1
Introduction

For several decades, interest in optimizing performance and health in many segments of the U.S. population has increased, and the corresponding use of dietary supplements and performance-enhancing substances has grown substantially. The increase in use of these products has raised concern regarding their immediate and long-term efficacy and safety. The evaluation of such products is especially difficult as many are used intermittently at doses difficult to measure or contain multiple ingredients, and manufacturers may change their formulation. Because of these difficulties, it may take a long time for the current system of reporting adverse events to help detect problems. While the vast majority of military personnel are assumed to be at the same general risk of adverse effects as the overall U.S. population, additional diligence should be exercised both with respect to possible benefits and to the possible risks when these products are used by military personnel in particular job classifications and/or environments. For special military subpopulations, relatively minor adverse effects could seriously impair the ability of the individual or the unit to perform its mission. 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) was requested to convene an ad hoc expert committee under the oversight of



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1 Introduction For several decades, interest in optimizing performance and health in many segments of the U.S. population has increased, and the correspond- ing use of dietary supplements and performance-enhancing substances has grown substantially. The increase in use of these products has raised con- cern regarding their immediate and long-term efficacy and safety. The evalu- ation of such products is especially difficult as many are used intermittently at doses difficult to measure or contain multiple ingredients, and manufac- turers may change their formulation. Because of these difficulties, it may take a long time for the current system of reporting adverse events to help detect problems. While the vast majority of military personnel are assumed to be at the same general risk of adverse effects as the overall U.S. popula- tion, additional diligence should be exercised both with respect to possible benefits and to the possible risks when these products are used by military personnel in particular job classifications and/or environments. For special military subpopulations, relatively minor adverse effects could seriously impair the ability of the individual or the unit to perform its mission. 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) was requested to convene an ad hoc expert committee under the oversight of 

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 USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL the Committee on Military Nutrition Research to provide recommenda- tions on an approach to manage the use of dietary supplements by military personnel. This expert committee analyzed the patterns of dietary supplement use among military personnel, and selected a subset of dietary supplements to evaluate; for these, by examining published reviews of the scientific evidence, the committee identified those dietary supplements that are ben- eficial and/or warrant concern due to risks to health or performance. The committee also developed a system to monitor adverse health effects and recommended a framework to identify the need for active management of dietary supplement use by military personnel. Specifically, the committee did the following: 1. It reviewed survey data and findings made available to the com- mittee related to supplement use by military personnel to identify (a) which dietary supplements are of most prevalent use, with consideration of differ- ences according to demographic factors such as age, rank, sex, deployment status, and military occupational specialty, organization, and unit; and (b) expectations of benefits and reasons for use of dietary supplements by military personnel. 2. It identified information gaps regarding dietary supplement use by military personnel and recommended processes and designs by which cur- rent and future usage of supplements (including dosages, quality, and forms of supplement) should be monitored, surveyed, analyzed, reported, and the resultant data shared. 3. It selected a limited number of dietary supplements from those identified as commonly used. On the basis of already published reports that review the available scientific evidence, the committee identified those sup- plements that may be of benefit and/or pose serious hazards to the health and/or physical and cognitive performance capability of military personnel and determined whether further examination and integrative evaluation or research on each is warranted. The committee considered potential effects of supplement withdrawal and interactions. 4. It considered existing military policies for managing dietary supple- ments, and assessed the applicability to a military setting of the framework outlined in the 2005 IOM report Dietary Supplements: A Framework for Ealuating Safety and determined how it could be modified to determine which supplements need active management by the military. 5. It proposed an approach to monitor military personnel for adverse health effects that might indicate a concern associated with consumption of dietary supplements.

