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Contents
Overview
Warnings and Safety Information
Adverse Reaction Reporting
Announcements & Meetings
General Information
Industry Information & Regulations
Questions & Answers
Other Sources of Information
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Dietary Supplements:
Aristolochic Acid
Please Check Dates for Latest Information
FDA Concerned About Botanical Products, Including Dietary Supplements, Containing Aristolochic Acid
The agency has issued a Consumer Advisory and sent updated letters to industry and
health professionals to communicate our concern about the use and
marketing of dietary supplements or other botanical-containing
products that may contain aristolochic acid. The use of products
containing aristolochic acid, including botanical products marketed
as traditional medicines, has been associated with nephropathy.
Because of our concerns about botanical-containing products known
or suspected to contain aristolochic acid, we will be pursuing
appropriate regulatory action regarding these products.
- Consumer Advisory (April 11, 2001)
- Letter to Health Professionals
(April 4, 2001)
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Updated Letter to Industry (April 9, 2001)
- Import Alert #54-10,
"Detention Without Physical Examination of Bulk or Finished Dietary Supplements and Other
Products that may Contain Aristolochic Acid" (July 6, 2000;
Revision April 6, 2001)
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Pacific Biologic Recalls Seven Herbal Products That Contain the Herb
Akebia Trifoliata Caulis (Mu Tong)
and the Herb Asarum Sieboldii Herba Cum Radix (Xi Xin) Because
of a Possible Health Risk (July 31, 2001)
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FDA
Issues a Nationwide Alert on the Recall of Thirteen "Treasure of the
East" Herbal Products Because of a Possible Health Risk
(June 20, 2001)
- Vital
Nutrients Recalls Joint Ease & Verified Quality Brand Joint
Comfort Complex Because of Adverse Health Risk Associated with
Aristolochic Acid (May 21, 2001)
- BMK
International Voluntarily Recalls Neo Concept Aller Relief
Because of Possible Health Risk (January 19, 2001)
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East
Earth Herbal Products that Contain Potent Carcinogen Recalled
(November 21, 2000)
- Determination of Aristolochic Acid in Traditional Chinese
Medicines and Dietary Supplements
(available in PDF)
- Laboratory Information
Bulletin
- California Department of Health Services News Release - Warning About
Herbal Product (link coming soon)
- Past FDA Actions
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