Study Finds Most Melatonin Gummies Inaccurately Labeled, Poses Risks for Children
A recent study conducted by a team from the Cambridge Health Alliance and the University of Mississippi has found that 88% of melatonin gummy products analyzed were inaccurately labeled.[0] The study tested 25 samples of melatonin gummies and found that 22 of them had significantly more melatonin than stated on the packaging, with amounts ranging from 74% to 347% of the labeled quantity.[0] Melatonin is an over-the-counter supplement that helps regulate sleep-wake rhythms and is commonly used for sleep, stress, and relaxation in both adults and children. However, the study warns that the efficacy of melatonin for healthy children is not supported by high-quality evidence.[1]
The study also found that the actual quantity of melatonin in the products ranged from 1.3 mg to 13.1 mg per serving, whereas doctors often recommend 1 to 2 mg of the supplement.[2] Furthermore, a 2022 report by the US Centers for Disease Control and Prevention found that calls to poison control about melatonin ingestion by children rose 530% between 2012 and 2021, with the largest spike in calls occurring between 2019 and 2020.[2] The American Academy of Sleep Medicine has also issued a health advisory over the use of melatonin, particularly in children, and advises parents to talk with pediatricians before using the hormone.[3]
The study warns that clinicians should advise parents of the use of melatonin gummies because it may result in the ingestion of unpredictable quantities of melatonin and CBD, which some products contain despite being illegal. The study notes that while a few melatonin products carry a “USP verified” mark, which offers more certainty that the product contains what is on the label, it does not mean they have been proven safe and effective.[4]
The study highlights the precariousness of the supplement industry, with supplements not being regulated as medicine or subject to the same rules by the US Food and Drug Administration.[5] Unlike prescription drugs, supplements are not reviewed by the agency prior to their release in the market.[6] The study has limitations, including its small sample size, only one sample of each brand being tested, and only gummies being analyzed.[5]
The CEO of the Council for Responsible Nutrition, representing supplement manufacturers, Steve Mister, disregarded the results by stating that supplement companies take extensive measures to guarantee the precision and safety of their labels.[7] However, the study warns that children consuming melatonin gummies as directed could be exposed to between 40 and 130 times higher quantities of melatonin, and that unintentional ingestions could lead to consumption that greatly exceeds these dosages of melatonin. Troubling side effects can occur from taking too much melatonin, such as trouble breathing, vomiting, and excessive sleepiness. In children, experts say melatonin risks include excessive drowsiness and increased bedwetting, plus many things that could disrupt sleep, such as headaches, nausea, nightmares, dizziness, and mood changes.[8]
0. “Your melatonin gummies may hold higher doses than you realize, new study finds” The Boston Globe, 25 Apr. 2023, https://www.bostonglobe.com/2023/04/25/metro/melatonin-gummies-higher-doses-mislabeled/
1. “Unpredictable Amounts of Melatonin, CBD Identified in Kids' Gummies” MD Magazine, 25 Apr. 2023, https://www.hcplive.com/view/unpredictable-amounts-of-melatonin-cbd-identified-in-kids-gummies
2. “Melatonin gummies may have a higher dose than what's on the label” The Washington Post, 25 Apr. 2023, https://www.washingtonpost.com/wellness/2023/04/25/melatonin-gummies-dose-safety/
3. “Sleep aid gummies contain way more melatonin, CBD than advertised: study” New York Post , 25 Apr. 2023, https://nypost.com/2023/04/25/sleep-aid-gummies-contain-way-more-melatonin-cbd-than-advertised-study/
4. “Supplements can contain far more melatonin than is safe, upping odds for illness” Medical Xpress, 25 Apr. 2023, https://medicalxpress.com/news/2023-04-supplements-melatonin-safe-upping-odds.html
5. “Melatonin Gummy Mislabeling Is a Problem, New Study Suggests” CNET, 25 Apr. 2023, https://www.cnet.com/health/nutrition/melatonin-gummy-mislabeling-is-a-problem-new-study-suggests/
6. “With little FDA oversight, melatonin supplements vary widely in actual dosage, study finds” STAT, 25 Apr. 2023, https://www.statnews.com/2023/04/25/fda-melatonin-supplements/
7. “Is melatonin safe for kids? Gummies can cause poisoning, study finds” USA TODAY, 25 Apr. 2023, https://www.usatoday.com/story/news/health/2023/04/25/melatonin-supplement-sleep-gummies-safety-kids/11731017002/
8. “Melatonin in sleep-aid gummies can be off by up to 350%, study finds” Ars Technica, 25 Apr. 2023, https://arstechnica.com/science/2023/04/crazy-variability-of-melatonin-in-sleep-aid-gummies-may-keep-you-up-at-night/
