Foreword

The first step in quality control of botanical preparations, as an essential component of Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP), is ensuring the correct identity of the desired species intended for use. Before other important quality considerations can be properly addressed—e.g., taste, fragrance, microbial limits, potency, safety, efficacy, etc.—the accurate botanical identity, i.e., the proper genus and species of the plant, must be guaranteed.

Quality control can be conducted via a variety of techniques. These methods are summarized in the Introduction to this book, which focuses on the macroscopic botanical aspects of quality control in order to help determine definitively the proper species of plant material being collected, harvested, or processed, i.e., while the plant material is still in its whole, uncut and/or non-powdered or non-extracted form.

The past decade has witnessed a surge in quality control and the introduction and institution of many new voluntary GMPs by members of the herb manufacturing industry in the United States. While herbal dietary supplement manufacturers in the U.S. are currently required by law to meet the same level of GMPs as required for manufacturers of conventional foods (e.g., sanitary measures, et al.), the demands of ensuring proper identity of botanical raw materials, as well as their cleanliness, purity, and other aspects, often requires a level of manufacturing and testing sophistication that exceeds the current GMPs required for most conventional food ingredients and food products. It was for this reason that the U.S. Congress, when it passed the Dietary Supplement Health and Education Act of 1994 (DSHEA), authorized the Food and Drug Administration (FDA) to issue new GMPs specifically designed for dietary supplements, including herbs and botanical materials., which include raw materials, intermediates, and finished products of botanical origin intended for use in or as dietary supplements. (Dietary supplements are technically foods under U.S. federal law, so the new GMPs authorized in DSHEA are meant to be modeled after food GMPs, not the much more stringent GMPs required for pharmaceutical drugs. It should also be noted that some companies in the U.S. manufacture herbal products as nonprescription, i.e., over-the-counter, drugs and/or manufacture herb products for export to countries with different, drug-oriented regulatory systems; such manufacturing in the U.S. is subject to the more stringent drug GMPs.).

New GMPs from FDA for herbs and other dietary supplements are believed to be coming from FDA by the end of 2006 or early 2007. Nevertheless, many responsible manufacturers of botanical ingredients and herbal dietary supplement products in the U.S. have not waited for the publication of these final rules from FDA but have instead instituted new voluntary improvements in their internal standard operating procedures and other processes that generally are governed by GMPs. This includes, but is not limited, to internal testing programs for all raw materials and finished products, and/or the increased reliance on outside third-party laboratories to test materials and products for identity, adulteration with foreign materials or substitute materials, microbial contamination, chemical marker compounds for quality purposes, and so on.

In Europe, where many herb products are regulated as some form of nonprescription medications, most herb ingredients must meet the standards established by an official compendium like the European Pharmacopoeia,the Deutches Arzneibuch (German Pharmacopoeia), or some other recognized standard for raw material or botanical extracts. Included in such requirements is the need to define the identity of the botanical material as a precondition of further downstream processing (e.g., comminution [grinding], extraction, etc.). Refinements to identify methods and evolution of standards is an on-going centuries-old process which responds to the public need for quality assurance in the safety of food and drug supplies.

The adulteration of drugs or foods, defined by Ernest W. Stieb as “any practice which, through intent or neglect, results in a variation of the strength and/or purity from the professed standard . . . ”1 has a storied history dating from the fourth century B.C.E. to the present day. From the sixteenth century onward, according to Steib, official pharmacopeias set standards for the preparation and evaluation of drugs, a primary role of pharmacopoeias and monograph systems today. Frederick Accum’s “A Treatise on Adulterations of Food, and Culinary Poisons, published in London, 1820, serves as the starting point for modern literature on adulteration and focused attention to the subject, eventually leading to enactment of legislation such as the Pure Food and Drug Act of 1906 which sought specifically to deal with adulteration problems, among other issues.

Botanicals by nature are variable. Proper attention to identity is the foundation of classical pharmacognosy, which as defined by Heber W. Youngken, Sr., is “the science which treats of the history, commerce, collection, selection, identification, valuation and preservation of crude drugs, and other raw materials of vegetable of animal origin.”2 Whether one calls dried plant materials, herbs, spices, botanicals, or as historically known,” crude drugs”, quality assurance and quality control begins with proper identification of the source plant material. A herbarium—a collection of dried pressed specimens, identified by botanical experts—is the reference standard by which plant identification is established. Heber W. Youngken, Sr. (whose herbarium was rescued by the American Botanical Council from imminent destruction at the Massachusetts College of Pharmacy where it had resided for decades and then donated by ABC to the Botanical Research Foundation of Texas in 19933) wrote: “There has always been a wide variance in the quality of crude drugs [i.e., medicinal plants]. This is generally due to one or more of the following causes: (1) Deficiency in knowledge or carelessness on the part of the collector; (2) want of care in preparing them for the market; (3) carelessness in garbling [removing foreign objects] them; (4) carelessness in storing and preserving them; (5) accidental contamination with another drug; (6) adulteration; and (7) substitution.2

