The TGA has announced the current ban on nicotine in e-cigarettes will remain in place
An applicant had proposed that nicotine should be exempt from Schedule 7 at concentrations of 3.6% or less for self-administration via e-cigarette, for the purposes of reducing harms caused by smoking tobacco.
The applicant had stated that tobacco harm reduction provides an alternative pathway for smokers who are unable or unwilling to quit nicotine.
The ACCS-ACMS advised that the current scheduling of nicotine remains appropriate, however, due to factors including the risk of nicotine dependence associated with delivery via vaping, lack of evidence regarding safety of long-term exposure via the devices, and the risk that inappropriate marketing and advertising, including to under-18s, would follow a reschedule.
Simon Chapman, Emeritus Professor at the Sydney School of Public Health, University of Sydney, welcomed the decision.
“Australians have relied on the TGA scientific umpires to make decisions on the safety and effectiveness of drugs for decades,” he says.
“We have among the best drug regulation systems in the world and I’ve full confidence in the process.
“In light of recent evidence, the WHO’s international Agency for Research in Cancer has named nicotine as high priority for carcinogenic assessment.
“The recent US Surgeon General’s report on e-cigarettes listed serious concerns about nicotine and adolescent brain development.”
Against that background, the TGA’s decision is commendable, Prof Chapman says.
“Australia has one of the lowest rates of smoking among adults and youth of any nation. It has been falling almost continually since the 1960s, and especially since the 1980s.
“This has been achieved without e-cigarettes.
“The tobacco industry will unanimously condemn this decision. This is all anyone needs to know about why it should be welcomed.”