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focused monograph). When concerns center around one type of adverse effect or potential toxicity, it will often be more efficient to focus data collection and analysis efforts on those particular concerns rather than including in the monograph all data about the ingredient. When the focused monograph is prepared, the focus should be clearly described so that the monograph is not interpreted as a complete summary of all risks associated with the ingredient.

Chaparral and saw palmetto are examples of when it may be more practical to focus the integrative evaluation on key issues of concern. Concerns about the safety of chaparral stemmed from a signal of reported hepatotoxic adverse events in humans. Thus all efforts could have focused on collecting and evaluating human, animal, in vitro, and related substances data that might have shed light on the relationship between chaparral and liver effects. Similarly, efforts for saw palmetto could have been focused on antiandrogenic concerns. To demonstrate the differences between focused and broad-based integrative evaluations, the chaparral and saw palmetto prototype monographs are presented both ways. The broader-based versions are available for review at, along with the other full prototype monographs; the focused versions are included in Appendixes J (chaparral) and K (saw palmetto).

Data Gathering for the Integrative Evaluation in the Form of a Monograph

The first step in the integrative evaluation is collecting data about the ingredient, usually collated in the form of a monograph without summary and conclusion statements. The most valuable information is studies specifically designed to evaluate toxicity and detect adverse events. Sufficient data of this type rarely exist for dietary supplement ingredients,5 so relevant information found in studies not focused on safety also needs to be collected. For example, clinical studies on glucosamine and osteoarthritis had to be reviewed to determine if any information was presented regarding the development of insulin resistance in individuals taking glucosamine.

Strategies for collecting the needed information on the prototype dietary supplement ingredients were refined through the development of the six prototype evaluations. Specifically, for chaparral and shark cartilage, the first two ingredients to which the original proposed framework was applied, almost all information was collected and included. The second two ingredients, saw palmetto and glucosamine, were prepared by collecting almost all information that the scientists involved thought could provide


Except for some vitamins or minerals; see Chapter 3.

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