Health
Melatonin Supplements: Safety Concerns and New Guidelines Unveiled
Sleep disturbances are a common issue among adults, with approximately 30 percent experiencing symptoms of insomnia and 13.5 percent feeling fatigued most days, according to the National Council on Aging. To combat these issues, many individuals turn to sleep aids, including melatonin supplements. Melatonin is a hormone that naturally increases in your brain when it’s dark and decreases when it’s light. While the body typically produces enough melatonin, supplements are available to aid sleep and have been deemed “safe for short-term use”. However, experts are now raising concerns about “serious risks” associated with melatonin supplements.
The Council for Responsible Nutrition (CRN) recently approved “two new sets of voluntary guidelines” for melatonin-containing dietary supplements and gummy dietary supplements. These guidelines, which pertain to labeling and packaging, come in response to a rise in accidental ingestion of melatonin by children. A recent report from the Centers for Disease Control and Prevention (CDC) revealed that about 7 percent of emergency room visits related to “unsupervised medication ingestions” among children were linked to melatonin between 2019 and 2022.
Gummy formulations were the most frequently ingested, accounting for 47.3 percent of cases. While few of these incidents resulted in hospitalization, concerns remain. A study conducted in April 2023 found that some over-the-counter melatonin supplements contain higher levels of the hormone than advertised, while another contained cannabidiol (CBD) instead of melatonin.
Pieter Cohen, MD, an associate professor of medicine at the Cambridge Health Alliance in Somerville, Massachusetts, and lead author of the study, spoke with CNN about the new CRN guidelines. He noted that these warnings are a positive step, stating, “What’s significant here is that the industry recognizes that melatonin supplements do pose serious risks—particularly to children—and that the industry needs to do a much better job at ensuring the products are safe and well-manufactured.”
However, Cohen also highlighted that these guidelines are “voluntary,” meaning manufacturers can choose whether or not to adopt them. The CRN is urging manufacturers of melatonin-containing supplements to implement changes within 18 months, and manufacturers of gummy supplements to do so within 24 months. Cohen expressed uncertainty about whether these voluntary recommendations will be followed, stating, “Whether this voluntary recommendation will be followed, is another matter entirely, and we’ll need to see.”
The updated melatonin guidelines from the CRN “provide recommendations addressing intentional overages during manufacturing, child-deterrent packaging, and precautionary label statements for melatonin-containing products,” ensuring that products are “responsibly formulated, labeled and packaged.”
The CDC report highlighted that melatonin products are not required to have child-resistant packaging. However, in about 75 percent of emergency room visits where the type of container was documented, children accessed melatonin from bottles, suggesting that the bottles may have been easy to open or not properly closed.
The CRN’s new recommendations for gummy supplements, which have become increasingly popular, apply to all gummies, including those containing melatonin. The CRN is asking manufacturers to focus on “labeling clarity, reducing unsupervised access by children, addressing potential choking hazards for small children, and ensuring products are used as intended.”
CRN President and CEO Steve Mister emphasized the organization’s commitment to consumer well-being and market integrity, stating, “By setting these high standards, we help our members offer products that are responsibly manufactured and marketed, and widely trusted by consumers.”
As always, it’s important to consult your healthcare provider directly with any questions or concerns about the medication you’re taking.
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