Sleep Gummies Found to Contain Unsafe Levels of Melatonin and CBD

Prior to the COVID-19 pandemic, melatonin was a popular dietary supplement among children in the US, with an estimated 1.3% of children using it for sleep, stress, and relaxation. However, the use of melatonin has increased during the pandemic, with more parents turning to this supplement as gummies to help their children cope with the stress and anxiety of the pandemic.

While melatonin is widely available over the counter as a dietary supplement or food, it is not approved by the US Food and Drug Administration (FDA). Instead, it is sold as a dietary supplement or food, with some products including prohibited drugs such as cannabidiol (CBD).

A recent study published in JAMA Network Open has shed light on the accuracy of labeling in melatonin gummies. The study examined 30 different brands of melatonin gummies sold in the US, analyzing the actual quantity of melatonin and CBD in these products compared to the quantities declared on the labels.

The results of the study were concerning. Of the 25 products that were analyzed, only 3 products (12%) contained a quantity of melatonin that was within ±10% of the declared quantity. In the remaining products, the actual quantity of melatonin ranged from 74% to 347% of the labeled quantity. Furthermore, 22 of the 25 products (88%) were inaccurately labeled, with most products exceeding the declared amount of melatonin and CBD.

The study also found that one product did not contain detectable levels of melatonin but did contain 31.3 mg of CBD. In products that did contain melatonin, the actual quantity of melatonin ranged from 1.3 mg to 13.1 mg per serving size, potentially exposing children to between 40 and 130 times higher quantities of melatonin than recommended.

Consuming melatonin gummies as directed could expose children to unpredictable quantities of melatonin and CBD. Unintentional ingestions could lead to consumption that greatly exceeds these dosages of melatonin. With respect to CBD, the drug is FDA-approved to treat refractory seizures caused by 3 rare genetic disorders, but the FDA has not approved the use of CBD for any indication in healthy children.

The findings of this study have important implications for parents and clinicians. Clinicians should advise parents that pediatric use of melatonin gummies may result in the ingestion of unpredictable quantities of melatonin and CBD, potentially leading to adverse effects. Parents should also be aware of the labeling inaccuracies and exercise caution when purchasing melatonin gummies for their children.

This study has limitations, including the small sample size, analysis of only one sample of each brand, and analysis of only gummies. It is not known if the results are generalizable to melatonin products sold as tablets and capsules in the US or if the quantity of melatonin within an individual brand may also vary from batch to batch. Further research is needed to assess the accuracy of labeling in other forms of melatonin products.

In conclusion, melatonin gummies are a popular dietary supplement for children, commonly used for sleep, stress, and relaxation. However, the accuracy of labeling in these products is concerning, with most products exceeding the declared amount of melatonin and CBD. Clinicians and parents should be aware of these labeling inaccuracies and exercise caution when purchasing melatonin gummies for children. Further research is needed to assess the accuracy of labeling in other forms.

Experts caution that parents should be careful when giving any supplements to their children, especially those with potentially dangerous levels of melatonin or other substances. It’s also important to talk to a healthcare provider before giving a child any supplement, including melatonin.

The FDA is in the process of releasing its CBD regulations, which should help to address some of these concerns. The new Farm Bill is also coming at the end of 2023, which is expected to have an impact on the regulation of hemp and CBD products.

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