From October 1st 2021, Australian vapers will require a valid Australian medical prescription to access nicotine e-cigarettes (and other nicotine products).
This guide covers:
- Regulation of nicotine in Australia
- Why the TGA requires a prescription to vape nicotine in Australia
- Obtaining nicotine e-cigarettes in Australia
- How to get a prescription for nicotine vaping products in Australia
- Safety standards for unregistered vaping products in Australia
Regulation of Nicotine in Australia
While the Australian Treasury oversees taxation levels of tobacco taxes, nicotine is overseen by the Therapeutic Goods Authority (TGA). The reason for this is because nicotine has historically been governed under The Poisons Standard. In December 2020, the TGA made an amendment to the poisons standard, reclassifying nicotine (for human use) from a Schedule 7 Substance (Dangerous Poison) to a Schedule 4 substance (Prescription only medicine).
In addition, the TGA has created various quality standards for nicotine products including toxicity (strength), labeling and child resistant packaging for more information please refer to "Safety standards for unregistered vaping products in Australia".
Why the TGA requires a prescription to vape nicotine in Australia
Although the TGA acknowledges that vaping nicotine is less harmful than smoking, the decision to regulate nicotine as a prescription only medicine is based on a cautious approach aimed at striking a balance between prevention of adolescents and young adults from taking-up nicotine while still allowing current smokers to access these products for smoking cessation with appropriate medical advice.
The Australian prescription model is in stark contrast to most other developed nations such as the United Kingdom, Europe, the United States and New Zealand who taken more of a light touch approach; embracing nicotine vaping as a tobacco harm reduction tool, classified as a consumer good.
Obtaining nicotine e-cigarettes in Australia
Usually, prescription only medicines are listed as approved by the TGA on the Australian Register of Therapeutic Goods (ARTG). Obtaining an approval from the TGA on any Therapeutic Good is an extremely complex and costly process, designed for use for large Multinational Pharmaceutical Companies. For this reason, there are currently no TGA approved nicotine e-cigarettes in the Australian Register of Therapeutic Goods (ARTG).
The "good" news is, there are established pathways for consumers to access medicines not included in the ARTG are known as 'unapproved' medicines. Which implies the TGA is genuinely serious about continuing legal access to "unapproved" nicotine e-cigarettes, with a valid prescription.
Pathway 1: Personal importation
If you've ever purchased nicotine vaping products from overseas, you're already well versed in the personal importation pathway. Under the TGA Personal Importation Scheme, users can import nicotine e-cigarettes legally, so long as you have a doctor's prescription. If a medical practitioner believes it is appropriate for you to use nicotine vaping products, they can prescribe it to you without the need for TGA approval.
The TGA recommends that you request the overseas store you purchase nicotine vaping products from to put a copy of your prescription inside your order to ensure minimal delays at customs when the Australian border force are inspecting your package.
Pathway 2: Supply in Australia
You will also be able to obtain nicotine vaping products from local pharmacies (online and in store) based in Australia. However, under this pathway you will need to acquire a prescription from an authorized prescriber. Because this is a "new pathway" for vaping, if you're looking for a particular brand or flavor that works well for you, you're probably best suited to the personal importation scheme.
How to get a prescription for nicotine vaping products in Australia
If vaping is right for you, you shouldn't have any problems getting a prescription for nicotine.
Vaping could be right for you if:
- You're a current or ex-smoker
- You're an adult aged 18+
- You want to stop smoking, and cold turkey and/or other nicotine replacement therapy hasn't worked for you.
Your first port of call should naturally be your local GP. While there are relatively few current medical practitioners actively prescribing nicotine vaping products face to face - check out the Athra website here, there are some incredibly effective Doctors who specialise in online consultations.
We tried out QuitClinics and successfully obtained a 12 month nicotine prescription in less than 2 hours for AUD $85.
Step 1: Go to the QuitClinics.com website and click "Apply for Prescription"
Step 2: Enter your contact details
Step 3: Complete your Smoking History Details
Note here you should answer them honestly to ensure you get prescribed the right nicotine vaping products (if any) for you.
Step 4: Complete your vaping details
In this section, be as detailed as possible when answering what vaping products you have used. If you tend to use a multitude of nicotine strengths, enter the maximum, QuitClinics will also provide you a weaning off plan to help you down-nic. The "weaning off plan" is a recommendation
Step 5: Continue to checkout
In this step you will need to have your drivers license on hand to verify your age, use code 'FRIEND10' to save 10% off the consultation fee.
Step 6: Consultation Complete
Within a few hours (up to 24 hours) you will receive your consultation documentation including a prescription, weaning schedule and a letter you can hand to your GP.
Safety standards for unregistered vaping products in Australia
The TGA have set quality standards for unregistered vaping products in Australia that you should pay attention to when purchasing under the personal importation scheme. The good news is these standards are based on pre-existing product standards already in place within the United States, Europe and New Zealand.
The full standards are known as Therapeutic Goods (Standard for Nicotine Vaping Products (TGO 110) Order 2021(link is external) A summarized version of these standards is as follows:
- Maximum Nicotine Concentration of 100mg per ml. Please note this allows for mix your own nicotine (where you buy locally made eliquid and mix in nicotine concentration). In Ready to vape premixed eliquids, the maximum you should use is 50mg/ml for nicotine salts and 24mg for freebase nicotine.
- Nicotine tolerance threshold of +/- 10% , meaning the actual measured nicotine content must be between 90% and 110% of the labeled concentration.
- Prohibited Ingredients - in line with USA, European and New Zealand nicotine vaping product standards.
- diethylene glycol
- dl-alpha-tocopheryl acetate
- ethylene glycol
- Labeling Requirements (In English)
a list of ingredients contained in the nicotine vaping product as follows:
(a) the name of each active ingredient; and
(b) the name of each other ingredient; and
(c) where the product contains a flavour—either:
(i) the word “flavour” or a description that includes the word “flavour” (such as “cherry flavour”); or
(ii) the name of each ingredient contained in the flavour
- the concentration of nicotine contained in the nicotine vaping product as "mg per ml"
the following warning statements:
(a) “KEEP OUT OF REACH OF CHILDREN”; and
(b) “Avoid contact with eyes”; and
(c) “Avoid contact with skin”
- Child Resistant Packaging - compliant if products comply to either of:
- Canada Vaping Products Labelling and Packaging Regulations
- European Union - Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014
- New Zealand Smokefree Environments and Regulated Products Act
- United Kingdom Tobacco and Related Products Regulations (TPD)
- United States Poison prevention packaging standards