Dietary Supplements: What Price for Glory?

Gina Blunt Gonzalez, PhDJennifer Dearden, EdD

Dayna Seelig, PhDMorehead 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

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What is a Dietary

Supplement?

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Dietary Supplement Health and Education Act of 1994 (DSHEA)

Food Drug? ?DS

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

DSHEA 1994

Image from http://www.healthline.com/blogs/diet_nutrition/uploaded_images/pills-736655.jpg

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.”

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Precautions in Dietary Supplements

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/chinery/chinery.shtm

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What are some possible areas of supplement

misuse?

Consumer Mis-use• Use DS first for

treatment• 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

Injury/ IllnessCombo DS, Rx,

OTC

Use Rx drug First

Use DS First

Supplements in the Health Professions

Personal TrainersAthletic 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

Yout

h Sp

orts

Par

ticip

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n

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 student-

athletes 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-and-safety/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

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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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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