The U.S. Food and Drug Administration (FDA) has received fewer reports than it expected of health problems potentially related to dietary supplements. Under a new law that began in December 2007, supplement manufacturers must tell the FDA about serious health problems—called adverse event reports (AERs)—that require a doctor’s attention. An AER does not mean that a supplement caused a health problem and the FDA says that most involve people who are already ill and who are also taking prescription or over-the-counter drugs. There were 214 AERs in the first three months of 2008, causing the FDA to lower its full-year estimate to 856 from 960. This compares favorably to the more than 450,000 prescription drug AERs the FDA recorded in 2007 and supports natural products industry claims that dietary supplements are safe.
Reference: Federal Register; 2008, Vol. 73, No. 179, 53252-4.