The Therapeutic Goods Administration has added unapproved peptide products to its priority compliance focus areas, citing increased detection of unlawful importation, supply and advertising in Australia.
The regulator said the decision reflects rising concern about peptide products being marketed online for uses including performance enhancement and anti-ageing, despite many not being included on the Australian Register of Therapeutic Goods (ARTG).
Professor Anthony Lawler, Deputy Secretary of the Department of Health, Disability and Ageing and head of the TGA, said the move was part of a deliberate, risk-based response to changing market activity.
‘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.’
Peptides move further into regulatory spotlight
The announcement follows a series of recent warnings and enforcement actions involving unapproved therapeutic goods, including products promoted in aesthetic, wellness and performance settings.
In April, the TGA issued a warning on peptide imports and compounding, cautioning that unapproved peptide products may pose risks including contamination, incorrect dosing and variability in formulation.
Much of this activity is occurring through the peptide grey market, where products are often sourced directly from overseas suppliers and promoted across social media and wellness communities for aesthetic, performance, longevity and body composition claims.
The issue sits within the wider growth of wellness medicine, including increasing interest in peptides, GLP-1s and other metabolic therapies, where the regulatory distinction between approved medicines and unapproved products can be blurred in public-facing promotion.
The TGA said unapproved peptide products were increasingly being unlawfully advertised and supplied to Australians, including through online platforms, overseas websites and social media.
Many of these products have not been assessed by the TGA for safety, quality or effectiveness. The regulator warned they may not meet required standards, may be incorrectly labelled or promoted and may pose health risks if used without medical supervision.
Recent seizures point to wider enforcement activity
The formal addition of peptides to the TGA’s compliance priorities reflects increased regulatory attention in response to rising importation, broader online advertising and supply and emerging safety concerns.
In April, a joint operation involving the TGA, Australian Border Force and Victoria Police led to the seizure of peptide products, performance and image enhancing drugs and illicit steroids with an estimated street value of more than $2 million.
In May, AMP reported that the TGA and INTERPOL had seized more than 900,000 unlawfully imported therapeutic goods in Australia as part of Operation Pangea XVIII, including counterfeit botulinum toxin and semaglutide products.
Earlier this year, the TGA also issued infringement notices to practitioners over the alleged unlawful importation of unapproved injectables, reinforcing its focus on therapeutic goods used in cosmetic procedures and the broader wellness sector.
Peptides prioritised
The TGA said it is now 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.
Professor Lawler urged Australians to be cautious about purchasing unapproved peptide products online, particularly from overseas websites or through social media.
‘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,’ he said.
Consumers and practitioners can report suspected unlawful importation, supply or advertising of therapeutic goods via the TGA website.
