(NewsNation) — New guidelines for melatonin were adopted by the Council for Responsible Nutrition in March, the same month the Centers for Disease Control and Prevention published a report showing tens of thousands of children went to the emergency department after accidentally ingesting it.
The Council for Responsible Nutrition, which is the leading trade association for the dietary supplement and functional food industry, announced the updated guidelines in a news release Monday.
According to the CDC report, melatonin was implicated in 11,000 emergency department visits among infants and young children from 2019-2022, many of which involved flavored products. Between 2012 to 2021 there was a 530% increase in poison center calls for pediatric melatonin exposures. From 2009-2020, there was a 420% increase in emergency room visits for kids who accidentally consumed melatonin.
In addition, an April 2023 study published in JAMA showed a majority of the 25 melatonin gummy products they tested were mislabeled. Although the study said this was the first report to quantify melatonin in over-the-counter products, a Canadian study also found similar issues. An analysis of 16 Canadian melatonin brands found the actual dose of melatonin in the products ranged from 17% to 478% of the declared quantity.
This comes as melatonin use among adults rises, according to the CDC. It “quintupled” from 0.4% during 1999–2000 to 2.1% in 2017–2018.
“These are just the latest in a series of Voluntary Guidelines that CRN members have adopted that underscore CRN’s unwavering commitment to the well-being of consumers and the integrity of the dietary supplement market,” CRN President and CEO Steve Mister said in a statement. “By setting these high standards, we help our members offer products that are responsibly manufactured and marketed, and widely trusted by consumers.”
The council says these suggestions should be put in place for melatonin-containing supplements within 18 months, and within 24 months for gummy supplements.
What are the new melatonin guidelines?
Melatonin Supplements
New melatonin guidelines for supplements say there needs to be label statements telling customers that it can cause drowsiness, not to take it with alcohol and that products should only be used occasionally.
Any overages of melatonin added in the product’s manufacturing should be “informed by data to support stability and safety,” the CRN said.
Federal regulations do not require that there be childproof closures for products with melatonin, but the CRN says its revised recommendations urge manufacturers to use childproof packaging, especially for flavored, chewable forms.
Gummy Supplements
CRN said products for both adults and kids should have detailed labeling advisories, and inform about potential choking hazards.
Manufacturers are also being asked to consider packaging gummy melatonin in child deterrent closures.
What is melatonin?
Melatonin, according to the National Center for Complementary and Integrative Health, is a hormone that people’s brains create in response to darkness. It helps with people’s circadian rhythms, also known as their 24-hour “internal clock,” and with sleep.
While they can be made from animals or microorganisms, most melatonin dietary supplements are made synthetically.
Because melatonin is considered a dietary supplement, it is regulated less strictly by the Food and Drug Administration than a prescription or even over-the-counter drug would be, the NCCIH wrote. Some countries only make melatonin available with a prescription, however.
“Short-term use of melatonin supplements appears to be safe for most people, but information on the long-term safety of supplementing with melatonin is lacking,” the NCCIH noted.
Anyone taking medicine who wants to use dietary supplements, including melatonin, should consult their health-care providers before doing so, particularly those with epilepsy or blood thinners, per the NCCIH.