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In This Issue of the AHPA Report The Official Publication of the American Herbal Products Association March 2011 www.ahpa.org Volume 26, Number 3 In this issue of the AHPA Report Inside AHPA 2 • AHPA Board Election: Candidates Represent Impressive Cross Section of Industry • FDA Health Fraud Coordinator and Industry Marketing Expert to Present at Annual Member Meeting • The AHPA Expo West Schedule of Meetings and Events • AHPA Members Eligible for SupplySide East Discount • Savings Opportunities for AHPA Members Special Topics 7 • Understanding the Complexities of Customs Regulations for Herbal and Dietary Supplements by Adonica-Jo R. Wada and Neil S. Helfand • Kava and the Risk of Liver Toxicity: Past, Current, and Future Aspects by Rolf Teschke Legal & Regulatory 18 • GAO Calls for FDA Inspection Authority on Food Claims Records by Michael McGuffin • Status of 111th Congressional Legislation in the 112th Congress by Peter Evich • Dear Retailer: There’s a Hole in the cGMP Bucket by Anthony L. Young, Esq. • FDA Issues First Reportable Food Registry Report by Anthony L. Young Botanical Science Update 25 • NCCAM Strategic Plan Includes “Integration of Alternative Treatment” • Literature Citations by Steven Dentali, PhD, and Francis Brinker, ND English Plantain Shows Ulcer-Healing Properties; Fenugreek Fiber Prevented Heartburn in Humans; Common Herbal Extracts Prevent Bacterial Adhesion; Herbal Traditions in Bosnia and Herzegovina; Cannabis Extracts Fight MS Symptoms in Mice; Passionflower Slightly Improved Sleep; Purple Granadilla Shows Anxiolytic Activity; Passionflower Synergistically Improves SJW Activity; “Toothache Plant” Puts the Hurt on Malarial Parasites; Patented Essential Oils Used to Repel Mosquitoes; Muira Puama Performs Well in Mouse Alzheimer Model; Rhodiola Reviews Well; More Quality Research Needed; Free Fitoterapia Special Edition on Research Since DSHEA; Diet, Supplements, and Mental Energy: A Review; Herb, Drug, and Author Interactions; Considerations Concerning Kids Consuming Caffeine Calendar of Botanical Events 33 Inside AHPA AHPA Board Election: Candidates “AHPA is pleased to have such an excellent group of board candi- Represent Impressive Cross Section dates seeking to represent our diverse membership,” says Michael McGuffin, AHPA president. “It’s inspiring to see such a high level of of Industry commitment to the organization. This interest in engagement on the board and in our many committees has been a hallmark of this Absentee ballots are due by March 7 organization for many years and bodes well for its future The 13 candidates running for election or re-election to the Board successes.” of Trustees of the American Herbal Products Association (AHPA), The election will take place at the Annual Member Meeting, the voice of the herbal products industry, represent an impressive Thursday, March 10, in the Avalon Ballroom of the Anaheim Hilton cross section of industry executives that have expressed interest in in Anaheim, Calif. Ballots have already been sent via email to com- joining the governing body of the association. pany representatives, along with candidate statements expressing The group of highly qualified candidates brings valuable skills, lead- their interest in joining the board. Members are encouraged to re- ership, and experience to the board, including scientific and legal view the candidate statements prior to the Annual Member Meeting. expertise, long-term industry experience and knowledge, and herbal (Note: The PDF containing the candidate statements may take 3-4 or integrative medicine backgrounds. minutes to load.) 2011 Candidates for the Board of Trustees Candidate Name Title Company Name Cindy Angerhofer Executive Director of Botanical Research and Aroma Aveda Volker Wypyszyk CEO Azile, LLC Rupa Das VP, Global Quality & Compliance BI Nutraceuticals Jackie Greenfield VP, Global Sourcing & Sustainability Gaia Herbs Daniel Gagnon Owner Herbs, Etc. Skye Sturgeon Quality Assurance Manager Mayway USA Olaf Weitz Head of Business Development, Supplements Group MB North America Steven Yeager QC/Laboratory Manager Mountain Rose Herbs Tim Callahan VP of Quality New Chapter Wilson Lau VP of Sales and Marketing Nuherbs Co. Richard Kaufman Chief Operating Officer Paragon Labs Michael Friedman President Restorative Formulations Stefan Gafner Director of Analytical Chemistry Tom’s of Maine The AHPA Report, the official voice of the AHPA Staff Send inquiries, comments or American Herbal Products Association Michael McGuffin, President requests to: (AHPA), is published monthly as a service Steven Dentali, PhD, Chief Science Officer American Herbal to AHPA members and friends of the , Chief Operations Officer Devon Powell Products Association herbal products industry. The material Frank Lampe, Director of