENDS, and – short of seizing and destroying the goods for nicotine testing in the laboratory – the authorities cannot refute this claim in any way.
Failure to enforce the prescription model has several consequences. By far the most significant is the growing use of vaping by children and the public health tragedy it portends. Other implications relate to minimizing the known harms of e-cigarette use and maximizing potential benefits for smoking cessation.
First, the illicit consumer market undermines therapeutic use by people who might benefit from it. Second, there is no commercial incentive for ENDS manufacturers to submit their product for TGA approval, which would reduce the key medico-legal interest of GPs and pharmacists. Third, none of the illegally sold e-cigarettes meet the very minimum safety standards set out in the TGA’s Therapeutic Goods Order (TGO 110) for prescribed “nicotine vaping products” available for sale in Australian pharmacies. The lack of child-resistant packaging combined with deliberately mislabeled ENDS is of particular concern given the risk of nicotine poisoning for children.
There is another significant consequence of the failure to advance the prescription model as a matter of critical urgency. The longer we wait for strong action to stop the sale of illegal e-cigarettes, the harder it will be for governments to resist the continued efforts of those with commercial interests to subvert the creation of sound public policy.
All signs point to Big Tobacco deliberately (again) using the “regulation affects small business” strategy. The tobacco industry already funds many retail associations and interest groups to lobby politicians. These groups are now cynically calling for “regulation to protect children”, but their idea of ”regulation” is to scrap the prescription model and make ENDS available as a consumer product.
We made that mistake with cigarettes in the 1920s; we have certainly learned enough to not repeat this mistake in 2020. If we fail now – as a matter of urgency – to push through regulations designed to promote access to prescription e-cigarettes, we will fail to protect the health of current and future generations of Australians.
|Three steps that would simplify and strengthen enforcement to support the Australian model of regulation:
Dr Sandro Demaio is the CEO of VicHealth. He is a physician and globally recognized public health expert and advocate. Dr. Previously CEO of the EAT Foundation, a science-based global platform for food systems transformation, Demaio also held the role of Medical Officer for Noncommunicable Conditions and Nutrition at the World Health Organization.
Todd Harper is CEO of Cancer Council Victoria. Todd is a board member and past president of the Geneva-based NCD Alliance.
Dr Sarah White is Director of Quit Victoria. She was director of communications and fundraising at the Royal Women’s Hospital in Melbourne. Before that, Dr. White spent seven years managing communications at the Ludwig Institute for Cancer Research, an international research institute based in New York.
Statements or opinions expressed in this article reflect those of the authors and do not necessarily represent official AMA policy. SERVANT or InSight+ unless otherwise specified.
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