The Official Publication of the American Herbal Products Association January 2011 www.ahpa.org Volume 26, Number 1 In this issue of the AHPA Report You Need to Know 3 • Savings Opportunities for AHPA Members • New Members • Annual Call for Candidates to AHPA’s Board of Trustees Legal & Regulatory 5 • Industry Joins FDA in Confronting Illegal Drug Spiking, by Michael McGuffin and Anthony L. Young, Esq. • FDA on Spiked Products, cGMP Small Entity Compliance Guidance Guide, More Warning Letters and Free Form Plant Phytosterols, by Anthony L. Young, Esq. • The 112th Congress: Outlook and Opportunities, by Pete Evich • AHPA Comments on FTC “Green Guides,” by Michael McGuffin • AHPA Comments on USDA’s Draft Guidance on Organic Wild Crops, by Michael McGuffin • U.S. Senate Succeeds on Second Attempt to Pass "Food Safety Modernization Act,” by Jennifer Denhard Inside AHPA 14 • AHPA Looks Ahead to 2011, by Michael McGuffin • AHPA Trains Naturopaths in Quality Assessment of Dietary Supplements, by Jennifer Denhard Special Science Feature 16 • Reanalysis of ConsumerLab’s Valerian Product Review; Many Questions Still Unanswered, by Michael McGuffin Communications Update 19 • AHPA Media Scan: Notable “Herbal Headlines” Calendar of Botanical Events 20 Table of Contents continues on page 2 Table of Contents continued from page 1 Botanical Science Update 20 • Meeting Attended • China Pharmacopoeia Delegation • Literature Citations Analysis • Fingerprint Analysis of Ginkgo Leaves and Supplements • NMR Fingerprint Analysis of Hoodia Species and Supplements • FTIR Screening for Adulterated Raw Materials by NOW Foods • FTIR Analysis of Astragalus Root for Origin and Adulteration • Tea and Herbal Tea Safe from Mycotoxin Exposure • Ginger Analysis: Measurement of Components in Products • Eugenol in Clove Oil: A Validated HPLC Analysis Clinical and Pharmacologic • Ginger Reduced Exercise Induced Pain, Just Not Right Away • Clove Oil Reversed Memory Impairment in Mice • Valerian Extract Did Not Sedate Mice In Vitro Studies • Clove Extract Kills Lettuce Leaf Pathogens • Essential Oils in Preserving Lettuce Leaves • Synergistic Action of Aerial Goldenseal Plant Extracts Reviews, Etc. • Immunological Activity from Medicinal Herbs • All About Olive Oil • Critical Review of Synephrine in Supplements • Assigning Causality in Botanical Adverse Events • Ayurveda Literature Searching • ESCOP Monographs Scientifically Valuable • Southwest US Guide to Herbal Practice • Upcoming Event • U.S. Pharmacopeia (USP) Nomenclature, Safety and Labeling Expert Committee 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 Steven Dentali, PhD, Chief Science Officer of AHPA members. Although the information Silver Spring, MD 20910 [email protected] 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 Jennifer Denhard, Director of Communications without written permission from AHPA. [email protected] © copyright 2011, AHPA January 2011 • Page 2 You Need to Know Life Plus International is a manufacturer of dietary supplements and we sell our finished products, which include dietary supple- Savings Opportunities for AHPA Members ments, in tablet, capsule and powder form. Within the pages of this edition of AHPA Report, we are pleased to UST Corporation is a contract manufacturer of dietary supplements, provide our members with several valuable money-saving opportu- encapsulation, bulk powders, packeting, bottling, and stick packeting. nities. The following goods and services are offered at a discount National College of Natural Medicine (NCNM) is the oldest ac- for—or are uniquely available to—AHPA members this month: credited Naturopathic College in North America, with Graduate Programs in Naturopathic and Chinese Medicine. The college also AuthenTechnologies, 10% off for AHPA members (page 4) markets Chinese and Western herbs, professional lines of nutraceu- Guidance Documents (for the Manufacture and Sale of tical products, homeopathic remedies, Chinese patent medicines, Botanical Extracts), $30 discount for members (page 8) essential oils, and more through the NCNM Clinic Medicinary. 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For more information email Rakesh Amin at [email protected] or call 312.286.3925. www.AminTalati.com January 2011 • Page 3 Annual Call for Candidates to ongoing functions of the organization. While trustees receive no re- AHPA’s Board of Trustees muneration for their services, the benefits to the companies repre- sented, and the industry as a whole, are well recognized. The American Herbal Products Association (AHPA) announced on December 10 its annual call for candidates for elected trustees1 “With their individual experience, expertise and leadership, AHPA’s to the association’s Board of Trustees. The election for the 2011 board members create an essential guiding body as the association cycle will be held at AHPA’s annual meeting in Anaheim, CA on works to address challenges and opportunities facing this industry,” March 10, 2011. The association’s bylaws and election policies will said AHPA President Michael McGuffin. “All eligible companies govern this nomination process and election. This information is should consider nominating a representative and taking advantage available on our web site (www.ahpa.org), along with a list of trustee of the opportunity to become involved in this good work.” responsibilities. The deadline for submitting your intent to stand for election form A candidate for the board may be an owner, employee, consultant, is Feb. 8, 2011. All active AHPA members in good standing are or other designated representative of the company wishing to be qualified and encouraged to nominate a candidate. represented on the board. A candidate must be officially nominated If you have any questions about this process, or to request a copy of in writing by completing and returning an intent to stand for elec- the intent to stand for election form, please contact Devon Powell at tion form. 301-588-1171, ext. 102 or email [email protected]. The number of seats on the Board of Trustees consists of a mini- AHPA’s bylaws are available online at: http://www.ahpa.org/Portals/0/ mum of 22 seats. Two elected seats are reserved for “small business pdfs/04_11_AHPABylaws.pdf members,” defined as those active members with $5 million or less in annual