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While some constituents of conventional foods are subject to premarket approval, DSHEA excludes all dietary supplement ingredients from this requirement when labeled as dietary supplements, even though some of these ingredients would be subject to premarket approval as food additives if used in conventional foods. Moreover, while new drugs are subject to premarket approval, DSHEA excludes dietary supplements, despite the fact that they may possess biological activities similar, and in some case identical, to those found in medications and are frequently used by consumers for medicinal purposes according to survey data (Blendon et al., 2001; Chang et al., 2003; Johnson et al., 2000; Martin et al., 2002; Najm et al., 2003; Wood et al., 2003). Further, under the provisions of DSHEA, FDA has no authority to require submission of specific safety data from dietary supplement manufacturers or distributors either before or after their products are made available for sale to the public. (The manufacturer decides what information to provide when notifying FDA 75 days in advance of marketing a dietary supplement containing a new dietary ingredient.)

It is also very challenging to carry out some of the provisions of DSHEA given the limitations on the quantity and quality of the currently available scientific data related to the safety of dietary supplement ingredients. One of the key premises of DSHEA is that history of use is evidence of safety when applied to dietary supplements; as was indicated in the earlier chapters, significant scientific problems with this assumption have been identified. In line with these findings, some members of the scientific and medical community have strongly advised that the regulatory mechanisms for monitoring the safety of dietary supplements, as currently defined by DSHEA, be revised (Drazen, 2003; Fontanarosa et al., 2003; Marcus and Grollman, 2002; Palmer et al., 2003). These constraints imposed on FDA make it difficult for the health of the American public to be adequately protected.


Prospective Systematic Monitoring and Tracking Mechanism for Dietary Supplement Ingredients

Finding: A prospective, systematic method for recording and monitoring the history of safety issues with specific dietary supplements is necessary to implement a framework for FDA to evaluate the safety of dietary supplement ingredients. During the period of this study, FDA developed a new method of monitoring and tracking adverse event reports—the Special Nutrition/Adverse Event Monitoring System (FDA, 2002). However, a prospective system that enables tracking of information leading to all levels of concern is also needed.

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