American Herbal Products Association’s BOTANICAL SAFETY HANDBOOK Second Edition Edited by Zoë Gardner Michael McGuffin Expert Advisory Council Roy Upton Soaring Bear David Winston Daniel Gagnon Aviva Jill Romm Tieraona Low Dog Mary Hardy Lyle Craker Reviewers David Bechtel Leslie Beyer Bill J. Gurley Proofreaders Bill Schoenbart Constance A. Parks Boca Raton London New York CRC Press is an imprint of the Taylor & Francis Group, an informa business © 2013 by Taylor & Francis Group, LLC K15080_Book.indb 1 2/13/13 8:15 AM CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 © 2013 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Version Date: 20130125 International Standard Book Number-13: 978-1-4665-1695-3 (eBook - PDF) This book contains information obtained from authentic and highly regarded sources. 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Her interest, foresight, and willingness to have the Office of Dietary Supplements support a partnership with the American Herbal Products Association and the University of Massachusetts made this work possible. © 2013 by Taylor & Francis Group, LLC K15080_Book.indb 3 2/13/13 8:15 AM © 2013 by Taylor & Francis Group, LLC K15080_Book.indb 4 2/13/13 8:15 AM contents Preface to the First edition vii Preface ix acknowledgments xi Financial support xiii editors xv expert advisory council xvii introduction xix organization of Data xxv Disclaimer xxix a 1 B 123 c 151 D 307 e 321 F 365 G 385 H 431 i 469 J 483 K 491 L 493 M 539 n 593 o 599 P 613 Q 723 R 727 s 765 t 847 U 891 V 903 W 935 Y 941 Z 945 appendix 1: Herbal constituent Profiles 955 appendix 2 Herbal action Profiles 971 appendix 3 Herbal interaction Profiles 983 appendix 4 safety of Botanicals in Pregnancy and Lactation 989 appendix 5 Herb Listings by classification 995 v © 2013 by Taylor & Francis Group, LLC K15080_Book.indb 5 2/13/13 8:15 AM Contents index 999 safety and interaction classifications 1043 vi © 2013 by Taylor & Francis Group, LLC K15080_Book.indb 6 2/13/13 8:15 AM PReFace to tHe FiRst eDition Increased attention on herbal products, both in the mar- task, the Editors met with information that presented ketplace and in the legislative arena, has created a need significant challenges. Many authors utilize unrefer- for wider public access to data regarding the safety of enced data, perpetuate historical inaccuracies or display botanicals. The passage of the Dietary Supplement Health inherent biases against the use of botanicals. Also, con- and Education Act in October, 1994, furthered the need temporary reviews of the toxicity of many herbs are not for such information, as this law authorizes the use of available. Nonetheless, the Editors are confident that the cautionary labeling for dietary supplements, including body of information presented here is largely accurate. It those that contain herbs. is our sincere hope that readers of this work will find it to The American Herbal Products Association (AHPA), be a valuable reference and will address all useful criti- through its Standards Committee, convened a special cisms to our attention. SubCommittee (hereinafter “the Committee”) to address In sponsoring this effort, the American Herbal this need. The Committee members identified consid- Products Association (AHPA) addresses the common erable safety data in varied texts and journals and dis- interest of industry, the public, and regulatory agencies in covered that some attempts to classify herbs had been assuring safe access to a wide range of herbs and herbal undertaken in several other countries. No comprehensive products. This document provides accurate data to guide compilation or review of this data for botanical ingredi- manufacturers and consumers in safe utilization of herbal ents sold in the North American marketplace, however, products. As the most broadly established trade associa- was available in a useful format. tion in the herbal marketplace, AHPA has, by supporting The goal of the present work is to find a rational plat- and sponsoring the creation of this work, furthered the form for the evaluation of herb safety, neither assuming herb industry’s leadership role in promoting the respon- that all natural substances are inherently safe, as some sible use of herbs. popular references suggest, nor blindly accepting reports of toxicity from uncritical sources. In undertaking this vii © 2013 by Taylor & Francis Group, LLC K15080_Book.indb 7 2/13/13 8:15 AM © 2013 by Taylor & Francis Group, LLC PReFace This second edition of AHPA’s Botanical Safety Handbook safety determinations for the plants addressed in it. On