Melatonin Crackdown: When “Natural” Turns Risky | Hidden Currents

Description

Australia’s medicines regulator has found alarming inconsistencies in imported melatonin products, with some containing none of the hormone and others carrying more than four times the labelled dose. As poison hotline calls hit record highs and Border Force begins seizing unregistered imports, families face tough choices about safety, access, and trust in the system. In this episode, we unpack what melatonin really is, why regulation matters, and what households and policymakers need to do next.

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Speaker #0
The recent Australian investigation into melatonin products has exposed serious safety concerns that extend far beyond simple quality control issues. Laboratory testing of popular unregistered melatonin products revealed alarming variations, some containing more than four times the labelled dose, others with 50 to 70 percent more than advertised, and one product containing no melatonin at all. These aren't minor discrepancies. They represent fundamental safety risks. especially for children. Australian authorities have responded with clear directives, cease using unregistered imports and surrender them to pharmacies for safe disposal. Additionally, Border Force has been instructed to intercept and destroy these unregistered products. The core message emphasises that label information on unregistered products amounts to guesswork rather than guaranteed content. Melatonin itself is a hormone naturally produced by the brain in response to darkness. serving as one of the body's primary timekeepers for sleep-wake cycles. While it's often marketed as a gentle sleep aid, the natural label can be misleading. Natural doesn't automatically mean risk-free, especially when dealing with hormones. At appropriate doses, short-term use may benefit certain adults with sleep timing issues or jet lag. However, higher or inconsistent doses can trigger side effects, including morning sedation, headaches, nausea. and increase seizure frequency in vulnerable children with pre-existing conditions. The regulatory landscape varies significantly worldwide, contributing to consumer confusion. In the United States, melatonin is typically sold as a dietary supplement, avoiding the rigorous pre-market approval required for medications. Australia takes a more stringent approach, classifying it as medicine with specific restrictions. Adults can access certain products through pharmacists. including modified release, 2 mg tablets for short-term primary insomnia in those over 55, and immediate release formulations up to 5 mg for adult jet lag. For children, melatonin requires a prescription and is approved primarily for insomnia associated with autism spectrum disorder or Smith-Magenis syndrome. Global studies reinforce Australia's concerns. A 2023 analysis of 25 melatonin gummy brands in the US found 88% percent. were inaccurately labeled, with actual melatonin content ranging from 74% to 347% of stated amounts. One product contained CBD instead of melatonin. A Canadian study discovered similar inconsistencies with some products containing unexpected serotonin. Despite these risks, many Australian families continue purchasing melatonin online, driven by three main factors access and cost barriers, the appeal of gummy formulations, and sometimes conflicting advice from health care providers. The consequences are reflected in poison hotline statistics, with nearly 1,500 calls last year regarding children ingesting melatonin, often mistaking gummies for candy. For immediate safety, households should audit their melatonin products for proper registration, AUSTR slash L numbers, dispose of unregistered products at pharmacies through the Return Unwanted Medicines program, and secure all medicines. including gummies, out of children's reach. In cases of accidental ingestion, the Poisons Information Center, 131126, provides 24-7 assistance. Those considering melatonin should first implement basic sleep hygiene practices, maintaining dark, cool bedrooms, consistent bedtimes, avoiding bright screens before sleep, and getting morning daylight exposure. Adults should consult pharmacists about registered products. while children's use requires medical supervision, particularly for approved conditions. The situation demands broader policy responses, including enhanced enforcement against illegal supply, improved access to registered products, stricter safety standards for packaging, and increased responsibility from online marketplaces to block non-compliant products. Major platforms should implement geo-blocking for non-compliant melatonin listings to Australian addresses and requires suppliers To demonstrate proper registration, this issue highlights the critical intersection of natural, cheap, and available products, where loose regulations can lead to quality issues that put consumers, especially children, at risk. Australia's strict regulatory framework isn't excessive caution. It's necessary protection, ensuring that hormones don't become treated as candy. The priority isn't to discourage legitimate therapeutic use. but to ensure that what's in the bottle matches what's on the label, protecting public health through proper oversight and quality control.

