FDA announces TCM dietary supplement recall

In a press release on the FDA website here, FDA announced the recall of twelve dietary supplements made by Herbal Science International, Inc., a/k/a Jen-On Herbal Science. The products in question are alleged to be adulterated and contain ephedra, aristolochic acid or human placenta.

A review of the company’s website reveals that they offer a selection of Traditional Chinese Medicine (TCM) products.
According to the FDA, the company is recalling the following products that contain ephedra:

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

In addition, the company is also recalling two products containing aristolochic acid, a carcinogen and nephrotoxin found in certain plants and botanicals. The FDA cited risks of serious kidney damage or kidney failure, as well as an increased risk of kidney cancer, for the recall.

Finally, the recall includes a product sold as “Seng Jong Tzu Tong Tan” that the apparently contains human placenta. Placentophagy supplementation? That’s a new one for me.

The release notes that 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. The press release contains a statement from Herbal Science that says the company “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.”

Interestingly, the company website contains no reference to the recall. Moreover, as of this writing, all the products recalled are still listed for sale here.

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Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.

Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.

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