A
botanical drug product is intended for use in
the diagnosis, cure, mitigation, treatment or
prevention of disease in humans.
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A botanical
drug product consists of vegetable
materials, which may include plant materials,
algae, macroscopic fungi, or combinations
thereof.
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A botanical drug product
may be available as (but not limited to) a
solution (e.g., tea), powder, tablet, capsule,
elixir, topical, or injection.
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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
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.
No botanical
products that fulfill the Botanical Guidance
definition of a botanical drug product are
currently marketed as prescription drugs.
There are some botanical drugs, including
cascara, psyllium, and senna, that are
included in the over-the-counter (OTC) drug review. For a
botanical drug substance to be included in an
OTC monograph, there must be published data
establishing a general recognition of safety
and effectiveness, including the results of
adequate and well-controlled clinical
studies.
There are numerous botanical preparations that
are marketed in the U.S. as dietary
supplements.
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A dietary supplement is a
product taken by mouth that contains a dietary
ingredient intended to supplement the diet.
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The dietary ingredients in these products may
include: vitamins, minerals, herbs or other
botanicals, amino acids, and substances such
as enzymes, organ tissues, glandulars, and
metabolites.
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Dietary supplements can also be
extracts or concentrates, and may be found in
many forms such as tablets, capsules, softgels,
gelcaps, liquids or powders.
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Dietary supplements can also take
other forms, such as a bar. If they do,
information on their label must not represent
the product as a conventional food or a sole
item of a meal or diet.
Whatever their form may be, the Dietary
Supplement Health and Education Act (DSHEA) of
1994, places dietary supplements in a special
category under the general umbrella of foods,
not drugs and requires that every supplement
be labeled a dietary supplement. Dietary
supplements are labeled to describe how a
nutrient or dietary ingredient affects the
structure or function in humans or to describe
the documented mechanism by which a nutrient
or dietary ingredient acts to maintain the
structure or function. The labeling on a
dietary supplement can not make a disease
claim to diagnose, cure, mitigate, treat or
prevent disease.
For information on the regulation of dietary
supplements and the reporting of safety
problems for dietary supplements currently on
the market, please see the FDA Center for Food
Safety and Applied Nutrition (CFSAN) website
FDA/CFSAN Dietary Supplements: Overview
FDA
Information for Consumers
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Botanical Review Team