Definitions of botanical

Sources

“A botanical is a plant or plant part valued for its medicinal or therapeutic properties, flavor, and/or scent. Herbs are a subset of botanicals. Products made from botanicals that are used to maintain or improve health may be called herbal products, botanical products, or phytomedicines.”

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A “drug made from part of a plant, as from roots or bark.”

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“A drug, medicinal preparation, or similar substance obtained from a plant or plants.”

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A “substance obtained from a plant and used typically in medincinal or cosmetic products.”

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Botanical Drug Product: A product that is used as a drug and that contains as ingredients vegetable materials, which may include plant materials, algae, macroscopic fungi, or combinations thereof. Botanical drug products may be available as (but are not limited to) solutions (e.g., teas), powders, tablets, capsules, elixirs, topicals, or injectables. For the purposes of this MAPP, fermentation products and highly purified (or chemically modified) botanical substances are not considered botanical drug products. See the Botanical Guidance for a more comprehensive definition of botanical products. Allergenic extracts and vaccines that contain botanical ingredients are regulated by the Center for Biologics Evaluation and Research (CBER) under section 351 of the Public Health Service Act (42 U.S.C. 262).

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