FDA Approves Special Green Tea Extract as a New Topical Drug for Genital Warts Expert Says Development Marks the Birth of a 'New Industry'

摘要

On October 31, 2006, the US Food and Drug Administration (FDA) approved a special extract of green tea as a prescription drug for the topical (external) treatment of genital warts caused by the human papilloma virus (HPV).1 The new drug, called Polyphenon E (Veregen) Ointment, is the first prescription botanical (herbal) drug approved by FDA under its current regulatory policy for botanical products as well as FDA's new Drug Application Process. The active drug ingredient, Polyphe-non E (15% strength), represents a proprietary mixture of naturally occurring phytochemicals called catechins, produced from a partially purified water extract of green tea leaves. Catechins are polyphenolic compounds with antioxidant properties. Tea, brewed from the leaves of the tea plant (Camellia sinensis, Theaceae), is considered the most popular beverage worldwide, second only to water. Unlike leaves used for black or oolong teas, leaves used to prepare "green" tea do not undergo a fermentation process, thereby retaining higher levels of antioxidants.