top of page

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 The FDA’s CFSAN/Office of Nutritional Products, Labeling and Dietary Supplements has issued draft guidance for claims substantiation.

bottom of page