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

CNN

A new study found that some of the melatonin "gummies" sold as sleep aids contained potentially harmful amounts of this hormone, which helps regulate sleep.

One product contained 347 percent more melatonin that was listed on the label, said Pieter Cohen. He is an associate professor at the Cambridge Health Alliance, in Somerville Massachusetts.

Cohen says that a jar of gummies may also contain ingredients that you did not expect. 'One product listed as melatonin actually contained no melatonin. It was cannabidiol or CBD.

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According to the US Food and Drug Administration 'it's currently illegal to sell CBD by adding it into a food product or labeling as a nutritional supplement.' Cohen noted that several of the products tested in the study, which contained CBD, openly promoted the addition of this compound to their product melatonin.

Cohen stated that four of the products tested contained CBD levels between 4% to 18% higher than the labels.

The use of CBD as an over-the counter aid is especially concerning, because parents may purchase gummy products for their children to assist them in sleeping, according to Dr. Cora Collette Breuner. She is a professor of Pediatrics at Seattle Children's Hospital, part of the University of Washington.

Breuner said that there was no evidence to support the use of CBD for children. Breuner did not participate in the study. It's only currently recommended for very specific uses in children older than 1 years old with intractable seizures disorders.

Breuner said that consuming a gummy containing extremely high levels of Melatonin, well above the daily dose of 0.5-1 milligrams per night, that is shown to induce sleep among children, is dangerous. The American Academy of Pediatrics is writing new guidelines for supplements in children.

Melatonin can cause drowsiness in children, as well as headaches, agitation and an increase in bedwetting. According to the National Center for Complementary and Integrative Health (a department of the National Institutes of Health), there is the possibility of harmful interactions with medication and allergic reactions to melatonin.

The agency warns that supplements can affect hormone development. This includes puberty, menstrual cycle, and the overproduction of prolactin which is responsible for breast and milk production in women.

Select carefully from the government database

Researchers sent 25 products labeled melatonin gums to an external lab for testing. The tests measured the levels of melatonin as well as other substances.

Cohen explained that the team did not choose products randomly from the internet. Scientists carefully selected the top 25 gummy melatonin supplements displayed in the National Institutes of Health database. The public can view the labels of dietary supplement products sold in the United States by checking the database.

Cohen stated that they chose gummies because they thought parents would choose edibles for their children. Cohen said that they wanted to look more closely at these products because last year, poison centers received over a quarter of a million calls regarding pediatric ingestion. This led to thousands of hospitalizations and ICU visits as well as some deaths.

The US Centers for Disease Control and Prevention published a report in 2022 that found the number of calls made to poison control by parents about their children consuming melatonin increased by 530% from 2012 to 2021. Report said that the highest spike of calls (38%) occurred between 2019-2020.

The majority of calls came from children under 5 years who had eaten gummies that their caregivers hadn't properly locked away.

Cohen stated that gummies were appealing to children who saw them as candy. Cohen said that they wondered if the products were causing the increase in calls to poison control centers.

Cohen, who studied incorrect labeling for years, found that 88% of gummies had been inaccurately labelled. Only three contained a melatonin quantity within 10% of the amount listed on the label.

He said that the regulatory framework for supplements was broken. 'Manufacturers are not following the law and the FDA does not enforce the law.' This means that there are a lot low-quality products on the market.

A spokesperson from the FDA confirmed to CNN that they would be reviewing the findings of this study. They added that, while the FDA does not comment on specific studies in general, it 'evaluates' them as part of a body of evidence which helps us understand a certain issue.

The spokesperson stated via email that it is important to emphasize that the FDA has no authority to approve supplements before they're marketed. It's the responsibility of the firms to ensure their products are not misbranded or adulterated before they're distributed.

Steve Mister is the president and CEO of Council for Responsible Nutrition. This trade association represents the dietary supplements industry. He released a press release saying that manufacturers can add more melatonin in order to ensure the product stays at the levels listed on the label, as natural degradation occurs over time.

Mister stated that while there may be some variation in the overages, as companies adhere to FDA requirements regarding shelf-life and potency, this does not mean that there is any risk when taking these products in their intended form.

Melatonin, a hormone

Experts say that people often mistake melatonin for a herbal supplement or vitamin. Melatonin, a hormone produced by the pineal, deep in the brain, is released into the bloodstream and regulates the body's sleeping cycles.

Breuner explained that studies have shown that melatonin is helpful for promoting sleep when used properly -- a small dose taken at least two hours prior to bedtime -- but its actual benefits are small.

She said that in six randomized controlled studies on melatonin treatments for children, the time to fall asleep decreased from 11 to 51 minutes.

Breuner stated that these studies were small and had widely varying results. "So, I tell parents that you can reduce the time your child takes to fall asleep by as little as 11 seconds."

If you are considering buying melatonin, make sure the bottle is stamped with the United States Pharmacopeia's (USP) stamp. This organization hires manufacturers to test and verify their products.

Cohen stated that if the product has the USP stamp, it is labeled accurately. Cohen said that this does not mean that melatonin will work or be a good thing to take.

He said, 'That is not the USP.' "But at least, the verification of the labels should eliminate the issues we see here in our study."