The Council for Responsible Nutrition has introduced new packaging guidelines for melatonin supplements in response to a report from the U.S. Centers for Disease Control and Prevention revealing that thousands of children were rushed to the emergency room after ingesting melatonin unsupervised. The guidelines focus on improving the formulation, labeling, and packaging of melatonin-containing dietary supplements, with a particular emphasis on child-deterrent packaging to prevent accidental ingestion by kids.
A study conducted last year found that many melatonin products are mislabeled, sometimes containing over 300% more melatonin than stated on the bottle. The new voluntary guidelines aim to address this issue by recommending cautionary label statements, regulating melatonin overages, and promoting child-deterrent packaging for flavored chewable products. The Council for Responsible Nutrition urges manufacturers to implement these guidelines promptly to ensure the responsible manufacture and marketing of melatonin supplements.
Concerns about the risks associated with melatonin, especially in gummy form, have continued to rise. Reports of melatonin ingestion among children have increased significantly, with more than 94% of cases being unintentional. While excessive melatonin consumption is not usually fatal, it can lead to various side effects such as rebound insomnia, irritability, and sedation. The FDA, despite not regulating melatonin like prescription drugs, still has oversight over the product and dietary supplements through the Dietary Supplement Health and Education Act of 1994, allowing them to address manufacturing and labeling issues.