Supplements Linked to Over 600 Adverse Events

September 2008

Dietary supplements, often taken to promote health, have been linked to over 600 serious adverse reactions, including five deaths. These reports were received within the first six months after adverse-event reporting for supplements became mandatory.

The Office of Nutritional Products, Labeling, and Dietary Supplements said that it received 368 reports from supplement manufacturers and 236 reports from consumers or medical professionals. The Food and Drug Administration (FDA) has not announced which particular supplements are linked to the adverse side effects. The FDA defines dietary supplements as vitamins, minerals, amino acids, enzyme supplements, and herbs or botanicals.

Consumer advocates have long been critical of the fact that supplement manufacturers are not required to prove that their products are safe or effective before being put on the market. The bill mandating adverse reaction reports for dietary supplements became effective on January 1, 2008. Adverse-event reporting has been mandatory for prescription and some non-prescription drugs for years, and the FDA received 482,154 adverse-event reports for prescription drugs last year.