April 26, 2023 – A brand new evaluation shows that many melatonin gummies contain far more melatonin than is indicated on the label. Researchers said the mislabeled products pose a serious risk to children and teenagers, pointing to recent data showing that young persons are increasingly using the frivolously regulated complement – and becoming poisoned in consequence.
While a few of the 25 gummy bear brands tested contained less melatonin than stated on the label, almost all the others contained far more. One brand called “Sleep Plus Immune” contained 347% of the stated amount of melatonin.
Melatonin is a hormone produced by the brain in response to darkness. Dietary supplements containing melatonin are sometimes marketed as sleep aids. The CDC recently said that the primary 12 months of the pandemic saw the biggest increase in a decade in reports to poison control centers of cases of youngsters inadvertently taking melatonin. Although most youngsters didn't show any symptoms, report said 15% of youngsters were hospitalized, five children required respiratory support on a ventilator and two died.
The evaluation of the melatonin gummy bears was conducted by researchers on the University of Mississippi and Harvard Medical School's Cambridge Health Alliance Teaching Hospital. The researchers conducted sensitive laboratory tests to find out the quantity of melatonin within the gummy bears in comparison with the quantity listed on the label. They also tested the CBD amounts, as five of the products contained CBD along with melatonin. The Results were published on Tuesday in The Journal of the American Medical Association.
“Consumption of melatonin gummy bears as directed could expose children to 40 to 130 times the amount of melatonin” beneficial for young adults, the authors wrote.
Of the 25 products, all of which contained melatonin on the label:
- For most products, the melatonin content was incorrect.
- Only three products contained inside 10% of the quantity of melatonin stated on the label.
- One product didn't contain melatonin, but only CBD, which was also stated on the label.
Melatonin is assessed as a dietary complement, which suggests that the products are usually not tested by the FDA. A spokeswoman for the federal agency said The Wall Street Journal that the agency takes concerns about product quality and content seriously, but doesn't want to comment on a particular study.
An industry organization that advocates for the dietary supplements industry called the newly published evaluation of the gummy bears flawed.
“This research letter raises unnecessary concerns about these products and demonstrates a complete lack of understanding of federal requirements for dietary supplements and the strong safety profile of melatonin in users of all ages,” the Council for Responsible Nutrition said in a opinion. “Almost all of the 25 products studied contained adult portions and are specifically labeled for adult use, yet the authors confuse their results with pediatric data.”
The study's lead researcher, an associate professor at Harvard Medical School who also practices internal medicine, said the study results made him skeptical about whether dietary supplements contain what they claim.
“I cannot be sure that the supplements my patients see on the shelves are correctly labelled,” Dr Pieter Cohen told the diary“Many manufacturers have no respect for the FDA.”