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Australian smokers denied a safer alternative

Posted on June 10, 2020

THE THERAPEUTIC GOODS ADMINISTRATION has failed Australia's smokers by rejecting an application for heated tobacco products to be made available in Australia.

In its interim decision today, the TGA has ignored the scientific literature and international experience that heated tobacco products (HTPs) are significantly safer than combustible cigarettes. The products have helped millions of smokers quit smoking overseas and are sold in over 50 countries, including New Zealand, the UK, US and EU.

HTPs are an alternative to smoking for adult smokers who can’t quit. They are battery operated devices which  heat a processed tobacco stick without burning to release nicotine and tobacco flavour. As there is no combustion or smoke, the resulting vapour has far fewer toxins than smoke and is considerably less harmful.

‘Safety not demonstrated’

The compelling scientific evidence that HTPs are substantially safer than smoking has convinced the US Food and Drug Administration (FDA), but the TGA remains unmoved.

The FDA recently concluded that HTPs were “appropriate for the protection of the public health because, among several key considerations, the products produce fewer or lower levels of some toxins than combustible cigarettes"

HTPs are not risk-free and do release low levels of toxic compounds. However the risk from these low doses of chemicals is substantially less than from smoking. Any risk for smokers should be compared to the toxic combustible products they are designed to replace.

There is clear evidence that smokers who switch to HTPs significantly reduce their exposure to toxins. Biomarker studies show that levels of toxins in the blood and urine of smokers are substantially reduced

The TGA claim that HTPs contain toxic compounds that can “potentially produce pathophysiological changes in human tissues comparable to those produced by cigarette smoke" is patently absurd. The low levels or toxins in HTP vapour are clearly less harmful.

“No demonstrated benefit”

The TGA decision denies any public health benefit from HTPs in spite of the growing evidence from overseas jurisdictions.

In Japan, HTPs are disrupting the combustible cigarette market. Cigarette sales by Japan Tobacco fell by an unprecedented 27% over 2 years from 2016-2018 after HTP products were introduced in late 2015

The rate of decline was five times faster than in the years preceding 2016. Similar rapid declines have been seen in other markets.

The TGA raised the concern about youth uptake of HTPs. However, there is almost no evidence of this. A recent study from Japan found that "Uptake by never users of tobacco products was minimal".  The evidence to date suggests that regular HTP use is overwhelmingly by adult smokers as a safer substitute for smoking.

Furthermore the claims of a “high risk of dependence” are meaningless if use is almost exclusively in former smokers who are already addicted to nicotine.

Tobacco harm reduction denialism

Incredibly, the TGA “did not identify compelling evidence in support of these claims for Harm Reduction”.

Tobacco Harm Reduction aims to reduce the health risks in continuing smokers by switching from combustible tobacco to a lower-risk smokeless alternative. This is exactly what HTPs do.

It is absurd that Australian law specifically allows combustible tobacco to be sold, but will not allow a much safer alternative which will save lives

This report calls the scientific credibility of the TGA into question.

Further submissions in response to this report can be made up till 9 July, and a final decision will be released in August.


Notice of interim decisions on proposed amendments to the Poisons Standard - ACMS/ACCS/Joint ACMS-ACCS meetings, March 2020

ATHRA's submission to the TG A 30 January 2020

Posted by Colin Mendelsohn,

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One Reply to “Australian smokers denied a safer alternative”

Suzanne Richards

Gave up cigarettes took up vaping and lost my smokers cough. Think about the butts on the ground from smokers, none from vaping also no disgusting smell. You legalise drug houses but ban vaping are you mad.

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