www.herbalgram.org
59>
7 25274 81379 7
Nature's Resource® is listening.
Consumers asked for more information to help make educated decisions about herbal supplements.
Nature's Resource is providing it with our new multi.. page label called Herbal ABCs™.
• Multi-page educational booklet provides safety and usage information for consumers on 21 Nature's Resou rce herbs.
• Written in a consumer-friendly way in a format our consumers can understand.
• A prime example of Nature's Resource's commitment to educating our consumers.
• Consumers get the information they need at no additional cost.
• Nature's Resource's new bottles with the informational label will be in stores starting Fall 2003.
NEW HERBAL ABCs"' LABEL INCLUDES: • Herbal Information
• Contraindications The new multi-page label is a joint effort of Nature's Resource® • Pregnancy & Lactation and the Ameri can Bot anica l Council. Guidelines • Adverse Effects • Drug Interactions Fo r additional information, • Safety Statement NATURE'S RESOURCE® call 1-800-314-HERB, or vi sit • Suggested Other HERBAL SUPPLEMENT www.naturesresource.com Products i I Individuals, organizations, and companies who share our vision support our goals through membership. The American Botanical Council Invites You to e r------~ Yes, I want to join ABC! o1n Pl ease derach applica rion and mail ro : American Borani cal Council , P.O. Box 144345, Ausrin , TX 787 14-4345 or join onli ne ar To join, please fill out this form or and fax or mail or call us at 800/373-7105 x 119 www. herbalgram.org 0 Individual - $50 or fill out an application online at www.herbalgram.org 0 Academi c - $1 00 0 Professional - $ 150 Membership Leve Is Please add 520 for addresses outside tile u.s. 0 O rganiza rion - $250 (Add $20 postage fo r international delivery for above levels.) 0 Corporare and Sponsor levels. Individual- $50 Academic - $1 00 (Contact Wayne Si lverman, PhD, 512/926-4900, ext. 120.) • Subscription to our highly All Individual membership Payment instructions acclaimed journal, benefits, plus: 0 Charge credit card (Visa or MC onl y) HerbaiGram • Online access to : # ______• Access to members-only • HerbCiip™ Online critical exp. date: ______information on our website, reviews www.herbalgram.org (Please include the 3-digir number following rhe • HerbMedPro™ evidence accoum #on signature line on back of card.) • HerbaiGram archives based herbal studies • Complete German • Complimentary CD, Herbal 0 Send invoice to the address below Commission E Medicine: Expanded 0 C heck enclosed Monographs Commission E Monographs 0 Do not share my contact info • Herbal Medicine: ($39 value) 0 Include me AB C e-mail updates Expanded Commission E Professional - $150 Monographs All Academic membership • Botanical Booklet Series benefits, plus: name • Herb Reference Guide • 50% discount on first order of
• Common Herbs Pamphlet ABC publications company, organization or agency • Free 1/2 hour research • Membership certificate
session with our Education Organization - $250 profession/ride Department For nonprofit organizations, all • 40% discount on additional Professional membership phone fax research from our Education benefits, plus: Department • 1 additional subscription to address • One complimentary book, our highly acclaimed journal, Echinacea: The Immune HerbaiGram Herb by C. Hobbs • 3 user logins to members • 10% discount on publications only information on our from our Herbal Education website, city stare/province Catalog www.herbalgram.org • Membership card zi pi posral code
Corporate and Sponsorship country Small to large organizations can receive additional benefits, including the bi-weekly HerbCiip service, and also extend their support of ABC's mission through Corporate or e-mail Sponsor level membership. To learn more, please contact Wayne Silverman, PhD, at [email protected], or 800/373-71 OS x120. advisory board Each issue of Herba!Gram is peer reviewed by members of our Advisory Board and other qualified experts before publication.
Cindy K. Angerhofer, Ph.D. Adriane Fugh-Berman, M.D. Mark J. Plotkin, Ph.D. Director of Botanical Research, Aveda Institute, Author, Assistant Clinical Professor, George Washington University Author, Executive Director, Amazon Conservation Team, Minneapolis, Minnesota School of Medicine, Washington, DC Arlington, Virginia John Thor Amason, Ph.D. Joe Graedon, M.S. John M. Riddle, Ph.D. Professor of Biology, Department of Biology, Author, syndicated columnist, radio host, Durham, North Carolina Professor of History, Department of History, University of Onawa, Ontario, Canada North Carolina State University, Raleigh Mary Hardy, M.D. Dennis V. C. Awang, Ph.D., F.C.I.C. Director, Cedars-Sinai Integrative Medicine Medical Group, Eloy Rodriguez, Ph.D. MediPiant Natural Products Consulting Services, Los Angeles, California James Perkins Professor of Environmental Studies, School of White Rock, B.C., Canada Agriculture & Life Sciences, Cornell University, Ithaca, New York Christopher Hobbs, L.Ac., AHG Manuel F. Balandrin, R.Ph., Ph.D. Herbalist, botanist, licensed acupuncturist, Davis, California Victor Sierpina, M.D. Research Scientist, NPS Pharmaceuticals, Salt Lake City, Utah Associate Professor of Family Practice Medicine, David Hoffmann, B.Sc., M.N.I.M.H University ofTexas Medical Branch, Galveston Bruce Barrett, M.D., Ph.D. Medical herba list,a uthor, Santa Rosa, California Assistant Professor of Family Medicine, University of James E. Simon, Ph.D. Wisconsin-Madison Medical School Maurice M.lwu, Ph.D. Professor of New Use Agriculture, Director of the Center for New Use Bioresources Development and Conservation Program, Senior Agriculture and Natural Plant Products, Rutgers University, Marilyn Barrett, Ph.D. Research Associate at the Division of Experimental Therapeutics, New Brunswick, New Jersey Pharmacognosy Consulting Service, San Carlos, California Walter Reed Army Institute of Research, Washington, D.C. Beryl Simpson, Ph.D. Bradley C. Bennett, Ph .D. Timothy Johns, Ph.D. C. L. Lundell Professor of Botany, Department of Botany, Associate Professor of Biology, Florida International University, Professor, School of Dietetics and Human Nutrition; Centre for University ofTexas at Austin Miami Indigenous People's Nutrition and the Environment, McGill University, Montreal, Canada S. H. Sohmer, Ph.D. Joseph M. Betz, Ph.D. President and Director, Botanical Research Institute ofTexas, Director of the Dietary Supplements Methods and Reference Steven King, Ph.D. Fort Worth Materials Program, Office of Dietary Supplements, National Vice President, PS Pharmaceuticals, Inc., Institutes of Health, Bethesda, Maryland South San Francisco, California Barbara N. Timmermann, Ph.D. Professor of Pharmacology and Toxicology, College of Pharmacy, Francis Brinker, N.D. Tieraona Low Dog, M.D. University of Arizona,Tucson Lead Instructor on Botanical Medicine for Associate Fellows, Chair: United States Pharmacopoeia Dietary Supplements/Botani Program for Integrative Medicine, University of Arizona, Tucson cals Expert Panel Clinical Asst. Professor, Dept of Family and G. H. Neil Towers, Ph.D. Community Medicine, University of New Mexico Professor Emeritus, F. R. S.C., Botany Department, Donald J. Brown, N.D. University of British Columbia, Vancouver, Canada Director, Natural Products Research Consultants, Seattle,Washington Tom Mabry, Ph.D. Professor of Plant Biochemistry, Department of Botany, Arthur 0. Tucker, Ph.D. Thomas J.S. Carlson, M.S., M.D. University ofTexas at Austin Research Professor of Agriculture and Natural Resources, Delaware Associate Adjunct Professor, State University, Dover Department of Integrative Biology; Director, Center for Health, Gail B. Mahady, Ph.D. Ecology, Biodiversity, & Ethnobiology; Curator of Ethnobotany, Research Assistant Professor, Department of Medical Chemistry & Nancy Turner, Ph.D. University and Jepson Herbaria; University of California, Berkeley Pharmacognosy, Co ll ege of Pharmacy, University of Illinois, Chicago Professor and Ethnobotanist, Environmental Studies Program, University of Victoria, British Colu mbia, Canada Jean Carper Robin J. Maries, Ph.D. Author and syndicated columnist, Washington, D.C. Director of the Bureau of Research and Science, Natural Health Daniel T. Wagner, R.Ph., MBA, Pharm.D. Products Directorate, Health Products and Food Branch, Owner, Nutri-Farmacy, Wildwood, Pennsylvania Jerry Cott, Ph.D. Health Canada, Ottawa Pharmacologist, U.S.Food and Drug Administration, Andrew T. Weil, M.D. Center for Drug Evaluation and Research, Rockville, Maryland Dennis J. McKenna, Ph.D. Author, Director of the Program in Integrative Medicine and Executive Director, Institute for Natural Products Research; Associate Director of the Division of Social Perspectives in Medicine, Paul Alan Cox, Ph.D. Senior Lecturer, Center for Spirituality and Healing, University of College of Medicine, University of Arizona, Tucson Director, National Tropical Botanical Garden, Kauai, Hawaii Minnesota, Minneapolis Bernd Wollschlaeger, M.D. Lyle E. Craker, Ph.D. Daniel E. Moerman, Ph.D. Family practice physician; Clinical Assistant Professor of Medicine Professor, Department of Plant and Soil Sciences, William E. Stirton Professor of Anthropology, and Family Practice, University of Miami, School of Medicine, Florida University of Massachusetts, Amherst University of Michigan/Dearborn Edward M. Croom, Jr., Ph.D. William Obermeyer, Ph.D. Scientific and Regulatory Affairs Manager, lndena USA East, Inc., Vice-President of Research and Technology, ConsumerLab.com, ad hoc advisor: Oxford, Mississippi Annapolis, Maryland David M. Eisenberg, M.D. Wade Davis, Ph.D. Samuel W. Page, Ph.D. Director, Center for Alternative Author, ethnobotanist, Washington, D.C. Director, Division of Natural Products, Center for Food Safety Medicine Research, Beth Israel Hospital/Harvard Medical School, Boston, Massachusetts Steven Dentali, Ph.D. and Applied Nutrition, U.S. Food and Drug Administration, Vice President of Scientific and Technical Affairs, American Herbal Washington, D.C. Products Association, Silver Spring, Maryland Joseph E. Pizzorno, Jr., N.D. Hardy Eshbaugh, Ph.D President Emeritus, Bastyr University, Seattle, Washington Professor of Botany &Assistant Curator, Willard Sherman Turrell Herbarium, Miami University, Oxford, Ohio
4 I HerbaiGram 59 2003 www.herbalgram .org dear reader from the desk of
BC co ntinues its ro ll out of strategic educa could be fo rced out of business. Although some industry tional projects. In our last iss ue, we intro groups are filin g critical comments with constructi ve duced the publica ti on of ABC Clinical suggesti ons to FDA, industry leaders are careful not to Guide to Herbs, our new book for health appear to be against the G MPs in ge neral, so as not to a professionals. We now introduce our new appear in the media as "anti-quali ty," an epithet that no Safety Labeling Program (SLP), intended for consumers one can afford at a time of continuing negative media arti and healthcare profess ionals alike. SLP was initiated with cles and mounting Congressional pressure on the industry. the help of Pharmav ite Corporati on for its Along these lines, U.S. Senator Richard new ex panded labels on its Nature's Durbin (O-IL) has introduced the Dietary Resource® line of herbs. The labels co ntain a Supplement Safety Act of 2003 (S. 722), a bill 4-page "brochure" that peels back from the that, if passed with any of its current provisions, fro nt panel of a borde, offering guidelines for would substantial ly alter the way the dietary responsible use by consumers. T he label text supplement industry conducts business, in addi is based on ABC's comprehensive pee r tion to the changes required by the Bioterrori sm reviewed assess ments of the safety literature. Act (see last issue) and the proposed new G MPs. T hese new labels will be on 4 million bottles Sen. Durbin has held several hea rings on the within a yea r on 21 Nature's Resource prod safety of ephedra, the new bill being a direct ucts. SLP labeling is ava il able to other quali result of his and others' mounting concerns over fi ed manufac turers. T his nonprofit/industry irs safety. S. 722 would require companies to initiative is particul arl y significant since there are few FDA submit reports of all se rio us adve rse eve nt reports (AE Rs) label guidelines regarding the safety of herb products. to the FDA within 15 days, fil e an annual report of all FDA's pro posed good manufac turing practices (GMPs) AERs, obtain FDA approval for the safety of many ingre fo r dietary supplements are causing considerable concern dients, and would require FDA approval of all supple among many industry groups. FDA has based the GMPs ments intended as "s timulants" (except coffee and upon those fo r drugs, des pite Congressional guidance that caffeine). In this se nse, the bill takes an interesting strate they be modeled on food GMPs. The differences are gic step: instead of go ing after specific individual ingredi significant in the amount of testing required for ingredi ents used for stimulation or weight loss, the bill targets rhe ents and finished products - the testing is expected to be entire category. The recent Nati onal Nutritional Foods so prohibitively expensive that even FDA spokespersons Associati on convention in Las Vegas was buzzing about are said to have acknowledged that if the proposal is fin al ized in its present form, several hundred small companies Continues on page 74
board of trustees
Mark Blumenthal (President), Founder and Executive Steven Foster, President Steven Foster Group, Inc .. Director (ex officio member) Brixey, Missouri
Michael J. Balick, Ph.D., D irector and Philecology Fredi Kronenberg, Ph.D., Director, Rosenthal Center Curator. Institute of Economic Botany. The New York for Complementary and Alternative Medicine, Botanical Garden, Bronx, New York Columbia University College of Physicians and Surgeons, New York Peggy Brevoort, President, Brevoort, LLC, Seattle, Washington Thomas L Kurt, M.D., M.P.H., Clinical Professor of Internal Medicine, University ofTexas Southwestern, James A Duke (Treasurer), Ph.D., Economic Botanist Dallas, Texas (USDA, ret) Author, Fulton, Maryland Morris Shriftman, CEO, Mozart Inc., Ponte Vedra Norman R. Farnsworth (Secretary), Ph.D., Research Educating the Beach, Florida Professor of Pharmacognosy. Program for Collaborative Public on the Research in the Pharmaceutical Sciences, University of Use Herbs & of Illinois at Chicago Phytomedidnes
www.herbalgram.org 2003 HerbaiGram 59 I 5
HERBAIGRAM The journal of the American Botanical Council
Mark Blumenthal Editor I Publisher Karen Robin Managing Editor Sean Barnes Art Director Steven Foster Associate Editor Maureen Jablinske Proofreader Sarah Jackson Editorial Intern
Advertising Sales Jared Hensley Rector-Duncan & Associates Inc. 512/454-5262 ext. 123 jhensle)'@rector-duncan.com
American Botanical Council Wayne Silverman, Ph .D. Chief Administrative Officer
Kathleen Coyne Sales Coordinator Cheryl Dipper Executive Assistant Stacy Elliott Receptionist Gayle Engels Education Coordinator Lori Glenn HerbCiip Managing Editor Tara Hall Special Projects Coordinator George Solis HerbCiip Production Assistant Nate Sponseller Gardener Cecelia Thompson Finance Coordinator Kim West Membership/Development Coordinator Margaret Wright Accounting Coordinator
Subscriptions are a benefit of membership at every level. One year member ships: Individual $50; Academic $1 00; Professional $150; Organization $250; Corporate; Sponsor. Add $20 for memberships outside of the U.S. Student. Senior. and Business Memberships also available, see ad in this issue. © 2003 American Botanical Council. ISSN #0899-5648. Printed in the U.SA The information in HerbaiGmm is intended for educational purposes only and is not a substitution for the advice of a qualified healthcare professional. Although we attempt to ensure that advertising in HerbaiGmm is truthful and not mislead ing. the publication of an ad for a product or company in Herba/Gmm does not constitute an endorsement by ABC of the product or the company being adver tised. Publication of an ad that makes a health claim or structure-function claim does not necessarily constitute an approval of that claim by ABC. Further. ABC has not reviewed any manufacturer's Good Manufacturing Practices.
Herba/Gram is printed on recycled paper at Branch-Smith Printing. Ft Worth. Texas abc news ABC Expands Safety Information for Herbal Product Labels by Mark Blumenthal, Gayle Engels, provided by ABC. Other manufacturers are at least one prescription drug, and 7 percent and Wayne Si lverma n, Ph.D. also considering participation in the SLP. rook five or more drugs simultaneously.3 Fourteen percent said they used herbs and onsumers, patients and clinicians, who Rationale for SLP: Responsible use supplements while 16 percent of the Cuse or recommend herbal supplements of herbs prescription drug users also take an herbal as a part of an integrative approach to Concern about the safety of herbs and supplement. The authors concluded that healthcare, all face the same dilemma: herbal products is one of the most signifi one in seven adults consumes at least one confidence in herbal supplements has cant issues affecting consumer and health herbal supplement annually and that one in eroded in recent years. This has happened, care practitioner decisions about use of six patients taking a prescription drug is in part, because of continued negative herbal supplements. Recent survey results concurrently taking one or more herbal reports in the media (some erroneous and show that 50 percent of all consumers are supplements, raising the potential for inter biased, some warranted). Safety seems to be concerned about interactions between actions. a key question. In the face of concerns With the potential for herb-drug interac about safety and the preference for addi tions increasing, how do consumers and tional safety information on the labels of health professionals gain access to reliable herbal supplements, Pharmavite Corpora information on what constitutes a potential tion approached the American Botanical interaction? Many interactions reported in Council (ABC) to request the development the literature are either theoretical or specu of a program to address these concerns. As a lative, often based on in vitro laboratory result of this collaboration, ABC launched data or animal studies, which are inconclu its Safety Labeling Program (SLP), a sive for humans. A recent systematic review program that provides expanded safety of herb-drug interactions concluded that of information for manufacturers. Pharmavite the 108 interactions evaluated from reports Corporation is using the SLP information in the medical literature, 74 (68.5 percent) on its Nature's Resource® herbal product were unable to be evaluated due to the lack labels in a new program called Herbal of adequate information, 20 (18.5 percent) ABCsn.' . were considered "possible" interactions, and 14 (13 percent) were considered "well ABC's Safety Labeling Program documented" and thus likely. The authors To help bring greater clarity to the safe supplements and prescription drugs, and 61 emphasize the need for better documenta use of herbs (including potential interac percent of herb users are concerned about tion of all relevant data in case studies of tions, adverse effects, and contraindica the same topic. 1 Unless consumers inter potential interactions.4 tions), and through consumer research, ested in herbal alternatives know where to suggestions, and initial funding by Phar look for the information, or have a knowl How SLP works mavite, ABC initiated SLP to provide some edgeable healthcare practitioner with whom As an independent organization, ABC guidance in this area. SLP provides science they can discuss their questions about conducts a literature search on a particular based safety information on specific herbs herbs, they may have difficulty finding herb, evaluates the data and formulates a for manufacturers to use as a basis to accurate information that explains which review of essential safety information, and develop product labels (see How SLP herbs are safe for them to use, and how to then licenses the use of the manufacturer's works, below). This program will benefit use them. Likewise, clinicians and pharma version of the ABC information along with consumers and patients, who need more cists are increasingly expected to serve as the ABC name and logo to qualifying information about the herbs they use, and educators when it comes to safety issues. manufacturers. The safety information is healthcare professionals, who can use such While continuing education on these initially provided in a format called a Safety information to help assess the potential risk matters is essential for healthcare profes Information Sheet (SIS). and appropriate use of many popular herbs. sionals, expanded safety information on the The SIS presents a rational interpretation label may be an effective part of the overall of the literature on the safety of a particular First use of SLP solution. herb, and provides accurate, useful informa Pharmavite Corporation, which produces Several surveys have suggested that a tion on contraindications, adverse effects, Nature's Resource herbs, a brand marketed significant number of people use herbs actual and potential interactions with Rx in mass-market locations, worked with concurrently with conventional drugs. A and OTC drugs, as well as pregnancy and ABC to develop the SLP and is the first Prevention magazine survey a few years ago lactation warnings and guidelines. A draft company to print expanded label informa suggested that about one-third of herb users version of each SIS is sent to expert review tion based on ABC's research and bear the also are taking either over-the-counter ers who check accuracy and clinical rele ABC logo. By the end of 2003, approxi (OTC) or prescription (Rx) drugs.2 In a vance. Reviewers' comments are then evalu mately 4 mill ion labels on 21 Nature's more recent report of 2,590 participants, 81 ated and researched by ABC and may be Resource products will contain peel-back, percent stated that they used at least one included in the final version of the SIS. multi-page safety text based on information medication (Rx or OTC), 50 percent rook Each SIS includes information about
8 I Herba iGra m 59 2003 www.herbalgram.org abc news
ABC and disclaimers relating to ABC's generall y are accepted as reliable by the pendent and science-based safety informa li ability (e.g., noting that ABC has neither scientific herbal community, including tio n. verified the contents of a herbal package nor some of the sources named above. tested the product). In addition, after the As part of the ongoing activity of the SLP, The future of SLP manufacturer creates its revised safety infor key safety informatio n in the SIS will be ABC has reviewed the li terature o n inter mation based on the SIS for its label, ABC updated o n an as-needed basis, and the acti ons, contraindicatio ns, adverse effects, then revi ews the proposed label text to updated SIS will be fo rwarded to participat warnings, and other potential ri sks in o rder determine whether it is accurate and ing m anufac turers so that they may to cl ari fY their signi fica nce (or lack rhereoD adequately reflects the infor- consider whether in each SIS. U ltimately, however, it is the mation in the SIS. This step is to revise their manufacturer's responsibili ty to determine Common name: Echinacea Species:(fJIIPfiN(UE...... _E.,.. d b 1 required before ABC will allow ro uct Ia e s. the extent of disclosure on a product's label HERBALABCs"' olthiNativeAmericansottheGreat P Plains . Ofthenineidentifiedspe c~es I · · and in marketing materi als. It is the res pon the label to display the ABC I~~· 1 Echinacea,also ofechinecea,onlythreeareused t IS Important 1 known as purple rnedic•nally 1n commercial h · name and logo. £ cooaflower,isone preparatioos:Echi'lacespurpt~rea, (0 note ( at, In sibility of the clinician and pharmacist to 11 ot the most widely E. angustifoia.and E. pallida. The This label text is formatted i ~ usad herbs in United Statas Pharmacopeia (USP), adequately inform patients about poten the U.S., Canada, a develo(wlr nf """'liN d11nt1.11n1o; tor into a product label, which l__ Europe, and drugs an ti al ri sks and interactions associated with Australia.Echinacea current!>t may include accordion-style ~c::::=~ ~~ :r::!~.~;'~~ is ~~:~:~~.' Family: AstBr•c•• e Parts used: I trill parts 1nd roots herbal supplemenrs, and to work with labels, peel-out labels, package ::~eigl:'a:~==c~l~!:ot :~=preparations . ThisrHtarchstr~ly one ormcWI ~lalerv-ns. pati ents to interpret this informatio n several different rypes of echinacaa trials hr. suggests that echlflacn prtperlbonl resulbng in conditions.._ as#vnl. were the most widety used medicines safety ar can ~sale and may bl effldi'n WI htyftvtf, and ttopic dtrml1ibl). inserts, or a box panel. In some helpmg to stimulate Mtlniii'Mi:slllnce Accordingly, it mey t. prudent tot and make ratio nal decisions fo r individ by supporting imroone ~ conwmers to consdt thew hnllhCire cases, a m anufacturer may strength.t providM before lolling echineCN it ual therapy. It is the res ponsibility of ,.,.,_...,~c-ta~...-~N rheyareknownlol'ltveanyMf\lltMty decide not to dedicate the :::-"-:;.:tro":.:=::.~ or an allergic orinflanwnatory consumers, many of whom choose to ,.,_,~,.,. reactiontoplantsmthedailylamiy extra cost or space required fo r an expanded gen e ral, CGmnindle~~tloas IAitmnle, ~i(lcluding. sel f-medicate, to become better label or to minimize the information used :~~n~~~~s~~=~c::~n :::.=·:,==:: info rmed abo ut the safety of the prod A B C reported, mact ofttn in individuals ragweed, alters end~mJW . The with lfopiC diMJN• (ellergic Gtmlln cOfi'WIIidfon E. one of the o n the label from the SIS, instead directing does nor pradiJpolibofl or ttypersansitMly 10 lf'IOSt recogoi:rtd authorities on herblll ucts they are considering using to the patients to find more information on be li eve improve or maintain health. As the SLP the company website where space is nor an t h a t ex pands, it may help to fac ili tate this iss ue. In all cases, the consumer, pari enr, there is process fo r health professio nals, manu- and healthcare professional are provided a safety problem with appropriate use of facturers, patients, and consumers, and may significantly expanded, independent safety herbs. H owever, ABC considers it part of its reverse some recent trends by increasing information to help promote the safe and educatio nal miss io n to provide consumers confidence in the respo nsible use of herbal beneficial use of herbs. and health p rofessio nals w ith accurate dietary supplements and related products. guidelines fo r the res po nsible use of herbal For mo re info rmation abo ut ABC or SLP Sources of safety information products. The Guide, provides both ex ten contact Wayne Sil ve rman, Ph.D ., at The primary source of informatio n for sive guidance information o n the therapeu
www.herbalgram.org 2003 HerbaiGram 59 I 9 abc news
Sustainable Health and Beauty: Aveda Sponsors Benefit for ABC
tepping from a taxi onto a busy street in the SoHo district of rices. The idea can go further. Through the use of healthy SManhattan, New York, one could not feel further removed substances and practices, we will sustain health and beauty for our from the rainforest, the Andes, or any similarly enriching space. planet and ourselves for many years to come. ABC advocates the Yet something magical happened on the Avenue of the Americas, use of sustainable practices in harvesting and cultivating the herbs on the top floor and roof of a beautiful, newly refurbished historic used in herbal medicine. Likewise, Aveda has always advocated the building. As the elevator doors opened, South American music use of organically produced products and sustainable practices in wafted through the air, mixing the scent of essential oils and delec the development table food and drink with the sounds oflaughrer and conversation. of its product This was the site of an evening of ideas and connections sponsored lines and busi by the Aveda Corporation; "Sustainable Health and Beauty- An ness practices. evening with Andrew Weil and the American Botanical Council In addition to Celebrating the Benefits of Medicinal Plants." Dr. Weil, speak On the evening of June 11 , 2003, Aveda Corporation hosted an ers included event for more than I 00 academic and healthcare professionals, Aveda Founder leaders in the field Horst Rechel- of integrative medi bacher (now cine, people from founder and the herbal industry, Sustainable-z president of and representatives Intelligent of the media from Nutrients), and the New York health -() ABC Founder region. In keeping and Executive Julie Naughton of Womens Wear Daily and Chris with their vision of Director Mark Moli nari, vice president of communications for Aveda, "connecting beauty, Blumenthal. enjoy the evening with their inscribed copes of The Guide in hand. Photo ©2003 Patrick McMullan. environment and &beauty Chris Hacker, well-being," Aveda's seniOr Sustainable Health vice president for marketing and design, welcomed more than 100 and Beauty was the theme for the evening. Aveda hosted the event guests and explained the design and purpose of Aveda's environ to showcase its new Manhattan marketing offices; to support the mentally friendly Manhattan office (Aveda headquarters are in educational and research work of ABC and launch ABC's new Minneapolis). Rechelbacher then sketched a brief history of the book, The ABC Clinical Guide to Herbs, and to provide an educa company, and his professional and personal relationship with tional and social opportunity for those in attendance. This theme ABC. Blumenthal expressed his appreciation to Aveda and the captures the link between the mission of ABC and the vision of many old and new friends who attended the event, saying, "We are Aveda. Sustainabil deeply grateful for the excellent support ABC receives from Aveda . ity has been a guid Just as ABC has been an innovative leader in the field of nonprofit ing principle for herbal education, Aveda is a universally recognized pioneer and progressive innovator in the cosmetics and salon industries by using ethical economic develop ment of agricultural and other natural resources. In the same way, progres- s10 ve compames,0 organizations and individuals are now increa s ingly concerned about usmg sustainable Authentic South American music was provided by resources and find Ch'uwa Yacu Boliv ia. Photo ©2003 Patrick McMullan. ing ways to main- tain the health of entire ecosystems. Sustainable Health and Beauty implies that the methods by which we improve our health and beauty follow the same concepts. Whenever possible, the raw materials, herbs, plants, drugs, and cosmetics used on and in our bodies should be derived from resources that can be renewed, are healthy, and are From left: Aveda founder Horst Rechelbacher (now founder/president of Intelli harvested and tested using ethical, sustainable, and renewable prac- gent Nutrients), ABC founder/executive director Mark Blumenthal, best-selling natural medicine author, Andrew Wei I, M.D. Photo ©2003 Patrick McMullan.
10 I HerbaiGram 59 2003 www.herbalgram.org abc news and sustai nable techniques and practices." He went on to say that Abkit/Lichrwer Pharma, Bristol-Myers Squibb, Estee Lauder, "ABC co ntinues to be a primary suppli er of science-based in fo r Maitake, New C hapter, Novagen, and Vitamin Shoppe, among mation on the benefi ts of herbs and phytomedicin es. For 15 yea rs, others. ABC has consistently reported on clinical research on herbs - Aveda and ABC's especially when few people even realized that there even was scien eve ning of "Sustainable tific research on herbs." He also provided highlights on ABC's new Health and Beauty" book and Safety Label ing Program. provided a gathering Dr. Weil, a member of ABC's Advisory Board, discussed the place for individuals wi th state of integrative medicine. He praised ABC's role as a leader in a common purpose: bringing solid, science-based herbal in fo rmation to health practi responsible use of natural tioners, consumers, government offi cials, the industry, and the renewable resources fo r media. Weil and Blumenthal were in New York as fac ul ty members long- term natural health. of the eighth Columbia University conference, "Integrating Botan ABC is grateful to al l who ical Medicine into Modern Clinical Practice." attended and to Ave da fo r Aveda provided an elegant, all vegetari an, all organic asso rtment transporting guests from of hors d' oeuvres and beverages. Guests contributed financial the busy streets of support to ABC and we re each given an inscribed copy of The Manhattan to a magical Guide, the latest issue of HerbalGram, general information about space of learning and ABC, information about Aveda, and sample products from Ave da. harmony.... T hey also had the opportunity to purchase other ABC books and -Laura and Scott Hoyt of Hoyt Tea and Fredi Kronenberg, have The Guide and the other books inscribed by Blumenthal and Wayne Silverman PhD, of Columbia University and member of the other speakers as a memento of the event. Many guests toured ABC's Boa rd ofTrustees. Photo ©2003 Patrick Aveda's new offi ces, which include plans fo r an ex tensive rooftop McMullan. herbal garden. During the eve ning and in the weeks that foll owed, many people commented that the event Federal Employees Can was informative, entertain ing, and enjoyable. Among Support ABC through the participants was Jill Workplace Giving Baron, M .D., a New York city phys ician who practices he American Botanical Council, listed under the name integrative medicine. She THerbal Medicine Institute (Combined Federal said, "T he event at Aveda Campaign code# 1220), is participating in the Combined was inspiring and informa Federal Campaign (CFC) as a member organization of the tive," she said. "H aving such Independent Charities of America federation. luminaries as Andrew Weil speaking to rei nforce the The CFC is the annual workplace fund-raising drive need for complementary conducted by federal employees between September 1 and and al ternative therapies in December 15. Each year federal employees and military healing, was supportive of personnel raise millions of dollars through the CFC to the work of many of the support thousands of non-profit charities. Friends of ABC, guests. It is really a tribute to who are also federal employees at any level, can support ABC Mark Blumenthal and ABC through their local campaign. for diligence and hard wo rk The CFC is the only authorized solicitation of employees in putting botanical medi Horst Rechelbacher answers questions in in the federal workplace on behalf of charitable organiza cine on the map as a viable front of the "A veda Environmental tions, and is the largest and most successful workplace and necessary discipline in Lifestyle Store," a prototype retail environ fundraiser in the world. The CFC allows federal employees ment. ABC photo. the healing armamentar- to contribute to organizations of their choice through a ium." single brochure and to make their contributions through T hieme Publ ishing
Dietetic Interns from Mayo Clinic Help ABC While Learning
his past May, ABC hosted two dietetic interns from the Mayo Chamis and Rasmussen worked on the online version of the TSchool of Health Related Sciences, of Rochester, Minnesota. courses. They created the initial drafts of the course introduction Heather Rasmussen and Cassie C hamis spent a week with ABC, and the post-test for the cardiovascular section. developing continuing education materials for dietitians. In addition to working on the module, both Rasmussen and The women approached ABC Chamis worked for a day in ABC's gardens, gaining "hands-on" on their own. In the summer of experience with herbs. 2002, Chamis' sister was a dietetic ABC has hosted many interns in the past. Dietetics students at intern with ABC, and she gave Southwest Texas State University are required to intern with ABC such a glowing recommendation to for a week and pharmacy doctoral candidates at the University of Cassie that she sought out Gayle Texas have the option of a six-week rotation with ABC. Engels, Education Coordinator for Chamis sees ABC's internship program as a vital educational ABC, to inquire about an intern opportunity for dietitians. "As a dietetic intern it is important to ship for herself and Rasmussen. be exposed to as much new information as possible so that you can "We saw the ABC as a good way better assist your patients with decisions," she said. "I also think to explore our interests and incor that the experience at ABC is so much better than textbook learn porate that knowledge into our ing. I knew the information was from a reliable source and that the future profession of dietetics," said organization is not out Rasmussen. to 'sel l a product' but The benefit went both ways, as rather to inform the the Education Department also publi c. " received valuable help in the Mayo Clinic intern s Heather Rasmussen had some Ras mussen (left) and Cass ie construction of continuing educa early family experience Cha mi s (r ight) on the front porch tion classes relating to ABC's latest of ABC's headqu arters, th e Case in gardening and book The ABC Clinical Guide to Mill Homestead. botany, and ABC's Herbs (2003). The templates and hi storic Case Mill formats designed by Rasmussen Homestead felt familiar and Chamis will help form the basis for courses to follow. to her. As she noted in ABC has offered continuing education modules since 1995. her final report on her As part of her ga rden experience, intern One module, "Popular Herbs in the U.S. Market," was released in time at ABC, "Having a Hea ther Ras mu ssen repots Plumeri a with ABC 1997 and accredited for and distributed to almost I 00,000 phar family full of self Educa ti on Coordi nator, Gayle Eng els. macists. Plans for the next generation of continuing education proclaimed botanists include live and online sessions. provides for good expo- sure. Like them, it is apparent that the people at the American Botanical Council love growing, researching, writing and sharing information about herbs, herbal supplements, and plants in general." Engels describes the real hindrance to the internship program is a lack of funding. At present, ABC usually hosts interns from Central Texas. Those who are interested in an internship, but are outside that area, must travel to Austin and find accommodations on their own, as ABC lacks the means to offer a stipend or reim burse travel expenses. Requests for internship information come from as far away as Europe, Africa, and India, but, because of lack of funding, those people must gain their internship experience elsewhere. ~ - Sarah Jackson
Don't Miss An Issue of HerbalGram Don't risk having an incomplete Basil: Herb of the Year HerbalGram collection. All members of the American Botanical Council receive a Basil (Ocimum basi/icum 'Genovese' and 0 basilicum 'Dark Opal') growing in the American Botanical Council's gardens. Basil is the International year's subscription, along with many Herb Association's Herb of the Year for 2003. Not only is basil great in other great benefits. Please see page 2 for pesto, it has numerous medicinal and aromatherapy uses in the United States and various cu ltures around the world. ABC photo. more information of becoming an ABC member.
