Transcript Dietary Supplements: What Price for Glory?

Dietary Supplements:
What Price for Glory?
Gina Blunt Gonzalez, PhD
Jennifer Dearden, EdD
Dayna Seelig, PhD
Morehead State University
Intro/Goals
• Who we are and why we’re interested in DS
• What are dietary supplements?
• Regulation and research/precautions
• Role of
• Fitness professionals
• Youth Educators
• Health Care Providers
• Who do we have in our audience?
• Recommendations and Resources
Who Takes Dietary
Supplements?
• 69% US adults reported taking dietary
supplements in 2011 (Center for Responsible
Nutrition)
• CDC (2003-2006) NCHS, 53% of US
population take DS regularly
• Women are more likely to take DS than men
• Over a 30 billion dollar industry
Top Supplements 2007-2010
• Multivitamins/
minerals
• Calcium
• Fish oil
• B vitamins
• Vitamin C
• Joint
supplements
• Vitamin E
• Vitamin D
• Vitamin A
• Iron
• Folic Acid
• Protein/sports
Bailey 2013 Why US Adults Use
Dietary Supplements
Primary Motivations Supplement Use
• Health, disease related
• Performance related
(fitness, sex)
• Appearance
• Someone recommended
• Many people don’t
really know why they
use supplements
http://newsinhealth.nih.gov/images/DietarySupplements_web_pur.gif
What is a
Dietary
Supplement?
http://www.virginmedia.com/images/dietary-supplements.jpg
Dietary Supplement Health and
Education Act of 1994 (DSHEA)
Food
?  DS
?
Drug
Dietary Supplement
“a product (other than tobacco)
intended to supplement the diet that
bears or contains one or more of the
following ingredients:
Dietary Supplements cont.
• a vitamin, mineral
• an herb or other botanical
• an amino acid
• a dietary substance for use by man to
supplement the diet by increasing the total
dietary intake
• or a concentrate, metabolite, constituent, extract,
or combinations of the ingredients set forth above
Dietary Supplements cont.
• Intended for ingestion
• Pill, capsule, or liquid form
• Can not be represented
• Conventional food
• Sole item of a meal
• Sole item of total diet
Image from
http://www.healthline.com/blogs/diet_nutrition/uploaded_images/pills736655.jpg
DSHEA 1994
Dietary Supplements cont.
• Must be labeled as a‘dietary supplement”
Food and Drug Administration’s Role
• DS do not need approval from FDA for safety or
effectiveness prior to marketing unless contain New
Dietary Ingredient NDI
• Notification 75 days prior
• Demonstrate history and “reasonably expected to be safe”
• The manufacturer of the DS is responsible for safety and
efficacy prior to marketing.
• FDA is responsible for taking action in the case that a DS
is unsafe after it is marketed.
Label Statement Required by DSHEA
“This statement has not been
evaluated by the Food and Drug
Administration. This product is not
intended to diagnose, mitigate, treat,
cure, or prevent any disease.”
Precautions in Dietary
Supplements
http://www.naturalherbalguide.com/sites/meaunspaw/_files/Image/Herbal%20Supplements(1).jpg
Quality of DS
• Raw materials
• species/variety, plant part, growing conditions,
harvest practices, storage conditions
• Contaminants/Adulteration
• Intentional and unintentional
•
•
•
•
Biological: dirt, insect parts, microorganisms, toxins
Vegetable: other plants, wrong plant part
Mineral: heavy metals
Pharmaceuticals: Viagra, steroids, pesticides
• Standardization
Good Manufacturing Practices GMPs
• June 25, 2007 - FDA published the DS GMP
rule.
• Manufacturers must instill proper controls
• Processed consistently
• High quality products
• Unadulterated
• Accurate labeling
Supplement Fraud
• Federal Trade Commission (FTC)
• Works closely with FDA on DS.
• FDA – labeling
• FTC – advertising
FTC Settlement Example
 Complaint: X-EFX made
false/ unsubstantiated claims
of rapid weight loss
 Placebo lost more weight
than test group
 Falsely represented weight
loss by endorsers solely by
X-EFX without diet/
exercise
 Ordered to pay $8 to 12.8
million in redress to
consumers
For more information
http://www.ftc.gov/os/caselist/chiner
y/chinery.shtm
http://www.dietsupplementreviews.com/images/
products/35991246xenadrineefx.jpg
What are some possible
areas of supplement misuse?
