The Council for Responsible Nutrition in Washington, D.C., has introduced new guidelines for melatonin packaging to address the growing issue of children ingesting the supplement without supervision. This action follows a report by the U.S. Centers for Disease Control and Prevention (CDC) citing approximately 11,000 emergency room visits by children who had consumed melatonin unsupervised between 2019 and 2022.
Researchers highlighted in a previous study the mislabeling of melatonin products, with some containing significantly higher levels of melatonin than indicated on the packaging. The Council’s new voluntary guidelines focus on improving the formulation, labeling, and packaging of melatonin-containing dietary supplements, particularly gummy forms that are appealing to children.
Among the proposed guidelines are cautionary label statements for melatonin supplements warning about potential side effects like drowsiness and advising against alcohol consumption. Moreover, child-deterrent packaging is recommended for products in chewable forms that may attract young children.
The Council is urging industry members to adopt these guidelines promptly, with the first set expected to be implemented within 18 months and the second within 24 months. The move aims to ensure that products are responsibly manufactured, marketed, and trusted by consumers.
Melatonin in gummy form poses a significant risk to children as it can be mistaken for candy due to its appearance and taste. Reports show a substantial increase in calls to poison control centers related to melatonin ingestion, particularly among children under the age of five.
While excessive melatonin consumption is not usually fatal, high doses can lead to adverse effects such as rebound insomnia, irritability, and sedation lasting for several days. The lack of FDA regulation for melatonin means that manufacturers must adhere to the guidelines to ensure the safety and proper labeling of their products.
In conclusion, the new guidelines set forth by the Council for Responsible Nutrition aim to address the alarming increase in children ingesting melatonin unsupervised. By promoting responsible manufacturing and labeling practices, the industry seeks to enhance consumer trust and protect the well-being of children who may inadvertently consume these products.