Final TGA decision: no vaping nicotine


The TGA has decided to maintain the current scheduling of nicotine, but harm minimisation stakeholders are concerned

The TGA has handed down its final decision on nicotine, which is to maintain the ban on the substance for use in e-cigarettes. The New Nicotine Alliance Australia consumer group had applied to exempt e-cigarette liquids containing low concentrations of nicotine from the Poisons Schedule.

This denies Australia a tool to reduce the high toll of death and disease from smoking, two tobacco harm reduction advocates said today.

“This runs against the growing evidence showing ‘vaping’ to be far less harmful to users and bystanders than deadly tobacco smoke,” says Dr Colin Mendelsohn, Associate Professor in the School of Public Health and Community Medicine at the University of New South Wales.

“Overseas experience and research shows e-cigarettes with low concentrations of nicotine can play an invaluable role as a quitting aid or long-term safer alternative to smoking. To ban them without giving due weight to that evidence is poor science and misguided, short-sighted policy.”

A/Prof Mendelsohn says it makes no sense that the TGA has banned low concentrations of nicotine for use in e-cigarettes to help smokers quit, yet specifically allows nicotine in “tobacco prepared and packed for smoking” to be sold widely in Australia.

E-cigarette researcher Professor Riccardo Polosa of the University of Catania in Italy is currently visiting Australia and is chairing a European Union expert technical committee developing e-vapour standards under the EU’s Tobacco Products Directive.

Professor Polosa says the best approach is to make these products available for adult smokers while setting sensible and enforceable quality and safety standards to protect users and the wider community.“Banning e-cigarettes with nicotine simply drives the market underground. The resulting unregulated market increases the risks of harm for users,’’ he says.

“Banning e-cigarettes with nicotine simply drives the market underground. The resulting unregulated market increases the risks of harm for users,’’ he says.“Ten years of overseas experience has found the claims of e-cigarette opponents are overstated. There is no reliable evidence e-cigarettes are acting as a gateway to smoking for children, or that they are ‘renormalising’ smoking behaviour.”

“Ten years of overseas experience has found the claims of e-cigarette opponents are overstated. There is no reliable evidence e-cigarettes are acting as a gateway to smoking for children, or that they are ‘renormalising’ smoking behaviour.”Simon Chapman, Emeritus Professor at the Sydney School of Public Health, University of Sydney,

Simon Chapman, Emeritus Professor at the Sydney School of Public Health, University of Sydney, welcomed an earlier decision by the TGA last month.“Australia has one of the lowest rates of smoking among adults and youth of any nation,” he told the AJP at the time. “It has been falling almost continually since the 1960s, and especially since the 1980s.

“Australia has one of the lowest rates of smoking among adults and youth of any nation,” he told the AJP at the time. “It has been falling almost continually since the 1960s, and especially since the 1980s.

“This has been achieved without e-cigarettes.”

The TGA received 71 public submissions on the matter, of which, 54 supported and 17 opposed the proposal.

The TGA’s reasons for its decision included:

  • Potential risk of nicotine dependence associated with the use of e-cigarettes.
  • Lack of evidence regarding the long-term safety of nicotine exposure using the devices.
  • Nicotine can cause nausea, vomiting, convulsions, bronchorrhoea, high blood pressure, ataxia, tachycardia, headache, dizziness, confusion, agitation, restlessness, neuromuscular blockade, respiratory failure and death in overdose.
  • The proposed maximum amount of 900 mg of nicotine per pack is within the estimated lower limit causing fatal outcome (500 mg to 1g). There have been reports of unintentional ingestion of ENDS liquid by children with severe outcomes in some cases.
  • Excepting nicotine from Schedule 7 would likely result in increased nicotine exposure via e-cigarettes.
  • The use of a label warning statement ‘not to be sold to a person under the age of 18 years’ is not likely to be effective unless there is enforcement of this requirement. There is a risk there will be inappropriate marketing and advertising of nicotine for use with ENDS if nicotine for use with ENDS is exempted from Schedule 7.

Read the full decision here.

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5 Comments

  1. Ben Howse
    24/03/2017

    Big Tobacco wins again. Wonder how much the advisory councils get from Big Tobacco/Pharma. I’d hope its a lot because to me, selling your soul seems like a pretty steep price.

  2. Adrian Miller
    24/03/2017

    “Nicotine can cause nausea, vomiting, convulsions, bronchorrhoea, high
    blood pressure, ataxia, tachycardia, headache, dizziness, confusion,
    agitation, restlessness, neuromuscular blockade, respiratory failure and
    death in overdose.”

    So, thats only nicotine in ecigs then…smoke sin every shop are safe TGA?

    Market protection by big Pharma and tobacco companies

    Noooo, Gary

  3. Fella
    24/03/2017

    if they stop me from my e cigs, i’m leaving the country to go somewhere where I can have them with nicotine legally.. I don’t drink or do other drugs (i suppose nic is a drug), I have back disabilities, it’s my absolute only vice. I’m a grown man, and I quit smoking with e cigs after 25 years of a pack a day or more, i enjoy them just as much as I did smoking, yet the government is happy for me to be poisoned with tobacco cigarettes but not with MUCH less harmful vapor e cigs. This is a dictatorship because we are talking about something that is available for routine purchase in a way more dangerous form. Sure there are dangers to children, but the fact is, most vapor users are ex smokers, who have chosen it for a healthier lifestyle.. All my coughing and phlegm stopped within a month.. tell me again how cigarettes are any better? Nicotine is no more dangerous than caffeine, as proven countless times.. If a child somehow got a large dose of caffeine, they’d be sick also. I import my nic from OS, i was hoping i could do it locally like a normal civilised country would allow, but if they stop me importing it, really, i am gone. Why would I stay? I can’t enjoy the one thing that makes me happy and is of no harm to anyone else and minimal to myself? Do they WANT me to go back to smoking? I haven’t had a cig in 3 whole years after i tried vaping.. 3 years.. guess what this is about guys, it taking away from tobacco sales, nothing more nothing less.. how dare they ban this, and allow cigarettes to be sold and smoked around children, or even smoked my pregnant mothers.. there is no law against that! This obsession with not allowing us to locally source nicotine for our e cigs is an absolute disgrace, to put it mildly.. Once e cigs take off in OZ and big tobacco are behind them, you watch the tune change.. just mark my words.. it’s all about government taxes and money for big tobacco and big pharma (patches and inhalers – oh but they are safe of course, even though a kid could think they are stickers and put them all over their body and die.. ever think of that?) The government is SO corrupt it is sickening. Just sickening.

  4. charlie
    26/03/2017

    Abolish excise taxes on tobacco and everybody will love ecigs and the inventors will get the Nobel prize in medicine. So called public health has nothing to do with the public’s health.

  5. Andrew Thompson
    28/03/2017

    > “Australia has one of the lowest rates of smoking among adults and youth of any nation,” he told the AJP at the time. “It has been falling almost continually since the 1960s, and especially since the 1980s.

    > “This has been achieved without e-cigarettes.”

    He can’t stop telling this fiction. That last part should read:

    > “This has been achieved without LEGAL e-cigarettes.”

    And those illegal e-cigarettes help hide the fact that his one idea of ‘bash smokers until they agree to try cold turkey the 12-14 times needed for it to take hold’ has run its course. The low hanging fruit of smokers who can be ‘encouraged’ into quitting by bullying tactics – has already been harvested.

    Simon has retired, time to retire his defunct ideas for the sake of the smokers who might prefer to trade up to a form of nicotine that has less than 5% of the risk, with all the satisfaction, of smoking.

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