Medical groups have welcomed the TGA’s rejection of a bid by tobacco companies to sell ‘heat-not-burn’ (HnB) vaping products in Australia.
On 10 June the regulator rejected an application by Philip Morris International to exempt nicotine in tobacco prepared and packed for heating [also known as heated tobacco products or HTPs] from current restrictions imposed on nicotine products.
The TGA did not accept the tobacco company’s claim that there would be a public benefit from offering heat-not-burn product as a safer alternative to cigarettes. It said there were already evidence-based nicotine replacement products on the market, and the tobacco company had provided no evidence that heat-not-burn products were as effective in smoking cessation or that they were safe.
The nicotine in heat-not-burn products presents a severe hazard from repeated use leading to potential addiction and a significant risk of producing irreversible toxicity, which may involve serious, acute or chronic health risks or death, the TGA found. It also pointed to the risks of tobacco/nicotine products in children and young people who were never smokers.
The proposal was opposed by 23 healthcare and medical groups including the Stroke Foundation, the National Heart Foundation of Australia, The Australian Council on Smoking and Health and the AMA.
“As the nation’s leading and most trusted lung health charity, we endorse the unequivocal, evidence-based decision of the TGA,” said Lung Foundation Australia Chief Executive Officer Mark Brooke.
“On behalf of Australians experiencing lung disease and those health professionals that support our work – and all Australians who contributed to our submission to the TGA, we are pleased that the TGA has taken the decision to reject PMI’s application to sell HnB products in Australia.”
“In taking such a clear and strong stance, the TGA have protected the 30 plus year gains Australians have made in ending nicotine addiction and secured stronger respiratory health for all Australians – particularly young Australians.
“HnB devices are addictive, dangerous and designed to deliver big profits to Big Tobacco. Lung Foundation Australia will continue its fearless evidence-based advocacy to achieve a tobacco-free future for all Australians.”
The TGA decision was condemned by Dr Colin Mendelsohn of the Australian Tobacco Harm Reduction Association, who said that smokers had been denied a safer alternative product.
He said the TGA had ignored evidence that heat-not-burn products were substantially safer than smoking and that misuse was minimal.
“Any risk for smokers should be compared to the toxic combustible products they are designed to replace,” he said.