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Summary
Pages 1-16

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From page 1...
... to guide commanders in management practices for safe use of dietary supplements; furthermore, there is no formal military pathway to report adverse events potentially associated with dietary supplements. The lack of consistent policies for the safe use of dietary supplements has raised concerns owing to the vulnerabilities of some military subpopulations.
From page 2...
... This approach may not be sufficient to ensure the safe use of dietary supplements in some military contexts, which inherently present considerable risk to individuals. Based on the heightened risks, potential for benefits, frequency of use among military service members, the lack of consistent policies, and the absence of an internal process to report adverse events as they occur in military settings, the Department of Defense (DoD)
From page 3...
... using a framework to determine the level of concern for dietary supplements in a military context, (3) implementing a system to report adverse events associated with dietary supplements, and (4)
From page 4...
... For the approach to succeed, it is crucial that a military committee or entity (hereafter referred to as the designated oversight committee) has the responsibility for coordination and oversight of various dietary supplement activities (Recommendation 8)
From page 5...
... Surveys should be designed in consultation with the proposed designated oversight committee, which could oversee many aspects of dietary supplement management including adverse event reporting, as described below. The system of surveillance needs to be comprehensive and include the collection of data as described in Box S-1.
From page 6...
... might compromise the performance of a military service member and therefore initiate a review. Also, in contrast to the IOM framework, the review of dietary supplements and corresponding management actions attends to the specific environment, missions, and military subpopulations.
From page 7...
... High Concern Moderate Concern Low Concern Minimal Concern FIGURE S-1  Framework to review the safety of dietary supplements aHigh physical activity, calorie restriction, hydration, gastrointestinal tract (diarrhea/nausea) , liver health/function (xenobiotic  clearance)
From page 8...
... rule should minimize the potential for inclusion of adulterants or contaminants. Recommendation 4:  The decision to initiate a review of a dietary supplement should be based on two criteria: severity and number of adverse events, and prevalence of use.
From page 9...
... . The committee recommended that the evidence (e.g., how many adverse events were associated with the dietary supplements, how strong the association, level of intake, intake of other medications/supplements, actual circumstances, characteristics of the individual)
From page 10...
... This model can be useful in making policy only when scientists work in consultation with military leadership, so that technical questions arising from reviews or other data and questions on the circumstances of military subpopulations can be clarified. Implementing an Adverse Event Surveillance System The military lacks a systematic process by which adverse events linked to dietary supplement use are reported, analyzed, and used as the basis for making management decisions.
From page 11...
... In addition, future electronic health records should be capable of generating standard reports on frequency of use and adverse event data that can be aggregated for analysis; and automated alerts to signal a significant change in usage or adverse event reporting, or to signal a risk of interaction with a medication or other treatment. Recommendation 8:  The military should designate a committee or military entity to be responsible for the oversight and coordination of dietary supplement-related activities, such as overseeing the adverse event surveillance system and parallel educational components.
From page 12...
... Members would also share data related to sales and use of dietary supplements and associated adverse events (or beneficial effects) in the military and civilian populations.
From page 13...
... Consequently, the committee did not attempt to provide an exhaustive listing of research needs and instead, presents key considerations for conducting dietary supplement research in a military context and an approach to prioritize research needs according to the special needs of military subpopulations. Key Considerations for Conducting Military Nutrition Research Study Designs Studies to investigate the safety and efficacy of dietary supplements in a military context should be performed using the existing military human models that mimic the physical stresses and environments that accompany military missions and training programs (e.g., a predefined course)
From page 14...
... gaps identified in the reviews conducted for specific dietary supplements, and (3) occurrence of adverse events of military importance associated with the use of specific dietary supplements.
From page 15...
... might need to be restricted) ; follow the ULs for the general population and include them in Military Dietary Reference Intakes • Continue collecting and analyzing data on dietary supplement use • Monitor the frequency and severity of adverse events associated with popular or potentially beneficial dietary supplements • Develop methodologies to assess safety (and efficacy)


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