CRN issues voluntary guidelines for melatonin-containing dietary supplements

The voluntary guidelines specifically concern the formulation, labelling, and packaging of melatonin-containing dietary supplements marketed for sleep support. The second set of guidelines provide advice regarding the labelling of gummy dietary supplements.

Adopted by the trade association’s board of directors in March, the guidelines recommend precautionary label statements for melatonin-containing products as well as overage considerations during manufacturing and the use of child-deterrent packaging.

“FDA [US Food and Drug Administration] regulations require that dietary supplements contain at least 100% of the melatonin amount declared in the supplement facts panel throughout the product’s shelf life,” the guidelines state.

“The amount of any overage used to ensure this requirement is met in the finished product on market should be informed by data to support stability and safety.”

Use of child-deterrent packaging gives parents another safeguarding tool

CRN said: “Since melatonin may cause drowsiness, it’s important that it is taken at the appropriate time of day and in the amount listed in the directions for use.

“The recommendation for companies to use child-deterrent packaging for certain forms of melatonin products gives parents another tool – in addition to keeping products out of children’s reach – to ensure appropriate use and reduce unsupervised access.”

The guidelines come amid research suggesting that melatonin consumption by US children and adolescents is increasing.

Data analysed in a research letter looking at 993 children and adolescents found that the prevalence of melatonin consumption in the past 30 days was significantly higher for school-aged children and preteens than preschool children.

The research also referenced another recent examination of 25 commercial supplements, which found that melatonin content ranged from 74% to 347% of the labelled quantity.

Melatonin is 'used safely by millions of American families', says CRN

CRN was highly critical of the research, released in November 2023, stating that the investigation into the commercial supplements did so without acknowledging that federal regulations allowed reasonable overages and that actual ingredient levels were safe.

“This research letter should be received as a call to paediatric doctors to have candid and open conversations with parents about their children’s sleep patterns, and about the use of melatonin, which these findings, and our own data, show is used safely by millions of American families,” said CRN president and CEO Steve Mister.

“What this study doesn’t show is how many families already administer melatonin to their children safely, in consult with, and in many cases, at the suggestion of, their healthcare providers.

“Misrepresenting the state of regulation and mischaracterising the data to paediatric doctors make those candid and fact-based conversations less likely.”

Gummy guidance reduces unsupervised access and addresses choking hazards

CRN’s latest guidance also provides labelling advice for gummy dietary supplements, emphasising the reduction of unsupervised access by children, addressing potential choking hazards for small children, and ensuring products are used as intended.

“Our vantage point as an industry association gives us a broader perspective on trends and allows us to develop responses using those insights to facilitate change on a broader scale than actions taken by an individual company,” said CRN.

“We take pride in being the association that focuses on responsibility and the guidelines we adopted are one part of fulfilling that mission.”