12 I HerbaiGram 59 2003 www. herbalgram .org abc news
ABC Board of Trustees Adds Three Members
he American Botanical Council Board of Trustees has Business at Jackso nville Unive rsity. Texpanded to include three new members. Peggy Brevoort, Tom Another change in the Board makeup will res ult from ABC Kurt, M.D., and Morris Shriftman bring new ideas and energy to Founder and Executive Director Mark Blumenthal resigning in ABC's mission of research and education into herbal medicine. October from his position as board pres ident. Blumenthal will still Peggy Brevoort and her husband, Bill, founded East Earth H erb, be involved with the board , acting as an ex officio member, Inc. in 197 1, working to place C hinese herbal products in the co ntributing information and ideas. The new president has nor American and, later, worldwide markets. She se rved as CEO of the been elected yet. Blumenthal will continue to lead ABC as irs exec company from 1990 to 1999 and as president from 1997 to 1999. utive director and editor of Herba!Gram and HerbC iip. The company was acquired in 1999 by the A.M. Todd Company. Traditionally, ABC's Board of Trustees has been comprised of After that purchase, Brevoort served as president of A.M. Todd people with significant ex peri ence in field s such as pharmacognosy, Botanicals until her retirement in April of 2000. ethnoborany, and the merging of botanical and conventional Brevoort has also served as a member of the boards at Biomed medicine. However, Blumenthal said , "Non-profit organizations Comm Inc.; United Plant Savers; Bastyr Unive rsity Board of have experi enced a difficult rime in rh e economy of a posr-9/ 11 Regents; the Corporate Alliance for Integrative Medicine, Inc.; world. ABC's Board must go in a different direction, and draw C itize ns for Health; and the American Herbal Products Associa upon broader ex peri ence. tion, where she is a past president. "I beli eve it is necessary to begin to add people to the board who She was named 1990 Woman of the Year by the Association of have expertise in business, marketing, finance, and med icine," Women in Natural Foods, and earned Natural Business Commu Blumenthal said. He also expects rh ar the changes will "help ABC nication's 1999 Leadership in Business Award. She was also a grow to a new level of public se rvice to meet the growing needs for member of rhe first herbali st delegation to the People's Republic of reliable herbal informati on and at the sa me rime help develop and C hina in 1988. maintain fin ancial stability for ABC." Her literary credits include material published in Herba!Gram One of the seats bei ng filled had been occupied by Prof. Yarro and Pharmaceutical News. She has also delivered doze ns of presen E. Tyler, who died suddenl y in August, 200 I. Blumenthal tations on botanical issues. explained the delay in filling the sear, "Our of respect to his T homas (Tom) L. Kurt, M .D., M.PH., the founder of the certi memory and the major role he played in helping se t ABC's direc fied regional poison center in Dallas, is a consultant in medi cal tion and policy, we waited to fill his Board sear, leaving ir empty in toxicology, pharmacology, and adverse drug reactions. He is also a a kind of 'missing man' formation in military memorial rituals." clinical professor in the Department of Internal Medicine at rh e Blumenthal looks forward to rh e future of the ABC Board, University ofTexas Southwestern Medical School. expecting that the changes being implemented will be of lasting Dr Kurt, who received his B.S. from Notre Dame, his MD from benefit to the Board and to those invo lved in herbal med icine. Kansas, and MPH from H arvard, se rved as regional medical offi "I beli eve that the new co mposition of the ABC Board will cer for the U.S. Food and Drug Administration (FDA) from 1989 continue to help guide ABC so it will retain irs position as th e lead to 1991 and continues to serve on FDA panels, as we ll as being a ing nonprofi t organization disse minating accurate, responsible, member of the Texas Drug Utilization Review Board, which sets reliable information on rhe benefits of herbs and phyromedicines," Medicaid outpatient prescription policies. He has published more Blumenthal said. "At the sa me rime, it will help ABC establi sh a than 150 scientific papers and is an editorial reviewer for medical strong fin ancial basis to ex pand our educational programs and journals. publications." -"' Morris Shrifrman is rh e CEO of Mozart, Inc., of Ponte Vedra - Sarah Jackson Beach, Florida, a marketing communications firm which special izes in the natural and organic food, and herbal and alternative medicine industry, offering identity and branding, strategic Successfully marketing and positioning, advertising, packaging, public rel a tions, and interactive digital communications. Mozart clients growing your include Tree of Life, United Natural Foods, Whole Foods Marker, business Horizon Organic Dairy, Smucker Quality Beverages, and Tradi tional Medicinals. starts Shrifrman has also been a speaker and panelist at natural prod uct expositions, most recently at the 2003 Organic Trade Associa tion's "All Things Organic" conference. At the BioFach 2003 Congress in Nuremberg, Germany, Shrifrman spoke on what European natural and organic product companies can do to create marketing success in the U .S. market. Shriftman earned a B.S. degree in industrial and labor relations from Cornell University in 1964. His M.A. degree from New York University is in British and American literature, and he completed all bur the dissertation on a doctoral degree in the same program. He has been a visiting professor of marketing at Davis College of www.herbalgram.org 2003 HerbaiGram 59 I 13 organization news-----==~
CRN Aims for Congressional Education, Dialog with New Ads
he Council for Responsible Nutrition display ads The ads complement monthly mailings to T(CRN) has released a new campaign appeanng more than 500 congressional offices. Each designed to educate the U.S. Congress on between mailing focuses on a different category: the benefits of dietary supplements and the June and multivitamins, calcium, folic acid, ginkgo, role of the Dietary Supplement Health and September antioxidants, echinacea, glucosamine/chon Education Act (DSHEA) as a "viable frame m Roll droitin, and omega-3 fatty acids. work" for regulation. CRN, an industry "We really want to open a dialog," said trade association based in Washington, Judy Blatman, CRN vice president of D .C., also sees the program reaffirming communications. "It's a little too early to its role as a reliable source of information tell with the ads, but the response to the on science-based dietary supplements. mailings has been positive. People are really "With all the recent controversy receptive." surrounding a few specific products, we A sample of the ad is available online at felt it important to point out that our
AHP Adds Ginkgo Leaf Monograph to Series
he American Herbal Pharmacopoeia United States in excess of $100 billion available for $19.95 (except St. John's Wort T(AHP), a California-based non-profit annually. This latter benefit alone could which costs $9.95 each). The fu ll set of 18 research organi zation, wi ll save hundreds of millions in monographs costs $328. Order through release its quality control health care costs." AHP or through the American Botanical standards and therapeutic Each monograph represents a Council's website
14 I HerbaiGram 59 2003 www.herbalgram.org organization news
Georgetown School of Medicine Creates First-ever Masters Program in Complementary and Alternative Medicine
his fall the Georgetown School of Medicine, Washington, program is to promote complementary medicine as an academic TD.C., wi ll start the first masters-level basic sciences program in field . We're looking to build a doctoral track as well. It's develop complementary and alternative medicine. Students who complete ing parallel to the master's program, but more work still needs to the three- to four-semester-long program will receive an M .S. in be done." Physiology. Response to the course has already been positive, Myers said. "A In an email dated April 3, 2003, Adriane Fugh-Berman M.D., a survey course was held last yea r and students were very enthusias Georgetown School of Medicine alumna, described the course as tic about the ideas. focused on training basic science researchers. T he integrative "The thrust of the program is to teach people to look critically curriculum includes courses in the fundamentals of biochemistry at alternative medicine, not necessa rily to practice. Experimental and physiology as well as "mind-body medicine, experimental Design and Biostatistics are required courses for any scientific design, and biostasis." The principals of pharmacology of drugs, background, but they would be especially important with the supplements, and herbal medicines are also part of the planned study of alternative medicine. We're trying to create a new curriculum. academic field - the histories and theories of CAM and how to "The course came about after a faculty member received an R25 use it scientifically." Grant from the National Center for Complementary and Alterna The university's home page for the program is online, tive Medicine," said Adam Myers, Ph.D., who, along with Hakima
Australasian College of Herbal Studies Receives National Accreditation
he Accrediting Commiss ion of the Distance Education and [Australasian Coll ege of Herbal Studies. Australasian Coll ege Granted TTraining Council (DETC) has awarded national accreditation National Accreditation [press release]. June 12, 2003.] to the Australasian College of Herbal Studies (ACHS). 'The accreditation is yet another validation that Australasian College's distance learning and on-line classes, in addition to its on-site programs, offer quality educational opportunities to students," said ACHS Vice-President Erika Yigzaw. The DETC has been monitoring and accrediting educational institutions for more than 75 years, and has been recognized and approved of by the U.S. Department of Education and the Coun cil for Higher Education Accreditation, both based in Washington, D.C. The two-year process began with a thorough review by the co ll ege, based in Portland, Oregon, going through every aspect of its operations. Program materials that would be part of the courses were sent to experts chosen by ! ' the DETC for review. Most of the documenta tion was triplicate copies of course and material Bastyr is proud to be the country's first accredited institution descriptions for 15 courses, to offer an herbal sciences program. Explore medicinal herbs. including master herbalist, diploma in aromatherapy, flower - Get to the root of herbal quality issues. And be prepared for a essences, and nutrition. Accreditation will make students' coursework and credits more growing career in your choice of fields. likely to be accepted if they transfer to another institution. Tuition assistance from the military or employers is more readily avai lable when students are enroll ed in an accredited school. ACHS was founded in 1978 in New Zealand by Dorene 425/60 2 · 3330 :: :: WWW .BASTYR.EDU Petersen and relocated to Portland 111 1991. More information about ACHS can be found at the coll ege's website ~YR UNIVERSITY
Evidence-Based Naturopathic Medicine Residency Program Started by Standard Process
tandard Process Inc. (SP), a supplier of former pres ident of NCNM. ing both conve ntional and complementary Sdietary supplemenc formulati ons for Fo r the research requirements of the methods when participating in rotati ons in healthca re practitioners, is providing natur Natural H ealthcare practi cum, residents other healthcare and research areas. Rota opathic phys icians with experi ence in des ign and conduct clinical trials, and ti ons include emergency medi cine, geri evidence-based medicine. The program analyze related healrhcare outcomes data. atrics, intensive care, pain management, reams SP with rhe Nati onal College of Additionally, the res idents are enroll ed in pediatrics, sports medicine, and women's Naturopathic Medicine (NCNM), of Port the physician inves ti gator program at the health. Residents also make or participate in land, Oregon, to administer a naturopathic Medical College of Wisconsin , leading to a presentations every two weeks about their medicine res idency program. mas ter's degree in epidemiology. T he resi cases to review the safety and impact of T his is the program's first year; two natur dents will gain industry awareness by shad their work. opathic phys icians are working at di fferenc owing SP managers and observing opera "In their work at the SP employee well conventional and complementary medical ti ons of the herbal and dietary supplement ness cl ini c, they will report to me," Birdsall fac ilities as we ll as in the resea rch depart product industry, such as new pro duct sa id . "T here will also be a quarterly evalua ment and rh e employee wellness program at development, production, quali ty concrol, tion process through the res idents' school. SP's headquarters in Palmyra, W isconsin. sales and marketing, and management. Standard Process employees who participate "This program is a culmination of several "This program is unique in that it blends in the wellness program will co mplete eval iss ues," said T im Birdsall , N .0 ., res idency practi cal clinical training and experience uation sheets as well." program director. "SP wants to stay abreast wi th hands-on training in the natural prod T he program las ts one yea r, with the of scientific devel opment, crea te a robust ucts industry," Birdsall said. "T hose who poss ibility of returning for a second year or scientific approach to nutritio n, and complete the res idency will have unique joining the SP staff. Birdsa ll sa id pl ans to support rhe naturopathic and herbal medi experi ence, not onl y clinical training, but continue the program have been made, cine professions in general. " Birdsall is training with natural products. " and one res ident has been selected for nex t ass isted by C lyde Jensen, Ph.D ., director of In addition ro their work at SP, residents year. A scientific and integrative affairs at SP, and also learn about integrated medicine, blend- - Sarah Jackson
with distinguished international faculty
the worlds of nature and health
a prosperous and fulfilling career
Contact us for information, to arrange a visit, or to attend our next open house.
Be part of the nation's first graduate degree in Western herbs. This ri go rous academic program, taught by presti gious internati onal fac ul ty, offers students abundant experiences in nature and the opportunity for cl inical experience. Delive red in a fu ll -ti me, fl exible fo rmat.
16 I Herbal Gram 59 2003 www.herbalgram.org organization news
New Official Monographs Published in the European Pharmacopeia
ive new monographs for herbal stan [Matricaria flower] (Matricaria recutita L.) • Plantain, English [Ribwort Plantain] Fdards have become official in the 6th • Dog rose (Rosa canina L. ) (Plantago lanceolata L.) supplement to the European Pharmacopoeia, • Eleuthero [Eleutherococcus] (Eieuthe • Tolu balsam (Myroxylon balsamum (L.) 4th edition, and will be implemented by rococcus senticosus (Rupr. & Maxim.) Harms) January I, 2004, at the latest. The new Maxim.) The monographs in the European Phar monographs include the following (noted • Eucalyptus o il (Eucalyptus gfobufus macopoeia represent the co ll ective consensus in their U.S. common names, with the Labill.) of leading phytomedicinal experts and regu European Union monograph name in • Gentian root ( Gentiana lutea L.) and latory authorities in the European Union brackets and Latin binomials in parenthe Gentian tincture countries, and often contain different stan sis): • Ipecac [Ipecacuanha] liquid extract, dards for identity and purity than standards • Belladonna leaf tincture, standardized standardized (Cephaelis acuminata monographs issued by the United States (Atropa belladonna L.) Karsten or Cephaelis ipecacuanha Pharmacopeia (USP). For more informa • Goldenrod, European (Solidago virgaurea (Brot.) A. Rich.) and Ipecacuanha tinc tion on the European Pharmacopoeia, visit L.) ture, standardized
. ~ have been technically revised since their last • Bitter-orange flower (Citrus aurantium -Josef Brinckmann publication; the revisions to be imple L. ssp. aurantium) [Source: Brinckmann J. (ed.). Market News mented on January I, 2004: • Oregano (Origanum onites L. or 0. Service for Medicinal Planrs & Extracts. June • Chamomile flower, German/Hungarian vulgare L. ssp. hirtum (Link) letswaart) 2003, Number 7. Geneva: International Trade Cenrre/UNCTAD.]
7dS!knaa/ SUPPLYSIDE® WEST International Trade Show & conference Presentations from all six NIH-funded Botanical Dietary Oct. 1-3, 2003 Supplement Research Centers (Exhibit Hall- Oct. 2 & 3) on Wed., Oct. 1. (Education Program- Oct. 1, 2 & 3) • UCLA • University of Illinois, Chicago • The University of Arizona • Purdue University and The Venetian &The Sands ExPO University of Alabama • Missouri University Las Vegas, NV • Iowa State University and University of Iowa
-Plus Speakers From- • NCCAM • Federal Trade Commission • CRN • AHPA • NNFA • Natural Marketing Institute • and other leading organizations!
www.herbalgram.org 2003 HerbaiGram 59 I 17 research reviews Effects of Juice on Kidney Stone Formation
eviewed: Kessler T, Jansen B, Hesse A. Effect of black or juice from either plums (Prunus domestica L., Rosaceae), cran Rcurrant-, cranberry- and plum juice. European journal of Clin berries ( Vaccinium macrocarpon Aiton, Ericaceae), or black ical Nutrition 2002;36: 1020-1023. currants (Ribes nigrum L., Grossulariaceae). High fluid intake is widely regarded as the most important Changes were noted in several urinary parameters following preventive treatment for kidney stones, reducing the concentration consumption of each juice. Black currant juice significantly alka of constituent ions and saturation of stone-forming salts. The most lized the urine (P < 0.0 1) , increased citric acid excretion (P < 0.01 ), suitable fluids for this purpose are mineral water, orange juice, and oxalic acid excretion (P < 0.05). Cranberry juice significantly apple juice, and fruit and herbal teas. Patients with a history of acidified the urine (P < 0.05) and showed a small, not statistically kidney stones should avoid fluids that contain stone-forming significant decrease in citric acid excretion. Oxalic acid excretion agents and promoters; these include coffee, black tea, alcohol, and was significantly increased after ingestion of cranberry juice (P < cola soft drinks. Cranberry juice has been used extensively to 0.05). Black currant juice did not significantly affect the relative prevent and treat urinary tract infections, and small studies on the supersaturation for calcium oxalate, uric acid, brushite, and stru effects of ingestion of black currant juice and prunes (dried plums) vite, but cranberry juice significantly increased the relative super have shown an acidifYing effect on urine in humans. Various short saturation of uric acid (P < 0.05) and decreased the relative super comings in these studies and a lack of scientific evidence have led saturation of struvite and brushite. Plum juice had no statistically these researchers to evaluate the influence of these three juices on significant effect on any of the urinary parameters measured. urinary composition and kidney stone formation. Excretion of calcium, magnesium, and uric acid were not signifi Twelve healthy male subjects (ages 18-38 years) with no history cantly changed by any of the experimental juices. of kidney disorders participated in four consecutive trial phases of The increased excretion of oxalic and citric acids with black five days each. All phases were equivalent in dietary intake and currant juice was attributed to the content of these acids and asco r included a four-day adaptation period during each phase before bic acid (which is metabolized to oxalic acid) in the consumed the experimental load on the fifth day. Creatinine was measured on juice. The alkalizing effect of black currant juice did not decrease days 1-4 to ensure compliance with the diet, and 24-hour urine the relative supersaturation of calcium oxalate and uric acid as samples were collected each day. Day five of each phase was the would be expected, which the authors attributed to the increase in experimental day with consumption of 330 ml of either mineral oxalic acid excretion. The decrease in pH with cranberry juice was water (co ntrol, assumed to have no effect on urinary composition), expected and is associated with increased risk of uric acid stone formation; however, the relative supersaturation for struvite and brushite were slightly decreased. The authors speculate that the effect of cranberry juice might be larger if more juice was ingested. The authors conclude that black currant juice could be used as a preventive and treatment for uric acid stones due to its alkalizing effect on the urine. Cranberry juice could be of use when acidifi cation of the urine is indicated, as with apatite, brushite, and srru vite stones as well as with urinary tract infection. This well-designed study compensated for the perpetual prob lem of quantifying food and beverage intake by requiring subjects to consume a standardized diet, followed by biochemical and phys ical measurements to ensure compliance. Adequate research and annotation supported the study topic. The claims made for black currant and cranberry juices were not completely substantiated by the results; however, the authors noted that this study was conducted in healthy subjects and suggested that further research Distribution partners and into the usefulness of these juices should be done in patients with business contacts sought. .. a history of kidney stone formation. However, it should be noted that there are different types of for high-quality pharmaceuticals in the tradition of the German Homreopathic kidney stones. If possible, stones that are passed should be caught Pharmacopoeia. in a strainer and then analyzed for their content. Most are calcium, bur a minority are uric acid (an indication of gout) or oxalic acid Hommopathic original tinctures (0) (an inherited trait) . Calcium kidney stones are best treated with Dilutions, potencies, injection ampoules, globuli and triturations acidic drinks, but the acid stones need basic (bicarbonate, etc.) drinks to dissolve. Treating uric acid and oxalic acid kidney stones Spagyric essences with acidic beverages is ineffective. Uric acid kidney stones comprise only 20-30 percent of kidney stones, yet universal state Contract manufacturing! ments about kidney stone treatment must be considered in this context . ...- As a contract manufacturer we can make small, medium-sized and -Diane S. Graves, MPH, RD large batches.
18 I HerbaiGram 59 2003 www.herbalgram.org research reviews
Effectiveness of Ginkgo Extract in Persons with No History of Neurocognitive Dysfunction
eviewed: Mix J, Crews WD. A double-blind, placebo also demonstrated significantly greater improvement on the Rcontrolled, randomized trial of Gingko biLoba extract EGb WMS-III FII subtest assessing delayed recognition of visual mate 761 ® in a sample of cognitively intact older adults: neuropsycho rial (human faces), compared with the placebo group (P < 0.025). logical findings. Human Psychopharmacology: Clinical and Experi However, there was a significant difference found berween the rwo mental2002;17:267-277. groups' pretreatmenr baseline scores on the WMS-111 FII (P < In recent years, the use of ginkgo (Ginkgo biloba L., 0.03), suggesting that this result should be interpreted with Ginkgoaceae) extract for the treatment of dementia and cerebral caution. Overall, the res ults from both objective, standardized, insufficiency has increased significantly. The results from a number neuropsychological tests and a subjective, follow-up, self-report of clinical trials have demonstrated the efficacy of ginkgo extract in questionnaire provided complementary evidence of the potential cognitively impaired persons. In the last decade, ginkgo was efficacy of ginkgo extract in enhancing certain neuropsychologi approved as a treatment for dementia in Germany. The majority of cal/memory processes of cognitively intact, older adults. studies have been conducted in Europe. Relatively few studies Only one se rious adverse effect was reported during the current (approximately eight) have examined the effectiveness of ginkgo study and that was in the placebo group. All of the remaining extract in persons with no history of neurocognitive dysfunction. adverse events reported were rated as either mild or mild to moder The importance of such clinical research appears paramount in ate in intensity and no causal relationship was determined with the light of the number of products containing ginkgo with claims of ginkgo treatment. Overall, more adverse events were reported in enhanced cognitive performances that are currently being widely the placebo group than the treatment group. marketed to cognitively intact adults. The results bolster the findings from the few previously The purpose of this research was to conduct the first known, published, small-scale studies that have found improvements in large-scale clinical trial to ascertain the efficacy of ginkgo extract cognitive functioning among older cognitively intact adults and (EGb 761, Dr. Willmar Schwabe GmbH & Co., Karlsruhe, young, healthy volunteers. Although the precise mechanisms Germany) on the neuropsychological functioning of cognitively responsible for the current findings remain speculative, it seems intact older adults. This study was intended to expand upon the plausible that several factors may have interacted additively to authors' previous smaller study, which found that the extract had a promote the enhancement of the gi nkgo groups' memory positive effect on this particular group. 1 processes. ---' In the current study, 262 male and female volunteers, 60 years -Densie Webb, Ph.D. of age and older, who reported no history of dementia or signifi Reference: cant neurocognitive impairment were enrolled and randomized. I. Mix J, Crews D. An examination of the efficacy of Ginkgo biloba The study utilized a 6-week, randomized, double-blind, fixed extract EGb 761 on the neuropsychologic functioning of cognitively intact older adults. J Altern and Complement Med 2000;6:219-29. dose, placebo-controlled, parallel-group experimental design. Indi 2. Solomon PR, Adams F, Silver A, Zimmer J, DeVeaux R. Ginkgo for viduals were randomly assigned to either the ginkgo extract ( 180 memory enhancement: a randomized controlled trial. JAMA mg daily, 60 mg three times per day) or placebo for six weeks. Prior 2002;288:835-40. to the beginning of the study, participants were asked to complete an initial medical history questionnaire. Those with unremarkable medical or psychiatric history were administered the MMSE (Mini-Mental State Examination). Participants meeting the preliminary cognitive and medical inclusion criteria were subse Habitual Tea Drinkers May Have quently administered a series of neuropsychological tests immedi Increased Bone Mineral Density ately prior to the initiation of ginkgo or placebo therapy, again after 6 weeks of treatment, and just prior to the termination of the eviewed: Wu C, Yang Y, Yao W, Lu F, Wu J, Chang C. study. Efficacy measures consisted of participants' raw changes in REpidemiological evidence of increased bone mineral. Archives performance scores from pretreatment baseline to those obtained ofInt ernal Medicine 2002; 162: 1001-1007. just prior to termination of treatment on the following standard After water, tea (Camellia sinensis (L.) Kuntze, Theaceae) is the ized neuropsychological measures: Selective Reminding Test most common, regularly consumed beverage in the world. It is (S RT), Wechsler Adult Intelligence Scale-III Block Design (WAIS categorized into three types: green (nonfermented), oolong III BD), Digit Symbol-Coding (WAIS-III OS) subtests, and the (partially fermented), and black (fe rmented). Tea contains several Wechsler Memory Scale-III Faces I (WMS-III FI) and Faces II hundred compounds that may affect the body. According to (WMS-III FII) subtests. A subjective, follow-up, self-report ques epidemiological studies, the evidence strongly suggests that rea tionnaire was also administered to participants just prior to termi (particularly green tea) may prevent cardiovascular disease, athero nation of the treatment phase. sclerosis, and some types of cancer; however, information about the The analysis of the data revealed that participants who received effects of tea consumption on bone mineral density (BMD) IS 180 mg of ginkgo per day exhibited significantly more improve limited. This study so ught to answer: ment on SRT tasks involving delayed (30 minutes) free recall (P < 1) Is there relationship berween tea consumption and BMD? 0.04) and recognition of noncontextual, auditory-verbal material (P < 0.0 1) , compared with the placebo controls. The ginkgo group Continues on next page www.herbalgram .org 2003 HerbaiGram 59 I 19 research reviews
2) Is there a dose- response effect? and consumption, not amount of daily tea consumption, was the only 3) Which characteristics of tea consumption influence BMD? independent determinant of BMD. The authors found that the This prospective epidemiological survey of chronic disease in change of BMD is always gradual. Long-term, moderate tea Tainan, Taiwan included a total of 1,037 subjects (497 men and consumption appears to influence BMD more than short-term 540 women), 30 years or older in the fin al analys is. Subjects were consumption of high amounts of tea. questioned on their lifestyle and tea consumption, and had BMD According to the authors, tea's bone protective effects may be due screening of total body, lumbar spine (Ll-L4), hip neck, and to its fluoride content. Fluoride intake can alleviate osteoporosis Ward's triangle (a specific region of the hip bone, or femur, within progression. Also, tea contains flavo noids which have been shown the narrowest part of the hip). to improve BMD. (The authors mistakenly suggest tea contains There was a positive correlation between duration of habitual tea ipriflavo ne- a synthetic fl avonoid preparation not found in tea.) consumption and BMD in the four body regions. Five hundred and Any or all of these hypotheses may explain tea's protective effect on two subj ects (48.4 percent) were habitual tea drinkers, with a mean BMD. _A duration of tea consumption of approximately 10 yea rs . Compared -HeatherS. Oliff, Ph .D with nonhabitual tea drinkers, subjects with habitual tea consump tion of 6-10 years showed higher lumbar spine BMDs when compared to nonhabitual tea drinkers, and those with consumption of more than I 0 years showed the highest BMDs in all measured Lloyd Herbert Shinners: By Himself regions. There was no significant difference in BMD between By Ruth Ginsburg habitual tea drinkers with 1 to 5 yea rs' duration and nonhabitual S1da. Bot. M1sc. 1\'o. 22, 2002 155110883-1-\75. pbk tea drinkers. Men had hi gher BMDs than women, and BMD rsbn 1-889878-10-3. pbk decreased with age for both genders. Total physical activity also had 5 ;,••, 9'" xu+ 223 pp. 63 h/w flgurcs S28 + p&h (USA S3: mtcrnational $5) a positive effect on BMD of the total body, hip, and neck. After Texas residents add $2 .3 1 sales tax . adjustment for all covariants, no significant differences of BMD Available from could be found between those who drank green or oolong tea Botanical Research Institute ofTexas Press compared with those who drank black tea. 509 Peca n Street Fort Worth, TX761 02-4060 USA Consistent with other findings, tea had a protective effect on E-mail: [email protected] BMD of the total body, lumbar spine, and hip regions. To the t Fa x 1-817-332-411 2 BR I T authors' knowledge, this was the first study to compare the three PRESS www.brit.org/sida/sbm/sbm23toc.htm types of tea and BMD in both sexes concomitantly. Duration of tea
WHY ROOIBOS LTD. IS THE PREFERRED SUPPLIER AROUND THE WORLD ~ ® • Rooibos Ltd. is the World's leading source for ~itOO..... iBOS bulk supply of Rooibos and Honeybush raw --LIMITED-- materials with 70% of the market internationally. ~~S~ • We have been a reputable supplier to the SINCE 1954 industry since 1954. • We are the leading supplier of high quality powder and liquid extracts for use in the food, nutritional, cosmetic and pharmaceutical industries. • All products are Kosher and Organic certified . • We have comprehensive warehousing facilities on both the East and West coasts of the USA in order to provide continuous supply, with short Contact•• Details:• delivery lead times, throughout North America. Rooibos Ltd . Marketing USA Toll free 877- 433- 3832
20 I HerbaiGram 59 2003 www.herbalgram.org research reviews
Lavender Oil May Help Agitation in Severe Dementia
eviewed: Holmes C, H opkins V, Hensford C, Mac Laughlin V, with either standard 2 perce nt conce ntrati on of lave nder oil RWilkinson D , Rosenvinge H. Lavender oil as a trea tment for (Tisse rand; Tunbridge Wells, Kent, England) or water (placebo) on agitated behaviour in severe dementia: a placebo controlled srudy. alternate days. During the fin al hour, an independent blinded International j ournal of Geriatric Psychiatry 2002; 17:305-8. (wearing nose clips) rarer, unaware of the study des ign, assessed Berween 18-65 percent of people with dementia exhibit agitated individual behav ior of the pati ents wi th rh e Pirrsburgh Ag itati on behav ior. Pharmacological treatment using neuroleptics (a ntipsy Scale (a 16-point obse rver ra ring scale of fo ur domains: aberra nt choti c drugs that reduce confusion, delusions, hallucinations, and vocalization, motor agitati on, aggress ion, and res istance to care). psychomotor agitati on in patients with psychoses; also known as Five treatments and fi ve placebo periods were carried out fo r each major tranquilize rs and antipsychotic drugs) is often the first line of pati ent over rwo-weeks. treatment. H owever, neuroleptics have only modes t effi cacy, are nor During aromatherapy, nine patients (60 percent) showed approved in rhe U.S. for rhis indica ti on, and can res ult in severe improve ment, fi ve (33 percent) showed no change, and one pati ent adve rse side effects, including stro ke. (l ess than 7 percent) showed a worsening of agitated behav ior Essential oil of Engli sh lave nder (Lavandula angustifolia Mill. , compared to placebo. Res ults were described as "modest effi cacy" Lamiaceae) flower, used in aromatherapy as a relaxant, has bee n by the authors. This was the first published placebo-controll ed shown in animal and human studies to have sedati ve qualities upon study of lavender oil in agitated dementia patients. Eve n though the inhalati on. According to D r. Duke's Phytochemi cal and Ethnob pati ent number is small , essential oil oflavender may be a non-inva otani cal D atabases
www. sun n roo I 6os. com
www.herbalgram .org 2003 HerbaiGram 59 I 21 research reviews
Intake of Dietary Catechins May Reduce Risk of Death from Ischemic Heart Disease
eviewed: Arts ICW, Hollman PCH , Fes kens EJM, deMesquita subjects was 72 ± 47.8 mg/day (range: 0-355.4 mg/day) at baseline RHBB, Kromhout D. Catechin intake might explain the inverse in 1985. Black rea accounted for 87 percent of catechin intake, and relati onship between tea consumption and ischemic heart disease: apples and chocolate contributed 8 percent and 3 percent, respec T he Zutphen Elderly Study. American j ournal of Clinical Nutrition tively. Legumes and fruits other than apples were minor so urces of 2001 ;74:227-32. catechins, whereas vegetables did nor contribute any carechins. The Some epidemiological studies have found evidence that drinking authors write, "Because tea was the most important source of care tea (Camellia sinensis (L.) Kuntze, Theaceae) may protect against chins in this populati on, tea consumption increased dose-depend cardiovascular and cerebrovascular diseases. However, other studies ently with catechin intake." Howeve r, it would seem that the fo und either no effe ct or a slightly higher risk of ischemic heart reve rse would be the case (i. e., catechin intake increasing with tea disease (I HD, inadequate blood circulatio n to the heart, usually as consumption). a res ult of coronary artery disease) with greater tea consumption. The subject populati on was followed for 10 years, during which Tea contains fl avo noids, natural plant chemicals that appear to be rime 374 men (46 percent) had died. The cause of death was stroke responsible for any protective effects of tea . Scientists have identi for 47 men and IHD (as either the primary or secondary cause) for fi ed over 4,000 different Aavonoids, whi ch are found in numerous 90 men. A significant inve rse association was found between total plants. One subgroup of the fl avonoid family is known as the care catechin intake and ri sk of death from IHD; the adjusted ri sk ratio chins. was 0.49 in the highes t category of catechin intake. Thus, IHD Carechins are the main components of rea, accounting for mortali ty risk was reduced by 51 perce nt in the highes t third of approximately 30 percent of the dry weight of green rea and 9 catechin intake. The three groups of total catechin intake were percent of the dry weight of black rea (black rea is fermented gree n defined as low (0-49.0 mg/day), middle (49.1-85.8 mg/day), and tea). Researchers have identified several possible mechanisms by high (85.9-355.4 mg/day) . T he authors also found that a 50-mg which carechins could inhibit rhe development of cardiovascul ar increase in catechin intake was linked to a 25 percent decrease in disease. Carechins may prevent oxidative damage to low-density ri sk; 50 mg is found in l cup of black tea plus a small piece of dark lipoprotein choles terol by scavenging free radicals, and inhibit chocolate or in two large apples. inflammatory processes involved in atherosclerosis. Other potential The association betwee n total catechin intake and risk of death mechanisms have been proposed, bur in vivo studies have not yet fro m IHD remained essentially unaltered after adjustment for other confirmed any of these theo ri es. vari ables, including prevalence of myocardial infarction or angina Tea is not the only so urce of catechins in human diets- apples pectoris at baseline, physical activity, age, body mass intake, alcohol and chocolate are two other exa mples of dietary so urces. Catechin intake, smoking, dietary facto rs, prevalent hypertension or diabetes, intakes fro m other foods may have confounded the results of previ serum total or HDL cholesterol , and systolic blood press ure. The ous studies that attempted to link tea consumption to ri sk of authors note that prevalent myocardial infarction (heart attack) or cardiovascul ar disease. Also, reli able data on the catechin contents angina at baseline had an important influence on mortali ty. of va ri ous foo ds were nor ava il able until recently, when the authors However, "catechin intake was inve rsely associated with IHD developed a method for measuring the six major catechins in foods. mortali ty both in subj ects fre e of disease at baseline and in subjects This article describes the authors' evaluation of the possible link with prevalent disease at baseline." between catechin intake and incidence of and mortality from IHD The data we re also analyzed to identifY possible associations and stroke. T hey used data from the Zutphen Elderly Study, a betwee n catechin intake and both myocardial infarction and stroke. prospective co hort study of Dutch men who were 65 to 84 years old For incidence of fa tal and nonfa tal myocardial infarcti on, the age at study entry in 198 5. Complete data were available fro m 806 adjusted reduction in risk with higher catechin intake was not as men. large as that for IHD mortality. T he risk ratio for incidence of T he results showed that the mea n catechin intake of the 806 myocardial infarction was 0.70 for the highest category of catechin intake, bur this was no longer statistically significant after adjust ment for possible confounders. For stroke incidence and mortality, there was no relationship with catechin intake. T he authors conclude, "in our study of elderly men in the American Netherl ands, catechin intake was inversely associated with IHD mortality but not with [heart attack] incidence or stroke." Their Botanicals study was the first to evaluate links between cardiovascular diseases and catechin intake. However, the study was limited in irs ability to d is tinguish between the effects of rea, catechins from all so urces, and dietary flavonols. Future research should attempt to confirm these res ults and also investigate whether catechins or other substances in tea have protective effects against IHD. __... -Christina Chase, MS, RD Allen Lockhard Phone: 573-485-2300 President Fax: 573-485-3801 ambotncls@aol. com Toll Free: 800-684-6078
22 I HerbaiGram 59 2003 www.herbalgram.org research reviews
Treatment of Constipation-Predominant Irritable Bowel Syndrome with Padma lax
eviewed: Sallon S, Ben Arye E, David purshiana (DC.) ].G. Cooper, Rhamnaceae; three months may indicate that the patients Rson R, Shapiro H , Ginsberg G, Ligum syn. Rhamnus purshiana DC.), 70 mg were receiving more benefit from Padma sky M. A novel treatment of constipation Chinese rhubarb root (Rheum pafmatum L. Lax therapy. Laboratory investigations predominant irritable bowel syndrome var. tangaticum Regel, Polygonaceae), 1.75 showed no clinically relevant changes after using Padma Lax, a Tibetan herbal formula mg nux vomica seed (Strychnos nux-vomica three months for either the Padma Lax or tion. Digestion 2002;65:161-171. L., Loganiaceae), 70 mg ginger root placebo group in electrolyte levels, in liver Irritable bowel syndrome (IBS) is a (Zingiber officinale Roscoe, Zingiberaceae), and kidney function tests, or blood tests. gastrointestinal disorder characterized by 25 mg heavy kaolin (clay), 15 mg sodium The manufacturer's website notes that pain, disturbed defecation, bloatedness, and bicarbonate, and 35 mg sodium sulfate. those who take the product without a distention, which are unexplained by struc Symptoms, stool consistency, bowel doctor's supervision should not take it more tural or biochemical abnormalities. Accord movement frequency, pain, urgency, incom than 1-2 weeks, and that exceeding the ing to three studies cited in this article plete evacuation, and abdominal distension recommended dose can lead to depletion of under discussion, 15-20 percent of people were recorded. essential electrolytes, especially potassium, worldwide suffer from IBS. Drugs, dietary Both groups increased their stool which can lead to health complications. modifications, behavioral treatments, and frequency throughout the study. However, Patients raking cardiac glycosides are alternative therapies are current treatment by the end of three months, subjects receiv cautioned to exercise particular care with strategies. Herbal remedies are growing in ing Padma Lax increased their mean stool stimulant laxatives. Further, taking laxatives popularity, but the value of such treatments frequency to 6 days per week compared to 5 beyond the recommended duration can has not been well studied. Based on a days per week for placebo-treated subjects damage intestinal mucosa and lead to Tibetan recipe traditionally used to treat (P = .002). Severity of constipation dependency, a significant reduction in the constipation and aid in digestion, improved in both groups, but was signifi ability to perform normal bowel functions Padma®Lax is a complex formula of 15 cantly better in patients treated with Padma without the use of laxatives. Laxative prod herbs and minerals. This article reports on a Lax by the end of the study (P = .0001). ucts should not be used for longer than 1 pilot study evaluating the efficacy and safety After three months of treatment, there was week, unless directed by a doctor. of Padma Lax in patients with constipation a significant decline in the severity of It should also be noted that the American predominant IBS. abdominal pain in the Padma Lax-treated H erbal Products Association's Botanical Eighty men and women (aged 20-81 subjects (P = .05). Compared to baseline, Safety Handbook states that the aloe species years) with diagnosed constipation subjects receiving Padma Lax experienced a listed above are contraindicated in " . .. any predominant IBS participated in this significant decline in flatulence (P < .05) inflammatory condition of the intestines . .. randomized, double-blind, placebo and abdominal distension (P < .0 I) after [including IBS]." That same source notes controlled study. All patients entered the 2- three months of treatment. At the end of that products containing cascara sagrada week run-in period where an initial the study, a general improvement in bowel bark, frangula bark, and/or rhubarb root gastroenterological screening, blood tests, habit was reported by 70 percent of Padma should be labeled to caurion consumers to and daily diaries were recorded for a base Lax subjects, compared to 11 percent of follow directions carefully, and not to use if line measurement. After the 2-week run-in, placebo subjects (P = .00 I). Of the 34 they have diarrhea, loose stools, or abdomi patients rook 2 capsules of Padma Lax (n = Padma Lax subjects who completed the nal pain. 42) or an identical looking placebo (n = 38) study, 10 had mild side effects, including Padma Lax has been marketed in Switzer for 12-weeks. Padma Lax (Padma AG, slight headache, nausea, and hoarseness. land for more than 30 years, the authors Schwerzenbach, Switzerland) 482 mg Seven subjects developed diarrhea, includ report, with no adverse effects reported to capsules contain: 12.5 mg Aloe standard ing one who additionally complained of a the Swiss health authorities. ----' ized extract (Aloe vera (L.) Burm. f., mild episode of dizziness, shortness of -HeatherS. Oliff, Ph .D. Aloaceae and A. ferox Mill.), 10 mg breath, and chest pain which resolved calumba root Uateorhiza palmata (Lam.) within 24 hours. Patients with diarrhea Miers, Menispermaceae), 10 mg were permitted to decrease the dose to 1 HerbCiip™ condurango bark (Marsdenia cundurango capsule per day. There was no difference in The preceding Research Reviews are drawn Rchb. f. , Apocynaceae), 52.5 mg frangula final outcomes between patients who main from the 2,000 critical reviews available bark (Frangula alnus Mill., Rhamnaceae), tained the regimen of 2 capsules daily and online to members of ABC ar rhe Academic 35 mg gentian root ( Gentiana lutea L., those who lowered their dosage to 1 capsule level and above. The full HerbClip Educa Gentianaceae), 35 mg elecampane rhizome per day. tional Mailing Service is distributed (!nula helenium L., Asteraceae), 35 mg IBS is a chronic condition with sponta bimonthly and includes 12 critical reviews chebulic myrobalan or tropical almond fruit neous fluctuations, so three months is the along with many of rhe original articles drawn from a variety of professional and mainstream ( Terminalia chebula Retz. var. tormentella minimum time required to see an effect. sources. To receive the full service, contact (Kurz) C. B. Clarke, Combretaceae), 3.5 mg During the first month of treatment, Wayne Silverman, PhD, at 512/926-4900 ext. long pepper (Piper longum L., Piperaceae), placebo and Padma Lax caused nearly the 120, or via email at
www.herbalgram.org 2003 HerbaiGram 59 I 23 plant patents Using Plants for Coloring, and as a Potential Treatment for Melanoma by Anthony L. Almada T he applied stress conditions were exposure to room or ultravio let (UV) light, or hear. T he natural colorants assessed were: red cabbage (anthocyanin-based), "Carthamus Yellow" (flavo noid The Colors of Money: Extending based), "Gardenia Blue," purple sweet potato (flavonoid-based), the Lifespan of Natural Colors and purple corn (flavonoid-based). A common fi nding was a dose dependent increase in color persistence with any of the colorants Parrent No.: USA 6572906 and any of the oligosaccharides used, compared to a control with Date of issuance: 3 June 2003 out oligosaccharides. Similar fi ndings were noted with food Assignee: San-Ei Gen FFI, Inc. (Japan) samples, including juices, syrups, and jell ies. A comparison was Priority date (Japan): 16 March 2000 made ro other sugars and oligosaccharides, revealing superior anti Method fo r inhibiting the fading of natural colorants with fading properties with the carbohydrates claimed in the invention oligosaccharides (NOS was used most frequently) . T he antioxidant used in combi nation with the claimed oligosaccharides was an enzymatically Background modified isoquercitrin (15 percent by weight; other constituents The consumer-driven search for natural colors is not altruisti c: not disclosed; an ingredient sold by San-Ei Gen). Subjecting the natural food colorants generate approximately $1 billion on a natural colorants to UV irradiation, when combined with an global scale, with U.S. sales just under $300 million. 1 Nearly half oligosaccharide and the isoquercitrin antioxidant, showed of the sales are garnered by Europe, with the United States (30 substantially greater color persistence. A primary disadvantage of percent) and Japan (20 percent) making the balance. T he leaders using a natural colorant is the limited shelf stability and color in natural colorants are Roche, Sensient, Wild Flavors, GNT, retention. T his starts with processing-associated heat exposure and C hris Hansen, and San-Ei Gen. T his last company has a suite of continues through light and oxygen exposure with an on-shelf natural colorants derived fro m various plant sources. O ne derived product, in addition to interactions with other constituents in the from the juice of purple sweet potaroes is a red ro purple antho product. cyanin-rich extract. San-Ei Gen also manufactures carotenoid colors. T he company has used plant cell cultures to produce Notes commercial quantities of colorants. San-Ei Gen first fi led for this Increasing the shelf stabili ty of a naturally colored food product patent in Japan in March of 2000. T his patent described a natural has large economic implications, presuming the cost of the ingredient-based method to prolong the durability and stabili ty of colorant system is not prohibitive. T he allure of a natural color natural colorants, the lack of which has been a primary disadvan system from a consumer/marketing perspective continues to be a tage, the other being generally higher prices compared to synthetic very attractive value offering. What is not addressed in the patent dyes and colorants. is whether other sensory features of a product are altered (e.g., microbial shelf stabili ty or taste), bur the typical concentrations Claims added were less than 3 percent. Those who are keenly interested in T he lead independent (broadest) claim involves the addition of natural colorants may consider attending the 5th International one or more specific oligosaccharides to a natural colorant, or one Symposium on Natural Colorants, scheduled for November 8-12, or more specific oligosaccharides and an antioxidant to a natural 2003, in San Diego, CA. Contact Peter C. Hereld/Hereld O rga colorant, as a method to inhibit fading. In general, oligosaccha nization (203/28 1-6766) for more i nfo rm at i o n. ~ rides are complex, short-chain sugar compounds. T he oligosac Reference: charides called out are panose (PAN), an isomalto-oligosaccharide I. Anon. Natural colors making a splash. Food l ngred N ews that is a trisaccharide composed of three glucose units with two 2003;11:1-2. different types of linkages (alpha-! ,4 and alpha- ! ,6), maltooligosaccharide (MOS), an oligosaccharide defined by 2-1 0 glucose units, linked by 1-4 links, and nigerooligosaccharide (NOS), a mixture of nigerose (a disaccharide of glucose with alpha- I ,3 links, present in honey and beer, fo r example) and larger chains (the niger- prefix originates from the discovery of this class of carbohydrates in the cell wall of the mold Aspergillus niger). N umerous antioxidants are described in the patent specifica tions, incl uding a number of phytochemical and botanical antiox idants. T hose specifically described (yet consistently omitting basic botanical identificati on of the species) are "Chinese bayberry extract, rutin extract, coffee bean extract, rosemary extract" and similar plant extracts, and "enzymatically modified rutin, and enzymatically modified isoquercitrin." T he invenrors undertook a series of proof-of-concept experi ments, using diffe rent concentrations of the three oligosaccha rides, with or without antioxidants, and various natural colorants.
