2FIRSTS | Australia Adds 6-Methylnicotine to Schedule 9 Prohibited Substances, Effective October 1

Australia's Therapeutic Goods Administration (TGA) published a final decision on September 25, 2026, classifying 6-methylnicotine as a Schedule 9 prohibited substance under the Poisons Standard, effective October 1, 2026. The government originally proposed a Schedule 7 Dangerous Poison classification but, following consideration by the Advisory Committee on Medicines Scheduling, adopted the stricter Schedule 9 designation, citing acute toxicity, dependence risk, use in unapproved consumer products, misleading "nicotine-free" marketing, and lack of identified therapeutic benefits. TGA noted that 6-methylnicotine has been found in e-cigarette liquids sold in Australia as nicotine-free or nicotine alternatives, and in preparations such as oral pouches. A 2024 study in the Medical Journal of Australia found 6-methylnicotine in all nine nicotine-alternative vape products tested, with concentrations reaching about 100 mg/mL; routine nicotine analysis had failed to identify the compound, requiring nuclear magnetic resonance spectroscopy and mass spectrometry for characterization. Researchers noted the substance has higher affinity for some nicotinic cholinergic receptors than nicotine and psychotropic potency around three times that of nicotine, though long-term inhalation data remains limited. TGA considered 163 public submissions during the pre-meeting consultation. The decision targets the substance itself rather than any specific brand, and unlawful supply and possession will be subject to stronger legal controls under Commonwealth and state or territory drug laws. This follows earlier tightening of nicotine pouch regulation in July 2026, which eliminated all lawful consumer pathways to import or purchase nicotine pouches in Australia.

(Source：2Firsts)