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 INTRODUCTION Approach of the Committee: Definitions and Collection and Analysis of Data The committee defined dietary supplements and reviewed the safety assessment procedures in place for those products in the United States. In particular, the committee explored the legal definitions of medications, food, food additives, and dietary supplements (Box 1-1) and mechanisms that are in place to protect the public. The federally approved definition of a dietary supplement determines the procedures used to ensure its safety; however, in informal usage, the term dietary supplement applies to a broader range of products that, while not meeting the legal definition of a dietary supplement, are used in similar ways as dietary supplements and which include ingredients with similar risks and benefits. For the purposes of this report, dietary supplements included those that meet the legal definition as well as some products that are commonly perceived as nutritionally enhanced with ingredients such as botanicals, vitamins, and minerals (e.g., sports drinks and sports bars). The first and second parts of the committee’s statement of task refer to a description of the use of dietary supplements by military personnel (i.e., identifying which dietary supplements are used by whom and under what circumstances). Such usage information was identified or inferred from the results of surveys of military personnel from both published and unpublished sources. Unfortunately, many questionnaires from published sources, which are valuable because the publications have been peer re- viewed, were not available to the committee. On the other hand, more recent surveys, though not peer reviewed, offer the advantage that the questionnaires themselves were available for review. Because the focus of the report was the recent military surveys (for which the committee had the actual questionnaires), the committee decided not to contact the authors of the published papers to obtain the questionnaires. The findings from the surveys provided useful background information to help the committee se- lect 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. Army Medical Command has the official responsibility to make decisions regard- ing nutrition for all military services, many of the studies or policies refer to them. However, the approach of the committee applies to all branches of the military. To develop an approach to managing the use of dietary supplements in military settings, the committee drew from experience with other consumer products. Mechanisms intended to protect the public health vary among the various categories of products (e.g., can include premarket safety and benefit assessments as well as postmarket surveillance). The main basis

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0 USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL BOX 1-1 Legal Definitions of Drug, Food, Food Additive, and Dietary Supplement Drug: Section 201(g) of the Federal Food, Drug, and Cosmetic Act states: (1) The term drug means (A) articles recognized in the official United States Pharmaco- peia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement (FDA, 2004). Food: Section 201(f) of the Federal Food, Drug, and Cosmetic Act states: the term food means (1) articles used for food or drink for man or other animals, (2) chew- ing gum, and (3) articles used for components of any such article (FDA, 2004). Food additive: Section 201(s) of the Federal Food, Drug, and Cosmetic Act states: The term food additive is defined as any substance the intended use of which results or may reasonably be expected to result—directly or indirectly—in its becoming a component or otherwise affecting the characteristics of any food (FDA, 2004). This definition includes any substance used in the production, processing, treatment, packaging, transportation, or storage of food. The purpose of the legal definition, however, is to impose a premarket approval requirement. Therefore, this definition excludes ingredients whose use is generally recognized as safe (where government approval is not needed), those ingredients approved for use by the U.S. Food and Drug Administration or the U.S. Department of Agriculture prior to the food additives provisions of law, and color additives and pesticides where other legal premarket approval requirements apply (FDA, 2004). Dietary supplement: Section 201(ff) 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) or their constituents; is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and is labeled in the front panel as being a dietary supplement (FDA, 2004).

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 INTRODUCTION for the differences in mechanisms appears to be differences in perceptions about the safety and expected outcome of use of each category; that is, food is perceived as natural and intended to nourish, while drugs are perceived as artificial and intended to cure or treat diseases. Society and individuals are generally willing to take higher risks (e.g., adverse neurological effects) when the potential benefits are substantial (e.g., to guard against heart disease). The underlying assumptions for each type of product inform the rationale for the protective mechanisms that have been established and were also the basis for the approach recommended by this committee. These mechanisms are further explained later in the report. As an example, medi- cations (drugs) require extensive premarket studies in animals and humans to demonstrate their benefit as well as document the level and type of side effects that can be expected. In this way, the relative benefits and risks are both addressed prior to a product’s release to the marketplace. These pre- market studies also provide the scientific basis for determining an associa- tion with an unexpected adverse event as reported through a postmarket surveillance system. Food additives are also subject to a premarket petition for a safety assessment and routinely undergo research studies that document adverse events and establish the potential for risk to public health prior to their introduction to the marketplace. There is no established postmarket sur- veillance system for foods or food ingredients, but the U.S. Food and Drug Administration (FDA), the federal agency responsible for regulating foods and drugs, can informally ask a manufacturer to conduct postmarket moni- toring of adverse events when a new ingredient is marketed. If there are postmarket problems reported, the FDA can ask the company to recall a product and remove it from the marketplace. There is, however, no premar- ket assessment required for foods. Under current law, dietary supplements are regulated as foods, not as drugs. As foods, dietary supplements are not subject to the rigorous premarket safety assessments required for drugs. Postmarket surveillance systems for dietary supplements have therefore been voluntary until now, and less well developed than for drugs. The 1994 Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food, Drug, and Cosmetic Act (FFD&C Act) and established a new regulatory frame- work for the FDA’s regulation of dietary supplements (Dietary Supplement Health and Education Act of , Public Law 103-417, 108 Stat 4325, 103rd Congress, October 25, 1994). 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 supple- ments (Dietary Supplement and Nonprescription Drug Consumer Protec-

