The Council for Responsible Nutrition (CRN) and the Consumer Healthcare Products Association (CHPA) have provided their comments on the recent report of increased, unintentional pediatric melatonin ingestion. A 10-year study, released by the Centers for Disease Control and Prevention (CDC) on Thursday, June 3, found a sharp increase in the use of melatonin by children specifically.

According to the study, "During 2012–2021, the annual number of pediatric ingestions of melatonin increased 530 [percent] with a total of 260,435 ingestions reported. Pediatric hospitalizations and more serious outcomes also increased, primarily because of an increase in unintentional melatonin ingestions in children aged ≤5 years."

As a result of this increase, the study reported, the amount of inadvertent poisonings among children increased throughout the 10-year period. " ... pediatric melatonin ingestions accounted for 4.9 [percent] of all pediatric ingestions reported to poison control centers in 2021 compared with 0.6 [percent] in 2012."

In response, Dr. Andrea Wong, senior vice president, Scientific and Regulatory Affairs, CRN, commented "Just as there are many reasons for sleep issues, there can be different approaches, including using melatonin, to help get a better night’s sleep. Research shows that melatonin can be helpful in addressing sleep issues in children and is safe when used as directed. We recommend that parents consult their children’s health care providers for the appropriate approach."

She added, "It’s important to understand that a reported ingestion to a poison control center does not mean an adverse event occurred. In fact, this study shows that 97.8 [percent] of the reports had an outcome of no effect or minor effect following melatonin ingestion, and the vast majority of children were asymptomatic (82.8 [percent]). For the few reports associated with an adverse outcome, it is not possible to confirm whether the outcomes were caused by melatonin ingestion since poison control data do not include patient medical records.

"Looking at the reported numbers without context can mislead parents and raise undue alarm. During the last decade, melatonin use has grown exponentially. Nutrition Business Journal reports the market for melatonin increased 288 [percent] in the past five years alone—of course that would correlate with an increasing number of instances where a parent called a poison control center out of an abundance of care and caution. Unavoidably, more use means more possibilities for accidental ingestion."

Lastly, Wong advised that natural product retailers can "remind parents to keep all supplements out of children’s reach and to follow the directions for use on the label."

CHPA's Duffy MacKay, senior vice president of dietary supplements, stated, “Keeping young children safe by preventing them from accidentally ingesting dietary supplements is of the utmost importance to manufacturers. Melatonin is a safe and beneficial dietary supplement for adults and children, regulated by the FDA and consumed by millions of Americans to support and promote healthy sleep and wellness when used as directed on Supplement Facts labels."

Concurring with the report's conclusion, MacKay added “The CDC report appropriately calls for more public education initiatives to prevent accidental unsupervised pediatric exposures to melatonin, such as ‘safe storage’ and ‘appropriate use’ initiatives, and CHPA agrees. CHPA and our members are involved in a number of long-term efforts targeted at preventing accidental unsupervised ingestions by young children including the Up and Away campaign led by CHPA’s Educational Foundation and the CDC’s PROTECT Initiative, which works to educate and remind parents and caregivers about safe use and storage of healthcare products, always keeping them out of reach and sight of curious, young children." The association advised concerned consumers to view the Up and Away campaign and speak with their health care providers to learn more about safe storage of dietary supplements.

For more information, visit www.cdc.gov.