Regulate the Sale and Use of Melatonin

Target: Dr. Stephen Ostroff, M.D., Commissioner of Food and Drugs

Goal: Regulate the sale and use of the hormone melatonin to prevent health problems and overdose.

The United States is currently the only country where melatonin is completely unregulated. Melatonin is a hormone that is released naturally in the human body, typically with the onset of darkness. This hormone regulates the circadian rhythm, or the biological timing of sleep, as well as regulating blood pressure, seasonal reproductive function, and several other bodily functions. Like any hormone in the human body, the delicate balance of secretion and bodily need is difficult and often unnecessary to control.

Currently, melatonin is available in the United States over the counter in most drugstores for anyone to take. Often, melatonin is advertised and marketed as a natural sleep aid. That, and the fact that it is widely available for purchase without a prescription, can lead people to believe it is a safe way to moderate sleep. Instead, failure to regulate this precarious hormone properly can result in further disruption of the sleep cycle and changes in the cardiovascular, immune, and metabolic systems.

Furthermore, parents have recently been administering melatonin to their children when they have experienced sleep disruption, which can lead to even greater problems long-term. In Australia, melatonin is only prescribed as sleep therapy to individuals aged 55 and older since the body’s natural secretion of melatonin drops with age. Even then, it is carefully regulated by medical professionals to ensure patients are not over-dosing themselves with the hormone. Parents should not be misled to believe this naturally-occurring hormone is safe to administer in larger doses to their children.

Sign the petition below to urge the Commissioner of Food and Drugs to further regulate the sale and use of melatonin in order to protect people from incorrectly self-prescribing this hormone to themselves and their children.


Dear Dr. Ostroff,

The United States is currently the only country where the hormone melatonin is unregulated and sold as a “dietary supplement.” The overuse of melatonin can lead to further sleep disruption as well as problems with the cardiovascular, immune, and metabolic systems of the human body. It is imperative that melatonin is no longer available over the counter in drugstores in order to prevent incorrect self-administration of this hormone.

With age, the body secretes less melatonin, which occasionally leads to sleep disruption in the elderly. Melatonin is available by prescription only to individuals over the age of 55 in Australia. In the United States, however, the hormone can be administered to children since it is marketed as a natural sleep therapy.

I am urging you to further regulate the sale and use of the hormone melatonin. Please take actions to enforce policies against reckless self-prescription of this precarious hormone.


[Your Name Here]

Photo Credit: Murrur

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308 Signatures

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