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1 Introduction
Pages 17-35

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From page 17...
... It is clear that these subpopulations within the military are different from the general civilian population, and guidance on managing their use of dietary supplements needs to be tailored to address their specific needs. COMMITTEE'S TASK AND APPROACH Statement of Task For the reasons stated above, the Institute of Medicine (IOM)
From page 18...
... 4. It considered existing military policies for managing dietary supplements, and assessed the applicability to a military setting of the framework outlined in the 2005 IOM report Dietary Supplements: A Framework for Evaluating Safety and determined how it could be modified to determine which supplements need active management by the military.
From page 19...
... The findings from the surveys provided useful background information to help the committee select the elements of a system to help ensure safety and to assess the efficacy of dietary supplements used by military personnel. Because the U.S.
From page 20...
... of the Federal Food, Drug, and Cosmetic Act defines the term dietary supplement as a product (other than tobacco) that is intended to supplement the diet; contains one or more dietary ingredients (in cluding vitamins, minerals, herbs or other botanicals, amino acids, and other sub stances)
From page 21...
... . The 2007 Dietary Supplement and Nonprescription Drug Consumer Protection Act amended the FFD&C Act to require, among other things, the mandatory reporting by manufacturers of serious adverse events associated with the use of dietary supplements to the FDA, an improvement in the postmarket monitoring of dietary supplements (Dietary Supplement and Nonprescription Drug Consumer Protec
From page 22...
... To help with this challenging implementation, the FDA asked the IOM to prepare the report Dietary Supplements: A Framework for Evaluating Safety (IOM, 2005) , including a cost-effective approach for evaluating the safety of dietary supplements under DSHEA.
From page 23...
... The committee also recommends specific responsibilities for military organizational units and committees; in making these recommendations, the committee considered existing military infrastructure, policy, and organizational units and their responsibilities. ORGANIZATION OF THE REPORT This report has been organized into the following sections: Chapter 2 describes the survey methodology to monitor the use of dietary supplements and describes the results from available surveys.
From page 24...
... Chapter 7 presents an approach to identify research needs. Tables and appendixes provide the workshop agenda, summary data from results of current surveys of dietary supplement use, key elements from the selected safety monographs from dietary supplements of high usage, adverse event reporting forms, biographical sketches of committee members and speakers, and a glossary of terms.
From page 25...
... . The final rule establishes the minimum cGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure that qual ity standards are met.
From page 26...
... . The 2007 Dietary Supplement and Nonprescription Drug Consumer Protection Act BOX 1-2 United States Pharmacopeia's Role in Certification of Dietary Supplements The United States Pharmacopeia (USP)
From page 27...
... . MILITARY'S INTEREST IN MANAGING DIETARY SUPPLEMENT USE Reports from the IOM's Committee on Military Nutrition Research have concluded that some military populations differ sufficiently from the general civilian population in terms of their dietary needs and health considerations to warrant special guidance or recommendations.
From page 28...
... For that reason, it is expected that dietary supplements intended to enhance performance would be much more widely used in certain segments of the military population than in the general civilian population. Soldiers are likely to be involved in demanding physical tasks requiring strength and endurance; most require lifting and carrying heavy loads.
From page 29...
... For example, the U.S. Air Force is currently testing protein powders for pilots; this dietary supplement is already very popular among military recruits, who expect that it may increase their BOX 1-3 Military Subpopulations Whose Tasks and Risks Differ from Those of the General Population • Military units or specialties where there are requirements for high levels of physical activity and/or prolonged periods of mental alertness may have unique needs.
From page 30...
... For example, the review of data from sales of dietary supplements to military personnel indicates that one of the biggest sellers (second only to multivitamin supplements) at military bases, Hydroxycut, is sold in various forms as a thermogenic weightloss product; it contains herbal extracts (e.g., Gymnema sylvestre extract)
From page 31...
... Specific Subpopulations Within the Military Within the general military population, there are subpopulations with heightened concerns for both the benefits and safety of dietary supplement use, based on special military mission requirements and possibly special nutrition needs. These subpopulations may be defined by the type of strenuous performance required as part of their mission or by the unusual environment in which routine activities must be performed.
From page 32...
... . Current Military Policies to Manage Dietary Supplement Use As a large organization and with a focus on health protection and readiness, many responsibilities of the DoD are dedicated to maintaining the health and well-being of the armed forces and their families; these responsibilities include policy development and education regarding dietary supplements.
From page 33...
... This approach might be adequate for the general public and for those in the military service performing tasks similar to those of civilians; however, as discussed above, a different approach is needed for specific military subpopulations (Box 1-3) so that risks that might compromise the success of military operations are not overlooked, and potential benefits in performance or health from use of dietary supplements by military personnel are realized.
From page 34...
... young adult population. Institute of Medicine Committee on Dietary Supplement Use by Military Personnel meeting, Washington, DC.
From page 35...
... Washington, DC: Department of the Army. USP (United States Pharmacopeia)


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