The Food and Drug Administration (FDA) defines a “botanical” as a product that exclusively contains ingredients from plants, algae or fungi.  In contrast to most conventional pharmaceutical drugs comprised of one single chemical, botanicals contain complex mixtures of naturally occurring chemicals. In order to more appropriately evaluate herbal mixtures, in June 2004 the FDA published Guidance for Industry for Botanical Drugs, a new policy providing advice for potential botanical drug manufacturers, describing both the application process and providing recommendations as to how chemically complex products might satisfy the requirements of FDA’s rigorous “new drug” review process.

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A botanical product may be a food (including a dietary supplement), a drug (including a biological drug), a medical device (e.g., gutta-percha), or a cosmetic.  Whether an article is considered a food, drug, medical device, or cosmetic depends on its “intended use”.  “Intended use” is created by claims made by or on behalf of a manufacturer or distributor of the article to prospective purchasers, such as in advertising, labeling, or oral statements.
 

Botanicals used for food and consumed primarily for their taste, aroma, or nutritive value (e.g., lettuce, herbs used as seasonings) are regulated as foods. Botanicals can also be dietary supplements if they are labeled as dietary supplements and otherwise meet the dietary supplement definition in section 201(ff) of the Federal Food and Drug Cosmetic Act of 1906 (the Act).
 

A New Drug Application (NDA) for a botanical drug could seek approval for either prescription or OTC use, depending on the indication and characteristics of the product and whether it is safe for use outside of the supervision of a practitioner licensed by law to administer it. If existing information on the safety and effectiveness of a botanical drug product is insufficient to support an NDA, the FDA recommends that new clinical studies be conducted to demonstrate safety and effectiveness.
 

Let Clintract help guide your company through the complex FDA regulatory requirements and registration options for your company’s nutritional supplements and botanical products.