Experts Are Demanding Melatonin Supplements Get New Warning Label: "Serious Risks"

man getting ready for bed holding melatonin supplement — Prostock-studio / Shutterstock

Having trouble sleeping isn't an uncommon experience, as most of us know all too well. In fact, according to data from the National Council on Aging, roughly 30 percent of adults have insomnia symptoms, and 13.5 percent feel tired or exhausted most days. With that in mind, many of us turn to sleep aids, including supplements like melatonin.

The hormone naturally occurs in your body, increasing in your brain when it's dark outside and decreasing when it's light, per the Mayo Clinic. While your body typically makes enough, supplements are available to help you sleep, and have been deemed "safe for short-term use"—but that doesn't mean they come without risks. Now, experts are highlighting "serious risks" related to melatonin supplements, calling for manufacturers to take action.

In an April 15 press release, the Council for Responsible Nutrition (CRN) announced that it approved "two new sets of voluntary guidelines" for melatonin-containing dietary supplements and gummy dietary supplements.

The new guidelines pertain to labeling and packaging, and follow a rise in accidental ingestion of melatonin by children, CNN reported. According to a recent report from the Centers for Disease Control and Prevention (CDC), roughly 7 percent of emergency room visits related to "unsupervised medication ingestions" among kids were tied to melatonin between 2019 and 2022.

Gummy formulations were the most commonly ingested, reported in 47.3 percent of cases—and while few resulted in hospitalization, there are still concerns. An April 2023 study identified some of these issues, finding that some over-the-counter melatonin supplements have higher levels of the hormone than advertised, while another contained cannabidiol (CBD) instead if melatonin.

Speaking with CNN regarding the new CRN guidelines, study lead author Pieter Cohen, MD, an associate professor of medicine at the Cambridge Health Alliance in Somerville, Massachusetts, noted that these warnings are a step in the right direction.

"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," Cohen told the news outlet.

However, Cohen also pointed out that the guidelines are "voluntary," meaning manufacturers will have to elect to adopt them. The CRN is encouraging manufacturers of melatonin-containing supplements to make changes within 18 months, while manufacturers of gummy supplements have 24 months.

"Whether this voluntary recommendation will be followed, is another matter entirely, and we'll need to see," Cohen told CNN.

According to the CRN, the updated melatonin guidelines "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 noted that melatonin products don't require child-resistant packaging. However, in roughly 75 percent of emergency room visits where the type of container was documented, children accessed melatonin from bottles, suggesting that the bottle may have been easy for them to open or not properly closed.

The CRN's new recommendations for gummy supplements—which have become increasingly popular—apply to all gummies, including melatonin. To reduce risks, 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," the press release states.

"These are just the latest in a series of Voluntary Guidelines that CRN members have adopted that underscore CRN's unwavering commitment to the well-being of consumers and the integrity of the dietary supplement market," CRN President and CEO Steve Mister, said in the release. "By setting these high standards, we help our members offer products that are responsibly manufactured and marketed, and widely trusted by consumers."

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Abby Reinhard Abby Reinhard is a Senior Editor at Best Life, covering daily news and keeping readers up to date on the latest style advice, travel destinations, and Hollywood happenings.Read moreFiled UnderHealth Advice • Medicine • News • Safety • SleepSources referenced in this article