Businesses will face fines of up to $11 million from later this year if they supply nicotine vaping products that fall foul of a strict new set of safety guidelines from the medicines regulator.
From October, minimum safety and quality standards will come into effect for vaping goods that are supplied into Australia and are not registered in the Australian Register of Therapeutic Goods. There are currently no nicotine vaping products in the register.
Major reforms to vaping products will come into effect in October.
The move comes as part of an overhaul of vaping regulations which will mean Australians must have a prescription before buying e-cigarettes and vaping products online from overseas.
The new quality rules specify that the products must not contain any active ingredients other than nicotine. They also detail set labelling and packaging rules, including warnings to keep the goods out of reach of children.
Certain ingredients used for flavouring will also be banned from use because of evidence they pose health risks to consumers. These include cinnamaldehyde, which is used to create a cinnamon flavour, and acetonin, which is used to create a creamy flavour but has been associated with serious lung damage. Flavoured vape products are also particularly popular with younger Australians, with concerns that products containing nicotine also appeal to those under 18. Surveys reviewed by the Australian Drug and Alcohol Foundation suggest around 14 per cent of 12-14 year-olds have tried an e-cigarette.
A TGA spokeswoman said supplying non-compliant products was a criminal offence and could also result in civil penalties and fines “up to 5,000 penalty units for an individual – up to $1,110,000 – and 50,000 penalty units for a corporation – up to $11,100,000”.
The federal Department of Health held widespread consultation on the new standards, with advocacy group Quit arguing in its feedback that the regulator should be regularly tracking and updating restricted ingredients in line with new evidence about the risks they might pose.
“The TGA will revise the list in Schedule 1 to TGO 110 if and when more evidence becomes available showing that other ingredients used in nicotine vaping products carry demonstrable health risks associated with inhalation,” the TGA spokeswoman said.
British American Tobacco Australia argued in its submission on the rules that flavoured products should be available in the Australian market but with restrictions on the ingredients used.
“We support regulation that ensures that flavours and flavour ingredients in vapour products are not harmful to consumers’ health,” the company said.
Changes to Australia’s e-cigarette regulations mean that from October, the pharmacy sector will have a much larger role to play in sales of the product. Liquid nicotine will be able to be legally supplied domestically by pharmacists upon the presentation of a prescription.
The Pharmacy Guild of Australia says the move will be a significant change in the industry. “It is important for pharmacists to be assured that unapproved vaporiser nicotine products have met a minimum safety and quality standard prior to supply to a patient,” the group said in its submission on the new rules.