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USP Establishes Botanical Advisory Panel

The United States Pharmacopeia (USP) has created a new panel of leading experts in herbal medicine, including the marketing, trade, cultivation, sourcing, and processing of herbal products.

"With the formation of the advisory panel, we will be able to obtain and disseminate information on how to improve the quality of botanicals," said David B. Roll, director of dietary supplements at USP. "Historically, USP has created standards for botanical products, however, we have never looked at factors that favor optimal growth, handling, and storage of botanicals."

The new USP Botanical Advisory Panel will provide information to the Dietary Supplements – Botanicals Expert Committee, a standing USP committee chaired by Paul Schiff, Ph.D., of the University of Pittsburgh College of Pharmacy, which develops monographs and establishes standards for botanical dietary supplements.

The new panel will develop information on:

Historical uses

Commercial growing sources

Good agricultural practices, including collection and harvesting (conservation status, optimal times of harvest, optimal handling process, optimal collection practices), plus information on cultivation, including packaging practices; handling and processing; drying and storage conditions; adulterants

Botanical identification

Chemical constituents

The feasibility of developing Authentic Plant Reference Materials that would be used by regulatory agencies within and outside the United States

Regulatory status in other countries

The panel also plans to create additional information chapters for a future edition of the United States Pharmacopeia and National Formulary (USP-NF).

The panel agreed to focus on the most important botanicals in the market, including, but not limited to, the 25 botanicals for which USP has already developed monographs (from 1995 to 2002 USP has published 86 standards monographs on 25 herbs). These 25 herbs were previously picked by USP because of their relative popularity in the U.S. market (See Table 1). The first four botanicals to be examined are ginger, valerian, saw palmetto, and black cohosh.

USP Standards monographs for botanicals and other dietary supplements are recognized by the U.S. Food and Drug Administration (FDA) as the official standard for a substance and can be the basis for enforcement policy and actions by FDA.

In general, the new Botanical Advisory Panel will focus on information about specific herbs that are not intended to be incorporated into the monographs.

The USP was established in 1820 and is recognized as the official U.S. organization empowered to establish standards for pharmaceuticals, healthcare technologies, and dietary supplements.

– Mark Blumenthal

USP Botanical Advisory Board Members

>The new 12-member Botanical Advisory Panel includes representatives from academia, government, and industry. The panel is chaired by William F. Popin, the director of research and development and quality for Young Living Essential Oils, of Payson, Utah. He also is a member of USP's Dietary Supplement – Botanicals Expert Committee.

Other members of the panel are:

Simon Mills, M.A., FNIMH, NCPP, director of the Centre for Complementary Health Studies, at the University of Exeter, Devon, England; Rudolf Bauer, Ph.D., professor at the Institut fŸr Pharmakognosie, Graz, Austria; Mark Blumenthal, founder and executive director of the American Botanical Council; Amala Raman, senior postgraduate tutor, King's College, London, England;Roy Upton, executive director of the American Herbal Pharmacopoeia, Scotts Valley, California; John Cardellina, Ph.D., vice president of the Council for Responsible Nutrition, Washington D.C.; James Miller, Ph.D., curator and head of the Applied Research Department, Missouri Botanical Garden; Greg Pennyroyal, president of Growing Medicine Inc., Signal Hill, California; Ezio Bomabardelli, Ph.D., of Indena S.p.A., Milan, Italy; Kathy Sharpless, Ph.D., research chemist with the Analytical Chemistry Division at the National Institute of Standards and Technology, Gaithersburg, Maryland; Edward Fletcher, Ph.D., Strategic Sourcing Inc. of Banner Elk, North Carolina; Gabriel Giancaspro, Ph.D., USP senior scientist, is the USP staff liaison to the panel.

Table I Species of USP Botanical Monographs Published 1995-2002

  • Black cohosh
  • Chamomile
  • Chaste tree
  • Cranberry
  • Echinacea angustifolia
  • Echinacea pallida
  • Echinacea purpurea root
  • Eleuthero
  • Feverfew
  • Garlic
  • Ginger
  • Ginkgo
  • Ginseng, American
  • Ginseng, Asian
  • Goldenseal
  • Hawthorn leaf with flower
  • Horse Chestnut
  • Kava
  • Licorice
  • Milk Thistle
  • Myrrh
  • Nettles
  • Red Clover
  • Saw Palmetto
  • Valerian