| U.S. Food and Drug Administration |
FDA Press Release, Apr 10, 2008
Herbal Science International, Inc. Recalls Twelve Dietary Herbal Supplements
Nationwide Because of Possible Health Risk Associated with Ephedra, Aristolochic
Acid and Human Placenta
FOR IMMEDIATE RELEASE -- City of Industry, CA--April 10,
2008- 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.
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.
This advisory was prepared by the FDA Office of Public Affairs.