Melatonin - The Law

The Law

Melatonin is neither an illegal drug nor is it monitored by the U.S. government. It is illegal to use it without a prescription in other countries. Under the U.S. Dietary Supplement Health and Education Act (DSHEA) of 1994, it is legal to sell melatonin as a dietary supplement in the United States. According to this Act, a dietary supplement:

  • is a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by people to supplement their diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.
  • is intended for ingestion in pill, capsule, tablet, or liquid form.
  • is not represented for use as a conventional food or as the sole item of a meal or diet.
  • is labeled as a "dietary supplement."
  • includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the Secretary of Health and Human Services waives this provision).