Editor’s note: This story has been updated to clarify how dietary supplements are regulated by the Food and Drug Administration.
Melatonin makers are being asked to implement new safety measures based on updated guidelines that follow a rise in accidental ingestion of by children.
The Council on Responsible Nutrition (CRN), a trade association for dietary supplement and functional food manufacturers and ingredient suppliers, announced in a press release Monday “the adoption of two sets of new voluntary guidelines,” with one of them targeting the “formulation, labeling, and packaging of melatonin-containing dietary supplements and the other aimed at “the labeling of gummy dietary supplements.”
The Centers for Disease Control (CDC) found in recent data that the number of kids ages 5 and younger who went to the emergency room for unsupervised melatonin ingestion went up by 420 percent from 2009 to 2020. Melatonin is sold as a dietary supplement, which is regulated by the Food and Drug Administration, but under a different set of rules from those that cover over-the-counter medications.
The revised guidelines on melatonin supplements include a “call” for the adoption of “child deterrent packaging for products containing melatonin that are in flavored chewable forms that could be especially attractive to children,” according to the press release. CRN is asking its members to put the new guidelines on melatonin supplements in place within 18 months.
When it comes to gummy dietary supplements, CRN is asking its members to improve the safety by having “detailed labeling advisories for products aimed at both adults and children” that include “specific considerations for gummy supplements intended for young children and underscore the importance of using these products under appropriate conditions and guidance,” according to the press release. CRN is asking its members to put the new guidelines on gummy dietary supplements in place within 24 months.
“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,” CRN President and CEO Steve Mister said in the release. “By setting these high standards, we help our members offer products that are responsibly manufactured and marketed, and widely trusted by consumers.”
Updated at 3:07 p.m.