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 USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL tion Act, Public Law 109-462, 109th Congress, December 22, 2006). The act also requires the collection, documenting, and archiving of non-serious adverse events reported to the manufacturer by consumers. The general public appears to regard dietary supplements as natural alternatives to tra- ditional Western medicines for the reduction of risk or treatment of disease or the optimization of performance. The recent increase in market sales (Figure 1-1) has generated growing concern about how to appropriately ensure the safety of dietary supplements. (Unfortunately, the source of the information does not explain if the increases in value of market sales are due to sales increases alone or also to rising prices. However, it is unlikely that the increases of more than 10 percent market sales per year are due only to rising prices, especially given the increase in prevalence of use in- dicated by surveys mentioned above.) Because they are a unique class of products, typically consumed to sustain health but considered neither foods nor medications, the current models for evaluation of safety or efficacy of foods or medications are not entirely appropriate for dietary supplements. Implementing DSHEA has been a challenge for various reasons; unlike regulations for medication, DSHEA mandates that the FDA itself is respon- sible for making the determination that a dietary supplement is unsafe. This determination is not easy to make in the absence of any requirement for premarket safety assessments. To help with this challenging implementa- tion, the FDA asked the IOM to prepare the report Dietary Supplements: A Framework for Ealuating Safety (IOM, 2005), including a cost-effective approach for evaluating the safety of dietary supplements under DSHEA. This proposed framework formed the foundation of this committee’s explo- ration options and examined potential adaptations for use by the military. In Billions FIGURE 1-1 Dietary supplement sales, years 1994 through 2000. NOTE: The sales figure for 2005 is estimated as $21 billion (Saldanha, 2007). SOURCE: CFSAN, 2002. Figure 1-1, R01214

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 INTRODUCTION The committee considered that for the majority of military personnel whose jobs are administrative in nature and whose work environment is otherwise similar to a civilian setting (e.g., members of Special Forces Operations constitute only about 3 percent of U.S. Army personnel [DoD, 2007a]), the risks and benefits of the use of dietary supplements would be the same as for the general population (see below for a description of the differences between the environment of the general civilian population and that of specific military subpopulations). The 2005 IOM report framework to determine the safety of dietary supplements could therefore apply for this general population. The adapted safety framework recommended by the committee for military use was based on lessons learned from implement- ing safety systems for drugs, foods, and dietary supplements for the general population as well as consideration of the heightened demands and risks faced by some military subpopulations, and is targeted at these military subpopulations. Although the development of a detailed process to establish a dietary supplement’s level of efficacy was not within the scope of the cur- rent task and this committee was not constituted to address the question of efficacy, the committee did consider the importance of efficacy in developing policy on the use of dietary supplements in a military context. The com- mittee 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. Chapter 2 also describes improvements to the current surveillance methodology, that is, the addi- tion of targeted survey designs as well as surveillance methods that may be necessary for special military populations and improvements in the ques- tions to be used. Chapters 3 and 4 summarize current knowledge about multivitamin and mineral supplement risk and benefits (Chapter 3) and provide monographs on selected dietary supplements that are of interest to the military or in highest use as of February 2006 (Chapter 4). Although minerals and vitamins are classified as dietary supplements, they were addressed as a separate category in Chapter 3 because they are essential nutrients, and their safety as well as their necessity in the human diet have been assessed numerous times (IOM, 1997, 1998, 2000, 2001, 2002/2005, 2004). Chapter 5 describes elements of the IOM framework developed to evaluate dietary supplement safety in the general population. A modified framework that considers special military environments and performance demands is recommended; the chapter also describes when and what type

