Dietary Supplements - Human Performance Resource Center

Report
Dietary Supplement Education
for DoD Healthcare Providers
DoD Human Performance Resource Center
Website address: humanperformanceresourcecenter.org
Contact e-mail: [email protected][email protected]
v4: 082212
1
Overview
• Introduction
• Objectives
• Definitions and
Regulations
• Military Personnel and
Supplements
• Safety Concerns
• Healthcare Providers
and Supplements
• Finding Science-Based
Information
2
Introduction
• Military-specific guidelines on how to use dietary
supplements (DS) are needed.
• Currently, there are no integrated, service-wide
policies to guide military personnel on how to use
DS safely.
• Therefore, the Institute of Medicine (IOM)*
recommended that healthcare personnel should
be trained to:
– Evaluate DS use.
– Inform and obtain information from their service members.
– Report adverse events through a standardized process.
*IOM Report, Use of Dietary Supplements by Military Personnel, 2008
3
Objectives
• Define and describe a DS
• Explain why military personnel use DS
• Explain how DS, as well as medical drugs and food,
are regulated
• Explain nutritional requirements for service members
and identify the contribution of functional foods
• Discuss safety concerns associated with DS use
• Explain the importance of taking a DS history
• Provide science-based resources on DS
4
What is a Dietary Supplement
and how is it regulated?
5
What is a Dietary Supplement?*
• Product intended to supplement the diet and
containing one or more dietary ingredients:
–
–
–
–
Macronutrients
Vitamins, minerals, amino acids
Herbs or other botanicals
“Other” dietary substances
• Intended to be taken by mouth
• In the form of a capsule, powder, softgel, gelcap,
tablet, liquid, etc.
• Not represented for use as conventional food
• Labeled as a dietary supplement
*Adapted from the U.S. Dietary Supplement Health and Education Act of 1994
6
What is a Botanical?
• Plant or plant part valued for its medicinal or
therapeutic properties, flavor, and/or scent.
• Herbs are a subset of botanicals.
Flaxseed
Linum usitatissimum
St. John’s Wort
Hypericum perforatum
Soybean
Glycine max
Thyme
Thymus vulgaris
7
Why do Military Personnel Use
Dietary Supplements?
Demographics
Age
Gender
Duty assignment
Education
Ethnicity
Motivations
for use
Attitudes
Determine
the
selection
of specific
products
Promote health and prevent illness
Enhance physical/cognitive performance
Increase strength and stamina
Build muscle mass
Boost energy
Lose weight
8
Regulation of DS, Foods, and
Drugs in the United States
Food Additives
Dietary Supplements
Medical Drugs
Subject to many laws
and regulations closely
monitored by the U.S.
Department of
Agriculture (USDA), the
Food and Drug
Administration (FDA),
and local agencies
Subject to limited pre-market
review and no pre-market
approval
Subject to many laws
and regulations that are
closely monitored by
the FDA, Drug
Enforcement Agency
(DEA), or other
agencies
Mandatory
inspections and
incident reports
*No formulation standards
No product registration
No approval of claims Manufacturer responsible for
ensuring safety and compliance
Mandatory reporting of
adverse events
Mandatory reporting
of adverse events
* No formulation standards. However, manufacturers must follow
current good manufacturing practices (cGMPs) - 21 CFR Part 111.
9
Regulation of DS in the
United States
• Under the 1994 Dietary Supplement Health and
Education Act (DSHEA), the FDA regulates DS by
holding manufacturers accountable in five
important areas. Manufacturers are required to:
–
–
–
–
–
Ensure the supplement is safe
Make truthful claims
Adhere to current Good Manufacturing Practices (cGMPs)
Submit all reports of serious adverse events to the FDA
Notify the FDA before it markets a supplement containing a
“new dietary ingredient” (NDI)
10
Regulation of DS in the
United States: Labels
• Most closely regulated part of a supplement
• Must conform to FDA standards
• Requires the following information on labels:
– Descriptive name of the product stating it is a "supplement"
– Name and place of business of manufacturer, packer, or
distributor
– Complete list of ingredients
– Net contents of the product, e.g., number of pills
– *Nutrition labeling (i.e., "Supplement Facts" panel)
• Does not have to state the amount of active
ingredients
*Except for some small-volume products or those produced by
eligible small businesses
11
Regulation of DS in the
United States: Labels
Regulation of DS in the
United States: Claims
• Claims on Labels
– Must be truthful
– May not say the DS can be used to prevent, treat, or cure a disease
– Must have FDA disclaimer, if it has a structure/function claim:
– "This statement has not been evaluated by the FDA. This product is not
intended to diagnose, treat, cure, or prevent any disease."
