NOVEMBER 14, 2023
Authors’ attempt to raise concerns should fall flat with informed parents, healthcare providers
WASHINGTON – The Council for Responsible Nutrition (CRN), the leading trade association representing the dietary supplement industry, has responded to a newly published research letter ("Characteristics of Melatonin Use Among US Children and Adolescents") appearing in the Journal of the American Medical Association (JAMA) Pediatrics, which cites irrelevant and flawed data to raise unnecessary alarm about pediatric use of melatonin.
Basing their findings on what the authors conceded was a “relatively small” sample from a “homogenous” group of just over 900 participants who were taking melatonin, they concluded “that melatonin consumption by US children and adolescents is exceedingly common, with some parents beginning administration to their children at an early age.” They added, “Furthermore, parents reported administering melatonin for an extended period…” These outcomes were neither surprising nor pejorative on their face.
However, as a preface to their findings, the authors cited two previous studies about melatonin that are flawed. One cited study raised concerns about melatonin levels in products without acknowledging that federal regulations allow reasonable overages and that actual ingredient levels were safe. The other cited study failed to point out that an increase in calls to poison control centers coincided directly with increasing usage patterns but did not correlate with supposedly harmful overdoses related to using the products as intended. Rather the increase in calls from parents regarding real and suspected accidental ingestion by children rarely resulted in the need for medical intervention.
The author also falsely asserts that dietary supplements “are not regulated by the [FDA]”, when, in fact, the agency has an entire office that does just that. According to the agency: “FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering ‘conventional’ foods and drug products.” Repeating this false narrative to JAMA readers—and JAMA knows better—undermines their confidence in a safe market.
“This Research Letter should be received as a call to pediatric doctors to have candid and open conversations with parents about their children’s sleep patterns, and about the use of melatonin, which these findings, and our own data, show is used safely by millions of American families,” said Steve Mister, President & CEO, CRN. “What this study doesn’t show is how many families already administer melatonin to their children safely, in consult with, and in many cases, at the suggestion of, their healthcare providers. Misrepresenting the state of regulation and mischaracterizing the data to pediatric doctors make those candid and fact-based conversations less likely.”
Mister added that the review process at JAMA Pediatrics should be questioned when it permits the spread of alarming misinformation and doesn’t hold authors accountable that these products are indeed regulated, the levels of melatonin in both pediatric and adult products are in compliance with FDA regulation, and harmful pediatric overdoses of melatonin are exceedingly rare.
Press Release: JAMA Research Letter Raises False Alarm Over Levels of Melatonin in Gummies (2023)
CRN Fact Sheet: The Truth about Melatonin (2022)
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 200+ dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Follow us on Twitter @CRN_Supplements and LinkedIn.