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 Botanical Drug Development Guidance for Industry 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.
To date, two botanical products have fulfilled the Botanical Guidance definition of a botanical drug product. Both botanical drug products have been approved for marketing as prescription drugs (sinecatechins, Veregen® and crofelemer, Mytesi™). 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.
What is a Dietary Supplement?
There are numerous botanical preparations that are marketed in the U.S. as dietary supplements.
A dietary supplement is a product taken by mouth that contains a dietary ingredient intended to supplement the diet.
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.
Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids or powders.
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’s Center for Food Safety and Applied Nutrition (CFSAN) webpage on dietary supplements.
FDA Information for Consumers