of data that may be available, providing a mechanism to evaluate the totality of the available data. The priority-setting step weights the different kinds of data available.

When considering the various types of data, the framework outlines how to consider both the strength of the evidence and the seriousness of harm suggested by the evidence. The evidence of possible risk incorporates both the methodological quality and the quantity of the available evidence, components that are important when considering any scientific data. Considering the potential seriousness of harm enables higher priority to be given to items that are of most concern because of their potential to adversely affect human health.

In addition to the methodology outlined for integrating various types of information, the proposed framework is also practical because it allows FDA to respond to new information in that the categorization of priorities easily changes to reflect new data.

Limitations are also inherent in the proposed framework. By definition, this framework cannot be used to consider the possible benefits of consuming dietary supplements. Another limitation is that, as with any evaluation of dietary supplement ingredients under the current regulatory scheme, this framework’s evaluation of safety depends on publicly available data or data made available voluntarily by industry. A major component of this framework in particular is human data, which unfortunately can be highly variable in quality and quantity.

INGREDIENTS FOR PROTOTYPE MONOGRAPH REVIEWS

The second phase of FDA’s charge to the Committee on a Framework for Evaluating the Safety of Dietary Supplements is, after release of the proposed framework for comment, to develop at least six scientific reviews as prototypes for the system outlined in the framework. The six supplement ingredients selected for the prototype reviews include the following (in no particular order other than alphabetical): chaparral, chromium picolinate, glucosamine, melatonin, saw palmetto, and shark cartilage. These six ingredients were selected to fulfill specific criteria. They include at least one botanical, one vitamin or mineral, one animal product, and one hormonal product. The selected ingredients also include substances for which a range of different types of available information and a range in quality of information available is anticipated. Ingredients included are those that would be expected to be flagged in the screening process and therefore enter the priority-setting step. Based on very preliminary data, it is also expected that this list includes substances that when initially reviewed in the priority-setting step, would not all be placed in the top priority category.

SECOND PHASE OF THIS STUDY

The second phase of this study will be to oversee the preparation of prototype monographs on the six ingredients, following the framework outlined in this report. As outlined in Chapter 6, industry will be requested to provide safety information about the ingredients undergoing in-depth safety evaluation. Panels will be organized to review information included in draft monographs and to arrange for public input on the evidence about safety.

During this phase, comments regarding the proposed framework detailed in this report will be solicited, reviewed, and revisions made as appropriate, followed by release of a revised framework and the six prototype monographs as examples of the safety evaluation envisioned.



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