Sleep Gummies: Potentially Harmful Doses of Melatonin, CBD Found

(CNN) According to a new study, testing of more than two dozen melatonin “gummies” sold as sleep aids found some contained potentially dangerous amounts of the hormone that helps regulate sleep.

“One product contained 347% more melatonin than what was actually listed on the gummies label,” said study co-author Dr. Pieter Cohen, associate professor of medicine at the Cambridge Health Alliance in Somerville, Massachusetts.

A jar of gummies may also contain ingredients you weren’t counting on, Cohen said: “One of the products that lists melatonin doesn’t contain melatonin at all. It was just cannabidiol, or CBD.”

According to the United States Food and Drug Administration, “it is currently illegal to market CBD by adding it to food or labeling it as a dietary supplement.” Still, several of the CBD-containing products tested in the study openly advertised the addition of the compound to their melatonin product, Cohen said.

“Four of the products tested contained levels of CBD that were between 4% and 18% higher than on the label,” Cohen said.

The use of CBD in over-the-counter aids is of particular concern because parents could buy gummy products to give their children to help them sleep, said Dr. Cora Collette Breuner, professor of pediatrics at Seattle Children’s Hospital in Washington. University of Washington. .

“There is no data that supports the use of CBD in children,” said Breuner, who was not involved in the study. “It is currently only recommended for very specific use in children over the age of one with intractable seizure disorders.”

Besides CBD, consuming a candy that unknowingly contains extremely high levels of melatonin – well beyond the daily 0.5 to 1 milligrams per night that has been shown to induce sleep in children — is also dangerous, said Breuner, who sits on the Integrative Medicine Committee. from the American Academy of Pediatrics, which is currently writing new guidelines for supplements in children.

Side effects of using melatonin in children can include drowsiness, headache, restlessness, and increased bedwetting or urination in the evening. There is also the potential for harmful drug interactions and allergic reactions to melatonin, according to the National Center for Complementary and Integrative Health, a department of the National Institutes of Health.

The agency also warns that the supplements could affect hormonal development, “including puberty, menstrual cycles, and overproduction of the hormone prolactin,” which causes breast and milk development in women.

Carefully chosen from government database

In the study, published Tuesday in the journal JAMA, researchers sent 25 products labeled as melatonin gummies to an outside lab that tested levels of melatonin and other substances.

However, the research team did not choose the products “willy-nilly” on the Internet, Cohen said. Scientists carefully selected the top 25 melatonin gummy products displayed in the National Institutes of Health database, which the public can search to see the labels of dietary supplements sold in the United States.

“We choose gummies over other products because we thought parents would choose edibles to give their kids,” Cohen said. “”We also wanted to take a closer look at these products after last year’s report that poison control centers received more than a quarter of a million calls regarding pediatric ingestion, thousands of hospitalizations, visits in intensive care, or even death. “

A 2022 report from the US Centers of Disease Control and Prevention found that poison control calls about children’s melatonin ingestion increased 530% between 2012 and 2021. The biggest spike in calls – 38% – occurred between 2019 and 2020, according to the report.

Most of the calls were for children under the age of 5 who had accidentally eaten gummies that caregivers had not properly sealed away.

“The gummies are appealing to young children, who see them as candy,” Cohen said. “We wondered if there was something going on with the products that might contribute to poison center calls.”

The new study found that 88% of the gummies were inaccurately labeled and only three had less than 10% melatonin of what was listed on the label, said Cohen, who studied the invalid labeling of gummies. supplements for years.

According to the study, the gummies sold as sleeping pills had much higher levels of melatonin than stated on the label, as well as CBD.

“The regulatory framework for supplements is broken,” he said, “Manufacturers aren’t following the law and the FDA isn’t enforcing the law. So that means we have a lot of poor quality products out there.”

An FDA spokesperson told CNN the agency would review the study results, adding that the FDA does not typically comment on specific studies, but “evaluates them within the context of the total body of evidence for further investigation.” our understanding of a particular issue.”

“It is important to emphasize that under current law, the FDA does not have the authority to approve dietary supplements before they are marketed, and companies have the primary responsibility to ensure that their products are not tampered with or mislabeled prior to distribution,” the spokesperson said. said by email.

Steve Mister, President and CEO of the Council for Responsible Nutrition, a trade association for the dietary supplement industry, released a statement saying that manufacturers can add supplemental melatonin to ensure the product remains at levels listed on the label, as degradation occurs naturally over time. .

“While there may be some variability in overages when companies adhere to FDA requirements for shelf life and potency, that does not mean there is a risk in taking these products as intended,” said Mister.

Melatonin is a hormone

People often think of melatonin as an herbal supplement or vitamin, experts say. Instead, melatonin is a hormone which is made by the pineal gland, located deep in the brain, and released into the bloodstream to regulate the body’s sleep cycles.

Studies have shown that melatonin use can be helpful in inducing sleep if used correctly — taking a small amount at least two hours before bedtime — but the actual benefit is small, Breuner said.

In six randomized controlled trials of melatonin treatment in the pediatric population, she said, melatonin reduced the time it took to fall asleep, ranging from 11 minutes at 51 minutes.

“However, these were very small studies with widely varying results,” Breuner said. “So I tell parents, ‘You’re really only watching 11 minutes to reduce the time it takes your child to fall asleep.'”

Anyone considering melatonin should make sure the bottle bears the seal of the United States Pharmacopeia (USP), which manufacturers hire to test and verify products.

“If there’s a USP stamp on the label, you can be sure the product is accurately labeled,” Cohen said. “However, this does not mean that melatonin products will work or that they are a good idea to take.

“That’s not the goal of USP,” he said. “But at least checking the label should eliminate the problems we see here in our study.”

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