• Claims on Brochures
– Claims on supplement labels and content of separate brochures
and fliers are subject to FDA and Federal Trade Commission (FTC)
oversight.
Federal Trade Commission (FTC) regulates
DS advertising for false and misleading
health claims.
13
Regulation of DS in DoD
• Generally, if a supplement is not banned or
recalled by the FDA, the FTC, or DEA, it is not
banned by DoD at large.
• DoD has the authority to issue guidance on
specific supplements and/or categories of
supplements.
• Check to see if your unit/command/base has a
DS policy in effect.
14
Regulation of DS in the
United States:
THE BOTTOM LINE
• FDA has “post-market” responsibility to
ensure compliance with regulations.
• DS do not require pre-market approval.
• There is no guarantee of quality, purity,
composition, safety, or effectiveness of dietary
supplements.
• Many DS contain banned or harmful
substances not declared on the label.
15
Making Informed
Decisions on DS Products
• RECOMMENDATION: Shop for products with
seals from third party/independent verification
programs. These programs evaluate and
certify DS for quality. Examples are:
–
–
–
–
United States Pharmacopeia (USP)
NSF International
Informed-Choice, HFL Sport Science
ConsumerLab.com
16
Third-Party Verification Programs
CL*
HFL Sport
Science
NSF
USP
Voluntary
Certification
Program
Informed
-Choice
NSF/ANSI
173 DS
Program
DS
Verification
Program
Reviews products for
contaminants?
Yes
Yes
Yes
Yes
Reviews products for quality?
Yes
Yes
Yes
Yes
Reviews to ensure ingredients are
present in quantities specified on
label?
Yes
Yes
Yes
Yes
Reviews labels to ensure they
meet FDA specifications?
Yes
Yes
Yes
Yes
Name of Company
Name
of program
*CL = ConsumerLab.com
17
Third-Party Verification Programs
Name of Company
CL*
HFL Sport
Science
NSF
USP
Tests for dissolution and
disintegration?
Yes
No
Yes
Yes
Screens for banned substances?
No
Yes
Yes
No
Inspects manufacturing facilities
for GMP**?
No
Yes/No***
Yes
Yes
Conducts random off-the-shelf
tests on approved products?
No
Yes
No
Yes
Provides certification/seal on
approved products?
Yes
Yes
Yes
Yes
Lists evaluated and approved
products/brands?
Click here for list
Click here for list
Click here for list
Click here for list
*CL = ConsumerLab.com
**GMP = Good Manufacturing Practice
***Click for additional information
18
Military Personnel
and Supplements
Balancing Foods and Supplements
20
Warrior Athletes:
Nutritional Requirements
• Athletes may have an increased need for
protein.
• Athletes need to maintain hydration by
consuming 1 L (~36 oz) of fluid for every 1,000
calories expended.
• Athletes can meet their nutritional
requirements with foods alone and do not
require dietary supplements.
• Many Warfighters are like athletes with respect
to nutritional needs.
21
Warrior Athletes:
Nutritional Requirements
Nutrient
Recommendations for
Athletes
Carbohydrates
6 -10 g/kg (2.7-4.5 g/lb)
body weight
Protein
Recommendations vary
-Endurance
1.2-1.4 g/kg
(0.55-0.64 g/lb) body
weight
-Resistance
(up to 1.7 g/kg (0.8 g/lb)
body weight
Fat
Micronutrients
Guidelines for
Americans
45 - 65% of calories
from carbohydrates
0.8 g/kg ( 0.4 g/lb)
body weight
20-25% of calories from 20-35% of calories
fat
from fat
Meet DRIs
Function in
Exercise
Maintains glucose
levels
Energy metabolism
Build and repair
muscles
Provides energy
Co-factors in energy
metabolism
22
Nutritional Requirements in
Extreme Environments
23
Functional Foods
• Category of foods that supposedly provide health benefits
beyond basic nutrition.
