Melatonin fracas shows how mainstream media gets it wrong about poison control data

A recent study on melatonin gummies and the subsequent flurry of news reports has highlighted how often the mainstream media misrepresents the true nature of poison control center data, an expert said.

The news reports stemmed from a study conducted by prominent industry critic Dr. Pieter Cohen and a team of researchers from the National Center for Natural Products Research at the University of Mississippi. Cohen’s study, published in the Journal of the American Medical Association, concluded melatonin gummies presented a public health hazard.

The researchers found 22 out of 25 melatonin gummies did not meet label claim, with some containing significant overages. That finding was placed in the context of a more than 530% jump in cases referred to poison control centers involving melatonin ingestion among children over the past decade.

Melatonin is a naturally occurring hormone that governs the sleep-wake cycle. It has been marketed as a sleep aid, a way to deal with jet lag and other conditions.

Its popularity skyrocketed during the pandemic, when many consumers were reporting sleep problems related to general overall stress. Many of these products are formulated with CBD, which has been marketed for similar conditions.

According to the latest data from Nutrition Business Journal, melatonin supplement sales totaled $826 million in 2022 and showed 2.3% year-over-year growth.

Related:Melatonin gummies deemed 'unsafe' but are they really? — analysis

Along with many other supplements, melatonin saw a big jump in the gummy delivery format.  NBJ data presented at the recent SupplySide East trade show revealed gummies are now the most popular delivery format for supplements in general.

While the big jump in case reports from poison control centers is a potential cause for concern, that data needs to be put into context, said Rick Kingston, PharmD, head of scientific and regulatory affairs for SafetyCall International, which specializes in adverse event management and regulatory compliance services. Kingston is also a professor in the School of Pharmacy at the University of Minnesota.

Poison control centers meant to cull wheat from chaff

First off, the standard way to refer to such an increase in case reports by mainstream news outlets is to characterize them as an “increase in poisonings.” This reveals a misunderstanding of the central purpose of poison control centers, Kingston said.

The modern poison control center system is a surprisingly recent innovation. The first crude centers started to appear in the late 1950s. These often consisted of a phone line and a dedicated person to answer that phone who had access to some reference material. The system has developed to the point where there are now 64 centers around the country covering 100 percent of the U.S. population.

“It performs a triage function. Before that, they had people showing up in emergency rooms who had no real need to be there,” Kingston said.

“The vast majority of calls that come into poison control centers are nontoxic in nature,” he added. “They result in either no effect or no adverse effect.”

Nearly 85% of the melatonin “poisonings” and “pediatric overdoses” referred to in the bombastic headlines were calls from concerned parents that didn’t require a visit to a doctor. According to the study that reported the 530% increase, of more than 260,000 reports of melatonin ingestion by children from 2012 to 2021, about 4,000 of those required hospitalization. Of those, 287 were treated in an intensive care unit and two deaths were associated with melatonin ingestion.

Kingston said even in the tragic case of the death of a child, it’s unwise to jump to the conclusion that melatonin was the culprit. He said he’s still reviewing whether those cases had enough information to draw a definitive conclusion.

“Correlation does not equal causation,” Kingston said.

A recent story in Natural Products Insider on this issue makes the case that the big increase is mostly reflective of the growth in melatonin sales over recent years. The most recent mainstream media report about the melatonin research—this one in The Atlantic magazine—also acknowledges that fact.

What about the caps?

The increase in gummy delivery format is a different issue, Kingston said. In his view having an attractive product to a child like a gummy in a bottle without a protective cap is something the industry might want to rethink, especially if such a product features an active ingredient like melatonin.

A federal regulation on child resistant packaging does not appear to take into account the increasing popularity of the gummy delivery format. Only two supplement products—effervescent potassium tablets and supplements containing iron—are on the federal list as requiring child proof caps.

“It’s not a surprise that kids will get into [melatonin gummies] and might eat a bunch,” Kingston said.

Quality control question

Kingston said that while raising a red flag about melatonin safety is a “lot of hullabaloo about nothing,” he acknowledged the picture painted by the Cohen study of variable quality control is a potential black eye for the industry.

“When I saw the numbers, I said, ‘That’s not great. You want more consistency than that.’ But it’s not like children were being poisoned because of an overage.”

Data intersections

Kingston said in the work his company does to monitor the marketplace for manufacturers to uncover potential problems with their products, it’s intersections that count. One stream of data (such as uncorroborated poison control center reports) by itself might not raise an alarm.

“If you are seeing multiple steams of data confirming not only exposure but also adverse consequences, that’s when you start to be concerned you might have a problem,” he concluded.