represents a significant modification from the first edi- the other hand, the process for compiling information tion, published in 1997. At the same time, the second edi- for this second edition, as described in the introduction, tion reflects the continued commitment of the American involved a much more thorough review of primary ref- Herbal Products Association (AHPA) to provide accurate erences (i.e., published research papers, case reports, information about the safe use of herbs in a practical and and other original literature). Thus, while the first edi- accessible format. tion included just 280 references to evaluate the over 500 The original edition classified botanical ingredients plants addressed therein, this revision cites 301 references in four safety classifications to differentiate those that can just in its treatment of St. John’s wort herb (Hypericum per- be safely consumed when used appropriately from those foratum), ginkgo leaf and seed (Ginkgo biloba), and garlic for which some contraindication or other restriction is bulb (Allium sativum). known, as well as those that should be used only under Any attempt to provide a summary of safety informa- the guidance of a qualified expert. A handful of entries tion on botanicals will encounter certain prejudices and in that edition were also placed in a separate class if the inaccuracies in the published record. One such prejudice, editors had insufficient data for classification. The revised often repeated in reviews of herbal medicines and dietary edition largely retains this safety classification system, supplements, is the view that consumers have been led to except that if the review process did not provide enough believe the myth that “anything natural is safe” (Barnes information to make a knowledgeable decision on any 2003; Dasgupta and Bernard 2006). While one survey of specific herb, that species was removed from the text. consumer attitudes in Canada found that 7 percent of The present edition also includes a separate classifica- respondents completely agree that there is no risk associ- tion system to address what is known about the potential ated with products made with natural ingredients (Anon. for an herb to interact with any drugs. Each of the herbs 2005), there are no published analyses of consumer beliefs listed here is identified in one of three interaction classes that indicate that there is broad acceptance of any such to differentiate between those for which no clinically rel- assumption. evant interactions are expected and those for which clini- It is, however, true that many of the plants that enjoy cally relevant interactions are biologically plausible or broad culinary and traditional therapeutic usage are are, in fact, known to occur. generally safe. We can safely season our food with any Botanical products continue to be broadly used number of herbs to make a meal more flavorful. We can throughout the world. In the United States, most herbs are appreciate a delicious cup of peppermint leaf or rose sold in loose form or as tablets, capsules, or tinctures, and hips tea, or safely take an herbal supplement containing regulated as dietary supplements (this product class also dandelion root, saw palmetto berries, or any number of includes vitamins, minerals, amino acids, and numerous other herbs. Although allergies and individual reactions other ingredients). Many herbs are also common flavor- have been recorded for a few herbs that are widely used ings for foods, or are used in teas. In addition, a handful in foods and supplements, such individual concerns are of herbs provide active ingredients in non-prescription also seen with many other foods, and do not diminish the drugs. The U.S. marketplace for herbal products in the safety profile of the many herbs that are widely regarded supplement category has increased significantly in the as safe. years since publication of the first edition, and the retail On the other hand, and as everyone knows, there are value of this product category grew from $3 billion in any number of plants that are highly toxic, even deadly. 