How retailers can address melatonin gummy questions after JAMA report

At the end of April, the top-shelf medical publication Journal of the American Medical Association released a paper that made splashy headlines throughout the media. The story is that the popular melatonin gummies are actually unsafe for children and that all contain more melatonin than what their labels claim. 

All the major mainstream media outlets covered the report, from The New York Times (“22 out of 25 melatonin products were mislabeled, study finds”) to The Wall Street Journal (“Those melatonin gummies may have more than you bargained for”) and CNN (“Potentially dangerous doses of melatonin and CBD found in gummies sold for sleep”). 

The JAMA paper noted that calls to poison control centers for melatonin overconsumption by children jumped more than 500% in the last decade. It also noted dosage levels in the gummies far exceeded the label claims. The report mentioned a 10% overage threshold for pharmaceutical drugs, and it noted none of the supplements came within 10% of stated label claim for melatonin quantity. 

'Supplements are not drugs'

What are retailers to say in the face of prominent medical journals and the media amplifying messages that consumers should stay away from melatonin gummies, especially for kids? What it reveals is that the pharma foundation of the American mainstream medical model does not understand supplements regulations. And the mainstream media is not all that interested in finding out, either.

Related:Unboxed: 7 sleep supplements that lead with melatonin

For one, the 10% overage rule is a drug rule, not a supplements rule. Two, melatonin is not unsafe. Health Canada advises melatonin under 10 mg is perfectly safe, and none of the products in the report exceeded this amount, with most coming in under half that. 

“When you look at the safety data, it’s mostly unintended ingestion,” said Steve Mister, president and CEO of the Council for Responsible Nutrition trade group. “It’s the mother who turns her back and the kid got into an adult version of a product, and in an overabundance of caution, she calls the poison control center. About 85% of the reports are asymptomatic.”

The likelihood that a child got into a bottle of gummies and popped a handful like candy is also all too real.

“That’s the concern with gummies in general,” said Tara Couch, Ph.D., the owner of TLC Regulatory and Laboratory Consulting and an organic chemist with 35 years’ experience in laboratory and regulatory environments and quality control. “Child-resistant caps should be used for any gummy for that reason.”

The other notable point—that the dosage quantity exceeded label claims—is not just the law, but it’s a good idea. Here's why. 

“Dietary supplements are not drugs,” Couch said. “If a supplement product is tested and does not meet 100% of label claim, it’s misbranded. Dietary ingredients degrade rapidly in the body, that’s what a vitamin does. If you formulate to 100%, there’s no way a product would meet that in two years or even less. So the dietary supplement industry has to formulate with overages to accommodate test method variability and any potential degradation.”

And the emergency room visits by children were, by and large, because of overdosing on too many gummies, not because melatonin is inherently a cause of safety concerns. 

"It's true that there has been an increase in the number of reported exposures, [but] that is not uncommon for products that experience significant market penetration," said Rick Kingston, Pharm.D., co-founder and president of regulatory and scientific affairs with SafetyCall International, which operates a 24/7 adverse event call center. "As regards the number of reported melatonin exposures, it’s not uncommon for younger children [under age 5] to ingest a variety of substances that are inherently safe. Parents may take them to emergency clinics out of an abundance of caution. This is especially true when there are reports of exposures for a given substance and isolated incidents where more serious effects have been reported.”

Is quality a problem with melatonin?

Yes, there can be select problems with ingredient quality by brands that do not do a good enough job of qualifying vendors and testing ingredients at every step along the value chain, as well as brands that do not have a robust stability program to ensure dosage levels will remain above 100% by the end of shelf life. But by and large, supplements remain a safe class of consumer products.

Although the JAMA paper does not explicitly list the companies targeted in the study, the paper makes clear the list came from the National Institutes of Health Office of Dietary Supplements dietary supplements label database when it is filtered for on-market melatonin gummies. While the majority of brands are relatively unknown companies, the list included seven products from Vitafusion; two from Nature Made, Nature’s Way and Vicks; and one each from Bayer, Carlson, GNC, Nature’s Answer and Vital Proteins. These are quality brands.

