Ephedra, Human Placenta Trigger Supplement Recall

CITY OF INDUSTRY, Calif.—Herbal Science International Inc. (HSI) has recalled 12 dietary supplements containing ephedra, aristolochic acid or human placenta, because they may present a serious health hazard to consumers. FDA ruled in February 2004 to prohibit the sale of dietary supplements containing ephedrine alkaloids, because they present an unreasonable risk of illness or injury, due to their effects on the heart. To date, no illnesses have been reported to HSI to date in connection with these products and the company has ceased distribution of all of these products.

Overall, the company recalled nine products 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 Tan, Feng Shi Zhi Tong Wan (Joint Relief), Guo Min Bi Yan Wan and Fang Feng Tong Sheng San.

HSI, also known as Jen-On Herbal Science International, is also recalling Tou Tong San (Headache Formula) and Du Huo Ji Sheng Tang (Du Huo Joint Relief), two products containing aristolochic acid, 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, which may transmit disease, not to mention cause the "dietary supplement" containing it to be unlawfully marketed in the United States.

According to company, 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.

The company apologized for any inconvenience and expressed its concerns for the health of consumers by conducting a voluntary recall action. It promised to ensure quality and integrity of all its products and is working closely with FDA in the recall process.

FDA advised 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 HSI at (626) 333-9998; and 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 FDA.gov/medwatch/report.htm.