1. NS 270 NUTRITION ASSESSMENT AND MANAGEMENT Unit 9: Dietary Supplements Amy Habeck, RD, MS, LDN

2. Unit 9 Learning Objectives: o Discuss o Nutrition supplements o Review- Nutrition and Diet Therapy o Stanfield and Hui, Chapter 11 – Nutritional Supplements o Answer your questions o Unit 9 Project

3. Dietary Supplements 25 billion dollar business (2008) Fastest growing industries in the world (12-14% growth/yr) Over ½ the population uses dietary supplements Once a product is marketed it must be shown unsafe before FDA will take action to restrict it’s sale Passage of DSHEA in 1994 greatly expanded marketing opportunities and put more responsibility on the consumer

4. Dietary Supplement Health and Education Act (DSHEA of 1994) Product intended to supplement the diet that contains one or more of the following ingredients 1 2 3 4 5 6

5. Dietary Supplement Health and Education Act (DSHEA of 1994) Product intended to supplement the diet that contains one or more of the following ingredients 1. Vitamin 2. Mineral 3. Herb or other botanical 4. Amino acid 5. Dietary substance to supplement the diet by increasing the total dietary intake 6. Concentrate, metabolite, constituent, extract, or a combination

6. DSHEA of 1994 Can make structure/function, nutrient content, and health claims on their products May not:  Make claims of cure or relief of specific health conditions or diseases  Claim pharmacological uses Manufacturer NOT required to:  Test for safety  Prove the supplement does what it claims to do

7. Trends in dietary supplement use (2002). Retrieved from : http://www.fda.gov/ope/fy02plan/dietsupp.html

8. Picciano, M. (n.d). Who is using dietary supplements and what are they taking. NIH 0ffce of Dietary Supplements

9. Complementary & Alternative Medicine Use 38% of adults in U.S. use CAM 17.7% used various nonvitamin, nonmineral, natural products such as herbal medicines and other dietary supplements fish oil/omega 3/DHA glucosamine echinacea flaxseed oil ginseng

10. Complementary & Alternative Medicine Use CAM used most often for pain back pain or other back problems neck pain or other neck problems joint pain or stiffness or other joint condition arthritis Other reasons for using CAM anxiety cholesterol control head or chest cold.

11. Drugs Dietary Supplements 1. Must undergo clinical studies before marketing 2. Clinical studies to evaluate:  Effectiveness  Safety  Possible interactions  Appropriate dose 3. FDA review & approval 1. New dietary ingredients may be used if the ingredient has been in the food supply. 2. Manufacturer of food supplements must notify FDA at least 75 days before marketing 3. FDA review & approval before marketing not required Approval Process

12. Claims Cannot claim  1.  2.  3. May claim  1  2  3

13. Claims Cannot claim  1. cure  2. relief  3. contains pharmacological uses May claim  1.  2.  3.

14. Claims Cannot claim  1. cure  2. relief  3. contains pharmacological uses May claim  1. Structure/function  2. Nutrient content  3. Health claims

15. Dietary Supplements: Allowed Claims 1. Nutrition content claim label can state: “ high in calcium” if the supplement contains 200 mg calcium/tablet 2. Disease claims link between calcium and lower risk of osteoporosis 3. Nutrition support (structure-function claim) calcium builds strong bones

16. Dietary Supplement Claims Health Claims - describe relationship between a food, a food component, or supplement ingredient and reducing the risk of a disease or health related condition. Example – “diets high in calcium may reduce the risk of osteoporosis” Nutrient Content Claims – describe the relative amount of a nutrient or dietary substance in a product. (Protein, Fat, Carbohydrate, vitamin or mineral) Example – “High in Calcium” may be used if it contains >200 mg Calcium. Structure/functions claims – do not require FDA approval and must include a disclaimer “This statement has not been evaluated by the FDA. This product is not intended to diagnose, cure, treat or prevent any disease. Example – “Calcium builds strong bones”

17. The use of CAM in the united states. (2009). Retrieved 5/10/09 from: http://nccam.nih.gov/news/camstats/2007/camsurvey_fs1.htm

18. Evidence of effectiveness for the top 5 products used Omega 3 fatty acid – reduce causes of mortality and CVD outcomes. Evidenc graded as good Glucosamine – used to reduce pain in osteoarthritis. May be effective when combined with chondroitin for a subset of the population that have moderate pain. Echinacea - used to treat/prevent colds, flu, and other infections, to stimulate the immune system. Most studies show it is not effective to treat colds/flu. It maybe beneficial for upper respiratory infections. Health topics A – Z National Center for Complementary & Alternative Medicine