24 I HerbaiGram 59 2003 www.herbalgram.org plant patents
Betulinic Acid Derivatives for Skin tumor cel l lines, using BeruA and other anticancer agents. Related to the claimed invention, a few of the synthetic derivatives were Melanoma compared ro BetuA using cultured human melanoma cells. Several of the derivatives displayed similar selective cytotoxicity, with one, Patent No.: EP 0981341 derivative 9, showing superior melanoma cytotoxicity. Date of issuance: 11 June 2003 Assignee: University of Illinois Notes Priority date (Japan): 16 May 1997 Although the patent claims ropical use of the invention, no Berulinic acid derivatives for treating and preventing melanoma experiments delivering BeruA or any of its derivatives were Background described. Moreover, the ex periments where BetuA was evaluated in vivo (mice with a compromised immune system, injected subcu Betulinic acid (BetuA) is a steroidal triterpene that has been taneously with human melanoma cell s) employed intraperitoneal explored as an anti-cancer agent for over a decade. Irs mechanism injections. Japanese researchers have also undertaken the chemical of action involves activating apoptosis (programmed cell death) by modifications (C3 position) described in the invention, and targeting mitochondria (the organelle in every cell that provides showed superior apoptosis induction in mouse melanoma ce lls in energy for cel lular function), a mechanism similar to that exerted vitro.3 It wi ll be of interest to see if this semi-synthetic natural by hyperforin, found in St. John's wort (Hypericum perforatum L., product derivative enters the drug development pipeline and 1 Clusiaceae) . Pezzuro and his former colleagues from the Univer demonstrates significant therapeutic and/or prophylactic effects as sity of Illinois first described the selective induction of apoptosis in part of a topical therapeutic for a difficult-to-treat condition 2 human melanoma cells (Pezzuto is now at Purdue University). (melanoma) of increasing concern in public health. -"' Undoubtedly, this work compell ed the leaders of this group to pursue synthetic derivatives of BetuA as agents capable of topically Reference: treating or preventing melanoma. I. Schempp CM, Kirkin V, Simon-Haarhaus B, Kersten A, Kiss ], Termeer CC, et a!. Inhibition of tumour cell growth by hyperforin, Claims a novel anticancer drug from Sr. John's wo rt that acts by induction of The patent has only four claims, the primary and lone inde apoptosis. Oncogene 2002;21: 1242-50. pendent (broad) claim being a composition for ropical treatment 2. Pisha E, Chai H, Lee 1-S, Chagwedera TE, Farnsworth NR, Cordell GA, et al. Discovery of betulinic acid as a selective inhibitor of of metastatic melanoma of the skin, comprising BetuA modified at melanoma that functions by induction of apoptosis. Nature Med its C-3 position. The described modifications include a hydrogen 1995; I: I 046-51. atom, alkyl groups of varying lengths, or bromine, chlorine, fluo 3. Hata K, Hori K, Takahashi S. Differentiation- and apoptosis-induc rine, iodine (halide) atoms. The patent asserts that modification of ing activities by penracyclic triterpenes on a mouse melanoma cell BetuA renders the derived compound much more water soluble lin e. j Nat Prod 2002;65:645-8. and, as a result, more bioactive, suited for topical delivery. Sourcing of BetuA, as described in the patent specifications, is described in two ways. The abundant presence of betulin (22-25 CANCELLATION NOTICE percent) in the bark of birch (Betula pubescens Ehrh., Betulaceae, syn B. alba L.) is mentioned, but, due to the 1 ,000-fold lower BetuA content, a semi-synthetic process of converting betulin into BetuA is suggested. The inventors used a biological assay to assess antitumor activity of the extract. The extract is described as extracting air-dried, milled stem bark of a species of jujube (Zizi phus mauritiana Lam., Rhamnaceae) with 80 percent aqueous methanol. This extract was then partitioned successively with hexane and ethyl acetate to provide hexane, ethyl acetate, and aqueous extracts. The ethyl acetate extract that demonstrated cyto toxicity against a cultured melanoma cell line was ch ro matographed to yield 10 additional fractions. T he patent describes several cytotoxicity studies with various
Support ABC
Federal Employees May Support the American Botanical Council in the Combined Federal Campaign Select the Herbal Medicine Institute f.Jv\ERICAN CFC Code #1220 BoTmiCAL COUNCIL www.herbalgram.org 2003 HerbaiGram 59 I 25 The Questions:
Consider the Herbs that You and Your Patients Might be Taking:
l~ How do they interact with conventional medications?
l~1 What are the potential side effects?
l~ What is the common therapeutic result that can be expected?
l~ What are the safety issues and contraindications?
l~ Is the brand being taken backed by clinical studies?
l~ How long should they be taken?
l~ How much should be taken?
l~ Where can healthcare professionals turn to for reliable guidance? The Answer.
The ABC Clinical Guide to Herbs Mark Blumenthal, Senior Editor Scientifically-Based. Objective. Useful.
\rt< Self-paced course/reference guide includes comprehensive clinical monographs, clinical overviews, patient information sheers, and tables of clinical studies, for 29 widely used herbs, as well as additional infor mation about popular combination proprietary products lrt< Clear, science-based information about safety and drug interactions lrt< Descriptive dosage and administration guidance A 512-page, peer-reviewed medical guide offering comprehensive information about the top selling herbs, The Guide includes information about the history of the herbs, their use, potential drug interactions, safety information, clinical studies, and a proprietary products section. Nationally approved for Continu ing Education Credit, The Guide is unique in that it provides healrhcare professionals with in-depth data, as well as offers their patients easy-to-rake home information sheets. Healthcare Professionals and Patients Will Benefit From: "Fortunately, a 512-page scientific lrt< Comprehensive Clinical Monographs evaluation of herbal supplements, The lrt< Focused, concise Clinical Overviews ABC Clinical Guide to Herbs, was just lft; Useful, one-page Patient Information Sheers published by the American Botanical lrt< 29 Single herb chapters Council, a non-profit education and lrt< 13 Proprietary product monographs research group I belong to. Although lrt< 588 Clinical studies summarized intended as a reference book for doctors and other health professionals, lft; 180 Branded products noted in studies it's rich in facts for consumers, too." lrt- 52 Tables (46 tables of clinical studies) lrt< 53 Black & white photographs Jean Carper lrt< 31 Illustrations USA Weekend; EatSmart Section, June 6-8, 2003 lrt< 5 Healthcare professions eligible for continuing education credit lrt- 512 pages, hardbound
Buy your copy now for $49.95 (plus shipping and handling) Please call 800-373-7105, ext.118 or visit www.herbalgram.org or use the order form on the inside back cover of this issue.
Exclusive Worldwide Trade Distributor, hJ\ERICf'N Thieme New York 800-782-3488, 212-760-0888 or visit BoTfNICAL COUNCIL Thieme www.thieme.com
Perhaps because of the gentle tranquilizing effects of kava, "Liver-related ri sks associated with the use of kava have during the last two decades non-indigenous use of kava-based prompted regulatory agencies in other countries, including products skyrocketed throughout North America, Western those in Germany, Switzerland, France, Canada, and the United Europe, and Asia. In 200 I in the United States alone, kava prod Kingdom, to rake action ranging from warning consumers about ucts garnered over $9 million in sales in mainstream retail outlets the potential risks of kava use to removing kava-containing (a statistic that does not include sales in Wal-Mart stores, some products from the marketplace. Although liver damage appears healthfood stores, mail order, multilevel marketing companies, or to be rare, FDA believes consumers should be informed of this from health professionals).2 The estimated total sales for kava in potential risk. " the United States alone could thus be in the range of $30-50 As a basis for its warmng, the FDA relied on adverse event million in 2001, according to a June 2002 letter from the Ameri reports from European countries as well as reports that it had ca n Botanical Counci l's Mark Blumenthal. The res ultant impact of received since it reques ted global commerciali za tion of information about adverse kava on the economies and events in the United States in cultures of small island a public statement in Decem nations has been large. Many ber 200 I. The March island nations in the Pacific Consumer Advisory summa Ocean, faced with the loss of ri zed these reports in this copra, or dried coconut (Cocos way: nuciftra L., Arecaceae alt. Pal mae) and cocoa ( Theo "Kava-containing products broma cacao L., Srerculi aceae) have bee n associated with as viable export commodities, li ver-related InJunes have been dependent on kava including hepatitis, cirrhos is, cultivation as a major source and liver fa ilure - in more of hard currency earnings. In than 25 reports of adverse contrast to the previous colo events in other countries. nial plantation economies, Four patients required li ver kava cultivation has been transplants. In the U.S., FDA largely compatible with has received a report of a indigenous agroforestry prev iously healthy yo ung systems, allowing small family female who required li ver and vi ll age-based enterprises transplantation, as well as to spring up along lines sensi several reports of liver-related tive to local folkways and InJUries." mores .3 To the authors' knowledge, "Although the mam no studies in animal models economic attraction of kava," or clinical obse rva tions in a writes Vincent Lebot a decade carefully controlled double ago, "is its high cash return blinded study in human per work day, it has other beings have been made to advantages over coconuts, examine potential hepatotox cocoa, coffee [ Cojfea spp., Kava Piper methysticum Photo ©2003 Diane Ragone icity of kava or kava ex rracrs. 4 Rubiaceae], and, to some Two case reports of liver toxi- extent, black pepper [P city from kava products nigrum L. , Piperaceae]. It matures earl ier than major tree crops. As where there was no history of concomitant use of other medica population press ure on land resources increases, the shorter rime tions or alcohol were recently published.' Since some European from planting to harvest wi ll make kava an even more attractive regul atory settings accept a history of traditional folkloric use of an crop for small holders."3(p1771 herb to contribute towards a broad picture of safety and presumed efficacy, patterns of kava use within indigenous societies might be The promise of kava as a culturally benign, economically viable of interest. Given the authors' previous erhnoboranical studies in model of village-based development came to an abrupt halt when the islands of the South Pacifi c,6 we decided to investigate indige concerns were recently raised about the safety of kava products. nous knowledge about adverse effects, including hepatotoxicity, Precipitated by events in Germany and Switze rland where both from kava consumption among islanders who consume kava on a governments iss ued statements concerning the potential hepato regular and frequent basis, and who have traditions of doing so for toxicity (liver damage) of kava, the U.S. Food and Drug Adminis thousa nds of years. T he purpose of our study - based on inter tration (FDA) stated that it "is advising consumers of the potential views conducted on Savaii Island, Samoa in May 2002 -was to risk of severe live r injury associated with the use of kava-contain inves tigate the availability of evidence of liver damage In nanve ing dietary supplements." In irs March 25 , 2002, Consumer Advi res idents of Samoa resulting from kava consumption. sory the FDA reported: www.herbalgram.org 2003 HerbaiGram 59 I 29 hospital on the island of Savaii. All interviews were conducted in the Samoan language except for the hospital interviews of western trained healthcare professionals. Informed consent was obtained from each informant for our use of notebooks, cameras, video cameras, and tape recorders as documentation aids. We sought to ascertain the informants' knowledge of the differ ent cultivars of kava, how kava is prepared, how and when kava is used, and the effects of kava drinking, especially from excessive or long-term consumption. Questions were asked about any possible contraindications involving kava, and where none were noted, we specifically asked about any possible effects of excess kava consumption on the liver. Together with the physicians on our team, we listened carefully for any descriptions of signs and symp toms related to liver dysfunction. In the case of the interviews with healers, we asked specific questions about liver dysfunction only after we had exhausted opened-ended inquiry about effects of excessive kava consumption. We also investigated origin myths, social customs, and restric tions related to kava consumption. During our interviews, we participated in three kava ceremonies and drank infusions of kava prepared according to tradition. We observed informal kava consumption by men at work and heavy kava drinking by men in the marketplace. Results In Samoa, words for kava are typically binomials, with the generic level term 'ava being modified by a specific level epithet. In Savaii island, two principal cultivars of kava are in cultivation: 'ava
The tautu serves kava to the vi llage matai. Photo ©2003 Jim Wise man La' au and 'ava le' a. The most widely used cultivar of P methysticum was 'ava La' au, which is distinguished by its short internodes. 'Ava le'a has internodes up to 30 em long. Our informants identified six Research Site and Methods additional varieties of kava. 'Ava toga has a strong taste and ordi Savaii, the largest island (1 ,820 square km) in the independent narily is not used for drinking. 'Ava talo and 'ava tuna are foreign nation of Samoa (13° S, 172° W), has a rugged mountainous inte cultivars not considered appropriate for traditional ceremonial use. rior and a tropical climate. Its rainfall is 200 em or more per year Other names given were 'ava mumu, or red kava, 'ava Samoa, and and annual temperatures average 26°C (79°F). Savaii is 'ava inu, which means "drinking kava. " Our informants the least Westernized of the islands in the archipel· distinguished these cultivar names from others given to ago, with most people living in villages as subsis In none of our forms of kava during kava ceremonies to fulfill ritual tence agriculturists and reef foragers. Tradi interviews with traditional dictates. Hence kava that is chopped up into small tional culture, preserved by a system of healet·s or with \Vestet·n pieces is called uga o le z' a sa ("turtle scales"), village chiefs or matai who are responsible trained healthcare profession small roots bundled together are called Jetaia' i for the village and law enforcement, als was a linkage repm·ted rna uso ("fellowship and brotherhood"), long remains strong. At the beginnings of meet· between kava drinking and ceremonial kava sticks are called lupe sina ings of the village council, kava is usually liver dysfunction despite (white pigeons), and stout kava sticks are called served according to rank, reaffirming village nearly universal participation tugase ("s tanding alone"). In addition, the chiefly tides and hierarchy. by adult males in kava generic level term 'ava appears reduplicated as the local name of the forest vine Macropiper graef In Savaii, we interviewed chiefs (typically ceremonies or informal fei Warb., Piperaceae, 'ava' ava a' itu (a' itu = male) and traditional healers (typically female) in kava use. "demon") and as an unrelated term for bioactive water the villages of Saipipi, Falealupo, and Tafua. In Saip- infusions including the fish poison derived from 'ava sa ipi, we interviewed four matai and one female healer. In ( Tephrosia purpurea (L.) Pers., Fabaceae alt. Leguminosae)7 and the Falealupo, one interview was conducted immediately following a imported ava niukini (Derris malaccensis (Bench.) Prain, Fabaceae). kava ceremony, and questions were addressed to the assembly of Liquor is also called 'ava malosi (malosi ="strong") 30-40 chiefs and orators. One matai and one healer also were interviewed individually at Falealupo. One healer was interviewed Preparation and Uses of Kava in Tafua. Informants ranged in age from their late 30s to 70s. We Consistent with information obtained in published ethnobotan interviewed two Western-trained physicians and two nurses at ical accounts, our group found that 'ava is consumed during Matietoa Tunumafili hospital in the village of Tuasivi, the main formal ceremonies, at informal social gatherings, and as medicine.8
30 I HerbaiGram 59 2003 www.herbalgram.org According to our informants, kava is also used frequently by men Effects of Kava Use doing hard labor. Kava is a mild, non-addictive drink that creates feelings of well For ceremonies the 'ava is prepared by the taupou, traditionally being and promotes cooperative social behavior. l.9 Consuming the virgin daughter of a paramount chief, who mixes the dried quantities of kava leads to sleepiness and unsteadiness without the powdered roots with water in a special bowl, the tanoa 'ava which loss of mental faculties. While participating in is invariably made from the dense timber of ifilele (fntsia bijuga 'ava ceremonies, we noted that after drink- Kuntze, Fabaceae alt. Leguminosae). She strains the solids from the ing 'ava there was a tingling sensation :\o one n·pol·ted liquid with a strainer made from the vascular bundles of the leaf and slight numbness in the mouth, majo1· clinical ,ign' petioles of Heliconia paka A. C. Smith, Musaceae. The kava is then presumably a result of the well-docu or (j, c·1· malrunction sequentially served in a coconut shell bowl to the matai and guests mented local anes thetic effect of in association\\ ith in strict order of rank. Tugase, the ceremonial kava sticks made kava. No other sym ptoms were '""a 'ava on a regular basis reported that rol' sign' or '-LIC h drinking 'ava helps a person to relax, S.' mptom,. think more clearly, and sit cross-legged on floor mats for long periods of time during the 'ava ceremonies. For working men, 'ava promotes strength and suppresses thirst and appetite. All informants reported that excessive consumption of 'ava is very rare and that its symptoms are reversible. Men, such as those who drink 'ava all day in the markets, may experience transitory dizziness, dry pale skin conditions, weight loss due to appetite suppress ion, drowsiness, watery eyes, hair loss, or upset stomach. In contrast to literature reports, 10 the healers did not identify ichthyosis (a type of dermatitis) as a consequence of excessive kava consumption, but did describe for the dermatologist in our team a condition of dry, pale ski n. The healers indicated a simple cure for problems associated with excessive kava co nsu mption: cessati on of 'ava consumption, and sweating through hard work. They Presenting kava to one of the village matai (Metuli Ah-Chew). Photo ©2003 Jim Wiseman Kava is also consumed in non-ceremonial situations. As a bever age drunk prior to and during phys ical labor, amounts between one to eight liters or more may be consumed. Drinking 'ava is said to slake thirst and hunger, promote sweating, and reduce the heat of the sun on the skin. Recreational drinking also occurs in Samoa. At public markets in Salelologa on Savaii and in Apia, on the island of Upolu, we observed groups of men seated around large kava bowls, drinking continuously, and playing mu, a game similar to checkers. Exces sive 'ava drinking, however, is frowned on by the community, and some churches oppose the use of' ava except in ceremonial situa Offering a tali, libation or blessing, of kava before drinking. Photo ©2003 Jim Wiseman tions, viewing the idleness associated with marketplace drinking as a bane in and of itself. reported that when 'ava consumption stops and the person works Kava is also used in traditional healing. Samoan healers use 'ava up a sweat that the symptoms quickly disappear. T he difference as medicine in treating both men and women for a variety of between the effects of 'ava Samoa and 'ava palagi (alcohol) were ailments. An infusion of stems and bark is used for back pain and strongly emphasized by the matai and hospital staff interviewed. stomach upset. For severe back or stomach pain, they use an infu sion of roots, which they believe are stronger in effect. Two of the vi llage healers, one from Saipipi and one from Falealupo, were able to describe in detail the signs and sym ptoms www.herbalgram.org 2003 HerbaiGram 59 I 31 of liver dysfunction including jaundice and abdominal distention to the satisfaction of the physician and medical student on our team. Patients with ma' i ake (liver dysfunction) are referred by the healers to the Western hospital for treatment. Both healers and hospital personnel report an association between excessive alcohol consumption and liver dysfunction, or with a combination of excessive alcohol and kava consumption, but no liver problems were reported from patients who have a history of drinking only kava. Two nurses reported seeing liver damage and peptic ulcers among patients with a history of alcohol and kava drinking, but specifically stated that they have never seen liver problems among those who drink kava exclusively. We did not, however, see patients or review case histories, and so this conclusion is based solely on interviews with hospital physicians and nurses. Tugase, ceremonial kava sticks, presented to vis itors by the high ranking matai of the host village. Photo ©2003 Diane Ragone Acknowledgments The authors thank Fuiono Mase' e Lifo Manuele, Lemau Seumanutafo, Tiuli Paulo, Tapusoa Utu, Nu' uleleinokise, Fa' ifili Malo, Tamara Rasmussen, M.D., Leutogi Te' o, Lupe Levi/a, and Lusila Tinei Tofo and the villagers of Falelaupo and Saipipi, Samoa for assistance. Gaugau Tavana is Director ofEducation at the National Tropical Botanical Garden (NTBG) in Hawaii and a Samoan chief Patricia Smiling taupou, daughter of a high-ranking matai, who mixes the kava, Stewart is a dermatologist in Santa Barbara, California; Sarah surrounded by marai of her village. Photo ©2003 Diane Ragone Snyder is a medical student at the University of Utah; Diane Ragone is Director of Horticulture & Conservation at the NTBG; Krisa Fredrickson is an anthropologist studying at the University of Canter Discussion bury, Kent; Paul Alan Cox is Director ofthe NTBG; and joan Borel In none of our interviews with traditional healers or with West is an anthropologist who works in Key West, Florida. ern-trained healthcare professionals was a linkage reported between kava drinking and liver dysfunction despite nearly univer References sal participation by adult males in kava ceremonies or informal I. Balick MJ, Cox PA. Plants, People, and Culture: An Introduction to the kava use. Many Samoans were familiar with the effects of excessive ScienceofEthnobotany. New York: W. H . Freeman; 1997. p. 160-4. kava use, especially sleepiness and dry skin, but reported that 2. Blumenthal M. Herb sales down in mainstream marker, up in natu excessive consumption was rare. No one reported major clinical ral food stores. HerbalGram 2002;55:60. signs of liver malfunction in association with kava drinking, such 3. Lebar V, Merlin M, Lindstrom L. Kava: The Pacific Drug. New Haven, Connecticut: Yale University Press; 1992. as yellowing of the eyes, brown urine, and changes in stool, even 4. Blumenthal M. Kava safety questioned due ro case reports of liver when asked specifically for signs of such symptoms. The native toxicity. HerbalGram 2002;55;26-32. healers we interviewed are able to recognize the symptoms of liver 5. U.S. Centers for Disease Control and Prevention. Hepatic toxicity injury, and their diagnoses have been confirmed in hospitals, yet possibly associated wirh kava-containing producrs-Unired Stares, they maintain that they have never seen liver damage as a result of Germany, and Switzerland, 1999-2002. JAMA 2003;289:36-7. 6. Cox PA, Banack SA, eds. Islands, Plants, and Polynesians. Porrland, kava drinking. Physicians and nurses working at the hospital agree. Orgeon: Dioscorides Press; 1991. Based on the uniformity of these reports and the complete lack of 7. Cox PA. Use of plants as fish poisons in Samoa. Economic Botany any diagnostic symptoms of liver damage reported among the 1980;33(4):397-9. Samoans who are heirs to thousands of years of knowledge and 8. Whisrler WA. Plants in Samoan Culture. Honolulu, Hawaii: Isla experience with kava, we believe that the assertion by the FDA and Borani ca; 2000. 9. Singh YN, Blumenthal M. Kava: An overview. HerbalGram other groups that moderate consumption of kava may result in 1997;39:33-56. liver dysfunction should be subjected to rigorous testing and veri 10. Ruze P. Kava-induced dermopathy: a niacin deficiency? The Lancet fication. Given their economic stake in kava production, Pacific 1990;335: 1442-5. nations would likely welcome research applications to study the effects of kava on liver enzymes and liver function among tradi tional kava consumers. -" 32 I HerbaiGram 59 2003 www.herbalgram.org Symposium 2003 American Herbalists Guild October 17-19, 2003 Preconference intensives will be held on October 16 La Posada de Albuquerque, New Mexico Keynote Speaker Tieraona LowDog, M.D. Over 40 workshops by leading herbalists. Teachers include: Mary Bove NEW!!! 2-DAY POST-CONFERENCE Francis Brinker Isla Burgess CLINICAL INTENSIVE. Bevin Clare OCTOBER 20 & 21. Mitch Coven Improve your clinical skills and gain valuable Steven Dentali hands-on experience. Special opportunity Robin Dipasquale for in-depth study with AHG teachers. Margi Flint Daniel Gagnon Continuing education Christopher Hobbs Phyllis Hogan credits for nurses, KP Khalsa pharmacists, Brigitte Mars acupuncturists, Michael Moore Aviva Romm and naturopathic Robert Rountree physicians. James Snow Kevin Spelman For information contact: Jill Stansbury AHG Shelley Torgove 1931 Gaddis Rd Jonathan Treasure Canton GA 30115 David Winston Donald Yance 770.751.6021 fax: 770.751 .7472 and many others. email : [email protected] www.americanherbalist.com by Laurie Erickson Left: During spring, the Cedarberg region Is transformed as Wild~ millions carpet the earth with brilliant color. Photos Q2003 Rooibos Ltd/SunnRooibos A Note on Tea Terminology contains nodules of nitroge n-fixing bacteria on irs roots; this In the strict sense, the word tea has been reserved for infu characteristic helps the plant survive in the poor Cedarberg sions made from leaves of the evergreen shrub Camellia soils and minimizes the need for fertilizing commercial crops 8 sinensis (L.) Kuntze, Theaceae, while infusions made from with nirrogen. The bacteria convert nitrogen dioxide to herbs such as rooibos have been called tisanes. Over time, biologically useful ammoni a in a process known as nitrogen however, the common use of the word tea has been extended fixation. The plant absorbs the nitrogen and benefits from ir to include herbal infusions, and this relaxed usage is in exchange for providing rhe bacteria with food sources followed here. Rooibos is ofi:en referred to as red tea because created from photosynthesis. it makes a vibrant red-colored tea, which can be confusing O ne srudy found genetic vari ations between four 1 because black tea and hibiscus herbal tea are also sometimes morphologically different populations of A. linearis. The ca ll ed red tea. authors suggest that the wi ld forms of A. linearis might be used to improve characteristics, such as yield and disease Botanical Description res istance, of the cultivated form. They also observe that Rooibos is a shrubby legume that is indigenous to the because the cultivated Rockl ands form is being grown mountains of South Africa's Western Cape. 1·3 T he genus outside of its original Pakhuis Pass location, this introduc Aspalathus includes more than 200 species native to South tion of the cultivated form into new areas could threa ten rhe Africa. 2· 5 A. linearis is a polymorphic species; various wild generi c integrity of the wild forms in these areas. 7 forms have been described, each with characteristic A later srudy showed genetic differences berween popula morphology and geographical distribution. J.3 Some fo rms tions of A. linearis that are sprouters (plants that ca n resprour from a deep rootstock to regenerate afi:er a fire) and popula- are prostrate and remain less than 30 em (1 foot) tall, while Above : Rooibos growing in other forms grow erect and may reach up to 2 m (about 6 the Cedarberg region of South Africa. Photos ©2003 feet) in heighr. 1·3·6 The types of wild rooibos that have been Rooibos Ltd/SunnRooibos used to make rea are sometimes referred to as the Red, Black, Left: Workers process tradi Grey, and Red-Brown types. l.2 tional rooibos on a tea court, The type of A. linearis that is cultivated commercially for where the leaves and stems tea is the Red type, also known as the Rocklands type; 1.6 ir is are spread to dry in the sun. native to the Pakhuis Pass area in rhe northern Cedarberg Photo courtesy ASNAPP. region.6 The Rocklands type grows erect, up to 1.5 m (about 5 feet) in height. It has a single basal stem that divides just above the ground surface into multiple thin branches that carry bright green, needl e-like leaves of about I 0-40 mm (0.4-1.6 inches) in length/ The plant produces small yell ow flowers in spring through early summer,6 and each flower rions that are seeders (plants that re ly on producing plentiful generates a one-seeded leguminous fruir. 4,5 seeds to reproduce). The authors suggest rh at reseeding is rhe Rooibos has adapted to coarse, nutrient-poor, acidic soil primitive character stare in A. linearis and resprouting is a and hot, dry summers.4·5·8 In addition to a nerwork of roots derived stare rhar evolved to help the plant survive in a just below the soil surface, the plant has a long tap root that region prone to wi ldfires. T he rooibos plant that is commer 7 reaches as deep as 2 m (about 6 feet) and helps the plant find cially grown for tea is rhe seeder type. moisture during summer droughr.5 As a legume, rooibos In addition to diffe rences in morphology and generics, www.herbalgram.org 2003 HerbaiGram 59 I 35 I ' I. . . . " . Roughly 70 percent of the bulk rooibos that is exported goes .r,<( ){)it)~ )S -rt~p through Clanwilliam-based Rooibos Ltd. 36 I HerbaiGram 59 2003 www.herbalgram.org ' . . I ' , tea is processed today in much the same way as the indigenous people processed it hundreds of years ago, including the sun I [~< )( )jt)<) S - 1 {~~1 ' I drying step, but the tools are more sophisticated now. The fermented type is called red tea because fermentation turns tion is the reason the tea changes color with fermentation.20 the leaves and the resulting tea a rich orange/red color; this distinc Phenolic Acids: In addition to flavonoid antioxidants, rooibos tive color led to the Afrikaans name rooibos, whi ch means "red also contains phenolic acids that have been shown to have antiox bush." The unfermented type, often called green rooibos, contains idant activi ty.I 4, 1B.2 1 Like flavonoids, phenolic acids are polyphenol higher levels of polyphenol antioxidants because fermented rooi substances that are found in fruits, vegetables, and whole grains. bos loses some antioxidants during the fermentation process. The The phenolic acids identified in rooibos tea, in decreasing order of unfermented type was developed to maximize antioxidant levels in antioxidant activity as measured in one study21 with the commonly response to recent interest in the health benefits associated with the antioxidants found in C. sinensis teas. Unfermented rooibos tea is a tan/yellow color rather than the rich reddish color of fermented rooibos. Both types of rooibos tea are available plain or flavored, loose or in tea bags, organic or conventionally grown. Rooibos is graded according to color, flavor, and cut length, with the highest grade labeled "supergrade." The tea has a smooth, non-bitter flavor that is pleasant hot or chilled. The unfermented variety has a very mild "green" taste reminiscent of green tea but without the astringency; the fermented type is quite different, with a stronger sweet and fruity taste. The mild flavor of rooibos has made it popular in multi-ingredient herbal tea blends. Antioxidants in Rooibos Free radicals (unstable molecules that have lost an electron) can Indian Ocean damage the DNA in cells, leading to cancer, and they can oxidize cholesterol, leading to clogged blood vessels, heart attack, and Rooibos grows in the Ceda rberg Mountain region of South Africa. stroke. Antioxidants can bind to free radicals before the free radi cals cause harm. Some antioxidants are called polyphenols because these substances contain a phenolic ring in their chemical struc used 1, 1-diphenyl-2-picrylhydrazyl (DPPH) radical scavenging ture. Polyphenols are common in plants; they act as pigments and assay, include caffeic acid, protocatechuic acid, syringic acid, sunscreens, as insect attractants and repellants, and as antimicro ferulic acid, vanillic acid, p-hydroxybenzoic acid, and p-coumaric bials and antioxidants.12·13 The polyphenol group is further divided acid.14, IB Using the DPPH assay, caffeic acid was just as active an into subgroups such as flavonoids and phenolic acids. Polyphenols antioxidant as the most potent flavonoids tested (quercetin, can also be class ified as monomeric (molecules containing a single isoquercitrin, and aspalathin).21 unit) or polymeric (larger molecules containing more than one Total Polyphenol Content: Despite some promotional claims, unit). As described in this section, laboratory studies have found a serving of rooibos tea has less total polyphenols than the sa me that rooibos tea contains polyphenol antioxidants, including size serving of green or black tea. Serving size varies, but for flavonoids and phenolic acids, that are potent free radical scav comparison purposes a 150 to 200 ml serving is often used (about engers. 3f4 of a standard baking measuring cup). Elizabeth Joubert, Ph.D., Flavonoids: The polyphenol antioxidants identified in rooibos tea include the monomeric flavonoids aspalathin, nothofagin, quercetin, rutin, isoquercitrin, orientin, isoorientin, luteolin, Table 1: Flavonoids in Aqueous Extract of Fermented vitexin, isovitexin, and chrysoeriol. 14·19 Currently, rooibos is the Rooibos (mg/g +/-SO) 1 only known natural source of aspalathin. 5 Nothofagin is similar in Flavanoid (mg/g +/-SO) structure to aspalathin and has only been identified in one other isoorientin 0.833 +/- 0.007 natural source besides rooibos: the heartwood of the red beech tree orientin 1.003 +/- 0.010 (Nothofagus fosca (Hook F.) Oerst, Nothofagaceae), which is native aspalathin 1.234 +/- 0.010 to New Zealand.2o vitexin 0.330 +1- 0.002 A recent analysis of fermented rooibos measured the levels of all rutin 1.269 +/- 0.006 19 the flavonoids listed above except nothofagin (see Table 1) . Of the isovitexin 0.265 +1- 0.002 10 flavonoids measured, the three that occurred in largest amounts isoquercitrin and hyperoside 0.429 +/- 0.002 were aspalathin, rutin, and orientin, followed by isoorientin and luteolin 0.029 +1- 0.001 isoquercitrin. Nothofagin was identified by mass spectrometry but quercetin 0.107 +I- 0.002 was not quantified because a standard was not available. The chrysoeriol 0.022 +I- 0.001 amount of nothofagin in fermented and unfermented rooibos was total 5.521 +/- 0.003 estimated to be about three times less than aspalathin in one Note: The extracts were prepared using 1 g of rooibos in 60 ml of hot distilled water, steeped study. 20 Aspalathin and nothofagin are present in relatively large for 10 minutes. After removal ofthe tea leaves, the solution was cooled and filtered. The table amounts in unfermented rooibos tea, 19·20 but some of the aspalathin gives the amounts of flavonoids in mg per g of extract. and nothofagin oxidizes to other substances during fermentation; Source: Bramati l., Minoggio M, Gardana C, Simonetti P. Mauri P, Pietta P. Quantitative charac terization offlavanoid compounds in Rooibos tea (Aspalathus linearis) by lC-UV/DAD.JAgric thus, fermented rooibos contains less aspalathin and nothofagin Food Chern 2002 Sep 25;50(20):5513-9. than unfermented rooibos.20 The change in polyphenol composi- www.herbalgram.org 2003 HerbaiGram 59 I 37 ' I I ' growth and prevented metastasis in a model of pancreatic cancer.25 I f~< )( )j t)< )S -r(~n Luteolin and quercetin inhibited proliferation of thyroid28 and ' ' colon29 cancer cells, respectively, in vitro. Quercetin inhibited speciali st researcher at South Africa's ARC Infruitec-Niervoorbij cyclooxygenase-2 (COX-2) ex pression in colon cancer cell s, whi ch and a rooibos expert, says that the total polyphenol content of an may help prevent colon cancer. 30,3l Both luteolin and quercetin can average 150 to 200 ml serving of rooibos tea ca n be as much as 60 block the formation of lipid peroxides.J2-34 to 80 mg, depending on factors such as the brewing time and Although studies like these show quercetin and luteolin are amount of leaves used. 22 For compariso n, one study found that strong antioxidants, researchers have n't yet determined whether brewing black tea leaves for I to 3 minutes at a concentration of 1 enough of either of these two fl avo noids are present in rooibos tea g leaves per 100 ml water res ulted in black tea that contains 128 to and absorbed by the body to have benefi cial effects. As shown in 199 mg of polyphenols per 200 ml se rving of tea.23 The types of Table I , recent analys is of ferm ented rooibos found considerabl y polyphenols in rooibos tea are different than those in green and more quercetin than luteolin, l9 but even quercetin was present in black teas, so the potential health benefits of the teas cannot be much lower amounts than aspalathin, orientin, and rutin. compared solely on their total polyphenol content. Rooibos tea Based on the data in Table I, a 150 ml serving of fermented does not contain epiga ll ocatechin gallate (EGCG), which is a rooibos tea made with 2.5 g of tea leaves has about 0.27 mg of quercetin; for comparison, one study found that C. sinensis Rooibos growing in the Cedarberg reg ion of South Afr ica. Photo ©2003 Rooibos Ltd/SunnRooibos polyphenol in green tea that has shown anticarcinogenic and contains 1.5 to 3.75 mg of quercetin per 150 ml serving of tea. 35 antioxidant capabilities, but many of the polyphenols in rooibos A previous study36 found 1.5 mg of quercetin per 150 ml serving tea are also strong antioxidants. of fermented rooibos, but that may be an upper limit. Joubert says Quercetin and Luteolin: Two of the fl avonoids in rooibos tea, that the 1.5 mg estimate is probably high,22 but emphas izes that quercetin and luteolin, are potent antioxidants found in many these estimates will vary with parameters such as the brewing time fruits and vegetables. Studies in vitro (in the test tube) have shown and the amount of water and tea leaves used. At any rate, the that these antioxidants can cause cancer cells to "commit sui cide, " amount of quercetin per se rving of rooibos is a small percentage of referred to as apoptosis. 24·27 Quercetin decreased primary tumor the total polyphenol content per se rving of rooibos. 38 I HerbaiGram 59 2003 www.herbalgram.org I . . ' Aspalathin and Nothofagin: A unique polyphenol that is one 1 )(.)it)< of the most abundant monomeri c Aavonoids in rooibos tea, 19·20 r<( )S -r< ~ ~ ~· 1 ' I aspalathin seems to contribute to the antioxidant capabilities of rooibos,21 but aspalathin is not as well studied as quercetin and the I 0 fl avonoids in the table. Many other polyphenols are pres luteolin. Nothofagin is similar in structure to as palathin and may ent, but they have not all bee n identified or quantified. have similar antiox idant capabilities. To assess the antioxidant capability of rooibos tea as a whole, Joubert says that chief research technologist Perra Snijman of the researchers compared the antioxidant ac tivity of ro oibos rea Program on Mycoroxins and Experimental Carcinogenes is ex tracts to that of gree n and black tea ex tracts with the D PPH (PROMEC) at the Medical Research Council of South Africa radical scavenging assay as we ll as the beta-carotene bleaching recently developed a way to isolate pure as palathin and nothofagin method Y All the teas showed strong antioxidant activity with both from rooibos. Joubert says, "According to unpublished in vitro methods. Using the DPPH method, rhe ranking from hi ghest to studies done at ARC Infruitec-Niervoorbij, aspalathin compared lowest antiox idant activity was gree n tea (90.8 percent inhibi tion) , well with quercetin in terms of antioxidant activity, except in a far unfermented rooibos (86.6 percent), fe rmented rooibos (83.4 medium where quercetin demonstrated much higher potency than perce nt), and blac k tea (8 1. 