TGA issues warning against unapproved peptides

Healthcare practitioners who compound, prescribe or supply unapproved peptide products have been warned by the Therapeutic Goods Administration (TGA) to comply with regulatory requirements and professional practice standards.
 
The regulator has expressed concerns that the ‘use or supply of unapproved peptide products is being promoted on a number of online and social media platforms’, with claims they have ‘a range of health benefits including weight loss, muscle growth, anti‑ageing, and enhancing cognitive and athletic performance’.
 
The warnings around products that have not been evaluated by the TGA echo GPs’ concerns about the rise in import, supply, compounding and advertising of such products – and the potential associated safety risks.
 
RACGP NSW&ACT Deputy Chair Dr James Kelly said regulation and evidence are key, and it is the consumer, not the seller, who is always the one carrying the risk.
 
‘There are peptide-based medicines that have gone through rigorous clinical development and have a strong evidence base behind them,’ he said.
 
‘Semaglutide and tirzepatide are good examples – they’re both peptides, they’re both well-studied, both approved through proper regulatory pathways, both prescribed for diabetes and weight loss with appropriate clinical oversight.’
 
But Dr Kelly says many of the products being sold online are a ‘completely different category’ and have not undergone TGA assessments for safety, quality or efficacy.
 
‘They may look scientific, the packaging often sounds very credible, but ... there’s no reliable assurance about what’s actually in the vial, whether the dose is accurate, or whether it’s sterile,’ he said.
 
‘And that’s a significant problem. Even if the drug on the label has performed well in early clinical trials, what’s inside might be a contaminated or poorly made version that could harm a user due to that contamination, or may simply not work.’
 
Peptide products are regulated as therapeutic goods in Australia under the Therapeutic Goods Act 1989, with the TGA issuing approval for several peptide-based medicines, such as insulin products for the management of diabetes.
 
Unapproved peptide products not included in the Australian Register of Therapeutic Goods include those containing BPC‑157, GHK‑Cu, TB‑500, retatrutide and CJC‑1295, often supplied in injectable form.
 
The TGA says using these products raises ‘significant regulatory and public health risks’, stating it is ‘actively monitoring this issue from both safety and law enforcement perspectives’.
 
Unregulated use of peptides is part of a wave of medical misinformation from social media influencers, with the TGA recently clamping down on unlawful promotions.
 
‘Advertising or promoting unapproved products, particularly through social media or influencer channels, is likely to breach Australian therapeutic goods advertising laws,’ the medicines watchdog says of the peptide products.
 
Dr Kelly says while these online promotions have been building for a couple of years, social media has ‘accelerated’ them and made it easier to market the products directly to consumers.
 
‘I’m hearing about it more and more from patients – people who’ve seen something on TikTok or been offered a product through their gym or a fitness group,’ he said.
 
‘And what concerns me most is that a lot of these are not approved medicines. If something hasn’t gone through the TGA’s assessment process, nobody, not the person selling it, not the person buying it, can reliably tell you what’s in it, whether it works, or whether it’s safe.’
 
The TGA has listed safety considerations for healthcare professionals to advise patients who are using unapproved peptide products.

It also details key information for suppliers to ensure they understand and comply with legal requirements, including meeting all obligations under relevant federal, state and territory legislation.
 
‘Healthcare practitioners who compound, prescribe or supply unapproved peptide products must also comply with all regulatory requirements and relevant professional practice standards, including those set by the Australian Health Practitioner Regulation Agency,’ the TGA states.
 
A warning is also being issued about the risks associated with importing and using unapproved peptide products under the Personal Importation Scheme, with healthcare practitioners urged to report non-compliance.
 
While TGA-approved peptide-based medicines such as semaglutide and tirzepatide have undergone extensive trials and have strongly backed evidence, Dr Kelly said there is limited scientific evidence behind the claims being made for other peptide products promoted and sold online.
 
‘[These approved products are a] very different thing from the broad lifestyle claims being made for “research peptides” and unregulated products,’ he said.
 
‘What concerns me is that people end up taking genuine health risks and spending vast sums of money on something that exists to generate profit, not to improve their health.’
 
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