The U.S. Food and Drug Administration (FDA) has sent a letter to natural food manufacturers saying new research has deepened the agency's concerns about dietary supplements that may contain aristolochic acid. The letter urged manufacturers and distributors to review their manufacturing procedures to ensure that botanical products are free of aristolochic acid. The agency says the use of products containing aristolochic acid has resulted in several life-threatening adverse incidents. Aristolochic acids are potent carcinogens and nephrotoxins that are primarily present in plants of the family Aristolochiaceae. In recent years, there have been several reported instances of severe nephropathy as a result of the consumption of products containing aristolochic acid. The incidents range from a few cases to and incident in Belgium in which more than 100 cases of nephropathy linked to the use of an herbal product containing aristolochic acids. In each incident the source of the aristolochic acids was determined to be from an ingredient in the herbal product which is a member of this plant family. The plant material used in the suspect products was either misidentified or the name of the plant ingredient was confused with that of another plant. In the letter, the FDA said recent research further defines the health risks associated with oral exposure to aristolochic acids. This information comes from new reports from other countries of adverse health consequences in consumers who used products that contained aristolochic acids, as well as recent reports of adverse effects in consumers in the United States.
FDA concerned about acid in supplements
The U.S. Food and Drug Administration (FDA) has sent a letter to natural food manufacturers saying new research has deepened the agency's concerns about dietary supplements that may contain aristolochic acid. The letter urged manufacturers and distributors to review their manufacturing procedures to ensure that botanical products are free of aristolochic acid. The agency says the use of products containing aristolochic acid has resulted in several life-threatening adverse incidents. Aristolochic acids are potent carcinogens and nephrotoxins that are primarily present in plants of the family Aristolochiaceae. In recent years, there have been several reported instances of severe nephropathy as a result of the consumption of products containing aristolochic acid. The incidents range from a few cases to and incident in Belgium in which more than 100 cases of nephropathy linked to the use of an herbal product containing aristolochic acids. In each incident the source of the aristolochic acids was determined to be from an ingredient in the herbal product which is a member of this plant family. The plant material used in the suspect products was either misidentified or the name of the plant ingredient was confused with that of another plant. In the letter, the FDA said recent research further defines the health risks associated with oral exposure to aristolochic acids. This information comes from new reports from other countries of adverse health consequences in consumers who used products that contained aristolochic acids, as well as recent reports of adverse effects in consumers in the United States.
Sidebar:
The National Association of Manufacturers is warning members to get ready for some type of "Patients Bill of Rights" legislation. The association said it expects both the House and Senate to take up the issue before the August recess. NAM has told its contacts in Congress and the Bush Administration that a law containing employer liability would be a big mistake, and that "manufacturers' opposition has not softened." Sen. John Breaux (D-LA) is pushing a "patients" bill that shields employers from direct liability, but is not optimistic his version will prevail.Looking for a reprint of this article?
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