Use of Dietary Supplements by Military Personnel (2008) / Chapter Skim
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5 Framework to Review the Safety of Dietary Supplements for Use by Military Personnel
5 Framework to Review the Safety of Dietary Supplements for Use by Military Personnel
Pages 296-335
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From page 296... ...
of 1994 designated the FDA as the agency responsible for determining whether a marketed dietary supplement is unsafe (Dietary Supplement Health and Education Act of 1994, Public Law 103-417, 108 Stat 4325, 103rd Congress, October 25, 1994)
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From page 297... ...
. The 2007 Dietary Supplement and Nonprescription Drug Consumer Protection Act represents a step forward in ensuring safety by mandating that companies report to the FDA any serious adverse event derived from the use of dietary supplements, but the success of this act in establishing an effective signaling system to identify supplement ingredients particularly in need of safety evaluation is still unknown.
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From page 298... ...
Benefits and/or risks to military personnel from use of a particular dietary supplement might also differ from those of the general population owing to specific unit missions and environments; for example, the thermoregulatory effects of some dietary supplements could be critical for military personnel operating in extreme temperatures, while they would be less important for the general population or for military personnel deployed to a more temperate area. Some groups of military personnel might experience risks and benefits from the use of dietary supplements different from those of other military personnel because of their unique responsibilities and tasks (e.g., aviators, those with access to nuclear weapons, or those conducting special operations)
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From page 299... ...
improving monitoring of the use of dietary supplements by military personnel, (2) using a framework to determine the level of concern for dietary supplements in a military context, (3)
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From page 300... ...
This section describes the second component, that is, elements of the safety framework outlined in the 2005 IOM report that are particularly useful to the military in its need to understand the safety (and possible benefits) of the use of dietary supplements by military personnel.
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The 2005 IOM report framework suggested that if the FDA were able to operate proactively, review of a dietary supplement ingredient should be initiated on the basis of either a high prevalence of use in the general population, or a high level of use by a particularly vulnerable population. As Modified for the Military: Adverse Events and Frequency of Use Monitoring The military should proactively concern itself not only with dietary supplements associated with an adverse event but also with those most commonly sold on base, and with consideration for the safety of those military personnel who, because of their duties, would be particularly vulnerable to the adverse effects of specific supplements.
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From page 302... ...
(See Chapter 6 for recommendations on a system to monitor adverse events for the military.) Military health care professionals should identify any adverse events associated with dietary supplement use that might compromise the performance or survivability of military personnel.
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From page 303... ...
Because of the low reporting rates for adverse events, the lack of data on adverse events does not necessarily show that a dietary supplement is safe. Also, because these products are bioactive, a review of the safety of widely used dietary supplements is warranted unless the dietary supplement has been declared to be of minimal concern.
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From page 304... ...
: – Product significantly inhibits clotting time – Product significantly promotes dehydration – Product significantly inhibits immune system – Product significantly disrupts body's ability to maintain thermal regulation • Animal data signaling: Serious adverse events as described above for human data, seen in ani mals at doses 10× recommended exposure for humans Neoplasia Severe organ toxicity (necrosis/dysplasia) Reproductive failure/developmental effects Severe neurological/behavioral changes • In vitro data signaling: Multiple different assays suggest the same pathological condition related to serious adverse events described for human data above Concentrations of the dietary supplement causing severe adverse effects in vitro are similar to reported blood or plasma levels in humans following consumption of this dietary supplement Chemical or plant species is similar to known toxic compound and/or banned dietary supplement, or similar to products having adverse effects described above in humans verse effects are noted from the use of a specific supplement and its safety review reveals no concern, then the determination would be made that the dietary supplement is of minimal concern and no further evaluation would be needed.
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From page 305... ...
evidence (e.g., how many adverse events were associated with the dietary supplements, the strength of the association, level of intake, intake of other medications or supplements, actual circumstances of use, characteristics of the individual user)
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From page 306... ...
High Concern Moderate Concern Low Concern Minimal Concern FIGURE 5-1 Framework to review the safety of dietary supplements. aHigh physical activity, calorie restriction, hydration, gastrointestinal tract (diarrhea/nausea)
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From page 307... ...
The designated oversight committee may call a special meeting or conference call if adverse events are serious or frequent, as judged by the MTF P&T Committees. Integrated Safety Evaluation 2005 IOM Framework: Integrated Safety Evaluation The third step of the 2005 IOM report framework is a fully integrated safety evaluation (conducted by a panel of experts)
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From page 308... ...
of a dietary supplement used by military personnel: (1) identify the dietary supplement that warrants review, (2)
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A military review panel should write a monograph for a dietary supplement that raises concerns (see models in Chapters 3 and 4)
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From page 310... ...
