E-cigarette vapour comprises micro- and nano-particles. There's little to no understanding of what the health consequences will be of deep inhaling these thousands of times a year across many years. Credit:Eddie Jim Both of these have been strongly contested. The world's leading assessor evidence of therapeutic effectiveness, the Cochrane Collaboration, described the quality of the evidence about smoking cessation with e-cigarettes as "low" or "very low", because of imprecision due to the small number of trials. The "95 per cent safer" claim is nothing more than guesswork by a small hand-picked group, convened with the support of a Swiss-based agency with ties to the tobacco industry. It cannot refer to any real-world health data because e-cigarettes have only been used for a few years. Smoking skyrocketed when cheap, affordable cigarettes first appeared early in the 20th century with the invention of mechanised rolling machines. Over the next 20 years, lung cancer remained an uncommon, even rare disease. It then began to rapidly increase but it was not until 1950 that definitive evidence was published that long-term smoking caused lung cancer, by far the most common form of fatal cancer today. Knowledge about other diseases followed. If any scientist had declared in 1920 that cigarette smoking was all but harmless, history would have judged their call as dangerously incorrect. But this is the reckless call e-cigarette spruikers are making today, after just 10 years.

The typical e-cigarette user inhales a vapourised mixture of propylene glycol, nicotine and flavouring chemicals deep into their lungs 200 times a day . Some inhale as many as 600 times a day. The heating of these ingredients changes their chemistry. A recent report in the Journal of the American Medical Association found that vapour released from a new "heat not burn" tobacco product produced volatile organic compounds like acrolein, formaldehyde and benzaldehyde in significant amounts. E-cigarette vapour comprises micro- and nano-particles. There's little to no understanding of what the health consequences will be of deep inhaling these thousands of times a year across many years. E-cigarette advocates argue that even if vapers don't quit smoking, many reduce how much they smoke. And surely, it's self-evident that halving what you smoke must reduce harm? Unfortunately for commonsense, several very large longitudinal studies which have followed reducers over many years show that this is not the case. Only stopping confers significantly reduced smoking-caused disease. Australia introduced drug regulation in 1963 following the thalidomide tragedy. The TGA and its predecessors have had responsibility for the evaluation, regulation and scheduling of any product where therapeutic claims are made. Quack claims about cures for deadly and common diseases like cancers, HIV/AIDS and asthma have long been with us. But we don't allow those with an alleged cancer cure to by-pass the TGA assessment process and sell and promote a substance as cancer-curing simply on the strength of "this is so important" emotional rhetoric designed to put it above regulatory, consumer-protecting red tape.

Vaping advocates walk on both sides of the regulatory street. When it suits, they highlight claims about the therapeutic value of e-cigarettes in quitting. But when they are asked for high- quality evidence, they deny e-cigarettes are therapeutic and switch to premature "less harmful than cigarettes" arguments. They argue that if e-cigarettes makers had to convince the TGA on safety and effectiveness, only Big Pharma and Tobacco could afford to conduct the research to the standards required. This may well be true. But the alternative -- to allow any backyard "kitchen chemist" maker of vaping equipment and ingredients to sell and promote their products without TGA regulation – is an outrageous proposal that would set a very dangerous precedent. Barely a day passes without a new reports of e-cigarette explosions causing serious burns. Nearly all airlines ban e-cigarettes because of the potential disaster that could follow such an explosion and fire on board. Without regulation of this cowboy industry, it is only time before this occurs. Every major tobacco company has invested in e-cigarettes and made statements urging smokers to migrate to e-cigarettes. Only those with weapons-grade naivety swallow their nonsense. Their statements are empty public relations gestures because all these companies continue to aggressively oppose any tobacco-control policy like excise tax and plain packaging with proven ability to reduce smoking. They want people to smoke and vape, not vape instead of smoking. Australia's smoking rates have never been lower in both adults and children. Our achievements place us in the frontline of nations reducing smoking. Tobacco control is the crown jewel of successful chronic disease reduction. To remove nicotine regulation from the TGA would be to learn nothing from the historic failure to regulate cigarettes. The argument being made is "cigarettes are an unregulated disaster and are freely available. Let's take the same route with e-cigarettes."

Loading Australia's successful efforts to reduce smoking have had multi-party support for 40 years. All parties must affirm the regulatory expertise and authority of the TGA and encourage manufacturers of vapourisers to submit their evidence-based applications for TGA approval, as manufacturers of any product making therapeutic claims must do. If these products are as effective and safe as claimed, they will have nothing to fear. Simon Chapman is an emeritus professor in public health at the University of Sydney.