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expert committee. It was suggested that a representative for consumers and an expert on evidence-based analysis be included in the advisory group. It was also suggested that pharmacognosists and others with experience with botanical products also be included.

Regulatory Situation of Dietary Supplements

Several comments received applied more to the appropriateness of the current regulatory situation that to the report itself, an issue that the committee did not specifically address in the first report.

Comments were received stating that the risks and benefits of dietary supplements should be considered in evaluating the safety of dietary supplements.

A few comments were also received questioning whether FDA had the legal authority under the Dietary Supplement Health Education Act to develop monographs on dietary supplements and whether the study commissioned is scientifically valid.

One comment was also received suggesting that the description for the 75-day advanced notice for new dietary supplements should be compared with the self-declaration of “generally recognized as safe” used for conventional food ingredients.

Testing the Framework

A few comments called for a description on how the six supplements chosen for monograph development as part of this report came through each of the steps of the proposed framework.



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