Unregulated GLP-1 access under the spotlight

GPs are being encouraged to talk to patients about the safety of unapproved weight-loss medications, following new concerns over unregistered GLP-1 products being promoted online.
 
The Therapeutic Goods Administration (TGA) has issued a safety advisory about the importation of unregistered GLP-1 products promoted online for weight loss, flagging a role for health professionals to advise patients of the risks.
 
The products are often marketed as ‘GLP-1 peptide’ oral drops or liquids and may be falsely labelled as approved by international regulators or advertised with misleading quality marks or claims with the aim of deliberately deceiving consumers, the TGA stated.
 
‘GLP-1 receptor agonists (like semaglutide, tirzepatide, liraglutide) are synthetic analogues of the naturally occurring GLP-1 peptide and are designed to mimic the same effects,’ the TGA said.
 
‘They are prescription-only medicines and are used to treat type-2 diabetes and, in some cases, weight management under medical supervision.
 
‘The native GLP-1 peptide are not included in the Australian Register of Therapeutic Goods and cannot lawfully be supplied in Australia. Further, there is no indication of medical efficacy of these unregistered products with GLP-1 claims, in particular for weight-loss.’
 
The TGA urges consumer caution when purchasing medicines from unknown overseas websites, suggesting these products could be fake, contain incorrect or undisclosed and harmful ingredients, and may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.
 
It adds that health professionals have a key role in ‘identifying and managing the risks associated with unregistered GLP-1 products and should advise patients accordingly’.
 
Along with providing advice about safety, GPs are also being encouraged to report adverse events involving medicines, including unapproved medicines, to assist the TGA in identifying previously unknown side effects and other safety issues.
 
It comes just days after the United States’ Food and Drug Administration issued a similar alert over concerns that unapproved GLP-1 drugs are being used for weight loss.
 
Chair of RACGP Specific Interests Obesity Management, GP and dietitian Dr Terri-Lynne South says she is pleased the TGA has issued an alert and is raising awareness of a growing number of scams, some of which have been brought to her attention by her own patients.
 
‘Everyone seems to know the term GPL-1 now – I’ve seen GLP-1 drops, and I’ve seen things that claim to maximise your own natural GLP-1 – so they’re using that word to really garner the attention of vulnerable people,’ Dr South told newsGP.
 
‘I think if GPs get the opportunity, they need to make their patients aware that there are 100% scams out there. Scams about supplements, or ingredients, or medication-like products that can be bought online without a prescription and that are not proven.
 
‘And some of the scams look to be endorsed by the TGA and other organisations, when they are not, and that’s certainly what I saw from one of my patients.
 
‘We need to be very mindful of any products that may not be proven and therefore may have no effect or unknown negative consequences.
 
‘We also need to be aware of medication that people might be trying to personally import – there is no quality control with products they might be buying online and overseas. They may technically include real GLP-1 medication, but we have no idea about whether it’s compounded and therefore poses safety risks.’
 
Dr South said GPs can push against this by directing their patients to trusted, quality information, including from the government and not-for-profit health organisations.
 
The RACGP has been calling for effective obesity-management medication to be subsidised on the Pharmaceutical Benefits Scheme (PBS) to reduce health inequity and remove the cost barrier for many Australians.
 
Its position statement released earlier this year recommends increased government support for clinical services, effective obesity-management adjunct therapies, including equitable access to public-funded bariatric metabolic surgery, and PBS-subsidised obesity-management medication. 
 
While high costs were likely contributing to patients seeking alternative treatments, Dr South said there were a number of additional reasons for seeking weight-loss information online.
 
‘Cost is the biggest barrier, but I do feel that there is still a lot of stigma and discrimination in regard to treating obesity, and therefore having that pushed underground somewhat is a consequence of that,’ she said.
 
‘But I'm actually hopeful that we can use the current fervour around GLP-1 to re-educate the general public that obesity is a chronic medical condition.
 
‘It’s quite complex, and it actually needs multifaceted care, just like what we talk about with type 2 diabetes or heart disease as an example.
 
‘If patients are needing to go to a qualified medical practitioner to access the PBS-reduced medication costs, then there’s an opportunity there for that prescriber to really help the individual with wraparound multidisciplinary care, so that they are getting best practice care and not just a script and off you go, which I think could actually make an individual’s health worse in the long term.’

A spokesperson for the TGA said there are no medicines specifically for the treatment of overweight or obesity currently being considered for listing on the PBS by the Pharmaceutical Benefits Advisory Committee (PBAC). 
 
However, in March 2025, Federal Health Minister Mark Butler wrote to the PBAC to seek their expert advice on equitable access to obesity medicines through the PBS, recognising the potential benefits but also the significant cost to the healthcare system of subsidising these medicines, the spokesperson told newsGP.
 
‘The PBAC will discuss this issue at its November 2025 meeting and provide advice to the Minister by end 2025.’

 
In a separate notification, the TGA also flagged it has issued 10 infringement notices to telehealth operator Midnight Health Pty Ltd ‘for the alleged unlawful advertising of prescription-only weight-loss medicines.
 
Midnight Health allegedly promoted the use and supply of Schedule 4 prescription-only medicines, including tirzepatide and semaglutide.
 
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