7 percent). G ree n tea was signi fica ntly aspalarhin. What is important in these comparative studies is the hi gher than the others (P < 0.05), bur the other three teas did not rest environment. Relative efficacy will depend on the test sys tem diffe r from each other signi fica ntly with respect to DPPH inhibi used (the polari ty of the medium, the type of free radical that ti on. Us ing the beta-carotene bleaching method, the ranking was needs to be scavenged, etc.)."zz green tea, black tea, fermented rooibos, and unfe rmented rooibos. Joubert co-authored a study21 that found aspalathin compared The rel ati ve ranking va ri es with the type of test because the well to other antioxidants with the DPPH radical scavenging assay. substance to be tes ted will have di ffe rent reactivity to the different The study measured the antioxidant capability of many of the ox idizing agents used. These rests only measure the antiox idant flavonoids and phenolic acids found in rooibos tea and compared capability of substances outside of the body and don't provide data them to several reference standards such as alpha- tocopherol (vita on whether the antioxidants are absorbed by the body and effective min E). T he percent inhibition of the DPPH radical by quercetin, after the food is consumed. isoquercitrin, as palathin, rutin, luteolin , and alpha-tocopherol was In this study, all the tea ex tracts were diluted to the same amount 98 .27, 9 1. 99, 9 1. 74, 91.18, 90. 85, and 75.10, respectively (using of solu ble solids rather than to the amounts of solids found in the a 0.25 mole ratio of antioxidant to DPPH). All of the fl avonoids teas Y T his method all ows a co mpa ri son of antiox idant capability tested showed potent hydrogen donating abilities with DPPH on a mass equival ent bas is, bur does not refl ect a compariso n of the except for vitexin, which only had a 7.26 percent inhibition even antioxidant strength of equal vo lume se rvings of the teas. Although at a 0.5 mole ratio to DPPH. the soluble solid content va ri es with the method of tea preparati on, According to the data in Table I, a 150 ml se rving of fermented it usually decreases in the ord er green tea, black tea, unfermented rooibos made with 2.5 g of tea leaves has about 3 mg of aspalarhin; rooibos, fermented rooibos .47 T he percent of soluble solids repre since the amount of norhofagin was measured to be three times less sented by polyphenols is similar fo r the four teas and the DPPH than as palathin in one study,20 a 150 ml serving of fermented roo i antioxidant activity is similar on a mass equiva lent bas is, so the bos has on the order of I mg of norh ofagin . A se rving of unfe r D PPH antioxidant capabili ty of equal-sized servings will decrease mented rooibos has considerably more as palathin and nothofagin in the ord er of the soluble solid content.4- Black and gree n teas than an equal se rving of fermented rooibos because a portion of have over twice as much soluble solids as ro oibos tea when these flavo noids oxidizes to other substances during fermenta prepared conve ntionally, so over two 200 ml servings of rooibos tea tion.20 would need to be consumed to receive the same antiox idant bene Orientin and Rutin: Orientin and rutin are two of the other fit (as measured by DPPH) as one 200 ml serving of black or gree n most abundant monomeric flavonoids in rooibos, 19 and both have tea (or the rooibos would need to be brewed to twice the standard been associated with health benefits. Orientin is a potent free radi concentration).4- This res ult agrees with the data give n previously cal scavenger. It reduced by half the number of cancer-associated for 60 to 80 mg polyphenols fo r a 150 to 200 ml se rving of rooi changes in ce lls of human blood ex posed to radiation.38 When bos tea 22 as compared to 128 to 199 mg polyphenols for a 200 ml mice were exposed to radiation, ori entin protected against lipid se rving of blac k rea. 23 peroxidati on in the live r and also reduced damage to the bone T he studies referenced above show that rooibos tea co ntains marrow and gas trointestinal rracr. 39.40 Rutin, a fl avo noid fo und in antiox idants that have positive effec ts when res ted as isolated buckwheat (Fagopyrum esculentum Moench, Polygo naceae) and substances and that the tea as a whole has good antioxidant activ some fruits and vegetables, seems to help maintain the strength of ity in vitro. So, do all these antioxidants in rooibos tea lead to capillary walls; oral rutin as well as oral and topical o-(beta health benefits for tea drinkers? Hydroxylethyl)-rutoside (HR) have been used to treat hemor rhoids, vari cose ve ins, and the lower leg edema associated with Rooibos Research in Live Animals and Animal Cells ve nous insufficiency and venous hypertension.41·46 According to Laboratory studies have demonstrated potential health benefits the data in Table 1, a 150 ml se rving of fermented rooibos tea of rooibos in vitro (in tes t tubes) and in vivo (in live animals), but made with 2.5 g of tea leaves has about 2.5 mg of orientin and 3.2 human studies have not been conducted . Much more research is mg of rutin. needed, but the studies so fa r look intriguing. Total Antioxidant Capability: Although the I 0 flavonoids in Fermented Rooibos against Mutagens: Researchers found that Table I are important because they are known to have antioxidant fermented rooibos tea reduced cancer-associated changes in ani mal properties, they only represe nt a small perce ntage of the total cell s induced by the mutagens benzo[a] pyrene (B(a) P) and mito polyphenol content of a serving of fermented rooibos tea. A 150 to myc in C (MMC) both in vitro and in vivo. 48 T he in vitro part of 200 ml se rving of rooibos can have up to 60 to 80 mg of total the study meas ured chromosomal aberrations in animal cell s polyphenols,2 2 and Table I shows that a 150 ml serving of caused by exposure to the mutagens. T he ce lls were treated with tea fermented rooibos made with 2.5 g of leaves has about 14 mg of ex tract either at the sa me time as the mutagen or after the muta- www.h erbalgram.org 2003 HerbaiGram 59 I 39 I , ; ' I' 1 bos rea reduced the level of MNRETs by about 34 percent, and f.<()() it)( )S -l(~n , I green tea reduced the level by about 38 percent. When the mice received the single dose of tea either after the mutagen or 24 hours gen. Some of the tests used rat liver microsomal enzyme, called 59, prior to the mutagen, neither green rea nor rooibos rea reduced the to provide metabolic activation of the mutagen; B(a)P requires frequency of MNRETs. metabolic activation, bur MMC can act with or without it. Both green rea and rooibos rea suppressed aberrant cells caused by B(a)P and MMC in the presence of 59, but rooibos showed a greater suppression of aberrant cells than did green tea (see Table 2). In fact, when the cells were exposed to B(a) P and 59 simulta neously with rooibos rea, the highest concentration of rooibos rea (1000 microgram/ml) completely inhibited the aberrant cells, bringing their percentage down to the level of the controls that were not exposed to any mutagen. Also, rooibos tea suppressed aberrant cells caused by MMC both with and without the presence of 59, bur green rea showed no suppression without 59. Treating the cells simultaneously with the mutagen and tea extract caused a greater protective effect than treating the cells with tea extract following exposure to the mutagen (compare Tables 2 and 3). In the in vivo part of this study, mice were given oral doses of rea and an injection of B(a)P or MMC.48 The researchers measured the frequency of micronucleated rericulocyres (MNRETs), which Aspalanthus linearis seedl ings with tap roots. The long tap roots evolved to reach are cells with damaged DNA that may lead to cancer. In one exper deep into the ground for moisture in drought-prone South Africa. iment, a single oral dose of rea (1 ml of 0.2 percent green rea or 0.1 Photo courtesy ASNAPP. percent rooibos tea) was given 6 hours prior to an injection of MMC and the number of MNRETs was counted at 24, 48, and 72 hours after the MMC. Rooibos rea and green rea provided simi When the teas were given as one oral dose daily for 28 days and lar inhibition of the frequency of MNRETs. After 48 hours, rooi- then the mutagen was injected on day 29, both rooibos tea and green rea reduced the frequency of MNRETs caused by B(a)P. Daily doses of 0.2 percent green rea reduced MNRETs by about Table 2: Percent Aberrations in Cells Treated Simultane- 62 percent 48 hours after B(a)P exposure, and daily doses of 0.1 ously with Tea Extract and the Mutagen B(a)P or MMC percent rooibos tea reduced MNRETs by about 49 percent. Daily (+/- 59) doses of 0.1 percent rooibos rea reduced MNRETs by about 34 percent 48 hours after MMC exposure, but daily doses of green tea Mutagen Tea Extract without S9 (%) with S9(%) did not provide a significant reduction with MMC. (microgram/mil Fermented Rooibos against Irradiation: Another research None None 3 4 group found that extract of fermented rooibos tea reduced cancer ous transformation of mouse cells exposed to x-rays in vitro. 49 The B(a)P None NA 35 amount of protection correlated with the dose of rooibos, and an Green tea 125 NA 25 extract concentration of 10 percent reduced the cell transforma 250 NA 20 * tions to a level similar to the spontaneous level of the controls. 500 NA 19* Interestingly, green tea in equivalent concentrations did not show 1000 NA 8 *** any detectable protective effect. In another study, fermented rooi Rooibos 125 NA 9 *** bos tea reduced cell damage in live mice that were exposed to irra NA 7*** 250 diation two hours following a single dose of rooibos administered 500 NA 6 *** by gastric intubation.34 1000 NA 3 *** Fermented Rooibos against Brain Lipid Peroxidation: Rats given fermented rooibos tea daily ad libitum (free access) from the MMC None 40 43 to Green tea 125 42 38 age of 3 months 24 months had grearly reduced age-related lipid 250 41 35 peroxide accumulation in four areas of their brains compared to 500 38 23 ** rats that drank plain water.5° Increases in lipid peroxides in the 1000 44 18 *** brain may damage neuronal cells and contribute to age-related Rooibos 125 25 * 15 *** diseases.50 The lipid peroxide levels were evaluated by measuring 250 15 *** 10 *** the amounts of thiobarbituric acid reactive substances (TEARS) in 500 9 *** 8 *** eight regions of the brain. The 24-month-old rats that had been 1000 8 *** 9 *** drinking plain water had significanrly higherTBARS in the frontal cortex, occipital cortex, hippocampus, and cerebellum compared Note: Tea extracts were prepared with SO g of tea leaves and 1.5 I of boiling water. Cells to 5-week-old rats, but the 24-month-old rats that had been drink were treated with 100 microM B(a) P and 59 for 3 hours or 1 microM MMC (+/ -59) for 1 hour. ing rooibos tea had no increase in TEARS in those four areas of the Significant difference:*0.01 < P < 0.05, ** 0.001 < P < O.Dl, *** P < 0.001. brain. The TEARS of the 24-month-old rooibos group were simi Key: 59= rat liver enzyme; B(a) P = benzo[a]pyrene; MMC = mytomycin C Source: Sasaki YF, Yamada H, Shimoi K. Kator K. Kinae N. The clastogen-suppressing effects of lar to the TBARS of the young 5-week-old group (see Table 4). green tea, Pcrlei tea and Rooibos tea in CHO cells and mice.Mutat Res 1993;286(2):221-32. The authors give a bar chart that summarizes the TBARS data for each area of the brain. 5° The TEARS values in nmol/g for 24- 40 I HerbaiGram 59 2003 www.herbalgram .org I I ; ' \ ! I month-old rats without rooibos tea, 24-month-old rats give n rooi bos tea, and 5-week-old rats, respectively, were approximately 120, , .r~ () ( ) i l) ( )s -1< ~ f1 80, 80 in the frontal cortex; 11 5, 70, 80 in the occipital cortex; 80, 40, 50 in the hippocampus; and 115 , 80, 85 in the cerebellum. effects against DNA damage when tes ted in an in vitro assay as well T he authors say these res ults suggest that the administrati on of as in an in vivo animal system." 53 The in vitro studies fo und rooibos tea protected several regions of the rat brai n against li pid unfermented rooibos was generall y more protective aga inst D A peroxidati on accompanying aging. Magneti c reso nance images damage than fermented rooibos. But Marn ewick says her group's taken of the brain were consistent with the TSARS data. research shows that fe rmented rooibos has a stronge r effect against Fermented vs. Unfermented Rooibos: Another study fo und that both fe rmented and unfe rmented rooibos tea exhibits antimu tagenic properties in vitro as measured by the Salmonella typhimurium mutagenicity assay with several different mutagens; the antimutagenic activity was stro nger against the metaboli cally activated mutagens 2-acetylaminoAuorene (2-AAF) and aflatoxin 51 8 1 (AFB 1) than it was against three di rect-acti ng mutagens. Further research showed that the fe rmentati on process causes a decrease in the antimutagenic and antioxidant activity of rooibos tea as meas ured by the Salmonella typhimurium mutagenicity assay (with 2-AAF), the hydrogen donating ability (assessed with DPPH), and the superoxide anion radical scavenging assayY T he researchers suggest that fermented rooibos may show less antioxi dant and antimutage nic activity because it has less polyphenols than unfe rmented rooibos. O ne analysis showed that polyphenols represent about 4 1 percent of the total so li d matter in unfermented rooibos tea extract, but only about 30 percent of the total solid matter in fermented rooibos tea extract.51 Aspalanchus linearis. Photo courtesy ASNAPP O ne of the authors of both these studies is senior research scien tist Jeanine Marnewick of the Program on Mycotoxins and Exper some mutagens. She says, "Both the fermented and unfermented imental Carcinogenesis (PROMEC) at the Medical Research roo ibos showed a significant protection, and we're busy el ucidating Council of South Africa. She says, "Rooibos showed pro tective the mechanisms." 53 She is currently evaluating the protective effect of rooibos on liver, esophageal, colon, and ski n cancer induced in li ve animal models. T he studies are in the ea rly phases and she Table 3: Percent Aberrations in Cells Treated With B(a)P cautions, "Very li ttle is known about the effect of roo ibos on or MMC and Post-Treated With Tea Extract +/- S9 cancer development." 53 Joubert also adds a cautionary note, sayi ng that many questions Mutagen Tea Extract without with about rooibos still need to be answered. 22 She says that researchers (microgram/ mil 59 (%) 59 (%) need to determine which of the antioxidant substances in rooibos B(a)P None 44 35 tea are absorbed by the body and how much tea is needed ro Green tea 25 or 125 40 28 produce a measurable benefit. She also emphasizes that no human 50 or 250 45 19 * studies have been conducted yet. 100 or 500 48 19 * Whole Foods vs. Isolated Antioxidants: T he full benefits of 200 or 1000 42 20 * teas are li kely to come from a combination of all the antioxidants Rooibos 25 or 125 35 23 in them rather than from just one substance. Q uite a few studies 50 or 250 34 19 * have found that isolated antioxidants don't have as positive an anti 100 or 500 27 * 17 ** cancer effect as the mixture of antioxidants found in natural food 200 or 1000 22 *** 11 *** sources; whole apple extracts were better than pure quercetin at MMC None 42 44 4 Green tea 25 or 125 49 48 inhibiting the growth of cancer ce lls in vitro, l3.5 rom a to powder 50 or 250 48 43 100 or 500 40 33 200 or 1000 43 27 * Table 4: Thiobarbituric Reactive Substances (TBARS) Rooibos 25 or 125 45 48 (nmol/g) 50 or 250 36 38 Area of Brain 24-month old 24-month old 5-week old 100 or 500 22 ** 29 * no rooibos w ith rooibos no rooibos 200 or 1000 22 ** 23 ** frontal cortex 120 80 80 Note: Tea extracts were prepared with 50 g of tea leaves and 1.5 I of boiling water. Cells occipital cortex 11 5 70 80 were treated with 100 microM B(a)P and 59 for 3 hours or 1 microM MMC (no 59) for 1 hour, hippocampus 80 40 50 and then cells were post-treated with tea extracts for 3 hours with 59 or for 20 hours with cerebellum 11 5 80 85 out 59. The larger concentrat ions of tea extracts were used with 59. Significant difference: *0.01 42 I HerbaiGram 59 2003 www.herbalgram.org tea, 73 percent for hot cocoa, and 47 perce nt for tea of chamomile (Matricaria recutita L., Asteraceae). 62 The teas still inhibited iron absorption to the same degree eve n if milk was added to them. Some of these beverages contain only low levels of tannins, but The Bottom Line other polyphenols in foods and beverages can also reduce iron Rooibos tea has become popular because of irs fruity, sweet tas te absorption.62.G4 The ability of polyphenols to chelate prooxidant and its caffeine-free, low tannin, antioxidant-rich status. Although metal ions might provide some antioxidant protection, but it can more research is needed, rooibos appears to be safe and free of side also be a disadvantage by decreasi ng absorption of necessary effects. The antioxidants present in rooibos may help protect dietary minerals such as iron.64 agai nst free radical damage that can lead to cancer, heart attack, T he low tannin content of rooibos is sometimes used to infer and stroke. Unfermented (green) rooibos has a higher amount of that rooibos tea won't inhibit iron absorption, but that conclusio n polyphenols than traditional fermented rooibos and generally is not automatic since rooibos is rich in other polyphenols that demonstrates higher antioxi dant and antimutagenic capabilities in might decrease iron absorption. In one small study, three groups of vitro. Future research should reveal whether the antioxidant bene young healthy men were given an oral dose of iron, followed by 10 firs of rooibos observed in vitro and in animals translates into rooibos tea, C. sinensis tea, or plain water.7 1 Iron absorption was health benefits for humans. -"' measured to be 7.25 percent for rooibos tea, 1.70 percent for C. sinensis tea, and 9.34 percent for plain water. The result for C. Acknowledgments sinensis was significant (P < .0001), but the data for rooibos did not The author thanks Elizabeth Joubert, Ph.D., specialist researcher at reach statistical significance (that is, the data for rooibos were not South Africa's ARC !nfruitec-Nietvoorbij, and j eanine L. Marnewick, good enough to determine whether this result can be generalized senior research scientist at the Program on Mycotoxins and Experi to the whole population or whether the result was just chance). mental Carcinogenesis (PROMEC) at the Medical Research Council More studies are needed to better document the effect of rooibos of South Africa, for their quotes and technical input, as well as for on iron absorption, but this study implies that rooibos might not providing copies of several research papers. Their expertise on rooibos inhibit iron absorption nearly as much as C. sinensis tea. has contributed much valuable information to this article. Lorenzo Rooibos growing in the Cedarberg region of South Afri ca. Photo ©2003 Rooibos Ltd/SunnRooibos www.herbalgram.org 2003 HerbaiGram 59 I 43 I I '. 15. Koeppen BH, Roux DG. C-glycosylflavonoids. The chemistry of I (~< )( )j t)<)S - 1 (~~1 aspalarhin. Biochem j 1966;99:604-9. • I 16. Koeppen BH, Roux DG. C-glycosylflavonoids. The chemistry of orienrin and iso-orientin. Biochem J 1965;97:444-8. Bramati, Ph.D., research scientist at the Instituto Tecnologie 17. Koeppen BH, Smit CJB, Roux DG. The flavone C-glycosides and Biomediche CNR in Italy, provided helpfol input and copies ofseveral the flavonol 0-glycosides of Aspalathus acuminatus (Rooibos tea). research papers. Erica Renaud, a member of the quality control Biochem j 1962;83:507 -11. program for ASNAPP (Agribusiness in Sustainable Natural African 18. Ferreira D, Marais C, Steenkamp JA, Joubert E. Rooibos tea as a Plant Products) at the Center for New Use Agriculture and Natural likely health food supplement. In Proceeding ofRe cent Development of Plant Products at Rutgers University provided valuable input and Technologies on Fundamental Foods for Health; Korean Society of photos. Marc S. Micozzi, M.D., Ph.D., director ofthe Policy Institute Food, Science and Technology: Seoul, Korea 1995:73-88. 19. Bramati L, Minoggio M, Gardana C, Simonetti P, Mauri P, Pi etta P. for Integrative Medicine, offered helpfol review and comments. Quantitative characterization of flavanoid compounds in Rooibos Rooibus Ltd./SunnRooibos also provided valuable insight and photos. rea (Aspalathus linearis) by LC-UV/DAD. J Agric Food Chern 2002;50(20):5513-9. Laurie Erickson, a freelance writer in Mountain View, California, 20. Joubert E. HPLC quantification of the dihydrochalcones, aspalathin is interested in the medicinal and horticultural aspects of herbs. She and norhofagin in rooibos rea (Aspalathus linearis) as affected by began investigating rooibos out ofpersonal curiosity and has no finan processing. Food Chern 1996;55(4):403- 11. cial connections with the rooibos industry. Her educational back 21. Von Gadow A, Joubert E, Hansmann CF. Comparison of antioxi ground includes a B.S. in Environmental Earth Science and an M.S. dant activity of aspalarhin with that of other plant phenols of rooi bos tea (Aspalathus linearis), alpha-tocopherol, BHT and BHA. j in Geomechanics from Stanford University. She has also written the Agric Food Chern 1997;45:632-38. medical website 44 I HerbaiGram 59 2003 www.herbalgram.org es trogen-related endometrial ca rcinogenesis model and on an in vitro model in human colo rectal cells. Mutat Res 2001 ;480-48 1 :201 -7. 30. Mutoh M , Takahashi M , Fukuda K, Matsushima- Hibiya Y, Mutoh H , Sugimura T, Wakabayas hi K. Suppression of cyclooxyge nase-2 effects of Rooibos tea, Aspalathus linearis, on X-ray- induced promoter-dependent transcriptional activity in colon cancer cells by C3H IOT I/2 cell transformation. Cancer Lett 1994;77(1):33-8. chemopreve ntive agents with a resorcin-type structure. Carcmogene 50. Inanami 0, Asanuma T, lnukai N, Jin T, Shimokawa S, Kasai N, sis 2000;2 1(5):959-63. Nakano M, Sato F, Kuwabara M. T he suppress ion of age-related 3 1. Mutoh M, Takahas hi M, Fukuda K, Komatsu H , Enya T, accumulati on of lipid perox ides in rat brain by administration of Matsushima-Hibiya Y, Mutoh H , Sugimura T, Wakabayashi K. rooibos tea (Aspalathus linearis). Neurosci Lett 1995;196(1-2):85-8. Supression by flavo noids of cyclooxyge nase-2 promoter-dependent 51. Marnewick JL, Gelderb lom WC, Joubert E. An investigation on the transcriptional activity in colon cancer cells: structure-activity rela- antimutagenic properties of South African herbal teas. Mutat Res tionship. ]pn J Cancer Res 2000;91 (7):686-9 1. . . . 2000;471(1- 2): ! 57 -66. 32. Rifi ci VA, Schneider SH, Khachadurian AK. Lipoprotein oxidati on 52. Standley L, W interton P, Marnewick J L, Gelderblom WC, Jo ubert medi ated by j774 murine macrophages is inhibited by individual red E, Britz TJ. Infl uence of processing stages on antimutagenic and wine polyphenols but not by ethanol. J Nutr 2002; 132(9):2532-7. antiox idant potentials of rooibos tea. j Agric Food Chern 200 I; 33. Hirano R, Sasamoto W, Matsumoto A, !takura H , Igaras hi 0 , 49(1):11 4-7. Kondo K. Antioxidant ability of various fl avo noids against DPPH 53. Marnewick JL. Perso nal co mmunica tion. Aug 2002. radicals and LDL oxidati on. J Nutr Sci Vitaminol (To kyo) 54. Eberhardt MV, Lee CY, Liu RH . Anti oxidant activity of fresh apples. 2001 ;47(5):357 -62. Nature 2000;405(6789):903-4. 34. Shimoi K, Mas uda S, Shen B, Furugo ri M, Kinae N. Radioprotec 55. H adley CW, Miller EC, Schwanz SJ, Clinton SK. Tomatoes, tive effects of antioxidative plant fl avonoids in mice. M utat Res lycopene, and pros tate ca ncer: progress and promise. Exp Bioi Med 1996;350(1) : 153-61. 2002;227( I 0):869-80. 35. Hertog M G, Hollman PC, Van De Putte B. Content of potentiall y 56. Stoner, JD, Kresty LA, Carl ton PS , Siglin JC, Morse MA. lsothio anticarcinoge ni c fl avonoids in tea infusions, wine and frun JUi ces.] cyanates and freeze-dried strawberries as inhibitors of esophageal Agric Food Chern 1993;41:1242-6. . . . cance r. Toxicol Sci 1999;52(2 Suppl):95- l 00. 36. Snyckers FO, Salemi G. Studies of South Afncan MediCinal pl ants . 57. Santana-Rios G, O rner GA, Amantana A, Provost C. Wu SY, Dash Part I. Quercetin as the major in vitro active co mponent of ro01 bos wood RH . Potent antimutage nic activity of white tea in comparison tea. ]SA Chern lnst 1974;27:5-7. with green tea in the Salmonella assay. Mutat Res 200 I ;495(1-2):61- 37. Hillis WE, Inoue T. T he polyphenols of Nothofogus species- II. The 74. hea rtwood of N othofogus fusca. Phytochem 1967;6:59-67. 58. Micozzi, MS. Perso nal co mmunication via email. June 2003. 38. Vrinda B, Uma Devi P. Radiation protection of human lymphocyte 59. Morton JF. Rooibos tea, Aspalathus linearis, a caffeineless, low-tannin chromosomes in vitro by ori entin and vicenin. Mutat Res beverage. Econ Bot 1983;37(2): 164-73. . 2001 ;498( 1-2):39-46. 60. Kunishiro K, Tai A, Yamamoto I. Effects of ro01bos tea extract on 39. Uma Devi P, Ganasoundari A, Rao BS, Srinivasan KK. In vivo radi o antigen-s pecific antibody production and cytokine generation in protecti on by ocimum fl avonoids: survival of mice. Radiat Res vitro and in vivo. Biosci Biotechnol Biochem 2001 ;65( 10):2 137-45. 1999; 15 1(I ):74-8. 6 1. Nakano M, Itoh Y, Mizuno T, Nakashima H . Polysaccharide from 40. Uma Devi P, Ganasoundari A, Vrinda B, Srinivasan KK, Unnikrish Aspalathus linearis with strong anti-HIV activity. Biosci Biotechnol nan MK. Radiation protection by ocimum fl avonoids orientin and Biochem 1997 ;6 1(2) :267-71. vice nin: mechanisms of acti on. Radiat Res 2000; 154(4):455-60. 62. Hurre ll RF, Reddy M, Cook ]D. Inhibition of non-haem iron 4 1. Cesarone MR, Belcaro G , lncandela L, Geroul akos G , Griffin M, abso rption in man by polyp henolic-containing beverages. Br J Nutr Len nox A, DeSa nctis MT, Acerbi G. Fl ight microangiopathy in 1999;81 (4):289-95. medium-to-l ong distance fli ghts: prevention of edema and microcir 63. Disler PB, Lynch SR, Torrance JD, Sayers MH, Bothwell TH, Charl culati on al terations with HR (Paroven, Ve noruton; 0-(beta-hydrox ton RW. T he mechanism of the inhibition of iron abso rption by tea. yethyl)-rutosides): a prospective, ra ndomized, contro lled trial. ] S Afr j Med Sci 1975;40(4): I 09- 16. Cardiovasc Pharmacal Ther 2002; 7 Suppl I :S 17-20. 64. Sam man S, Sandstrom B, To ft MB, Bukhave K, Jensen M, So rensen 42. MacLennan WJ , Wilson J, Rattenhuber V, Dikland WJ , Vanderdon SS, H ansen M. Green tea or rosemary extract added to foods reduces ckt, Moriau M. H ydroxyethylrutosides in elderly patients with nonheme- iron absorption. Am j Clin Nutr 2001;73(3):607- 12. . chronic venous insuffi ciency: its effi cacy and tolerability. Gerontology 65 . H al lberg L, Rossander L. Effect of diffe rent drinks on the absorpti on 1994;40(1 ):45-52. of non-heme iro n from compos ite meals. H um Nutr Appl Nutr 43. Gouny AM, Horovi tz D, Gouny P, Sauvage E, N ussaume 0 . Effec 1982;36(2): 11 6-23. tive ness and safety of hydroxyethyl-rutosides in the local treatment of 66. Zijp IM, Korver 0, Tijburg LB. Effect of tea and other dietary symptoms of venous insuffi ciency durin g air travel. j Mal Vase factors on iron abso rption. Crit Rev Food Set Nutr 2000;40(5):371- 1999;24(3):2 14-20. 98. 44. Titapant V, lndrasukhsri B, Lekprase rt V, Boonnuch W. Trihydrox 67. C hung KT, Wong TY, Wei C I, Huang VW, Lin Y. Tannins and yethylrutos ides in the treatment of hemorrhoids of pregnancy: a human health: a review. Crit Rev Food Sci Nutr 1998;38(6):421-64. double-blind placebo-co ntrolled tri al. j Med Assoc That 68. Bravo L. Polyphenols: chemi stry, dietary so urces, metabolism , and 200 I ;84( I 0): 1395-400. nutritional signifi cance. Nutr Rev 1998;56(11):317 -33. 45. Nocker W, Diebschlag W, Lehmacher W. A 3-month, randomized 69. Butler LG. Anrinutritional effects of condensed and hydrolyzabl e double-blind dose-response study with 0-(beta- hydroxyethyl)-ruto tannins. Basic Life Sci 1992;59:698-8. side oral solutions. Vasa 1989; 18(3):235-8. 70. Zeyuan D, Bingying T, Xiaolin L, Juinming H , Yifeng C. Effect of 46. Cataldo A, Gasbarro V, Viaggi R, Soverini R, Gres ta E, Masco li F. green tea and black tea on the metabolisms of mineral elements In Effectiveness of the combination of alpha tocopherol, rutin, melilo old rats. Bioi Trace Elem Res 1998;65(1):75-86. tus, and cenrella asiatica in the treatment of pati ents with chro ni c 7 1. Hessel in g PB , Klapper JF, va n Heerden PD. The effect of rooibos tea ve nous insuffic iency. Minerva Cardioangio/200 I ;49(2): 159-63. on iron absorption. S Afr Med j 1979;55(16):63 1-2. 47. Von Gadow A, Joubert E, H ansmann CF. Compariso n of the antiox idant activity of rooibos tea (Aspalathus linearis) with green, oolong and black tea. Food Chern 1997;60(1):73-7. 48. Sasaki YF, Yamada H , Shimoi K, Kator K, Kinae N. T he clastogen suppress ing effects of green tea, Po-lei tea and Rooibos tea in CH O cells and mice. M utat Res 1993;286(2):221-32. 49. Komatsu K, Kator K, Mitsuda Y, Mine M, Okumura Y. Inhibitory www.herbalgram.org 2003 HerbalGram 59 I 45 Objections to "The Patterson Bundle" would first like to thank the American Botanical Council for irs support and co mmitment to outstanding educational programs I regarding herbal medicine, and for its attempts to promote and preserve a better understanding of indigenous cultures. I have numerous concerns, though, regarding the article entitled "The Patterso n Bundle," from Herba/Gram 55. Though I cannot express the views of tribal people who lived in the area of the Bundle's origin, I can Guest Commentary share my own 17 yea rs of by Cindy Bloom ex peri ence in working with repatriation officers and elders from federally recognized tribes concerning these iss ues. T he article states on page 35: "The Bundle was discovered by the Pattersons in the 1980s on BLM land. Ms. Patterson dug the layers of bark that must have served to protect and preserve the contents." (e mphasis mine) [Note: it has since become illegal to disturb or dig up Native American artifacts on public lands.] This distortion of facts is a perversion of my understanding of several laws. The Antiquities Act of 1906 was strengthened by several other laws including the Archaeological Resources Protec tion Act of 1979. These laws make the actions of the Pattersons ille gal for almost one hundred years, punishable by substantial fines and jail se ntences. The Patterso ns did not discover the Bundle. They illegall y desecrated an ancient and sacred Indian site and then stole a sacred object. Why were the Patterso ns never charged with these two crimes? The Bundle, along with a large asso rtment of other artifacts, was buried on the ledge of a cave in a pit lined with juniper bark. To Native people, the excavation of this site evokes centuries of dese cration and scientific mutilation of the bodies of their ancestors and their most sacred possessions. The Native American Graves Protection and Repatriation Act (NAGPRA) of 1990 was created in res ponse to the cries of tribal people for the return of over two hundred thousand ancestral remains and tens of thousands of sacred objects and objects of cultural heritage. The passing of NAGPRA and individual state burial protection laws heralded the new era of Native control over their own cultural heritage. The subsequent formation of intertribal coalitions and the appointment of NAGPRA represe ntatives throughout the many Native Nations marked the ensuing stance of self-determination that characterizes the Indian in the 21st century. Pemina Yellowbird, official NAGPRA representative for the Sahnish and Hidarsa First Nations of Fort Berthhold Reservation, 2003 www.herbalgram.org North Dakota, has spoken many times about shared with others eve n within the same U.S. government policies that defin e "trust tribal clans. T he foll owing two examples responsibili ty. " Federal agencies (the Burea u demonstrate the intense res pect required in of Land Management or BLM, Nati onal handling sacred objects. Park Service, Corps of Enginee rs, etc.) are Curly Bear Wagner, Re patriati on Officer supposed to interpret laws in favor of Nati ve of the Blackfeet Nati on, received 32 of his people and as Native people would under Nation's ancestral remains from the Field stand them. As one of the original consult Museum of Chicago. A sacred obj ect that was ants during the formation of NAGPRA, identified as belonging to his great-grandfa Pemina has stated, "Nothing in NAG PRA ther, Chief Red C row, was not claimed for should be construed as authorizing any new return because no one now knows the prayers scientific study. " M aurice Eben, former and so ngs associated with it. To rake it home Repatriation Office r for the to tribal land could have devastat Pyramid Lake Paiute Nati on, has in g spiri tual impl ications fo r all said , "NAGPRA is a spiritual law of his peo pl e. that was created for Indian D avid Smith, Repatriation people." Indian people Officer of the W innebago Tribe In January of 1998, I attended of Nebras ka, had been as ked to have a social a NAG PRA Committee meeting reveal specific informati on about in which the di scuss ion centered and sacred objects claimed by his peopl e. on compliance with the mandate Since this informati on would relationship, that all private and federal insti become public reco rd , he chose tutions were to have completed not only to their to leave the obj ects in the institu inve ntori es of ancestral remains ti ons, as this transfer of knowl ancestors, but to and obj ects of cultural patrimony edge woul d violate the "intell ec by November 16, 1995. Penalties the heritage and tual pro perty ri ghts" that Native were already in effect for smaller people continue to struggle to institutions (i.e. , museums and objects they protec t. unive rsities could be fined as have created. Cultural items can no longer much as $200 a day for being be thought of as scientific speci pas t the inventory deadline). It mens. NAG PRA requires non was revealed at this meeting that Indian and federal institutions to federal agencies had fa iled to consider what is sacred from an meet the deadline across nearly all of its divi Indian perspective. In the article, Bennie Le sions. Upon as king BLM representative Beau and Woableza made the definition very Stephanie D emadis for a projected comple clear, as well as the spiritual impact of dese tion date, she stated Aady, "It could take crating Indian si res: "W hether it is a burial, decades. " The BLM houses some of its pot, an arrowhead or Bundle, this is all sacred collecti ons in private museums, and these to us and when it's disturbed, we beli eve it museums do not report such additional hold causes things in the world to be out of ings, so it is imposs ible even to get an accu balance" (p. 38). Native rel igious beliefs and rate es timate. At the meeting, the federal the sacred nature of rhe Bundle are fully agencies we re advised that coming in to recognized throughout the article bur they compliance, which involves compulso ry are continually and del iberately ignored. consultation with tribes, must be a priori ty as W hy was n't the study "bl ocked or curtail ed" it was required by law. In this li ght, what (p. 37) immediately? justificati on did the BLM have for turning Indian peo ple have a social and sacred re la over the Bundle to non-Indian peo ple fo r ti onship, not onl y to their ancestors, bur to scientific research? Why was the legal process, the heritage and objects they have created . A binding to all private and federal institutions, bundle, cl ay pot, mask, baskets, etc., are all ignored? living. Each has a spirit that cannot be sepa To Wes tern thinking, using Ameri can rated from its originating Nati on, and this Indian coll ections for intellectual pursuit and connection continues beyond death. educational research is both acceptable and The dichotomy between the treatment des irable. To most Ameri can Indians, it is a bestowed on the author and M r. Le Beau is crime against their spiritual beli efs and ri ghts striking. The author was given complete as sovereign peo ple. In many tri bes, only permiss ion to view, photograph, and phys i spec ific individuals have the right to share cally handle the Bundle and a carton of other informati on concerning sacred obj ects. The artifac ts. The spiritual leader was first inter knowledge, songs, prayers, etc., are often not roga ted by the BLM, bur "once it was es tab- Leh and right: Native America n petrog lyph from southeastern Utah. Photo ©2003 Jim Blazik www.herbalgram.org 2003 li shed that he was not there to officially claim the contributes to the ongoing genocide of American Bundle, he was given permiss ion to sing prayer Indian cultures and religions. Thus readers have not songs in the parking lot." (emphasis mine) . Only only been misled, they lack imperative information after that was he allowed to pray over the Bundle in needed to evaluate the article with accuracy. the disp lay case. NAGPRA provides a mechanism The American Botanical Council's first obligation for Indian people to make claims on sacred objects, is to the indigenous cultures it chooses to interact not to prevent them from doing so. Another with, and secondly, to the ethnobotanists and others congressional directive, the American Indian Reli who have worked to protect and honor the lifeways gious Freedom Act of 1978, states that all fed eral and intell ectual property rights of these cultures. Irs agencies have a res ponsibility to avoid infringement third responsibility is to its readers, to provide a of American Indian religious practices, and this comprehensive and credible format, and finally, to applies to the illegal transfer of the Bundle into all the people who handled the Bundle or associated layman's hands. artifacts. Not only are there spiritual repercussions To prevent the involved tn hav ing mishandling of our contact with these sacred objects, correct sacred objects, but cultural information there are phys ical To Western must be available to dangers now associated the public. The with the routine meth thinking, using raci a ll y- bia se d ods of preservation, American Indian language and mislead including pes ti cides, ing information in the arsenic, mercury, and collections for article perpetuate a other haza rdous intellectual romantic stereotype substances. These and an inve nted toxins now pose a pursuit and mythology surround health threat to both educational ing Indian identity. rhe examiner and the Examples include: tribal inheritors of research is both "I noticed nothing repatriated items, and acceptable and of European nature all individuals involved included tn the need to be forewarned. desirable. contents, i.e., no Native people live metal, woven fabrics anything but romantic To most or thread." lives. They endure the American "There was nothing highest rates of unem exoti c such as macaw ployment, poverty, and Indians, it is a feathers or pigments violent crime victim crime against from another part of IZation. Indian youth the world . .. " suffer the highest their spiritual Such erroneous suicide and school beliefs and comments obscure the dropout rates of any rich ancient heritage of cultural group. This rights as Indian people. To the These engraved ceremonial she ll cups are not actual artifacts, but, to article is a dangerous protect the sacred nature of Native American objects, have been sovereign readers, it might step backwards for the appear that the items replicated by Dan Townsend, a contemporary Native American artist. harm lies not only in Photo courtesy of the author. people. mentioned only exist the irretrievable losses outside of pre- of life and culture in Columbian American, yet American Indian metal the pas t, but in the continued ignorance and misun lurgy dates back 5,000 years, intricate weaving derstanding in the present. 