19. Top 5 – evidence continued Flaxseed oil/pills – arthritis, high cholesterol levels. Not enough reliable data to determine effectiveness. Ginseng – herb used to boost the immune system for recovery from illness, increased well-being and stamina, erectile dysfunction, hepatitis C, menopause symptoms, lower blood glucose and control blood pressure. Most of the studies are small and flawed. Some studies show it may lower blood glucose and be beneficial to the immune system. Health topics A – Z National Center for Complementary & Alternative Medicine

20. Reliable references Science based data on supplements Federal Trade Commission. http://www.ftc.gov/.htmlhttp://www.ftc.gov/.html National Institutes of Health Office of Dietary Supplements. http://dietary- supplements.info.nih.gov/index.aspxhttp://dietary- supplements.info.nih.gov/index.aspx The National Center for Complementary and Alternative Medicine (CAM): http://nccam.nih.gov/http://nccam.nih.gov/ U.S. Department of Agriculture, National Agricultural Library: http://fnic.nal.usda.gov/nal_display/index.php?tax_leve l=1&info_center=4&tax_subject=274 http://fnic.nal.usda.gov/nal_display/index.php?tax_leve l=1&info_center=4&tax_subject=274 U.S. Food and Drug Administration. Center for Food Safety and Applied Nutrition. http://www.cfsan.fda.gov/~dms/supplmnt http://www.cfsan.fda.gov/~dms/supplmnt International bibliographic Information on Dietary Supplements: http://ibids.nal.usda.gov/clinical/index.php?aid=1

22. Examples of Supplements that have FDA caution about safety Ephedra Kava Some dieters tea L-tryptophan PC SPES SPES Comfrey Some brands of Red Rice yeast St. John’s Wort GHB (gamma hydroxybutyric acid) GBL and BD Certain products marketed for sexual enhancements and claimed to be natural versions of the drug Viagra which were found to contain an unlabeled drug Get the Facts. National Center for Complimentary and Alternative Medicine.

23. Safety considerations Tell your health care providers about your complimentary and alternative practices and dietary supplements Read label instructions. Talk to your provider about strength of dose and potential side effects. Natural does not mean “safe”. Comfrey and Kava are natural but can cause serious harm to the liver. Standardized or Verified on the label does not guarantee product quality or consistency. Herbal supplements can have dozens of compounds – the active ingredients may not be know. May contain incorrect plant species. May have more of less than what is on the label. May be contaminated with other herbs, pesticides, metals, prescription drugs Get the Facts: Using Dietary Supplements Wisely. (2009) NCCAM Publication No D426

24. United States Pharmacopeia In existence since 1820 Not-for-profit organization Dedicated to setting public standards for quality of health care products Developed quality standards for dietary supplements in 2003  USP-verified™  Listed ingredients  Verify ingredients  Test for contaminants  Bioavailability  Good manufacturing processes

25. Summary of supplement regulation Manufacturer is responsible to ensure the product is safe before it is marketed. FDA is responsible to take action against unsafe products after they are on the market. Must prove it is unsafe first. Consumer and health providers complete volunteer problem reports. Manufacturers responsible for truthful product label information. FDA’s post marketing responsibility – monitor safety, volunteer adverse event reporting, product information, labeling, claims, package inserts and accompanying literature The Federal Trade Commission (FTC) regulates advertising – national, local magazines, radio, TV, internet, direct mail etc..

26. Unit 9 Project GradingPointsTime Table APA format/file10 In-text citations/reference list 20 Question 145Week 5 Question 230Week 6 Question 320Week 6-7 Question 450Week 5-9 Question 520Week 8-9 Question 615Week 8

27. Unit 9 Project Overview Question 1. Assess DB’s intake  Analyze 24 hour recall & show work (a,b)  Identify DB’s intake goals (c)  Compare DB’s intake to goals (d) Questions 2. Nutrient Deficiencies  List & describe current nutrient deficiency (a)  List and describe potential nutrient deficiency (b,c,d) Question 3. Pharmacotherapy issues  Identify pharmacotherapy issues for each medication

28. Unit 9 Project Overview Question 4. Create a 1 day meal plan  Identify calorie and % CHO, PRO, FAT goals  Identify timing for meals and snacks  Identify CHO goals for meals and snacks  Create a sample menu to match your goals  Complete a nutrient analysis on your menu Question 5. Describe how you would educate  DB on the meal plan you created and health maintenance recommendations. Question 6. Your counsel to DB regarding sale of her  prescription medications?

29. Unit 9 Project This week  Counsel client regarding prescription sales  Motivational interviewing Any questions?

30. Farewell Thank you for your kind attention and participation I have enjoyed having each one of you in class this term Any questions? Feedback  What worked?  What could be improved?