Consumer Mis-use
• Use DS first for
treatment
Use Rx
drug
First
• Cautious of neglect of
better tested treatments
• Use DS in large doses
or many DS
• Use DS, conventional
medical therapies and
CAM all together for
disease treatment
Combo
DS, Rx,
OTC
Injury/ Illness
Use DS
First
Supplements in the
Health Professions
Personal Trainers
Athletic Trainers/Coaches/Physical Educator
Physicians, Physical Therapists, Nurses
Personal Training
Professionals
The Personal Training
Profession
• Governing bodies/credentialing agencies
• ACSM, NSCA, ACE, NASM, AFAA
• Educational backgrounds
• Health, fitness, wellness bachelors to masters
• Not all are required to have educational
background related to the field
Position Statements
•
ACSM: specific to athletes “used with caution and only after careful product
evaluation for safety, efficacy, potency, and legality. A qualified sports Dietitian
should be consulted.
•
NSCA: must not prescribe, recommend or provide supplements that are illegal,
prohibited or harmful to participants for any purpose including enhancing
athletic performance, conditioning or physique. Only those substances that are
lawful and have been scientifically proven to be beneficial, or at least not
harmful, may be recommended or provided to participants by S& C professionals
and only to individuals 18 and above.
•
AFAA recommends fitness professionals should not sell, recommend, or
provide DS unless it is justified by existing sound scientific and medical
research (beyond manufacturer). Use of supplements should be monitored by a
health care provider.
•
ACE “it is outside the defined scope of practice of a fitness professional to
recommend, prescribe, sell, or supply nutritional supplements to clients.
Recommending supplements without possessing the requisite qualifications
can place the client’s health at risk and possibly expose the fitness professional
to disciplinary action and litigation.
Unique Problems and
Opportunities
• Wide range of viewpoints on supplements and
the use in the PT field
• Positioned in the field to be a source of
information for consumers
• Clients looking for nutritional advice
• Offer guidance on precautions, side effects, proper
use, reliable sources of information
Unique Problems and
Opportunities
• Some personal trainers choose/are required to sell
or recommend DS
• Ethical concerns with recommendation and
distribution
• Overwhelming number is challenge to stay up-to-date
• Very few show improved performance and some may
cause harm
• Depending on your state, it could be against the law to
practice nutritional counseling
• Legal implications in case of adverse event
State Laws
(nutritionadvocacy.org)
Supplements in Youth:
Physical Educators, Athletic
Trainers, and Coaches
Youth Sports Participation
Use of Dietary Supplements
by Adolescents
• There is very little data regarding
current use
• Most recent data is from 2008 National
Health Interview Survey—pub. 2012
• Effects differ from adults
• Maturation/Growth and development
• Side effects
Use-con’t
• As much as 70% of youth under 18 year of
age have consumed dietary supplements.
(Evans, et al, 2012)
• Most used for an athletic edge
American Academy of
Pediatrics
• Substances are performance-enhancing if:
(AAP)
• Benefits strength, power, speed, or endurance
• Alters body weight or composition
• Substances that improve performance through
changes in behavior, arousal, pain perception
• Creatine should never be prescribed under 18
(AAP. ACSM)
Sport and energy drinks
(AAP):
• Educate regarding the risks and differences between sport and
energy drinks
• Energy drinks pose potential health risks because of
stimulation, they should never be consumed by children.
• Drinking carbohydrate heavy drinks will cause weight gain and
tooth decay
• Sports drinks have a specific limited function for child and
adolescent athletes. They should be used during periods of
prolonged, vigorous sports participation or other intense
physical activity.
• Promote water, not sports or energy drinks
Position Statements
Lacks recommendation from several
organizations:
• American College of Sports Medicine
(ACSM), American Dietetic Association
(ADA)., American Academy of Pediatrics
(AAP), National Federation of State High
School Associations
• Adolescents should always consult a
pediatrician.
National Athletic Trainers'
Association
• Coaches should not provide athlete
information on diet, body composition,
weight, or weight management practices. In
addition they should refrain from making
comments on or participating in the
monitoring of body composition and weight.
Dealing with parents and
adolescents
• Recommendations for discussion
AAU and NCAA
• Two approaches for coaches and teachers:
• Education
• Policies and/or rules
• NCAA Policies (by-law 16.5.2)
• Permissible: Can be provided to student-athletes
by athletics department
• Impermissible: cannot be provided to studentathletes by athletics department
• Banned: substances banned for use
NCAA Nutritional/Dietary Supplements
Warning:
• Dietary supplements are not well regulated and may
cause a positive drug test result.
• Student-athletes have tested positive and lost their
eligibility using dietary supplements.
• Many dietary supplements are contaminated with
banned drugs not listed on the label.
