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Foreign product alert

Archived – Numerous herbal dietary supplements

Starting date:: November 17, 2008
Posting date:: November 17, 2008
Type of communication:: Foreign Product Alert (FPA)
Subcategory:: Natural health products
Source of recall:: Health Canada
Issue:: Important Safety Information, Unauthorized products
Audience:: General Public
Identification number:: RA-12000613

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These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Source of alert

U.S. Food and Drug Administration (FDA)

Product names

Seng Jong Tzu Tong Tan
Tou Tong San (Headache Formula)
Du Huo Ji Sheng Tang (Du Huo Joint Relief)
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 (Breathe Smooth)
Xiao Xu Ming Tang
Feng Shi Zhi Tong Wan (Joint Relief)
Guo Min Bi Yan Wan
Fang Feng Tong Sheng San

Manufacturer / Place of origin

Jen-On Herbal Science International Inc. (also known as Herbal Science International Inc.) / City of Industry, CA, U.S.A.

Product description

The 12 products listed above are promoted as all-natural herbal dietary supplements, used to treat a variety of health conditions and/or disorders. They come in labelled white plastic bottles of 100 capsules.

Reason for warning

The FDA informed consumers of a voluntary manufacturer recall of the above 12 products because they were found to contain human placenta, aristolochic acid and/or ephedra. Consumers who had purchased these products were advised to discontinue their use immediately and return them to the place of purchase for a full refund.

Seng Jong Tzu Tong Tan contains human placenta while Tou Tong San (Headache Formula) and Du Huo Ji Sheng Tang (Du Huo Joint Relief) contain aristolochic acid. The remaining 9 products, 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 (Breathe Smooth); Xiao Xu Ming Tang; Feng Shi Zhi Tong Wan (Joint Relief); Guo Min Bi Yan Wan; and Fang Feng Tong Sheng San, contain aristolochic acid and/or ephedra.

Human placenta derived from unknown sources or prepared using inadequate processes may transmit blood-borne diseases such as the hepatitis virus or HIV.
Aristolochic acid is a naturally occurring toxin that can cause cancer, mutations in human cells, and kidney failure.
Ephedra or ephedrine, when used either alone or in combination with caffeine or other stimulants may cause serious, possibly fatal, adverse effects. Health Canada has previously warned consumers against the use of unauthorized Ephedra/ephedrine-containing products, first in 2003 and again in 2005, 2006 and 2008 due to potential health risks.

Possible side effects

Ingestion of human placenta derived from unknown sources or prepared using inadequate processes may risk infection by blood-borne diseases such as the hepatitis virus or HIV.
Health risks associated with the use of aristolochic acid include cancer and kidney failure.
Ephedra is a plant source of the active ingredient ephedrine. Side-effects associated with the use of ephedrine include dizziness, headache, decreased appetite, anxiety, restlessness or nervousness, digestive problems, irregular or fast heartbeat, insomnia, flushing, sweating, high blood pressure, stroke, seizures, psychosis and death.

Use of products containing Ephedra/ephedrine is not recommended for people with heart problems, high blood pressure, thyroid disease, diabetes, enlarged prostate, anxiety and restlessness, glaucoma (serious eye disorder) and pheochromocytoma (serious gland disorder). These products should also be avoided by pregnant and nursing women.

Consumers should use Ephedra/ephedrine products only for the acceptable indication of nasal decongestion, and should not exceed the maximum allowable dosage or duration of use described in the Ephedra and ephedrine labelling standards, unless recommended and supervised by a health care practitioner. Labelling standards for Ephedra and ephedrine are on the Health Canada web site.

What you should do

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed above in the Canadian marketplace.

Background

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.

Report a health or safety concern

Call toll-free at 1-866-234-2345.
Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.