Melatonin Gummies More Potent Than Labels Indicate: Analysis

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April 26, 2023 – A new analysis shows that many melatonin gummies contain far more melatonin than their labels indicate. The researchers said the mislabeled products pose a serious risk for children and teens, pointing to recent data that shows young people are increasingly using – and being poisoned by – the lightly regulated supplement.

While a few of the 25 brands of gummies tested contained less than the label indicated, nearly all others contained much more. One brand, called “Sleep Plus Immune,” had 347% of the labeled amount of melatonin.

Melatonin is a hormone produced by the brain in response to darkness. Dietary supplements containing melatonin are often marketed to help with sleep. The CDC recently said the first year of the pandemic saw the largest jump in a decade of reports to poison control centers of cases where children took melatonin unintentionally. Although most children had no symptoms, the report said, 15% of the kids were hospitalized, five children needed breathing assistance from a mechanical ventilator, and two died.

The analysis of melatonin gummies was done by researchers from the University of Mississippi and from the Harvard Medical School teaching hospital Cambridge Health Alliance. The researchers did sensitive laboratory testing to determine the amount of melatonin in the gummies, compared to how much was stated on the label. They also tested for CBD amounts, since five of the products were labeled as having CBD in addition to melatonin. The results were published Tuesday in The Journal of the American Medical Association.

“Consuming melatonin gummies as directed could expose children to between 40 and 130 times higher quantities of melatonin” than is recommended for young adults, the authors wrote. 

Of the 25 products, all of which included melatonin on the label:

  • Most were inaccurately labeled regarding how much melatonin they contained.
  • Only three products contained within 10% of the amount of melatonin listed on the label.
  • One product didn’t contain any melatonin, and only contained CBD, which had also been on the label.

 Melatonin is classified as a dietary supplement,  meaning the products are not tested by the FDA. A spokeswoman for the federal agency told The Wall Street Journal that the agency takes product quality and content concerns seriously, but it would not comment on a specific study.

A trade organization that advocates for the dietary supplement industry called the newly published analysis of gummies flawed.

“This research letter raises unnecessary concern about these products and evidences a complete lack of understanding of the federal requirements for dietary supplements as well as the strong safety profile of melatonin among users of all ages,” the Council for Responsible Nutrition said in a statement. “Almost all of the 25 products sampled contained adult servings and are expressly labeled for use in adults, yet the authors conflate their findings with pediatric data.”

The lead researcher of the study, a Harvard Medical School associate professor who also practices internal medicine, said the study results make him wary of whether supplements contain what they claim.

“I can’t be assured the supplements my patients will see on store shelves are going to be accurately labeled,” Pieter Cohen, MD, told the Journal. “A lot of manufacturers have no respect for the FDA.”