Dietary Supplements: Aristolochic Acid

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

• Updated Letter to Industry April 9, 2001

  • Listing of Botanical Ingredients of Concern (Updated April 9, 2001)
  • Botanical Products Determined by FDA to Contain Aristolochic Acid (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)

• 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)

• 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)

• East Earth Herbal Products that Contain Potent Carcinogen Recalled* (November 21, 2000)

• Determination of Aristolochic Acid in Traditional Chinese Medicines and Dietary Supplements

 Laboratory Information Bulletin*

• California Department of Health Services News Release - Warning About Herbal Product*

• Past FDA Actions

  • Letter to Industry (May 16, 2000)

  • Letter to Health Care Professionals (May 31, 2000)

  • Listing of Botanical Ingredients of Concern* (Updated May 30, 2000 )

   

*Document is temporarily unavailable online.