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Dietary Supplements: A Framework for Evaluating Safety
Recommendation: FDA should continue to maintain and refine a prospective system for monitoring and tracking reports of adverse events as well as other information related to safety concerns associated with consumption of dietary supplement ingredients. The system should be open, transparent, and useful for establishing varying levels of concern relating to dietary supplements as outlined in the Framework. Relationships with professional societies, scientific journals, other federal agencies, consumer protection groups, and collaborative scientific groups should be continued and enriched to facilitate the ability of FDA to collect and monitor information regarding the use of dietary supplement ingredients. Resources to support these activities should be provided to FDA.
Adequate Resources to Protect the Consumer Under DSHEA
Finding: While the committee did not conduct an analysis of the cost of implementing this Framework, implementation of any framework for comprehensive safety evaluation generates an additional workload for the responsible staff at FDA. For the framework to be effective, adequate resources must be available to FDA to collect and analyze available information. DSHEA establishes that the determination of the potential for harm from dietary supplement use be done postmarketing, but resources may not be sufficient to fulfill this task.
Recommendation: In order to fully protect the public health, Congress should ensure that FDA is provided with adequate personnel and resources to protect the consumer under DSHEA.
Adverse Event Reporting
Finding: Reports of adverse events are an important source of information by which FDA becomes aware of potential risks to public health from exposure to dietary supplement ingredients. It has been estimated that FDA receives reports of less than 1 percent of all adverse events associated with dietary supplements, according to the Inspector General’s Report, Adverse Event Reporting for Dietary Supplements: An Inadequate Safety Valve, which also documented the limitations in the reports that are received (OIG, 2001). While spontaneous adverse event reports have recognized limitations, they have considerable strength as potential warning signals of problems requiring attention, making monitoring by FDA worthwhile.
Under DSHEA, there is no requirement for distributors or manufacturers to collect and maintain records of adverse effects associated with the use of dietary supplements. Further, distributors and manufacturers are not required to submit adverse event reports of which they are aware to FDA,