10,000 years, and the trade network for transport In the spirit of cooperative change, I urge all to ing dive rsely constructed materials was active for see an upcoming Native American exhibit at the Art many thousa nds of years throughout the Americas. Institute of C hicago entitled, "Hero, Hawk and Macaw or owl feathers have specific ceremonial Open H and: American Indian Art of the Ancient meaning to individual tribes. Red ocher is a sacred Midwest and South" (scheduled for the fall of 2004 paint and its use in burials, ceremonies and rituals then travelling to the Sr. Louis Museum of Art and dates back 6,000-7,000 years. the Smithsonian National Museum of Natural Off-handed comments that liken the impression History). C urators are co nsulting with tribal repre of the Bundle contents to "seeing the co ntents of a sentatives and adviso rs regarding this exhibit, and woman's purse," and " ... the coll ection wasn't as the Native worldview and perceptions of what is 'sexy' as the fascinating hunting Bundles . .. " rrivial sacred will determine what art pieces are shown. My ize the Bundle's cultural importance and are used as friend, Dan Townsend (Creek/Cherokee), has been an oppressive tactic for justifying invas ive studies of given tribal permiss ion to replicate ancient shell sacred materi als . This type of exploitation engravings and to speak about the traditions. Plants 48 I HerbaiGram 59 2003 www.herbalgram.org rhar were used in ceremony over 1,000 years ago are still mixed today for the same purposes. I believe that an article written through Indian eyes could address many of the concerns of tribal people that I have covered in this letter. T he Ameri can Botani cal Council must be accountable to a hi gher consciousness and vision rhar better refl ects irs goals of respect and justi ce. I see ABC and an increasing number of people in the community working to honor those high goals. In that I was granted this opportunity to address these iss ues here, I'm deeply grateful. T he acti ons of all involved in this matter set in motion a spir itual travesty that cannot be ca ll ed back. U ltimately, only the people whose ancestors created the Bundle can spirituall y care for it. __.- Cindy Bloom was born of Cherokee heritage from the so utheastern US. She has served on the board ofthe American Indian Council of ILLinois and other Native-based organizations focused on the protection and conservation of sacred sites and the return of ancestral remains and sacred objects. Her 19 years ofarchaeological experience and the study of Indigenous medicines and cultures throughout the Americas include essential knowledge of the state and federal Laws that govern human rights issues ofNat ive peoples. The results ofthi s work include the restoration of native flora and founa at numerous sites as weLL as the acquisition of an ILLinois burial site for the estimated 12, 000 ancestral remains yet to be repatriated. She fives with her fomify outside of Chicago on 50 acres of Land formally designated as a sanc tuary, where she grows endangered native plants that are used for medicine, food and ceremony, and fibers and dyes for traditional basket weaving. She also teaches on-site classes in Native medicine, Indian Lifeways, and pre-Columbian cultures. Native American petroglyph from southeastern Utah. Photo ©2003 Jim Blazik S T E Y E ~ F 0 S T E R G R 0 l . P . I ~ C . eaturerl in HerbaiGram f or over a rlerarle, !h e photographs of Steven Fosler are available f or lire nsing for editorial or commercial projerts. Specializing in medicinal and aro matic plants, our stock photo files include more than 70, 000 images, including most major herbs sold as dietary supplements. Steven Foster Group, Inc. Steven Foster, President PO. Box 57, Brixey, MO 65618 4 17/261-2663 f ax 4 17184 1-4843 email: sfoster@stevenfoster. com www.stevenfoster. com C 0 \1 E T 0 T H E S 0 l . R C E www. herbalgram .org 2003 HerbaiGram 59 I 49 legal & regulatory The Slow Demise of FDA Censorship Recent Court Cases on Health Claims that Define the Scope of Speech Rights for the Manufacturers and Distributors of Herbs and Other Dietary Supplements by Jonathan W. Emord ummary: Certain herbs, like saw palmetto, have physiological scientific evidence inconclusive or not fully supportive of the S effects upon the body that are useful in mitigating or preventing claim, or that consumers cannot be trusted to act res ponsibly if disease and health-related conditions. Even in the presence ofcredible they receive the claim). At fi rs t FDA was quite reluctant to foll ow scientific evidence supporting claims for such products, the Food and the Court's decision. A change of administration brought new offi Drug Administration has often censored them, denying manufacturers cials to the agency in late 2002, like Commissioner Mark B. ofsuch p roducts the right to inform consumers oftruthfol and nonmis McClellan, M .D ., Ph.D ., Associate Commissioner Lester M . feading health information. The foss of that information harms C rawford, and C hief Counsel D aniel E. Troy, all of whom share a consumers. Indeed, in certain instances it may be responsible for the profound respect for the need to comply with the Court's orders. worsening ofhu man health. This article provides a detailed history of While that respect has led FDA to all ow a seri es of nutrient-disease recent federal court decisions that speLL a new day for those who wish prevention claims, it has not led FDA to change irs position on to communicate on dietary supplement product labels and in labeling claims of a nutrient's effect on an existing disease (so-called "treat truthfol and nonmisleading health information concerning the effects ment" claims) . With res pect to the latter, FDA still refuses to allow ofherbs and other nutrients upon disease. them to be made as health claims for dietary supplements. FDA [Editor's note: j ust before p resstime, on j uly II, 2003, the U.S. will only all ow such claims for drugs, foll owing approval of new Food and Drug Administration announced plans to aLLow "qualified drug applicati ons. That position of the agency, however, is now the health claims "for foods and dietary supplements under the Nutrition subject of litigation in the federal courts. In Whitaker v. Thompson, Labeling and Education Act of 1990, the subject of much of the arti now pending before the U.S. Court of Appeals for the D.C. cle below. H erbal Gram wiLL cover the new FDA policy in a foture C ircuit (the sa me co urt that held against FDA health claim issue.} suppression in Pearson v. Shalala), the court will decide whether or decades the U .S. Food and Drug Administration (FDA) FDA may constitutionally suppress a claim associating consump Fcensored nutrient-disease rel ationship claims (so-called "health ti on of saw palmetto (Serenoa rep ens (W Bartram) Small , claims") with impunity. Agency scientists and officials have long Arecaceae) extract with a reduction in the symptoms of benign believed it was FDA's unique role to determine for Americans what prostati c hyperplas ia (BPH). is in their own bes t interest and to deny them access to informa FDA originally justified its claim bans with anti-fraud and with ti on on how nutrients, and foods in general, co uld affect disease, health and safety rati onales .4 It largely ignored the implications of reasoning that less-than-ce rtain informati on of this kind could irs acti ons on Fi rs t Amendment-protected freedom of speech.S result in dangerous self-medication by consumers. The era of Touted as a means to end fraud and enhance health and safety, censorship with impunity is now coming to a close. A new era of FDA's censorship never produced those effecrs;6 it may well have agency res pect for the First Amendment* appears in the offing.1 encouraged fraud and diminished health and safety. By denying Nevertheless, legal battles against FDA censorship of claims consumers access to truthful and nonmisleading information concerning a nutrient's effect on existing disease continue. about how nutrients affect disease, FDA may well have created an As explained in greater detail below, in 1999 the U.S. Court of environment where fraud could fl ourish uncontested by truthful Appeals for the District of Columbia (D.C.) C ircuit held in Pear health information and may well have sacrificed public health. son v. Shalala that FDA violated the First Amendment by denying Hucksters depend upon igno rance to defraud consumers. all health claims except those backed by near-conclusive proof of a Consumers armed with accurate health information are less likely nutrie nt-disease relationshi p. Although at first unwilling to to be victimized by fraud than those denied that informati on and comply with that decision,2 FDA became chastened by three lower are also more apt to make health-enhancing market choices.? federal court orders that demanded immediate compliance, repeat Conversely, consumers unaware of the actual effe cts of nutrients edly finding agency noncompliance incompatible with the Court are more apt to believe falsehoods about those products and less of Appeals' orders. Indeed, the lower court (Judge Gladys Kessler likely to make health-enhancing market choices. pres iding) imposed injunction after injuncti on on the agency to Under the current administrati on, which is committed to prevent continued acts of censorship.3 "purring credible, science-based information in the hands of T he federal courts have made it clear that if a statement is true, consumers," 8 FDA seems willing to comply with the federal court or is capable of being rendered so through the addition of a orders, but will that compliance be complete? In at leas t one area, disclai mer, the FDA has no power under the First Amendment's that of claims concerning the effect of a nutrient on an existing free speech provision to censor the statement (even if FDA believes disease, the answer appears to be no. There FDA censorship co ntinues as it had before the Pearson decision; consequently, the battle for First Amendment freedom continues. The battle centers The First Amendment is part of the Bill of Rights, the first I 0 amendments to the U.S. Consti tution rati fied in 179 1. The First on whether FDA will all ow consumers to receive info rmati on Amendment reads, "Congress shall make no law res pecting an estab about how foods and food ingredients, including dietary supple lishment of rel igion, or prohibiting the free exercise thereof; or ments, affect existing diseases and their symptoms. FDA takes the abridging the freedom of speech, or of the press; or the ri ght of the position that such claims are not allowable as health claims, but peopl e peaceably to assemble, and to petition the government for a only as "drug claims," by whi ch FDA means that no one may be redress of grieva nces." 50 I HerbalGram 59 2003 www.herbalgram.org legal & regulatory allowed to make such claims on foods and on dietary supplements eve of a U.S. Senate Labor and Human Resources Committee without first obtaining FDA new drug approval for the products. hearing (at which Dr. Kessler would have been made to account That approval is a virtual impossibility. The cost of the new drug publicly for his refusal to all ow the claim.) 10 approval process ranges from a conservative low of $200 million to The U.S. Senate Committee on Labor and Human Resources a high of $800 million or more. Most foods and most dietary investigated FDA's refusal to allow the foli c ac id claim, while Durk supplements are unpatentable, so even were food or supplement Pearson, Sandy Shaw, the American Preventive Medical Associa companies wealthy enough to fil e a new drug application for a tion, and C itizens for H ealth sued the agency for its refusal. At the product, few, if any, could recoup their investments in the market, conclusion of its deliberations, the Senate Committee observed: lacking the monopoly protection that patents provide. Moreover, In September, 1992, the Public Health Service iss ued a few could afford to leave their present distribution and market recommendation that all women of child-bearing age have channels and market products anew as drugs. adequate folic acid to prevent against birth defects. The FDA has historically viewed scientific information destined for Centers for Disease Control had made a similar recommen consumer markets as a potential enemy: either a poss ible source of dation one year before. Despite these two recommendations, sophistication beyond the reach of the average consumer that and despite the fact that the FDA participated in the PHS could beguile, or a source of truth so profound that consumers proceedings leading up to the announcement, FDA did not could not be trusted to act rationally with it. The agency has long issue a regulation proposing approval of a health claim for vi ewed itself as the nation's ultimate authority on the interpreta foli c acid until October, 1993, one week before the commit tion of science, the first and las t determiner of what nutrient tee's hearing on dietary supplements. disease and nutrient content information may appear on the labels Absent approval of a health claim by the FDA, it was illegal and in the labeling of the commercial goods the agency regulates. for manufacturers or retail ers to advise the public about the In the exercise of health claims regulation,9 FDA has heeded benefits of folic acid, even though those benefits had been precious few external voices - whether from leading scientists of endorsed by the leading Federal public health agencies . 11 the world* or from other federal public health agencies.** Upon review of that same evidence three years later, the same committee found FDA squarely to blame for neural tube defect Folic Acid and the Health Consequences of Censorship births that could have been prevented by prompt all owance of the The paradigmatic example of how FDA censorship can affect folic acid/neural tube defect risk reduction claim: public health arose during the administration of former Commis The history of the foli c acid and neural tube defects health sioner David Kessler, M.D. Dr. Kess ler, and several of the agency's claim dramatizes the critical need for [passage of the FDA top scientists, beli eved folic acid was not adequately proven to be Modernization Act]. In 1992, the Centers for Disease Control a safe and effective means to reduce the incidence of neural tube and Prevention (CD C) iss ued the following recommendation defects (NTDs) . NTDs (e.g. , spina bifida) are horrific and often to women of childbearing age, aimed at reducing the ri sk of lethal conditions afflicting about 5,000 live births annually in the pregnancies affected by neural tube defects: United States. Despite overwhelming scientific evidence that 0.4 All women of childbearing age in the United States who are m g of folic acid did reduce the incidence of NTDs by 40 percent capable of becoming pregnant should consume 0.4 mg offolic to 50 percent, and the endorsement of the U.S. Public Health acid per day for the purpose of reducing their risk of having a Service and the U.S. Centers for Disease Control and Prevention pregnancy affected with spina bifida or [o ther neural tube for a folic acid/neural tube defect risk reduction claim, Dr. Kess ler defects]. maintained (until the winds of political and legal change became . .. The C DC es timated that this recommendation could unbearable for him) that there was not "significant scientific agree reduce the number of cases of spina bifida and other neural ment" among qualified experts that folic acid could safely reduce tube defects in the United States by 50 percent. the risk of neural tube defects and that there existed a ri sk Despite the significant scientific agreement among quali (unproven then and now) that those consuming folic acid may fi ed experts concerning the evidence supporting the recom m ask a vitamin B12 deficiency. On those grounds, he suppressed mendation, manufacturers of foods containing folic acid were the folic acid claim for more than a year, finally relenting to prohibited from making claims about the benefits of fo li c acid demands from U .S. Senator Orrin H atch (R-UT) and then in reducing the risk of neural tube defects until FDA Congressman (now Governor) Bill Richardson (D-NM) on the approved the claim through a notice and comment rulemak- Each health cl aim filed with th e agency has been accompanied by a 1997," 49-50 (1997). In addition, despite CDC's determination that scientific report from lead ing experts who study the nutrients in elevated homocys teine levels were an independent risk factor for question. vascu lar diseases in 1999 (CDC. Morbidity and MortaLity WeekLy For example, in 1992, the Centers for Disease Control and Preven Report, ovember 12, 1999), FDA refused to recognize it as such tion (CDC) recommended that all wo men of childbea ring age be and to permit a B6, B12, and folic acid claim for vascul ar disease ri sk informed of the need to consume 0.4 mg of folic acid daily to reduce reduction due to those nutrients' accepted homocysteine-lowering a woman's risk of neural tube defects by an es timated 50 percent effects until after Julian M. Whitaker, M.D., and others sued the (CDC. Morbidity and MortaLity WeekLy Report, September II , 1992) . agency in 2001. Compare Letter from FDA to Jonathan Emard FDA at first refused to follow CDC by authorizing a claim for folic denying B6, B12, Folic Acid/Vascular Disease cl aim, November 30, acid and neural tube defects. It finally changed irs position in March 1999, to Settlement Reached for Health Claim Relating B Vitamins 1996 only after the Pearson litigation began (which included this and Vascular Disease, May 15 , 2001 found on li ne at claim until FDA relented). See Senate Report I 05-43, "Food and ing procedure. sion as the operative rule in health claims review, held that claims Without appropriately accounting for the CDC recom nor passing FDA's scientific standard would nevertheless have to be mendation, FDA promulgated a rule in January 1993, allowed if they could be rendered nonmisleading with disclaimers, prohibiting claims concerning the relationship. In the wake of and held that FDA had to rely on disclaimers as a less restrictive controversy concerning FDA's action, and despite the absence alternative to censorship in all instances except the extremely rare of any change in the scientific evidence, the Agency reversed circumstance in which a claim was backed by no credible scientific course, proposing to authorize such claims in October, 1993. evidence.14 Final regulations authorizing the claim were promulgated in The Pearson I Court began its First Amendment assessment March 1996. Undoubtedly, many children suffered ftom quoting In re R.M.j. , 455 U.S. 191 , 203 (1982): that the govern p reven table neural tube defects as a result of FDA 's delay in ment "may not place an absolute prohibition on ... potentially authorizing health claims based on the 1992 CDC recommen misleading information . . . if the information also may be dation. [Emphas is added.] 12 presented in a way that is not deceprive. "15 The Pearson I Court Although Congressional angst reached a fever pitch in response explained the importance of the pres umption at some length and to FDA's refusal to allow the folic acid/neural rube defect claim, the fact that the burden cannot be mer except upon adduction of the world fundamentally changed for the FDA as a result of a seri es empirical evidence of misleadingness (a complete ban is only of judicial , not political and not legislative, decisions. Those deci appropriate if the government "demonstrate[s] with empirical sions repeatedly held FDA censorship of health claims unconstitu evidence that disclaimers ... bewilder consumers and fail to correct tional under the First Amendment and enjoined FDA from doing for deceptiveness" IG ). so. The world changed further when a new administration arrived Under Pearson I and its proge ny, before resorting ro censorship, in 2002, including Commissioner McClell an, Associate Commis FDA must determine based on empirical evidence that the cl aim sioner C rawford, and Chief Counsel Troy. Those officials have before it (not the nutrient-disease relationship per se or in the dedicated the agency to fulfillment of the First Amendment abstract) cannot be rendered nonmisleading through the addition mandate given FDA by the federal courts. Although it would be a of a reasonable disclaimer. Every disclaimer that could be used to hasty generalization ro conclude at this early dare that FDA's days eliminate a proven potential to mislead must be carefully assessed. of censorship are over, it may now be said with confidence that Only after establishing that no disclaimer can cure that proven addressing First Amendment iss ues has become obligatory for potential may the FDA suppress the claim. agency censors as a result of the new leadership at the agency. The Pearson I Court ex pl ained that disclaimers not only correct for what the Court termed "misleadingness" by informing Pearson v. Shalala I consumers of scientific inconclusiveness but also of adverse reac A bellwether of health claims regulation until 1999, FDA tions that may occur to some who use a dietary supplement, writ censorship first met the superior and countervailing force of the ing," ... [T]he government's interest in preventing the use oflabels American Constitution when the U.S. Court of Appeals for the that are true but do not mention adverse effects would seem to be D .C. Circuit decided Pearson v. Shalafa.13 In that landmark deci satisfied - at least ordinarily - by inclusion of a prominent sion, written for the Court by Senior Judge Laurence H. Silber disclaimer setting forth those adverse effecrs ." 17 It is rhus not man, the Court of Appeals for the D .C. C ircuit held that FDA enough ro justify suppression that at some dose level or in some violated the First Amendment by censoring four health claims, contexts a nutrient may cause an adve rse reaction. That, roo, is held that FDA had to favor disclosure of information over sup pres- reason for a disclaimer, not ce nsorship. AHPA's Input on Saw Palmetto Health Claims Filed in Court he American Herbal Products Association (AHPA) filed a court and Dr. Whitaker appealed. (See accompanying article.) Tfriend of the court brief1 ·2 in the U.S. Court of Appeals for AHPA's friend of the court brief pointed out that NLEA the District of Columbia Circuit in support of Julian Whitaker, requires FDA to consider any claim regarding the relationship M.D., and others who have filed for a health claim from FDA between a nutrient and disease and that FDA never rook the "no for saw palmetto (Serenoa repens) and its relationship to the treatment claims" position in regulations promulgated under symptoms of benign prostatic hyperplasia (BPH).3 The brief NLEA.5AHPA also pointed out that the District Court's ration was filed May 28, 2003, on behalf of AHPA by its General ale for determining that the health claim provision of NLEA is Counsel, Anthony L. Young, a partner at Kleinfeld, Kaplan and ambiguous is flawed because the statute clearly permits treat Becker, LLP. ment claims to be made as health claims.4 According to AHPA, FDA refused to evaluate the merits of AHPA also countered FDA's long-held position that al lowing Dr. Whitaker's health claim petition on the basis that it a treatment claim for saw palmetto would discourage men from describes how saw palmetto "treats" the symptoms of BPH. seeking proper medical evaluation and noted that AHPA Such claims, according ro FDA, may only be made for drugs recommends that the following or similar language appear on and the health claim provision of the Nutrition Labeling and the label of any products containing saw palmetto: Education Act (NLEA) of 1990 does not authorize health ''Notice: The National Institute on Aging recommends that men claims concerning a nutrient's ability to treat diseases or their get regular medical checkups with a thorough prostate exam. You symproms.4 FDA prevailed with these arguments in the lower should inform your health care practitioner that you are using this 52 I HerbaiGram 59 2003 www.herbalgram .org legal & regulatory The Pearson I Court relied heavily o n First Amendment prece Comm'n ofIlli nois}, 496 U.S. 9 1, 105 (1990) (rejecting pater dent in crafting its decision, delving into the philosophical under nali stic ass umptio n that the recipients of a letterhead are "no pinnings fo r the requirement that the claims in iss ue be protected mo re discriminating than the audience fo r children's televi fro m government suppression. Repeatedly in its decisio ns over the sion"). We reject it. 18 last two and a half decades, the U.S. Supreme Court has empha T he Court held FDA's scientific standard arbitrary and capri sized that full and faithful implementation of the First Amend cious under the Administrative Procedure Act because it was ment leads inexorably to preservatio n of a free and open idea and largely undefined but, the Court reasoned , even were FD A able to information marketplace and that, while imperfect, the free idea define a standard fo r health claims review, that could no t serve as market nevertheless serves as the best engine fo r advancement, a lawful basis upon which tO reject a health claim, writing: "[E]ven innovati on, and truth discovery. To be sure, the Court loathes if 'significa nt scientific agreement' were give n a more concrete censorship and prio r res traint, particularly w hen predicated on the meaning, appellanrs might be enritled tO make health claims that paternalistic noti on that those in government know better than the do not meet that standard - with proper discl aimers." 19 average individual how bes t to pursue that individual's own self The Court also rejected the notio n that unless info rmation is interest. The constitutional presumptio n favo ring disclosure of scientifically certain, it will mislead consumers and cause them to info rmation over its suppression is a strong one therefore, ari sing waste their resources, w riting: from the well -accepted and often cited conclusio n of the C ourt Because it is no t claimed that the product [s] [are] harmful, that under the First Amendment commercial speech doctrine, the government's underl ying - if unarticulated - premise there is no legitimate role of government in censoring, let alo ne must be that consumers have a limited amo unr of either atten res tricting access to, truthful info rmation . tion or doll ars that could be devoted tO pursuing health T he Court of Appeals had little d iffi cul ty rejecting FDA's justi thro ugh nutrition, and therefore products that are not indis fi cations fo r refusing to rely on disclaimers as a less speech res tric putably health enhancing should be discouraged as threaten tive alternative to censorship. It unceremonio usly rejected each of ing to crowd our mo re worthy expenditures. W e are rather the agency's justificati o ns. It rejected the notio n that a claim not dubious that this simplistic view of human nature o r market backed by "significant scientific agreement" was by that fact alo ne behavio r is sound, but, in any event, it surely canno t be said inherently misleading and could lawfully be ce nso red , reasoning that this notio n -which the government does not even dare that a claim could be true and protected under the First Amend openly to set fo rth - is a direct pursuit of consumer health; it ment even if it fa il ed to satisfy the agency's chosen scientific stan would seem a rather indirect route, to say the least. See Bates dard.: v. State Bar ofArizona, 433 U .S. 350, 375 (1977) ("We view As bes t we understand the government, its first argument as dubio us any justificati on that is based o n the benefits of runs along the foll owing lines: that health claims lacking pub li c ignorance. "); cf 44 Liquormart, Inc. v. Rhode Island, "significant scientific agreement" are inherently misleading 5 17 U .S. 484, 503 ( 1996) (opinion of Stevensw, ] ., joined by because they have such an awesome impact o n consumers as Kennedy, J., and G insburg, J. ) ("The First Amendment to make it virtually impossible fo r them to exercise any judg directs us to be especiall y skeptical of regulations [of indis ment at the point of sale. It would be as if consumers were putably no n-misleading informatio n] that seek to keep people asked to buy something while hypnotized , and therefore they in the dark for what the government perceives to be their own are bound to be misled. We think this contentio n is almost good.").10 fri volous. See Peel [v. Attorney Registration and D isciplinary The Court of Appeals understood FD A to have a high First product." to receiving and reviewing health claims for foods and supple AHPA's brief said: ments on their merits so that the claims may be properly quali "In the final analysis, there is no reason to believe that men fied and consumers can receive information about these prod will improperly use dietary supplements containing saw ucts. Information was the abiding goal of both NLEA and palmetto if they are marketed with the proposed health claim. DSHEA and FDA has simply lost sight of that goal."2 A Indeed, approving the saw palmetto health claim with accom Reference: panying language concerning the need for routine prostate 1. American Herbal Products Association. AHPA Files Friend of exams would benefit, not harm, the public health. If approved, Court Brief on Health Claim for Saw Palmetto. AHPA Update. the labels of most saw palmetto products will likely bear the May 28, 2003. health claim along with any additional language regarding the 2. Amicus Curiae Brief of the American Herbal Products Associa need for regular prostate exams required by FDA. Thus, tion, Whitaker v. Thompson· No. 03-5020, D.C. Cir. Friend of the court briefs, called briefs amicus curiae, are permitted in all courts approval of the proposed health claim would likely result in a with the permission of the litigants and the court. They are often wider dissemination of the National Institute on Aging's impor used by trade associations (e.g., AHPA) and other interest groups tant recommendation for regular prostate exams. (e.g., the Sierra Club) to present points of view of interest to their "We are pleased to support Julian Whitaker and his allies in members and to the Court. seeking reversal of FDA's position which seeks to rewrite the 3. Brief of the Appellants, Whitaker v. Thompson· No. 03-5020, NLEA's health claims provision. D.C. Cir. "FDA's refusal to look at Dr. Whitaker's proposed BPH claim 4. 21 U.S.C. §343(r)(6). on the merits needs to be brought up short. FDA must be open 5. 21 C.F. R. Parr 101 , Subpart E. www.herbalgram.org 2003 HerbaiGram 59 I 53 legal & regulatory Amendment burden of proof to justi fy censorship and meant to co ncluding otherwise. In short, even if the FDA's criticism of reve rse FDA's penchant for denying the public access to nutrient the sub-claim is va lid , this criticism does not make the C laim disease relati onship informati on. To satisfy its high constitutional inherently misleading; rather, it suggests the need for a well burden, FDA could not res t on a determination that a claim fail ed drafted disclaimer, which the FDA has steadfastly thus fa r to meet some FDA-decreed objecti ve or subjective scientific stan refu sed to even consider.25 dard or a determination that use of the claim could result in some T he Court emphas ized that FDA could not suppress health members of the public engaging in behavior FDA found inappro claims with impunity but had to satisfy a very high First Amend priate. Ra ther, FDA had to find empirical evidence that a claim ment burden of proof to show that suppression was constitutional; was inherently misleading and that no disclaimer co uld be used to indeed, in no instance would suppress ion be allowed when disclo el iminate the misleading connotatio n. If the science supporting a sure could se rve as a less restrictive alternative: clai m was inconcl usive, if only a minori ty of scientists endorsed it, or if there remained controversy in the scientific community concerning it, those qualificati ons were precisely the kind that the After three court decisions, Court expected FDA to write into disclaimers. Pearson /has there it is hard to believe that the fore made it incumbent upon FDA in the discharge of its consti tutional duties to stand aside, permitting as much information as FDA would continue to suppress possible to reach the public and relying on reasonable disclaimers as its primary corrective mechanism because that mechanism is information, but that is in va ri ably a less speech restrictive alternative to outright suppres precisely what it did SIOn . In sum, the FDA has simply fail ed to adequately consider Enforcing Pearson v. Shala/a (Pearson II, Pearson Ill, and the teachings of Pea rso n: that the agency must shoulder a very Wh itaker I) heavy burden if it seeks to totally ban a particular health Even aft er the Court of Appeals' re mand order, FDA co ntinued claim . W ith respect to the rwo disclaimers which the Pearso n to censor the very claims the Court hel d protected by the First Court suggested might cure all potential misleadingness, the Amendment. In Pearson v. Shalala //, 21 the U.S . District Court fo r FDA did not consider one of them at all, and summarily the D istrict of Columbia held unconstitutional under the First rejected the other in a single sentence. Nor did the FDA Amendment FDA's continuing refusal to all ow the foll owing "demonstrate with empirical evidence that disclaimers similar health claim (held pro tected by the First Amendment in Pearson f) to the ones" suggested by the Court of Appeals would "bewil to appear on the label and in the label ing of folic acid containing der consumers and fa il to correct for deceptiveness." Indeed, dietary supplements: "0.8 mg of fo li c acid in a dietary supplement the FDA did not consider any other disclaimers, except fo r is more effective in reducing the risk of neural tube defects than a "T he FDA has not evaluated this claim," a disclaimer no one lower amount in foods in common form." T he Court enj oined has suggested and which is obviously inaccurate.26 FDA fro m enfo rcing a second, post-Pearson I order denying the T he FDA refused to accept this second decision and moved to claim and ordered FDA to come up with "one or more alternative have it reconsidered by the trial judge, despite the absence of new disclaimers which may be chosen by des igners, sell ers, and manu evidence, new law, or clear error warranting reconsiderati on. In fac turers of dietary supplements" for use on folic acid-containing Pearson v. Thompson27 (Pearson Iff), the Court denied the govern dietary supplements.22 The Court found FDA noncompliance ment's motion, finding the moti on further evidence of the FDA's with Pearson v. Shalala I wholly unjustified, writing: "[I]t is clear "rel uctance to fully comply with Pearson I. .. ." 28 Significantly, the that the FDA simply failed to comply with the constitutional Court used this opportunity to reiterate that FDA could not justify guidel ines in Pearson. Indeed, the agency appears to have at best, censo rship of a health claim simply because it deemed the evidence misunderstood, and at worst, deliberately ignored, highly relevant in support of the claim insubstantial. Rather, FDA would have to portions of the Court of Appeals O pinion."23 T he Court found produce specific evidence that co ntradicted the ve ry claim in iss ue that FDA "continually refused to authorize the disclaimers and would have to show that the co ntradictory evidence substan suggested by the Court of Appeals - or any disclai mer, for that ti all y ourwe ighed the evidence in support of the claim. In the end, matter .... "24 T he Court reiterated that inconclusiveness in science onl y if the evidence for the claim was patently incredible by does not justify banning a claim backed by credible evidence. In comparison to the evidence specifically against it, could the claim such circumstances the First Am endment pro tects the speech in be censored. In all other circumstances, the claim would have to be iss ue and the government must rely on the less restrictive alterna all owed (with disclaimers performing the role of quali fying the ti ve of more speech, in the form of a disclaimer, to cure any poten relati ve level, quality, and quantity of evidence for the claim). T he tial misleadingness: Court wrote: [A] s the Pearso n opinion strongly suggests, the FDA may W ith respect to Defendants' request for clarificati on, whi ch not ban the Folic Acid C laim simply because the scientific asks under what circumstances the FDA may totally ban a li terature is inconclusive about whether syntheti c foli c acid is health claim, this iss ue is adequately addressed when Pearson superi or to naturally occurring folate .... The question which II is considered in co njuncti on with Pearson I. Pearson I indi must be answered under Pearso n is whether there is any "cred cates that "the FDA [may] impose an outright ban on a claim ible evidence" that syntheti c fo lic acid is superior to naturally where evidence in support of the claim is qualitatively weaker occurring food folate . ... T here clearly is such evidence, as the than evidence against the claim - for example, where the FDA itself acknowledged. Consequently, the agency erred in claim rests on only one or rwo old studies" or "where evidence 54 I HerbaiGram 59 2003 www.herbalgram.org legal & regulatory in support of a claim is outweighed by evidence against the palmetto, may inform consumers of the truthful and nonmislead claim." Pearso n II fl eshes out the term "against": "The mere ing fac t that the herb (usuall y in ex tract form) affects sy mptomol abse nce of significant affirmative evidence in support of a ogy of beni gn prostatic hyperpl as ia (BPH). 33 The case call s into particul ar claim ... does not translate into negative evidence ques ti on basic First Amendment tenets. The outcome will deter 'against' it .... , 29 mine whether FDA may censo r all health claims that accurately While from the outside looking in, one would find it hard to convey an unpatentable nutrient's effect on an existing disease (a believe that after three decisions condemning FDA censorship so-call ed "treatment" effect). (one from the U.S. Court of Appeals and two from the U .S. District Court) the FDA would continue along its speech suppres Challenging Whitaker II sive course; that is precisely what the agency did. Rather than heed Neither the plain language of the N utrition Labeling and Ed uca the Courts' orders and permit an antioxidant/cance r ri sk reducti on ti on Act ( LEA) nor the intent of Congress as articulated by key claim (e.g., "Consumption of antioxidant vitamins may reduce the committees, bill sponsors, or members reveal any evidence that the risk of certain kinds of cancer. "), properly disclaimed (e.g., "The health claims definition fo und in 2 1 U.S.C § 343(r)(l)(B) limits scientific evidence in support of this claim is inconclusive."), the the scope of nutrient-disease relati onship claims to disease preven FDA chose censorship once again, res ulting in a second court tion claims. To the contrary, the plain language permits the fil ing battle on that claim, a claim already held protected by the First of health claims that "expressly or by implication . .. characterize Amendment in Pearson l the relati onship of any nutrient ... to a disease or a health-rel ated In Whitaker v. Thompson (Whitaker [) ,3° the Court evaluated condition."34 Despite that fac t, the FDA prohibited review of a FDA's decision to refuse, on remand, to all ow a claim associating truthful and nonmisleading saw pal metto/BPH claim on the bas is consumption of antioxidant vitamins with a reduction in the risk that rhe health claims provision did not contemplate permitting a of certain forms of cancer. In holding FDA's censorship unconsti cl aim concerning an effect on an existing disease. T he cl aim is tutional under the First Amendment and enj oining FDA's rule documentable and supportable by a large body of generall y suppressing the claim, the Court explained in the greatest detail to accepted scientific and medical research, enough in fac t to possibly date that FDA was utterly powerl ess to suppress a health claim quali fY for the "signi fica nt scientific agree ment" standard , whi ch unless under no circumstances the claim could be rendered would not be necessary to pe rmit claim use under the Pearson non misleading through use of a disclaimer. The Court explained: precedent. 