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SIGNIFICANT GROWTH IN CONSUMPTION OF EPHEDRA
PRODUCTS WITH FEW ADVERSE REPORTS,
ANDERSEN SURVEY FINDS
Washington, D.C. (May 18, 2000)--- Consumption of dietary supplements containing Ephedra is on the rise, while the number of adverse reactions reported by Ephedra herbal product customers has been few for each of the last five years. This information is based on the first-ever Arthur Andersen survey of manufacturers who market dietary supplements containing Ephedra.
The survey showed that in 1999 sales increased to more than 3 billion servings, a 76% increase from the previous year. This is estimated to represent nearly 9 million Americans who consumed dietary supplements containing Ephedra last year. Despite this exponential growth in consumption there were only 25 serious adverse events reported to manufacturers, a total of just 8.1 adverse reports per billion servings.
"AHPA, in 1994, began the process of establishing meaningful self-regulations for supplements containing Ephedra. By 1997 these policies had been broadly accepted by industry and several states. The data in the survey dramatically confirms that these national industry standards, which include informative product labels and serving limits, assure the American consumer that if they follow the label directions, the use of Ephedra is appropriate and valid," said Michael McGuffin, president of the American Herbal Products Association, which sponsored the study.
The industry standards establish a limitation on serving size (25 mg ephedrine alkaloids) and daily consumption (100 mg); require labels with warnings and content disclosures; and set prohibitions against synthetic ingredients, against sales to minors and against illegal claims that the product may be used to "get high".
All but one of the 84 products covered by the survey conform to the industry standard for serving size. All products are in conformity with the daily consumption limits. Every manufacturer that responded uses a cautionary statement that is substantially the same as the industry standard, including a statement that products are not for use by minors. All products record the amount of ephedrine alkaloids on their labels. The companies report that no synthetic ephedrine is used as an ingredient in any product. Nearly all of the Ephedra products are marketed to help consumers lose weight or increase their energy. None of the products in the survey are sold with claims that the product can be used to "get high."
All companies in the survey reported that they are maintaining product quality control by following good manufacturing practices, including placing lot numbers on the product
"The declining ratio of reactions-to-consumption is what industry expected with the industry-wide adoption of national standards in 1997." said Wes Siegner, a partner in Hyman, Phelps & McNamara, counsel for the Ephedra Committee of AHPA. "Many products that are considered safe, such as analgesics, have a much larger number of reactions than do Ephedra products. According to the American Association of Poison Control Centers, for example, there are more than 73,000 reports of adverse reactions to analgesics each year."
The survey collected data for 1995-1999, and was conducted in early 2000 by Arthur Andersen LLP for the American Herbal Products Association, which represents manufacturers of herbal products. Of the 14 companies that responded to the survey, 64 percent have been in business for more than ten years and most sell 4 or more Ephedra products.
The American Herbal Products Association (AHPA) was founded in 1983
by a group of companies active in the trade in botanicals. AHPA
is now the national trade association and voice of the herbal products
industry, comprised of growers, processors, manufacturers, and marketers
of herbs and herbal products. AHPA serves its members by promoting
the responsible commerce of products that contain herbs. In that
capacity, AHPA has published Herbs of Commerce (1992), now incorporated
by reference in 21CFRß101.4; Botanical Safety Handbook (1997); and
numerous trade recommendations regarding labeling of botanical supplements.
For more information, logon to www.ahpa.org.
For more information on Ephedra, logon to www.EphedraFacts.com.
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