The Department of Health says it stands by the statements on its website that nicotine e-cigarettes are potentially unsafe and that there is no accepted evidence they contribute to smoking cessation.
A spokesperson for the department says it stands by these statements as well as the TGA's decision to allow their distribution from 1 October through community pharmacy to people with a prescription.
The spokesperson said the department's position on allowing the prescription-only distribution of these products "aligns" with advice from "Australia's medical experts" on the National Health and Medical Research Council and Australian Health Protection Principal Committee "who have warned of the health dangers of e-cigarettes."
"That decision also recorded that there is currently insufficient evidence to conclude whether e-cigarettes can benefit smokers quitting," said the spokesperson.
Against this backdrop, the spokesperson said the government is "taking a precautionary approach to e-cigarettes, based on the need to consider the overall impacts these products pose to population health, including on non-smokers and smokers."
They also dismissed any claim these products are significantly less harmful than tobacco. They said that while "it is generally accepted that" nicotine e-cigarettes are "less harmful" than tobacco products, the "precise extent of the difference is presently not clear and the 95% claim often referred to is widely discredited."
The TGA acknowledged this lack of evidence when it announced the plan to allow the distribution of nicotine e-cigarettes with a prescription.
The decision was quite the turnaround given its previous statements
The decision represented a significant backflip based on the evidence it gave to previous Senate committees on the risk of nicotine e-cigarettes, including as a 'gateway' to tobacco smoking.
During a Senate Estimates hearing in October 2018, Department of Health officials referred to evidence from the federal government's own CSIRO that "consistently suggests that the use of e-cigarettes by non-smoking youth predicts future smoking."
One official said, "Another piece of evidence from the United States National Academies of Sciences, Engineering, and Medicine that was released in January 2018 concluded that there was substantial evidence that e-cigarette use increases the risk of ever using combustible tobacco cigarettes among youth and young adults, and moderate evidence that e-cigarette use increases the frequency and intensity of subsequent combustible tobacco cigarette smoking."
These products are already freely available and now they can be advertised
TGA head John Skerritt was the delegate who made the decision in late 2020 to authorise their lawful distribution with a prescription. In early 2020, in evidence at a Senate Estimates hearing, Mr Skerritt acknowledged the existing ready availability of products for nicotine e-cigarettes. "It's very easy to obtain nicotine-containing e-liquids. A person in my block of units moved house recently, and I found on my doorstep, innocently and accidentally delivered, a very large bottle of nicotine-containing e-cigarette liquid. So it's very easy to purchase over the internet," he said.
The TGA head has publicly acknowledged the current but unlawful availability of products for nicotine e-cigarettes and he has now authorised their promotion through direct-to-consumer advertising.
The decision to allow the lawful distribution of these products has been accompanied by this recent authorisation that will allow the unbranded promotion of their availability with a prescription at pharmacies, including online through social media. The authorisation does not preclude the promotion of these products to children and adolescents.
The head of the US Food and Drug Administration (FDA) Dr Janet Woodcock recently told a congressional hearing that Altria, a tobacco company previously known as Philip Morris, significantly contributed to the current epidemic of youth nicotine vaping in the US. She said it was “the e-cigarette company most responsible for creating this epidemic.”
According to the US Centers for Disease Control and Prevention, in 2020 around one-in-five (19.6 per cent) American high school students reported they had used nicotine e-cigarettes in the past 30 days. In fact, young people in the US are four times more likely to use nicotine e-cigarettes than adults.
The FDA is now considering a possible ban on all flavoured e-cigarettes because of the risk to young people. The TGA has banned the promotion of flavours but not their sale.
Advocacy in support of nicotine e-cigarettes
At Senate Estimates in February 2019, South Australian Centre Alliance senator Stirling Griff revealed the extent of political advocacy in support of nicotine e-cigarettes. He said, "Most of us - probably all of us around here now - are constantly bombarded by lobbyists claiming that vaping is a life-saving technology because it helps smokers quit."
Two of the main makers and distributors of nicotine e-cigarettes are British American Tobacco and Altria.
Senator Griff's comment is an important backdrop to the performance of some government senators at Estimates in June. They were effusive in their support of the change to allow the availability of nicotine e-cigarettes. Senator Hollie Hughes questioned why general practitioners would not be compelled to prescribe the products. She described medical opposition to their availability as been based on "very strange ideological grounds". Senator Eric Abetz lamented the fact his home state of Tasmania has banned vaping in smoke-free areas. He then unsuccessfully pressured Mr Skerritt to agree that the use of nicotine e-cigarettes is less "injurious" than tobacco smoking. Senator Abetz also suggested access to nicotine e-cigarettes should not require a prescription.
Does this change make any sense?
Senior Department of Health officials publicly acknowledged these products are already freely available and that they are not safe, that they do not work as a tool to support smoking cessation and act as a 'gateway' to tobacco smoking, while a Senator has said the parliament has been "constantly bombarded by lobbyists" claiming the opposite. These products can now even be advertised through social media, albeit unbranded, but the regulator has not explicitly banned their promotion to children.
It is hard to make sense of this decision but Senator Griff's comment on advocacy as well as the performance of some other senators at Estimates in June seems quite revealing.