Calls for Melatonin Industry to Enhance Safety Measures Following Surge in Childhood ER Cases
Industry trade group urges melatonin manufacturers to enhance safety standards in response to a 530% increase in accidental ingestions among children, emphasizing the need for stricter regulations.
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According to the Council for Responsible Nutrition, manufacturers of melatonin supplements have 18 to 24 months to enhance child-resistant packaging and update warning labels on over-the-counter products. This initiative aims to promote safety and awareness in the dietary supplement and functional food industry.
Demand for melatonin has surged in the past decade, as experts note that it is a hormone produced by the brain in response to darkness. This hormone plays a crucial role in regulating the body's natural sleep-wake cycle, also known as the circadian rhythm. Despite its popularity as a dietary supplement, it is important to note that melatonin is not approved by the US Food and Drug Administration for safety, effectiveness, or labeling before being sold to the public.
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The council's decision comes after recent reports of a significant increase in accidental consumption of melatonin by children. In April 2023, a study revealed that 25 products labeled as melatonin gummies had unsafe levels of the hormone. Some products had up to 347% more melatonin than stated on the label, while others did not contain any melatonin at all and were made entirely of cannabidiol or CBD.
Dr. Pieter Cohen, an associate professor of medicine at the Cambridge Health Alliance in Somerville, Massachusetts, who conducted a study on melatonin gummies, pointed out that the industry acknowledges the serious risks posed by melatonin supplements, especially to children. It is crucial for the industry to improve in ensuring the safety and quality of these products.
Cohen expressed uncertainty about whether the industry will actually follow through with the voluntary recommendation. Only time will tell if the necessary actions will be taken.
There has been a significant increase in emergency room visits by children. According to a report from the US Centers for Disease Control and Prevention in March 2024, around 11,000 children were taken to emergency rooms from 2019 to 2022 after consuming melatonin without supervision. Specifically, melatonin gummies were linked to almost 5,000 of these cases.
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Children between 3 and 5 years old were involved in over half of accidental ingestions, with most cases only involving melatonin, according to the CDC.
In about three-quarters of cases, children were able to access melatonin from bottles, indicating that the bottles were either easily opened or not properly closed. While most cases did not require hospitalization, the report suggests that the actual number of ingestions by young children may be higher than reported.
Some melatonin gummies claim to have CBD in them, even though it's against the rules to add CBD to food or call it a dietary supplement, as per the US FDA.
When Cohen tested some gummies, he found that four of them had more CBD than what was stated on the label, with levels ranging from 4% to 18% higher.
Melatonin use can be especially dangerous in children and should only be used after consulting a pediatrician, experts say.
Melatonin use can be especially dangerous in children and should only be used after consulting a pediatrician, experts say.
Dr. Cora Collette Breuner, a professor of pediatrics at Seattle Children’s Hospital at the University of Washington, mentioned to CNN that there is no data supporting the use of CBD in children. She emphasized that it is currently only recommended for a very specific use in children over 1 year old with intractable seizure disorders.
Consuming a gummy that unknowingly contains extremely high levels of melatonin, aside from CBD, can be dangerous. Dr. Breuner mentioned that these levels are well over the recommended 0.5 milligram to 1 milligram per night for inducing sleep in kids.
The CDC researchers stated in their April report that any discrepancies in melatonin ingredients or strength could pose additional risk to children.
New labels have been recommended by the council to better inform consumers about the risk of drowsiness from melatonin supplements. It is advised that the labels also mention not to mix melatonin with alcohol. Moreover, purchasers should be aware that melatonin is meant for occasional use only.
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Freshly woken up young woman enjoying the morning sun rays.
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The council recommended adding extra cautions for melatonin gummies. For instance, a warning should be included stating that if not chewed properly, the gummies could pose a choking risk for children under 4 years old.
The council's updated guidelines emphasize the importance of using child-safety containers for gummies and chewable tablets.
According to the council, even though federal regulations do not mandate child deterrent closures for melatonin products, the revised guidelines recommend that manufacturers use child deterrent packaging for melatonin products in flavored chewable forms that may appeal to children.
Manufacturers of gummies will be given 24 months to make the necessary changes. The council encourages its members and the industry as a whole to adopt these guidelines as soon as possible. Specific timelines for implementing each set of guidelines will be provided to ensure a smooth transition. This story includes contributions from CNN's Amanda Musa.
Correction: A previous version of this story misstated the role of the FDA in regulating dietary supplements.
Editor's P/S:
The surge in melatonin use and the recent reports of accidental consumption by children are concerning. The lack of FDA approval and the potential safety risks, especially to children, should not be taken lightly. The industry's initiative to improve child-resistant packaging and update warning labels is a step in the right direction, but it is crucial for manufacturers to adhere to these guidelines and ensure the safety of these supplements.
The presence of CBD in some melatonin gummies is another cause for concern, as the FDA prohibits adding CBD to food or calling it a dietary supplement. The potential risks of CBD, especially in children, should be thoroughly investigated. It is essential for consumers to be aware of the potential dangers and to consult with healthcare professionals before using melatonin or any other dietary supplements, especially for children.