• Have been modified in some way to enhance health
(e.g., adding vitamin C to beverages).
• FDA-approved health claims may appear on labels
(e.g., soy protein may reduce the risk of cardiovascular
disease) if scientific evidence supports it.
• Currently no specific regulation in the United States.
• Examples of functional foods:
–
–
–
–
–
–
Juice with added calcium
Drinks with botanicals
Milk with vitamin D and DHA
Breakfast cereals with vitamins and minerals
Modified vegetable oils
Soy bars
24
Operational Rations:
Military Functional Foods
• Provide fat, protein, carbohydrates, fiber, and
micronutrients (vitamins and minerals).
• Nutritional standards for operational rations are based
on Military Dietary Reference Intakes (MDRIs).
– MDRIs are based on the IOM Dietary Reference Intakes (DRIs).
• Dietary supplements cannot be included in rations.
• Examples of Military Rations:
–
–
–
–
–
Meal, Ready to Eat (MRE)
First Strike Ration
Meal, Cold Weather/Food Packet, Long-Range Patrol
Light Weight Rations
Tailored Operational Training Meal
25
Description of Selected
Operational Rations
• Meal, Ready to Eat (MRE): standard individual
operational rations (3 MREs/day)
– Intended to be a Warfighter's sole sustenance for up to
21 days
– Meets AR 40-25 on nutritional standards
– One MRE provides ~1,250 calories
• First Strike Ration (FSR): restricted rations
used by Warfighters on extended foot patrols
for 3 to 10 days
– One FSR has ~2,900 calories
– Weighs much less than one MRE
26
Safety Concerns
Tainted Dietary Supplements
27
Beware of Tainted DS
• Dietary supplements with hidden drugs and
chemicals
• Potentially dangerous ingredients include:
– Approved prescription drug ingredients and their
analogs
– Drugs banned by the FDA for safety reasons
– Controlled substances such as anabolic steroids and
stimulant diet drugs
– Untested/unstudied new active drug ingredients
28
Health Hazards of Tainted DS
•
•
•
•
•
Contain undeclared ingredients
Sometimes 3 or 4 times recommended dose
Untested and unstudied ingredients
Interactions with other medications
Consumers/physicians unaware of possible
side effects
• Consumer perception that more is better
29
Red Flags to watch for
• High-risk category products:
–
–
–
–
Bodybuilding products
Sexual enhancement products
Weight-loss products
Diabetes products
30
Red Flags to watch for
• Claims on labels such as:
– “Do not take if you have any medical condition, if you are
taking any prescription medications, or if you are pregnant.”
– “May cause a positive result in a performance-enhancing
drug test.”
– An alternative to (or claiming to have similar effects to) an
FDA-approved drug—e.g., “All natural alternative to XYZ.”
These claims often indicate that the supplement may contain
substances not on the ingredients list, prescription drug
analogs, or banned substances.
31
Red Flags to watch for
• Claims about the supplement curing a wide range of
unrelated diseases (e.g., cancer, AIDS, in addition to
diabetes)
• Labels missing the statement below if supplement
claims to affect normal body structure or function (e.g.,
“helps promote bone health”)
– “These statements have not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat, cure, or prevent
any disease.”
• Supplements promising “quick fixes” (e.g., to cure XYZ
in seven days, lose weight in nine days, shrink tumors
in one week, cure impotency in two weeks, etc.)
32
Red Flags to watch for
• Labels that have…
– text in a foreign language
– directions or warnings that resemble FDA-approved drug products
– claims that it is as effective as an FDA-approved drug
– inadequate or absent safety warnings
– a black-box warning
• Supplements not verified by a third-party verification
program. Some third-party verification programs are:
– United States Pharmacopeia (USP)
– NSF International
– Informed-Choice, HFL Sport Science
– ConsumerLab.com
33
Red Flags to watch for
• Solicitations (e-mails) offering products in the
high-risk product categories
• Directions and warnings that resemble FDAapproved drug products
• Inadequate or absent safety warnings
• Product marketed with personal testimonials
about amazing results from using the product
• Products rated 7 or lower by the Natural Medicines
Comprehensive Database (NMCD)
• The NMCD rates commercial products based on safety,
effectiveness, and quality. Each product gets a rating of 1-10
with 10 being the best and 1 being the worst.
