Study: Some Melatonin Gummies Contain Unlabeled Levels of Melatonin, CBD

Last year, Morbidity and Mortality Weekly Report published a study that analyzed calls to U.S. poison control centers that involved pediatric melatonin ingestions, and the results were concerning. The researchers found that, between 2012 and 2021, poison control centers received more than a quarter of a million calls regarding melatonin ingestions in children, and that ingestions had increased 530% over the 10-year period. Of those, 27,795 children required medical evaluation, 4,097 were hospitalized, and two died.

There was little known about why melatonin products were causing these harms, which led another group of researchers, spearheaded by Pieter Cohen, MD, a general internist at Boston’s Cambridge Health Alliance and an assistant professor of medicine at Harvard Medical School, to study what was contained in melatonin gummies, which are commonly used as a sleep aid. He and his co-investigators published a research letter in JAMA last month reporting on their findings. “These ingestions [reported to poison control centers] were usually unintentional and, while the prior study did not report if the ingestions were with gummies, capsules or tablets, we were concerned that children might take too many gummies, leading to harm,” Dr. Cohen tells Food Quality & Safety. “That is why we set out to study melatonin gummies. What we found was that, in the products we sampled, the jelly matrix only infrequently delivered the dose listed on the label.”

The results were quite shocking, Dr. Cohen says. They found that melatonin gummies contained much more melatonin than what was listed on the label—up to 347% more. But excess melatonin wasn’t the only problem they discovered: A number of products also contained cannabidiol (CBD), an active ingredient found in cannabis.

While melatonin products are sold over the counter as dietary supplements or food, FDA has not approved the use of CBD for any indication in healthy children. Given these findings, the study authors recommend that clinicians should advise parents and guardians that pediatric use of melatonin gummies may result in ingestion of unpredictable quantities of melatonin and CBD.