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Melatonin Overdoses Among Children Spur Calls for Package and Labeling Changes

As cases of melatonin overdoses among children rise, an industry association is calling for melatonin producers to follow a new set of packaging and labeling guidelines.

After the CDC reported a 530% rise in melatonin overdoses among children from 2012 to 2021, an industry association is calling on manufacturers to follow a new set of packaging and labeling guidelines.
After the CDC reported a 530% rise in melatonin overdoses among children from 2012 to 2021, an industry association is calling on manufacturers to follow a new set of packaging and labeling guidelines.
David McCue via Getty Images

A rise in melatonin overdoses among children has prompted calls from the Council for Responsible Nutrition (CRN) to follow new child-safe packaging guidelines, according to a report from ABC News.

Melatonin is a hormone produced by the brain that helps with circadian rhythms and sleep, according to the National institutes of Health. Melatonin supplements are considered dietary supplements in the U.S., allowing them to be sold without prescriptions, ABC News says.

In March, the CDC reported there were about 11,000 emergency room visits involving children five and under who took melatonin unsupervised between 2019 and 2022. The CDC previously announced that cases of children overdosing on melatonin had increased by 530% from 2012 to 2021, ABC News reports.

Children who ingest too much melatonin may experience abdominal pain, nausea or vomiting, excessive tiredness, and trouble breathing, according to ABC News.

Packaging Guidelines to Prevent Melatonin Overdoses Among Children

In response to this uptick in child melatonin overdoses, the CRN on April 15 announced a new set of voluntary packaging and labeling guidelines for both melatonin supplements and gummy form melatonin supplements, as detailed on the association’s site.

For melatonin supplements, the CRN guidelines include cautionary label statements to tell consumers that “melatonin may cause drowsiness, not to take with alcohol, and that the products are intended for intermittent or occasional use only.”

The CRN also suggests that any overages of melatonin added during manufacturing be “informed by data to support stability and safety.”

Finally for melatonin supplements, the CRN calls for child-deterrent packaging, specifically for flavored chewable products that might be attractive to children. This suggestion goes beyond federal regulations for child-deterrent closures, which do not require the closures for melatonin products.

Members of the CRN association are being asked to implement these guidelines for their melatonin supplements within 18 months.

Gummy variations of melatonin supplements get a slightly different set of guidelines, and a request from the association to adopt the guidelines within 24 months.

The gummy supplement guidelines include targeted advisories for both adults and children. These advisories give special considerations for gummies intended for young children and urge consumers to use the products under appropriate guidance.

Among those recommended statements is a choking hazard warning for gummies intended for children under four years old.

The CRN asks that manufacturers consider packaging gummy melatonin supplements in child-deterrent containers as well.

“By setting these high standards, we help our members offer products that are responsibly manufactured and marketed, and widely trusted by consumers,” Steve Mister, CRN President and CEO says in the association’s announcement.

While CRN did specify the 18- and 24-month goals to implement these changes, it urges its members and others in the industry to “adopt these guidelines as soon as practical.”

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