Dietary Supplements: What Price for Glory?

1. Dietary Supplements: What Price for Glory? Gina Blunt Gonzalez, PhD Jennifer Dearden, EdD DaynaSeelig, PhD Morehead State University

2. 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

3. 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

4. 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

5. 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/Dietary-Supplements_web_pur.gif

6. What is a Dietary Supplement? http://www.virginmedia.com/images/dietary-supplements.jpg

7. Dietary Supplement Health and Education Act of 1994 (DSHEA) Food ?   ? DS Drug

8. Dietary Supplement “a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following ingredients:

9. 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

10. Image from http://www.healthline.com/blogs/diet_nutrition/uploaded_images/pills-736655.jpg Dietary Supplements cont. DSHEA 1994 • Intended for ingestion • Pill, capsule, or liquid form • Can not be represented • Conventional food • Sole item of a meal • Sole item of total diet

11. Dietary Supplements cont. • Must be labeled as a‘dietary supplement”

12. 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.

13. 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.”

14. http://www.naturalherbalguide.com/sites/meaunspaw/_files/Image/Herbal%20Supplements(1).jpghttp://www.naturalherbalguide.com/sites/meaunspaw/_files/Image/Herbal%20Supplements(1).jpg Precautions in Dietary Supplements

15. 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

16. 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

17. Supplement Fraud • Federal Trade Commission (FTC) • Works closely with FDA on DS. • FDA – labeling • FTC – advertising

18. 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 http://www.dietsupplementreviews.com/images/products/35991246xenadrineefx.jpg

19. What are some possible areas of supplement misuse?

20. 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 Use Rx drug First Injury/ Illness Combo DS, Rx, OTC Use DS First Consumer Mis-use

21. Supplements in the Health Professions Personal Trainers Athletic Trainers/Coaches/Physical Educator Physicians, Physical Therapists, Nurses

22. Personal Training Professionals

23. 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

24. 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.

25. 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

26. 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

27. State Laws(nutritionadvocacy.org)

28. Supplements in Youth:Physical Educators, Athletic Trainers, and Coaches

29. Youth Sports Participation

30. 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

31. 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

32. 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)

33. 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

34. 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.

35. 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.

36. Dealing with parents and adolescents • Recommendations for discussion

37. 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

38. 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

39. NCAA Banned Drugs • http://www.ncaa.org/health-and-safety/policy/2013-14-ncaa-banned-drugs

40. Health Care Providers

41. Physicians, PTs and Nurses • Professional Governing Bodies • Educational Attainment/ Coverage of information in the curriculum • Position Statements of Governing Bodies • Unique Problems and Opportunities

42. Epocrates • Used by physicians and other health professionals • Prescription Drugs, OTC, Vitamins, Minerals • FDA direct report options • Health Professional • Consumer

43. http://www.clarian.org/ADAM/doc/graphics/images/en/19306.jpg 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

44. Recommendations • Understand your scope of practice • Avoid prescribing, selling or recommending supplements • Educate yourself • Prepare a handout of resources

45. 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

46. Evaluating Information • Authority • Objectivity • Accuracy • Currency **Adapted from the original with permission, Eastern Kentucky University Libraries

47. 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?

48. 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?

49. Accuracy • Grammatically correct • Information accurate and verifiable? • Sources and references cited • Does the tone and style imply accuracy?

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