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Dietary Supplements: A Framework for Evaluating Safety
information obtained into a monitoring database for future use if new data regarding the ingredient become available.
Maintaining a database of specific issues to monitor would allow FDA staff familiar with the criteria outlined in Chapters 4 through 8 to systematically look for information that may address the data gaps. Similarly, data collected should be saved in case a decision is made to move to an integrative evaluation. If a decision is made to conduct an integrative evaluation, but a monograph is not subsequently prepared, then information and a summary of the thought processes involved in the integrative evaluation should be noted and filed for future consideration. Making data gaps and unanswered questions available to other interested parties such as the National Toxicology Program of the National Institute of Environmental Health Sciences (NIEHS) or the Office of Dietary Supplements, both part of the National Institutes of Health (NIH), Department of Health and Human Services, would allow them to incorporate these data needs on specific dietary supplement ingredients into their programs of work.
In summary, once the initial level of concern based on the initial review of the signal is determined, FDA might decide that continued routine monitoring is needed, or it could decide to proceed with an integrative evaluation. This depends on the level of concern raised by the signal: ingredients provoking higher concern should proceed to the integrative evaluation; ingredients resulting in lower levels of concern would generally not proceed; and ingredients with moderate concerns might proceed after considering additional information not necessarily related to the initial signal, such as prevalence of use or concern related to a specific vulnerable population group. Since it is assumed by the DSHEA that dietary supplements are safe, there should be relatively few dietary supplement ingredients that will be categorized as of higher concern after the initial review and thus warrant further examination. This allows FDA to focus its efforts on dietary supplement ingredients that are strong candidates for regulation.
The third component of the Framework is to conduct an integrative evaluation for those dietary supplement ingredients that are deemed to warrant further investigation, based on the preliminary data reviewed in the second component and the resulting relative placement on the spectra of concern continuums. There are four aspects to the Integrative Evaluation component (see Figure 3-1): in-depth literature search and review, drafting a safety monograph based on this information, integrating the available data into an analysis to complete the monograph, and possibly referring the draft monograph and accompanying information to an expert committee for additional input prior to determining whether to take regulatory action.