The Council for Responsible Nutrition is calling on melatonin manufacturers to adopt new packaging guidelines aimed at promoting responsible use. The move comes as a response to a surge in emergency room visits by children who have ingested melatonin supplements unsupervised.
Melatonin supplements are widely recognized as an effective sleep aid. While typically presenting few side effects, high-dose consumption can lead to complications. Recently, an alarming rise in ER visits by children who have taken these supplements without supervision has been reported, leading to a call for action.
“These guidelines are the latest in a series of voluntary measures that CRN members have adopted, demonstrating our unwavering commitment to consumer safety and market integrity,” said Steve Mister, the president of the Council for Responsible Nutrition.
The new voluntary guidelines include:
- Labels warning that melatonin may cause drowsiness.
- Child-deterrent packaging to prevent unsupervised ingestion.
- Packaging gummy products in containers with child-deterrent closures.
- Labeling advisories to promote the use of products under appropriate conditions and guidance.
The new guidelines come in the wake of a report by the Centers for Disease Control and Prevention (CDC) that unsupervised exposures to melatonin supplements among young children have significantly increased. The agency recorded 11,000 ER visits due to unsupervised melatonin ingestions by young children from 2019 to 2022.
“Melatonin products do not require child-resistant packaging, but such packaging can be voluntarily implemented,” the CDC stated. The report suggested that child-resistant packaging might be advisable in homes with young children.
The Food and Drug Administration does not regulate supplements like melatonin, but it recognizes it as a relatively low-risk treatment for insomnia. However, high doses can cause drowsiness, daytime sleepiness, headaches, and nausea.