3S.3G Specifically, Pearson I identified two situations in which a FDA's decision not to permit this cl aim to be processed as a complete ban would be reasonable. First, when the "FDA has dietary supplement health claim under N LEA (this is significantly determined that no evidence supports [a health] cl aim," it di ffe rent fro m a structure/functi on claim under the D ietary may ban the claim completely.. . . Second, when the FDA Supplement H ealth and Educa ti on Act of 1994, whi ch does not determines that "evidence in support of the claim is qualita requi re FDA preapproval) left onl y one alternative for the peti tively weaker than evidence against the cl aim - for example, ti oners: to seek new drug approval (N DA) for the supplement as a where the claim rests on only one or two old studies," it may condition precedent to making the claim. ew drug approval impose an outright ban ... . Even in these two situations, a woul d cost at least $58 million according to the economic expert complete ban would only be appropriate when the gove rn retained by the petiti oners. Neither the petitioners nor any other ment could demonstrate with empirical evidence that company rhar makes saw palmetto could afford such an exorbitant disclaimers similar to the ones [the Court] suggested above cost. Moreover, even if a company could afford the cost, the fac t ("The evidence in support of this claim is inconclusive" or that the nutrient is unpatentable ensures that none would fil e. It "The FDA does not approve this claim"] would bewilder would be impossible to recoup that ex traordinary investment (rel a consumers and fail to correct for deceptiveness. ti vely modes t in comparison to the cost of patentable new chemi T hus, two conclusions emerge from a cl ose reading of Pearson l cal entity drugs, whose N DA costs can run in the hundreds of First, the Court of Appeals did not rule out the poss ibility that millions of dollars, such costs being recoupable with exclusive disclaimers would not be able to correct the inherent misleading marketing ri ghts deriving fro m the patent and other statutory ness of some claims. Second, the Court stated that any complete protecti on). Moreover, the petitioners would be so rely disadva n ban of a claim would be approved only under narrow circum taged because they woul d also incur the costs of transforming stances (i. e., when there was almost no qualitati ve evidence in themselves from dietary supplement to drug manufacturers, rhe support of the claim and where the government provided empiri latter operating in a new market with an entirely different distri cal evidence proving that the public would still be deceived even if bution system. Despite those costl y, indeed practi cally prohibitive, the claim was qualified by a disclaimer).31 burdens on the right to communicate a truthful message, neither With Whitaker /, First Amendment protection for credible the FDA nor the U.S. District Court for the District of Columbia nutrient/disease relationship cl aims appea rs well -established . fe lt compell ed to evaluate the claim under the First Amendment However, as revealed in Whitaker /!, that pro tecti on applies only in standards applicable to stare suppression of speech. the context of claims about a nutrient reducing the risk of, or In the view of the petitioners, the FDA simply ignored the First preventing, a disease. The Court has hel d the First Amendment Amendment in irs decision. T he U.S. District Court based irs First not violated when FDA refuses to evaluate health claims that Amendment decision on a hasty ge nerali zati on unsupported by concern the effect of a nutrient on an existing disease (i.e., a so commercial speech precedent. Under rhe governing Central called "treatment" effect). That decision, Whitaker v. Thompson3 2 Hudson37 four-parr test, the first inquiry is to discern whether the (Whitaker ![) , is now on appeaL The appeal will determine speech in issue concerns an unlawful acti vity. If so, then it may be whether sellers of an unpatentable herbal dietary supplement, saw banned outright. The District Court made rhe mistake of defining www.herbalgram.org 2003 HerbaiGram 59 I 55 legal & regulatory rhe speech here in issue (a health claim) as concerning an unlawful to FDA's regul atory encroachment on free speech rights. Commis activi ty (the filing of an ungranted health claim petition), bur the sioner McClellan, Associate Commiss ioner C rawford, and C hief filing of a health claim petition, even an ungrantable one, is a Counsel Troy are all committed to ensuring freedom of informed perfectly legal action. Were the filing of a petition seeking a choice, but they stand in contrast to an entrenched bureaucracy government approval an "illegal" activity within the meaning of ori ginall y res ponsible for unconstitutional health claims suppres Central H udson, it would have been impossible for any parry to sion. While disease prevention claims are now enjoying the bene have ever won a commercial speech case against the government, fits of the new administration's labors to implement Pearson v. to have ever surmounted the first prong. That is because at this Shalala, the task of protecting truth remains unfulfilled so long as level of abstraction every pleading defin ed post hoc as seeking the saw palmetto/ BPH claim and others like it remain effectively ungranrable relief from government censorship would be ipso focto suppressed by the agency. Once again, parties have turned to the an illegal action. Ir would rhus be entirely within the government's courts for reli ef from government censorship. As before, so now power to define our of existence all First Amendment protection freedom hangs in rhe balance. __.- for commercial speech. In every prior commercial speech case decided against the government, the government's proscription j onathan W Emord is a principal with Emord & A ssociates, PC in against speech did not define an "illegal activity" within the mean Washington, D. C. Mr. Emord practices constitutional and adminis ing of Central Hudson. No, the government's speech proscription trative law before the federal courts and agencies. He served as the lead was the very fact in issue. T hus, the Court erred by deciding the counsel in Pearson v. Shalala and each oft he other three federal court case on an erroneous interpretation of the first prong of Central decisions holding FDA suppression of health claims unconstitutional H udson and by thereafter nor applying the remaining three pans of under the First Amendment. H e also represented Dr. Jo nathan V the Central Hudson rest. Were it to have applied all four pans of Wright before the US. Department ofjustice . He is also the author of rhe rest, the Court should have found under the last part an obvi Freedom, Technology, and the First Amendment (Pacific Research ous less speech restrictive alternative to the extraordinary burden Institute for Public Policy, 1991). placed upon the claim by the demand that a new drug appli cation be fil ed as a condition precedent for the utterance of truthful Reference: speech in the marker. The obvio us less restrictive alternative of a 1. On December 18, 2002, FDA Commissioner Mark B. McClellan, health claim petition is one nor proscribed by statute and one that M.D. an nounced that hencefo rth FDA wo uld "make avai lable more and better information about foods and dietary supplements to help comports fully with the First Amendment requirement placed American co nsumers prevent di seases and improve their health by upon FDA by Central Hudson and irs progeny. maki ng so und dietary decisions." See Anon. FDA Announces Initia Moreover, the Court ignored irs obli gations under what is tive to Provide Better Hea lth Inform ation for Consum ers. FDA known as the "avoidance doctrine" - a constitutional rule of News, Dec. 18 , 2002. T he initiative is a dramatic departure from construction that our Supreme Court expects to be followed when preceding agency history which was characterized by claim suppres it is possible to interpret statutory language to avoid a constitu sion. In the words of the U.S. Court of Appeals for the D.C. Circuit: ti onal iss ue. In this case, the First Amendment iss ue could have "FDA appears quite relu ctant to ap prove health claims on dietary been avoided in its entirety were the Court to have interpreted the sup plements." Pearson v. Shalala, 164 F.3d 650, 654 n. 3 (D.C.Cir. 1999). stature in accordance with irs plain meaning. Deference to an 2. See Pearson v. Shalala, 172 F.3d 72 (D.C. Cir. 1999) (wherei n FDA administrative agency taking a contrary interpretation in such un successfully sought rehearing of the Court's decision). 38 instances is forbidden. Yet that is precisely what the Court did. 3. See Pearson v. Shalala, 130 F.Supp.2d 105 (D.C.D.C. 2001); Pear This case is now pending before the U.S. Court of Appeals for son v. Thompson, 141 F.Supp.2d 105 (D.C.D.C. 2001); Whitakerv. the D.C. C ircuit. Resolution of the case will likely trigger a peti Thompson, 2002 U.S. Dist. LEXJS 25299 (D.C.D.C. 2002) . tion to the U.S. Supreme Court from the losi ng parry, seeking that 4. See, e.g., Pearson v. Shalala, 164 F.3d at 655 (fraud rati onale); 164 Court's review. Ultimate resolution of this case will determine F.3d at 656 (safety rationale) . whether companies rhar manufacture unpatentable nutrients will 5. See, e.g., Pearson v. Shalala, 164 F.3d at 654 (expl aining that when the Plaintiffs presented FDA with First Amendment argument in enjoy the freedom to inform consumers of accurate, known disease favor of use of disclaimers as less speech restrictive alternatives to treatment effects of these nutrients. If the Court sides with the censo rship, "FDA declined to consider [that] altern ative ... ") . government, those truths wi ll remain locked out of the market 6. See, e.g., Pearson v. Shalala, 164 F.3d at 659 (rejectin g government place for the foreseeable future because no company will be able to conjecture of public harm as an insuffic ient substitute for proof that afford the high cost of the drug approval process as a condition the harms recited are real and that the restrictions will in fact allevi precedent to telling the public the truth. Furthermore, few would ate the alleged harms to a material degree). be willing to abandon established markets, enter costly new drug 7. Ippoli to PM, Pappalardo JK. Advertising Nutrition & Health: markets and fight for new drug distribution channels. As with Evidence .from Food Advertising 1977-1997. Bureau of Economics Staff Report, Federal Trade Commission, September 2002. Pearson v. Shalala I, this case, Whitaker v. Thompson III, wi ll deter 8. Anon. FDA Announces Initiati ve to Provide Better Health Informa mine whether the right to communicate a truthful and nonmis tion for Consumers. FDA News. Dec. 18, 2002. leading message will survive the contrary will of the FDA. 9. Under the LEA, 21 U.S. C.§ 343(r)(J)(b), a claim of a relationship of a nutrient to a disease or a health-related co ndition may not Ensuring Freedom of Informed Choice appear on the label or in the labeling of a dietary supplement or It has become a truism that eternal vigilance is the price of free conventional food unless pre-approved by the FDA. That pre dom. T hose individuals who, and companies that have fought the approval process requires, in the case of foods (by statute, 21 U .S.C. FDA to ensure freedom of informed choice have paid the price, § 343(r)(3)) and dietary supplements (by regulation, 21 U.S.C. § 343(r)(5)(D)) that FDA find "based on the totality of publicly ava il- and others also will have to guard against a loss ofliberry attendant Continues on page 67 56 I HerbaiGram 59 2003 www.herbalgram.org legal & regulatory Industry Increasingly Nervous about Drug Orientation of FDA's Proposed GMPs for Dietary Supplements: High Costs Threaten Smaller Companies by Mark Blumenthal little mark-up to make sure the formulas are afford able. However, it was not [o ri ginally] clear that this is the nature of uch of the activity in herb industry circles over the spring and the [FDA's] requirements. M summer has focused on the proposal by the U.S. Food and The apparent confusion about how the proposed rules require Drug Administration (FDA) for current good manufacturing prac ingredients and finished products to be tested twice appears to be ti ces (cGMPs) for dietary supplements. 1 As discussed in the last fairly common within some pans of the herb industry. Annette issue of HerbalGram, 2 the 106-page proposal published on March Dickinson, Ph.D., president of the Council for Responsible urri 13 has bee n long-awaited and was initiall y welcomed by industry rion (CRN), a leading industry trade associati on, attempted to organizations. They have been pleading with FDA for years to clarify the situation, explaining that rh e proposed rule's primary publish new rules for the manufacture of dietary supplements requirement is to rest everything in the finished product. If the ava il (including herbs) , as authorized by Congress in 1994 when it able tes ting methodology is not suitable, such tes ting, as an alter passed the Dietary Supplement Health and Education Act native, may be done on all raw ingredients before manufacturing (OSHEA). Congress included this provision in OSHEA to help and again at some point during the manufacturing process. This, ensure that dietary supplement products were properl y manufac in effect, will result in double testing of ingredients to some degree tured, and the materials were properly identified and free of poten if the fin ished product does nor lend itself to the required resting, tially harmful contaminants, so that consumers could have confi and to the ex tent that the suppli er(s) of the ingredient(s) presum dence in these products. ably tested each ingredient prior to se nding them, and then they The biggest iss ue of concern among industry members is the are tes ted again during the processing of the product. apparent drug orientation of the cGMPs. Although OSHEA clearly stipulates that new cGMPs should be "modeled" on GMPs AHPA Holds Reg ional GMP Meetings that are in effect for the manufacture of conve ntional foods, the The American H erbal Products Association (AHPA) held a FDA has added numerous testing provisions that are clearl y based se ri es of fi ve meetings with its members around the country to on pharmaceutical drug GMPs, not food G MPs. The costs discuss the cGMP proposa l. Each of the meetings (in Los Angeles; involved are estimated to be so significant that the general consen Portland, Oregon; San Francisco; Sa lt Lake C ity; and New sus is that many smaller to medium size firms will not be able to Brunswick, New Jersey) was fac ilitated by AHPA Pres ident meet the requirements and will be forced out of business. Ironi Michael McGuffin. A total of 94 individuals from 65 companies cally, this may result in consumers finding a smaller va ri ety of (including 50 AHPA members, about 25 percent of the AHPA herbal supplements from which to choose in the marketplace, membership) attended one of these meetings.3 whi le at the sa me time there may be a higher level of confidence in The agenda for each meeting included the following items: the remaining products. • a general overview of rhe proposed cGMP rul e and of FDA For example, one manufacturer of C hinese herbal formulas, who Press Rel ease of March 7, 2003; reli es on a third-party contract manufacturer to produce the prod • a brief disc uss ion of the impact of the rule on various indus ucts, as is the case with many companies, told HerbalGram that the try segments (e.g., raw material processors; fini shed product continuous testing required under drug GMPs for pharmaceutical manufacturers; marketers); companies might work for so-called "nutraceutical" ingredients • an in-depth review of the proposed rule (from an AHPA (e.g., luteine, lycopene) where there is one plant-derived pure prepared worksheet); substance (or a group of chemically related compounds) where the • a brief review of FDA's 1999 survey of the dietary supplement manufacturer produces and se lls millions of dosage forms of the industry; one product or ingredient. However, he said, his company markers • discussion of FDA's economic analys is of the projected impact more than 100 products, each containing up to a dozen ingredi of the proposed cGMPs. ents. If each ingredient is subjected to quali ty control tes ting, and "Visiting our members in their own neighborhoods has been, if then the finished product is also required to be tested, the costs somewhat roo fast a pace, a very satisfying process," said McGuf were simply too hi gh and were not reaso nab le nor sustainable, he fin. "I have heard several clear messages from the industry, wh ich said. He would simply have to go out of business. In an email to cl ea rly support prompt implementati on of cGMP for supplement the author on June 26, 2003, he wrote: products that will meaningfully address manufacturing iss ues, but I had a chance to go over in some more detail the GMP who see real problems with FDA's proposal and especiall y with that proposal by FDA. The rather extreme testing protocols that agency's erroneous ass umptions about this trade. The input that we had been relayed to me previously do not seem entirely have now received from AHPA's members and others has been evident from the proposal. For example, [a nother C hinese essential to the initial preparation of our co mments." The period herb manufacturer] suggested that every materi al would have for publi c co mment on the cGMPs was extended to August 11. to be tes ted thoroughly prior to use in manufacturing, and They were origi nally due June II, but FDA res ponded favorably again after manufacturing, including rests of microbiology, to industry req ues ts for the extension due to the massive amount pes ti cides, heavy metals, etc. Such testing, especially double of material to evaluate in the proposal. testing, is ruinous to a small organization such as ours where AHPA has now prepared a report that summarizes all of the we produce over 150 different formulas, with an average of input from the participants at these five regional meetings. The two batches per year, and 500 different raw materials, with document can be accessed by AHPA members at the AHPA www.herbalgram.org 2003 HerbaiGram 59 I 57 legal & regulatory website, 58 I HerbaiGram 59 2003 www.herba lgram.org market report Phytomedicine Sales Off Slightly in Germany espite increas ing sales of conventional medicines, the sale of herbal prepara D Table I: Conventional Drug, Phytomedicine, and Nutritional tions (phytomedicines) dropped almost two percent in Germany in 2002, according to Supplement Sales in Germany 2002* recent data obtained from a leading organi Product Class Euro value Units sold zation that compiles sales statistics of (change from 200 I) (change 200 I) conventional drugs, phytomedicines, and Human medicines 16.7 bil lion Euros 1.341 billion packs conventional nutritional supplements. All (+ 8.8%) (+ 0.2%) data in the table below are related to the Phytomedicines 965 million Eu ros (-1.8%) 185 million packs ( -6.2%) "ambulatory" or retail sector (i. e., excluding Nutritional supplements 133 million Euros (-1 1.3%) 23 million packs (- 11.9%) sales in hospital pharmacies), and include Total market 18.7 billion Eu ros 1.654 billion packs wholesale sales by distributors and sales directly to pharmacies by the manufacturer * 12-month period from O ctober 200 I to September 2002 at factory-direct prices. The sales data [Source: Mertens, G. Personal communication to M. Blumenthal. Nov. 30, 2002 with data from reflect net sales, with promotional and Remed ·x Gesellschaft fUr Trendanalysen im Gesundheitssektor [Remed'X Society for Trends Analysis volume rebates and returns already in the Health Sector], Mainz, Germany.] deducted. _A he Atlas of Texas covers about haseoltts beans are a fascinating T6000 taxa. This is the result of Pgroupl So much variability exists 54 years of herbarium and fieldwork that five distinct species have been by B.L. Turner, beginning in 1948 at domesticated-a size, shape, color Sui Ross State University, Alpine, pattern and flavor to satisfy most Texas. In short, the senior author has everyone, and nutritious, tool This lavishly illustrated monograph is the examined personally, touched, or most comprehensive botanical treat "pored over" an estimated seve ral ment of beans to date. It starts with hundred thousand sheets in the a brief history about the former taxo preparation of the forthcoming Atl as nomical treatments of the ge nus, vo lumes. Contents include an intro and goes on with the taxonomical duction, atlas of Texas plants arranged alphabetically by family, by criteria and a presentation about genus, by species, and an index. discriminant characteristics. It presents a full description of each www. brit.org/sida/sbm/sbm24toc.htm section and species, its distribution and habitat, relationships with Atlas of the Vascular Plants of Texas other species, uses and potentially useful traits, and historical By B.L. Turner, Holly Nichols, notes. Color pictures, line drawings and distribution maps lead Geoffrey Denny, Oded Doren easily to the right identification of each species. Sida, Bot. Misc. No. 24, 2003 www.brit.org/sida/sbm/sbm23toc.htm issn 0833-14 75 Taxonomy, Distribution, and Ecology rsbn (vol. l) 1-889878-08-1 of the Genus Phaseolus (Leguminosae-Papilionoideae) isbn (vol. 2) 1-889878-09-X 1 11 in North America, Mexico and Central America 7 '!2' X 10 Vol. 1 approx 630 pp . By George F. Freytag Vol. 2 approx. 275 pp. Daniel G. Debouck Vol. 1 $50+ p&h* Vol. 2 $40 + p&h* Sida. Bot. Mrsc. No. 23. 2002 Set $80 + p&h • issn 0833-1475. isbn 1-88878-11-1 . *USA: $10 (vol. 1); $9.50 (vol. 2) ; $12 (se t) 7"' )Q". X".iii + 300 pp. 'International: $12.50 (vol. 1); 97 b/w figures and distribution maps, 5 color plates (60 figs .) . $11.50 (vol. 2); $25 (set) 540 + p&h Texas residents add sales tax: $4.13 (vol. 1); $3.30 (vol. 2): 57.43 (se t) (USA $4; international $8) Texas residents add $3.30 sales tax. Available from Botanical Research Institute of Texas Press 509 Pecan Street· Fort Worth, TX 76102-4060, USA BRIT E-mail: [email protected] ·Fax 1-817-332-4112 www.brit.org PRESS www.herbalgram .org 2003 HerbaiG ram 59 I 59 conference report Third World Congress on Medicinal and Aromatic Plants for Human Welfare by Bill Schoen bart, L.Ac. he Third World Congress on Medicinal and Aromatic Plants for Bachrach and Prof. Zohara Yaniv. Dr. Bachrach showed that THuman Welfare (WOCMAP III) was held in Chiang Mai, epigallocatechin-3-gallate (EGCG), one of the well-known Thailand, on February 3-7, 2003. Occurring every five years, this polyphenols in tea (Camellia sinensis (L.) Kuntze, Theaceae), is able latest WOCMAP conference was attended by more than 500 to shut off a gene related to the transformation of normal cells into participants from 50 countries. Over the course of the week, there cancer cells. The EGCG had no effect on normal cells, while it were 130 oral presentations, 415 poster presentations, and 120 inhibited the growth of transformed cell s. For many in the audi exhibitors. This article can only summarize the topics discussed and ence, this was the first time they had seen the direct effect an herb highlight a few of them. can have on a gene. The theme of WOCMAP III was "Biodiversity and Sustainable Prof. Yaniv presented Use through Science and Technology, Trade and Industry." The epidemiological data conference had many co-sponsors and was co-hosted by the Inter that showed an associa national Council for Medicinal and Aromatic Plants, the Faculty of tion between green tea Science at Chiang Mai University, the International Society for consumption and lower Horticultural Science, and in association with the National rates of prostate and Research Council of Thailand, the Ministry of Agriculture and stomach cancers in Cooperatives, the Ministry of University Affairs, the Science Soci China. She also pointed ety of Thailand Under the Patronage of His Majesty The King of out that the addition of Thailand, the National Center for Genetic Engineering and milk or soy milk to tea Biotechnology, the Government Pharmaceutical Organization, and can inactivate many of the United Nations Food and Agricultural Organization Regional the polyphenols. The Office for Asia and the Pacific. conclusion of these two The opening ceremony featured Her Royal Highness Princess researchers was that Maha Chakri Sirindhorn, who welcomed the attendees to T hai green tea, and specifi- Her Royal Highness Princess Maha Chakri Sirind- horn welcomed the attendees to Thailand and land. The princess, who speaks five languages and holds a degree in cally EGCG, can be opened the exhibi ti on hall with a formal ribbon chemistry, also stressed the need to preserve and protect medicinal used to prevent and cuttin g ceremony. and aromatic plants worldwide and encouraged everybody to possibly to cure certain appreciate the importance ofThailand's rich botanical heritage. types of cancer. On the first evening, a reception was held for all the attendees on In another look at green tea, Dr. K. Ingkaninan and his associates the campus of Chiang Mai University. Showing their renowned from Thailand reported on a clinical trial using green tea and guava hospitality, the Thai hosts went out of their way to make everybody (Psidium guajava L., Myrtaceae) fruit as a mouthwash. The feel welcome. Students from randomized, double-blinded crossover study demonstrated that the the university, wearing tradi herbal mouthwash was just as effective as Listerine® in suppressing tional dress, offered aromatic mouth odor. garlands and gifts to the guests There were quite a few oral and poster presentations that demon at the entrance to the lakeside strated the efficacy of medicinal and aromatic plants as antibacter area. Numerous booths offered ial and antifungal agents. Dr. Rudolf Bauer, professor at the Insti delicious Ianna (Northern tut fiir Pharmakognosie, Karl-Franzens-Universitat, Graz, and a Thai) food, while dozens of researcher widely known for his work on echinacea (Echinacea spp.) small glowing hot air ball oons and the anti-inflammatory effects of Chinese herbs, presented his were released into the night findings on a traditional Thai herb used for diarrhea. Along with sky. Traditional musicians and Dr. 0. Luanratana and Dr. M . Phadungkit ofThailand, he showed dancers performed on the main that fractions of the herb shoe-button ardisia (Ardisia elliptica stage, while a small replica Thunb., Myrsinaceae) were active against va ri ous species of Salmo village displayed a wide variety nella, Shigella, Staphylococcus, and Escherichia coli. of village crafts, foods, and A number of oral and poster presentations discussed the antifun herbal preparations. This gal and antibacterial properties of essential oi ls of cloves (Syzygium extraordinary show of affection aromaticum (L.) Merr. & L.M. Perry, Myrtaceae) and cinnamon and hospitality by the Thai ( Cinnamomum verum J. Pres! , Lauraceae). In one study, a concen hosts was greatly appreciated tration of 1 percent w/v of each essential oil inhibited bacteria and by all the attendees. fungi better than synthetic chemical preservatives. The official opening ceremonies of the Back at the conference, the In summary, the topics discussed during WOCMAP III include exhibit ofWOCMAP Ill in Chiang Mai, numerous excellent presenta the following: Thailand, included students in tradi tional Thai dress releasing illuminated tions included a husband-and • The importance of biodiversity and sustainable management hot air balloons into the night wife team from Israel, Dr. Uriel practices to the survival and development of existing and new 60 I HerbaiGram 59 2003 www.herbalgram.org conference report products from medicinal and aromatic plants. va nous kinds. PPOs' • The iss ues and implications of regulation on the economics mechanisms of action and marketing based on the European experi ences, and the have also been restrictive issues for suppliers and manufacturers. discovered. • The role played by plant alkaloids in the world pharmace utical • The announcement industry. of a project involving • The significance of biodiversity as fundamental to plant the production of improvement by breeding and biotechnology of medicinal and organically certified aromatic plants. medicin al, aromatic • Sustaining the harvest of medicinal and aro matic plants and and dye plants in the challenges to be met in both production and marketin g, Asia to be under based on current and future likely demands, consumer prefer taken by member ences, perceptions, and demographics. countries with the The exhibition hall included 120 different • An in-depth evaluation of the use of C hinese medicinal plants Food and Agriculture vendors and exhibits. including th ose that in western medicine. Organization of the demonstrated the biodiversity ofThailand • The biologically active substances from medicinal and United Nations. and other region s. Photos by the author. aromatic bryo phytes and inedible mushrooms. • Creating li veli hood- • The research approaches for bio-pros pecting and sc reening of based sys tems in vo lving medicinal and aromatic plants for medicinal and aromatic plants. smallholder farmers in As ia. • Issues relating to conservation of medicinal and aromatic At the conclusion of the conference, the participants all agreed plants, specifically the huge conservation efforts for more than that it was highly informative and inspiring. We all look forward to 1,700 medicinal and aromatic plants in China. the next WOCMAP conference in five years. ---' • Standards and quality control of medicinal and aromatic plant products. Bill Schoenbart is a licensed practitioner of traditional Chinese • Use of marker technologies and genomics for quality co ntrol medicine. He is the author of two books on herbal medicine and is a and efficacy of medicinal and aromatic plants. contributing author for the American Herbal Pharmacopoeia. Bill is • The myriad of medicinal and aromatic plant products the manager ofbotanical science for the Perrigo Company ofGreenville, produced and sold in Thailand. South Carolina, and is a member of the Board of Trustees for the • Positive scientific proof that the polyphenol oxidases (PPOs) American Herbal Products Association. found in green tea can prevent and poss ibly cure ca nce rs of International Council for Medicinal and Aromatic Plants Background The International Council for Medici fields related to these plants that play such University in Eskisehir, Turkey nal and Aromatic Plants (ICMAP) was an important part in the lives of human Vice-President: Prof. Or. P. Pushpan founded on June 8, 1993 at the Secretariat beings throughout the world. Its website is gadan, Director, National Botanical of the International Union of Biological etiveria: The Genus Vetiveria, edited ities reported for veti ve r. V by Massimo Maffei. Taylor & Francis: C hia's Chapter 5, Ethnopharmacology New Book Profiles New York; 2002. 19 1 pp., hardcover, and Pharmacological Properties of Vetiveria includes index, photos, tables, references. zizanoides- Including Pharmacologic and ue to economic considerations $96.00 ISBN 0-4 15-27586-5. Pharmacokinetic Properties, is admittedly Dand the natural evolution of book T his is my second review of a useful book "a short communicati on" on the "personal marketing and sales, the American in the ongoing Taylor & Francis seri es, Cameroonian experi ence of Dr. Nwaimbi Botanical Council is adding to its cata Medicinal and Aromatic Plants: Industrial Simon Chia who collected a certain amount log very few of the good new books Profiles. Perhaps it is my personal bias, but of data." that are being published. However, we I did not feel this book was as tightly edited "(R]ootsoo. have bee n shown to take care do intend to keep our readers informed as the volume I previously reviewed of a va ri ety of unrelated health haza rds. of books of particular interest that have (A rtemisia in HerbalGram 57). Amongs t such uses are arrived in our offices. In this issue we Howeve r, all in all , it is a antibiotherapy, antimalarial launch a new feature, New Book useful volume. treatment, anti-inflammatory Profiles. Here, we only describe these Vetiver ( Vetiveria zizanoides effects, and the treatment of new books; we have not yet had them (L.) Nas h ex Small, Poaceae) is stomatological and dietetic reviewed. one of those rare plants that is problems." If you wish to purchase any of these both economicall y and I suspect that the foll owing books or those that have been reviewed ecologica ll y important. T he quote derived from a study of fully, please go to the book review essential oil from the roots, one patient: "Roots oo• have a section on our website Ethnopharmacology and Pharmacological of the ground powder of the roots 00 0 when Properties. Maffei also gives a half page of chewed will relieve toothache in less than The Herbal Internet Companion: Herbs colloquial names, including approximately fifteen minutes. This treatment can be and Herbal Medicine Online, by David Owen, MLS , PhD. The Haworth Press: Bing 30 Sanskrit names alone. repeated as often as four times a day." hamton, NY; 2002. 193 pp., softcover. In C hapter 2, co ntributing authors In Chapter 6, Veti ve r Grass Technology, $49.95 ISBN 0-7890-1051-8. Bertea and Camusso cover the anatomy, Truong discusses the morphology, physiol Explains how to assess the quality of health biochemistry and physiology. Zarotti, in ogy, ecology, and weed potential, and how information on the internet; use online C hapter 3, covers collection, harvesting, the plant can be used in erosion control; so il indexes and database such as Medline; find mailing lists, chat rooms, and newsgroups; processing, alternative uses, and production conservation and stabilizati on; reclaiming examine evidence about specific products; of the essential oil. T he updated U.S. saline and acid sulfate so il s, mine rehabilita access internet resources in specialized health Department of Agri culture phytochemical tion, trapping agrochemicals and nutrients, areas; research product side effects, adverse database (o nline at < http:/ /www.ars etc. In Chapter 7, Biotechnology, Muccia reactions, drug interactions and more. grin.gov/dukel>) sugges ts a much wider relli and Leu pin stress cell and tissue culture Phytochemicals in Nutrition and Health, edited by MarkS. Meskin, Wayne R. Bidlack, range of essential oil content than Zarotti methods, underscoring the importance of Audra J. Davies and Stanley T. Om aye. CRC (USDA database 0.2-3.3 percent, prese rving and in vestigating the ge ne pool Press: Boca Raton, FL; 2002. 203 pp., hard compared to Zarotti's 0.5-2 percent). to find useful traits that might be improved cover. $109.95 ISBN 1-58716-083-8. Akhilka and Rani in Chapter 4, Chemi or engineered. Provides answers to questions concerning the cal Constituents and Essential Oil Bioge ne In Chapter 8 (Economic Importance, mechanisms of action associated with benefi sis in Vetiveria zizanoides, lamentably give Market Trends and Industrial Needs, and cial phytochemical groups. It examines new areas such as the efficacy and safety of medic no quantitative data, but they are ge nerous Environmental Importance), Pease suggests inal herbs, the use of biotechnology to manip with structural diagrams (more than 75) that creating a "vetiver hedge" can cost less ulate and enhance the phytochemical profiles and esse ntial chemical detail s, well refer than US$30 per hectare compared to more of various plants, and the pharmacokinetics of enced. I have added those that were new to than $500 for conve ntional engin eered phyrochemicals in humans. the US DA phytochemical database, and terraces. But in the same chapter Pease cites Natural Medicine Instructions for Patients, by Lara U. Pizzorno, Joseph E. Pizwrno Jr., will make the updated li st of more than 100 costs of US$ 11.55 equivalent per linear ND, Michael T. Murray, ND. Churchill phytochemicals ava ilable to HerbaLGram meter. He eve n offers some medicinal infor Livingstone: Philadelphia, London; 2002. readers who so reques t, along with a mati on: sleep inducer, nerve tranquilize r, 374 pp., softcover, illustrated, CD-ROM. summary of reported indications and activ- and diaphoreti c; and mentions its insect $49.95 ISBN 0-443-07128-4. continues on next page 62 I HerbaiGram 59 2003 www.herbalgram.org book reviews repell ent qualities, especially against fl eas and medical foods. The regul atory frame and moths. H e further mentions its use as a work for di etary supplements is descri bed, Gives clear, concise, accurare, and readable information for patienrs abour narural medi leaf tea, curry seasoning, mea t spice, and as are the interacti on of the food, drug, cine approaches ro the rrearmenr of more than pleasant aroma, as well as adding roots to homeopathic drug and di etary supplement 70 speci£c conditions. In addition ro helping drinking water or insect repellant sachets. definitions. Against this framework, there is patienrs to understand their condition better, Vietmeyer, in the fin al chapter, Beyond the a discuss ion of the present state of law it covers more than 70 conditions with full Vetive ri a H edge - Orga ni zing Vetive r's enforcement. Importantly, there is a descriptions of each condition, prevenrion measures, expected outcomes, and rrearment Next Steps to Global Acceptance, notes that substantial discuss ion of the complex regu options. Creared as a companion to Tht! Tt!Xt controlling so il erosion is, by fa r, the bes t latory scheme for the ingredients used in book of Natural M t!dicinf! (Churchill Living understood and farthest advanced property. foods and dietary supplements. stone, 1999), the book is inrended ro be "This coarse grass with its roots like chicken There is a good and understandable photocopied as needed for patienrs; accompa nying CD-ROM enables users to select and mesh projecting several metres into the soil explanation of DSH EA's new dietary ingre prim files. probably can strengthen earthen structures di ent notificati on provision, the ga tekeeper Herbal Medicine: Chaos in the Market such as small dams and dikes." It holds soil. provision that applies to dietary ingredients Place, by Rowena K. Richrer, MPH, MBA. It converts greenhouse gases into useful that were not on the market in dietary Haworth Press; Binghamron, NY; 2003. 220 solids. supplements at the time D SH EA was pp., sofrcover. $19.95 ISBN 0-7890-1619-2. If vetiver could be of use to you, this enacted in October of 1994. This provision Conrains a thorough historical accounr of botanical regulation including insighr inro the book would be of use to yo u. Unfortu and this discuss ion is important because developmenr of the most relevant current law, nately, the peo ples of the Third World who this is the provision that allows the Food the Dierary Supplemenr Health and Educa need it most can afford it least. ---" and Drug Administration (FDA) to look at, tion Act of 1994. In addition, it provides -James A. (Jim) Duke, Botanist evaluate, and pertinent information on the regulation of Green Farmacy Garden provide its vi ews herbal products in other nations, including Canada, Germany, France, and the Unired Fulton, MD on new ingredi Kingdom. Illusrrative examples of porentially ents that are useful and potenrially harmful herbs are also ietary Supplements and Functional intended for use discussed. DFoods: A Practical Guide to FDA in dietary Herbs in the Treatment of Children: Lead Regulation, by Stuart M . Pape, Dani a! A. s upplem e nts . ing a Child to Health, by Julian Scott, PhD, Teresa Barlow. Churchill Livingstone: St. Kracov, Paul D. Rubin. Thompson Publish The book 1s Louis, MO; 2003. 333 pp., sofrcover, photo ing Group: Tampa, FL; 2001. 394 pp., instructive with graphs. $36.95 ISBN 0-443-07163-2. including nine appendices, plus index, soft res pect to the Guides readers through the use of therapeutic cover. $307 ISBN 1-930872-02-X. do's and don'ts herbs in the rrearmenr of childhood illnesses, of notifications focusing on methods thar lead a child back ro health rather than jusr suppressing symproms. Comprehensive is the signal word that under this provi lr also provides inforrnarion on recurrenr and describes Dietary Supplements and Func sion and provides a li sting of "all owed" and chronic illnesses, cause and patterns of each tional Foods: A Practical Guide to FDA Regu "rejected" new dietary ingredient notifica illness, and complications and dangers associ lation. Authored by three seasoned and tions. It is interes ting to note that the listing ated with using herbs to rreat children. experienced food and drug lawyers, the of allowed new dietary ingredient filings CRC Handbook of Medicinal Spices, by James A. Duke, PhD, Mary Jo Bogenschucz book tracks the history of dietary supple shows that important new dietary ingredi Godwin and Judi Ducellier. CRC Press: Boca ment law and regul ation, and the political ents have met the requirements of the act Raron, FL; 2003. 