Drug approval

Drug approval is the formal decision by a regulator that a specific product is safe and effective for a defined use, allowing it to be marketed as a medicine.

In the United States the U.S. Food and Drug Administration grants approval after reviewing a New Drug Application that contains manufacturing data, animal studies and the results of adequate and well-controlled clinical trials. Approval is tied to a labeled indication, a dosage form and a manufacturing process, and it carries ongoing obligations for adverse-event reporting and, sometimes, post-marketing studies. A product that is not approved cannot legally claim to diagnose, cure, mitigate, treat or prevent disease, regardless of how much research exists.

The distinction matters for cannabinoids: one purified cannabidiol product has been approved for specific seizure disorders, and synthetic THC drugs such as dronabinol and nabilone are approved for nausea and appetite loss in defined patients. Hemp-derived CBD sold as a supplement, food or cosmetic has no approval, which is why its labels may make only structure/function or wellness statements and why FDA warning letters target disease claims.