Potentially dangerous doses of melatonin and CBD found in gummies sold for sleep

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

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

A jar of gummies might also contain ingredients you didn’t rely on, Cohen said: “One of the products that listed melatonin didn’t contain melatonin at all. It was just cannabidiol or CBD.”

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

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

The use of CBD in over-the-counter aids is especially concerning because parents may be buying gummy products to give their children to help them sleep, said Dr. Cora Collette Breuner, a professor of pediatrics at Seattle Children’s Hospital at the University of Washington. .

“There is no data to support 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 1 year of age with intractable seizure disorders.”

Aside from CBD, consuming a gumdrop that unknowingly contains extremely high levels of melatonin well beyond the daily 0.5-1 milligram per night that has been shown to induce sleep in children is also dangerous, said Breuner, who does part of the integrative medicine committee of the American Academy of Pediatrics, which is currently writing new guidelines on supplements in children.

Side effects of melatonin use in children can include drowsiness, headache, agitation, and increased nocturnal enuresis or urination in the evening. There is also the possibility of 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 breasts and milk to develop in women.

Handpicked from government database

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

However, the research team didn’t pick the products willy-nilly from the Internet, Cohen said. Scientists handpicked the top 25 melatonin gummy products displayed in the National Institutes of Health database, which the public can check 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 to their children,” Cohen said. We also wanted to take a closer look at those products after last year’s report that poison centers received over a quarter of a million pediatric ingestion calls, thousands of hospitalizations, ICU visits, and even some deaths. .

A 2022 report from the U.S. Centers for Disease Control and Prevention found that poison control calls about children ingesting melatonin increased 530 percent between 2012 and 2021. The largest spike in 38% of calls occurred between 2019 and 2020, the report said.

Most of the calls involved children under the age of 5 who had accidentally eaten gummies that health care workers had not properly locked away.

“Gummy candies are appealing to young children, who see them as candy,” Cohen said. “We wondered if there was anything going on with the products that might be contributing to the calls to poison control centers.”

The new study found that 88 percent of the gummies were mislabeled and only three contained an amount of melatonin that was within 10 percent of what was labeled, said Cohen, who has studied labeling for years. invalidity of supplements.

“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 will review the study results, adding that the FDA generally does not comment on specific studies, but “evaluates them as part of the body of evidence to deepen our understanding of a particular issue.”

“Importantly, 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 adulterated or misbranded before their distribution,” the spokesperson said. told 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 manufacturers can add extra melatonin to make sure the product stays up to the levels on the label. as degradation occurs naturally over time.

“Although there may be some variability in overages as companies adhere to FDA requirements regarding shelf life and potency, that doesn’t mean there is a risk to taking these products as intended,” said Mister.

Melatonin is a hormone

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

Studies have found that while using melatonin it may be helpful in inducing sleep when used correctly by 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 pediatric populations, he 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, ‘Are you really only looking at 11 minutes to decrease the amount of time it takes your child to fall asleep.'”

Anyone considering melatonin should be sure the bottle has the United States Pharmacopeia (USP) stamp, which manufacturers hire to test and verify products.

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

“That’s not what USP is about,” he said. “But at least verifying the label should eliminate the issues we’re seeing here in our studio.”