'It's being promoted like there's absolutely no risk': Why some experts say melatonin should be considered a drug rather than a supplement

Melatonin occupies a regulatory gray zone in the United States. Sold as a dietary supplement rather than a pharmaceutical drug, melatonin escapes the rigorous testing and labeling requirements that govern prescription and over-the-counter medications. This classification allows manufacturers to market the hormone with minimal oversight, a situation experts say poses public health concerns.

The supplement industry generates roughly $50 billion annually in the U.S., with melatonin among the fastest-growing categories. Yet the hormone carries documented risks that consumers often don't understand. Sleep specialist Dr. Shalini Paruthi and other researchers published findings showing melatonin can interfere with blood pressure regulation, increase seizure risk in people with epilepsy, and potentially affect reproductive function in adolescents whose hormone systems remain developing.

The most immediate problem involves dosing accuracy. Studies consistently find that melatonin supplements contain wildly inaccurate amounts. Some tablets contain 10 times their advertised dose. Others contain none. The lack of standardization means consumers cannot reliably know what they are ingesting.

Current labeling requirements for supplements are far less stringent than for drugs. Manufacturers need not prove efficacy or safety before marketing. They only must report serious adverse events after products reach shelves. Drug companies, by contrast, must conduct clinical trials demonstrating both safety and effectiveness before FDA approval.

Researchers argue melatonin merits reclassification. Reclassifying the hormone as a drug would require manufacturers to conduct premarket testing, establish standard dosages, and clearly communicate risks on labels. The National Institutes of Health acknowledges melatonin's effectiveness for circadian rhythm disorders and certain sleep problems, but questions remain about long-term effects and optimal dosing for different populations.

The supplement industry resists stricter regulation, citing consumer access and freedom. However, physicians note