Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

Dietary Supplements Efficacy, Safety and Regulations


Published on

The use of dietary supplements increased in the last decade to maintain or improve health or specifically to supplement a vitamin deficiency, lose weight, or support organ function. Mostly, consumers believing them to be more natural, potent or safer than pharmaceutical drugs. However, that it not always the case. The current FDA Dietary Supplement regulations do not require premarketing efficacy and safety studies of any dietary supplement product. I will explore these issues in some details in my lecture.

Published in: Health & Medicine
  • Be the first to comment

Dietary Supplements Efficacy, Safety and Regulations

  1. 1. Introduction to Dietary Supplements: Efficacy, Safety and Regulations Ali Alhammad PhD Student President, VCU-ISPOR Chapter Department of Pharmacotherapy and Outcome Sciences School of Pharmacy, VCU Saudi Student Organization (SSO) April 8, 2011
  2. 2. Overview <ul><ul><li>Overview of Dietary Supplements (DSs) </li></ul></ul><ul><ul><li>Overview of DS Efficacy </li></ul></ul><ul><ul><li>Overview of DS Safety </li></ul></ul><ul><ul><li>Overview of DS Regulations </li></ul></ul><ul><ul><ul><li>Dietary Supplement Health and Education Act (DSHEA) </li></ul></ul></ul><ul><li>How to get the high quality DS </li></ul><ul><li>Conclusions </li></ul>
  3. 3. Introduction <ul><li>How many of you are currently taking a dietary supplement? </li></ul>
  4. 4. What is A Dietary Supplement (DS) <ul><li>Before 1994, no official definition of DS </li></ul><ul><li>Dietary Supplement Health and Education Act (DSHEA) definition of a dietary supplement: “a product take by mouth that contains a ‘dietary ingredient’ intended to supplement the diet …[may include]…vitamins, minerals, herbs , botanicals, amino acids, enzymes, extracts…” </li></ul>
  5. 5. Types of DS <ul><li>Vitamins </li></ul><ul><li>Minerals </li></ul><ul><li>Botanicals (herbal) </li></ul><ul><li>Sports nutrition supplements </li></ul><ul><li>Weight management products </li></ul><ul><li>Specialty supplements </li></ul>
  6. 6. Forms of DS <ul><li>Capsules </li></ul><ul><li>Softgels </li></ul><ul><li>Tablets </li></ul><ul><li>Liquids/tinctures </li></ul><ul><li>Powders </li></ul><ul><li>Bars </li></ul><ul><li>Beverages </li></ul>
  7. 7. What is DS <ul><li>Distinguished from Drugs : </li></ul><ul><ul><li>Drug = article intended to diagnose, cure, treat, or prevent disease </li></ul></ul><ul><ul><li>Both intended to affect structure and function of body </li></ul></ul><ul><ul><li>Drug must undergo FDA approval </li></ul></ul>
  8. 8. What is DS <ul><li>Distinguished from Foods : </li></ul><ul><ul><li>Foods not intended to affect structure and function </li></ul></ul><ul><ul><li>DS intended only to supplement diet </li></ul></ul><ul><ul><li>Not for use as conventional food (a meal or the diet) </li></ul></ul><ul><ul><li>No premarket approval </li></ul></ul><ul><ul><li>No premarket testing </li></ul></ul>
  9. 9. Growth in DSs Use <ul><li>Increased cost and consumer dissatisfaction with conventional health care </li></ul><ul><li>More people have turned to herbal medicine and ‘natural’ treatment options than to traditional medical treatment </li></ul><ul><li>½ of US population use DS </li></ul><ul><li>Herbal use increased by 380% from 1990-1997. </li></ul><ul><li>Eisenberg DM et al. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA 1998;280:1569-75. </li></ul>
