Daily Dose: Mislabeled Melatonin Gummy Products

Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

On April 27, 2023, we reported on a study published in JAMA that assessed the actual quantity of melatonin in melatonin gummy products compared with the quantities declared on the labels.

The study

Products formulated as gummies with “melatonin” on the label were identified in September 2022 using the National Institutes of Health’s Dietary Supplement Label Database. The 30 unique brands added to the database in 2021 were purchased online. Researchers examined the products’ labels and excluded those without “melatonin” on it. The gummies were reconstituted in methanol and an aqueous mixture of acetonitrile-methanol and then analyzed for the presence and quantity of melatonin, CBD, and serotonin using ultra high-performance liquid chromatography–photodiode array analyses.

Of the 30 brands that met inclusion criteria, 4 were not available for purchase and 1 did not have “melatonin” on the label. In the remaining 25 products, the quantity of melatonin ranged from 1.3 mg to 13.1 mg per serving size. In gummy products that did have melatonin, the actual amount ranged from 74% to 347% of the labeled quantity. Only 3 products contained an amount of melatonin within ±10% of the quantity declared on the label.

Five products declared CBD as an ingredient, and the quantity of CBD ranged from 10.6 mg to 31.3 mg per serving. The actual quantity of CBD ranged from 104% to 118% of what was reported on the label. Serotonin was not found in any product.

A note from authors

"Administration of as little as 0.1 mg to 0.3 mg of melatonin to young adults can increase plasma concentrations into the normal nighttime range. Consuming melatonin gummies as directed could expose children to between 40 and 130 times higher quantities of melatonin. Unintentional ingestions could lead to consumption that greatly exceeds these dosages of melatonin...given these findings, clinicians should advise parents that pediatric use of melatonin gummies may result in ingestion of unpredictable quantities of melatonin and CBD."

Click here for more details.