Melatonin Gummies for Children Raise Ongoing Safety and Labeling Concerns

Concerns about the safety and regulation of melatonin gummies for children have grown as studies and official data highlight inconsistent labeling and increased emergency visits related to accidental ingestion.

In the United States, melatonin is classified as a dietary supplement, which means it is not subject to the same level of Food and Drug Administration oversight as prescription or over-the-counter medications. This regulatory status allows manufacturers to sell melatonin products with less stringent requirements for ingredient verification and labeling accuracy.

Scientific studies have found that the actual melatonin content in gummy supplements can differ greatly from what is stated on product labels. Research has documented that some gummies contain less than half the labeled dose, while others have more than triple the stated amount. In one 2023 study, 22 out of 25 tested brands had inaccurate labeling, with melatonin levels ranging from 74% to 347% of the declared dose.

What the numbers show

• Melatonin content in gummies has ranged from under 50% to over 300% of labeled amounts
• Between 2019 and 2022, nearly 11,000 US children visited emergency departments after ingesting melatonin
• Calls to US poison control centers for pediatric melatonin ingestion rose by about 530% from 2012 to 2021

Further analysis by FDA scientists in 2024 identified even larger discrepancies, with some gummies containing up to 667% of the labeled dose and as much as 50 mg per serving, which is far above recommendations for children. These findings indicate that some products may deliver doses much higher than intended, especially for pediatric use.

Accidental ingestion of melatonin gummies by children has led to a substantial increase in emergency department visits and poison control calls in the United States. From 2019 to 2022, nearly 11,000 children required emergency care after consuming melatonin, with about half of these incidents involving gummies. Over the previous decade, poison control center calls related to pediatric melatonin ingestion increased by approximately 530%, and emergency visits rose by about 420%.

In addition to dosage inconsistencies, some melatonin supplements have been found to contain undeclared substances such as cannabidiol (CBD) or serotonin. The presence of these substances, which are not always listed on product packaging, may pose additional risks to children.

Short-term use of melatonin in children may be considered safe, but the long-term effects, particularly on development and puberty, remain uncertain. The American Academy of Sleep Medicine advises parents to consult healthcare professionals before giving melatonin to children and to store these products securely, treating them like any other medication.

Internationally, regulatory actions have also taken place. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) ordered the removal of children’s gummies sold by Nutrition Ignition after independent testing found each gummy contained approximately 0.53 mg of undeclared melatonin, which is around the recommended starting dose for children.

* This article is based on publicly available information at the time of writing.