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 USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL of safety review would be needed and provides a decision-making rubric so that educational materials are designed for and targeted to commanders, educators, health care personnel, and physical trainers. Chapter 6 describes the current civilian adverse-event monitoring system and describes a system that would meet the need for timeliness and other special military needs. 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. USE AND MANAGEMENT OF DIETARY SUPPLEMENTS IN THE UNITED STATES The prevalence of usage of dietary supplements has been estimated in national dietary surveys (e.g., the National Health and Nutrition Examina- tion Surveys [NHANES] I, II, III) as well as other national and local sur- veys. These surveys indicate that the percentage of individuals reporting the use of dietary supplements rose from 23 percent in 1971 to 37 percent in 2002 (Gardiner, 2007; Radimer et al., 2004). There is a greater tendency to use alternative medicine, including dietary supplements, to optimize perfor- mance and health, demonstrating a shift in the public’s perceptions about health self-care. The range of products in the marketplace has expanded from traditional vitamin and mineral once-daily supplements to a plethora of herbals, botanicals, and combination products with a variety of bioac- tive ingredients, marketed in a manner that implies they will improve some aspect of health or performance. For example, the Sloan Survey, a telephone survey of a random representative (compared with 2000 U.S. Census data) sample of the U.S. population (at least 18 years of age), reports an increase from 14.2 to 18.8 percent in the use of nonvitamin/nonmineral dietary supplements from 1998 to 2002 (Figure 1-2) (Kelly et al., 2005). As men- tioned above, the increase in dietary supplement use is also shown in earlier survey results (e.g., from 23 percent to 37 percent from 1971 to 2002). In response to this rise in dietary supplement consumption, the 1994 DSHEA was implemented to govern their safe use in the U.S. population. However, with the absence of any requirement for a premarket safety assessment, many products reach the market despite a lack of clinical studies proving their safety. In 2007, one regulation was adopted, and one Act was enacted to protect the general population from health risks before and after dietary supplements reach the consumer. The FDA issued a final rule regarding current Good Manufacturing Practices (cGMPs) for dietary supplement quality (Current Good Manufacturing Practice in

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 INTRODUCTION 1998-1999 Men 2000 25 2001 2002 20 % of Subjects 15 10 5 0 Women 30 25 20 % of Subjects 15 10 5 0 ≥65 18-44 45-64 Age Group, y FIGURE 1-2 Use of dietary supplements in the United States by age group and gender from 1998 to 2002. SOURCE: Reprinted with permission from Kelly et al., 2005. Copyright © 2005, American Medical Association. All rights reserved. Figure 1-2, R01214 Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Final Rule, 21 CFR Part 111). 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. This rule will give the FDA the necessary tools to enforce rigorous manufacturing standards across the industry, which is to comply by 2008 or 2010, depending on the size of the manufacturing