34
Red Flags to watch for
• Products that contain any of these problematic
ingredients…
5-HTP
(5-Hydroxytryptophan)
Aconite
Adrenal extract
Aga
(Amanita muscaria)
Alkanna
American mistletoe
Apricot kernel
Aristolochia
Beth Root
Bitter Orange
(Synephrine)
Bittersweet nightshade
Bladderwrack
Blue Cohosh
Blue Flag
Butanediol (BD)
Buttercup
Calamus
Calotropis
Canadian hemp
Catnip
Cesium
Chaparral
Chenopodium oil
Clematis
Clubmoss
Colloidal Silver
Coltsfoot
Comfrey
Country Mallow
Coltsfoot
Comfrey
Country Mallow
35
Red Flags to watch for
• Products that contain any of these problematic
ingredients…
DMAA
(1,3 dimethylamylamine)
Dolomite
Ephedra
European mandrake
Germanium
Gamma-butyrolactone
(GBL)
GHB (Gamma
hydroxybutyrate)
Gravel root
Greater Celandine
Hawaiian baby
woodrose
Heartleaf (Sida
cordofolia)
Hemp oil
Horny goat weed
(Epimedium
grandiflorum)
Indian snakeroot
(Rauwolfia)
Jaborandi
Jimson weed
Kava
Laminaria
Lobelia
Pinellia ternata
Salvia
(Diviner's sage)
Usnea or Usnic acid
Vinca rosea
(madagascar periwinkle)
Wild indigo
Yohimbe
36
Additional Safety Concerns
• Lack of information
– Research studies usually focus on young, healthy
individuals (often males) as study subjects
• Excess protein intake
– Individuals consuming protein shakes, bars, and
powders may exceed recommended protein intake
•
Ephedra/
Synephrine
20 - 25 mg
Excess nutrient intake
– Many individuals use more than one type of
supplement; many of these products are
excessively fortified
• Stacking
Aspirin
80 mg
Caffeine
200 mg
– Taking multiple ingredients together to
increase effects of selected ingredients
37
Additional Safety Concerns
• Proprietary Ingredients
– Actual ingredients and their amounts are not always
provided
• Multiple-ingredient products
– Some products contain several ingredients, which may
or may not be listed on the label
38
Wishful Thinking
Common sense tells us that popping a pill alone does not build muscles.
In reality, individuals must use skills, disciplined physical training,
personal effort, and good nutrition to realize their full potential.
39
Healthcare Providers and
Dietary Supplements
Asking about DS use and evaluating
supplements
40
Healthcare Providers should:
•
•
•
•
Query service members on supplement use.
Document use of specific supplements by patients.
Support patient desire to improve performance/health.
Educate service members about safety concerns.
– Tainted and contaminated supplements
– Facts vs. claims
• Know where to find relevant research on supplements.
• Be on the lookout for possible adverse reactions to
supplements and know how to report them.
• Be informed on and advise service members about
third-party certification programs.
41
Healthcare Providers should
ask about DS use
• Sample questions:
– Do you take any DS in the form of pills, shakes or drinks, powders,
bars, sprays, gums, or gels?
– Do you take anything to improve your workout or performance?
– Do you take anything to increase muscle mass or provide energy?
– Do you follow any special practices to enhance your performance?
– Do you take any products to improve your health?
• Accurate information may not be given in response to
general questions.
• Response rates may double when you ask specific
questions.
• Phrasing of questions may determine accuracy of the
information.
42
Guidelines for Evaluating DS
•
•
•
•
•
•
•
•
•
What is in it?
Does label conform to FDA rules?
Is it safe?
Is it the right stuff?
Does it make sense?
Does it work?
Does it reach its target?
What other sources exist?
Why take it?
43
Guidelines for Evaluating DS
• What is in it?
– What does DS contain? Are there multiple ingredients?
• Does label conform to FDA rules?
