FDA – Regulatory Updates: Aristolochic Acid – April 21, 2011

April 21, 2011 By

April 11, 2011

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.