U.S. Department of Health and Human Services
U.S. Food and Drug Administration
What is a Botanical Drug?
A botanical drug product is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans.
A botanical drug product consists of vegetable materials, which may include plant materials, algae, macroscopic fungi, or combinations thereof.
A botanical drug product may be available as (but not limited to) a solution (e.g., tea), powder, tablet, capsule, elixir, topical, or injection.
Botanical drug products often have unique features, for example, complex mixtures, lack of a distinct active ingredient, and substantial prior human use. Fermentation products and highly purified or chemically modified botanical substances are not considered botanical drug products.
A botanical drug's special features require consideration and adjustment during the FDA review process. CDER issued a Guidance for Industry- Botanical Drug Products (PDF - 437KB) to take into consideration these features and to facilitate development of new therapies from botanical sources. The Botanical Guidance applies to only botanical products intended to be developed and used as a botanical drug product.