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regarding a risk to human health. This component is not envisioned as a detailed analysis of data, but rather as an assessment of the concern level warranted by the nature of the evidence (e.g., quality of the report, applicability to humans, route of exposure) and whether the information raises questions that require further examination.

Second, some effort can be made to gather easily available data to place the detected signal in context; such additional information may come from many sources, including other categories of data. Thus this initial review of the signal information need not be limited to reviewing only the information associated with the signal. For example, if the signal is a case report suggesting a possible problem in an elderly woman and clinical trials of the ingredient exist, these should be considered during the initial review.

Level of Concern

The outcome of the initial review is a determination of the initial overall level of concern to decide if an integrative evaluation is needed. Higher concerns warrant an integrative evaluation; lower concerns do not.4 A decision about an ingredient with a moderate concern level should be made after a review of other information to see if other signals are apparent; for example, if the initial signal is animal data that warrant moderate concern, a cursory literature search on the substance or a review of FDA’s adverse event monitoring system could be conducted to determine if other data about the ingredient raise concerns as well, leading to the need for further evaluation.

Assuming that sufficient evidence may not be available from just one type or category of data to cause a higher level of concern, it is important for FDA to consider data from other categories to determine if a higher level of concern may exist.

Decisions Possible Based on Initial Review

When the initial review of the nature of the evidence available indicates a higher level of concern, FDA would then initiate an integrative evaluation process or possibly decide to take immediate action, if the concern is serious enough and the data are strong. If the level of concern is categorized as relatively low, FDA would continue to monitor signals and incorporate the

4  

“Higher” level of concern is relative to the level of concern warranted by other evidence. The terms “higher” and “lower” are used to indicate that the level of concern is relative, rather than categorical.



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