Announcement date
15/12/23
Link to announcement
- Therapeutic Goods (Excluded Goods) Amendment (Vaping) Determination 2023
- Therapeutic Goods (Medicines—Authorised Supply) Amendment (Vaping) Rules 2023
- Therapeutic Goods (Articles that are Not Medical Devices) Amendment (Vaping) Declaration 2023
- Therapeutic Goods (Medical Devices—Specified Articles) Amendment (Vaping) Instrument 2023
- Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Amendment (Vaping) Order 2023
- Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023
- Therapeutic Goods (Information Specification—Therapeutic Vaping Goods and Vaping Devices) Instrument 2023
- Federal Register of Legislation - Customs Legislation Amendment (Vaping Goods) Regulations 2023
- Federal Register of Legislation - Customs (Prohibited Imports) (Vaping Goods) Approval 2023
- Federal Register of Legislation - Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023
Problem being addressed
Vaping is rapidly increasing in Australia, particularly among youth and young adults. The latest available trend data shows that among young people aged 14 years and over, current use of vapes (defined as use at least once in the month prior to being surveyed) increased from 2.5% to 7.5% between 2020 and 2022. The increase was even more marked among people aged 18-24 years old, increasing from 5.6% in 2020 to 21.4% in 2022. The health risks of vaping are substantial. A review of global evidence published in April 2022 found substantial evidence that vaping by non-smokers results in dependence and conclusive evidence that vape use can cause respiratory disease, severe burns, poisoning and seizures. Collectively, this evidence highlights that the existing controls governing the marketing and use of vapes should be strengthened.
Proposal
The Impact Analysis (IA) examines options to reduce vaping-related harm among Australian adults and teenagers. The proposed measures would strengthen regulatory arrangements to ensure consumers would only be able to lawfully access vapes under a prescription from a registered pharmacist or other person authorised to supply prescription medicines. Relevant product standards would also be strengthened to limit flavourings, introduce plain packaging, and reduce the maximum allowable nicotine concentration in vaping e-liquids. Disposable single use vapes would be banned.
Assessed Impact Analysis outcome
Good practice
Assessment comments
The IA includes an excellent implementation plan for recommended option, including a detailed explanation of the expected rollout of the proposed new regulatory framework. To have been assessed as ‘exemplary’ under the Guide, the IA would have needed improvement across all questions, but would have benefited most from further detailed analysis of the evaluation activity and of alternatives to Government action.
Regulatory burden
$59.46m