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 21CFR�101.4;
Botanical Safety Handbook (1997); and numerous trade
recommendations regarding labeling of botanical supplements.
For more information, logon to www.ahpa.org.