348 pp., hardcover, illus basis for the stunning passage of the Dietary (e.g., huperzine, SAM-e, as taxanthin, plant rrated. $119.95 ISBN 0-8493-1279-5. Supplement H ealth and Educati on Act of stanol fatty es ters, vinpocetine, 7-keto Provides the science behind the folklore of 1994 (DSHEA). All of the rel evant Federal DHEA, and stevia). This demonstrates that more than 60 popular spices. Ir presenrs a chemical analysis of each spice, their biologi regulatory authorities and their jurisdic the dietary supplement industry is being cal activities, indications, and the cuJinary ti ons are described. The role of the States is attentive to the requirements of law. aspecrs of many medicinal spices. It also lisrs also briefly di scussed. Most importantly, Since this book was only recently septic organisms killed or whose growth is this book, in detai l and with substantial published, it does not di scuss the newly curbed by each spice. citati on to the law and to FDA's regul ati ons, proposed dietary supplement current Good Lavender: The Genus LAwznJ.u/4, edired by puts the li e to the nati onal press mantra that Maria Lis-Balchin. Taylor & Francis: New Manufacturing Practi ces (cGMPs) that York; 2002. 268 pp., hardcover, phorographs. dietary supplements are not regulated. were published by FDA in ea rl y March $128.00 ISBN 0-415-28486-4. The authors orga nize this book into rele 2003. This does not detract fro m the value A comprehensive volume covering all aspecrs vant subject areas that correspond to the of the book to the industry because it will of our current knowledge of lavender, includ areas of most interes t to product devel opers take FDA some time to sort out the many ing: taxonomy, hisrory of usage and nomen clarure; lavender cultivation; phyrochemistry and manufacturers, with chapters that comments it will receive on its proposal and of the genus; chemisrry of Lavandu/4 oils; include history, safety, good manufacturing to put together fin al cG MP regulati ons. It pharmacology and therapeutic properties; use practices, labels, claims, advertising, inspec took FDA almost eight yea rs to evolve fro m of lavender oil in aromatherapy, cosmetics, tions and enforcement, and an overview of the industry's draft cGMPs to a Federal perfume, and food processing; theory and international regulati ons. They address in Register proposal. Moreover, the publisher practice of disrillation and standardization of lavender oils. detail the most popular relevant product provides an on-line service that provides categories: conventional foods, so-called more current materi als. The on-line service functional foods and dietary supplements, continues on next page www.herbalgram.org 2003 HerbaiGram 59 I 63 book reviews is helpful, but attentio n ro FD A's and FT C's hour of time fro m any of the lawyers who Phytomedicines for Respiratory Tract websites a nd their repo rts o n current wrote It. Diseases, by Sigrun Chrubasik, MD, Basil Roufogalis. Australian Pharmaceutical matters can be used ro keep current. H opefully, this book will not become yet Publishing Company: Balmain, NSW, As Casey Stengel used ro say, "Yo u can another unregarded primer o n regulatory Australia; 2002. 80 pp., softcover. $A27.50 look it up." T his book puts FDA enforce compliance and lawful business practices in (± US$18) ISBN 0-9580664-0-X. ment powers and acti o ns near the end of an industry so blinded by no n-enfo rcement Lists 45 phytomedicines traditionally used to the text, appropriately eno ugh. Enfo rce and indifference that it has a very difficult treat respiratory tract diseases. Each entry lists ment has, so fa r, been at the end of FD A's time staying on the ri ght side of the road. the effectiveness of the product based on clin ical studies, human pharmacological investi li st of priorities, and you can look it up on T his book sho uld be read and fo llowed - gations, and in vivo and in vitro experiments. FDA's website fo r W a rning Letters to and copies should be provided by the indus It also provides the recommended dosage, dietary supplem ent m arketers and fo r try ro the press so that they can heft the information on adverse events, toxici ty, seizures, injunctions, and criminal prosecu weight of regulatio n on this industry. ___.. contraindicatio ns, warnings and precautions. tio ns in the dietary supplement industry. -Anthony L. Yo un g Growing At-Risk Medicinal Herbs: Culti vation, Conservation and Ecology, by T his lack of enforcement led the trade asso Klei nfeld, Kapla n & Becker, LLP Richo Cech in cooperation with United Plant ciations of the dietary supplement industry Washingto n, D.C. Savers. Horiron Herbs: Williams, OR; 2002. ro ask Congress ro earmark funding for apping the Green Market: Certifica 323 pp., softcover, illustrated. $14.95 ISBN FDA to enfo rce OSHEA. In contrast, the tion & Management of Non-Timber 0-9700312-1 -1. T book places dietary supplement and func Forest Products, edited by Patricia Shanley, Provides information needed to grow at-risk plants from the foundation knowledge of a ti o nal fo od ad ve rtising ahead of FDA Alan Pierce, Sarah A. Laird & Abraham seedsman, grower, and conservationist. A enforcement and describes the controlling G uillen . Earthscan Publicatio ns Ltd., compelling book on one of the most impor principles fo r advertising, incl uding the Lo ndon, U .S. distributors: Stylus Publish tant issues facing the future of botanical competent and reli able scientific evidence ing 64 I HerbaiGram 59 2003 www.herbalgram.org book reviews systems, with a fo cus on the relationship of and cons of potential certificati on are timber certification to the ce rtification of prese nted and discussed. The species Alkaloids: Nature's Curse or Blessing? non-timber fores t products (NTFP). The described represent a dive rse cross secti on of by Manfred Hesse. Verlag Helvetica editors of this volume have extensive expert plant parts including res ins, barks, roots, Chemica Acta, Wiley-VCH: Zurich, Switzerland; 2002. 413 pp., hardcover, ise in the area of timber certifi cation and fibers, and herbs. photographs, illustrations. $135.00 ISBN the realities of people and communities in T he profiles of greates t interes t to 3-906390-24-1. biodive rsity-rich nations. The las t part of Herba!Gram readers will be the medicin al Provides detailed information regarding Section 1 provides an overvi ew of three fi eld pl ants that are sold as phytomedicines and alkaloids. Information includes classifica tests of guidelines (presented Appendix I) dietary supplements: Ameri can ginse ng, tion and structure, synthesis and chemotax onomy, and chiroptical properties of alka fo r NTFP certification of sapodilla or chicle griffo nia, yo himbe, amla, pau d'arco, ca r's loids. Also talks about biogenesis and (Manilkara zapota) in Mex ico, Braz il nuts claw, sangre de drago, and copaiba. I was biological significance of alkaloids, active (Bertholletia excefsa) in Bolivia, and hearts of es peciall y fascinated with the profile of grif principles from selected alkaloid sources, cabbage palm (Euterpe oleracea) in Brazil. fonia, and the impact of the rapid rise in and their cultural and historical signifi These three cases are fasc inating. T he fact demand for ex tracts containing 5-HTP, cance. Case Studies in Natural Medicine, edited that there was no chicle harvest in 1999, due considered a possible wei ght-loss pro duct, by Melvyn R. Werbach, MD. Third Line to a drop in demand from Japan, clearly that began in 1997. One of the important Press Inc.: Tarzana, CA; 2002. 408 pp., ill ustrates that certification of NTFPs as a and common lesso ns lea rned from the gri f hardcover with diskette. $49.95 ISBN 1- value-added marketing tool will always fonia story is that the crea ti on of ex traction 891 710-02-8. need to be closely linked to creating and facilities in Wes t Afri ca can grea tl y enhance A compilation of 668 individual case reports in the field of natural medicine maintaining markets. In fact, the innovative the local va lue of the NTFP in the country selected for their educational value. The company call ed Wild Things is creating of ori gin. One plant that would have bee n a reports are grouped according to the illness awareness and demand in the U .S. and good addition would be dev il 's cl aw whose treatment they best illustrate, and European marketplace with it chicle-based (Harpagophytum procumbens) fro m the contain acrual stories of people treated with "Jungle G um." T he Brazilian case study south Afri ca region. M uch has been nutrition and supplements. In addition, it provides information on dietary, nutri presents a number of details and observa published recently on harves ting and tional, and herbal treatments for 15 5 differ tions. One of the reasons that the Brazilian social/benefit sharing iss ues associated with ent illnesses. palm heart harves ting operati on sought this medi cin al herb. Ancient Herbs, Modem Medicine: NTFP certification from the Forest Stew T he third section of the book discusses Improving Your Health by Combining ardship Council (FSC) was that the envi the fundamental elements of NTFP certifi Chinese Herbal Medicine and Western Medicine, by Henry Han, OMD, Glenn ronmental policies of fin ancial inves tors cati on, including chapters on the iss ues E. Miller, MD, and Nancy Deville. required third-parry ve rificati on o f the associated with marketing, ecology, techni Bantam: New York; 2003. 468 pp., soft company's fores t management practices. cal pro blems and the social framework of cove r. $13.95 ISBN 0-553-38118-0. T he second section of the book presents harves ting communities . A ve ry important Demonstrates the many important, highly profil es of NFTP species from around the chapter discusses the importance of TFPs effective ways Chinese medicine and West ern medicine can complement each other world. The li st includes chicle, Brazil nuts, as part of subsistence li velihoods among the in treating everything from allergies and palm hea rt, pau d' a reo ( Tabebuia impetigi cui tures that harvest these plants. insomnia to mental illness and cancer. Ir nosa), eat's claw ( Uncaria tomentosa), breu The fourth and fin al section of the book also offers informative case studies on the res in (Protium spp.), titica vine (Heteropsis provides an overview of what primary importance of Western techniques in diag spp.), amapa (Parahancornia spp. and lessons have been learned about the process nosing serious diseases, and why Chinese medicine offers the most effective treat Brosimum spp.), copaiba (Copaifera spp.), of working to certi fy NTFPs and the chal ment for many chronidrecurrem illnesses, and dragon's bl ood croton (Croton lechleri, lenges that will need to be addressed in restoring essential balance to the five ener or sangre de drago) from Larin Ameri ca. The order to create a functi onal system ofNTFP getic systems (the heart, lung, spleen, liver, North Ameri can species include American certification. The actual tec hnical guide and kidney). ginse ng (Panax quinquefolius), maple trees lin es for assessin g the management of Mosby's Handbook of Herbs and Supplements and Their Therapeutic (Acer saccharum) and fiddlehead ferns NTFP and reso urces for doing this are Uses, edited by Steven Bratman, MD, and (Matteucia struthiopteris). Afri can species presented in Appendi x I, II , III. Andrea M. Girman, MD, MPH. Mosby: include griffonia ( Gri/fonia simplicifolia), T hi s is an excell ent book, offering much St. Louis, MO; 2003. 1334 pp., sofrcover. baobab (Adansonia digitata) , yohimbe derail , history, and practi cal data on the $34.95 ISBN 0-323-02015-1. (Pausinystalia johimbe), and rattan (various entire issue of how to approach the certifica Provides information on approximately 85 herbs, 80 supplements, and 75 common spp.). Asian species include amla (Phyllan ti on ofNT FP. We will need many more such conditions. Ir focuses on the issues most thus emblica), and Sumatra benzo in tree books and wo rks , if we are going to create relevant to actual clinical practice, such as (Styrax spp.). T he Mediterranean species sustain able and equitabl e long- term drug interactions, safety issues, and identi include mas tic gum (Pistacia lentiscus), cork managed producti on of many of the plants fication of the natural products patients oak (Quercus suber), pine nut (Pinus pinea) , desc ribed in this book. T his is, in many ways, may be using. For each herb and supple ment, provides scientific evidence (double argan (Argania spinosa), and ches tnut terra incognito and this publicati on is an blind trials) regarding the uses, dosage, and ( Castena sativa). in valuable primary resource. If a company ~echan_ism of~ ction , safety, and drug The species profil es present the sociolog wishes to sugges t that they are producing a mteracuons...... ,.. ical, ecologica l, cultural, and marketing product that is part of a sustai nable harvest derails for each of the species. Also, the pros ing sys tem, this book helps provide a reali ty www.herbalgram .org 2003 HerbaiGram 59 I 65 book reviews check for consumers, scientists, journalists, the color of roots, bark or wood, the scent, Plant Use) moves the reader into the "big development workers and environmentalists. texture, taste, and even the sound created picture" of resource utilization. This Congratulations are due to the editors and when bark is slashed. includes information on how to utilize authors for helping to lead the way toward The third chapter (Settlement, Commer aerial photographs and satellite images, responsible and sustainable approaches to the cialization and Change) contains an amaz along with local knowledge, to create maps management of NTFP. _. ing series of cools co understand the move as part of participatory mapping programs. ment of plant species of trade into and out The final part of Chapter 6 mentions -Steven R. King, Ph .D. of local and regional markets. The 35 pages cultural views of landscapes, which provides Vice President of Ethnobotany & Conservation on this copic begin with subheading "Local a wonderful introduction to the complex PS Pharmaceuticals Inc. Markets: order within chaos." Like most and critical cultural component of resource South San Francisco, California ethnobotanists, I have always been fasci use, conservation, and management. nated and intrigued by markets around the Chapters 7 and 8 (Conservation, Behav pplied Ethnobotany: People, Wild world. After reading this section, I wi ll ior, Boundaries and Belief, and Striving for APlant Use and Conservation, by never look at market the same way again. Balance: Looking Outward and Inward, Anthony B. Cunningham. Earthscan Publi For resource management studies, this respectively) seek co weave cogether the cations Ltd, London, U.S. distributors: chapter is an invaluable tool for under cultural and community boundaries of this Stylus Publishing 66 I HerbaiGram 59 2003 www.herbalgram.org FDA Continued from page 56 WELCOME TO THE WONDERFUL able scientific evidence (including evidence from well-designed stud ies co nducted in a manner which is co nsistent with generally recog WORLD OF ROOIBOS® nized scientific procedures and principles), that there is significant scientific agreement, among experrs qual ifi ed by scientific training and experience ro eval uate [the] cl aims, that the cl aim is supported by such evidence." 10. See generally Pearson v. Shalala, 164 F.3d at 654 {D.C.Cir. 1999) ("A ... folate-neural tube defect claim supported by appellants - that co nsumption of folate reduces the risk of neural tube defects - was in itially rejected bur ultimately approved for both dietary supplement and food labels .... The parties disagree on what caused rhe FDA's change of position on this claim. Appellants contend that political objections - Senator H atch was one of the complainers - concen trated rhe agency's mind. The FDA insists that its initial denial of the claim was based on a concern that folate consumption might have harmful effects on persons suffering fro m anemia, and that irs concern was alleviated by new scientific studies published after the initial Aspalathus linearis - Red Bush Tea denial of the claim.").] ROOIBOS® (Pronounced ROY-BUS) 11. Se nate Report 103-410, "Dietary Supplement Health and Education Act of 1994" {O crober 8, 1994) at 16. Rooibos® is no ordinary tea! It has a distinc 12. Se nate Report 105-43, "Food and Drug Administration Moderniza tive taste and aroma, is naturally calorie and tion and Accountability Act of 1997" Ou ly I, 1997) at 49-50. 13. 164 F.3d 650 (D.C.Cir. 1999) ("Pearson!'). caffeine free and contains no additives, preserv 14. FDA asked for rehearing of the case, but its request was denied in an atives, or colorants. The perfect drink for the 11-0 opinion of the entire Court of Appeals for the D.C. Circuit. See health conscious family. Pearson v. Shalala, 172 F.3d 72 (D.C.Cir. 1999). 15. 164 F.3d at 655. 16. 164 F.3d at 659-660. 17. 164 F.3d at 659. 18. 164F.3dar655. 19. 164F.3dat654. 20. 164 F.3d at 656. 2 1. 130 F.Supp.2d 105 (D.C.D. C. 2001). 22. 130 F.Supp.2d at 12 1. 23. 130 F.Supp.2d at 11 2. 24. 130 F.Supp.2d at 114. 25. 130 F.Supp.2d at 118. 26. 130 F.Supp.2d at 118. 27. 141 F.Supp.2d 105 (D .C. D.C. 2001). 28. 141 F.Supp.2d at 108. 29. 14 1 F.Supp.2d at 112. 30. 2002 U.S.Dist. LEXIS 25299 (D.C. D.C. 2002). 31. 2002 U.S. Dist. LEXIS 25299, *27-*29. Dr. Annique Theron has received international 32. 2003 U.S. Disr. LEXIS 777 (D.C.D.C. 2003). recognition for her research, development and 33. T he claim in issue reads: "Consumption of 320 mg daily of Saw promotion of products containing Aspalathus Palmetto extract may improve urine flow, red uce nocturia and reduce Linearis. Her company, ANNIQUE® Skin vo iding urgency associated wi th mild benign prostatic hyperplasia Care, formulated a complete line of products (BPH ). " 34. 2 1 U.S.C. § 343(r){l)(B). containing the patented Rooibos Extract. To 35. W ilt T, Ishani A, Stark G, eta/. Saw palmetto extracts for treatment learn more about the product line and request of benign prostatic hyperplasia: a systematic review. JAMA a FREE SAMPLE of ROOIBOS® visit our 1998;280{18): 1604-9. website: 36. Wilt T, Ishani A, Stark G, et a/. Serenoa repens for benign prostatic hyperplas ia. Cochrane Database Syst Rev 2000;2:CD001 423. www.rooibosteausa.com 37. Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n ofN.Y., 447 U.S. 557 (1980). SUPER GRADE ROOIBOS® TEA 38. See, e.g., Solid Waste Agency ofNorthern Cook County v. United States 40 Tea Bags - $9.95 Army Corps ofEngineers, eta/., 53 1 U.S. 159, 173 {2 00 I), ci ting De Toll Free: 877-839-0052 F ax: 21 4-341-6190 Bartolo Corp. v. Florida Gulf Coast Building & Constr. Trades Council, 485 U.S. 568, 575 {1988), "where an otherwise acceptable construc ROOIBOS® HERBAL TEA tion of a statute would raise serious constitutional problems, the Court will construe the stature ro avoid such problems unless such BURKE INTERNATIONAL - DALLAS, TEXAS construction is plainly contrary ro the intent of Congress. " better@airmail. net ANNIQUE® "THE REAL ROOIBOS® TEA" www.herbalgram .org 2003 HerbaiGram 59 I 67 tn• memortam• Kabochi. For Paul would always know dermy skills. exactly what ro do in such a predicament This work led ro associatiOns with the which fruits ro eat (a nd which ro avoid), likes of naturali st Jonathan Kingdon and which plants ro use in treating different Alistair Fothergill of the BBC Natural ailments, and so on. His intuitive under History Unit. With the proliferation in the standing of the natural world really was early 1980s of wildlife filmmaki ng and extraordinary." field-based wildli fe studies, came an Ethnobotany was Kabochi's lifelong unprecedented demand for animal trapping passion, and he was often desc ribed as a and handling skills. For both activiti es "walking encyclopaedia" of African medici required habituated wild animals. nal plants and their properties. Turner Such skills were second nature ro admits that, "At first, I was sceptical about Kabochi, who had kept wild animals some of the things Paul said about plants. (usually injured individuals he had rescued Paul Githinji Kabochi But when, a few years ago, he rook a party and nursed back to health) as pets since the 1942-2003 of U.S. Food and Drug Administration earliest days of his childhood. H e could scientists out on safari , they were all amazed have a wild se rval eating out of his hand in n ex traordinary talent for habituating by the soundness, and breadth, of his just three weeks. These talents were to keep Awi ld animals earned Paul Kabochi , who knowledge." him busy for the rest of his life on a succes died tragically on the morning of his 61 st Paul Githinji Kabochi was born in 1942 sion of wildlife documentary films set all birthday on 8 February 2003, a near near Nyeri, on Kenya's Aberdare Moun over Africa, including some in Sir David legendary status among wildlife researchers tains, of mixed Ogiek and Kikuyu parent Attenborough's Trials ofL ife se ri es. and filmmakers the world over. age. He received so me formal education at His great cunning was instrumental at At the time of his death, he was - as on the nearby Kiriti Primary School, but his times in enabling scientists to examine countless previous occasions - pav ing the real training ground was always the forest. little-known species. Three years ago, in way for the filming, near Kenya's Tsavo This he would enter at every poss ible nets mounted arop "rugby poles," he West National Park, of a wildlife documen opportunity, while tending the family goats succeeded in ca tching some giant African tary for television, this time on the behav as a boy. free-tailed bats for researchers from Bat iour of a pack of Dwarf Mongooses. The Mau Mau uprising and the ensuing Conservation International, a feat described The visiting film crew, from France's State of Emergency, declared in 1952, in SWARA (Vo l 24:3). Until then, this Aster Productions, was operating from the brought this idyllic childhood to an abrupt hi gh-flying species had been well out of the Taira Discovery Centre (TDC) run by East end. Like other fam ilies, the Kabochis were researchers' range. African Ornithological Safaris (EAOS) , for relocated ro pyrethrum plantations at Kabochi was himself the subject of a 30- whom Kabochi was for many years a Senior Ndondori, North Kinangop, ro se rve as minute documentary, Der Tiermagier G uide. On that fateful morning, neither farm labourers. But the life of a farm hand (Animal Magician), made in 2000 by Sam Kabochi nor the crew could locate the was not for Paul, and in 1960 he drifted ro and Armin Dhillon for German Television. mongoose pack they had been working Nakuru, in the Rift. He was remarkable, above all, for always with. So they drove around for a while, There, in 1961 , he landed his first "real" putting the welfare of the animals first. This searching for their subjects. job: that of a tracker on "leopard control" did not always endear him to film crews, Instinctivel y, Kabochi pointed to some duty for Colonial cattl e ranchers in what is who were often behind schedule and eager termite mounds where he felt the pack now Lake Nakuru National Park. This was to force the pace, even at the expense of might be hiding. His hunches, born of a risky work, and he emerged from one skir harming the animals they were filming. lifetime spent in the bush, were nearly mish with a leopard minus a large chunk Kabochi walked out on one crew who, always vindicated. But he offered to "stalk" from one of his buttocks. Ironically, he was protesting that "Time is money," refused to the anthills first, just to make sure. His lean, arrested in 1963 for possessing the skin of a accept that an elephant shrew that was sinewy form soon disappeared am id the leopard he had been paid ro kill. But, clearly stressed and hyperventilating needed intervening "cover" of dry thorn scrub. instead of being jailed, he was drafted into a nmeour. Paul Kabochi was never seen alive again . the Kenya Armed Forces and sent ro the Kabochi was a tireless promoter of Hours later, when EAOS trackers located then Northern Frontier District to help nature's small er creatures - reptiles, bats, his body, it was more than three kilometers track down 'shifta' bandits. insects. "While at TDC," his EAOS beyond the nea rest of the anthills. The On leaving the army in 1966, he became brochure entry reads, "be sure to explore the cause of death was plain to see. Kabochi had a collectOr and skinner of specimens for the fascinating world of the 's mall game' that is been trampled ro death by an elephant. National Museums of Kenya, accompany overshadowed by Africa's famous For Steve Turner, managing director of ing ornithologist John G. Williams and megafauna." EAOS, Kabochi's employer for the last 17 other eminent naturalists on field trips Less well known, but no less important, is years, Paul's death came as a terrible shock. throughout East and Central Africa. During the legacy of conse rvation awareness he "I have often rold people down the years," the 1970s, while still with the Museums, he spread among co mmunities of local people, Turner says, "that, if ever I were ro be cast prepared casts for the conserva ti onist and especiall y in the Rumuruti area where his into some remote jungle, and rold I could sculptor of wildlife bronzes, Rob Glen, family still lives. There, he will long be choose only one companion in the ensuing under whom he was able ro hone his taxi- remembered as Awa ('father' in Kikuyu), battle for survival, I should pick Paul 68 I HerbaiGram 59 2003 www. herbalgram .org . . zn memorzam "who loved animals and who liked to carry taught energy work. The Taoist Arts Center moment, to tickle the joy button of rhe a chameleon around on his head. " was also graced with hi s wisdom. He whole experi ence. He was so gracious. How The chameleon stunt was Kabochi's way continued his busy herbal practice, blend fortunate we were. of discrediting a superstition, rife in Africa, ing modalities of bodywork and incorporat Ir was good to see he had come back into rhar chameleons attach themselves to rhe ing herbs, energy work, and acupuncture. A his own li ght these pas t few yea rs. H e tops of people's heads and never let go. The perfectionist, William's book was constantly returned to his herbal famil y. What impact result of this irrational fear is rhar evolving. We hope to publish his works in can a single man make? The lineage of those chameleons everywhere are needlessly rhe next few yea rs. directly influenced during his life journey battered to death. Like so many people of genius, William walking our Earth includes a bounty of Never less than totally at home in the led a life full of intensity we would expect accomplished practitioners. I share Rose bush, Kabochi himself had no fear of wild from one who received formulas shared mary G ladsrar's se ntiment that William was animals. "And it was this loss of all fear, from the book of Pythagoras, in blasts of " ... sweet, rare and fairly complex. May our maybe, rhar got him in the end," laments white light. Thus, rhe birrh of rh e Triad hearts feel peace as his hea rt does. H e is Steve Turner. System ofFormulation 30 years ago, visually close, even close r now than in life. That is Paul Kabochi leaves his wife, Margaret drawing one triangle within another, with the gift of those who pass over. Our gift is Wakuhi, one son Daniel, and six daughters: the client's constitution/core condition in to remember them and to honor them." Mary, Virginia, Catherine, Florence, Caro rhe center. Herbs on rh e apex representing Herbalist, acupuncturist, artist, reacher, line and Ann. -"" the "king," the ruler/significa nt husband, fat her, keeper of his beloved - Gordon Boy, editor, SWARA, journal of the East herb/neutral signified by a circle, a "minis Virginian land - William was always a African Wild Life Society with reporting by Gichuki ter" the herb that communicates to other body worker. Matthew Wood so succinctly Kabukuru and Trupti Shah plants and rakes the message to the king, added, "William touched the four elements Reprinted from SWARA by permission signified by a plus sign, and a "servant" the - earth, air, fire, water - and then the reciprocal parr of the formula that acts fifth element which changes everything, as upon/eliminates through the "doorways of in the twinkling of an eye, in a magical the body." Measurement of herb was moment when no one sees . And then he formulated by energetic strength, nor was go ne. We thought we could always weight. William's Triad System of Formula lea rn from him, bur suddenly rhe book was tion continues to be taught from coast to complete. " coast. Spirit and wind are the sa me wo rd in Hanging in herb schools and practi Greek. To inspire is to breathe in . We all ti oner's offices around rh e country are share inspiration, our breath. To inspire is William's Facial Diagnosis Charts, which to excite with passion. William was my illustrate the five elements as they relate to inspirati on to be a better practitioner. He general and specific characteristics includ always liked an "Amen corner." I am not ing the shape of the face , temperament, alone in that corner. So An1en, my friend , tone of vo ice, and the myriad of fascinating amen. -"" descriptions that make up a "type" of - Margi Flint perso n. The chan is based on a combin a All are welcome to send stories or photo tion of traditional Chinese physiognomy graphs or, better still, to arrive and share at the William LeSassier and William's own interpretations. Cli ents Memorial Gathering for William LeSassier are always curious to discover their "type. " scheduled for Saturday, September 13, 2003, 1948 - 2003 William was exceptional and at the same 1 p.m. at The Breathing Project, 15 West 26th am honored to write words of remem rime completely human in experiencing the St., 1Oth Floor, New York City, New York. l brance for William LeSassier: the mystical extremes of life. Never one to moderate reacher of all my teac hers. He who dropped excess! A gifted man and blessed soul. So under rhe radar for so many years. The regular, so ordinary, so "no big deal" in his famous and infamous William LeSassier. beige turtleneck and sweats with words In the late '60s, William opened The falling our of his mouth in such profusion Christos School of Herbal M edicine in Taos, that one could easily forger that he was a New Mexico. By the 1970s, herbalism was brilliant genius and channeled the healing re-awakened. He was one of the most well energy of the universe. The flow of knowl known herbalists in the country. During edge while he taught was magical. Humor those early years he wandered and taught, and lighter entertainment interspersed selling herbs as he went. H e wrote so me of between rhe meati er portions of diagnostic the very first herb articles in Well-Being tone and color, nails and tongues . He magazine, poss ibly the first publication on grasped each line of the face, each subtle alternative medicine. In rhe earl y '80s, he marking, explained, and drew so beauti serried in New York City to open Chiron's fully. That smirk, hi s delightful wry Magic Minerals, where he practiced and comments sneaking in at just the right www.herbalgram.org 2003 HerbaiGram 59 I 69 letters CLARIFICATION TO EU LEGISLATION below the report enrirled "FDA Awaits Ephedra to a traditional protocol. hank yo u for your HerbalGram 57, which Report After Baseball Playe r's Death." How There are intriguing hinrs that at least some of Tarrived this morning. Ir is as excellenr as ever. IroniC. rhe native Americans migrated from Asia and One poinr I would like ro make. The arricle Maybe ma huang should be limited to brought their medicinal knowledge with them, headed "European Union passes Traditional purchase by herbalists who carry credenrials and maybe even their plants. For instance, it's Herbal Medicines Directive" is nor enrirely accu and/or licenses, but if it is banned, then why not believed that certain of the languages, such as rate. the same plight for all the substances that Amer Navaho, are linguistic cousins of Asian A report on the Direc icans use inappropriately? languages. Botanists since the 17th cenrury have tive from a committee Thank yo u for being there as a voice we can noticed a close similarity in the flora (and fauna) within the European count on ro represenr herbal medicine. of eastern North American and eastern Asia. Parliamenr was indeed -Therese A. Walsh, L. Ac. Duke and Ayensu include an interesting short voted upon last Novem and Traditional Chinese Herbalist essay at the beginning of their rwo-volume set, ber but, in no way, did Los Angeles, California Medicinal Plants of China (I 985, Reference this represent the final Publications). In it, they list over a hundred agreemenr ro the Tradi We appreciate M s. Walsh's letter. Unfortunately, genera of plants that are used similarly in tradi tional Herbal Medicinal many ofthe points on ephedra that Mark discussed tional Chinese medicine and traditional North Products Directive. with the USA Today reporter- including some of American Native medicine. Other medicinal We estimate that it will the potential and documented benefits of ephedra practices such as the use of moxa [cones made of be a year before the Directive is adopted by the - were not included in the articles because oflack mugwort] are similar. EU - that is, mid-2004 - and then another of space. This is a typical problem with the I believe that the study of traditional Oriental year before it becomes law in the Member States. reportage of that particular publication, where medicine offers us rhe opportunity to take rhe There will be a five-year transition period from conciseness has reached a new level, often leaving "royal road" toward re-creating an authenric adoption, which means products that need ro out important material information and nuance. native plant medicine on this continent. Fortu comply will have unril 2009 so to do. -Editors nately, there are now more than 40 accredited, Opinions vary as ro whether this will help or independent colleges in acupuncture and Orien hinder the herbals market in the EU and, in a FURTHER ON THE PATTERSON BUNDLE tal medicine and several professional organiza sense, it will depend from what Member State wish to express my thanks ro Merry Lycerr tions supporting this study. you come. IHarri son for her fine work in researching the - j ean Giblette, Director contents of the Parrerson Bundle. I very much High Falls Gardens Anthony Bush enjoyed rhe article published in HerbalGram 55, Philmont, NY European Regulatory Consultant and can't resist making some comments. CAMedica The overall character HAWTHORN INTERACTION POTENTIAL Henley on Thames, Oxfordshire, istics of rhe collection n Don Brown's review (High dose hawthorn United Kingdom - the small quanriries Iextract for advanced congestive heart failure, in of common and uncom HerbaiGram 57), he stares that "there are no ONE STEP FORWARD, ONE STEP BACK mon plants, the variety known inreracrions of hawthorn extracts with just finished reading the February 20, 2003 of material, and the care prescription cardiac drugs." Such interactions with which they have Icopy of USA Today and the various inrerview have "not been documented in any clinical trials clips quoting Mark Blumenrhal (happy ro see been prepared - are to dare nor has it been cited as a concern by that they wenr ro him for information) by Nanci familiar to anyone who either the German Commission E, rhe American Hellmich. But I was disappoinred that amidst all goes into a traditional Herbal Pharmacopoeia, or the American Botan of the explanation, none was given for the Chinese herbal phar ical Council monographs on hawthorn." macy here in the U.S. intended herbal uses for ephedra/ ma huang. He admits that some authors suggest the possi As an herbalist myself, I am grateful for the and fi lls a prescription for an herbal formula. Ten bility of such interactions. The idea of an inter powers that mahuang can deliver in an asthmatic to fifteen differenr ingredienrs for the formula, action actually arose in one of the very first arrack or acute episode of difficult breathing due including minerals, bones and other animal parts published studies on hawthorn extracts. Semm ro inflamarion in rhe bronchial pathways. It as well as the plant parts, are standard. Each (Arzneimittei-Forschung 1952;2:562) found that seems ro me Mark had the perfect opportunity ingredient is harvested and prepared according hawthorn fl avonoids produced a distinct synergy ro educate rhe public in the proper uses of ephedra and ro poinr out that the first American cultural belief that searches for a quick fix ro a AROMATIC HERBAL BATHS OF THE ANCIENTS: PHOTO CAPTIONS discipline problem (dietary judiciousness) is what got ephedra inro the wrong hands for the wo photo captions in the arricle Aromatic Herbal Baths of the wrong reaso ns. TAncients, published in HerbaiGram 57, were incorrect. The photo And let's not forget the second American reproduced ar left was described as a bath house, when it is actually a cultural belief rhar if the recommended dose can Middle-Eastern apothecary. And the photograph at right was described do "x" amount of effect, then more must be horsetail, but it is obviously plaintain (Plantago) . The Chinese charac better. Lost in all of the media frothy stirring ters, cheqianzi, just to the left of the image mean "plantain seed." These around ma huang is that the roxicology report is errors occurred during the production of this issue and Herba/Gram still being developed, and unril that happens, the regrets any confusion they have question of banning ma huang should not really caused. Our thanks to Wendy be enrertained. Applequist, Ph.D., of the In rhe same paper in rhe same day, there Missouri Botanical Garden appeared a report "College Blackout Drinkers Applied Research Department, Face More Risks" including death (by Kathleen for spotting the plantain error Fackelmann), and there was a beer ad directly and translating the Chinese. 70 I HerbalGram 59 2003 www.herbalgram.org letters with the classical cardiac glycosides from Digi 2.65 mg for oral saturation and he compared this In: Monographs On The Medicinal Uses of talis lanata. Bersin, Mueller and Schwarz value with data from the literature, which should Plant Drugs. Exeter, U.K.: European Scien (Arzneimittel-Forschung 1955;5:490-1) noted supposedly be about 6-8 mg digoxin. The mai n tific Cooperative on Phyrotherapy; Oct during a routine pharmacological screening tenance dose of 0.25 mg was apparently at the 1999. study, that in a frog heart preparation, a lower range of the literature findings (0.25-0. 75 4. Brinker F. Herb Contraindications and Drug hawthorn glycoside fraction increased the toxic mg). Howeve r, it is impossible to interpret these Interactions, 3rd ed. Sandy, OR: Eclectic ity of digitoxin in the frog. What they actually data without a control group and accurate infor Medical Publications; 2001. found was that heart tissue pretreated with either mation about the severity of the heart fa ilure. 5. Trunzler V, Schuler E. Comparative investi one becomes sensitized to the other, so that only In summary, it is imposs ible to deduce gation of the effect of a Crataegus extract, about half the normal dose of the second is evidence for potential interactions from these digoroxi n, digoxin and y-strophanthin on required to obtain the same res ult. Later on, early investigations. However, iris nor only proof isolated hea rt muscle. [in German]. Herbert Wolkerswrfer (Miinchen Medizinischer of pharmacodynamic interactions rh at is lacking. Arzneimittelforshung 1962; 12: 198. C ired Wochenscrift 1966;8:438-41 ) found that he Results from a recent study as well rule out phar in: Upton R (ed.) . Hawthorn leaf with could reduce the dose of digoxin by a consider macokinetic interactions between hawthorn and flower-Crataegus spp.: Analytical, quality able amount if he combined it with hawthorn digoxin (Tankanow R, Tamer HR, Streetman control, and therapeutic monograph. In: extract. If I read this study correctly, patients DS et al. Interaction study between digoxin and Upton R (ed.). American Herbal Pharma who were receiving doses of digoxin as high as a preparation of hawthorn ( Crataegus oxyacan copoeia and Therapeutic Compendium. Santa 6-8 mg did well on the hawthorn/digoxin tha). J Clin Pharmacol2003;43:637-42.) C ruz, CA:AHP; 1999. combination that contained just 0.25 mg of - Egon Koch, D.M. V 6. Hahn F, Klinkhammer F. Oberdorf A. digoxin, a dose that is at the very low end of the Head ofPh armacology Desc ription and pharmacological investiga dosage spectrum. The combination went by the Dr. Willmar Schwabe GmbH & Co. tion of a new therapeutic active agent name Crataelanat. Karlsruhe, Germany derived from Crataegus oxyacantha. [in I have not examined recent hawthorn work to German]. Arzneimitte/forshung determine if interactions between hawthorn Drug Interactions 1960; 10:825-6. In: Upton R. (ed .) . extracts and other cardioactive drugs have been HAWfHORN LEAF WITH FLOWER: No known H aw thorn leaf with fl ower-Crataegus ruled out. Would be curious to lea rn of such documented interactions, according to the spp.: Analytical. quality control, and thera work. Commission E monograph of 1994 and later peutic monograph. In: Upton R (ed.). - Daniel Mowrey, Ph.D. therapeutic reviews, including one by the Euro American Herbal Pharmacopoeia and Thera Director ofScientific Affairs pean Scientific Cooperative on Phytotherapy. 