The headlines blared that one product contained 347% of the labeled quantity of melatonin and another product contained none at all. While true, all the others contained overages that were not too outlandish. For instance, a product labeled to contain 1 milligram had 1.3 mg. A 5-mg product contained 5.9 mg, while another product labeled with the same amount contained 5.4 mg. Some other 3-mg products contained 3.7 mg, 3.8 mg and 4 mg.

Not all exactly spot on, it is true—but that’s not the legal expectation. 

“FDA regulations require dietary supplements to contain a minimum of 100% of the amount claimed on the product label throughout its shelf life,” said Duffy MacKay, the senior vice president of dietary supplements at trade group the Consumer Healthcare Products Association. “Intentional ingredient overage is permitted for nutrient longevity and safe for consumers when within known safety levels consistent with good manufacturing practices (GMPs).”

According to the National Center for Complimentary and Integrative Health at the National Institutes of Health, “melatonin supplements at normal doses appear to be safe for most children.”

The JAMA paper raises unnecessary concern about these products and evidences a lack of understanding of the federal requirements for dietary supplements as well as the strong safety profile of melatonin among users of all ages.

“The 347% product is probably a bad player,” said Couch. “The good part of the industry has robust stability programs to determine what these overages should be. That’s what stability studies are designed to do—figure out what is that sweet spot. You don’t want to put in too much; that’s expensive. But this paper infers that people are just throwing stuff in. That’s not true.”

Almost all of the 25 products sampled contained adult servings and are expressly labeled for use in adults, yet the JAMA paper conflates the findings with pediatric data.

“This report does a complete disservice to a safe product when it is used according to manufacturer’s instructions,” Mister said. “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.”

CRN also noted the findings didn't present any data to suggest any children were harmed by pediatric levels of melatonin given as directed. Instead, the study authors conflate the issue by attempting to connect poison control center data capturing unintended ingestion of presumably “overdose” levels of melatonin by children, with the potential overage amount of an ingredient a child could hypothetically be given in a single recommended serving of the product being used as intended.

“Supplement companies go to great lengths to ensure their products contain safe and consistent levels of dietary ingredients, as labeled,” Mister added. “And while there may be some variability in overages as companies adhere to the FDA’s requirements regarding shelf life and potency, it does not mean there is a risk in taking these products as intended. It’s a misleading comparison to look at scenarios where kids, for example, got their hands on an entire bottle of adult gummies and became ill after eating multiple servings, versus having slightly more of an ingredient in a single serving that, if taken as directed, would pose no harm.”

What’s next for melatonin?

Because the safety profile of melatonin—when taken according to label recommendations, hospital visits from overdosing notwithstanding—remains safe, this paper is likely to be just another tempest in a teapot.

“There’s no denying there’s a little of a PR issue here if people think they’re buying 3 mg and they’re getting 4,” Mister said. “But I keep coming back to it’s safe and it’s legal. Consumers don’t understand stability testing or labeling requirements. They’re certainly voting with their pocketbooks that they want gummies.”

We predict melatonin—and gummies—will march on, despite the mainstream media headlines that call into question a blockbuster supplement. Headlines mostly do not change consumer sentiment, especially with a popular, experiential supplement that resonates with consumers.

Not for nothing, a similar melatonin market assessment conducted by ConsumerLab found that 21 of 22 products actually passed a similar label test as conducted by researchers in this JAMA paper.

So retailers can counsel customers that, according to Health Canada, melatonin is a safe supplement when adults take up to 10 mg/day—an uber-high dose that is really more than what consumers should be taking anyway. And because children are smaller than adults, the melatonin gummies you stock for children's applications should be far less than 10 mg—perhaps as low as 0.5 mg per gummy. One study on children ages 6-12 found 5 mg melatonin taken an hour before sleep led the melatonin-supplemented children to fall asleep 57 minutes faster and sleep 29 minutes longer than the placebo group. 

The Canadian Paediatric Society (Canada, unlike the United States, allows health claims to be made for supplements) recommends 1 mg of melatonin in infants, 2.5 to 3 mg in older children, and 5 mg in adolescents.