Dietary supplement bill focuses on consumer safety

January 12, 2007

A new bill on dietary supplements recently passed by Congress will focus on adverse reactions that consumers suffer from supplements and various over-the-counter drugs, and should help identify those products that are most dangerous. The measure, S. 3546, would require that makers of dietary supplements and over-the-counter drugs inform the U.S. Food and Drug Administration (FDA) when they learn of "serious adverse events" linked to their products. The bill defines serious events as death, life-threatening experience, inpatient hospitalization, disability, birth defect, or medical/surgical intervention.

A new bill on dietary supplements recently passed by Congress will focus on adverse reactions that consumers suffer from supplements and various over-the-counter drugs, and should help identify those products that are most dangerous. The measure, S. 3546, would require that makers of dietary supplements and over-the-counter drugs inform the U.S. Food and Drug Administration (FDA) when they learn of "serious adverse events" linked to their products. The bill defines serious events as death, life-threatening experience, inpatient hospitalization, disability, birth defect, or medical/surgical intervention.

Unlike prescription drugs, dietary supplements are not required to be proven safe and effective before being marketed. Consumers Union has urged Congress to require adequate pre-market safety testing of dietary supplements and to give the FDA more authority to remove dangerous supplements from the market once safety issues arise.