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The Official Publication of the American Herbal Products Association August 2010 www.ahpa.org Volume 25, Number 8 In this issue of the AHPA Report You Need to Know 2 • New Members • Botanical Safety Handbook Revision Process Reaches Milestone; Support Needed to Reach Fundraising Target • AHPA Staff Contribute to ODS Publication on Dietary Supplement Ingredients • Upcoming AHPA Seminar Microscopic Identification of Popular Botanical Materials Special Topics 6 • Report of July 13, 2010 Meeting of the AHPA Board • How Big is the Global Trade of Medicinal and Aromatic Plants and Extracts? by Josef Brinckmann Legal & Regulatory 9 • Government Gets Tough with Purveyors of Drug-Spiked “Dietary Supplements” by Anthony L. Young, AHPA General Counsel, and Michael McGuffin, AHPA President • 52 New Proposition 65 Complaints Filed Against Supplement Companies; Settlements Now Exceed $4 Million by Michael McGuffin, AHPA President • FDA’s Moore Clarifies Statement on NDI Enforcement By Anthony L. Young, AHPA General Counsel • Warning Letter Addresses Unpermitted Irradiation, Labeling of Excipients in Extracts, and Application of Food cGMP to Ingredient Suppliers By Anthony Young, Kleinfeld, Kaplan and Becker, LLP, AHPA General Counsel • Safe Cosmetics Act Introduced in U.S. House By Stacy L. Ehrlich, Kleinfeld, Kaplan and Becker, LLP Communications Update 16 • AHPA Media Scan: Notable “Herbal Headlines” Calendar of Botanical Events 17 Botanical Science Update 20 • Meetings Attended USP Nomenclature Workshop and Expert Committee Meetings • Literature Citations Further research on topical aloe vera for burns and wound healing Aloe vera food and supplement ingredient reviews Hawthorn for heart health? You Need to Know Botanical Safety Handbook Revision Process Reaches Milestone; Support New Members Needed to Reach Fundraising Target Purest Colloids’ mission is to produce the finest colloidal AHPA’s Botanical Safety Handbook, first published in 1997, has been products, therefore providing the highest level of effective- undergoing substantial revision over the last three years. The initial ness. Purest Colloids offers superior metal colloid products phase of the revision process, consisting of a broad literature search for use as dietary supplements. To maintain a robust im- for each of over 500 herbs and review by an Expert Advisory Council mune system for optimum health, Mesocolloids contain to establish classifications for overall safety and for potential herb- minerals in trace amounts that our bodies can use. Our drug interactions, was completed at a teleconference meeting on products are in the forefront of quality and effectiveness be- June 25, 2010. cause we maximize the Particle Surface Area of the nanome- ter-sized particles. For quality and safety all Mesocolloids are Revision of the Botanical Safety Handbook has progressed under manufactured in an FDA Registered Facility. Website: www. the direction of the AHPA Foundation for Education and Research purestcolloids.com. on Botanicals (the AHPA-ERB Foundation). The AHPA-ERB Foundation is a 501(c)(3) foundation organized to perform the Stiebs is devoted to sourcing, processing and delivering the charitable, educational and scientific functions of the American world’s finest plant-based products. The company strives to Herbal Products Association (AHPA). meet its motto, Nature Elevated, by procuring the world’s finest ingredients for health and wellness based products and Zoë Gardner, M.S., a research fellow at the Medicinal Plant Program processing them in the cleanest, purest, most flavorful and at the University of Massachusetts, and Michael McGuffin, AHPA’s functional way possible, using the latest technology available. president, are the editors of the revised document. The Expert Advisory Council consists of Roy Upton, RH (AHG), D. Ayu.; Stiebs was formed in 2005 with the intent of becoming a Soaring Bear, Ph.D.; David Winston, RH (AHG); Daniel Gagnon, leading industrial supplier for pomegranate juice concen- RH (AHG); Aviva Romm, CPM RH (AHG), M.D.; Mary Hardy, trate. Building on that foundation, Stiebs has built a world- M.D.; and Tieraona Low Dog, M.D. Invited reviewers are David class processing infrastructure coupled with a worldwide Bechtel, Ph.D., DABT and Leslie Beyer, M.S., DABT. procurement and partnership network and has become a rec- ognized industry leader in the area of superfruits with its fo- “The AHPA Foundation greatly appreciates the diligence of all of cus on sustainability, market knowledge, and scientifically the experts who have devoted their time to this important project,” supported ingredients. noted Garry Pay, the foundation’s chair. “In addition, the generosity of the many companies and individuals who