Melatonin's regulatory crossroads: drug status vs. sleep supplement
Melatonin, a natural sleep hormone, is treated as a dietary supplement in the U.S. with limited pre-market safety testing, while other countries regulate it as a medication. Experts warn that variable labeling, unknown long‑term safety—especially for children—and potential misuse due to perceptions of harmlessness argue for tighter oversight or even drug status. A reclassification could improve dosing clarity and safety, but proponents contend it might limit access and raise costs; meanwhile, labeling guidelines exist but aren’t mandatory, and the regulation landscape remains unsettled.
