In a 'scaling up of regulatory attention’, the TGA has formally identified illegal peptides as a 2026 compliance priority.
The TGA has now expanded its priority focus areas for 2026–2027 to include unapproved peptide products amid rising concerns over consumer safety, importation, online advertising, and supply.
Deputy secretary of the Department of Health, Disability and Ageing and head of the TGA Professor Anthony Lawler said the decision was a risk-based response to an evolving market marked by increased imports and online advertising, including on social media, and emerging safety concerns.
“As the availability of unapproved peptide products has increased, so too has evidence of potential risk to consumers,” Professor Lawler said.
The push comes after the TGA reported seizing over 900,000 units of illegal therapeutic pharmaceuticals during a global operation targeting illicit and counterfeit drugs in May.
The regulatory watchdog also undertook a joint operation with the Australian Border Force and Victoria Police in April 2026, seizing more than $2 million worth of illicit steroids, performance and image enhancing drugs and peptide products.
Unapproved peptide products are those not listed in the Australian Register of Therapeutic Goods (ARTG).
Despite not having been evaluated for safety, quality or effectiveness, these illicit goods often claim a range of health benefits, including weight loss, muscle growth, anti-ageing, and enhancing athletic performance.
Dr Tim Jones, deputy chair of RACGP Tasmania and chair of the RACGP’s child and young persons’ health group, praised the TGA for advancing peptide regulation.
“It’s wonderful to see that they’re taking this step to better regulate a space where there really shouldn’t be as much marketing for these products as there is,” Dr Jones said.
He said unapproved peptides are not manufactured in accordance with Australian safety and quality standards.
“They may not contain the right ingredients or truly sterile ingredients, and there could be a risk of infection,” Dr Jones said.
Healthcare practitioners who compound, prescribe, or unlawfully supply unapproved peptide products may be subject to sanctions on their ability to practise by both the TGA and AHPRA, Dr Jones said.
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While GPs can apply to access unapproved therapeutic goods for individual patients through the Special Access Scheme, Dr Jones said these qualifying peptides have still been sourced through appropriate safety and quality channels.
Dr Jones emphasised the importance of adopting a harm minimisation approach when managing patients who are either interested in or already using unapproved peptides.
He said this includes ensuring patients are fully aware of the potential side effects, and for those continuing to use unapproved peptides, ensuring they are consistently monitored and supported through weaning off these products until the side effects settle.
“A lot of hype is out there about these products, but it’s not supported by high-quality clinical trials,” Dr Jones said.
Of the existing small trials, he said the populations examined aren’t relevant to those coming forward to request peptide prescriptions – namely, teenagers and young adults.
The TGA encourages consumers and health professionals to report any issues with unapproved peptide products.
