Herbal Science Recalls Dietary Supplements Containing Ephedra, Human PlacentaApr 15, 2008 | Parker Waichman LLP
Herbal Science International, Inc.—also known as Jen-On Herbal Science International, Inc.—is recalling twelve dietary supplements containing ephedra, aristolochic acid, or human placenta because they may present a serious health hazard to consumers.
The Food & Drug Administration (FDA) has long considered those dietary supplements containing ephedra as potential health hazards because of the ephedrine alkaloids—adrenaline-like stimulants that can have potentially dangerous effects on the heart—found in ephedra. Also, recent studies confirm that ephedrine alkaloids raise blood pressure and stress the circulatory system, effects which are linked to adverse health effects such as heart attacks and strokes. Because of this and other confirming findings, the 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.
Herbal Science International, Inc./Jen-On Herbal Science International, Inc. is recalling nine products that contain ephedra as an ingredient and 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./Jen-On Herbal Science International, Inc. is also recalling Tou Tong San (Headache Formula) and Du Huo Ji Sheng Tang (Du Huo Joint Relief), because they contain aristolochic acid—a potent carcinogen—as well as nephrotoxin, a chemical found in certain plants and botanicals that can cause serious kidney damage. The use of products containing 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.
Herbal Science International, Inc./Jen-On Herbal Science International, Inc. is also recalling Seng Jong Tzu Tong Tan, a product that contains human placenta, which can transmit disease. Dietary supplements that contain human placenta may not be lawfully marketed in the United States.
All twelve products under voluntary recall are packed in white plastic bottles of 100 capsules and all lots are covered in this recall. The 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. Questions may be directed to the company at (626) 333-9998. Consumers who have been taking the products and experienced adverse reactions should consult their health care professional immediately; 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 in connection with these products and the company has ceased distribution of all of these products.
Meanwhile, the FDA recently issued a warning that some brands of red yeast rice supplements may contain a prescription medication that could be harmful to human health and issued a recall for a number of supplements containing the prescription medication lovastatin.