New Guidelines for Melatonin Announced Amidst Accidental Overdoses

The Council for Responsible Nutrition (CRN) recommends that supplement manufacturers adopt cautionary label statements and child-deterrent packaging to address recent concerns about melatonin misuse and accidental overdoses among children.

On April 15, The Council for Responsible Nutrition (CRN), a trade association for the dietary supplement and functional food industry, announced new voluntary melatonin supplement guidelines for manufacturers. The association aims to address the intentional addition of melatonin during manufacturing, promote child-deterrent packaging, and add precautionary labeling on melatonin supplements.

CRN's guidelines also provide new recommendations for melatonin-containing gummies.

Andrea Wong, Ph.D., Senior Vice President of Scientific & Regulatory Affairs at the Council of Responsible Nutrition, tells Healthnews, "The Council for Responsible Nutrition (CRN) updated our guidelines for melatonin supplements from 2015 as this product category continues to grow. These guidelines were designed to ensure responsible formulation, labeling, and packaging practices."

What are the new melatonin guidelines?

The new guidelines include revising labels to warn consumers about melatonin's potential effects, including drowsiness, and that people should not take the supplements with alcohol. In addition, labels should state that melatonin-containing products are intended for occasional use only.

CRN also recommends supplement makers should alert consumers about overages that occur during manufacturing. Overages are the intentional addition of melatonin to supplements to offset losses that occur during the product's shelf life.

Why are new melatonin guidelines necessary?

Wong tells Healthnews that CRN's move was also in response to increasing concerns about children's unsupervised access to melatonin-containing products.

For example, recent reports from the U.S. Centers for Disease Control and Prevention (CDC) show that accidental melatonin ingestion among children has increased by 530% in the past decade. These incidents resulted in nearly 30,000 emergency room visits and two deaths.

Moreover, reports suggest that melatonin use among children is increasing.

To address the issue, CRN is calling for supplement manufacturers to adopt child-deterrent packaging for melatonin supplements that come in flavored, chewable forms.

In addition, melatonin-containing gummies should have detailed advisories for parents considering these supplements for children. For example, labels on gummy products should include a potential choking hazard statement. Like non-gummy melatonin supplements, the packaging for gummy forms should also be child-deterrent.

CRN has requested that supplement makers comply with melatonin supplement guidelines within 18 months and melatonin gummy recommendations within 24 months.

However, industry compliance is voluntary and not required.

"Our members formed a task force to recommend updates to the guidelines that were ultimately approved by our Board of Directors," Wong explains. "Since our members were closely involved in the process, we expect the guidelines will be positively received."


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