Melatonin manufacturers are facing calls to implement enhanced safety measures following a concerning uptick in accidental ingestion incidents involving children.
The Council on Responsible Nutrition (CRN), a prominent trade association representing dietary supplement and functional food producers, has announced the adoption of new voluntary guidelines aimed at addressing these safety concerns.
One set of guidelines focuses on the formulation, labeling, and packaging of melatonin-containing dietary supplements, while the other targets the labeling of gummy dietary supplements.
The move comes in response to alarming data from the Centers for Disease Control (CDC), which revealed a staggering 420 percent increase in emergency room visits by children under the age of 5 due to unsupervised melatonin ingestion between 2009 and 2020.
Melatonin, classified as a dietary supplement, is not subject to regulation by the Food and Drug Administration (FDA).
The updated guidelines for melatonin supplements include a push for the adoption of child-deterrent packaging for flavored chewable forms of the supplement, which may be particularly appealing to children. CRN is urging its members to implement these new guidelines within 18 months to enhance product safety.
Regarding gummy dietary supplements, CRN is advocating for improved safety measures through detailed labeling advisories, particularly for products targeting both adults and children.
These advisories will emphasize specific considerations for gummy supplements intended for young children and stress the importance of using these products under appropriate conditions and guidance. CRN has set a timeline of 24 months for its members to adhere to these new guidelines for gummy dietary supplements.
CRN President and CEO Steve Mister emphasized the organization’s commitment to consumer well-being and market integrity, stating that these voluntary guidelines reinforce their dedication to offering responsibly manufactured and marketed products that are widely trusted by consumers.