1996 (Muth et al. 1999) to $5 billion in 2010 (Anon. 2011). Every savvy North American hiker knows to stay away An even more significant change in the past 15 years from poison ivy (Toxicodendron spp.) when walking in the has been the emergence of the Internet and online scien- woods. The death sentence imposed on Socrates by an tific databases as tools for accessing scientific informa- Athenian jury 2,400 years ago was carried out with a fatal tion. The first edition of this book relied almost entirely dose of poison hemlock (Conium maculatum). The poison on secondary references (i.e., books and other summa- curare, a blend of several equatorial rain forest plants (e.g., ries of traditional or scientific information), and the edi- species of Chondrodendron, Curarea and Strychnos) is used tors of that document used their personal collections of by some South American hunter cultures to make their such texts to compile the information needed to make arrows more deadly (Schultes and Raffauf 1990). And in ix © 2013 by Taylor & Francis Group, LLC K15080_Book.indb 9 2/13/13 8:15 AM Preface the “concrete jungle” of Los Angeles, two young boys choices. AHPA’s Botanical Safety Handbook, 2nd edition is died in 2000 from ingesting a few leaves of the ubiqui- designed to provide the information needed by each of tous oleander (Nerium oleander) (Garrison 2000). Federal these audiences. law and good common sense, however, prevent the use of It should be recognized, however, that this reference any such highly toxic plants in products that are readily is not an herbal user’s guide. Numerous excellent refer- available to consumers. ences exist that provide information on the uses and The revised edition of the American Herbal Products benefits of herbs. Readers of the present document are Association’s Botanical Safety Handbook fills the need for a advised to seek out these references, or to consult with reference that neither promulgates the myth that all herbs experts qualified by training and experience, for advice are always safe, since they are “natural,” nor accepts on when and how to use herbs for their health benefits. without review every case report or conceptual theory The editors are confident that the body of information that draws an unsubstantiated or illogical conclusion of presented in this second edition of the AHPA Botanical harm from an herb or herbal product. In assembling this Safety Handbook is largely accurate, and hope that readers revision, significant effort has gone into sorting out refer- of this work will find it to be a valuable reference. Useful ences that are factual from those that are inaccurate. Texts criticisms will nonetheless be welcome, and should be that communicate that all natural substances are inher- addressed to the attention of the editors. ently safe would not have been included here, though in fact no such documents were encountered. More effort was needed to avoid blind acceptance of reports that Literature Cited purport to identify herbal safety concerns with unrefer- enced statements or incomplete records of specific herbal Anon. (Ipsos-Reid). 2005. Baseline Natural Health Products preparations, which are unfortunately quite common, Survey Among Consumers: Final Report. Health even in peer-reviewed scientific journals. Such references Canada, Natural Health Products Directorate. may nonetheless be included in this text to provide read- Anon. 2011. Organic wins big in 2010. Nutr. Bus. J. 16(6):1-8. ers with a complete record, though efforts were made to Barnes J. 2003. Quality, efficacy and safety of complemen- highlight any perceived flaws. tary medicines: Fashions, facts and the future. Part II: Even as the consumer market for herbal supplement Efficacy and safety. Br. J. Clin. Pharmacol. 55:331-340. Dasgupta, A. and D.W. Bernard. 2006. Herbal remedies: products expands and scientific information becomes Effects on clinical laboratory tests. Arch. Pathol. Lab. more accessible, the goals of the second edition of the Med. 130:521–528. AHPA’s Botanical Safety Handbook are essentially the same Garrison, J. 2000. Two Toddlers Died from Oleander as those of the original edition. Companies that market Poisoning, Coroner Says. Los Angeles Times: July 26, herbal products are bound by federal regulations to dis- 2000. close known safety concerns that may result from a prod- Muth, M.K., D.W. Anderson, J.L. Domanico, J.B. Smith, and uct’s use. Health care providers, especially those lacking B. Wendling. 1999. Economic characterization of the in training or experience in the use of herbs, are in need dietary supplement industry. Contract No. 223-96-2290: of accurate data if they are to provide guidance to their Task Order 3. Final Report. Research Triangle Park, NC: patients who use herbs. And consumers of herbs and Research Triangle Institute. herbal products need readily understandable information Schultes, R.E., and R.F. Raffauf. 1990. The healing forest. to assist them in making safe and appropriate health care Portland, OR: Dioscorides Press. x © 2013 by Taylor & Francis Group, LLC K15080_Book.indb 10 2/13/13 8:15 AM