HerbalEGram: Volume 5, Number 5, May 2008

The US Food and Drug Administration (FDA) announced in April that the company Herbal Science International, Inc. (also known as Jen-On Herbal Science International, Inc.) has recalled 12 dietary supplement products containing potentially harmful ingredients.¹ (This company should not be confused with HerbalScience Inc. of Naples, FL and Singapore [herbalsciencegroup.com], which makes extracts from plant materials according to a highly sophisticated proprietary process and is in no way connected with the company issuing the recall.)

The company has recalled 9 products that contain alkaloids from the herb ephedra (Ephedra sinica). Supplements containing ephedrine alkaloids have been banned from sale in the United States since 2004, due to concerns that ephedrine alkaloids can potentially adversely affect the cardiovascular and nervous systems (although a number of products are approved in limited dosages for sale as nonprescription drugs). The FDA ban of ephedra was largely motivated by the high profile deaths of several sports figures who used ephedra, although a direct causality between the deaths and ephedra use was never established.

Herbal Science International, Inc., has also recalled 2 supplements containing aristolochic acid (AA), which is a known carcinogen and nephrotoxin. Found in plant species of the family Aristolochiaceae, AA can cause serious kidney damage, and products containing the ingredient have been associated with kidney failure and increased risk of kidney and bladder cancer. Cases of nephropathy associated with Chinese herbal products first arose in Belgium in the early 1990s,² and the FDA began to express concerns about products containing AA in 2000.³ In some instances, it would appear that botanical species with AA were used in products as a result of misidentification or adulteration.² The American Herbal Pharmacopeia, in collaboration with the American Herbal Products Association and regulatory authorities, has published a monograph on selected plants containing AA, which includes methods for detecting AA. An article about AA and its nephrotoxicity was published in HerbalGram 48, available here.²

Herbal Science International, Inc., has also recalled one supplement containing human placenta.¹ This ingredient could potentially transmit disease, and it is illegal to sell dietary supplements containing this ingredient in the United States.

The recalled products are: Wu Yao Shun Qi San (for stimulating the nervous system), Qing Bi Tang (a nasal cleanser), Zhong Fong Huo Luo Wan (a stroke revitalization formula), Xiao Qing Long Tang (to relieve chilliness and asthma), Ding Chuan Tang (for relief of cough and fever), Xiao Xu Ming Tang (for health maintenance), Feng Shi Zhi Tong Wan (for joint relief), Guo Min Bi Yan Wan (for treating allergies), Fang Feng Tong Sheng San (for illness of obese patients), Tou Tong San (for headache), Du Huo Ji Sheng Tang (for joint relief), and Seng Jong Tzu Tong Tan (use unknown).

According to an FDA press release, the products have been sold nationwide in herbal stores, by acupuncturists, and on the Internet. Consumers who have purchased the recalled products have been advised by the FDA to return them to the place of purchase for a full refund. The press release notes that no illnesses have been reported to the company in connection with the products and that the company has ceased distribution of all recalled supplements. As of May 1, however, the majority of these supplements were still listed for sale on the company’s website, http://www.hsusa.net/.

According to American Botanical Council Founder and Executive Director Mark Blumenthal, “It is abundantly clear that this company came into the American market without ever having done even some of the most minimal market research and regulatory diligence.” He continued, “If company executives had contacted a consultant and/or attorney familiar with the history of herbs and other dietary supplements in the United States in the past 5 years, they would have been told immediately not to even consider marketing such products.”

—Courtney Cavaliere

References