This is quite the wake-up call.
Emerging research out of Harvard T.H. Chan School of Public Health has revealed that sleep aid gummies boasting melatonin may contain alarming amounts of the hormone — much more than the manufacturers claim.
One brand tested contained more than 300% of the melatonin promised per serving, according to the study published in the JAMA Open Network on Tuesday, while a majority of others were found to be “inaccurately labeled.”
Led by supplements industry expert Dr. Pieter Cohen, the research team tested 25 different varieties of gummy vitamins for sleep, some of which were marketed with misleading labels and contained higher than advertised doses of melatonin as well as CBD (cannabidiol), a chemical derived from the federally prohibited cannabis plant.
Touted as a remedy for sleep disorder symptoms, supplements for melatonin – a hormone that plays a role in circadian rhythm – has seen growing interest among American consumers, with sales surging to $821 million as of 2020.
But supplement regulation by the Food and Drug Administration is practically nonexistent, raising experts’ concerns.
“When it comes to products like melatonin sold in the US as dietary supplements, the current law leaves consumers at the mercy of the marketplace — whatever a manufacturer places into the product is what you get,” Cohen told The Post.
“The FDA does not test products to ensure that they are accurately labeled,” he reiterated.
The agency does not have the authority to vet supplements before they hit store shelves, which leaves the manufacturers responsible for ensuring the safety and efficacy of their products. While regulations state that all ingredients should be listed on supplement packaging, there lacks an industry-wide standard for serving sizes, doses of dietary supplements and quality control.
Cohen, an associate professor of medicine and internist at the Massachusetts Cambridge Health Alliance, discovered that many of the melatonin-containing supplements tested were misleading, and comprised of higher-than-announced levels of melatonin or even CBD.
This is a significant risk for children, the study authors warned, due to the possibility of both intentional and unintentional consumption — and the fact that we don’t have a lot of research on the effects of too-much melatonin.
Cohen’s team cited a 2022 report from the Center for Disease Control and Prevention that saw a 530% increase from 2012 to 2021 in pediatric ingestion of melatonin.
The report stated that a majority of pediatric calls to Poison Control were due to unintentional consumption, and, in some instances, ingestion resulted in hospitalization and even death.
Inspired by the alarming data, the researchers used the Dietary Supplement Label Database by the National Institutes of Health to identify new melatonin- and CBD-containing sleep aid gummies.
Of the 30 chosen by the team and ordered online, only 25 made the cut. Those without “melatonin” explicitly on the label were excluded from the study.
“To our knowledge, this is the first US study to quantify melatonin in over-the-counter melatonin products,” the study authors wrote.
Of the gummy brands analyzed, 88% were “inaccurately labeled,” with percentages of melatonin ranging from 74% to as much as 347% of the declared amount. Only three products contained the approximate amount of melatonin as printed on the label.
One product contained no “detectable levels” of the hormone at all but did have just over 31 milligrams of CBD.
Five products the team investigated claimed to contain amounts of CBD ranging from 10.6 milligrams to 31.3 milligrams per serving. But, according to the study, those products contained anywhere from 104% to 118% of the declared quantity of CBD.
Despite the limited scope of just 25 types of gummies, the study “represents newly introduced melatonin gummies” which are currently hot on the market, Cohen told The Post,
But the Council for Responsible Nutrition, a supplements manufacturers and suppliers interest group, disputed the study’s findings that ingredient quantities are “unpredictable.”
The association claimed that pediatric doses of melatonin can be issued safely under the supervision of a physician, arguing that “supplement companies go to great lengths” to ensure the safety of their products.
“This report does a complete disservice to a safe product when it is used according to manufacturer’s instructions,” Steve Mister, the President and CEO of CRN, said in a statement. “Parents know how to take care of their own kids, and, often in consultation with their health care providers, have been safely giving the pediatric versions of these melatonin products to their children for years.”
But last year, the American Academy of Sleep Medicine urged parents to refrain from giving melatonin to healthy kids due to limited evidence that “it can help healthy children or adults fall asleep faster.”
Previous studies have discovered nonuniform levels of melatonin present in supplements – consistent with Cohen’s findings.
Adults can take 1 milligram to 10 milligrams of melatonin, but experts warn that, in addition to people tolerating different amounts, there is no standard dosage of either product. This makes overdoses, which are possible, difficult to define.
But products that receive National Sanitation Foundation (NSF) or United States Pharmacopeia (USP) stamps of approval can give consumers peace of mind. Supplements that are verified undergo rigorous testing to ensure the ingredients’ quantity is accurate.
As a general rule of thumb, Cohen advised parents to keep sleep aid gummies out of kids’ reach – as they would with medications like Benadryl or Tylenol – to avoid unintentional ingestion.
As for adults, he told The Post that “it’s not possible to just select any melatonin gummy and assume it’s accurately labeled.”