Introduction - In April 2001, the FDA identified botanicals known of suspected to contain aristolochic acid, and others as potentially adulterated with species containing aristolochic acid. This potential adulteration can occur when an aristolochic acid containing herb is mistakenly identified as an herb that does not contain aristolochic acid. The FDA lists can be found HERE. AHPA has identified several articles of trade where Aristolochia spp. could be mistaken for the genuine article. They are identified below with the corresponding adulterant:
For further information on FDAs concerns and communications on this issue, please view the following links:
- April 4, 2001 Letter to Health Professionals regarding safety concerns related to the use of botanical products containing aristolochic acid
- April 9, 2001 Aristolochic Acid: Letter to Industry Associations Regarding Safety Concerns Related to the Use of Botanical Products Containing Aristolochic Acid
- 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)
The FDA provided an analytical method for the determination of aristolochic acid in Traditional Chinese Medicines and dietary supplements, which can be found by clicking HERE.
Dietary supplements containing aristolochic acids (AAs) are adulterated, regardless of the source of AAs. FDA has been active regarding AA-containing products since issuing information letters in May of 2000. More recently, several products offered for sale at internet websites have been identified as AA-containing on the basis of listing Aristolochia spp. or Asarum canadense as ingredients, or labeled as containing Chinese herbs that are known to be occasionally adulterated with species of Aristolochia. Of the three types of fang ji sold, only one contains AA: guang fang ji (Aristolochia fangchi). The roots of han fang ji (Stephania tetrandra) and mu fang ji (Cocculus trilobus) can be mistakenly substituted for guang fang ji. More than 30 products suspected as possibly AA containing were purchased and tested for the presence AA by HPTLC and HPLC-UV, and the results compared and summarized in this AHPA 2004 poster presentation.
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