Figure 5-2, R01214 the safety and efficacy evaluation as it applies to military situations would be best conducted by a military review panel because they will be more cognizant of the demands and conditions unique to military operations and more experienced in identifying safety concerns relevant to military performance and survivability than a nonmilitary group. In special cases, this activity could be followed by a more comprehensive safety review of original research, focused on performance and survivability as well as the particular health and environmental situations characteristic of military personnel.
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From page 311... ...
The committee did not provide a framework to evaluate efficacy; however, information on efficacy should also be collected and included in the monograph, since the potential for benefits of a dietary supplement will be factored into the final level of concern. Decision to Take Action 2005 IOM Framework: A Safety Model for Decision Making The 2005 IOM report recommends that the results of the safety evaluation should play a pivotal role in the FDA's determination of whether a supplement ingredient is unsafe.
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From page 312... ...
Conversely, the 2005 IOM report suggested that when review of information (either at the initial review stage or as a result of an integrated safety evaluation) indicates a lower level of concern, the FDA should continue to monitor information about the dietary supplement ingredient.
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From page 313... ...
Any decisions for action should be made in consultation with the review panel of experts and the designated oversight committee, who will have a deep understanding of the scientific data. The framework developed should help the military make decisions regarding the risks and benefits of dietary supplement use by carefully examining the science-based evidence, and should point to research gaps.
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From page 314... ...
Education: 8. Educate commanders, health care personnel, and fitness center and unit trainers on risks and benefits of specific dietary supplements to enable them to make management decisions. 9. Educate all service members on risks and benefits of dietary supplements in general.
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From page 315... ...
The specific actions taken in response to a dietary supplement review should be the prerogative of military commanders who are knowledgeable about the demands of a particular military subpopulation and its tasks. This model can be successful only when the scientists in the review panel and the designated oversight committee (see Chapter 6)
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From page 316... ...
316 USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL TABLE 5-3 Summary of Risks and Putative Benefits for Selected Dietary Supplements Used by Military Personnela Potential Detrimental Effects to Dietary Military Supplementsb Performancec Military Survivabilityd Other Health Riskse Performance enhancers Caffeine Elevation of Moderate caffeine intake of No data foundi core body 400 mg/d has not been temperature associated with adverse by restriction effects in most people of peripheral heat loss Mild to moderate locomotor agitation, Elevation of tachycardia, diuresis, and circulating anxiety. Sleep disturbance catechol- can occur if ingestion is amines at within a few hours of sleep high dosages time Garlic No data Méniere's disease, asthma, Epidural hematoma, found bleeding, gastrointestinal increased international disorders normalized ratio (INR)
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From page 317... ...
Saquinavir: Clinically No data No clinical studies for High due to substantial reduction of AUC found mental or physical potential performance impact of Ritonavir: No effect on AUC chronic use on but increased incidence of Evidence of antimicrobial blood clotting gastrointestinal side effects effects Warfarin: Increased clotting Low potential for benefit time and INR, additive effect (substantial evidence of minimal beneficial effects) Chlorpropamide: Increased hypoglycemic effect Acetaminophen: Altered metabolism but not clinically substantial continued
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From page 318... ...
318 USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL TABLE 5-3 Continued Potential Detrimental Effects to Dietary Military Supplementsb Performancec Military Survivabilityd Other Health Riskse Ginkgo biloba No data Transient headaches, No data found found gastrointestinal disturbances, sleep disturbances, bleeding with Warfarin and aspirin Ginseng No data Gastrointestinal effects No data found found Tyrosine No data No data found No data found found Quercetin No data No data found No data found found
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From page 319... ...
alcohol concentration Theoretical with monoamine No data Evidence of improvement of Minimal oxidase inhibitors found cognitive function, mood states, and psychomotor functions especially under stressful situations Moderate potential for benefit (moderate level of science but high desirability) No data found No data Some evidence of immune Minimal found system improvement and antiviral properties Moderate potential for benefit (some level of science but high desirability)
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found correlation to breast cancer in epidemiological studies, androgenizing effects in women Nonsteroids Beta-hydroxy-beta- No data No data found No data found methylbutyrate found
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From page 321... ...
No data found No data Some evidence of increase in Minimal found lean tissue and muscle strength of untrained individuals Moderate potential for benefit for untrained individuals or those in catabolic states such as negative energy balance (moderate level of science but high desirability) continued
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From page 322... ...
