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 drugs.