(Austin, Texas. November 10, 2011) The American Botanical Council (ABC) announces its publication of a new quality specifications resource that assists the herb industry in matching the various existing quality standards for botanical ingredients with their intended uses in foods, dietary supplements, and medicines.1
In a detailed and thorough review of the myriad standards for botanical ingredients, ABC Advisory Board member Josef Brinckmann provides examples of quality and labeling standards for various botanicals. He quantifies differences in the “composition, purity, quality, and strength” of commercially-traded ingredients, while providing links to specific monographs and compendia that contain various specifications for botanical quality. With an increasingly complex system of criteria and qualifications, this article serves as a resource for manufacturers and any others concerned with botanical quality. The article appears in the Fall 2011 issue of HerbalGram (#91).
“Botanicals often have multiple end uses and purposes, and each could necessitate a different quality standard in order to deliver the intended effect of the product and/or to comply with regulatory requirements,” Brinckmann writes in the article.
The safety and efficacy of certain botanical ingredients depend on consistent replication of the product. “Reproducible results, whether they affect sensory satisfaction or relief of symptoms, are intrinsically linked to consistent and reproducible quality,” the article says.
“As a prerequisite of reproducible efficacy, an herbal product manufacturer can define the effective quality of an ingredient as accurately and as narrowly as possible in the form of a written specification that the company’s quality unit can implement.”
Brinckmann's article begins with an introduction of the large number of groups that act as standards-setting organizations for botanical ingredients around the world. The United States Pharmacopeial Convention is considered the standards-setting authority for prescription and over-the-counter (OTC) active ingredients and medications in the United States, as well as for certain food ingredients and dietary supplements. The organization has specific monographs for each category of ingredients. Further, the US Department of Agriculture’s Agricultural Marketing Service has produced optional quality standards for many agricultural products, including some botanicals. Pharmacopeial quality is required if the ingredient is part of a US Food and Drug Administration (FDA)-approved OTC drug product.
Throughout the extensive and information-dense feature, Brinckmann provides readers with comprehensible tables that outline various quality standards. For example, one table compares food and therapeutic quality standards established for psyllium husk (Plantago psyllium). Another examines international standards of quality for Capsicum peppers (chili peppers). The article concludes with a number of resources for those interested in particular monographs and specifications for dietary supplements, spices, and herbal medicines.
“Manufacturers and marketers of herb-based products are seeking reliable information on how to ensure the safety, benefits, and quality of their products,” said ABC Founder and Executive Director Mark Blumenthal. “That’s why we thought it was so important to devote 16 pages in HerbalGram to this subject, and there is no one who is more knowledgeable on this subject than the author of this paper, Josef Brinckmann.”
The article contains 10 tables related to quality specifications, authoritative standards-setting organizations, websites, and much more. It is intended for an audience of industry members, particularly purchasing agents, quality control directors, laboratory personnel, research and product development personnel, and others who are involved in setting specifications for botanical ingredients employed for the dietary supplement industry and other industries where botanical materials are used.
“My hope is that this article will stimulate increased awareness. There are distinctly different grades or qualities of herbs in commerce and suitable quality standards exist which can help companies to develop appropriate quality specifications that correspond to the intended use of the product, whether a dietary supplement, food, or drug component,” said Brinckmann.
About Author Josef Brinckmann
Josef Brinckmann is the Vice-President of Research and Development at Traditional Medicinals Inc., a leading manufacturer of herbal teas, in Sebastopol, California, He is a member of the Dietary Supplements Monographs Expert Committee of the United States Pharmacopeia (USP), a member of the Advisory Committee of the American Herbal Pharmacopoeia (AHP), a consultant on market intelligence for medicinal plants & extracts to the International Trade Centre (ITC) of the United Nations for which he is the editor of its Medicinal Plants & Extracts newsletter, and a member of the Advisory Board of ABC.
1. Brinckmann J. Reproducible Safety and Efficacy of Herb Products Depend on Reproducible Quality: Matching the Various Quality Standards that have been Established for Botanical Ingredients with their Intended Uses in Cosmetics, Dietary Supplements, Foods, and Medicines, HerbalGram 2011;91:40-55. Available here.