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 USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL company. The United States Pharmacopeia (USP) developed voluntary dietary supplement standards that companies can use to differentiate their products from others for marketing purposes (Box 1-2). 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) is a nonprofit, standards-setting or- ganization for foods, drugs, and dietary supplements. The USP has served as an independent, science-based public health organization since its foundation by an independent group of practitioners in 1820. Two of its principal publications, the United States Pharmacopeia (USP) and the National Formulary (NF), are recognized in the Federal Food, Drug, and Cosmetic Act (FFDCA) as official com- pendia of the United States (Bhattacharyya et al., 2004; Schiff et al., 2006). USP documentary standards and reference materials (RMs, also termed official USP Reference Standards) are recognized not only in the United States but also in ap- proximately 130 nations worldwide. USP’s voluntary standards-setting body is the Council of Experts, which has five expert committees devoted to creation of official standards for dietary supplements. These are the Dietary Supplement Information, Bioavailability, Botanicals, General Chapters, and Nonbotanicals, Nutrition, and Electrolytes expert committees (USP, 2007). Beyond USP’s documentary stan- dards and RMs, USP has established a dietary supplement verification program (DSVP), which includes audit, review, and testing components to assist manufac- turers in assuring the public that they are making dietary supplements and dietary supplement ingredients of good quality (Atwater et al., 2005). The current edition of the USP and NF (USP30-NF25) includes several quality monographs for dietary supplement ingredients. In addition, the USP provides several general chapters as guidance (such as 2021, Microbial enumeration tests; 2022, Microbiological procedures; 2030, Supplemental information for articles of botanical origin; 2040, Disintegration and dissolution of dietary supplements [USP, 2008a]). The USP general chapters includes recommended good manufacturing practices and the methods to be used in, and the facilities and controls to be used for, the manufacturing of a dietary supplement to assure that such a product meets the requirements of safety, meets the quality and purity characteristics, and has the identity and strength that it is represented to possess. The USP’s DSVP performs a comprehensive verification process on specific dietary supplements. Supplements that pass this process are given the USP veri- fied dietary supplement mark. Manufacturers can display this mark on the label of USP-verified products. The mark indicates that USP has rigorously tested and verified the supplement to assure that all the listed ingredients are present in the declared amount; that the supplement does not contain harmful levels of contami- nants; that the supplement will break down and release ingredients in the body; and that the supplement has been made under good manufacturing practices that ensure safe, sanitary, well-controlled, and well-documented manufacturing facilities (USP, 2008b).

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 INTRODUCTION (Dietary Supplement and Nonprescription Drug Consumer Protection Act, Public Law 109-462, 109th Congress, December 22, 2006) serves as an additional safety measure by mandating that manufacturers forward to the FDA reports of life-threatening events associated with dietary supplements that are submitted voluntarily by consumers. In addition, the FDA continues to obtain adverse event reports on a voluntary basis from consumers, health care providers, food manufacturers, and others. Prior to 2007, there was no required standardization of quality of dietary supplements, and there was no mandatory system of adverse event report- ing. Further complicating the assessment of dietary supplement safety is the lack of a national or standardized database listing products and ingredients. Thus, establishing an association between an adverse event and a product or ingredient is often difficult. Some product marketing claims have been questioned and then modi- fied, and a few dietary supplement products have been removed from the marketplace after reports of safety issues were documented. One example of particular concern to the military was the recall of ephedra. In this case, there were reports of adverse events including a death, and public testimony on deaths that were associated with intake of ephedra by military personnel was given at a senate hearing (U.S. Senate, 2002). The FDA finalized the ban on ephedra on February 6, 2004, and the sale of dietary supplements containing ephedra became illegal on April 12, 2004 (Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk, Final Rule, 21 CFR Part 119). Although there has been concern over the safety of dietary supplements, there has also been considerable interest in documenting their potential benefits. The National Institutes of Health Office of Dietary Supplements (ODS) has embarked on a research agenda to address the efficacy as well as the safety of dietary supplements, and several systematic reviews have been commissioned to determine research gaps (ODS, 2007). The ODS has also established and continues to update an extensive database that documents federally funded research on dietary supplements (ODS, 2006). 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. For ex- ample, the IOM report Nutrient Composition of Rations for Short-Term, High-Intensity Combat Operations recommended higher protein intake for soldiers on sustained operations to ensure nitrogen balance and minimize