Description

Hosted on Ausha. See ausha.co/privacy-policy for more information.

Transcription

Speaker #0
The recent Australian investigation into melatonin products has exposed serious safety concerns that extend far beyond simple quality control issues. Laboratory testing of popular unregistered melatonin products revealed alarming variations, some containing more than four times the labelled dose, others with 50 to 70 percent more than advertised, and one product containing no melatonin at all. These aren't minor discrepancies. They represent fundamental safety risks. especially for children. Australian authorities have responded with clear directives, cease using unregistered imports and surrender them to pharmacies for safe disposal. Additionally, Border Force has been instructed to intercept and destroy these unregistered products. The core message emphasises that label information on unregistered products amounts to guesswork rather than guaranteed content. Melatonin itself is a hormone naturally produced by the brain in response to darkness. serving as one of the body's primary timekeepers for sleep-wake cycles. While it's often marketed as a gentle sleep aid, the natural label can be misleading. Natural doesn't automatically mean risk-free, especially when dealing with hormones. At appropriate doses, short-term use may benefit certain adults with sleep timing issues or jet lag. However, higher or inconsistent doses can trigger side effects, including morning sedation, headaches, nausea. and increase seizure frequency in vulnerable children with pre-existing conditions. The regulatory landscape varies significantly worldwide, contributing to consumer confusion. In the United States, melatonin is typically sold as a dietary supplement, avoiding the rigorous pre-market approval required for medications. Australia takes a more stringent approach, classifying it as medicine with specific restrictions. Adults can access certain products through pharmacists. including modified release, 2 mg tablets for short-term primary insomnia in those over 55, and immediate release formulations up to 5 mg for adult jet lag. For children, melatonin requires a prescription and is approved primarily for insomnia associated with autism spectrum disorder or Smith-Magenis syndrome. Global studies reinforce Australia's concerns. A 2023 analysis of 25 melatonin gummy brands in the US found 88% percent. were inaccurately labeled, with actual melatonin content ranging from 74% to 347% of stated amounts. One product contained CBD instead of melatonin. A Canadian study discovered similar inconsistencies with some products containing unexpected serotonin. Despite these risks, many Australian families continue purchasing melatonin online, driven by three main factors access and cost barriers, the appeal of gummy formulations, and sometimes conflicting advice from health care providers. The consequences are reflected in poison hotline statistics, with nearly 1,500 calls last year regarding children ingesting melatonin, often mistaking gummies for candy. For immediate safety, households should audit their melatonin products for proper registration, AUSTR slash L numbers, dispose of unregistered products at pharmacies through the Return Unwanted Medicines program, and secure all medicines. including gummies, out of children's reach. In cases of accidental ingestion, the Poisons Information Center, 131126, provides 24-7 assistance. Those considering melatonin should first implement basic sleep hygiene practices, maintaining dark, cool bedrooms, consistent bedtimes, avoiding bright screens before sleep, and getting morning daylight exposure. Adults should consult pharmacists about registered products. while children's use requires medical supervision, particularly for approved conditions. The situation demands broader policy responses, including enhanced enforcement against illegal supply, improved access to registered products, stricter safety standards for packaging, and increased responsibility from online marketplaces to block non-compliant products. Major platforms should implement geo-blocking for non-compliant melatonin listings to Australian addresses and requires suppliers To demonstrate proper registration, this issue highlights the critical intersection of natural, cheap, and available products, where loose regulations can lead to quality issues that put consumers, especially children, at risk. Australia's strict regulatory framework isn't excessive caution. It's necessary protection, ensuring that hormones don't become treated as candy. The priority isn't to discourage legitimate therapeutic use. but to ensure that what's in the bottle matches what's on the label, protecting public health through proper oversight and quality control.

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