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  • The description of the framework and criteria for categorizing the safety of dietary supplement ingredients shall contain sufficient information to describe the rationale used.

  • The prototype monographs shall contain information to document the science base and rationale for the conclusions and recommendations contained in these documents.

  • The framework shall outline approaches to be used to conduct the review of available research regarding the safety of each dietary supplement ingredient.

The project shall be conducted in several phases:

Phase I. The contractor shall identify a framework for categorizing and/or classifying ingredients based on safety concerns. Across and within the categories, the contractor shall give criteria for how ingredient reviews should be prioritized. The contractor shall publish its proposed framework and rationale for this framework and shall also solicit public comment on these.

Phase II. The contractor shall develop prototype monographs for at least six of the most critical risk categories. The prototype monographs shall consist of, but are not limited to, (a) a description of the ingredient under review, (b) a critical evaluation of the state-of-the-art science relative to the adverse effects of the ingredient, (c) a review of the research on the ingredient’s chemical and pharmacological properties and use conditions that could adversely affect health, (d) identification of research needed to further characterize its adverse effects, and (e) conclusions as to what is known and unresolved issues about the safe use conditions for this ingredient when included as part of a dietary supplement.

The contractor shall publish a final report for the proposed framework and rationale.

COMMENTS RECEIVED ON THE PHASE I FRAMEWORK

As part of the requirements noted in the scope of work for this project, a proposed framework was released for comment. The committee received more than 20 oral or written comments from various stakeholders related to the proposed framework. Below is a summary of the comments that were the most useful to the committee as they revised the framework.

Comments are summarized into four broad areas: scientific concepts that need to be addressed or addressed in more detail, process related, regulatory situation of dietary supplements, and testing the framework.



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