By Authority Of THE UNITED STATES OF AMERICA Legally Binding Document By the Authority Vested By Part 5 of the United States Code § 552(a) and Part 1 of the Code of Regulations § 51 the attached document has been duly INCORPORATED BY REFERENCE and shall be considered legally binding upon all citizens and residents of the United States of America. HEED THIS NOTICE: Criminal penalties may apply for noncompliance. e Document Name: CFR Section(s): Standards Body: Official Incorporator: THE EXECUTIVE DIRECTOR OFFICE OF THE FEDERAL REGISTER WASHINGTON, D.C. ld AHPA AMERICAN HERBAL PRODUCTS ASSOCIATION HERBS OF COMMERCE 1'T ED.. PUB. 1992 NOTE: This file may not be transferred or sold. © 2010 American Herbal Products Association 8630 Fenton Street. #918 Silver Spring. MD 20910 ph: (301) 588-ll71: fax: (301) 588-ll74: email: [email protected] AMERICAN HERBAL PRODUCTS ASSOCIATION HERBS OF COMMERCE American Herbal Products Associatiou Standards Committee Timothy Moley, Chairman Edited by Steven Foster SCIENTIFIC ADVISORY PANEL Dr. Dennis Awang Bureau of Drug Research Natural Products Section Health and Welfare Canada. Dr. Shiu Ying Hu Arnold Arboretum Harvard University (retired) Dr. John Kartesz Nonh Carolina Botanical Garden University of North Carolina at Chapel Hill Dr. Arthur O. Tucker Department of Agriculture and Natural Resources Delaware State College Dr. Varro E. Tyler School of Pharmacy and Pharmacal Sciences Purdue University AMERICAN HERBAL PRODUCTS ASSOCIATION Austin, Texas 1992 Published by the American Herbal Products Association Adminsitrative Offices: 8630 Fenton Street Suite 918 Silver Spring, MD 20910 AHP A Standards Committee: 8630 Fenton Street Suite 918 Silver Spring, MD 20910 Timothy Moley, Chairman © 1992 by theAmericao Herbal Products Association. All rights reserved. Printed in the United SUItes of America INTRODUCTION In an effort to reduce nomenclatural problems in the herb trade, the American Herbal Products Association (AHPA) has proposed a compilation of common names "standardized" to botanical names. The foot of the concept is that a single common name in trade should apply to only one botanical name. The naming of plants has always presented problems for professional botanists and lay people alike. Cornmon plant names can be ambiguous. A single species may have dozens of common names applied to it in a language. On the other band, based on the most current taxonomic treatment, only one Latin binomial (scientific name) can validly apply to a plant. Scientific names are precise and internationally recognized. Herbs in commerce are described predominantly by common names. FDA regulations (2ICFRI01.3) state that the common or usual name shall be used for label ing food products. According to FDA regulations [2ICFR Ch.I, Sec. 102.5(a) (4-1-87 ed.) J: "The common or usual name of a food. which may be a coined tenn. shall accurately identify or describe in as simple and direct tenns as possible. the basic nature of the food or its characterizing properties or ingredients. The name shall be uniform and may not be confusingly similar to the name of any other food that is not reasonably encompassed with the same name. Each class or subclass of food shall be given its own common or usual name that states. in clear terms. what it is in a way that distinguishes it from different foods." A bewildering number of common names, as well as out-dated scientific names are applied to herbs in commerce. AHPA initiated the current project to reduce such ambiguities and confusion. Names serves as reference points - a vehicle for distinguishing one entity from another. Given the fact that common names have never served to clearly distinguish one plant from another, it is necessary that all herbs sold be properly identified, and that the identity be correlated to Latin binomials. and that a method of determining compli ance with appropriate standards of identity be implemented. This is at least a two phase task - first establishing widespread use of a uniform common name with a uniform Latin name. The second aspect, a separate issue, involves developing a system of compli ance of properly identified raw materials according to appropriate standards. presum ably those set forth in a botanical codex. Such a work may some day be developed through the concerted efforts of scientists, the industry, and regulators. Adopting the use of a uniform common or trade name corresponding to a single Latin binomial in I product labeling, will go a long way to solving potential confusion and perhaps misuse of botanicals on the part of manufacturers and consumers. BACKGROUND: The concept of producing a single standard common name to correspond with a single Latin binomial of plants in commerce is not a new idea. Long ago the American Pharmaceutical Association had a Nomenclature Corrunittee that dealt with standard ized names of crude drugs. In 1978, the Standards Committee of the fonner Herb Trade Association initiated a list of current botanical names for use by the herb industry. The list was circulated to members of that organization, but