Nicotine containing e-cigarettes are currently illegal to sell in every State and Territory (and illegal to have in your possession everywhere except SA) without a prescription, but oddly, and confusingly it is legal to import nicotine containing e-cigarettes. Following a lengthy review of this situation within the context of its role in designating and regulating controlled substances the Therapeutic Goods Administration (TGA), in a decision today, confirmed the earlier interim decision, to amend the Poisons Standard for Nicotine, from October 2021 consumers will require a doctors prescription to legally access or posses nicotine e-cigarettes and liquid. This decision creates a legal avenue to be in possession and use e-cigarettes that contain nicotine, but ONLY if you have a prescription.

In explaining the rational for the decision the TGA made reference to the 2,384 public submissions received following the opening of the interim decision for public comment and was predicated on protecting the benefit of nicotine as a smoking cessation treatment, when delivered as part of a medically supervised program and mitigating the risk of nicotine addiction in non smokers.

The decision of the TGA is “consistent with the existing ban in all states and territories on the sale of nicotine e-cigarettes without a doctor’s prescription” outlines the Government press release, that goes on to outline that in addition to removing duplication in the customs legislation the Government will also be working to ensure doctors and patients have access to the required resources to safely and effectively utilise the option of nicotine in e-cigarettes as part of a medically supervised smoking cessation plan. As part of this work the Government will also be providing $1M for an education campaign focused on smoking cessation.

While the program comes into effect from 1 October 2021 the Government highlights that any doctor may currently (right now) prescribe nicotine containing e-cigarettes that can be used by patients to achieve legal importation of personal use nicotine based e-cigarettes and that doctors can also register with the TGA to become “Authrorised Prescribers” which allows for dispensing through a pharmacy as an alternative to personal importation.

Business groups had lobbied for nicotine in e-cigarettes to be treated the same as in patches and gum, which are available for retail sale, however TGA outlined that the significant difference in the manner of use, delivery mechanism and use by the body itself and concerns over the safety of the delivery method in rejecting these calls, while at the same time highlighting that the patches and gum used to be prescription only when they were first introduced, and once they had a body of evidence of safe use were made more readily available.

Full copy of the decision of the Therapeutic Goods Administration, including research review – https://www.tga.gov.au/scheduling-decision-final/notice-final-decision-amend-current-poisons-standard-nicotine

Government press release – https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/preventing-nicotine-uptake-by-young-australians-with-prescription-based-vaping

ACAPMA

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