"The groundwork of all happiness is health." - Leigh Hunt

According to the industry group, changes are coming to the packaging of melatonin

April 16, 2024 – An organization representing dietary complement manufacturers has really helpful that its members update the packaging of melatonin sleep supplements and other gummies to stop children from eating the products.

The Council for Responsible Nutrition's move comes after a march report The CDC warned of increased calls to poison control centers and emergency room visits after infants and youngsters took melatonin supplements. The increases coincided with an overall increase in adults' use of lab-made versions of melatonin, a hormone that helps regulate sleep.

CRN is a trade group based in Washington, DC, that represents 180 firms that make dietary supplements or their ingredients. CRN members These include Liquid IV, 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 entire industry to adopt these guidelines as quickly as possible,” a Press release stated. The proposed time-frame for implementation is between 18 and 24 months.

Dietary supplements aren't as comprehensively regulated US Food and Drug Administration in the identical way as conventional food or as medicine. The agency typically doesn't approve dietary supplements before they hit the market, and the agency's dietary supplements webpage states that “companies are responsible for evaluating the safety and labeling of their products before marketing” to be sure that they comply with all government regulations.

The Mayo Clinic says melatonin supplements are “generally safe” but warns that they may cause headaches, dizziness, nausea and drowsiness. The Mayo Clinic Melatonin website says the supplements can even cause these less common unwanted effects: “short-lasting feelings of depression, mild tremors, mild anxiety, abdominal cramps, irritability, decreased alertness, confusion or disorientation.”

The CDC report, released just weeks before the CRN released recent voluntary guidelines, said melatonin use by adults within the U.S. has increased five-fold over the past 20 years, with estimates now suggesting it has increased by about 2 % of adults nationwide use the complement.

“During 2019-2022, melatonin was associated with approximately 11,000 (7%) infant and toddler emergency room visits for unsupervised medication use. Many incidents involved the ingestion of flavored products (e.g., gummy bears),” the report said.

CRN's recent voluntary guidelines provide guidance on the formulation, labeling and packaging of dietary supplements containing melatonin and marketed to support sleep. New guidelines have also been issued for the labeling of gummy dietary supplements. The recent guidelines recommend that labeling should clearly indicate the intended age groups and include instructions that they must be kept out of the reach of youngsters.

“While federal regulations do not require child-deterrent closures for melatonin-containing products, the revised CRN guidelines encourage industry members to adopt child-deterrent packaging for melatonin-containing products that come in flavored chewable tablets and may be particularly attractive to children,” the CRN press release states stated. “This recommendation gives parents and caregivers a tool to prevent unsupervised access to these products.”

The CDC report on emergency room visits following children's ingestion of melatonin urged people living in households with young children to pick out products with child-resistant packaging because many emergency room visit reports indicated that infants and youngsters could have opened bottles or got into bottles that weren't properly sealed.

CRN also urged manufacturers of melatonin products to higher control the quantity of melatonin within the products. Independent testing has shown that products sometimes contain significantly more melatonin than stated on the packaging label. In its notice to dietary complement manufacturers, CRN confirmed that products must contain 100% of the quantity stated on the label and that this amount have to be stable throughout the shelf life.

“The amount of excess used to ensure this requirement is met in the finished product on the market should be determined using data to support stability and safety,” recommends CRN.

Correction: An earlier version of this story stated that the FDA doesn't regulate dietary supplements. There are some regulations for dietary supplements, but they aren't as strict as those for foods and medications. The FDA also doesn't approve dietary supplements before they're sold.