http://www.theaustralian.com.au/national-affairs/health/bat-moves-from-packaging-to-sue-tga-on-nicotine-inhalers/story-fn59nokw-1227590164902
One of the largest tobacco companies in the world has sparked another legal battle with the Australian government, over its refusal to allow its electronic cigarette to be classified as a legal health product.
British and American Tobacco has launched legal action against the Therapeutic Goods Administration claiming that the health authority did not even consider an application to have its Voke nicotine inhaler listed, much like other nicotine products that could help smokers quit the habit.
BAT’s nicotine product arm, Nicovations, has filed a claim in the Federal Court claiming that the TGA erred by not even reviewing the application, with Britain’s Medicine and Healthcare products Regulatory Agency recently allowing the product to be licensed like other nicotine-quitting products.
“Nicovations is disappointed that the Therapeutic Goods Administration has refused to evaluate our application for Voke in Australia,’’ BAT said in a statement. “We’ve been forced to seek a review of the TGA’s decision not to assess our application.”
The big tobacco companies took the Australian government all the way to the High Court recently in a failed bid to have laws forcing them to sell cigarettes in plain packaging overturned.
In a statement, BAT said the inhaler could prove more effective than other quitting products such as patches or gums, with the inhaler working on a different system to other e-cigarettes and not requiring heating.
“Nicovations would like to see the Australian government take a pragmatic and proportionate approach to regulating next generation nicotine products,’’ the statement said. “It seems unreasonable that adult smokers in Australia currently can’t legally access these types of products.”
Despite e-cigarettes still being illegal for sale in Australia, hundreds of thousands of people here are now estimated to use the products, which have been approved for use in Britain and in the EU.
While not commenting on the case, the TGA directed The Australian to its current advice on the products, which claims its hard line on e-cigarettes is based on nicotine’s classification as a “dangerous poison”. But it accepted it had not conducted an assessment of the products for quality and safety.
“Unlike Nicotine Replacement Therapy products, which have been rigorously assessed for efficacy and safety and, therefore, approved by the Therapeutic Goods Administration for use as aids in withdrawal from smoking, no assessment of electronic cigarettes has been undertaken and, therefore, the quality and safety of electronic cigarettes is not known,” the TGA states on its website.
A recent independent paper by the British Health Department evaluating the use of e-cigarettes found they were about 95 per cent less harmful than smoking cigarettes, could benefit poorer smokers and release negligible amount of toxins to bystanders.
“On the evidence, we believe e-cigarettes have the potential to make a significant contribution to the endgame for tobacco,’’ it said. “With opportunity comes risk, and a successful approach will be one that retains vigilance and manages these risks, while enabling a flourishing and innovative market with a range of safe and effective products that smokers want to use to help them quit.”