To see if your product is a good candidate for the botanical drug IND development:
A Botanical Product Enhancing the Human Immunology System
A US company is currently developing a multiple-herb botanical drug product, which has been marketed as a dietary supplement in the US and in other countries for several years. There is real-world evidence to show effectiveness in enhancing the human immunology system, as shown in the table.
Although the mechanism of action for this product is fully described, it is not required in the FDA botanical drug IND process. The outcomes of enhancing the human immunology system are profound as there are multiple possible indications. The US company started the FDA botanical drug IND filing with the most promising indication of X. Additional FDA IND filings for other indications will follow after the first success.
An ABDA team is supporting this project.
Dantonic® (T89) Capsule to Prevent and Treat Stable Angina (CAESA)
Developed from a Chinese Traditional Medicine (CTM) herb, Dantonic® (T89) is a botanical drug consisting of extracts from 5 herbs including Danshen (Radix Salviae Miltiorrhizae) and Sanqi (Radix Notoginseng). It also contains borneol, and comes in capsule form. It is indicated for angina pectoris.
A Hemp Product-X for Treating Cancer
A hemp product, which is a mixture of cannabis and other botanical products but lacks THC, is now in the early stages of the US FDA IND process. The product is indicated for oncological purposes.
XueZhiKang (XZK) in Patients With Hyperlipidemia
Xue Zhi Kang (XZK) is a formulated traditional Chinese medicine product. It is an extract from fermented red yeast rice. It passed US FDA phase 1 and 2 clinical trials with demonstrated safety and lipid-lowering effects for patients with Hyperlipidemia.
A Hemp Product-Y for Pre-Diabetics and Type II Diabetics
CBD is a non-psychoactive part of the cannabis plant and is believed to have numerous medicinal benefits, including but not limited to; relieving symptoms of seizure disorders, relieving inflammation, anxiety, and nausea. Cannabidivarin (CBDV) is a homolog of CBD, a rare cannabinoid. Research revolving around CBDV is in its beginning stages but gaining momentum. While lesser known than its cousin cannabinoid, CBDV is very promising in its advantageous medicinal effects.
The Product Quality Certification Program
Two product certification programs:
Premium Quality Certification: a certificate for the overall product quality
NFC Certification: a certificate for the "Non Foreign Compound" test