TGA Consults on Vaping Regulatory Reform


Ellesmere Zhu


Australian Therapeutic Goods Administration (TGA) is seeking public comment on potential reforms to the regulation of nicotine vaping products in Australia. The potential reforms are aimed at preventing children and adolescents from accessing nicotine vaping products while supporting access to products of known composition and quality for smoking cessation with a doctor’s prescription.


The administration states that the reformed vaping regulatory system starting October 1, 2021 cannot fulfill its wish to limit vaping among prescribed smokers as "children are continuing to access nicotine vaping products in higher numbers, and many adults are accessing them on the black market, rather than lawfully with a prescription from an Australian registered doctor".


Public comment on potential reforms is sought in four main areas:


  1. Changes to border controls for nicotine vaping products to curb the unlawful supply of nicotine vaping products in Australia
  2. Pre-market TGA assessment of nicotine vaping products against a product standard to create a regulated source of quality products to encourage doctors to prescribe, pharmacies to supply and vaping consumers to purchase safer and quality assured products lawfully
  3. Strengthening the product standard regarding minimum quality and safety standards for nicotine vaping products to make them less attractive to children and adolescents
  4. Clarifying the status of nicotine vaping products as therapeutic goods to ensure that any vaping product containing nicotine is captured by the regulatory framework.

The public consultation will be open until 16 January 2023 and feedback can be submitted via the TGA Consultation Hub. The responses will be analyzed and any proposed reforms will be taken forward in discussion with the Government. If changes to the regulatory framework are made, suitable transition periods will apply.


A black market has escaped the hands of Australia's vaping regulatory policies. Vaping popularity has grown by 259% over the last five years, with 5.8% of the adult population regularly vaping. Some 88% of vapers are buying nicotine vapes without a prescription, while more than 1000 Australian stores illegally sell vapes to young people, reports The Australian.


2FIRSTS will continue to follow up on the dynamics of e-cigarette regulations worldwide. Please stay tuned.




*The content of this article is written after the extraction, compilation and integration of multiple information for exchange and learning purposes. The copyright of the summary information still belongs to the original article and its author. If any infringement is found, please contact us to delete it.