Adverse Event Reports Submitted to U.S. Food & Drug Administration Associated with Dietary Supplements

The Federal Food, Drug, and Cosmetic Act was amended in 2006 to require marketers of dietary supplements and nonprescription drugs to submit to the U.S. Food & Drug Administration (FDA), as of December 22, 2007, all reports of serious adverse events associated with and received by marketers of products in these regulatory categories. The new law established additional responsibilities with regard to follow-up reports and recordkeeping. Adverse event reports submitted to FDA during 2008 by marketers of dietary supplements were obtained from FDA through requests under the Freedom of Information Act. Analysis of these records shows that most reports are submitted by marketers, though reports are also submitted by individual consumers and health care practitioners. There are more reports associated with women than with men, and with individuals between the ages of 50 and 79 than with older or younger consumers. FDA's issuance on March 27, 2008 of a warning to advise consumers to refrain from purchasing products sold as Total Body Formula followed the agency's receipt of 25 adverse event reports associated with the products, indicating that the reporting system is functioning as a signal generator that assists FDA in acting promptly to protect the public health.