On September 25th, the Therapeutic Goods Administration (TGA) of Australia announced its final decision to include 6-methylnicotine in Schedule 9 “Prohibited Substances” of the Australian Toxics Standard. The new classification will take effect on October 1st, 2026.
TGA stated that 6-methylnicotine has been reported to be present in multiple e-liquids sold in Australia, which are marketed as “nicotine free” or “nicotine substitutes”. The regulatory documents also indicate that there is evidence to suggest that the substance has been added to formulations such as oral pouches.

Core Overview

Australia has listed 6-methylnicotine as a prohibited substance under Schedule 9, effective from October 1, 2026.
The regulatory authorities initially proposed Schedule 7 classification, which was eventually raised to Schedule 9 to strengthen law enforcement against illegal supply and possession.
TGA states that 6-methylnicotine has appeared in “nicotine free” or “nicotine replacement” e-liquids sold in Australia, and there is evidence to suggest that it is also used in oral pouches.
Australian researchers previously tested 9 “nicotine replacement” vape products, all of which detected 6-methylnicotine with a maximum concentration of about 100 mg/mL.

Australia Has Included 6-methylnicotine In Its Poisons Standards (1)

Upgrade from Schedule 7 to Schedule 9

The Australian Department of Health, Disability and Aging initially proposed to establish a Schedule 7 “Dangerous Poison” entry for 6-methylnicotine.
After review by the Advisory Committee on Medicines Schedu ling (ACMS), the regulatory authorities have finally confirmed their previous interim decision to include 6-methylnicotine in the more stringent Schedule 9 “Prohibited Substances”.
The main risks identified by TGA’s final decision include acute toxicity, use in unapproved consumer products, misleading marketing through “nicotine free alternatives”, and dependence risks, particularly the potential impact on vulnerable populations.
The regulatory authorities have stated that no therapeutic benefits have been found for 6-methylnicotine, and there are no legally sold products in Australia that will be affected by this decision.
TGA believes that Schedule 7 is insufficient to manage related risks, while Schedule 9 can provide a stronger legal framework for more effective enforcement of illegal supply and possession, and apply higher penalties.

2024 study: All 9 nicotine replacement vapes detected

6-methylnicotine has entered the regulatory field in Australia, which is directly related to the chemical analysis of market products previously conducted.
A study published in the Medical Journal of Australia in 2024 analyzed 9 vape products purchased by researchers from the Australian market in November 2023, involving 3 manufacturers, including 4 concentrated solutions for dilution and 5 disposable vape or cartridge ready to use products.
The related products use labels or promotional statements such as “nicotine derivative”, “nicotine alternative agent”, “no nicotine nicotine solution”, and “nicotine experience without nicotine”.
Laboratory analysis shows that all 9 products contain 6-methylnicotine.
Among them, two concentrated solutions labeled as “100 mg/mL nicotine equivalent” actually contain approximately 31.4 mg/mL and 20 mg/mL of 6-methylnicotine, respectively; Among the other two concentrated products labeled as “10%”, one has a detection concentration of about 100 mg/mL, and the other has a detection concentration of about 57 mg/mL.
The study did not disclose the brand names involved.

Australia Has Included 6-methylnicotine In Its Poisons Standards (2)

Conventional nicotine testing did not identify the substance

The researchers stated that the relevant components in these 9 products could not be identified by the conventional nicotine analysis methods used, and subsequently confirmed to be 6-methylnicotine through techniques such as nuclear magnetic resonance spectroscopy and high-resolution mass spectrometry.
The study also cited laboratory data stating that 6-methylnicotine has a higher affinity for some nicotinic acetylcholine receptors than nicotine, and reported that previous studies have shown that its psychoactive potency may be about three times that of nicotine.
Researchers also pointed out that there is currently a lack of sufficient data on the long-term inhalation and human health effects of this substance.

TGA receives 163 preliminary public opinions

TGA disclosed in the final decision that a total of 163 submissions were received during the public consultation stage prior to formal review, of which 9 included written materials.
In further public consultation after the temporary decision was released, TGA received one opinion supporting the adoption of a stricter Schedule 9 classification.
The final decision confirms the previous interim decision and sets the implementation date for October 1st.

New classification for 6-methylnicotine itself
Australia has previously tightened product regulations for vapes and nicotine pouches separately.
Since 2024, Australia has banned the sale of non therapeutic vapes through regular retail channels. Therapeutic vapes are supplied through the pharmacy system while meeting regulatory requirements.
Nicotine pouch regulation will be further tightened in 2026. Starting from July 24th, consumers are no longer allowed to import nicotine pouches through the Personal Import Program, nor can they obtain unapproved nicotine pouches through the Special Access Scheme, Authorized Prescriber Scheme, or pharmacist dispensing channels. TGA stated that there is currently no legal way for consumers to purchase or import nicotine pouches.
The Schedule 9 decision this time is not targeting any particular brand of vapes or nicotine pouches, but rather the chemical substance 6-methylnicotine.
The TGA’s final decision did not disclose the specific vape brand, oral pouch brand, or manufacturer name related to the substance.
Starting from October 1st, 6-methylnicotine will be subject to independent regulation as a Schedule 9 prohibited substance, and its illegal supply and possession may be subject to enforcement regulations under federal, state, and territorial drug laws.

Australia Has Included 6-methylnicotine In Its Poisons Standards (3)