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nin).4 Thus for the other four dietary supplement ingredients, a decision to flag the ingredient for continued monitoring might have been made based on the original presumed signal. Monitoring consists of either passively watching for new signals of other concerns about the ingredient or routinely searching the scientific literature for new data to address a specific existing concern. For example, if the concerns about glucosamine and insulin regulation were assigned only a lower or moderate concern level because glucosamine’s bioavailability in animals and humans is unclear in the data, the scientific literature should be regularly searched to determine if new evidence addresses glucosamine bioavailability in animals or humans. Monitoring might also include working with the National Toxicology Program at the National Institute of Environmental Health Sciences or the Office of Dietary Supplements at NIH to initiate research addressing unanswered questions relative to some of the signals detected.

Integrative Evaluation

Broad-Based Versus Focused Approaches to Integrative Evaluation

If the concern level is moderate or higher, a decision may be made to undertake an integrative evaluation. The integrative evaluations developed into the prototype monographs for this report were comprehensive and hence labor-intensive. This approach did accomplish the objective of gaining enough information to improve and refine the scientific principles included in the Framework, but it also clearly demonstrated that a broad-based and comprehensive collection and consideration of all information relevant to the safety of the ingredient can be a resource-intensive undertaking. This is especially true if the ingredient itself or its constituents have been extensively studied, but not in studies particularly designed to address safety (i.e., if studies are designed specifically to evaluate the safety, consideration of these studies may be conclusive and preclude the necessity of collecting related, but less directly relevant, non-safety-focused information).

For many situations, the concern is very specific and can be addressed with an integrative evaluation focused on those concerns (documented in a


This is not to say that only chaparral and melatonin raised significant concerns following the prototype integrative evaluation, but rather that they raised concerns following the initial review of the presumed signal. Other possible signals were also discussed for the prototype ingredients. As discussed, these signals might result in a different decision if they were subjected to the initial review.

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