Herbal Science International, Inc. Recalls Twelve Dietary Herbal
Supplements Nationwide Because of Possible Health Risk Associated with
Ephedra, Aristolochic Acid and Human Placenta
Contact:
Ginger Chang
(626) 333-9998
FOR IMMEDIATE RELEASE -- City of Industry,
CA--April 10, 2007- Herbal Science International, Inc. (AKA Jen-On
Herbal Science International, Inc.) is recalling twelve dietary
supplements that contain ephedra, aristolochic acid or human placenta
because they may present a serious health hazard to consumers.
FDA has long regarded dietary supplements containing ephedra as
potential health hazards because this botanical contains ephedrine
alkaloids. Ephedrine alkaloids are adrenaline-like stimulants that can
have potentially dangerous effects on the heart. Recent studies have
confirmed that ephedrine alkaloids raise blood pressure and otherwise
stress the circulatory system, effects that are linked to adverse
health effects like heart attacks and strokes. Based on this and other
evidence in the scientific literature, FDA issued a rule in February
2004 prohibiting the sale of dietary supplements containing ephedrine
alkaloids because they present an unreasonable risk of illness or
injury. The company is recalling nine products that contain ephedra, a
source of ephedrine alkaloids, as an ingredient sold labeled under the
following brands:
Wu Yao Shun Qi San
Qing Bi Tang (Nasal Cleanser)
Zhong Fong Huo Luo Wan (Stroke Revito Formula)
Xiao Qing Long Tang (Little Green Dragon)
Ding Chuan Tang
Xiao Xu Ming Tang
Feng Shi Zhi Tong Wan (Joint Relief)
Guo Min Bi Yan Wan
Fang Feng Tong Sheng San
Herbal Science International, Inc. is also recalling
Tou Tong San (Headache Formula) and
Du Huo Ji Sheng Tang (Du Huo Joint Relief)
,
two products containing aristolochic acid. Aristolochic acid is a
potent carcinogen and nephrotoxin found in certain plants and
botanicals. This chemical can cause serious kidney damage and the use
of products that contain aristolochic acid has been associated with
several occurrences of kidney failure. These products have also been
linked to an increased risk of kidney cancer in people who have
consumed them.
Finally, the company is recalling
Seng Jong Tzu Tong Tan,
a product that contains human placenta. Human placenta may transmit
disease and dietary supplements that contain it may not be lawfully
marketed in the United States.
All of the twelve products under voluntary recall are packed in
white plastic bottles of 100 capsules. All lots are covered in this
recall action. These products have been sold nationwide in herbal
stores, by acupuncturists and on the internet.
Consumers who have purchased these products should immediately
discontinue their use and return them to the place of purchase for a
full refund. Consumers with questions may contact the company at (626)
333-9998. Consumers who have been taking the products and have
experienced adverse reactions should consult their health care
professional. Consumers and health care professionals can also report
adverse events to the FDA's MedWatch program at 800-FDA-1088 or online
at www.fda.gov/medwatch/report.htm.
No illnesses have been reported to the company to date in connection
with these products and the company has ceased distribution of all of
these products.
.
Herbal Science International, Inc.
apologizes for any inconvenience and expresses its concerns for the
health of consumers by conducting a voluntary recall action. Herbal
Science International, Inc. promises to ensure quality and integrity of
all its products and the company is working closely with the FDA in the
recall process.
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