  10. 10. <ul><li>In 2007, the global sales approximately $53.4 billion </li></ul><ul><ul><li>In 2006, $51 billion (4.7%) </li></ul></ul><ul><ul><li>In 1997, $38.5 billion (38.7%) </li></ul></ul><ul><ul><li>Asia Pacific region, $22.6 billion (44.2% market share) </li></ul></ul><ul><ul><li>North American , $16.4 billion (32.2% market share) </li></ul></ul>Growth in DSs Use Hartmon Group Phase III National Study
  11. 11. Effectiveness
  12. 12. Commonly used DS <ul><li>St. John’s Wort </li></ul><ul><li>Echinacea </li></ul><ul><li>Ginseng </li></ul><ul><li>Garlic </li></ul><ul><li>Ginkgo </li></ul>
  13. 13. St. John’s Wort <ul><li>Most scientifically studied herbal supplement on the </li></ul><ul><li> market over the last 20 years </li></ul><ul><li>Uses: </li></ul><ul><ul><li>Anxiety </li></ul></ul><ul><ul><li>Bed-wetting, Bronchial inflammation, Burns, Cancer, Depression, Hemorrhoids, Insect bites, Insomnia, Kidney disease, Scabies, Digestive issues, Wound healing </li></ul></ul><ul><li>Interactions: </li></ul><ul><ul><li>Allergy medications, alcohol, amphetamines, antidepressants called MAOIs and tricyclics,Desyrel®, and oral contraceptives/pregnancy </li></ul></ul><ul><li>Side Effects: </li></ul><ul><ul><li>Allergic reactions, constipation, dizziness, dry mouth , restlessness, sensitivity to sunlight, stomach upset, sleep disturbances </li></ul></ul>
  14. 14. Echinacea <ul><li>Also among the most-studied herbs with St. John’s Wart </li></ul><ul><li>Said to stimulate the body’s immune system </li></ul><ul><li>Uses: </li></ul><ul><ul><li>Antibacterial, Antiviral, Blood Cleanser, Skin wounds </li></ul></ul><ul><li>Interactions: </li></ul><ul><ul><li>Allergic Reaction to any of its parts </li></ul></ul><ul><li>Side Effects: </li></ul><ul><ul><li>Fairly well-tolerated </li></ul></ul>
  15. 15. Ginseng <ul><li>Ancient Chinese herb used for over 2000 years and known as the ‘ultimate herb’ among most herbalists </li></ul><ul><li>Used by about 6 million Americans regularly </li></ul><ul><li>Uses: </li></ul><ul><ul><li>sleep aid, depression, diabetes </li></ul></ul><ul><ul><li>liver problems, energizer, healing, enhancer of physical and mental performance, resists stress, improves mental concentration </li></ul></ul><ul><li>Interactions: </li></ul><ul><ul><li>anti-hyperglycemia drugs (Insulin, Amaryl®),MAOIs, and stimulants like coffee and teal </li></ul></ul><ul><li>Side Effects: </li></ul><ul><ul><li>chest/breast pain, diarrhea, </li></ul></ul><ul><ul><li>headache, hypertension(high blood pressure), insomnia, </li></ul></ul><ul><ul><li>impotence, itching, nausea, nervousness </li></ul></ul>
  16. 16. Ginkgo <ul><li>Very old botanical [200 million years ago] </li></ul><ul><li>May be the most popular herbal in the world as it comes specifically as a standardized extract world-wide </li></ul><ul><li>Uses: </li></ul><ul><ul><li>Asthma, blood vessel disease, poor memory </li></ul></ul><ul><ul><li>dementia, inner-ear disorders, improving brain function, impotence treatment, premenstrual syndrome, macular degeneration, Alzheimer's (via increased mental alertness) </li></ul></ul><ul><li>Interactions: </li></ul><ul><ul><li>Coumadin and Aspirin </li></ul></ul><ul><li>Side Effects: </li></ul><ul><ul><li>Digestive upset (diarrhea, gas, nausea), </li></ul></ul><ul><ul><li>headache, seizures, skin irritation, </li></ul></ul><ul><ul><li>unusual bleeding or bruising </li></ul></ul>
