Are dietary supplements regulated by the federal government?
Yes. This is probably the most commonly misunderstood fact about the dietary supplement industry. Most of the misunderstanding occurs when people confuse dietary supplements with drugs and expect them to be regulated in the same manner. Dietary supplements are meant to supplement the diet; accordingly, the Dietary Supplement Health and Education Act of 1994 (DSHEA) defines them as a subset of foods, and they are regulated as such. Under DSHEA, the U.S. Food and Drug Administration (FDA) has several post-marketing responsibilities to ensure the safety of dietary supplements. Among those is enforcement of the final rule on dietary supplement Good Manufacturing Practices (GMPs), released on June 25, 2007. This rule establishes uniform standards needed to ensure quality throughout the manufacturing, packaging, labeling, and holding of dietary supplement products. FDA also oversees mandatory adverse event reporting by dietary supplement manufacturers. In 2006, Congress passed the Dietary Su