– Does product label state that it is a "supplement”?
Name and place of manufacturer/packer/distributor?
A complete list of ingredients?
• Is it the right stuff?
– Is the active ingredient of the same quality/quantity as
the one used in studies showing effectiveness?
44
Guidelines for Evaluating DS
• Is it safe?
– Have any adverse effects or concerns been expressed by
credible professional organizations? Have long-term studies
even been conducted?
• Does it make sense?
– Is the claim consistent with current knowledge of exercise
physiology and nutrition? (Is it biologically plausible?)
• Does it work?
– What effect does it have on performance and what is the
evidence for this? Is the intended use the same as that for
which there is evidence? Is the evidence applicable to the
general population or just specific groups?
45
Guidelines for Evaluating DS
• Does it reach its target?
– Are there differences in bioavailability between dietary
and supplemental sources?
• What other sources exist?
– Is this a dietary constituent? If so, how much is ingested
and what are the sources?
• Why take it?
– Supplements cannot compensate for training or overall
dietary adequacy.
46
Finding Science-Based
Information on Supplement Safety
and Effectiveness
Creatine: Is it safe?
Does it work?
47
Objectives
• Describe how to locate evidence-based
resources to determine safety and
efficacy/effectiveness of supplements.
• Provide tools for performing evidence-based
searches.
• Explain why evidence for reported effects of a
supplement applies only to the specific dose
and type of user studied.
48
Sample Questions
• Is it SAFE to use creatine supplements?
• Are creatine supplements EFFECTIVE for
increasing muscular strength?
49
Finding Information on
DS Safety or Effectiveness
Examples of credible resources:
–
–
–
–
–
Human Performance Resource Center
Natural Medicines Comprehensive Database
Office of Dietary Supplements
U.S. Food and Drug Administration
PubMed
Search Engines
– Google Scholar
– WorldCat
50
Strategies for a Search
• Search for published government guidelines.
• If none are available, search for systematic
reviews and reliable review articles.
– Systematic reviews provide a summary of available research
on a given topic.
• If reviews are not found, perform a literature
search for published, peer-reviewed materials to
ensure quality and plausibility.
– Randomized controlled clinical trials are the highest level of
evidence.
• Remember: Findings cannot be extrapolated to
other uses, doses, populations, outcomes, etc.
51
DoD Dietary Supplement
Classification System
• Classifies DS for DoD service members based on
expected risk and potential benefit
• Located at:
– http://hprc-online.org/dietary-supplements/dietary-supplementclassification-system-1#.UDP8no4Qh5g
– Accompanying monographs contain information on:
– Dose range/upper limit
– Potential benefits
– Military performance and survivability
– Medication interactions
– Withdrawal effects
– And more…
52
Benefit
Dietary Supplement Risk Matrix
Safety
< Minimal
Concern
Low
Concern
Moderate
Concern
High
Concern
High
Potential
1
2
7
9
Moderate
Potential
3
4
8
10
Low
Potential
5
6
11
12
53
Summary
• DS cannot offset the unfavorable effects of
poor food choices.
• Be an informed consumer and know:
–
–
–
–
How DS are regulated.
What third-party verification programs are.
Potential safety concerns and health hazards.
Which DS product categories are high risk.
• Use reliable science-based resources to stay
informed.
54
References and Resources
• Arsenault J, Kennedy J. Dietary supplement use in U.S. Army
Special Operations candidates. Mil Med. 1999;164:495-501.
• Athlete Advisory - Methylhexaneamine and Dietary Supplements
• Athlete Guide to the 2011 Prohibited List
• Human Performance Resource Center
• IOM (Institute of Medicine). 2008. Use of dietary supplements by
military personnel. Washington, DC: The National Academies
Press.
• Lieberman HR, Stavinoha T, McGraw S, White A, Hadden L, and
Marriott B. Use of dietary supplements among active duty US
Army soldiers. Am J Clin Nutr. 2010;92(4):985-995.
• Natural Medicines Comprehensive Database
• Nutrition Standards and Education. Army Regulation 40–25
BUMEDINST 10110.6. AFI 44-141.
• Office of Dietary Supplements
• U.S. Food and Drug Administration
55

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