never appeared in a final pub lished form. The World Health Organization has developed a working list of "international botanical names" (IBN) for medicinal plants, included in the "Initial List of Medicinal Plants Widely Used Throughout the World" (Penso 1980). The Therapeutic Goods Administration of Australia has produced a working list of "Botanical and Common Names for Herb Substances," in order to conform to the re quirements of Australian law. In essence, it will serve the same purpose as the AHPA "Herbs of Commerce" publication. The reason for the use of a single standardized common name with a single Latin name is simple, and clearly stated in the preamble of the first edition of Standardized Plants Names, a 1923 pUblication of the American Joint Committee on Horticultural Nomenclature: "To make buying easy by bringing about so far as practicable, the consistent use of a single standardized scientific name, and a single stan dardized common name for every tree, shrub, and plant in American commerce." The American Joint Corrunittee on Horticultural Nomenclature was formed in 1915 by committees of the American Association of Nurseryman and the Ornamental Grower's Association, By the time the second and last edition of Standardized Plants Names was published in 1942, the concept had been expanded to include the "wide fields of economic and social activity covered by plants and plant products." Special sections covered fiber crops. forestry. fruit crops. gums, pharmaceuticals. herb garden plants, spices and condiments, range and wildlife plants, etc. Many organizations and contributors participated in the effort. A list of "Standardized Drug Plant Names," for example, was provided for the work by the Nomenclature Committee of the American Pharmaceutical Association. "Herb Garden Plant Names" were prepared by the Herbarium Committee of the Herb Society of America. Many of the standardized common names proposed in the pages of the second edition of Standardized Plant Names have been relegated to the obscurity. Echinacea angusti/olia has not become known as uBlacksampson Echinacea," Luffa, as the work suggested it should, has not become known as "Suakwa Vegetablesponge," Perhaps the effort was too massive, too broad in scope, to be of lasting use, given the malleability of botanical nomenclature. Over 90,000 separate plants and plant products (not including cross-indexing) appeared in the 1942 edition of Standardized Plant Names. Kartesz and Thieret (1991) have published new guidelines for use and applica tion of common names for vascular plants. The publication includes suggested guide lines for spelling, hyphenation, capitalization, and other elements of style and conven- II tion for the use of common names. These guidelines have been considered, and in many cases, applied to the "Herbs in Commerce" list The current project was initiated in 1988 by the Standards Committee of the American Herbal Products Association which circulated a list of "herbs in commerce" prepared by the AHPA Standards Committee Chainnan, Timothy Moley. It consisted of those herbs and spices found in the Code of Federal Regulations Title 21 parts 172.5100,182.10 and 182.20. Comments, additions, and corrections were submitted by AHPA members and incorporated into the list The list was reviewed by Dr. Arthur O. Tucker (Delaware State College). Dr. Tucker corrected OtaDy nomenclatural problems and added additional species (including botanical and common names). Author cita tions to the binomials and scientific plant family names were also added. The list was again circulated to AHP A members and others in the herb trade for further comments and additions. Those comments, corrections, and additions, along with more species, many more synonyms, and other details were added to the text by Steven Foster. That draft was given the working title uAHPA Herbs of Conunerce - Working Draft Version 3," and was again circulated for comment, corrections and additions to AHP A members, and others in the herb industry, as well as the five-member Scientific Advisory Panel. This resulted in hundreds of changes, questions, corrections, and ad ditions, which are incorporated into the current version. REVIEW PANEL The Review Panel members were selected for their expertise and impartiality. In its current fonn, the list will be circulated to the Review Panel as well as AHPA members, and other scientists or persons involved in the herb trade. Comments and proposed changes or additions will be collected by the AHPA Standards Committee, collated, then forwarded to the Review Panel which will decide on such changes. Once this final stage is accomplished, a procedure will advise on changes. REVIEW PANEL MEMBERS: Dr. Denois Awang Bureau of Drug Research, Natural Products Section, Health and Welfare Canada. Dr. Shiu Ying Hu Arnold Arboretum, Harvard University (retired). Dr. John Kartesz North Carolina Botanical Garden, University of North Carolina at Chapel Hill Dr. Arthur O. Tucker Department of Agriculture and Natural Resources, Delaware State College. Dr. Varro E. Tyler School of Pharmacy and Pharmacal Sciences, Produe University. ill OWNERSHIP OF RIGHTS PERTAINING TO THE LIST All rights of ownership, reproduction, and publication shall be retained by ARPA. AMENDMENTS OR CHANGES TO THE LIST To keep this list current and accurate, AHPA has a procedure for selecting a Review Panel which will review and make amendments to the list of common names. These procedures are designed to achieve the goals stated above and to assure that standard ization does Dot amount to restraint of trade. 