FDA Announces Three Major Initiatives for the Regulation of Supplements

This month, the Food and Drug Administration (FDA) announced three major initiatives for the regulation of dietary supplements. The first, a regulatory strategy, will outline a “transparent, systematic, and predictable process to evaluate safety concerns for dietary supplements.” The strategy is organized into three sections: monitoring and evaluating product and ingredient safety, assuring product quality and monitoring and evaluating product labeling.

In the second initiative, the FDA will receive comments at a public meeting (on November 15, 2004) on the type, quality, and quantity of evidence that the manufacturer should provide when notifying the FDA of a new dietary ingredient (NDI). The agency also intends to clarify what constitutes a NDI.

The third initiative, providing a standard for substantiation of claims, will be consistent with the criteria applied by the Federal Trade Commission (FTC): “competent and reliable scientific evidence.” The FDA’s CFSAN/Office of Nutritional Products, Labeling and Dietary Supplements has issued draft guidance for claims substantiation.