FDA Botanical Drug Guidance

In 2004, the FDA issued Botanical Drug Development Guidance for Industry; In 2016, 2nd edition. If a drug product is derived from a single plant or from a mix of plants, the Guidance waives the requirement of:

• Identifying active ingredients;
• Description of the mechanism of action.

As long as a botanical product demonstrates safety and efficacy during phase I, phase II, and phase III clinical trials, it is approved as a prescription drug on the US market. Two botanical drugs are currently on the US market:

• Veregen (sinecatechins), a topical drug for the treatment of genital and anal warts
• Fulyzaq (crofelemer), an oral drug for control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy

There are over 600 botanical drugs in the FDA IND process.