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12 Factors Influencing Use of the Safety Framework
Pages 292-296

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From page 292...
... , the approach was modified to have fewer detailed steps in the process and to more explicitly define the indicators of risk across types of information instead of generalized descriptions of how to evaluate these types of data and available evidence. Further, the revised safety Framework now more specifically emphasizes the use of evidence from a variety of sources, in addition to self-reported human data.
From page 293...
... The public health perspective that a supplement ingredient used by more individuals warrants greater attention, given similar safety concerns, is included as part of the evaluative process. Consideration of likely users of particular supplement ingredients and the users' characteristics allows a more focused evaluation of risk for groups that might be particularly vulnerable to problems and thus at increased risk.
From page 294...
... Thus key information on the occurrence and severity of actual events affecting consumers is very limited and is likely to remain so unless concerted efforts are made to educate the public and health care providers about the importance of reporting these events. Combinations of Dietary Supplement Ingredients The heterogeneous and expanding nature of dietary supplements in the United States further constrains the development and utility of a scientifically based framework for evaluating safety.
From page 295...
... The utility and success of the Framework will ultimately depend on FDA being provided adequate resources to fully implement the goals of DSHEA. Use of Expert Judgment in the Safety Framework The Framework, by defining and giving examples of data that may elevate or decrease concern, seeks to explicitly evaluate the different components of the data -- considering the evidence of possible risk, seriousness of harm, and the potential public health impact as distinct variables.
From page 296...
... SUMMARY While the safety Framework outlined in this report is not based entirely on empirical data, it provides a mechanism for FDA to accomplish its goal of using a science-based approach to identify priorities for evaluating the safety of dietary supplement ingredients given available information and needed resources. Some of the factors that make the Framework less than ideal include the heterogeneity of the dietary supplement ingredients as currently defined by law, the shortage of quality studies designed specifically to assess safety, the difficulty in evaluating interactions in combination products using readily available data, and the need for adequate resources to ensure expert judgment is used in making determinations of when available data indicate that consumption of a dietary supplement ingredient presents an unreasonable risk of illness or injury.


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