Melatonin Manufacturers Urged to Adopt New Packaging and Labeling Rules Following Uptick in Hospitalizations Among Children

By Trisha Andrada

Apr 17, 2024 06:13 AM EDT

New melatonin safety measures were issued Monday, April 15, by the Council for Responsible Nutrition (CRN), and supplement makers are encouraged to put these recommendations into practice.

"By setting these high standards, we help our members offer products that are responsibly manufactured and marketed, and widely trusted by consumers," council president and CEO Steve Mister said, as reported by USA Today.

CRN Issues Voluntary Guidelines for Supplement Makers' Packaging and Labeling

Here are the recommendations for melatonin supplements:

  • Labels should inform buyers that melatonin could make them sleepy, that they should not mix it with alcohol, and that they should only use the medicine seldom or intermittently.
  • Overages of melatonin during production should be guided by evidence that supports stability and safety. Per the Food and Drug Administration (FDA) requirements, dietary supplements must maintain 100% of the melatonin quantity listed on the label throughout their shelf life.
  • Child-deterrent packaging would help parents keep their children safe from unsupervised access to melatonin products in flavored chewable forms, which are very appealing to youngsters.

Voluntary guidelines for packaging of gummy form supplements:

  • Targeted warnings: Comprehensive warnings for products would highlight the significance of utilizing gummy supplements under the right circumstances and include particular concerns for these products.
  • Warning about possible choking hazards: A label would be put on items meant for children under the age of 4 to indicate that they might choke if not consumed properly.
  • Packaging: Manufacturers should think about using containers with child-proof closures when packaging gummy items.

The first set of rules is expected to be adopted within 18 months, and the second set within 24 months. The council is urging its members and the industry at large to embrace them as quickly as possible.

Melatonin dietary supplement formulation, labeling, and packaging are the primary areas of attention for the new standards. The labeling of gummy dietary supplements, which is especially important for children's safety, is another area of emphasis.

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Nearly 11,000 American Kids Hospitalized Over Unsupervised Melatonin Intake, Study Finds

The new guidelines follow a report released by the Centers for Disease Control and Prevention (CDC) of the United States last month. The CDC found that nearly 11,000 American children who took melatonin unsupervised ended up in the emergency room between the years 2019 and 2022.

Last year, researchers examined 25 different melatonin products and discovered that most of them had incorrect labels. It turned out that some had over 300% more melatonin than was specified on the label.

READ MORE: Breaking New Ground in Mental Health Care with Dr. Olivia West's Innovative Strategies

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