CRN launches new labeling guidelines for melatonin supplements

On April 15, 2024, the Council for Responsible Nutrition (CRN), one of the most prominent trade associations for the dietary supplements industry, issued a statement highlighting new labeling guidelines for all gummy supplements, specifically melatonin gummy supplements.

Melatonin supplements have recently been critiqued for a lack of regulation despite increased use across the United States. For example, in May 2023, a JAMA research letter highlighted a lack of regulation by comparing melatonin concentrations across brands. The letter noted that melatonin concentrations varied from 1.3 to 12.1 mg per serving.

Additionally, a recent report from the CDC analyzing data from the National Electronic Injury Surveillance System revealed that 7% of all emergency department visits for infants and young children between 2019 and 2022 were associated with unsupervised melatonin ingestion. Among these visits, 70% were severe enough to warrant hospitalization, and 60% of the hospitalizations were in children under two.

Both of these examples highlight the dangers associated with unregulated and unsupervised melatonin ingestion.

Understanding these risks and the dangerous implications of mislabeled supplements, the CRN provided updated recommendations for melatonin supplements, covering labeling instructions, overages during manufacturing, and child deterrent packaging.

The first recommendation is asking melatonin manufacturers to include a warning on their supplement labels, notifying consumers that the product can cause drowsiness, should not be consumed with alcohol, and should only be used intermittently.

The following recommendation addresses the concerns of product concentration. According to the press release, federal regulations of supplements require that they contain 100% of the labeled amounts for the entirety of their shelf life. The CRN also asks that any higher melatonin concentrations be supported by safety and stability data.

Finally, the CRN hopes to address the unsupervised use of melatonin in infants and young children by recommending child deterrent packaging, emphasizing the importance of this packaging in supplements that may resemble candy or be attractive to children.

The CRN is offering manufacturers 18 months to adopt these guidelines.

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

While the FDA loosely regulates dietary supplements like melatonin, understanding trade association standards can help consumers make choices about over-the-counter supplements.