Communications & Editor, AHPA Report 8630 Fenton Street, Suite 918 contained in this publication is for the Yelena Teterina, Operations Manager information of AHPA members. Although Rosie Ysasi, Certification Program Coordinator Silver Spring, MD 20910 the information is believed to be correct, Merle Zimmermann, Information Analyst Phone: 301-588-1171 AHPA disclaims all responsibility for any Fax: 301-588-1174 Anthony Young, General Counsel, Kleinfeld, Kaplan & Becker damage or liability that may result from Peter Evich, National Legislative Consultant, Van Scoyoc Associates Email: [email protected] any reliance on the information contained Website: www.ahpa.org in this publication. Janice Chika, Graphic Designer, AHPA Report Breyeh Freesol, Media Production Coordinator Articles may not be reproduced or reprinted Monica Emerich, PhD, Copy Editor, AHPA Report © copyright 2011, American without written permission from AHPA. Bill Schoenbart, D.A.O.M., Proofreader, AHPA Report Herbal Products Association March 2011 • Page 2 Each candidate will be provided with an opportunity to address The Board of Trustees provides general oversight of the affairs, the membership at the March 10 meeting. In conformity with the business and concerns of the association. Its duties are carried out at AHPA Bylaws and Election Policies, nominations for additional regularly scheduled meetings and at other such times as provided by candidates will not be accepted from the floor and write-in votes association bylaws. The board has the power to admit, suspend or will not be accepted. expel members; to formally approve all operating budgets desirable All active members in good standing are asked to vote for nine of in the conduct of the business of the association; to establish trade the 13 candidates who have declared their intentions to stand for requirements as amendments to the association’s Code of Ethics & election to the board. Members may cast their votes in one of three Business Conduct; and to establish or recommend additional poli- ways: in person at the Member Meeting or via email or via mail-in cies and guidelines that are consistent with the association’s mission: ballots, which were sent to members on Feb. 10, along with candi- to promote the responsible commerce of herbal products, in date statements and complete instructions. Email or mail ballots addition to other responsibilities. are due at the AHPA office by March 7. If you are your company’s primary contact and have not received an Alternately, a member may assign their vote to a proxy by printing email containing the ballot and candidate statements, or if you have the ballot and filling in the “Proxy Assignment for Election of AHPA questions regarding the election process, please contact Devon Trustees, March 10, 2011” and giving it to their proxy, who will Powell, 301.588.1171 x102, or by email. then cast the member’s vote in-person at the Member Meeting. If you have not yet registered for the Annual Member Meeting and Members who will not be attending the Annual Member Meeting are Breakfast, you can do so here. encouraged to take the time to exercise one of the absentee options. March 2011 • Page 3 FDA Health Fraud Coordinator and FDA takes enforcement actions, seeks criminal prosecutions and Industry Marketing Expert to Present works to educate consumers to address this serious public health at Annual Member Meeting risk. He will also address how FDA is working with dietary supple- ment trade associations—such as AHPA—to educate the industry As part of its 2011 Member Meeting, AHPA is pleased to welcome and to help develop new strategies to combat this problem. Gary Coody, R.Ph., the Food and Drug Administration’s (FDA) na- Before his appointment as National Health Fraud Coordinator in tional health fraud coordinator in the Office of Enforcement, Office the Office of Enforcement, Mr. Coody dealt with policy issues relat- of Regulatory Affairs, and Steve French, managing partner of the ed to dietary supplements and drugs in the Office of Regulatory Natural Marketing Institute (NMI), who will both make presenta- Affairs’ Division of Compliance Policy. Mr. Coody began his FDA tions to the membership. career in 2000 at the Center for Food Safety and Applied Nutrition’s Office of Nutritional Products, Labeling, and Dietary Supplements. Coody to Discuss Drug Spiking of Supplements Before joining FDA, Mr. Coody served as Senior Pharmacist at the Gary Coody, a registered pharma- Texas Department of Health, and he practiced retail and hospital cist, will address the serious issue of pharmacy. dangerous drugs masquerading as dietary supplements. In recent French to Share Latest Consumer Herb Trends years, FDA has identified more than Steve French, who is an executive with one of the industry’s
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