• Any product containing a dietary supplement
ingredient is taken at your own risk
NCAA Banned Drugs
• http://www.ncaa.org/health-andsafety/policy/2013-14-ncaa-banned-drugs
Health Care Providers
Physicians, PTs and Nurses
• Professional Governing Bodies
• Educational Attainment/ Coverage
of information in the curriculum
• Position Statements of Governing
Bodies
• Unique Problems and Opportunities
Epocrates
• Used by physicians and other health
professionals
• Prescription Drugs, OTC, Vitamins,
Minerals
• FDA direct report options
• Health Professional
• Consumer
Supplement/Drug
Interactions
• 18.4% Rx users took meds
concurrently with herbal
remedies or high dose vitamins
• <40% of patients reveal use of
supplements to health care
providers
• Products contain multiple herb
components
• Botanicals have pharmacological
properties similar to or
completely opposite of
medications
http://www.clarian.org/ADAM/doc/graphics/images/en
/19306.jpg
Recommendations
• Understand your scope of
practice
• Avoid prescribing, selling or
recommending supplements
• Educate yourself
• Prepare a handout of resources
Recommendations
• Help your clients become well
informed consumers
• Remind clients to share usage with
their medical care professionals
• If required by your job to sell or
recommend
• provide standard handout, waivers, signatures, etc
Evaluating Information
• Authority
• Objectivity
• Accuracy
• Currency
**Adapted from the original with permission, Eastern Kentucky University Libraries
Authority
• Who published the source?
• Is the author’s name visible?
• Author’s credentials/ appropriate for
the topic
• Contact information available?
• Is the source a reputable organization?
Objectivity
• Various points of view
presented?
• Is the source free of bias
toward one point of view?
• Is the source fair in its
purpose?
• Is the source free of
advertising?
Accuracy
• Grammatically correct
• Information accurate and verifiable?
• Sources and references cited
• Does the tone and style imply
accuracy?
Accuracy?
• These products are
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In this article, you'll
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they warrant a special
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Currency
• When was the information
published?
• When was the information last
updated on a website?
• Do Charts and Graphs have dates
and describe the population it is
describing?
Resources – Text Based
• The Physician’s Desk Reference for Nutritional
Supplements (2nd edition)
• ISBN: 9781563637100
Resources – Text Based
• The Physician’s Desk Reference for Herbal
Supplements (4th edition)
• ISBN: 9781563636783
Suggested Websites
•
USDA Fraud and Nutrition Mis-informationFind resources and information for spotting
suspicious health claims and links for checking out food and nutrition myths and
misinformation. Includes resources specific to weight loss diets and products.
•
USDA Information on Dietary SupplementsFind links to general information about dietary and
nutritional supplements from both governmental agencies and non-governmental organizations.
Includes resource lists, individual supplement information, and links to resources for assessing
supplement use.
•
USDA Supplement Regulations, Reports, and WarningsInformation about supplement-related
regulations, reports, and warnings compiled by the USDA's Food & Nutrition Information center
(FNIC).
•
American College of Sports MedicineWe are the American College of Sports Medicine –
45,000 members and certified professionals strong from 90 countries around the globe
•
National Strength and Conditioning AssociationThe National Strength and Conditioning
Association (NSCA) is the world leading membership organization for thousands of elite
strength coaches, personal trainers and dedicated researchers and educators.
•
Food and Drug Administration"FDA is responsible for: 1.Protecting the public health by
assuring that foods are safe, wholesome, and sanitary.
Suggested Websites
•
Food and Drug Administration"FDA is responsible for: 1.Protecting the public health by
assuring that foods are safe, wholesome, sanitary and properly labeled; human and veterinary
drugs, and vaccines and other biological products and medical devices intended for human use are
safe and effective 2. Protecting the public from electronic product radiation 3. Assuring cosmetics
and dietary supplements are safe and properly labeled 4. Regulating tobacco products 5.
Advancing the public health by helping to speed product innovations 6. Helping the public get the
accurate science-based information they need to use medicines, devices, and foods to improve
their health"
From the FDA Basics page:
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194877.htm
•
FTC Consumer Information: Health"Welcome to the FTC's health page. Here you'll find links to
FTC articles and websites covering a variety of health-related topics important to you. Learn how
to spot health scams, like fake cancer cures and bogus weight loss products, or get the facts on
different health products and services, like generic drugs, Lasik eye surgery, and dietary
supplements. You may even discover rights you didn’t know you had — like your right to your
prescription for eyeglasses or contact lenses."
From the home page - http://www.ftc.gov/bcp/menus/consumer/health.shtm
Discussion/Questions