Botanicals as "new" drugs: US development

Area of Science:

• Regulatory Science
• Pharmacology
• Botanical Medicine

Background:

• Botanicals have diverse applications in the US, including food, cosmetics, and medical devices.
• When intended for disease treatment, botanicals are regulated as drugs by the US Food and Drug Administration (FDA).

Purpose of the Study:

• To review US regulatory requirements for botanicals intended for use as new drugs.
• To provide an overview of regulatory principles for categorizing botanical products.
• To outline the essential components of Investigational New Drug (IND) and New Drug Applications (NDA).

Main Methods:

• Review of US Food and Drug Administration (FDA) regulations and guidelines pertaining to botanical drugs.
• Analysis of regulatory principles for determining product classification (food, cosmetic, or drug).
• Summary of key elements required for Investigational New Drug (IND) and New Drug Application (NDA) submissions.

Main Results:

• Botanicals marketed for therapeutic purposes must comply with drug regulations.
• Successful navigation of the regulatory pathway requires understanding product categorization and submission requirements.
• The article provides a foundational understanding of the IND and NDA processes for botanical drug development.

Conclusions:

• Compliance with FDA regulations is crucial for botanical products intended as drugs.
• This review serves as a guide to the regulatory landscape for new botanical drugs in the US.
• Understanding these requirements is essential for the successful development and approval of botanicals for conditions like epilepsy.