As a dietary supplement, melatonin is not approved by the US Food and Drug Administration for safety, effectiveness or labeling before it is sold to the public.
The council’s action follows recent reports of a massive rise in accidental ingestions of melatonin by children and an April 2023 study that found 25 products labeled as melatonin gummies contained dangerous levels of the hormone.
Melatonin gummies were involved in nearly 5,000 of those cases.
While the vast majority of unsupervised melatonin ingestions did not result in hospitalization, the number of accidental ingestions by children 5 and under may be underestimated, the report said.
New and improved labelsThe council guidelines call for new labels that warn consumers about the danger of drowsiness after taking a melatonin supplement.
Persons:
—, ”, Pieter Cohen, ” Cohen, it’s “, Cohen, Catherine McQueen, ” Dr, Cora Collette Breuner, “ It’s, Breuner, Amanda Musa
Organizations:
CNN, Council for Responsible Nutrition, US Food and Drug Administration, Cambridge Health Alliance, US Centers for Disease Control, Prevention, CDC, Food and Drug Administration, Getty, Seattle Children’s Hospital, University of Washington
Locations:
Somerville , Massachusetts, Seattle