Case reports of cardiovascular adverse effects, stroke, psychosis, heart failure, seizure, vision impairment, transient ischemic attacks, muscle failure, and death Chromium No data Only isolated adverse Only isolated adverse picolinate found effects reported (changes in effects reported cognitive behavior, allergic skin disorders, renal failure, and liver dysfunction)
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(moderate level of science but high desirability) Absorption reduced with No data Some evidence of small Low phytates and medications that found effects on weight loss and alter acidity of stomach body composition Low potential for benefit (substantial evidence of minimal beneficial effects)
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324 USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL TABLE 5-3 Continued Potential Detrimental Effects to Dietary Military Supplementsb Performancec Military Survivabilityd Other Health Riskse Sleep aids Melatonin Drowsiness/ Loss of core body heat No data found sedation Drowsiness/ effects sedation effects Gastrointestinal effects Valerian Drowsiness/ Drowsiness/ No data found sedation sedation effects effects Gastrointestinal effects General healthj Energy supplementsk Sports bars No data No data found Could contribute to found superfluous calories for inactive personnel
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Unknown but unlikely, No data Evidence of improved Minimal depending on individual found exercise performance ingredients Supplement essential nutrients High potential for benefit (substantial evidence of benefits and high desirability) continued
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326 USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL TABLE 5-3 Continued Potential Detrimental Effects to Dietary Military Supplementsb Performancec Military Survivabilityd Other Health Riskse Sports drinks No data Hyponatremia (with Could contribute found excessive use) unnecessary calories for inactive personnel Vitamins and Minerals Calcium No data Minimal when below Minimal when below UL found Tolerable Upper Intake Level (UL)
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From page 327... ...
FRAMEWORK TO REVIEW THE SAFETY 327 Interactions with Medicationsf or Other Withdrawal Concern Bioactive Substances Effects Putative Benefitsg Levelh Unknown but unlikely, No data Evidence of improved Minimal depending on individual found exercise performance ingredients Some evidence of increased muscle protein synthesis, superior hydration, and reduction in muscle damage after strenuous exercise when drinks contain protein; requires further substantiation Plasma level better maintained during sweating when electrolytes are provided High potential for benefit (substantial evidence of benefits and high desirability) May reduce absorption and/ No data To reach adequate levels by Minimal when or efficacy of some found supplementing the diet below UL medications Sustain bone health and mood states; potential for further benefits with supplemental amounts High potential for benefit (substantial evidence of benefits and high desirability)
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328 USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL TABLE 5-3 Continued Potential Detrimental Effects to Dietary Military Supplementsb Performancec Military Survivabilityd Other Health Riskse Iron No data Minimal when below UL Minimal when below UL found Selenium No data Minimal when below UL Minimal when below UL found Zinc No data Minimal when below UL Minimal when below UL found Multivitamins/ No data Minimal when below UL Minimal when below UL multiminerals found
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From page 329... ...
No data To reach adequate levels by Minimal when found supplementing the diet below UL High potential for benefit (substantial evidence of benefits and high desirability) No data To reach adequate levels by Minimal when found supplementing the diet below UL High potential for benefit (substantial evidence of benefits and high desirability)
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From page 330... ...
bComposition of dietary supplements varies widely; these are general categories and many include other ingredients or a combination of ingredients. cCausing detriments to performance during military tasks (e.g., physical endurance, muscle strength, alertness, memory, stress, sleep patterns)
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From page 331... ...
Even if a study reported a lack of adverse effects, if the study is not adequately designed to identify risk (e.g., it is insufficiently powered, incompletely reported, does not include positive controls, or otherwise has inadequate mechanisms for detecting adverse events) , its scientific validity is reduced or even null.
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From page 332... ...
Communication with service members should not establish a presumption that using dietary supplements is the norm or the expected behavior. CHALLENGES OF THE PROPOSED FRAMEWORK FOR MILITARY PERSONNEL The three types of challenges in evaluating the safety or efficacy of dietary supplements with the framework proposed by this committee are outlined in this section.
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From page 333... ...
Because this rule will not be implemented until June 2008, its effectiveness remains to be evaluated. OVERALL RECOMMENDATIONS The committee recommends that the military use the proposed framework, modified from the 2005 IOM report framework, to determine whether a dietary supplement requires that military leadership take specific management actions to ensure optimal readiness and health protection of military personnel.
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The following are overall recommendations related to the application of the framework: • Determination of the level of concern for a dietary supplement should be based on published reviews of general safety concerns and on adverse effects and/or benefits specific to the military; the final integrated concern level should be predicated on safety concerns, modified by potential benefits, and based on special mission requirements and environments. • The final, integrated concern level and the need for dietary supplement management should be determined in the context of specific subpopulations of the military and based on their special mission requirements, environments, and locations.
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From page 335... ...
2005. Dietary supplements: A framework for evaluating safety.
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