News Briefs

Safety Concerns: Aristolochic Acid

July 2001; Volume 4; 83

In April 2001, the Food and Drug Administration (FDA) issued an alert to health care professionals regarding safety information about botanical products containing aristolochic acid, an ingredient in dietary supplements and other "traditional medicines." This letter follows an earlier letter from May 2000 that warned of nephrotoxicity and carcinogenicity of botanicals containing aristolochic acid. Since the earlier letter, and since publication of a warning about aristolochic acid in this publication (see Alternative Medicine Alert, August 2000, p. 95), additional information has surfaced regarding adverse effects from this harmful ingredient. Renal disease or malignancies associated with use of botanical preparations should be reported as soon as possible to the FDA’s MedWatch program by phone (800-332-1088) or the Internet (www.fda.gov/medwatch).

FDA Warns Food Manufacturers

July 2001; Volume 4; 83

The FDA in January 2001 sent warning letters to conventional food manufacturers whose products contain botanical ingredients or extracts, reminding companies that these additives must be proven safe before they can be added to food products. Since the initial letters in February, the number of food products containing herbal additives has grown, prompting the FDA to begin sending warning letters to specific manufacturers demanding that they prove the safety of herbal additives.