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Australia turns down appeal to reclassify nicotine for e-cigarette use

Written by || 23rd March 2017 || Regulatory news analysis |

Australia - Lenny K PhotographyAustralian authorities have refused to legalise nicotine-containing e-liquid despite appeals to support e-cigarettes for harm reduction.

A proposal submitted by the New Nicotine Alliance Australia (NNA), an e-cigarette lobbying group, was rejected by the Therapeutic Goods Administration (TGA) – an Australian Department of Health body charged with regulating products with potential medicinal claims.

The TGA had previously declared nicotine a controlled substance and banned its use outside of nicotine replacement therapy (NRT) products and tobacco products. As a result, the sale of nicotine-containing e-cigarettes is illegal in Australia, although there are users.

The NNA wanted the TGA to change its stance on nicotine in the light of evidence supporting e-cigarettes as a harm reduction technique.

It proposed strict requirements on allowable nicotine, including a maximum e-liquid concentration of 3.6%, a maximum container dosage of 900mg and for all e-liquids to come in child-resistant bottles with specific warning labels.

However, the TGA declined to make the change. It said the current classifications for nicotine were appropriate as there was a risk of nicotine addiction, there was little evidence on the long-term effects of vaping, and views varied on the effectiveness of e-cigarettes in smoking cessation.

 

For and against

 

According to the TGA, e-cigs also presented a risk of nicotine poisoning. It said labelling products as “18+” was not enough to prevent their use by young people without active enforcement, which would require further amendments.

The TGA said it had received a number of submissions from both sides. It said that 87 were in favour of e-cigarettes while 22 opposed measures which would increase their presence in the country.

The supporting arguments said that current law in Australia was confusing as vaping was already common in the country through personal importations. This meant changing the law would reduce confusion and the risks associated with grey market supply from uncertain producers overseas.

Changing the law would eliminate this and proper labelling, coupled with active policing of under-age sales, would reduce or eliminate many of the worries that lay behind the current prohibition.

Further submissions included international evidence on e-cigarettes and smoking cessation as well as personal accounts of quitting tobacco through e-cigarettes when other nicotine replacement methods had failed.

It was argued that nicotine itself was relatively harmless, that it was difficult to suffer nicotine poisoning as the substance is an emetic, which would cause vomiting if swallowed, and that other toxin levels in vapour were below occupational exposure levels.

 

Poisoning by contact

 

Opposing submissions linked youth e-cig use to taking up conventional smoking and suggested that poisoning in children can happen through ingestion or skin contact. They added that there was limited scientific evidence to support e-cigs’ effectiveness in smoking cessation, and no evidence on the long-term health effects of vaping.

They said nicotine was highly addictive, that most vapers dual use, and that much of the push behind e-cigs mirrors traditional tobacco advertising tactics, such as assertions that light or filtered conventional cigarettes are healthier.

The Intergovernmental Committee on Drugs (IGCD), which reports to the Australian Health Ministers’ Advisory Council Mental Health, Drug and Alcohol Principal Committee, has been asked to produce a report on the options available for dealing with e-cigarettes. The report, which was initially due in mid-2016, is expected soon, but it is unknown when the IGCD will meet to discuss it.

The decision to reject the NNA proposals means that nicotine can continue to be imported into Australia by an individual for use as an “unapproved therapeutic good”. However, the consumer must have a prescription from a doctor registered in Australia and is limited to a three-month supply as determined by the manufacturer’s product use guidelines.

 

What This Means: The decision, which was expected, means that Australia will continue to branch away from its Oceanic neighbour New Zealand on the subject of e-cigarettes. ECigIntelligence will provide a more in-depth look at the ramifications and fallout soon.

– Freddie Dawson ECigIntelligence staff

Photo: Lenny K Photography