G/TBT/N/AUS/151  
 
5 January 2023  
(23-0210) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  AUSTRALIA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Therapeutic Goods Administration, Department of Health and Aged Care  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
Department of Foreign Affairs and Trade  
tbt.enquiry@dfat.gov.au  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [X], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Nicotine -
containing products intended to be used in vaping devices such as e -cigarettes, e -cigars 
and other electr onic nicotine delivery systems (ENDs).  
One of the possible reform options would also affect the importation of vaping devices 
that do not contain nicotine (ENNDs).  
TOBACCO AND MANUFACTURED TOBACCO SUBSTITUTES (HS 24); PHARMACEUTICAL 
PRODUCTS (HS 30)  
5. Title, number of pages and language(s) of the notified document:  Potential 
reforms to the regulation of nicotine vaping products - consultation paper; (25 page(s), 
in English)  
6. Description of content:  The Therapeutic Goods Administration (TGA) is seeking 
comments on possible reforms to the regulation of ENDs. This includes vape liquids, e -
liquids and e -juices that contain nicotine and/or nicotine salts. This does not include other 
nicotine replacement therapies (NRTs) containing nicotine, such as patches, gum, 
lozenges, mouth spray and inhalators nor nicotine -containing products that are not 
intended for use in ENDs, such as chewing tobacco and snuff.  
One of the possible reform options would also affect the importation of vaping devices 
that do not contain nicotine.  
Since 1 October 2021, ENDs have been regulated as prescription medicines in Australia. 
The aim of the 2021 reforms was to prevent children and adolescents from accessing 
ENDs, whilst allowing smokers to access these products for smoking cessation with a 
doctor's prescription. However, evidence is emerging that the reforms are not meeting 
these aims. The TGA is considering whether refinements to the existing regulatory 
requirements for ENDs could be introduced to better support the intent of the 2021 
reforms , namely preventing children and adolescents from accessing ENDs while G/TBT/N/AUS/151  
 
- 2 - 
 
  supporting access to products of known composition and quality for smoking cessation 
with a doctor's prescription.  
The TGA is seeking comment on potential reforms in 4 main areas:  
1. Chang es to border controls for ENDs – to curb the unlawful supply of ENDs in 
Australia (one option includes to change the border controls for ENNDs to assist 
with the enforcement of the controls on ENDs (rather than with the aim of limiting 
access to ENNDs))  
2. Pre-market TGA assessment of ENDs against a product standard – to create a 
regulated source of quality ENDs to encourage doctors to prescribe, pharmacies 
to supply and vaping consumers to purchase 'safer' products lawfully  
3. Strengthening the product standard regarding minimum quality and safety 
standards for ENDs – to make them less attractive to children and adolescents, 
for example by not permitting certain flavours or labelling  
4. Clarifying the status of ENDs as 'therapeutic goods' – to ensure that any vaping  
product containing nicotine is captured by the regulatory framework.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The broad objectives of the potential reforms are to prevent children and 
adolescents from accessin g ENDs, while supporting access to ENDs of known composition 
and quality for smoking cessation with a doctor's prescription.  
Australia takes a precautionary approach to the regulation of ENDs because of the 
potential adverse health effects associated with their use. There is evidence that END use 
by young people can be a gateway to smoking and nicotine addiction. Further, given that 
ENDs are relatively new products, the effect on most clinical outcomes is unknown.  
However, there is some evidence that ENDs c an be useful for smoking cessation, and they 
are available for this purpose in Australia with a doctor's prescription. Some of the possible 
reforms are directed at ensuring that ENDs that are accessed for smoking cessation meet 
minimum quality and safety r equirements, including relating to consumer information and 
labelling.; Consumer information, labelling; Prevention of deceptive practices and 
consumer protection; Protection of human health or safety; Quality requirements  
8. Relevant documents:  The consultation paper is at: Proposed reforms to the regulation 
of nicotine vaping products - Therapeutic Goods Administration - Citizen Space 
(tga.gov.au)  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Proposed reforms to the regulation of nicotine vaping products - Therapeutic Goods 
Administration - Citizen Space (tga.gov.au) (see also link to relevant document in section 
8 of this notification).