| U.S. Food and Drug Administration |
FDA News Release, June 20, 2001
FDA Issues a Nationwide Alert on the Recall of Thirteen "Treasure of the East" Herbal Products Because of Possible Health Risk
The FDA is warning consumers to discontinue use of thirteen
Chinese herbal products containing aristolochic acid because they may present a
serious health hazard to consumers. Aristolochic acid found in certain plants
and botanicals is toxic to the kidneys and is a potent carcinogen. 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. The use of aristolochic acid-containing products has also been linked
to increased risk of kidney cancer in people who have consumed it.
Blue Light, Inc., Ithaca, N.Y., has initiated a recall of these
products sold under the "Treasure of the East" label with "MFG No.
200008" (2000=year, 08=month) and earlier production dates. Products with "MFG
No. 200009" and later production dates are not affected.
Products include:
| Item # |
Single-ingredient |
| 100176-0 |
Guan Mu Tong |
| 100644-2 |
Ma Dou Ling (Mi) |
| Item # |
Herbal combinations |
| B015 |
Ba Zheng San |
| D060 |
Dang Gui Si Ni Tang |
| D075 |
Dao Chi San |
| F050 |
Fu Fang Di Hu Tang |
| G005 |
Gan Lu Xiao Du Dan |
| K030 |
Kou Yan Ning |
| L070 |
Long Dan Xie Gan Tang |
| P005 |
Pai Shi Tang |
| X072 |
Xiao Ji Yin Zi |
| X125 |
Xin Yi San |
| Y020 |
Yang Yin Xiao Yan Tang |
These products were distributed nationwide in small quantities
primarily to acupuncturists, herbalists, and herbal stores. They are in powder
form (3.5 oz. bottles) or capsule form (100 per bottle) under the "Treasure
of the East" label.
The recall was initiated as a result of public health concerns
associated with the consumption of aristolochic acid products. No illnesses have
been reported. Blue Light, Inc., has discontinued the distribution and use of
products that may contain aristolochic acid.
Consumers who have purchased any of these products with affected
expiration dates should discontinue their use and may return them to place of
purchase for a full refund. Consumers with questions may contact the company at
1-888-258-3548.
The FDA posts press releases and other notices of recalls from the firms involved as a service to consumers, the media, and other interested parties. The FDA does not endorse either the product or the company.
The text in this article was prepared by the FDA Office of Public Affairs.