FDA Warning Regarding Aristolochic Acid

December 10, 2001

Warning available at: www.cfsan.fda.gov

Aristolochic acid is a phenanthrene alkaloid primarily found in the Aristolochia species of plants, but also present in other botanicals. Permanent renal damage, kidney failure with subsequent transplantation, and elevated risk for urethral carcinoma are documented following usage of dietary supplements and traditional medicines containing aristolochic acid. More than 100 cases of aristolochic acid induced renal disease have occurred in Belgium, as well as 2 cases in both the United Kingdom and United States. Aristolochia, Bragantia, or Asarum are ingredients to be aware of and are present in numerous products. The Food and Drug Administration (FDA) has urged all manufacturers and distributors to ensure that their products are free from aristolochic acid. The FDA has also taken steps to quarantine any botanical or dietary supplement, being imported into the United States, that are labeled with ingredients suspected to contain aristolochic acid. Both consumers and health care professionals should be aware of the risk associated with aristolochic acid.

Products Recalled within the United States due to Aristolochic Acid

  • Vital Nutrients Joint Ease
  • Verified Quality Joint Comfort Complex
  • Herbal Masters Arpanex B
  • Herbal Masters Cys
  • Herbal Masters Koms A
  • Balance & Harmony Artiflex B
  • Balance & Harmony Gentiana Combination
  • Balance & Harmony Allerhay
  • Pacific Biologic Orthoflex