Mommy’s Bliss Kids Sleep Melatonin Supplements Are Unsafe for Children, Class Action Lawsuit Claims

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A proposed class action lawsuit alleges that Mommy’s Bliss Kids Sleep supplements are falsely advertised as safe and effective for treating insomnia or sleeplessness in children, and labeled with efficacy claims prohibited for use on product packaging without FDA approval.

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The 44-page lawsuit says that although defendant Mom Enterprises, LLC claims that its Mommy’s Bliss Kids Sleep supplements “promote restful sleep” for children three and up and “support your child’s natural sleep process,” among other representations, melatonin is not safe for children, and the supplements cannot safely and effectively treat insomnia or sleeplessness as advertised.

In addition, the Mommy’s Bliss melatonin supplements at issue, which come in gummy, liquid and chewable tablet forms, are marketed with the same efficacy claims that can be found on prescription sleep disorder drugs, the complaint says. Because the Mommy’s Bliss supplements are advertised as intended to affect the structure or function of the body to treat insomnia, the suit says, they are in fact a “new drug” that requires Food and Drug Administration (FDA) approval in order to lawfully enter the market.

According to the lawsuit, the FDA has not reviewed or approved the supplements at issue, meaning there is no way to know whether they are safe or effective for their intended use.

The filing states that the sale of unapproved new drugs is unlawful and dangerous, as consumers may purchase and use a product that could endanger their health or cause them to forgo actual medical treatment in favor of an unapproved remedy that may not actually treat their condition.

The case goes on to cite an article from Tufts University School of Medicine that states that melatonin is not a safe sleep aid for children because there are few studies on the long-term effects of the hormone’s use in children. The complaint relays that melatonin use in children has been associated with adverse effects such as daytime grogginess, diarrhea, vomiting, confusion, short-term depression, and an increase in seizures.

The filing also says the American Academy of Sleep Medicine recently issued a health advisory about melatonin supplements, stating that the actual amount of melatonin in tablet or liquid supplements can vary significantly, with chewable tablets—the form most likely to be consumed by children—showing the biggest variation.

Per the case, each Kids Sleep gummy contains one milligram of melatonin, which the lawsuit stresses is three to 10 times more than the amount of melatonin that adults need to take to produce nighttime levels of the hormone. In fact, because a three-year-old typically weighs about 1/6 the weight of a median American adult, one gummy provides about 60 times more melatonin than is needed to produce nighttime levels of melatonin, the complaint relays.

The case says that such dosages are “absolutely reckless” and essentially give children’s developing brains “mega-doses of a hormone” that has not been proven to be safe or effective at treating insomnia and sleeplessness.

Worse still, from 2012 to 2021, calls to poison control centers regarding children who ingested melatonin rose by a staggering 530 percent, the lawsuit says. The suit notes that melatonin overdoses in children have been linked to thousands of hospitalizations and at least two deaths.

Although packaging for the products includes a back-panel disclaimer that the supplements “ha[ve] not been evaluated” by the FDA and are not intended to diagnose, treat, cure or prevent disease, the lawsuit claims that the disclaimer is improperly positioned. Indeed, under the FDCA, such disclaimers must be displayed on every panel where efficacy claims are made, the suit states.

Consumers would not have purchased the Mommy’s Bliss Kids Sleep supplements, or would have paid less for them, had they known the products were unlawfully marketed and sold, the complaint says.

The Mommy’s Bliss class action lawsuit looks to cover all United States citizens and residents who purchased 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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