The Government is responding to the independent regulatory decision of the TGA today with a range of measures to support the cessation of smoking, and to help prevent teenagers taking up pathways to smoking.
As noted in the TGA decision (https://www.tga.gov.au/scheduling-decision-final/notice-final-decision-amend-current-poisons-standard-nicotine), from 1 October 2021, consumers importing nicotine will require a doctor’s prescription to legally access nicotine e-cigarettes and liquid nicotine. Child resistant closures for liquid nicotine will also be mandatory.
The TGA’s decision follows extensive public consultation, and is consistent with the existing ban in all states and territories on the sale of nicotine e-cigarettes without a doctor’s prescription. This is an independent decision of Government, which is legally binding.
In response to today’s decision, the Government will be taking the following actions:
- The previously proposed Customs (Prohibited Imports) Regulations will not be proceeding due to the significant overlap with the TGA decision.
- In consultation with the RACGP, AMA and other medical experts, the Government will develop a Telehealth Smoking Cessation item that will be available 6 months prior to the 1 October implementation date.
- As part of this work the Government will provide $1 million for an education campaign focussed on smoking cessation.
It is important to note that any doctor may currently prescribe nicotine containing e-cigarettes that can be used by consumers for personal importation. This is not widely understood, and it is an important matter of public information that over 30,000 GPs may currently, and in the future, prescribe nicotine-based e-cigarettes for smoking cessation.
Secondly, any of these GPs can also register with the TGA to become what is known as an ‘Authorised Prescriber’. A GP who is an Authorised Prescriber can issue prescriptions for e-cigarettes for dispensing at a local pharmacy as an alternate option to personal importation.
Nicotine containing e-cigarettes are currently illegal to sell in every State and Territory, and possession in all jurisdictions (except South Australia) is also illegal without a valid medical prescription. That means that there is a current situation that legally imported materials are then illegally possessed under state law. This decision will both reduce the risk of an on ramp for teenagers as highlighted by the delegate, while rectifying the issue of legal importation but illegal possession.
The TGA scheduling delegate’s reasons for the decision included, but were not limited to:
- The current available evidence does not support that e-cigarettes are a safer alternative to smoking cessation aids currently available.
- There is also currently insufficient evidence to conclude whether e-cigarettes can benefit smokers in quitting.
- Risk of nicotine addiction for new or continuing users.
- The introduction of novel nicotine delivery system may have a negative impact on tobacco control and may re-normalise smoking.
- Exposure to nicotine in adolescents may have long-term consequences for brain development, potentially leading to learning and anxiety disorders.
- Unknown toxicity of long-term exposure to heated and inhaled chemicals.
- Risk of accidental exposure to children, particularly in relation to liquid nicotine.
The delegate outlined that restrictions on the availability of e-cigarettes are necessary to mitigate the potential uptake of smoking in young adults who would otherwise be at low risk of initiating nicotine addiction.
We have already seen rapid growth of youth uptake in vaping overseas and already emerging in Australia. Specifically:
- Between 2015 and 2019, current e-cigarette usage by U.S. youth increased by approximately 1,128,000 young people aged 14-19 years (71.9% increase). This has resulted in a total of over 4 million U.S high students currently using e-cigarettes.
- In Australia between 2016 and 2019, the number of current e-cigarette users aged 15-24 increased by approximately 72,000 (95.7% increase) for a total of approximately 147,000.
- In addition, recent research from the Australian National University has found e-cigarette users are three times more likely to take up traditional cigarette products.
In particular, the TGA delegate found:
I have considered the Irish HRB reports, which conclude that adolescents using e-cigarettes are between three to five times more at risk of future initiation of cigarette smoking when compared to those who have never smoked e-cigarettes.
The findings of the Irish HRB reports were consistent with the SCHEER report, which concluded that there is strong evidence that e-cigarettes are a gateway to smoking for young people. Similar conclusions were reached in the ANU report, which found that, across multiple settings, non-smokers who use e-cigarettes are consistently more likely than non-e-cigarettes users to initiate cigarette smoking.
I regard the reports of the Irish HRB, SCHEER and ANU to be independent, credible and relevant to my deliberations on nicotine addiction associated with e-cigarette use in adolescents. It follows that I have attached significant weight to these reports on the basis that these are current and comprehensive scientific reviews undertaken by leading international organisations. I note that the findings of the three reports are broadly consistent.
This can be characterised as seeking to avoid an ON RAMP for non-smokers, especially youth.
At the same time, today’s decision is designed to facilitate a simple and legal option to nicotine containing e-cigarettes for smoking cessation – to provide the OFF RAMP for smokers.
The RACGP smoking cessation guidelines stipulate that nicotine containing e-cigarettes are not first line treatment for smoking cessation. However, for people who have tried to achieve smoking cessation with approved pharmacotherapies but failed, and who are still motivated to quit smoking and have brought up e-cigarette usage with their healthcare practitioner, nicotine containing e-cigarettes may be a reasonable intervention to recommend.
Where appropriate, consumers will be able to continue using nicotine e-cigarettes as a smoking cessation aid based on their doctor’s advice. Consumers will be able to purchase nicotine e-cigarettes from overseas, online or from local pharmacies, with a prescription.
The decision also aligns with advice from Australia’s medical experts, including the National Health and Medical Research Council and Australian Health Protection Principal Committee (AHPPC), who have warned of the health dangers of e-cigarettes.
Around the world we have seen much evidence of young people being introduced to nicotine through vaping for the first time, and in July 2018, a Victorian toddler died from nicotine poisoning.
The former head of the Food and Drug Administration in the United States, Scott Gottlieb M.D, referred to use of e-cigarette use amongst American youth as an ‘epidemic’.
The Government supports the independence of the TGA in making decisions around medicine availability and the approval of medicines, medical devices and vaccines for supply to Australians based on expert health advice. Scheduling decisions of the TGA are not subject to disallowance either by the Parliament of the Minister.
The delegate also took into account the Senate Committee Report of 18 December 2020, in addition to international evidence. The decision includes a post-market review as recommended in the report, and follows majority support for the independent role of the TGA under its Act, and support for this course of action.