Australian Border Force intercepts 150,000 units of melatonin amid crackdown on unregulated products

The Australian Border Force (ABF) has intercepted the equivalent of thousands of bottles of melatonin in four months, as health authorities crack down on unregulated imports of the sleep hormone.

Figures obtained by the ABC show the ABF referred 150,000 units — defined as an individual tablet, capsule or gummy — to the medicines watchdog for assessment between September 1 and December 31 last year.

Once it receives a referral from the ABF, the Therapeutic Goods Administration (TGA) assesses the product to determine whether it was lawfully imported before notifying border force officials to either seize or release the goods.

The TGA has been warning patients to stop using unregistered imported melatonin products, after testing in its laboratories indicated "significant discrepancies" between the actual melatonin amount and what was on the label.

Some online products, which are popular with parents as a sleep aid for children, had as much as four times the amount of melatonin advertised.

"We are continuing to monitor signals relating to harmful unregistered products and will notify the ABF to seize and destroy any counterfeit products intercepted at the border," a TGA spokesperson said.

Royal Australian College of General Practitioners spokesman Tim Jones said while the border seizures might seem dramatic to some, imported products did not meet the TGA's strict safety standards and posed additional risks.

"There's an increasing amount of research overseas into the quality of these products and that really set off some alarm bells … when we saw huge variability in the actual melatonin content," Dr Jones said.

The symptoms of melatonin overdose range from headaches and drowsiness to less-common cases of nausea and vomiting, and Dr Jones said increased quantities of melatonin — whether taken intentionally or by accident — could heighten the risk of those side effects.

"As a doctor who sees a lot of children, I'm very much supportive of this idea that careful action is being taken to ensure that safety of things that we give to our children is paramount," he said.

'Taking the piss': Prescriptions cost 10 times more than online products

Perth public health professional Naomi Campbell-Smith has taken melatonin for about five years after her doctor prescribed it to help counteract the effects of ADHD medication.

"It just helps me go to sleep — it helps me fall asleep and stay asleep — which is kind of very important to functioning and existing as an adult in the workplace and in the world the day after," she said.

Generally, most Australians need a prescription to use melatonin, but many people circumvent the process by buying melatonin online from overseas retailers, because it is often significantly cheaper and can be bought without a script.

Ms Campbell-Smith has previously used prescriptions to get melatonin from the pharmacy and at one point was getting melatonin compounded by the chemist, but that is now only an option for medications that are not commercially available.

As a result, she said the pharmacy products now cost her anywhere from $300 to $480 for 90 tablets of 5mg melatonin, compared to $32 for 90 gummies online with the same amount of melatonin.

"I've always used it with a script. I'm very much a goody-two-shoes when it comes to this sort of thing," she said.

"I didn't opt to go online. The hand was sort of forced in that respect as there wasn't really a viable alternative at the time."

The 33-year-old argued health authorities should focus more on making the sleep hormone easier to buy locally.

"This feels like, rather than the TGA supporting Australians to be able to access goods for their health and wellbeing, that they are simply blocking it at multiple turns for people to be able to access safe and affordable medication in Australia," she said.

"If it still needs to be scripted, that's fine … but $300 is taking the piss."

What is melatonin?

Melatonin is a hormone that regulates the sleep-wake cycle and an increasing number of parents have turned to it to help their children sleep, sometimes in the form of flavoured gummies.

ABC News recently revealed Australian poisons hotlines received a record number of about 1,500 calls last year about children ingesting melatonin, a dramatic spike on previous years.

Popular online retailer iHerb suspended melatonin sales to Australia last August, after reports of a jump in calls to the WA Poisons Information Centre about children taking the sleep hormone.

But in a statement, an iHerb spokesperson said it had now resumed offering a "limited range" of products in Australia, with customers now advised that melatonin was subject to import restrictions at the check-out.

"To reduce the risk of improper use by children, iHerb will not be offering melatonin gummies to Australian customers and will monitor the situation closely," the spokesperson said.

Sarah Langston, president of the Australian Neurodivergent Parents Association, said the difficulties surrounding melatonin gummy supply had impacted many families across the country.

"To be clear, parents were directed for many years to purchase these gummies, by their child's paediatrician, and have acted in line with that advice," Ms Langston said.

"Our families are vulnerable to the whims of policy change and therefore partnership with our community is essential for the wellbeing of our kids."

Dr Jones said he believed paediatricians were recommending online products to try to help families grappling with cost-of-living pressures, but that advice pre-dated recent studies into the safety of unregulated melatonin.

He reiterated melatonin should only be used under ongoing supervision from a doctor.

"I've been increasingly concerned as a clinician that families are accessing online melatonin as a first step in trying to support their children who are struggling to sleep," he said.

"I'm worried that a lot of families are slipping through the cracks at the moment."