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draft Guidance for Industry Botanical Drug Products".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
and at http://www.fda.gov/cder/guidance/1221dft.htm
Dr. G. Brendelberger, CONCEPT HEIDELBERG