Changes Are Coming to Melatonin Packaging, Industry Group Says

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April 16, 2024 – An organization representing dietary supplement makers has advised its members to update packaging of melatonin sleep supplements and other dietary gummies to help prevent children from eating the products.

The move by the Council for Responsible Nutrition comes after a March report from the CDC warned of rising calls to poison control centers and visits to emergency rooms after infants and children ate melatonin supplements. The increases coincided with an overall increase in adult usage of lab-made versions of melatonin, which is a hormone that helps regulates sleep. 

CRN is a Washington, DC-based trade group representing 180 companies that make dietary supplements or that manufacture the ingredients in them. CRN members include Liquid I.V., Nature’s Way Brands, Nestlé Health Science, Plexus Worldwide, and SmartyPants Vitamins.

The guidelines are voluntary and were recently adopted by the organization’s board of directors.

“CRN urges its members and the broader industry to adopt these guidelines as soon as practicable,” a news release stated. The suggested timeline for implementation is between 18 and 24 months.

Dietary supplements are not as comprehensively regulated by the U.S. Food and Drug Administration in the same ways as conventional food products or as drugs. The agency typically doesn’t approve supplements before they are marketed, and the agency’s webpage on dietary supplements states that “firms are responsible for evaluating the safety and labeling of their products before marketing” to ensure they meet all government regulations.

The Mayo Clinic says melatonin supplements are “generally safe” but warns they can cause headaches, dizziness, nausea, and drowsiness. The Mayo Clinic’s melatonin webpage says the supplements may also cause these less common side effects: “short-lasting feelings of depression, mild tremor, mild anxiety, abdominal cramps, irritability, reduced alertness, confusion or disorientation.”

The CDC report, published just weeks before the CRN issued its new voluntarily guidelines, said that usage of melatonin by U.S. adults has quintupled in the past 2 decades, with about 2% of adults nationwide now estimated to use the supplement.

“During 2019-2022, melatonin was implicated in approximately 11,000 (7%) emergency department visits among infants and young children for unsupervised medication ingestions. Many incidents involved ingestion of flavored products (e.g., gummy formulations),” the report stated.

CRN’s new voluntary guidelines provide direction about formulation, labeling, and packaging of supplements containing melatonin that are marketed for sleep support. New guidelines were also issued for labeling gummy dietary supplements. Labeling should detail intended age groups and include language about keeping out of reach of children, the new guidelines advise. 

“While federal regulations do not require child deterrent closures for melatonin-containing products, CRN’s revised guidelines call for industry members to adopt child deterrent packaging for products containing melatonin that are in flavored chewable forms that could be especially attractive to children,” CRN’s news release stated. “This recommendation provides parents and caregivers with a tool to prevent unsupervised access to these products.”

The CDC’s report on ER visits after children ingested melatonin urged people living in households with young children to select products with child-resistant packaging, since many ER visit reports suggested that infants and children may have opened bottles or gotten into bottles that were not properly closed.

CRN also urged makers of melatonin products to better manage the amount of melatonin in products. Independent testing has revealed that sometimes, products contain significantly more melatonin than is stated on a package’s label. In its message to supplement makers, CRN acknowledged that the products are required to contain 100% of the amount stated on the label and that amount must be stable throughout shelf life. 

“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,” CRN advised.

Correction: Any earlier version of this story said the FDA does not regulate supplements. There are some regulations governing supplements, but they are not as rigorous as those for foods and drugs. The FDA also does not approve supplements before they are sold.