Makers of melatonin supplements have 18 to 24 months to voluntarily add child-deterrent packaging and improve cautionary language on labels of over-the-counter products, according to the Council for Responsible Nutrition, the leading trade association for the dietary supplement and functional food industry.
Melatonin is a hormone produced by the brain in response to darkness. It regulates the body’s natural sleep-wake cycle or circadian rhythm. As a dietary supplement, melatonin is not regulated by the US Food and Drug Administration, yet the demand for melatonin among both adults and children has skyrocketed over the last decade, according to experts.
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. One over-the-counter product contained up to 347% more melatonin than listed on the label, while another contained no melatonin at all — it was entirely composed of cannabidiol or CBD.
As my wife the pediatrician often repeats when it comes to medicine: “children are not just little adults.”