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 USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL muscle loss in situations of high energy expenditure (IOM, 2007). Also, a previous IOM report, Military Strategies for Sustainment of Nutrition and Immune Function in the Field, recommended that “Soldiers should be cautioned regarding the indiscriminate use of individual supplements” and stated that the preferred method of providing supplemental nutrients in the field environment was through a ration component (IOM, 1999, p. 131). A specific framework to manage dietary supplements is warranted because of the following military demands and cultural factors (described below): (1) heightened performance requirements; (2) strict weight stan- dards; (3) service members’ perceptions of military endorsement of the safety of dietary supplement products as a result of their sale on base; (4) risks, demands, and environments faced by specific subpopulations within the military; and (5) the insufficiency of current military policies to manage dietary supplement use. Heightened Performance Requirements While the general civilian population has an interest in maintaining health and preventing disease, the mission of the military forces makes health a key concern of the Department of Defense (DoD) (DoD, 2007b). Protecting the health of service members and ensuring that they are medi- cally ready for duty are important institutional concerns in the military. Therefore, the DoD emphasizes force health protection (defined as estab- lishing, sustaining, restoring, and improving the health of the active and reserve military forces [DoD Directive 6200.04]) and readiness (defined as a healthy and fit fighting force medically ready to deploy at all times [DoD Instruction, 6025.19]). With this emphasis on readiness and optimal per- formance, both mental and physical, military personnel have an additional interest in using products that might extend the benefits of a healthy diet. 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 requir- ing strength and endurance; most require lifting and carrying heavy loads. Combat activities can include patrolling, mountaineering, attacking, am- bushing, and raiding. Significant mental demands accompany the increased speed, complexity, and lethality of modern warfare; in this regard, every individual soldier may be called upon to make rapid decisions and judgment calls, may require fine psychomotor performance (e.g., marksmanship), spatial mapping ability, pattern recognition, and so on. It is also important to maintain mood and motivation as the foundation of all their exertions. In addition to physical and cognitive abilities, a fully responsive immune system is critical for protection against endemic and deliberate infectious threats that may endanger the success of a mission.

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 INTRODUCTION The various military services continuously seek to achieve optimal diets for the health and performance of their troops, especially for those with unique tasks (see Box 1-3). The military emphasizes human performance optimization through improved physical training regimens, acclimation techniques, and nutritional and pharmacological supplements. Products that benefit physical capacity (e.g., may help build muscle, relieve or retard fatigue, or improve endurance) or mental capacity (e.g., diminish sleep dis- turbance; increase memory, attention, or alertness; or decrease stress) are of special interest for the military. Because extrapolating results from the general population might not be appropriate, research is often conducted by the military services themselves. For example, the U.S. Air Force is cur- rently 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. In the case of high physical activity, these service members may be more similar to elite athletes than to the general population. • Military units that are deployed and need to perform their mission in extreme hot or cold environments that are unlike those of the general population. • Military members who may need to modify their diets or have periods of limited food consumption owing to specific types of missions. Special military rations are designed for their specific needs and logistical limitations (e.g., limited volume and weight). These missions and diets may also be conducive to the temporary use of dietary supplements in response to their availability during deployments or to the availability of other types of dietary supplements from local markets that might not be found in the U.S. marketplace. • Military members deployed in combat or peacekeeping situations are at much higher risk of injury than the general population. Thus, any dietary supplement that has an impact on the response to or recovery from injury (e.g., bleeding) would be of greater concern. • Military aviators share some of the same characteristics as commercial air- line pilots but their performance demands differ from those of civilians. For example, unique requirements to limit substances that would affect inner ear balance, cardiovascular function, and hydration are important to ensure that military aviators are capable of flying missions that may subject their bodies to significant g-forces. • Military members who are part of the Personnel Reliability Program (i.e., those having access to nuclear weapons) also have unique requirements to ensure that they are not taking any dietary supplements that would affect their ability to perform their mission (e.g., induce mood alterations).