have provided financial The company offers a full line of fruit based ingredients in- support for this work is a clear indication of the herb industry’s ac- cluding pomegranate, maqui berry, prickly pear cactus fruit, goji, mangosteen, acai, grape, tart cherry, passion fruit, kiwi, knowledgement of the value of this document,” he added. and blood orange as single strength juices, juice concentrates, Thanks to contributions already made in support of the revision (see purees, extracts, powders, and pomegranate arils sold to sidebar on next page), the foundation is less than $30,000 from its food, beverage, dietary supplement, and cosmetic companies. fundraising goal. Please consider making a donation to this Website: www.stiebs.com. important work today by contacting Michael McGuffin at [email protected]. The AHPA Report, the official voice of the American AHPA Staff Send inquiries, comments or requests to: Herbal Products Association (AHPA), is published monthly as a service to AHPA members and friends Michael McGuffin, President American Herbal of the herbal products industry. The material [email protected] Products Association contained in this publication is for the information 8630 Fenton Street, Suite 918 of AHPA members. Although the information Steven Dentali, PhD, Chief Science Officer [email protected] Silver Spring, MD 20910 is believed to be correct, AHPA disclaims all Phone: 301-588-1171 responsibility for any damage or liability that Devon Powell, Chief Operations Officer Fax: 301-588-1174 may result from any reliance on the information [email protected] Email: [email protected] contained in this publication. Website: www.ahpa.org Articles may not be reproduced or reprinted without written permission from AHPA. © copyright 2010, AHPA August 2010 • Page 2 The second edition of the Botanical Safety Handbook will represent Financial sponsors of the a significant modification from the first edition. The editors of the Botanical Safety Handbook, 2nd edition (to date) original edition relied heavily on secondary references, and fewer $25,000+ than 300 publications were identified in that work’s bibliography. NIH Office of Dietary Supplements By comparison, as many as 35,000 references were reviewed for the University of Massachusetts Medicinal Plant Program revised edition, and over 8,000 will be cited in the text. $10,000+ “Research on herbal ingredients has accelerated dramatically in the Herbs, Etc. last several years,” commented Gardner, the revised text’s co-editor. $5,000+ “Our compilation and review of this emerging data, along with old- Aveda, Nature’s Way er data that is now more easily accessible, will serve as the basis for an authoritative resource that will benefit consumers of herbal sup- $2,500+ plements as well as provide important data to health care providers CRC Insurance, Emerson Ecologics, General Nutrition who now lack adequate information on the herbs used by so many Centers (GNC), Herb Pharm, Michael McGuffin (AHPA), Pacific Nutritional, Inc. of their patients.” $1,000+ Additional work is now underway to complete the text, and publica- Arise & Shine, Herbalist & Alchemist, Mountain Rose Herbs, tion by CRC Press is projected for 2011, in both print and electronic NOW Foods, Jim Prochnow (Greenberg Traurig), formats. Systemic Formulas, Traditional Medicinals, Vitality Works “AHPA has been broadly credited for publishing the first edition of $500+ the Botanical Safety Handbook over a decade ago, at a time when it Jon Benninger (Virgo Publishing), was difficult to find accurate information on herbal safety issues,” Steven Dentali (AHPA), Greg Doherty (Poms & Associates), commented AHPA’s McGuffin. “The current revision of this semi- Frontier Natural Products, New Chapter nal text will reflect AHPA’s continued commitment to providing ac- $100+ curate information about the safe oral use of herbs in a practical and Cindy Angerhofer (Aveda), accessible format.” Mary Beth Watkins (Nutraceutical Corporation) August 2010 • Page AHPA Staff Contribute to ODS Publication anyone interested in a scientific and balanced presentation of both on Dietary Supplement Ingredients the science behind and the possible benefits (or not) of dietary supplements.” The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) recently announced the publication of its The title is available from Informa Healthcare Books at a retail price Encyclopedia of Dietary Supplements, 2nd Edition. This new edition of $1,000. AHPA members will receive a 15% discount by ordering contains chapters on several botanicals, including aloe vera, bilberry, online at http://www.informahealthcarebooks.com/ and using coupon bitter orange, black cohosh, kava, and saw palmetto. AHPA Chief code “COLLEAGUE” (case sensitive). Science Officer Steven Dentali,