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- In a new study, 88 percent of the melatonin gummy supplements tested were mislabeled by manufacturers.
- To ensure you’re getting the amount per serving size that it says on the label, opt for products that have been tested by a third party.
As a runner, you’re told to value and prioritize your sleep. After all, your sleep can influence your performance. This is likely why some people turn to supplements to fall (and stay) asleep—and one popular pick in the supplement aisle is melatonin.
Melatonin is a natural hormone your brain produces to help you fall asleep, but you can also find it in pill (or gummy) form to help your body wind down. But before you reach for this sleeping aid, you want to make sure you’re getting exactly what’s promised on the label—and according to new research, not many products meet that standard.
The new study, published in JAMA, analyzed 25 melatonin gummy products purchased in September 2022 and entered into the National Institutes of Health’s Dietary Supplement Label Database a year prior. Researchers examined the products for the presence and quantity of melatonin, CBD, and serotonin, which was previously found as a contaminant in melatonin products.
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Researchers found 22 out of the 25 products were inaccurately labeled and only three of the products contained a quantity of melatonin that was within 10 percent of what was listed on the label.
Also, one product contained 10.4 milligrams of melatonin, which was 347 percent more than what was described in the serving size. Another product did not contain detectable levels of melatonin, but did contain 31.3 milligrams of CBD. Five products listed CBD as an ingredient and in those products, quantities of CBD ranged from 10.6 milligrams to 31.3 milligrams. (For the record, CBD products aren’t allowed to be sold as dietary supplements, per FDA regulations.) There were no detectable amounts of serotonin in any of the products.
Researchers concluded that the majority of these products were inaccurately labeled, with the actual amount of melatonin falling between 74 percent and 347 percent of what was listed on the label. Researchers also specifically point out the dangers of melatonin supplements for kids.
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How to Choose the Right Melatonin Supplements
Although you may think melatonin gummies are regulated the same way as prescription drugs, they are not, because they’re considered dietary supplements.
Based on the FDA’s current regulations, dietary supplement manufacturers and distributors are responsible for evaluating the safety and labeling of their products before they reach the market to ensure they meet the standard of the Federal Food, Drug, and Cosmetic Act. This means the FDA is not required to approve these supplements before they hit shelves.
But there are some regulations to the ingredients included in the supplements. For example, manufacturers aren’t allowed to include any ingredient that the FDA has yet to approve. Also, the FDA can take actions against misbranded items.
Based on the study findings, Pieter Cohen, M.D., coauthor, general internist at Cambridge Health Alliance, and associate professor of medicine at Harvard Medical School tells Runner’s World, you can’t be assured that the melatonin gummies actually have the amounts described on the label.
This is why Cohen says it’s important to rely on a high-quality third party certification program like the United States Pharmacopeia (USP) or National Sanitation Foundation (NSF) because these programs complete “very robust evaluations of the manufacturing process.” Meaning they visit the factories and test the products. You’ll find these stamps of approval on the labels.
“If [the supplement gets] certified by one of those two programs, you’ll know that the five milligrams of melatonin you’re taking is accurately labeled,” says Cohen.
Another problem with these products—and what you should look for if you’re considering taking a melatonin supplement—is the dosage. Experts suggest starting with doses ranging from 0.3 milligrams to 3 milligrams, which is far less than what was found in some of the products included in this study.
Some potential good news: Cohen says this is only a snapshot of 315 melatonin products that were introduced in 2021, so it doesn’t mean every product is mislabeled. However, from these findings, it shows that many labels may not offer accurate information.
If you’re considering taking these supplements, be aware that there are also side effects, such as confusion, headaches, dizziness, and possible GI issues. For the supplements that contain CBD, there are also safety concerns associated with the long-term use of this ingredient, such as how it can interact with other medications, and its effects on the liver and male reproductive system.
Most importantly, you should always consult your doctor first before starting any new supplements, and let your medical provider know if you’re experiencing any new side effects as they might be related to supplements you’re currently taking.
Monique LeBrun joined the editorial staff in October 2021 as the associate health and fitness editor. She has a master’s degree in journalism and has previously worked for ABC news and Scholastic. She is an avid runner who loves spending time outside.
