Research letter raises concerns about melatonin product safety and consistency for children

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A research letter published in JAMA raises concerns about melatonin products sold for use by children, citing recent figures from the Centers for Disease Control (CDC) which found the annual number of pediatric melatonin ingestions reported to the Poison Control between 2012 and 2021 increased 530%, from 8,337 in 2012 to 52,563 in 2021. The letter also suggested that pediatricians advise parents about the “unpredictable” levels of melatonin in gummy products. A previous study in JAMA stated that some melatonin products contain upwards of 478% higher levels of melatonin than those advertised on the label.

As the demand of melatonin products has grown, industry has defended the safety of the ingredient. For example, with regard to the poison control numbers, this data is flawed because they rely on passive, voluntary, and self-reported communications, don’t confirm the accuracy of each case, nor do they include patient medical records or medical examiner reports to determine where adverse events or deaths occurred because of comorbidities.

Looking at this most recent research letter, the authors included 25 product samples to demonstrate the variability between the contents of the products and their labels. The Council for Responsible Nutrition (CRN; Washington, D.C.) has issued a statement highly critical of the letter, pointing out that the product samples the authors used were products marketed for adults and containing adult servings, yet the researchers conflated their findings with pediatric data. CRN also criticized the erroneous application of FDA’s drug standard for overage/underdage of ingredients (+/- 10%) for ingredient levels. According to CRN, dietary supplements must ensure that their products meet 100% of label claims throughout the shelf life of the product. Companies therefore determine a safe ingredient overage that would provide at least the labeled per serving amount of the ingredient when taking long term degradation into account. This practice is permitted by FDA.

“This report does a complete disservice to a safe product when it is used according to manufacturer’s instructions,” said Steve Mister, president and CEO of CRN in a statement. “Parents know how to take care of their own kids, and, often in consultation with their health care providers, have been safely giving the pediatric versions of these melatonin products to their children for years.”

“Supplement companies go to great lengths to ensure their products contain safe and consistent levels of dietary ingredients, as labeled,” added Mister. “And while there may be some variability in overages as companies adhere to the FDA’s requirements regarding shelf life and potency, it does not mean there is a risk in taking these products as intended. It’s a misleading comparison to look at scenarios where kids, for example, got their hands on an entire bottle of adult gummies and became ill after eating multiple servings, versus having slightly more of an ingredient in a single serving that, if taken as directed, would pose no harm.”

The Consumer Healthcare Products Association's (CHPA; Washington, D.C.) senior vice president of Dietary Supplements Duffy MacKay emphasized the safety of melatonin products in his own statement. “Melatonin is a safe and beneficial dietary supplement for adults and children, regulated by the FDA, and consumed by millions of Americans to support and promote healthy sleep and wellness when used as directed on Supplement Facts labels," said MacKay. “Intentional ingredient overage is permitted for nutrient longevity and safe for consumers when within known safety levels consistent with good manufacturing practices (GMPs)."

“CHPA takes very seriously the responsibility of educating consumers about the safe and proper use of products and following the recommended usage on the label," added MacKay. "We also remind parents about their role in helping to prevent accidental pediatric ingestions of consumer healthcare products, which is why melatonin should always be kept up and away and out of reach of young children."

For its part, CHPA has a public education campaign called Up and Away, in partnership with the CDC and its PROTECT Initiative, that MacKay says has successfully educated 150 million parents and caregivers about how to safely store medicine and dietary supplements.

Updated on April 26, 2023 at 9:54 AM