Botanicals as “new” drugs: US development

• Future treatments for seizure disorders may include complex botanicals.
• An overview of how the United States regulates products is presented.
• Claims to “treat” or “prevent” seizures require premarket approval in the US.
• As drugs, botanicals have unique characteristics.
• The pathway to US drug approval for botanicals is discussed.

Botanicals are ingredients that can be marketed as foods, drugs, cosmetics, and medical devices in the United States. When a botanical is intended to diagnose, treat, prevent, mitigate, or cure a disease, it is considered to be a “drug”. This article reviews the US regulatory requirements for botanicals as “new” drugs. An overview of the regulatory principles used to determine product category and the basic elements of an Investigational New Drug application and New Drug Application with the US Food and Drug Administration are presented.This article is part of a Special Issue entitled “Botanicals for Epilepsy”.