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Dietary Supplements: A Framework for Evaluating Safety
interactions is difficult to obtain and is currently even more limited than information relevant to evaluating the safety of a single ingredient.
Impact of Formulation and Processing
DSHEA does not distinguish the impact of different processing methods or varied formulations on the subsequent characteristics of dietary supplement ingredients; it allows manufacturers to market products containing ingredients that have been produced using manufacturing methods or in formulations altered without prior FDA review. These changes in product manufacture may lead to significant differences in bioavailability and chemical constituents of the resulting product, suggesting a need for reevaluation of any previous safety evaluations. The lack of this reevaluation, amplified by the increasing complexity of ingredients available for use and the lack of premarket examination, hampers the ability of the FDA to have the data needed to evaluate safety within the context of this Framework; this will continue to be the case until DSHEA is amended to require some type of premarket approval or review of any change in manufacturing process or formulation of a marketed product, thus redefining the point at which an ingredient is required to have an agency review for safety.
Availability of Resources
Another key consideration in the utility of this safety Framework, or any data- or information-driven framework, is the evident limitation in resources available to FDA to operate a framework adequately—particularly resources to support the long-term need for monitoring new information as it becomes available. Without increased availability of resources, any framework developed may have limited impact on protecting the health of the public because of a lack of human and material resources to collect, evaluate, and monitor relevant data. 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. This approach attempts to guide judgments made to assess when an unreasonable risk of illness or injury is likely to result from use of a dietary supplement ingredient. While the determination of safety can be, at least to some