Class Action Lawsuit Claims Olly Kids Sleep Melatonin Supplements Misleadingly Advertised, Unsafe for Children

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A proposed class action lawsuit alleges that Olly Kids Sleep melatonin supplements are falsely advertised as safe and effective sleep aids for children.

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The 31-page lawsuit claims that although Olly Public Benefit Corp. touts that its Olly Kids Sleep supplements “deliver a kid-friendly amount of Melatonin” to “promote peaceful slumber” for children aged four and up, the product’s claims are misleading as melatonin is not safe for children and the supplements cannot safely and effectively treat insomnia and sleeplessness.

According to the filing, the Kids Sleep supplements are marketed in a way that suggests the product can affect the structure or function of the human body by treating insomnia and sleeplessness and promoting healthy sleep cycles in children. Per the suit, these claims effectively render the supplements a new “drug” under the Federal Food, Drug and Cosmetic Act (FDCA).

However, the lawsuit alleges that Olly has not obtained required approval from the Food and Drug Administration (FDA) to sell the supplements as a new drug product. According to the suit, when a new drug has not undergone the FDA approval process, “there is no way to know” if the product is safe for its intended use, if it is manufactured in a way that ensures consistent quality or if the label is accurate.

The filing stresses that the sale of unapproved new drugs is both unlawful and dangerous, as consumers may forgo proven medical treatments in favor of unapproved new drugs that may not treat their condition and may endanger their health.

The case goes on to claim that melatonin, the primary active ingredient in Olly Kids Sleep supplements, is not safe for children. Per the complaint, Tufts University School of Medicine says that the long-term effects of melatonin supplements for children are not well understood and that taking too much melatonin can have adverse side effects such as daytime grogginess, diarrhea, vomiting, confusion, short-term depression and an increased risk of seizures.

Moreover, the lawsuit cites a Harvard University School of Public Health article stating that the amount of melatonin in a chewable tablet—the form of supplement children are most likely to take—can significantly vary from what the label states, noting that there have been many reports of children overdosing on melatonin.

The lawsuit states that Olly’s suggested dosage of one or two 0.5 milligram gummies is “absolutely reckless” and essentially gives children’s developing brains “mega-doses of a hormone.” Further, there are no studies on the effects of giving small children such amounts over long periods of time and “strong concerns” that it is unsafe to do so, the suit alleges.

Indeed, the filing conveys that doctors generally advise against using medication to treat sleeplessness in children because most sleep-related disturbances can be addressed with consistent nighttime or sleep routines.

Consumers would not have bought the Olly Kids Sleep supplements, or would have paid less for them, had they known the products were unlawfully marketed and sold, the lawsuit says.

The Olly class action lawsuit looks to cover all United States citizens and residents who purchased Olly Kids Sleep in the United States for their own personal or household use, and not for resale, from January 1, 2019 to the present.

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