1. Proposed changes to the AHPA list of standardized common names may be submit ted by either AHPA members or Review Panel members by presenting the pro posed cbanges in typewritten copy to the ARPA Standards Canunittee. 2. Proposals to cbange the list must state clearly why a cbange is requested and must be sponsored and signed by any three (3) members of ARPA (these need not be mem bers of the Review Panel). A Review Panel member needs no sponsor to propose changes to the list 3. After receiving proposals, the AHPA Standards Committee sends them on to the Review Panel. 4. On a publiShed schedule, and at least once annually, the ARPA members are notified of proposed changes to the list and are provided with brief arguments (no more than 100 words eacb) describing the need for each proposed cbange. All cbanges submitted are listed in the notice. 5. Proposed changes are accepted or rejected according to the following process and on the following time lioe: a. The ARPA Standards Canunittee notifies ARPA members and the Review Panel that proposals for changes to the list are being ac cepted. The notice states the calendar for the process. The time lioe of the comment period closes forty (40) days after the post mark of the notice. b. Comments and suggested changes (typewritten only) are compiled by the ARPA Standards Canunittee and mailed to the Review Panel. The ARPA Standards Conunittee has fifteen (15) days to complete this step. c. The Review Panel must produce a written decision on each item submitted, and return this decision to the ARPA Standards Committee. Decisions can be as short as one sentence, but should describe the reason why a proposed change was either ac cepted or rejected. Tbe Review Panel has forty (40) days from the pasttnark of the ARPA Standards Canunittee mailing to complete this step. IV d. The AHPA Standards Committee mails the Review Panel's com ments to the AHPA Board of Directors. The AHPA Standards Committee has fifteen (IS) days to complete this step. e. The Board must ratify the Review Panel's decision in order to make the changes official. The Board may ask for clarification from the Review Panel. If the Board chooses not to ratify such a decision. the status of the name in question remains as it was prior to the proposed change. The Board has forty (40) days from the postmark of the AHPA Standards Committee mailing. f. All AHP A members are notified that another review has been com pleted of the Standardized Common Names List. Ao addendum with recent changes to the List is printed and mailed to all AHP A members andlor is published in appropriate publications; copies are sent to each member of the Review Panel. A copy of the Review Panel's decisions is available to AHP A members upon request AHPA has thirty (30) days from the AHPA Board's rati fication of the changes to complete this step. FORMAT AND CONTENT OF THE PUBLICATION: I. The International Cnde of Botanical Nomenclature (ICBN) shall apply to any issue regarding use of Latin binomials. 2. The list is composed of botanical names, botanical synonyms, a proposed standard ized common name, cornman name synonyms. and in primary species listings. the scientific name of the plant family. The proposed standardized common name for each taxon is placed in bold-faced type in small capita1letters. Primary species ac counts consist of the Latin binomial. and author citation (author of the binomial). scientific plant family name. and common names. The primary proposed "standardized common name" follows in bold face type in small capital letters. Additional common synonyms are in plain type. In the case of herb commodities solely or primarily bnported from China, the stan dardized common narne consists of two parts. I). English name. 2). pin yin translit eration of the Chinese name as it appears in the 1985 edition of the Pharmacopeia of the People's Republic of China Vol. 1. As a matter of style, individual syllables are separated by a hyphen, rather than run together (as in the 1985 Chinese Pharmacopeia). The English name with the Chinese transliteration is included as bold face cross references in synonym indexing. It is suggested, however. that the English common name and transliteration in parentheses serve as the single "standardized common name" for the taxa involved. 3. The Review Panel will decide the correct botanical name for a plant and the standard ized common trade name for that botanical name. 4. The standardized common trade narne adopted by the Review Panel should be the only common name used for that plant in trade. v