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0 USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL endurance while carrying heavy packs or at high elevations. Other supple- ments that are under study are the herb Rhodiola rosea, or roseroot, and citrulline malate. The U.S. Army, which has been developing nutritionally rich foods for years, has considered adding more protein to the troops’ diet; to maintain muscle mass, it is currently considering adding more protein through beverages. Soldiers may already carry nutritional products such as First Strike energy bars, a drink known as ERGO (Energy Rich, Glucose Optimized), or caffeine-packed Stay Alert chewing gum. The U.S. Army Research Institute of Environmental Medicine (USARIEM) in Natick, Mas- sachusetts, has been evaluating drinks rich in carbohydrates and protein similar to those used by athletes. Strict Weight Standards Another difference between the military and the general civilian popu- lation is the emphasis on maintaining weight within established military standards. Like the general population, the military has experienced a rise in overweight and obesity.1 The rate of overweight within the military is 60 percent compared to 66 percent for all civilians; 12 percent of service mem- bers are obese compared to 31 percent of civilians (DoD, 2006). Because failure to maintain established weight standards (maximum allowable body fat percentage is 20 and 30 percent for 17–20-year-old males and females, respectively [U.S. Army, 2006]), can lead to discharge from the military and the end of a potential military career, there is high interest in dietary supple- ment products that are linked to weight control, especially those that prom- ise faster results than a diet or exercise program. 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 mili- tary bases, Hydroxycut, is sold in various forms as a thermogenic weight- loss product; it contains herbal extracts (e.g., Gymnema sylestre extract), caffeine, and several tea extracts among other ingredients. Ripped Fuel, another popular product among military personnel, is sold for its weight- loss effects. Its ingredients include ma huang (Ephedra spp.), guarana (Paul- linia cupana) extract, and green tea leaf. One form of Xenadrine—marketed as providing energy-promoting herbs and amino acids that support the body’s natural fat-burning capacity—includes a “proprietary Thermoxan- thin Blend” with l-tyrosine, yerba mate (Ilex paraguarensis) leaf, guarana seed, green tea leaf, green coffee bean extract, and caffeine. The survey of Army health care providers about dietary supplements found that, as shown by sales data, Hydroxycut, Ripped Fuel, and Xenadrine are among the five products most frequently used, as reported to health care providers. 1 Overweight is defined as a body mass index (BMI) of 25.0 to 29.9 kg/m2 and obesity as a BMI ≥ 30.0 kg/m2.

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 INTRODUCTION Perceptions About Safety of Dietary Supplement Products Sold at Installations Dietary supplements are widely marketed and available from both civilian stores and websites and more recently have been offered for sale in military installations in independent retail outlets and in fitness centers. While the military has not specifically endorsed the use of dietary supple- ments other than multivitamins (usually prenatal multivitamins), the fact that there are specific dietary supplement stores on many installations, dietary supplement sections in other stores (e.g., exchanges and commis- saries), as well as products being offered for sale in health promotion and fitness centers on base, may induce belief that the military leadership has evaluated and approved of their use. This impression may not be entirely logical, since the military also has policies discouraging consumption of tobacco and alcohol, yet, in response to consumer demand, still offers these products for sale on military installations. The only apparent differ- ence between the sale of dietary supplements and the sale of tobacco and alcohol is that tobacco and alcohol have a long tradition of availability to service members, and the movement has been to reduce their negative health impact after these products have long been widely available, while selling dietary supplements other than traditional vitamins and minerals is a relatively new phenomenon, and they were introduced for sale by a stand- alone commercial vendor in the last decade. Specific Subpopulations Within the Military Within the general military population, there are subpopulations with heightened concerns for both the benefits and safety of dietary supple- ment 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 un- usual environment in which routine activities must be performed. Some of the adverse effects that may not pose a serious health threat in the general civilian population may result in significant reduction in mission readiness or greater danger owing to the increased potential for impact of injury. Specifically, the committee attempted to respond to its statement of task with a focus on the needs of military subpopulations that engage in types of physical or mental performance that differ from those of the general public, and so would warrant additional considerations (Box 1-3). A deployed service member does not have the option to retreat from a mission and wait until symptoms subside. Because of their differences from the general civilian population, guidelines to manage the use of dietary supplements need to be tailored for them. The methods to evaluate these products in the general population might not be directly applicable to the

