[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 single plant or from mix of plants, the Guidance waives the requirement of:
identifying active ingredients
description of mechanism of action
As long as a botanical product demonstrates safety and efficacy during phase I, phase II, and phase III clinical trials, they are approved as prescription drugs on the US market. Two botanical drugs have been approved so far as prescription drugs 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
By the end of 2018, over 600 botanical drugs are in FDA IND drug development stages.
[Botanical Drug Development Pathway]
For cannabis-related products, sponsors often conduct "clinical trials" to show medical benefits, but their classification as dietary supplement prohibits sponsors from labelling medical claims. FDA encourages sponsors to develop cannabis products through the botanical drug development pathway for hemp products and for controlled products.
Modern herbal medicines in forms of pills or capsules with demonstrated safety and efficacy on large scale population are good candidates to develop into US prescription botanical drugs:
choosing known safe and effective herbal medicines reduces time and cost of drug discovery
demonstrated safety significantly increases success rates from pre-clinical tests up to phase-IIa
demonstrated efficacy significantly improves success rates of Phase-IIb and Phase-III trials
The technical challenge of developing CMC contents is tedious but doable.