The American Herbal Products Association (AHPA) published in July "Standardization of Botanical Products," a 33-page document that defines and discusses standardization of botanical products. This in-depth work was undertaken in order to provide an authoritative reference on the subject and to help clear up misinformation regarding the use of standardization as applied to botanical products. For example, it has been said that standardized botanical products
• concentrate "key" ingredients at the expense of, or to the exclusion of, others,
• require the use of highly toxic solvents in their manufacture,
• require more herb to make than a "regular" extract, and
• are products that are distinctly different from traditional preparations.
The fact of the matter is that many, if not most, standardized extracts
• are not highly concentrated and do not target one particular compound,
• are not made with toxic solvents,
• use the same range of herb to extract as regular extracts, and
• contain the same broad spectrum of components as traditional preparations.
These products are essentially traditional extracts that have been tested for the presence of particular compounds.
AHPA defines standardization as "the complete body of information and controls that serves to optimize the batch-to-batch consistency of a botanical product. Standardization is achieved by reducing the inherent variation of natural product composition through quality assurance practices applied to agricultural and manufacturing processes."
Some standardized extracts, such as standardized extracts of ginkgo (Ginkgo biloba L., Ginkgoaceae) leaf and milk thistle (Silybum marianum L., Asteraceae) fruit, are targeted to a narrow range of compounds (e.g., terpene lactones and flavonoids in ginkgo and flavonolignans in milk thistle). The extract manufacturing process and composition are manipulated in order to maximize the content of the target compounds. These extracts are more properly understood not as standardized, but as semi-purified. These special extracts, at least in Europe, are required to be studied for their safety and efficacy before gaining government approval for marketing. Such semi-purified extracts, says AHPA, must not be confused with traditional standardized extracts.
As AHPA’s botanical standardization white paper explains, standardization seeks to enhance the reproducibility of a product’s safety and efficacy. The process of assuring material of reasonable consistency involves careful production and selection of raw materials and the processes employed in product manufacture.
These controls, along with sections on examinations and tests, documentations and records, product types and their development, are in the white paper, which should aid companies in their considerations of GMP requirements for botanical products.
For example, an herbalist using a trained eye to secure quality materials and who follows a standard recipe to make a product, and a European phytomedicine manufacturer that grows black cohosh (Actaea racemosa L., syn. Cimicifuga racemosa (L.) Nutt., Ranunculaceae) and makes a complete extraction (or makes semi-purified products), are both producing standardized extracts. This complex topic is deserving of study and informed discussion. AHPA’s White Paper, available from the bookstore section of the association’s website <www.ahpa.org>, is a good place to start. The document costs $30 for AHPA members, $55 for nonmembers, plus $2 for shipping and handling.
[Source: The American Herbal Products Association’s "Standardization of Botanical Products" White Paper (press release). Silver Spring, MD: Botanical Extracts Committee, the American Herbal Products Association; September 9, 2003.]