1·3 peutic Compendium. Santa Cruz, Basic Research Other references suggest that hawthorn prepara CA:AHP; 1999. Salt Lake City, Utah tions may potentiate drugs containing ca rdiac 7. Newall C, Anderson L, Phillipson J. Herbal glycosides (e.g., digoxin) probably res ulting from Medicines, A Guide for Health-Care Profts [Editor's note: We turned to D r. Wilmar the positive inotropic and coronary vasodilating sionals. London, U.K.: The Pharmaceutical Schwabe GmbH, a German phytomedicine effects. 4 Earlier research suggested potentiation Press; 1996; 157-9. company that has researched hawthorn extensively, of digitalis glycosides with hawthorn,' and 8. Meyer-Buchtela E. Tee-Rezepturen-Ein for expert input on this query and provide, after another study suggested that hawthorn prepara Handbuch fur Apotheker und Arzte. that response, the summary of interactions from tions may potentiate the coronary artery dilating Stuttgart, Germany: Deutscher Apotheker The ABC Clinical Guide to Herbs, which is effects of theophylline, caffeine, papaverine, Verlag; 1999. based on the most recent clinical research.] sodium nitrate, adenosine, and epinephrine6 9. Upton R (ed. ). H awthorn berry-Gratae In the very old studies cited above, it is unfor Because of the si milari ty in actions, one reference gus spp.: Analytical, quality control, and tunately imposs ible to determine which extracts suggests that hawthorn should not be used with therapeutic monograph. In: Upton R (ed.). were actually administered and how the experi any other heart medi cations without the advice American Herbal Pharmacopoeia and Thera ments were exactly performed. The paper by of a healthcare provider. 7 peutic Compendium. Santa C ruz, Semm does not really show a synergistic effect HAWfHORN FRUIT: None known 8 Depending CA:AHP; 1999a. with digitali s, for example, but describes in obso on dosage the same interactions for leaf and lete pharmacological (in fact, toxicological) stud flower may be rel evant9 ies that the pre-treatment of guinea pigs (about Fro m: Blumenthal M, H all T, Goldberg A, 500 g body weight) with 1000 microL hawthorn Kunz T, Dinda K, Brinckmann J, et al. , editors. extract (with a content of 45 percent ethanol "' The ABC Clinical Guide to Herbs. Austin (TX) : 450 mg pure ethanol) increases the lethal effect American Botanical Council; 2003. p. 240. of digitalis. Indeed, it is a wonder that the References: HerbalGram welcomes letters to the animals did not die from the alcohol alone. 1. Blumenthal M, Busse WR, Goldberg A, editor as part of the ongoing dialog that Bersin et al. did not give an account of a glyco Gruenwald J, Hall T. Riggins CW, Ri ster makes science so vibrant, and as part of side fraction from hawthorn, but of an isolated RS (eds.). Klein S, Rister RS (trans.). The our efforts to learn as well as to educate. glycoside. If frogs were injected with 175 mg/ kg Complete German Commission E Mono Please submit your letters to Karen of this glycoside, only half the dose of digitoxin graphs-Therapeutic Guide to Herbal Medi Robin, managing editor, via email usually required was needed to kill the animals. cines. Austin, TX: American Botanical C lub and the Cornell Co-op Extension, activities October 2-4: 3rd International Symposium on 2003 include workshops, lectures, gin se ng products, Natural Drugs. Naples, Italy. Sponsored by the September 1-2: Latin American Herbal Medi crafts and refreshments. Ph: 518/622-9820. lmernational Council for Medicinal and Aromatic cines: Harmonization of Regulatory and Drug September 20-21: Cultivating the Herbal Medi Plants, rhi s symposium wi ll focus on botanical, Development. Santiago, Chile. Sponsored by the cine Woman Within with Kami McBride. chemical, and pharmacological aspects of medici Drug Information Association, th is conference Vacaville, CA. This experiential herbal studies nal plams, also sa rellire symposia on cannabis and wi ll analyze the regulatory status of herbal produce class is for women studying herbal medicine as a ca nnabinoids, chemical and pharmacological manufacturers and di stributors in Latin Ameri ca deepening relationship with the Earth and a way as pects of propolis and its co mponents, green tea and provide an open forum for discussing their of life. One weekend a month, September 2003 and cancer, and toxicity of amhraquinone drugs . potential fo r harmonization in a number of areas. through April 2004, and provides CEU credits for Contact: Dr. F. Borelli or Dr. N. Milic, Dept. of Website: 72 I HerbaiGram 59 2003 www. herbalgram .org calendar field, !A; New York, NY; Boulder, CO; and ar rhe sy mprom analysis, case follow-up, formulating, Webs ire: access In this department of Herba/Gram, we lisr resources such as publications, organizations, seminars, and nerworking for our readers. A listing in rhis section does nor co nsr irure any endorsement or approval by Herba/Gram, ABC, or irs Advisory Board. Recent papers on plant toxicity. Jean Bruneron's Organic Farming Research Foundation methods for THC and cannabinoids, and view website contains references on rhe main papers announces new grant appli cation deadlines. The points of key medica l associations. Website: deali ng wirh plant toxicity, adverse effects of foundation, whi ch has disbursed nea rl y $ 1.2 Medical Herbalism - Subrirled "A Clinical Correspondence Courses And Seminars Newsletter for the Herbal Practitioner. " Edited by Travel Paul Bergner. $36/yr, $60/2 yrs . Canada $39/yr. Aromatherapy and Herbal Studies Course by Hawaiian Herbal Education - Go beyond tradi Overseas $45/yr. Sample/$6. Medical Herbalism, tional herbalism ro learn Hawaiian plant medicine Jeanne Rose. Correspondence, certification, in P. 0. Box 20512, Boulder, CO 80308. person intensives. 160 CEU provided, California secrets. 3-day hands-on workshops at Hi'iaka's Board of RN Provider #CEP11659. Info: 219 Healing Hawaiian Herb Garden near Hilo. Sched Carl Sr., San Francisco, CA 94117 or FAX Schools uled for January, April, Jul y, October 2003. Indi 415/564-6799. vidual retreats also designed, scheduled upon Distance Learning Master Herbalist, Master requesr. $110/day includes lodging on-sire. Derails Aromatherapist. Australasian College of Herbal and images at D EAR READER the traditional and Western healers surveyed GMPs Continued from page 5 have not observed liver disease among native Continued from page 58 kava users. And, finally, a mea culpa. H erba!Gram 55 this bill, and NNFA has begun to arm retail 3. CGMP Review Update: Regional Meetings included an article on an herbalist's quest to Completed - Additional Input Requested. ers with instore promotion packets to elicit determine the botanical contents of the AHPA Update. Silver Spring, MD: Ameri consumer opposition of the bill. Patterson Bundle, an Indian medicine bag can Herbal Products Assn., Jun 19, 2003. In this issue, we also highlight rooibos, found in Utah. The author felt it important 4. Current Good Manufacturing Practice in the South African herb with a delightful Manufacturing, Packing, or Holding to determine the identity of the herbs, and flavor and a relatively high antioxidant Dietary Supplements: Proposed Rule. their known medicinal and/or sacerdotal effect. Rooibos was first introduced into the Federal Register Volume 62, No. 25, properties. One of our loyal readers, herbal U.S. market in the early 1980s by herbal tea Docket No. 5700-9. Washington, DC: ist Cindy Bloom, herself half Native Ameri leader Celestial Seasonings, but the product Food and Drug Administration. February can, was horrified to see what she considered 6, 1997. was avoided by many human rights the defiling of a sacred site and its contents. 5. GMP Comparison. Washington, D .C.: conscious health food consumers who did She contacted us, we invited to share her Council for Responsible Nutrition. not want to support a product from the concerns with us, and we now print her Accessed Jun 26, 2003 online at then-apartheid South Africa. Ironically, sales 74 I Herba!Gram 59 2003 www.herbalgram.org Educating the public on the use of herbs and phytomedicinals Summer 2003 ABc Members now receitre a Herbal 1 0% discount Educationon all orders! Catalog New Items Ginkgo Leaf & Ginkgo Leaf Extract: Ginkgo biloba L. Standards of Analysis, Quality Control, and Therapeutics. 2003. Editor: Roy Upton. The latest monograph from the American H erbal Pharmacopoeia. Comprehensive review of therapeutic uses; complete safety and toxicology data, and more. Fully referenced and peer reviewed. 14 pages. $24.95. Item 446. (Information on the complete series of AHP monographs is on page 3.) Herbal Medicines. Seconded. By Barnes, Anderson and Phillipson. 2002. Provides information on mediciannl herbs sold in UK pharmacies. Seven new monographs have been added to the second edition, 10 have been extensively revised and rewritten, and a further 33 have been updated. It new includes a total of 148 herbs. Includes references for each monograph as well as an index. 530 pp. $59.95. Item B198 Special Offer Herba/Gram BackPacks Don't leave any gaps in your library. Her6aLGram back issues provide a comprehensive store of information on herbs, book reviews, research, a nd conference reports, legal and regulatory developments. BackPacks are a set of Her6aLGrams from 1989, except the most current issue, and include a complete Cumulative Index. Order a complete set of BackPacks, Volumes II, III and IV for $95 and y ou'll receive 2 slipcases at no extra charge to protect and store those back issues. That's a $19 value. To order, use the order form on the inside back cover or, for secure online ordering, please visit the H erbal Education Catalog section of our website: www.herbalgram.org FEATURED ITEMS The ABC Clinical Guide to Herbs Ed. by Mark Blumenthal et a!. , American Botanical Council, 2003. How does the healthcare professional effectively respond to patient inquiries on the use of herbal supplements? What clinical research has been conducted? How is safety evaluated? This science-based educational course answers these and other questions for healthcare professionals, pharmaceutical compa nies, health management companies, policy makers, the dietary supplement industry and consumers. Hardcover, 512 pp. $49.95 . #905 Quick Access Guide to Conditions, Herbs & Supplements by Integrative Medicine Communications, 2000. This book has three broad catego ries for quick answers to consumer questions. The largest section deals with co nditions and covers various treatment options includ ing herbs, supplements, drugs, and other complementary and alternative therapies. Only alternative treat ments that are considered safe and effective when used with conventional medicine are included. Additional sections on herbs and supplements cover bas ic information, precautions, and dosage information. T he Quick Reference Guide found at the end of the book shows at a glance all the herbs and supplements that are useful in treating that co ndition. Softcover. 430 pp. $29.95. #B521. Special offer $24.00! Quick Access Patient Information on Conditions, Herbs & Supplements by Integrative Medicine Communicati ons. Consists of three types of monographs. Condition monographs provide patients with information on standard medical care with additional informati on on nutritional support and the use of alternati ve and complementary therapies. Herb monographs provide important information on their use in maintaining health or treating conditions. Supplement monographs provide information on the use of dietary supplements. Thirteen Quick Reference Guide lists allow easy and targe ted access to information by symptom, use, precautions, etc. Spiral bound. 266 pp. $49.95. #B522. Special offer $40.00! Quick Access Professional Guide to Conditions, Herbs & Supplements by Integrative Medicine Communications. Contains Condition, Herb, and Supplement Monographs with ex tensive information geared toward medical practitioners. Thirteen Quick References allow easy and targeted access to the information. 472 pp. H ardcover. $49.95. #B523. Special offer $40.00! Quick Access Professional Reference to Conditions, Herbs & Supplements CD-ROM by Integrative Medicine Communications. Monographs address numerous medical conditions, provide information on a range of treatment options, outline uses, dosages and interactions for over 115 herbs and supplements, and present nutrition depletions associated with the most popul ar drugs. PC compatible. $49.95. #COOl. Special offer $40.00! Steven Foster Photography Medicinal Plants - Volume 1 CD-ROM This royalty-free CD ROM contains 102 photos of some of the most popular medicinal plants in use today. Medicinal Plants - Volume I is designed for both Macintosh~' M and Windows TM operating systems. Item The images are high resolution: 8x12 inches at 300 dpi #COOS (20.3x30.5 em at 118 dpcm) and have excellent highlight and shadow detail. ~ For products produced in quantities of less than I 00,000 units. For a complete li sting of the plants in this coll ection, visit: http://www.herbalgram.org/default.asp?c=sfg_images M 0 N 0 G R A P H S ESCOP Monographs Chinese Herb Monographs Prepared by the European Scientific Cooperative on Chinese Drug Monographs and Analysis by H. Wagner, R. Phytotherapy (ESCOP), a group of herbal experts from Bauer et al. Monographs range from 8 to 17 pp. and include such academia and industry in the European Union. These mono information as: pharmacopeias found in , publication first cited in , graphs contain indications, contraindications, side effects, official drugs, substitute drugs, description of official drugs, falsifi dosage, interactions, and many other important therapeutic cation drugs, pretreatment of the raw drug, medicinal use, main parameters of 60 leading herbs and phytomedicines in Europe. constituents, pharmacology, toxicology, TLC fingerprint analysis, Well referenced. A must for physicians, pharmacists, natur evaluation, HPLC fin gerprint analysis, and references. opaths, herbalists, industry, and researchers. Radix Astragali (Huang Qi) Astragalus Item #0424A ESCOP monographs are published in loose leaf form, for insertion into a dedicated ring binder. ESCOP employs the Fructus Schi sandrae {Wuweizi) Schi sandra #0424B traditional pharmacopeia! name of the herb as the title of each monograph. Radix Rehmanniae (Dihuang) Reh mannia #0424C Radi x Bupleuri (Chaihu) Bupleurum #04240 For a complete li sting of monographed herbs and fascicule divisions, visit our website: fo r all 6 fascicules Item #42 1 Bulbus Fritill ariae (Beimu) Fritillariae #0424E www.herbalgram.org/mono- $225 graphs.html Rhizoma Pinelliae (Banxia) Pinellia #0424F Herbe Houttuy niae Cordatae (Xuxingcao) Houttuynia #0424G WHO Monographs on Selected Medicinal Herba Asari (Xix in) Asarum #0424 H Plants, VoL 1 Radix Angeli cae Pubenscentis (Duhuo) Angelica #0424J by the World Health Organization . 1999. Collection of 28 Rhi zoma Atractylodes Macrocephalae (Baizhu) Atractalodes #0242 K monographs covering the quality control and traditi onal and clinical uses of medicinal pl ants selected for inclusion on the Rhizoma Belamcandae Sinensis (Shegan) Belamcanda #0424L basis of their widespread use, particularly in countries that Herba Lycopi Lucidi (Zelan) Lycopus #0424M rely heavily on medicinal plants to meet primary health care needs. Aims to encourage standardized Rhizoma Seu Radix Notopterygii (Qianghuo) Notopterygium #0424N scientific approaches to ensuring the safety, $8280 #0424P quality, and efficacy of med icinal plants and Radix Angelicai (Danggui) their products. Softcover, 287 pp. Item #428 Radix Angelicai Dahuricae (Baizhi ) #0424Q Radix Ligustici Chuanxiong (Chuanxiong) #0424R WHO Monographs on Selected Medicinal Pericarpiu m Zanthoxyli (Huajiao) #0424S Plants, VoL 2 By the World Health Organi zation. 2002. Provid es an addi each Al l 17 monographs$185 (Save over 10%) #04241 tional coll ection of 30 monographs covering quality control $12 and traditional and clinical uses of selected medicinal plants reviewed by 120 experts in more than 50 countries, as well as American Herbal Pharmacopoeia Monographs by experts through a network of relevant • Comprehens ive review of the therapeutic uses NGOs. Al so included are two cumulati ve indexes to both volumes. Softcover, 362 pp. • Complete safety and toxicology da ta Item #428A. • Critical information on s ide effects, contraindications, all Fitoterapia aspects of quality control, historical use and more • Astragalus, Reishi and Schisand ra a lso include Extensive monographs and literature reviews fro m Fitotempltl, Traditional C hinese Medicine su pplement section a leading international botanical research journal, founded by lndena, the leading European supplier of botanical derivatives. • Ashwagandha inc ludes Ayurvedic supplement section • Fully referenced a nd peer reviewed by internationa l a uthorities Bilberry Vaccinium myrti!/u,, 26 pp. Item #425A St. John's Wort #5420 Ginkgo Ginkgo htloha 48 PP· #425B Hawthorn Leaf with Flower #426 $19?a~ Grape lft!t;, t'in~lera 25 pp. #425C Astragalu s Root #431 Hawthorn Berry #430 H orse Chestnut Ae.,cufu., /;ippoca. •fanum 28 PP· #42 50 St. John's Wort Valerian Root #427 lv\ilk Thisde Si/yhum marianum 39 pp. #425E Schisandra Berry #434 9 Pumpkin Cucurbita pepo II PP· #425F Willow Bark #433 $9 ?ach Pygeu m Prunu.• (~/rii.:ana 14 PP· #42 5G Ashwagandha Root #435 Black Haw Bark #436 Ginkgo Saw Palmetto Serenoa repen.• 14 pp. #425 H Chaste Tree Fruit #437 St. J ohn's Wort flypeni:um pnf;walum 25 pp #4251 Cramp Bark #438 $24?a~ Va lerian Va !eriana t~ l} ii.· tlw!t:• 13 pp. #425J Reishi Mushroom #439 Goldenseal #440 Stinging Netde Urticadim'm 16 pp. #425L All 18 monographs Bilberry #44 1 Black Cohosh Rh izome #442 0 $1 Oeach $98 for all II Item #425K Cranberry Fruit #443 $328° Dang Gui #445 (l 0% discoou n t) Ginkgo #446 Item #450 1- 800-373-7105 w w w. H ERBALGRAM • 0 R G 3 B 0 0 K S Evidence-Based Herbal Medicine by Tyler's Herbs of Choice: The Thera Cancer Research Michael Rotblatt, MD, and Irwin peutic Use of Phytomedicinals James Robbers and Varro Tyler. 1999 ...... ,,..... ,.., Natural Compounds In Cancer Ziment, MD. 2002. Analyzes a large quantity of the primary literature on 2nd edition. Up-to-date lega l data -=~-~- Therapy: Promising Nontoxic Anti tumor Agents from Plants and controlled clinical trials and provides about herb use in the U.S., cli nical Other Natural Sources by John Boik. reliable and practical information on studies and advances in determining 2001. Presents a solid scientific basis the uses, pharmacology, efficacy, and mechanism of action, information for the use of natural compounds in adverse effects of approximately 65 essential for understanding any medicinal agent and its rational use in therapeutics, ----- ca ncer treatment. Includes in-depth herbal medici nes and a few non-herbal dietary discussions of cancer at the cellular level and the supplements. Softcover, 464 pp. $29. #B5 16 easy-to-follow breakdown of how herbal remedies level of the org anism, as well as clinical considera are used to treat various conditions and systems, Herbal Medicine by Rudolf Fritz and an expanded introduction to phytomedicines tions covering trace metals, vitamin C and antioxi Weiss, M.D. 2000. 2nd Edition. The dants, polysaccharides, lipids, amino acids and and their respective application s. 287 pp. Softcover, now-classic text used by M.D.s in $19.95. #B079S re lated compounds, flavonoid s, nonflavonoid Germany. An indispensable modern phenolic compounds, terpenes, lipid-soluble text in medical herbalism. Many vitamins, and the effects of natural compounds herb s are illustrated. Plant drugs are Consumer Education on chemotherapy and radiation therapy. Soft arranged by cl in ica l diagnoses relat Herbs For Your Health by Steven cover, 52 1 pp. $32. #8494 in g to particular systems. Softcover, Foster. 1996. Designed as a quick refer 362 pp. $59. #B006 Clinical/Therapeutic ence guide to the SO most commonly Herbal Medicine - Classic Edition by used herbs available in the U.S. as The Clinician's Handbook of Natural Rudolf Fritz Weiss, M.D. 2000.This is a dietary supplements. Profiles include Medicine by Joseph Pizzorno Jr., key text in the field of phytotherapy, common and botanical name, brief :0~'7 Michael Murray, and Herb Joiner-Bey. used by both herbalists and medical history of traditional uses, summary of NATUII\L 2002. Provides an easily accessed set credible scientific reports, brief descrip MEDION£ profess ional s. Arranged by clinical of decision-making flowcharts and 4 tions of conditions and symptoms the herb treats, diagnoses related to organ system s, summary information based on the with guidelines for prescribing forms in which it is available in the U.S ., actions, best avai lable evidence on natural herbal remedies, sections on dosage, application dosage, ca utions or contraindications, and photo medicin ~ options, including herbs, and precautionary measures. Proprietary formula graph. Softcover, 121 pp. $6.00. #B232 supplements and dietary advice. Covers 74 common tions, full references, and a comprehensive subject Making Plant Medicine by Richo diseases and includes scientifically verified thera index of almost 2,000 entries round out the cover Cec h. 2000. Th e med icine making pies. Softcover, S22 pp. $39.95. #B506 age. Softcover, 362 pp. $49. #B006A section includes: drying and process ... _..... The Desktop Guide to Complemen Herbal Medicine: A Concise ing herbs; making tinctures the easy ~~ tary and Alternative Medicine: an Overview for Professionals Ed. by way; the mathematics of tincturing f-----1 Evidence-Based Approach Ed. by Edza rd Ernst. 2000. Evidence-based and sol ubility factors; basic formulas Edzard Ernst, Max Pittler, Cla re Stevin look at herbal medicine that will for fresh and dry extraction, including son, and Adrian White. 2001. Offers serve as a useful, fully-referenced dosages; vi negar extracts, glycerites, concise information on 64 popular guide for physicians, medical herbal herbal su cci and syrups; teas, decoctions, herbal _ CAM diagnostic methods and trea t- ists and other healthcare profession oil s, sa lves and creams; poultices, compresses and c:::::::...- ....,..., ments; summarizes clinical trial data als with an interest in plant-based soa ks; and a section with more than 100 herbs that on the effectiveness of CAM for 38 specific condi therapy. Addresses regulation in the are readily cultivated in North America. The listings tions; weighs the benefits and risks of each CAM UK and EU, safety issues, efficacy of herbal drugs, include conservation status, parts used, specific treatment; and includes a CD-ROM of the book that quality and standardization, synergy and more. formulas, practical uses, dosages, contraindications links to Medline. Softcover, 444 pp. $36.95. #B501 Softcover, 120 pp. $39 .95. #B509 and an overview of alternate species. Softcover, 282 pp.$14.95.#B490 Natural Medicine Comprehensive The Complete German Database compil ed by the editors of Commission E Mono Pharmacist's Letter an d Prescriber's General Herbals graphs-Therapeutic Letter. 2000. 2nd edition. Contains a Guide to Herbal Medicines New Encyclopedia of Herbs and listing for almost every natural medi Ed. by M. Blumenthal, W. Their Uses by Deni Bown. 2001 . 2nd cine sold in the U.S. and Canada and Busse, A. Goldberg, J. edition. The Royal Horticultural Soci a li sting for every product discussed Gruenwald, T. Hall, C. ety's new edition of the most in any reputable reference. Information covered Riggins, and R. Rister. 1998. comprehensive illustrated encyclo includes name of product, also known as, scientific The official English translation of the pedia of herbs. More than 1,000 names, uses, safety, effectiveness, possi ble mecha monographs resulting from the German species, varieties, hybrids, and cu lti nisms of action and active ingredients, adverse Federal Health Agency's expert commit vars listed alphabetically by genus. Addresses culi reactions including known allergi es, possible inter tee. The 2nd-ranked medical book of 1998 nary, medicinal, and economic properties of each actions, typical dosages and common modes of (Doody Publishing). Contains 380 mono herb along with cultivation information. More than administration, and other comments. Softcover, graphs, 190 herbs and fixed combinations 1500 color photographs by the author. Hardcover, 1,3 10 pp. $92. #B463 Access to web version for 1 approved for therapeutic use, 150 indica 456 pp. $40. #B156 year, updated daily. $92. #D008 Both book and web tions, and more. Hardcover, 685 pp. $89. access. $132. #B463C #B181.CD-ROM $49.#C181 Legal/Regulatory Herbal Medicine: Principles and Practice of PRINCIPLES Herbs of Commerce Ed. by M. McGuf Expanded Commission E AND Phytotherapy by Simon Mills and PRAC TIC E fin, J. Kartesz, A. Leung, and A. Tucker. Monographs Ed. by M. or Kerry Bone. 2000. Detailed, practical, !Jili,W,f!l' ~ 2nd ed ition. 2000. Destined to be the Blumenthal, A. Goldberg, and resea rch-based approach to the "de facto standard by which all plant and J. Brinckmann. 2000. use of herbal treatments in a wide common and scientific names will be Expanded content on the variety of clinical conditions and determined on all products containing Commission E herb mono problems. Includes a clear descrip r..=i---= herbs" (C hristopher Hobbs), this graphs for the most widely tion of the principles and foundations for the prac edition lists Latin binomials, Standard used herbs in the U.S. tice of phytotherapy; in-depth an d detailed profiles ized Common Names, Ayurvedic, Chinese (pi nyin), Includes updated, detailed information on of over 45 herbs, reviewing pharmacology, and other common names for 2048 species, includ their botany, history, chemistry, pharma research, and traditional use; therapeutics for actual ing 25 fungi and 23 seaweeds. A must-have for cology, safety, efficacy, and therapeutic disease states, supported by case histories; and anyone who writes about or manufactures herbal use. Extensive list of published references. coverage of challenging issues such as dosage, products. Hardcover, 421 pp. $95. #B47S Hardcover, 519 pp. $39.95. #B181E. CD safety, and drug-herb interactions. Fu lly referen ced ROM $39.95.K181E with more than 4,000 citations. Hardcover, 643 pp. $82.95. #B441 SPECIAL OFFER Purchase both Commission E books for $96.76. #B181S B 0 0 K S Regional Pharmacodynamic Basis of Herbal tial oil absorption, metaboli sm and exc retion; oils HERBAL Medicine by Ma nuchair Ebadi. 2002 . which may react adversely with certain drugs; and A Field Guide to Medicinal and Useful MEDICINE Demonstrates the beneficial effects extensive references. Hardcover, 279 pp. $55 . #B 169 Plants of the Upper Amazon by J. L. and adverse side effects of a large Castner, S. L.nmme and J.A. Duke. 1998. number of herbal drugs, showing their Herb Contraindications and Drug Practical guide to approximately 100 of actions and effects on organ, tissue, Interactions by Franci s Brinker, N.D. the most important and representative cellular, and subcellular levels. 2001 , 3rd edition. Information on 240 plants of the region. Includes a fascinat Includes herbal medications whose traditional therapeutic herbs expla in ing disc uss ion and beautiful color pharmacodynamic para meters have been delin ing documented contraindications photos of each plant. Softcover, 151 pp. eated at the molecular level. Discusses the potential and drug interactions. Appendices $35.#B358 interactions of dietary supplements with prescrip identify even more herbs as they affect certain condit ions and medicines. tion medications. Hardcover, 726 pp. $139.95 .#B517 i.,;_...,._.. Jamaica's Ethnomedicine: Its Poten Softcover, 432 pp. $25.95 #B282 tial In The Healthcare System by Quality Control Methods for Medici Henry Lowe, Arvilla Payne-Jackson, nal Plant Materials by the World The Toxicology of Botanical Medi Steven Beckstrom-Sternberg, and Health Organization. 1998. A collec cines by Francis Brinker. 2000. 3rd James Duke. 2001 . Provides a historica l tion of recommended test procedures edition. Provides essential information overview of Jamaica's hea lthcare for ass essing the identity, purity, and for a basic knowledge of human reac system from ethnomedical and content of medicinal plant materials tions to certain plant toxins. A concise biomedical perspectives; explores the intended to support development of compilation of traditional knowledge potential role of ethnomedical practices in public national standards based on local and up-to-date information on the healthcare; exa mines the potential benefits of market conditions. Includes macroscopic and toxic effects of plants and plant developing Jamaica's herbal medicines as a possi microscopic examination, thin-layer chromatogra extracts that may be used medicinally. Reviews the ble pharmaceutical resource; proposes an organiza phy, and tests for determination of many factors. toxicology of medicinal plants as noted in American tional structure for an indigenous drug industry; Softcover, 115 pp. $31.50. #B406 pharmacology, pharmacognosy and botanical medi cine texts and is updated with recent publication and presents an extensive listing of Jamaican Quality Management of Nutraceuti plants with their potential medicinal uses, along and articles from medical journals. Softcover, 296 pp. cals Ed. By Chi-Tang Ho and Qun Yi $35 .#8491 with the bioactivities related to these plants. Soft Zheng. 2002 . 21 symposium papers cover, 250 pp. $37 #B497 that examine the chemical and Plant Resources of South-East Asia biological qualit y management of Special Savings 12 (1) Medicinal and Poisonous nutraceuticals. Reviews several impor Sixty Medicinal Plants from the Peruvian Amazon. Plants 1 Ed . by L.S. de Padua, N. tant classes of compound s, flavonoids, $25 .00. B465 anthocyanins, and marine nutraceuti Bunyapraphatsara, and R.H.M .J. Ginseng: A Concise Handbook. $30.00. B047 Lemmens. 1999. Medicinal and cals. Discusses the chemical analysi s of some prod Illustrated Chinese Materia Medica. $67.95. B158 poisonous plants are a rich source of ucts on the market such as goldenseal, saw promising chemical compounds. Thu s, palmetto, green tea, cocoa, and black cohosh . Encyclopedia of Herbal Medicine. $34.00. B213 the best way to find new applications Addresses the bioactivity of several nutraceutical products such as ginger and gum guggal. Hard American Ginseng: The Root of North America's of plant-derived drugs would seem to be to Medicinal Herb Trade. $10.00. B347 co mbine local knowledge with the resu lts of cover, 327 pp. $135 . #B520 modern research on the properties of plant-derived Medicinal Herbal Therapy: A Pharmacist's View medicines. Th is book provides the latest informa Safety/Toxicology point. $7 .50. B372 tion on the botanical, agricultural, chemical, and Ginkgo Biloba Extract (EGb 761 ): From Chemistry Botanical Safety Handbook: Guide medicinal aspect of 92 genera and species. Als o to the Clinic. $16.00. B378 for Safe Use and Labeling for Herbs sections on phytochemistry, biological and phar in Commerce Ed. by M. McGuffin, C. Straight Path of the Spirit. $12 .00. B409 macological activity and therapeutica l applications, Hobbs, R. Upton, and A. Goldberg. botany, ecology, agronomy, ha rvesti ng and Canadian Medicinal Crops. $20.00. B429 1997. Provides safety data on more handling after harvest, processi ng, utilization and Ayahuasca Reader: Encounters with the Amazon's than 550 herbs as guidelines for prod quality control, genetic resources and breeding, Sacred Vine. $18.00. B473 uct labels, including contraindica and research and development. Hardcover, 711 pp. tions, side effects, and special warn Medicine Quest. S13 .95 . B481 $175. #B432 ings. Each herb is classed as can be safe ly Plant Resources of South-East Asia: Spices Edited consumed when used appropriately, herbs with the by C.C. de Guzman and J.S. Siemonsma. 1999. following restrictions, for external use only, or not to Addresses 61 important spices in 50 papers, includ be used during pregnancy. Hardcover, 256 pp. to see the complete ing origin and geographic distribution, historical $44.95. #B275 aspects, main product forms and uses, economic Herbal Education Catalog Essential Oil Safety by Robert aspects, biology, chemistry, botany, growth and Tisserand and Tony Balacs. 1995. Up and to see special offers, development, ecology, agronomy, harvesting, and to-date research findings. Practical, processing. 65 species of minor importance are visit us onlne at: comprehensive guide. Detailed described briefly and another 150 species second profiles of 95 essential oils, including www.herbalgram.org/ arily used as spices are listed. Hardcover, 400 pp. constituents, hazards, dosage, toxicity $112. #B45 3 bookcatalog data and co ntraindications; brief safety profiles of 311 essential oils and 135 essential Research /Technical oil components; safety guidelines, details of essen- ..------. Medicinal Plants: Culture, Utiliza jB~~~~ tion and Phytopharmacology by Thomas S. C. Li. 2000. Presents data PDR for Nutritional Supple PDR for Herbal Medicines 2nd for more than 400 species in tables ments, 1st edition. 2001 . Provides edition. 2000. Updated to include arranged in alphabetical order by detailed information on each the latest scientific findings, clini Latin binomial. Includes current nutritional supplement including cal trials (Including abstracts), information on major constituents clinical research summary; scien case reports, and meta-analysis and medicinal values, toxicity or tific and common names; chemi results. More detailed monograph hazards, essential oil and thei r fractions, value cal and physical attributes; indica- sections on herb/drug interaction added products and their possible uses, cultivation tions and usage; pharmacology and pharmaco side effects, contraindications, precautions, and harvesting, and infectious diseases and insects. kinetics; precautions, adverse reactions and adverse reactions, and dosage. Hardcover, 858 Three appendices cross reference major active contraindications; potential interactions with pp. $59.95. I B474 ingredients and their sources, essential oils and drugs, food, alcohol, and herbs; and dosage and their derivations, and the common and scientific administration. Hardcover, S75 pp. $59.95. 18500 names of the plants cited in the tables. Hardcover, 517 pp.$149.95 .#B510 1-800-373-7105 • www.HERBALGRAM . oRG HERBALGRAM One of the great benefits of Membership in the American Botanical Council The Journal of the American Botanical Council u In m.y opinion, Herbal Gram i1 the bec1t <1ource al'aiLaMe on aLL ac1pectc1 of phytomedicine, clinicaL data, hiAoricaL i1 ~{o rma tion, LegaL and reguLatory Jtatu.J, marlcet report.J, and nwre. " - Michael Flannery, Associate Director for Historical Collections, Lister Hill Library fo r the Health Sciences, University of Alabama at Birmingham Slipcases Protect and store valuable back issues! One sli pcase holds one BackPack Vo lume. Item # 550C HerbalGram Sample At all levels of membership, you will The current iss ue of the highly-acclaimed peer receive a new issue of Herba/Gra m four reviewed jo urnal. Item #CURR times each year. See appli cation on page 2 of this iss ue of Herba/Gram. BackPacks Volume II Volume III Volume IV HerbalGram back issues enhance your Herba/Gram issues Herba/Gram issues Herba/Gram issues library of information on herbal issues, #18/19-33 #34-49 #50-58 books, research, conferences, laws, and (1989-1995) (1995 to 2000} (2000 to 2003} related topics. The BackPacks are a set of Item #550B Item #5500 Item #550E Herba/Grams from 1989 through the $4000 $4000 second most current issue. $2700 Special Offer All three back packs, 2 slipcases and index. ($123 value} Item #5505 $9500 6 AMERICAN BOTANICAL COUNCIL HERBAL EDUCATION CATALOG 0 R D E R F 0 R M QTY ltem(s) # Description Price Total Credit Card holders call toll-free 800/373-7105 FAX this form: 512/926-2345 E-Mail: [email protected] Payment: 0 I have enclosed my check or money order (U.S. funds onl y. must be drawn on a U.S. bank) 0 Visa 0 MC Ex piration date ______Account # ------ (Pl ease include the 3-digit number following the account# on signature line on back of card .) ______ Shipping address name company profession phone fax Deduct 10% from merchandise total if you are already a member or joining at this time. address Shipp ing Please add $20 for rush orders Texas residents only add 8.25% Sales tax city sta te/province HG59 08/03 Minimum order - $9 TOTAL zip/postal code Sales Total u.s. Canada up to $20 s 5.75 s 8.75 $21 -50 8.50 12.50 country $5 1-1 00 11.50 17.25 s101-300 15.75 23.50 email $301-500 21 .00 31 .25 Rush orders, special shipping, foreign and orders over $500, Make checks payable to the American call1-800-373-7105 or email UPS is our preferred courier, as they ensure safe, accurate, and quick arrival of your goods. We accept returns for books only if they are return ed within 30 days. Vi deos an d CO-ROMs are non-refundable. Sale items may not be returned. Refunds or cred its are given for the cost of the book if it is ret urned in good condition. Shipping and handling costs are not refunded or credited unless it was our error. Returns after 30 days are subject to a 30% restocking fee. Please include an explanation of the reason for the return and a copy of the original invoice if possible. Please pack the items carefully, so that damage will not occur in the return shipment. Summer 2003 price list. Prices subject to ch ange. We occa sionally make our mailing list available to organizations that promote education events and conferences or provide a service that promotes ABC. We do not make it available to supplement companies to promote products. We respect your privacy. If you prefer not to be incl uded, you may request that your name be removed from speci al promotion lists. Write to ABC Customer Servi ce, P.O. Box 144345, Austin, TX 78714-4345. 1-800-373 - 7105 • www.HERBALGRAM . ORG Now in print! ' -n..~-..J.J~--· Get the Facts with T· H~ ABC - . CLI JCAL . GUIDE TQ. ~~ . The ABC Clinical Guide to Herbs _. H · E~RBS or healthcare professionals, researchers, consumers and retailers, it Fclarifies the evidence concerning the safe and effective use of herbs for prevention and treatment of conditions and diseases. This reference work delivers information about 29 commonly used herbs and 13 proprietary products: ~ Answer Complex Patient Questions ~ Review the Latest Clinical Research ---=---'•..·--- 1ft; Access Information in a Clinical Setting "This volume deserves • Give Patients Accurate Information to Take Home to stand alongside ~ Utilize a Reference Reviewed by Health Professionals Gray's Anatomy as one of the defining texts W. Identify Brand-name Products Backed by Clinical Research of medicine." • Obtain Continuing Education Credits - Larry Dossey, MD • Understand safety and regulatory issues Executive editor, Alt~rnativ~ Therapi~s In ABC Members receive 5% discount H~alth And Medicine Author, Reinventing M~dicine, Healing Beyond The Body, and Healing WOrd Order now for $49.95 (plus shipping and handling) Exclusive Worldwide Trade Distributor To order, please callS00-373-7105, ext.118 or Thieme Medical Publishers mERION 800-782-3488, 212-760-0888 visit www.herbalgram.org BoT,ANICAL ~ Fax 212-947-1112 COUNC IL Thieme or visit www.thieme.com F==::====t P.O. Box 144345 Non-Profit Org . Austin, TX 78714-4345 U.S. Postage 512/926-4900 Paid www.herbalgram.org Ft. Worth, TX Permit no. 1467 hv1ERI(}"..N BoTI"-NICAL COUNCIL CHANGE SERVICE REQUESTED POSTMAST ER:TIME SENSITIVE MATERIAL. PLEASE EXPEDITE DELIVERY. . and legis lation. Contact: Verna Breland. Ph: ity, environmental and human rights issues on an 202/204-800 I. E- mail: