Identifying Botanical Product Guidelines

As demonstrated, therapeutic effect is a result of the following variables: botanical identity, chemical profile, formulation, bioavailability, and dose. Therefore, characterization of botanical products, in publications and scientific studies, needs to include all of that information.

An adequate description of botanical products is needed in order to ensure a consistent therapeutic effect. It is also needed to be able to compare products and to conduct statistical analyses on the results of multiple trials. Editors of scientific, particularly medical, literature need to be cognizant of the breadth of information required.

The Journal of Natural Products, published by the American Chemical Society and the American Society of Pharmacognosy, provides guidance to its authors in the characterization of botanical substances. It requires that experimental biological material be authenticated as to its identity and that the herbarium which holds the voucher specimen be given along with the voucher number.

It further requires that the scientific name (genus, species, authority citation, and family) be given. It also requires authors who purchase dried “herbal remedies” or other materials from companies to deposit a specimen in an herbarium, for future access.

It requires that the extraction procedure be specified when studying a commercially available extract and that the identification of the extract be supported by an HPLC trace of known secondary metabolite constituents (Journal of Natural Products, 2003).

NCCAM, in its guidelines for clinical trial grant applications, suggests that when plant material is used in a trial, it be accompanied by a botanical description, extraction procedure, the quantity of any known active constituent(s), as well as identity and stability tests.

When a product is used, information about the manufacturing process, analysis for impurities, and quality controls for manufacturing must be included. In addition, disintegration/dissolution rates are required to estimate bioavailability (NCCAM, 2003).