A nicotine analogue found in supposedly “nicotine-free” vapes and oral pouches will become a prohibited substance this week after the TGA raised concerns over toxicity, dependence, and misleading marketing.
A nicotine-like substance found in vaping products marketed as “nicotine-free” will become a prohibited substance from 1 October after the Therapeutic Goods Administration concluded that lesser restrictions would not adequately protect the public.
The regulator has made a final decision to place 6-methylnicotine in Schedule 9 of the Poisons Standard, citing its acute toxicity, dependence potential, and appearance in unapproved consumer products.
The move goes further than the Department of Health, Disability and Ageing’s original proposal to classify the substance as a Schedule 7 dangerous poison.
According to the TGA, 6-methylnicotine has been reported in several e-cigarette liquids sold in Australia and advertised as either nicotine-free or a nicotine alternative.
There was also evidence of the substance being added to oral pouches, the TGA said in a statement.
The proposal was prompted by concerns about the potential public health risks of the substance.
But after considering advice from the Advisory Committee on Medicines Scheduling, the TGA delegate decided Schedule 7 restrictions would not be enough and opted for the more stringent Schedule 9 classification.
The regulator received 163 public submissions during consultation before the committee meeting, nine of which included written components. One further submission was received following publication of the interim decision and supported the tougher classification.
The TGA said its main concerns were the acute toxicity of 6-methylnicotine, its use in unapproved products such as vapes and oral pouches, misleading marketing, and the risk of dependence.
The potential impact on vulnerable populations was singled out as a particular concern.
“There are no identified therapeutic benefits, and the risks outweigh any claims of safety,” the delegate said.
The regulator also pointed to misleading claims around products being sold as “nicotine-free” alternatives.
Schedule 9 classification would provide a stronger legal framework than Schedule 7 and allow more effective enforcement through higher penalties for unlawful supply and possession under Commonwealth and state and territory drug laws, the delegate said.
“6-methylnicotine is a high-risk substance with no therapeutic value and currently there are no lawful products in Australia that would be affected by this decision,” the TGA delegate wrote in their reasons for the final decision.
“Therefore, I have decided to immediately implement my decision to classify 6-methylnicotine as a Prohibited substance.”
The regulator opted for immediate implementation when the new Poisons Standard takes effect on 1 October.
The September decision also contains several other changes with potential relevance to prescribers.
The long-acting human growth hormone analogues somatrogon and lonapegsomatropin will receive explicit Schedule 4 entries, bringing their scheduling into line with the functionally similar somapacitan.
Somatrogon and lonapegsomatropin are primarily used to treat growth failure in children with inadequate endogenous growth hormone production, while somapacitan is also used as replacement therapy in adults with growth hormone deficiency.
Somapacitan was already a prescription-only medicine, but somatrogon and lonapegsomatropin were not explicitly scheduled.
All three medicines will now also be included in clause 5 of Appendix D, imposing additional controls on their possession or supply.
The TGA said medical supervision was necessary for the diagnosis and treatment of growth hormone deficiency and highlighted the importance of correct dosing.
It also cited the risk of adverse events from overdose and the misuse potential of all three substances in supporting the additional controls.
No public submissions were received in response to consultation on the interim decisions for the three growth hormone analogues. The changes take effect on 1 October.
The new Poisons Standard will also add eight new chemical entities, including several medicines that could increasingly cross the desks of GPs.
Bempedoic acid, efanesoctocog alfa, eplontersen, and gadoquatrane will each receive new Schedule 4 entries.
Gepotidacin, olutasidenib, and tapinarof will likewise be classified as prescription-only medicines. The notice does not provide further detail on their approved indications, prescribing requirements, or Australian availability.
Teplizumab will also enter Schedule 4, but with additional warning requirements under Appendix L. The mandatory warning states that teplizumab should not be used during pregnancy or for at least 30 days before a planned pregnancy.
Patients should also not breastfeed during treatment or for at least 30 days following the final dose.
All the new chemical entity scheduling changes will take effect with the new Poisons Standard on 1 October 2026.
The full report can be accessed here.
Related
In more TGA news, the regulator has launched Federal Court action over alleged unlawful advertising of prescription-only peptides.
The former company behind BioV8 and two of its directors are facing Federal Court proceedings over allegations they unlawfully advertised prescription-only peptides for conditions including cancer, HIV/AIDS, and mental illness.
The TGA has commenced proceedings against A.C.N. 641 483 703 Pty Ltd (formerly BioV8 Pty Ltd), as well as former directors Edward McGill and Nicholas Austin.
The regulator alleges BioV8 advertised peptides including BPC-157, CJC-1295, and GHRP-6 on its website and social media between June 2024 and July 2025, in breach of the Therapeutic Goods Act 1989.
The advertising allegedly promoted peptides for the treatment of serious diseases and conditions, including cancer, HIV/AIDS, and mental illnesses, the TGA said in a statement.
The TGA alleges the advertisements included restricted or prohibited representations without the required approval or permission. It also alleges Mr McGill and Mr Austin aided, abetted, counselled, or procured BioV8’s unlawful advertising.
The regulator said it would be seeking declarations and pecuniary penalties against the company and the two former directors. Proceedings against the company, which is in liquidation, are subject to the Federal Court granting leave.
TGA head Professor Anthony Lawler warned that the regulator was stepping up enforcement across the peptide industry.
“Businesses and individuals are reminded that the TGA will take legal action against all entities unlawfully operating in the peptide industry,” he said.
“This includes health practitioners, compounding pharmacies, social media influencers and telehealth clinics where we identify unlawful advertising of peptides.”
The TGA recently added unapproved peptide products to its priority focus areas following increased detection of alleged unlawful importation, supply, and advertising.
Many peptide products imported into and supplied in Australia are not included on the Australian Register of Therapeutic Goods and have not been assessed by the TGA for safety, quality, or effectiveness.
