Key Points
- Australia will classify 6-methylnicotine as a Schedule 9 prohibited substance from October 1, 2026.
- The government initially proposed Schedule 7 but moved to Schedule 9 to strengthen controls over unlawful supply and possession.
- TGA said the substance has appeared in nicotine-free or nicotine-alternative e-cigarette liquids sold in Australia and is also being added to preparations such as oral pouches.
- An Australian study tested nine nicotine-alternative vape products and found 6-methylnicotine in all nine, with concentrations reaching about 100 mg/mL.
2Firsts
September 29, 2026
Australia's Therapeutic Goods Administration published a final decision on September 25 to classify 6-methylnicotine as a Schedule 9 prohibited substance under the country's Poisons Standard, effective October 1, 2026.
TGA said 6-methylnicotine has been reported in several e-cigarette liquids sold in Australia and advertised as nicotine-free or as nicotine alternatives. The regulator also cited evidence that the substance is being added to preparations such as oral pouches.
Australia Moves From Proposed Schedule 7 to Schedule 9
The Department of Health, Disability and Ageing initially proposed creating a Schedule 7 Dangerous Poison entry for 6-methylnicotine.
Following consideration by the Advisory Committee on Medicines Scheduling, the regulator ultimately confirmed an interim decision to place the substance in the more restrictive Schedule 9 category.
TGA cited acute toxicity, use in unapproved consumer products, misleading “nicotine-free” marketing and the risk of dependence, particularly among vulnerable populations.
The regulator said there are no identified therapeutic benefits for 6-methylnicotine and no lawful products currently available in Australia that would be affected by the decision.
TGA said Schedule 7 would not provide sufficient controls, while Schedule 9 offers a stronger legal framework for action against unlawful supply and possession, including higher penalties under Commonwealth and state or territory drug laws.
Study Found 6-Methylnicotine in All Nine Vape Products Tested
The regulatory decision follows earlier Australian research into products marketed as nicotine alternatives.
A 2024 study published in the Medical Journal of Australia analysed nine e-cigarette products purchased in Australia in November 2023 from three manufacturers. The samples included four concentrated solutions for dilution and five ready-to-use disposable devices or pod cartridges.
Products carried descriptions including “nicotine derivative,” “nicotine alternative agent,” “no-nicotine nicotine solution” and claims of a nicotine-like experience without nicotine.
Laboratory testing found 6-methylnicotine in all nine products.
Two concentrates labelled as equivalent to 100 mg/mL nicotine contained about 31.4 mg/mL and 20 mg/mL of 6-methylnicotine. Of two products labelled as 10% solutions, one contained about 100 mg/mL and the other about 57 mg/mL.
Brand names were not disclosed in the published study.
Routine Nicotine Analysis Did Not Identify the Compound
Researchers said the ingredient in all nine products was not identified by the routine analytical testing they used for nicotine.
They subsequently used nuclear magnetic resonance spectroscopy and high-resolution mass spectrometry to identify and fully characterise it as 6-methylnicotine.
The study cited laboratory evidence indicating that 6-methylnicotine has higher affinity for some nicotinic cholinergic receptors than nicotine and referenced earlier research reporting psychotropic potency around three times that of nicotine.
Researchers also said data on long-term inhalation and human health effects remain limited.
TGA Considered 163 Initial Public Submissions
TGA said it considered 163 public submissions during the pre-meeting consultation, nine of which included a written component.
One further submission was received during consultation on the interim decision and supported the stronger Schedule 9 classification.
The final decision confirmed the interim position and set an implementation date of October 1.
Schedule 9 Decision Targets the Substance Itself
Australia had already tightened separate product-level controls on vaping goods and nicotine pouches before the latest decision.
Non-therapeutic vapes cannot be supplied through ordinary retail channels, while regulated therapeutic vaping goods remain available through pharmacies under applicable requirements.
Australia tightened nicotine pouch regulation again in July 2026. From July 24, consumers can no longer import nicotine pouches under the Personal Importation Scheme or access unapproved pouches through the Special Access Scheme, Authorised Prescriber Scheme or pharmacist compounding pathways. TGA says there is now no lawful pathway for consumers to buy or import nicotine pouches in Australia.
The latest decision does not target a particular vape or pouch brand. It schedules 6-methylnicotine itself as a prohibited substance.
TGA's final notice does not identify specific vape brands, oral pouch brands or manufacturers linked to the substance.
From October 1, unlawful supply and possession of 6-methylnicotine will be subject to the stronger legal controls associated with Schedule 9 under Commonwealth and state or territory drug laws.
Follow 2Firsts for updates on global vape, nicotine pouch and novel nicotine-analogue regulation.
Cover Image: Therapeutic Goods Administration
