In August 2000 FDA published the draft “Guidance for Industry – Botanical Drug Products". In this guideline FDA describes when a herbal drug product can be sold over the counter and when a new drug application is required. It also deals with several topics concerned with the specific peculiarities of botanical drug substances in comparison with chemically defined substances, e.g. as regards the CMC (chemistry / manufacturing / control) part of the marketing authorization or as regards preclinical data which must be present at the start of the clinical trials.

This 32-page document should certainly be required reading for all those considering launching herbal drug products on the American market. You can find this document at http://www.fda.gov/cder/guidance/index.htm and at http://www.fda.gov/cder/guidance/1221dft.htm 

Author: Dr. G. Brendelberger, CONCEPT HEIDELBERG