TGA Admits Major Safety Failures in Australian Medical Cannabis System

Australia's medical cannabis regulator has confessed to a massive oversight failure - they haven't investigated the safety of most medicinal cannabis products despite receiving over 600 reports of serious adverse events including psychosis and suicidal behaviour.

The Therapeutic Goods Administration (TGA) has been busy chasing advertising breaches while completely ignoring hundreds of safety reports. Between July 2022 and June 2025, the TGA received 615 adverse event reports for unregistered medicinal cannabis products - yet hasn't investigated a single one.

More than 50 reports involved psychosis, 14 cases of suicidal thoughts or behaviour, and multiple instances of schizophrenia and homicidal ideation.

This shocking revelation comes as medical cannabis approvals have hit record highs, with over 150,000 Australians now having access to these largely untested products. The TGA's own data shows there are more than 1,000 different medicinal cannabis products available in Australia, yet only two have been properly assessed for quality, safety and efficacy.

A TGA spokesperson admitted they had the power to investigate when "safety signals" were identified, but bizarrely claimed "no such signals for specific unapproved medicinal cannabis products have been identified" - despite the hundreds of serious adverse event reports sitting in their database.

Only after questioning by the ABC did the TGA suddenly announce they would review the safety and regulation of medicinal cannabis products. Talk about closing the barn door after the horses have bolted.

The Australian Medicinal Cannabis Association pointed out the obvious - without proper investigation and publication of adverse events, it's impossible to draw conclusions about product safety. Meanwhile, Queensland alone consumes over half of Australia's medical cannabis, with patients essentially acting as unwitting test subjects.

Psychiatrists Sound the Alarm

Professor Brett Emmerson from the Royal Australian and New Zealand College of Psychiatrists believes the 615 reported adverse events are just "the tip of the iceberg". His colleagues have witnessed a significant spike in cannabis-induced psychosis hospitalisations since the medical cannabis boom began.

Professor Emmerson didn't mince words about the industry's priorities: "The medicinal cannabis companies are just like the tobacco companies - they want people to use their product, that's how they make their money and their profit."

This criticism becomes even more damning when you consider the TGA has been busy fining companies tens of thousands for advertising breaches while completely ignoring actual safety concerns affecting real patients.

System Completely Broken

The current regulatory framework is fundamentally flawed. Doctors can prescribe over 1,000 different cannabis products through the Special Access Scheme or Authorised Prescriber pathways, yet these products haven't undergone basic safety testing that every other medicine must pass.

Patient Alice Davy, who runs for the Legalise Cannabis Party and uses medical cannabis for endometriosis, was shocked by the lack of oversight: "How are we supposed to be able to know what's safe and what's not if there's no tests being done?"

The Australian Medical Association warned that medicinal cannabis is "being prescribed at alarming rates through direct-to-consumer telehealth models" with very little evidence supporting its use for most conditions.

Unlike overseas research that has debunked cannabis-schizophrenia myths, Australia's medical cannabis system operates in a regulatory vacuum where profit appears to trump patient safety.

Too Little, Too Late?

The TGA's belated safety review comes nine years after medical cannabis was legalised in Australia. In their consultation paper, they finally admitted that 24% of all adverse events since 2016 were considered "serious" and that under-reporting is "highly likely" due to stigma.

They also acknowledged increasing concern about "patients presenting to health services with a range of mental health issues including psychosis and dependency following the use of medicinal cannabis products."

This regulatory failure becomes even more stark when compared to the TGA's aggressive pursuit of advertising violations, including fining a WA pharmacy nearly $40,000 for promotional materials.

While the TGA has been playing advertising police, thousands of Australians have been taking unproven cannabis medicines with serious side effects going uninvestigated. It's a perfect example of regulatory priorities being completely backwards.

The medical cannabis industry's rapid growth to hundreds of millions in market value on the ASX has clearly outpaced any meaningful safety oversight. With public support for cannabis legalisation growing, proper regulation becomes even more critical.

The TGA's safety review is closing public consultation soon. Patients deserve to know their medicines are safe - not just that companies aren't advertising them improperly.