Inaccurate Labeling of Melatonin Gummies Cause for Concern for Pediatric Consumption

Children who consume melatonin gummies may be ingesting unpredictable quantities of melatonin and CBD, according to a research letter published in JAMA.¹

Because melatonin products are sold over the counter as dietary supplements or food, they are not regulated or approved by the FDA. In addition to the potential for incorrect dosing, these products may also contain drugs such as cannabidiol (CBD). Researchers sought to evaluate the differences between product labeling and the actual quantity of melatonin and CBD in these OTC products.

In 2022, investigators used the National Institutes of Health Dietary Supplement Label Database to identify gummy products that included the word melatonin on the label. Thirty unique brands were identified and purchased online; product labels were examined to ensure that “melatonin” did appear on the label. Four brands were not available for purchase and 1 brand did not meet inclusion criteria, for a total of 25 products included in the analysis.

Investigators reconstituted the gummies and analyzed each for the presence of melatonin, CBD, and serotonin using ultra high-performance liquid chromatography-photodiode array analyses. Serotonin screening was conducted, they noted, “as serotonin had previously been found as a contaminant in melatonin products.”

According to the researchers, 1 product did not contain any detectible levels of melatonin, but did contain 31.3 mg of CBD. In the other 24 products, melatonin quantity ranged from 1.3 mg to 13.1 mg per serving size; among these products, the actual quantity of melatonin ranged from 74% to 347% of the labeled quantity. Eighty-eight percent of products were inaccurately labeled, and only 12% of products contained a quantity of melatonin within ±10% of the quantity declared on the label.

Among the 5 brands that declared CBD as an ingredient, CBD quantity ranged from 10.6 mg to 31.3 mg per serving; actual CBD quantity ranged from 104% to 118% of the labeled quantity. Analyses did not detect serotonin in any product.

“The great majority of melatonin gummy products were inaccurately labeled, with most products exceeding the declared amount of melatonin and CBD,” the researchers wrote, noting that this study is, to the best of their knowledge, the first in the US to quantify melatonin concentrations in OTC melatonin products.

Studies from 2018 showed that an estimated 1.3% of children in the United States were using melatonin products for sleep, stress relief, and relaxation. However, between 2012 and 2021, calls for pediatric melatonin ingestion to Poison Control Centers increased 530%; pediatric melatonin ingestion was also associated with over 27,000 emergency department visits, 4097 hospitalizations, 287 intensive care unit admissions, and 2 deaths.

The consumption of melatonin gummies could, the researchers wrote, expose children to between 40- and 130-times higher quantities of melatonin than intended. Consumption of these products could also lead to consumption of CBD, which is not FDA approved with any indication for use in healthy children.

Study limitations include the small sample size and the evaluation of only 1 sample from each brand. Additionally, it is not known if results are generalizable to melatonin products in tablet or capsule form, or if melatonin quantity within a brand varies from batch to batch.

“Clinicians should advise parents that pediatric use of melatonin gummies may result in unpredictable quantities of melatonin and CBD,” the researchers concluded.

Reference

1. Cohen PA, Avula B, Wang Y-H, Katragunta K, Khan I. Quantity of melatonin and CBD in melatonin gummies sold in the US. JAMA. 2023;329(16):1401-1402. doi:10.1001/jama.2023.2296