November 3, 2025
Washington, D.C. — The Natural Products Association (NPA) today responded to a report from the American Heart Association warning that long-term use of melatonin supplements to support sleep may have negative side effects.
The preliminary study — finding an association between melatonin and increased risk of heart failure or death but noting that a cause-and-effect relationship cannot be proven — focused on medical patients with a disease, namely chronic insomnia. The American Heart Association’s announcement failed to recognize that supplements sold in the United States are not intended to treat, cure, or prevent disease, per express language in the Dietary Supplement Health and Education Act of 1994.
“We recommend that consumers with chronic sleeplessness and other chronic diseases always consult with their physicians to properly diagnose and treat their medical conditions,” said Daniel Fabricant, Ph.D., president and CEO of NPA. “The preliminary study examined whether melatonin use alters the risk of heart failure in chronic insomnia patients, which is not the supplement industry’s target population. Furthermore, the established literature demonstrates that short-term use of melatonin is safe. NPA agrees that consumers should not take melatonin supplements for chronic insomnia without a proper indication and in close consultation with a medical professional.”
NPA was disappointed in the American Heart Association’s erroneous statement that over-the-counter supplements in the U.S. “are not regulated.” Dietary supplements — including products containing melatonin — are subject to cGMPs (current good manufacturing practices) to confirm their identity, purity, strength and composition and that they contain no harmful adulterants. FDA inspects hundreds of supplement companies every year to review their manufacturing processes, and NPA has been committed to ensuring that its members follow the cGMPs applicable to dietary supplements since the final rule was promulgated in 2007.
In the American Heart Association-announced preliminary study covering more than 130,000 adults with insomnia, researchers segmented people into two groups: the “melatonin group,” those with chronic insomnia who had used melatonin for at least a year or more, based on their electronic health records; and the “non-melatonin group,” those with insomnia who did not have melatonin recorded in their medical records.
The study cited several limitations, including that the patient database did not include countries (including the U.S.) that don’t require a prescription for melatonin. Individuals who took over-the-counter melatonin supplements in the U.S. or other countries that don’t require a prescription would fall in the non-melatonin group, the American Heart Association said. This limitation raises additional questions about whether there is an actual cause-and-effect relationship and emphasizes that the study did not focus on the occasional use of melatonin for sleeplessness or other conditions, or FDA-regulated supplements containing versions of the hormone.
“While NPA supports further research to test the long-term safety of melatonin for the heart, it’s important to note that this preliminary study focused on a disease population,” Dr. Fabricant said. “We do not promote the use of melatonin supplements to treat chronic insomnia or any other disease. NPA and its members take very seriously the industry’s responsibility to manufacture quality products based on cGMP requirements that FDA enforces. This is part of the robust regulatory framework created over 30 years ago under DSHEA, which created a clear distinction between products to support health and wellness and those to treat disease, the subject of the preliminary study announced by the American Heart Association.”