The FDA “Botanical Drug Development Guidance for Industry" opens doors for botanical products like herbal medicines and cannabis-derived products to develop into prescription drugs; if a drug product is a single plant or from a mix of plants, the Guidance waives the requirement of
identifying active ingredients
describing the mechanism of action
If botanical products demonstrate safety and efficacy in phases 1, 2, and 3 of clinical trials, they are approved as a prescription medication in the US market.
Botanical Drug Facts:
Between 2016 and 2019, 195 botanical drug clinical trials were registered, of which 81 are phase 2.
By the end of 2018, over 600 IND applications were in clinical development under the botanical drug category
Two botanical products have been approved as prescription drugs:
Veregen (sinecatechins) – a topical drug for genital and perinatal warts
Mytesi® (crofelemer, old name Fulyzaq) - oral drug for control and symptomatic relief of diarrhea in patients with HIV/AIDS on antiretroviral therapy.
ABDA promotes FDA botanical drug guidance and collaborates with entities around the globe to advance the research and development of herbal medicines. Developing already-known safe and effective herbal medicines to botanical drugs through the FDA IND process is an efficient drug development pathway.