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Botanical Safety Handbook: Guidelines for the Safe Use and Labeling for Herbs in Commerce.
ISSUE:
Page:
59
by Michael McGuffin, Christopher Hobbs, Roy Upton, and Alicia Goldberg (eds.). 1997. CRC Press. 256 pp. Softcover. ISBN 0849316758. Price $39.95. Available from ABC Catalog #B275.

This book is destined to have a significant impact on the labeling of thousands of herb products in the U.S. marketplace. Section 10 of the Dietary Supplement Health and Education Act of 1994 (DSHEA) now allows manufacturers of herbal products and phytomedicines to include dosage information and, where appropriate, warnings that guide consumers toward the proper and responsible use of medicinal plant preparations. Such data include contraindications, side effects, and special warnings, information not previously allowed on herbal products. The liberalization of this situation is a great step forward toward assisting consumers in appropriate and responsible use of these products and reducing the possibility of adverse events. Since the safety of herbal products is a major concern of health professionals, consumers, regulators, and even the herbal industry, it is important that herbal products disclose potential adverse effects and warn certain specific groups (e.g., diabetics, pe ople with hypertension, pregnant and lactating women) that they should avoid an herb or seek professional advice, as the case warrants. Now, for the first time, a group of industry-based herbalists have reviewed the 540 herbs previously published in AHPA's Herbs of Commerce (1992) and have provided safety data on these herbs as guidelines for product labels. The herbs were reviewed according to an extensive list of reference books and original articles dealing with various areas of safety on specific botanicals, including an early draft of the American Botanical Council's English translation of the German Commission E Monographs.

Each herb is classified according to four classes of safety: Class 1: "Herbs which can be safely consumed when used appropriately." Class 2 are herbs for which the following use restrictions apply, unless otherwise directed by an expert qualified in the appropriate use of the herb. 2A: For external use only. 2B: Not to be used during pregnancy. 2C: Not to be used while nursing. No other use restrictions apply, unless noted. 2D: Other specific use restrictions, as noted. Class 3 herbs are those for which significant data exist to recommend the following labeling: "To be used only under the supervision of an expert qualified in the appropriate use of this substance." The labeling must include proper use information, dosage, contraindications, potential adverse effects, drug interactions, etc. Finally, Class 4 herbs are herbs for which "insignificant data is available for classification."

For example, the following herbs are classified as Class 1: Burdock (Arctium lappa); Cayenne (Capsicum annuum var. frutescens) with the editorial note, "The classifications and concerns for this herb are based upon therapeutic use and may not be relevant to its consumption as a spice." -- a note that accompanies a number of herbs that are used both medicinally and as food flavoring: Gotu kola (Centella asiatica); Ginger (Zingiber officinale); Valerian (Valeriana spp.); American Ginseng (Panax quinquefolius).

A significant number of the herbs listed in this book have a rating in various subsets of the category. For example, Asian Ginseng (Panax ginseng) is classed as 2D (contraindicated for hypertension). Juniper Berry (Juniperus comunis) is classed as 2B (contraindicated in pregnancy), as well as 2D (not to be used exceeding 4 to 6 weeks in succession and contraindicated in inflammatory kidney disease). The controversial herb Ma Huang (Ephedra sinica) is classed as 2B (pregnancy), 2C (contraindicated in nursing), and 2D (contraindicated in anorexia, bulimia, and glaucoma; persons with thyroid imbalance should avoid use; not recommended for excessive or long-term use; may potentiate pharmaceutical MAO inhibitors). Other notices for caution and specific dosages are included for Ma Huang. However, Mormon tea (Ephedra nevadensis) is listed as a Class 1 due to the fact that this particular variety of ephedra contains little or no ephedra alkaloids. The Chinese herb He Shou Wu, also refer red to in U.S. Commerce as "Fo-ti" (Polygonum multiflorum) is listed as Class 2D: Contraindicated with diarrhea; prepared root and stem may cause gastric distress; raw root is cathartic. The common herb Purslane (Portulaca oleracea), which Jim Duke often recommends as an excellent source of essential fatty acids, is classed both as 2B (pregnancy) and 2D (individuals with a history of kidney stones should use cautiously.) There is also a note regarding potentially high levels of oxalic acid.

Class 3 includes the herb Belladonna (Atropa belladonna), an herb seldom found in the U.S. market; it is appropriately relegated to status to be approved and administered by a qualified health professional.

Every page of this book includes a section at the bottom of a page which repeats the definitions of each of the classes in order to ensure that the reader is clear regarding the classification of the particular herb. This feature has been added by the editors as a measure of responsibility to help the reader understand the appropriate classification.

The book contains three appendices: The first contains profiles on various herbal constituents often considered a toxic, e.g., cardia glycosides, oxalates, pyrrolyzidines, safrole, thujone. Appendix 2 defines various actions of herbs which may have potential or actual safety implications, e.g., abortifacients, laxatives, emetics, emmenagogues/uterine stimulants, gastrointestinal irritants, MAO interactions, CNS stimulants. Appendix 3 lists herbs by classification and constitutes a cross-reference showing all the herbs in each of the classes for easy reference. The book also has 30 primary references (e.g., ABC's forthcoming Commission E Monographs, the British Herbal Compendium Volume I, Peter DeSmet's Adverse Effects of Herbal Drugs, Volume I and II, Leung and Foster's Encyclopedia of Common Ingredients Used in Foods, Drugs, and Cosmetics, Herbal Drugs and Phytopharmaceuticals, Hager's Hanbuch, and numerous other books on Chinese medicine and poisonous plants. Additionally, ap proximately 200 additional references are provided.

An important point about this book is that it deals with the relative safety of herbs based on their common usage within recommended dosage ranges and in product formulations commonly found in the marketplace. The book specifically excludes and is not relevant to data, conditions, and substances a) taken in excessive quantities, b) dealimg with the safety or toxicity of isolated plant constituents, c) or safety data based on intravenous or intraperitoneal administration, additional Chinese and Ayurvedic contraindications, gastrointestinal disturbances, potential drug interactions, idiosyncratic reactions, allergic reactions, contact dermatitis, and well-known toxic plants not found in the herb trade in the U.S. (e.g., aconite, hemlock, henbane, autumn crocus).

We commend the authors for their initiative and for the range and scope of their work. This publication surely will become a vital part of every herb and dietary supplement manufacturer's library, as well as an important and dispensable guide for all types of health practitioners, including physicians, pharmacists, dieticians, naturopaths, herbalists, acupuncturists, and the like. It would also be useful for journalists, consumers, regulators, and others interested in the safety of herbal products.

As the herb market continues to mushroom at unprecedented rates in the U.S. and many other places worldwide, additional authoritative information becomes increasingly valuable regarding the appropriate safe and responsible use of many of these products. Any guidance that can reduce the chances of a person misusing or abusing an herbal product is welcome and timely. This book makes a significant contribution to the herbal literature at the close of this century and will no doubt become a seminal and often cited work well into the next.

Article copyright American Botanical Council.

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By Mark Blumenthal