The American Herbal Products Association (AHPA) has published Guidance Documents for the Manufacture and Sale of Botanical Extracts, a collection of three documents that set forth guidelines for procedures and issues encountered in the manufacture, sale, and labeling of herbal extracts.
Each document explores a different aspect of herbal extracts:
Guidance for the Manufacture and Sale of Bulk Botanical Extracts provides definitions of extract terminology as well as detailed descriptions of the most common extract manufacturing, quality assurance, and quality control procedures, and offers guidance for bulk product labeling. It also contains philosophical discussions about various approaches to extract manufacture.
Guidance for the Retail Labeling of Dietary Supplements Containing Soft or Powdered Botanical Extracts offers standards for labeling consumer goods that contain soft or powdered botanical ingredients. The standards in this publication are intended to facilitate better communication with consumers of herbal extract products and provide information that will assist in product differentiation. This Guidance was adopted by AHPA's Board of Trustees in July 2000.
A White Paper entitled, Use of Marker Compounds in Manufacturing and Labeling Botanically Derived Dietary Supplements discusses both the advantages and pitfalls of using marker compounds in botanical extracts. Marker compounds are constituents that naturally occur in herbs and that are selected for special attention by a researcher or manufacturer. According to the document, marker compounds can have many constructive uses in the quality assurance of extracts, but they can also be abused. These issues are discussed in detail from the technical, scientific and marketing perspectives.
"These documents provide a comprehensive discussion of the topics that are essential for manufacturing and labeling herbal extracts," said Michael McGuffin, AHPA president. "AHPA's new publication fills an information void by compiling this complex and critical information into one resource."
Members of AHPA's Botanical Extract Committee and expert reviewers from around the world developed the documents over the past several years. The publication reflects the diversity and breadth of AHPA's membership, which includes many leading authorities in the science of botanical manufacturing.
"Complex issues such as the appropriate comparison of extracts, extract standardization, and the proper role of marker compounds are poorly understood in the United States by regulators, researchers, and consumers alike," said Staci Eisner, the publications' managing editor and technical director at ExtractsPlus.
"These documents address many of these issues in significant detail. The Committee is addressing other important topics and will be adding to this initial work in the future," Eisner said.
"These guidance documents establish a common terminology used in the herb trade that will enable intelligent discussion about what these products are and what they aren't," said Steven Dentali, Ph.D., one of the publications' contributors and senior director of botanical sciences at Nutricia USA. "They also provide the basic framework for understanding how botanicals are distinctly different from the drug model."
To purchase the entire set (all three documents) of Guidance Documents for the Manufacture and Sale of Botanical Extracts, email <firstname.lastname@example.org> or telephone 301/588-1171. Price for AHPA members is $30 and for non-members is $65 (plus $5 for shipping and handling.)
[AHPA publishes new guidance documents (press release) June 4, 2001.]