According to a new study that was published on April 24 in the journal JAMA, people who take the over-the-counter supplement melatonin for the purpose of improved sleep may be getting more—or less—of the medicine than they think they are. Researchers from the Cambridge Health Alliance and the University of Mississippi conducted an investigation into 25 different gummy supplements that claimed to include melatonin. They found that 22 of the supplements contained significantly different quantities of melatonin than what was stated on the bottle for each supplement.
It was discovered that the melatonin quantities in the 22 goods with inaccurate labels ranged from 74% to 247% of the amounts that were reported on those products. One contained no melatonin at all. Dr. Pieter Cohen, the lead author of the study and an associate professor of internal medicine at Harvard Medical School as well as an internist at Cambridge Health Alliance, said that this information did not come as a surprise to him. Even while melatonin supplements have long been “thought to be relatively safe,” the Food and Drug Administration (FDA) in the United States does not regulate supplements as stringently as they do over-the-counter medications. “Supplement manufacturers don’t need to keep the FDA happy,” he argues. “[T]he FDA is not a customer.” “They don’t need to prove anything to the agency—so they do whatever they want to do,” in reference to the quantity. It is possible to keep production costs down by avoiding an unhealthy preoccupation with quality control.
Following the publication of a research in 2022 which found that calls to U.S. poison-control centres for paediatric melatonin use had increased by more than 500% between 2012 and 2021, Cohen made the decision to examine more closely at melatonin gummies. ” The majority of those calls were due to unintentional ingestions,” he says, adding gummies are especially enticing to children, who can mistake the drug for candy. He also notes that the majority of those calls were due to accidental ingestions. Even though the majority of the children were fine, about twenty percent of the parents who called the poison control centre stated that their children were experiencing some symptoms. These symptoms included gastrointestinal distress, cardiovascular issues, and other symptoms. According to Consumer Reports, approximately ten percent of American parents have at least one child who uses melatonin. Despite this, the supplement has not been subjected to extensive research in children.
Previous studies have also discovered that the amount of the medicine that is contained in melatonin pills might vary widely from one brand to the next. A study that was conducted in Canada in 2017 indicated that 71% of over-the-counter supplements that were examined had mislabeled melatonin doses by a margin of at least 10%. Some of the supplements that were tested were likely also available in the United States at the time. According to Cohen, the fact that these findings have basically been duplicated with a newer generation of goods more than five years later demonstrates how the under-regulated supplement business in the United States gives no meaningful incentive for manufacturers to improve their practises.
Because melatonin is a hormone that is produced in the brain and released when it gets dark outside, firms will frequently emphasise in their marketing that the boost offered by a melatonin supplement is “natural.” This is because melatonin is a hormone that is released to make us feel tired when it gets dark outside. However, many of their real doses are significantly higher than what the body produces on its own, according to Cohen. “What we know is that if you give a 20-year-old adult a very small amount of melatonin in the morning—like a 10th of a milligramme, or three 10ths of a milligram—it raises their levels up to the normal nighttime levels,” says Cohen. “This raises their melatonin levels to the normal nighttime levels.” The manufacturers of many popular over-the-counter supplements state that each dose contains anywhere from five to even ten milligrammes of the active ingredient. A nighttime melatonin practise could add many times the amount that the body is able to make, taking into consideration the variable quantities that were discovered in Cohen’s study.