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New FDA Rule for Good Manufacturing Practices Now Applies to Most Supplement Manufacturers

(Austin, TX) June 26, 2009. New federal rules for the manufacture of dietary supplements go into effect this week for most manufacturers of these products.

The rules, called Good Manufacturing Practices (GMPs), were initially released by the US Food and Drug Administration (FDA) in June 2007. The schedule for compliance with the GMPs is based on the size of the company: large companies (500+ employees) were required to be compliant in 2008; middle-size companies (20-499 employees), which constitute most dietary supplement manufacturers, are required to be compliant as of yesterday; and small companies (under 20 employees) will have until June 2010 to be in full compliance.

The GMP rule covers all aspects of raw materials and finished products storage, processing, manufacturing, labeling, quality control testing, record-keeping, and much more. The goal of GMPs is to help ensure proper identity, cleanliness, quality, and general safety of dietary supplements so that consumers, health professionals, and other members of the general public can have greater confidence in this increasingly popular class of goods.

To assist manufacturers in the proper identification of plant raw materials, the nonprofit American Botanical Council (ABC) and the world-renowned Missouri Botanical Garden produced a guide for members of the herb industry, which is intended to help ensure accuracy in the growing, harvesting, collecting, drying, storage, and processing of medicinal plant materials.

This guide called, The Identification of Medicinal Plants: A Handbook of the Morphology of Botanicals in Commerce, focuses on the straightforward visual, macroscopic (examination under a hand lens or dissecting microscope) identification of more than 150 species of botanicals used in commercial herbal products in North America.

Written by Wendy Applequist, PhD, a botanist and assistant curator at the Missouri Botanical Garden in St. Louis, the handbook is intended to provide greater access to the information required for the accurate identification of medicinal plants. This will ensure availability to a wider group of quality control and laboratory technicians in the herb and dietary supplement industry, as well as botanists, medicinal plant collectors, researchers, students, and others who study or deal with medicinal plants.

The handbook features 113 botanical entries covering more than 150 different species of botanicals in commerce, as well as 87 detailed black-and-white line drawings. It also contains a brief review of basic plant structure, some practical advice on identification, an introduction to botanical nomenclature, a glossary, a reference list, and an index.

Detailed descriptions by Dr. Applequist, paired with detailed drawings by Barbara Alongi, provide excellent guidance to properly, effectively, and efficiently identify botanicals.

“One of the primary tasks of quality control is the need to accurately ensure the proper identity of the raw materials that are processed and put into capsules, tablets, extracts and other forms of dietary supplements,” said Mark Blumenthal, founder and executive director of ABC.

“Identity can be particularly challenging in the area of herbal raw materials, where many plants, especially dried plants, may look alike to the untrained eye,” he said. “This book will become a standard reference for all relevant parties in the herb industry to help ensure optimum quality control for the greatest benefit to consumers.”

Praise for the ABC Botanical Identity Handbook

The book has already received accolades from numerous herbal experts in a variety of fields including academia, pharmacology, and numerous others, particularly those with experience in botanical identification in setting quality standards in the herb industry. James A. Duke, PhD, internationally noted herbal expert and author, said the new handbook is a “great book” containing “good science” and “good art” and that it is “very useful.”

“As a collector of books and articles on powder analysis and the nomenclature of medicinal plants, this book is a good accompaniment that pulls together information from a wide number of sources. Great job and a great addition to my bookshelf!” said Arthur O. Tucker, PhD, research professor and co-director of the Claude E. Phillips Herbarium at Delaware State University.

Josef A. Brinckmann, vice-president of research and development at Traditional Medicinals, a leading marketer of medicinal herbal teas, stated, “The botanical glossary, the detailed macroscopic descriptions including sensory characteristics, and the illustrations will make this an often-used handbook sitting alongside the pharmacopeias and other essential laboratory handbooks.”

Sidney Sudberg, a chiropractor and acupuncturist who now is director of Alkemists Pharmaceuticals, Inc., a third-party quality control and consulting laboratory for the herb industry, said, “This book is indispensable to anyone who loves plants, and herbs in particular, and wants to know that they have the correct species. As a quality control professional interested in having as complete a picture as possible for accurate identification of herbs, this book is a necessity.”

The book retails for $89.95, with a discount for ABC members. To order, call 800-373-7105 and request item #B539. More information at the “Shop” button on the ABC website:

Book Data

The Identification of Medicinal Plants: A Handbook of the Morphology of Botanicals in Commerce by Wendy Applequist. Austin, TX: American Botanical Council; 2006. Item #B539; Hardcover; 231 pp.; 87 B&W line drawings; $89.95. ISBN 10: 0-9655555-1-8; ISBN 13: 978-0-9655555-1-7

About the American Botanical Council

Founded in 1988, the American Botanical Council is a leading international nonprofit organization addressing research and educational issues regarding the health benefits of herbs, medicinal plants, teas, phytomedicines, essential oils, and other plant-based ingredients. ABC’s members include academic researchers and educators, universities and libraries, health professionals and medical institutions, botanical gardens and arboreta, government agencies, members of the herb, dietary supplement, cosmetic, and pharmaceutical industries, journalists, consumers, and other interested parties from over 70 countries. The organization occupies a historic 2.5-acre site in Austin, Texas, where it publishes the quarterly journal HerbalGram, the monthly e-publication HerbalEGram, HerbClips (summaries of scientific and clinical publications), reference books, and other educational materials. ABC also hosts HerbMedPro, a powerful herbal database, containing thousands of abstracts of scientific and clinical publications on 221 herbs. ABC is tax-exempt under section 501(c)(3) of the IRS Code. Information: Contact ABC at P.O. Box 144345, Austin, TX 78714-4345, Phone: 512-926-4900. Website: