TGA strengthens compliance focus on unapproved peptide products as part of evolving risk response

The Therapeutic Goods Administration (TGA) has expanded its priority focus areas to include unapproved peptide products, following increased detection of unlawful importation, supply and advertising, posing potential risks to consumer safety.

Unapproved peptide products, often marketed for performance enhancement or anti-ageing, are increasingly being unlawfully advertised and supplied to Australians.

Professor Anthony Lawler, Deputy Secretary of the Department of Health, Disability and Ageing and head of the TGA, said the decision reflects a deliberate, risk-based response to an evolving market.

“The TGA’s compliance priorities are informed by intelligence and market monitoring, and updated as required,” Professor Lawler said.

“As the availability of unapproved peptide products has increased, so too has evidence of potential risk to consumers.”

The TGA has been monitoring peptide-related activity and is taking regulatory action in collaboration with partner organisations.

The TGA recently undertook a joint operation with Australian Border Force and Victoria Police, leading to the seizure of a vast quantity of peptide products, performance and image enhancing drugs (PIEDs) and illicit steroids, with an estimated street value in excess of $2 million.

The formal inclusion of peptides as a focus area reflects a scaling up of regulatory attention in response to increased importation, expanded online advertising and supply, and emerging safety concerns.

Many peptide products supplied in Australia are unapproved therapeutic goods, meaning they are not included on the Australian Register of Therapeutic Goods (ARTG) and have not been assessed by us for safety, quality, or effectiveness.

Unapproved peptide products may:

• not meet required standards for quality, safety or efficacy
• be incorrectly labelled or promoted, and
• pose risks if used without medical supervision.

“Australians should be very cautious about buying unapproved peptide products online, particularly from overseas websites or through online platforms or social media. If you don’t know exactly what’s in the vial, where it was made or whether it’s sterile, you could be putting your health at serious risk,” Professor Lawler said.

The TGA is prioritising compliance action against entities involved in the unlawful importation, manufacture, advertising and supply of peptide products.

Regulatory responses may include infringement notices, product seizures, import interventions and, where appropriate, civil or criminal penalties.

The compliance principles and full list of compliance focus products can be found on the TGA website Compliance Principles 2026 and 2027.

Consumers are advised that purchasing and using unapproved peptide products, particularly from online, social media or overseas sources, can pose significant health risks.

If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices or suspected non-compliant advertising on the TGA website.

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 7400