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 USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL military facing special conditions (e.g., high altitude, extreme heat and cold, intense or prolonged physical activity, caloric restriction) or risks (e.g., drug interactions, dehydration, infectious disease, injury or bleeding, impaired gastrointestinal or immune function, renal health, liver health/metabolism, cardiovascular health, and changes in mood/behavior or alertness). 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 re- sponsibilities include policy development and education regarding dietary supplements. The Office of the Assistant Secretary of Defense (Health Af- fairs) (OASD[HA]) is the main policy office for dietary supplement issues. For example, there is the DoD Directive (representing the highest level of DoD policy) on Health Promotion stating that the DoD should meet Healthy People 00 goals and objectives, including those listed in Chap- ter 19, “Nutrition and Overweight,” which mentions the use of dietary supplements. However, although it is “standard of care” to discuss dietary supplement use at patient encounters, there is little written policy on the use of dietary supplements. There are also campaigns to educate military populations on the use and safety of dietary supplements, but their effec- tiveness is not known. While the OASD(HA) has the responsibility and authority to direct DoD policy on dietary supplements, each military service has the capacity and authority to write specific dietary supplement policies for its own mem- bers. For example, there are service-specific policies or processes addressing the use of some nonprescription dietary supplements or prescription sub- stances in particular controlled settings, for example, pilots on extended missions. Each military service has its own medical department led by a Surgeon General (medical issues for the Marines are overseen by the Navy Surgeon General; there is also a senior Navy officer titled Medical Officer of the Marine Corps). The Surgeons General provide the medical care policies for their respective services. The DoD writes servicewide policy; the services may write policies that are even more specific or stringent. For example, when the DoD wrote a policy to ban ephedra-containing products, each of the Surgeons General advised their service secretary and defined the meth- odology to enact that policy for their own service (i.e., to accomplish the actual removal of the products) and educate their service members on the potential risks from these products (Lynn Pahland, personal communica- tion, OASD[HA], October 2, 2007). Some of the military leadership are aware of risks derived from dietary supplements because of the evidence from associated adverse effects seen in

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 INTRODUCTION military theaters, but still there is no consensus on a roadmap or guidance that provides a more uniform, consistent management approach. Concerns within the military over safety and efficacy led to the creation of a commit- tee (DoD Dietary Supplements and Self-Care Products Committee), whose charter is pending approval by OASD(HA). This commmittee, which in- cludes representatives from the OASD(HA), Uniformed Services University of the Health Sciences, and the military medical departments, will have formal authority and means to gather and discuss preliminary data about dietary supplement usage and provide policy recommendations regarding the use of dietary supplements. The USARIEM has already explored current usage as well as the ben- efits and adverse effects of a few dietary supplements (e.g., caffeine, tyro- sine, and creatine). The DoD has also added a large bank of questions about dietary supplement use and knowledge to the Survey of Health-Related Behaviors Among Active Duty Personnel, conducted every 2 to 3 years, and to the recent Survey of Health-Related Behaviors Among Reserve Component Personnel. These two surveys provide important information on dietary supplement use and identify areas of improvement in education or monitoring. Several other DoD surveys have addressed dietary supple- ment use with varying levels of scientific rigor. In summary, the DoD has provided many policies and regulations on nutrition for military personnel in different settings; however, there is cur- rently no systematic approach to evaluate the risks and benefits of the use of dietary supplements by the military or parallel servicewide policies to address their management. In the absence of such policies, the DoD relies on the monitoring of dietary supplement safety by the FDA and its Center for Food Safety and Applied Nutrition. 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. REFERENCES Atwater, J., J. Montgomery-Salguero, and D. B. Roll. 2005. The USP Dietary Supplement Verification Program: Helping pharmacists and consumers select dietary supplements. US Pharm 30(6):61-64. Bhattacharyya, L., T. Cecil, R. Dabbah, D. Roll, S. Schuber, E. B. Sheinin, and R. L.Williams. 2004. The value of USP public standards for therapeutic products. Pharm Res 21(10): 1725-1731.

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