Misidentification of botanicals can cause publicity and legal headaches for the botanical industry, and if the adulteration involves a toxic plant, it can cause real harm to consumers. One of the most egregious recent examples of the breakdown in macroscopic quality control measures occurred in the Europe and in the United States when woolly foxglove (Digitalis lanata Ehrh., Scrophulariaceae) was offered as plantain (Plantago majorL., Plantaginaceae). The case involved a product called “Chomper”, part of the “Cleanse Thyself” line once produced by the Arise and Shine company of Mount Shasta, California. A May 14, 1997 press advisory from the U.S. FDA warned consumers of the issue after a young woman suffered from “abnormal heart rate and heartblock”, cardiac symptoms consistent with potentially toxic ingestion of Digitalis glycosides, which are also used in prescription heart drugs. Subsequent FDA investigation found that the problem was more widespread, involving at least three shipments of approximately 3,000 pounds of mislabeled material shipped from Germany to Herbarium, an importer distributor in Kenosha, Wisconsin.4

In the early 1990s, herbal material sold as the root of eleuthero (Eleutherococcus senticosus (Rupr. & Maxim.) Maxim, Araliaceae), was found to be adulterated with unrelated plant, Chinese silk vine (Periploca sepiumBunge, Asclepiadaceae), a viney member of the milkweed family, presumably because of confusion caused by similarities of the Chinese names for the two distinct plants. A letter to the editor in the December 12, 1990 issue of the Journal of the American Medical Association, reported on a purported case of neonatal androgenization, associated with maternal “ginseng” use in Canada—the so-called “hairy baby” case. The isolated case was attributed to the mother’s use of “pure Siberian ginseng” (the name by whichEleutherococcus senticosus was previously sold in the American herb trade). To further confound matters, the authors’ of the JAMA letter erroneously confused eleuthero with Asian ginseng (Panax ginseng C.A. Meyer, Araliaceae) in their discussion.5 Further follow-up research by Dennis V.C. Awang, Ph.D. (then head of the Natural Products Section, Bureau of Drug Research, Health and Welfare Canada) revealed that the product in question, in fact did not contain eleuthero, but instead contained Periploca sepium.6,7 This case highlighted the need for proper botanical identification of herbal products and further alerted the herb industry to this potential adulteration problem, prompting new testing procedures.

Another well-known case in recent memory involved the widespread substitution of echinacea or purple coneflower (Echinacea purpurea (L.) Moench., Asteraceae) root with the root of Missouri Snake Root (Parthenium integrifolium L., Asteraceae). Parthenium is documented as an adulterant in commercial echinacea lots as early as 1909.8 The modern problem was first recognized in an early issue of HerbalGram.9Subsequently R. Bauer and colleagues at the University of Munich confirmed the appearance of P. integrifoliumin commercial lots of E. purpurea in Europe by comparing commercial samples with authenticated herbarium specimens of the source plants. Once authenticated botanical identification and chemical analysis methods forP. integrifolium and various Echinacea species were developed, it became clear, too, that many published studies on the chemistry and pharmacology of “Echinacea angustifolia” had actually involved misidentified material that was in fact Echinacea pallida. In the early 1990s, this revelation led to the development of entirely new German Commission E monographs on Echinacea species and their respective plant parts, resulting in negative monographs for E. purpurea root and E. angustifolia roots (due to the lack of supportive data from clinical trials at that time).

As these examples demonstrate, before botanical raw materials can be processed into teas, powders, extracts and other ingredients and/or preparations, there is no doubt that the fundamental priority for quality control technicians is ensuring the proper identity of these materials. This book is a major contribution to that end. It is a unique and highly valuable tool for various personnel along the botanical supply chain to utilize in order to document proper botanical identity.

The American Botanical Council is honored to have the opportunity to work with one of the world’s largest and most prestigious botanical institutions, the Missouri Botanical Garden, in producing this important and useful volume. Dr. Wendy Applequist’s excellent botanical descriptions coupled with Barbara Alongi’s exquisitely detailed drawings combine to offer herb industry personnel an important tool to helping ensure proper identity of the 113 medicinal herbs sold in world commerce that are described within these pages

References

1. Steib EW. Drug Adulteration: Detection and Control in Nineteenth-Century Britain. Madison, Wisconsin: The University of Wisconsin Press; 1966:3. 
2. Youngken HW. A Text Book of Pharmacognosy, 3rd ed. Philadelphia, PA: P. Blakiston’s Son & Co., Inc.; 1930:3.
3. American Botanical Council. ABC donates Youngken Herbarium to the Botanical Research Institute of Texas. HerbalGram. 2003;58:9.
4. Blumenthal M. Industry Alert: Plantain adulterated with digitalis. HerbalGram. 1997;40:28. 
5. Koren G, Randor S, Martin S, Danneman D. Maternal ginseng use associated with neonatal androgenization. Jama, Dec. 12, 1990;264(22):2866.
6. Awang DVC. Maternal use of ginseng and neonatal androgenization. JAMA. April 10, 1991;265(14):1828. 
7. Awang DVC. Maternal use of ginseng and neonatal androgenization. JAMA. July 17, 1991;266(3):363. 
8. Moser J. Echinacea and a spurious root that appeared in the fall of 1909. Am J Pharm. 1910;82:224.
9. Foster S. Herb traders beware. HerbalGram 1985;2(1):3.