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.