  17. 17. Ginkgo
  18. 18. Performance Enhancing Supplements <ul><li>Amino Acid powders/Protein drinks </li></ul><ul><li>Creatine </li></ul><ul><li>Anabolic Steriods </li></ul>
  19. 19. Amino Acids <ul><li>Amino Acids are building blocks </li></ul><ul><li>of proteins </li></ul><ul><li>Powder form for sport performance/body building </li></ul><ul><li>20 different amino acids </li></ul><ul><li>Get varying amounts from protein containing foods </li></ul><ul><ul><li>Animal products, grains, legumes </li></ul></ul>
  20. 20. Amino Acids <ul><li>Increases muscle size </li></ul><ul><ul><li>Weight gain </li></ul></ul><ul><ul><li>Must have training along with supplement </li></ul></ul><ul><ul><li>Will not make you look like a body builder unless you have type of body to do so. </li></ul></ul><ul><li>Side Effects: </li></ul><ul><ul><li>Well-tolerated </li></ul></ul><ul><ul><li>Stomach cramping, diarrhea, weight gain </li></ul></ul>
  21. 21. Creatine <ul><li>Phospho creatine for energy </li></ul><ul><ul><li>ATP -> Phosphocreatine -> Glucose -> Fat </li></ul></ul><ul><ul><li>Best used in sports/events needing short bursts of energy </li></ul></ul><ul><ul><ul><li>Sprinting </li></ul></ul></ul><ul><ul><ul><li>Wrestling </li></ul></ul></ul><ul><ul><ul><li>Shot put </li></ul></ul></ul><ul><li>Side Effects </li></ul><ul><ul><li>Nausea </li></ul></ul><ul><ul><li>Cramping </li></ul></ul><ul><ul><li>Diarrhea </li></ul></ul><ul><ul><li>Stomach pain </li></ul></ul>
  22. 22. Anabolic Steroids <ul><li>Synthetic form of testosterone </li></ul><ul><ul><li>Gels </li></ul></ul><ul><ul><li>Tablets </li></ul></ul><ul><ul><li>Injections </li></ul></ul><ul><ul><li>Patches </li></ul></ul><ul><li>Build muscle </li></ul><ul><li>3 million people use steroids, 1 in 4 started as teens </li></ul><ul><li>Side Effects </li></ul><ul><ul><li>Slow bone growth </li></ul></ul><ul><ul><li>Permanently short stature </li></ul></ul><ul><ul><li>Heart damage </li></ul></ul><ul><ul><li>Liver damage </li></ul></ul>
  23. 23. Safety of DS
  24. 24. Safety of DS <ul><li>Around 60% of people do not disclose their use of DS </li></ul><ul><li>DS-Drug Internactions </li></ul>
  25. 25. DS Purity <ul><li>Arpund 25% of DS are contaminated with heavy metals, steroids and/or medications </li></ul><ul><li>FDA imposed new regulations in June 2007 that DS must be: </li></ul><ul><ul><li>Produced in a quality manner </li></ul></ul><ul><ul><li>Free of contaminants or impurities </li></ul></ul><ul><ul><li>Accurately labeled </li></ul></ul><ul><li>Manufacturers are required to test all ingredients to ensure quality </li></ul>
  26. 26. Combining Supplements <ul><li>Additive or 1+1=2 </li></ul><ul><ul><li>When two supplements are combined so the effect = DS1 + DS2 (Calcium and Vitamin D) </li></ul></ul><ul><li>Antagonize or 1+1=0 </li></ul><ul><ul><li>When one supplement negates the effects so DS1 + DS2 = 0 (Creatine and Caffeine) </li></ul></ul><ul><li>Synergize or 1+1=3 </li></ul><ul><ul><li>When two supplements are combined so the effect > DS1 + DS2 (Coenzyme Q10 and fat) </li></ul></ul><ul><li>Potentiate or 1+1 = 10 </li></ul><ul><ul><li>Similar to synergism, but to a greater degree </li></ul></ul>
  27. 27. Choosing Supplements <ul><li>Supplements should be clearly labeled with “Seals of Approval” </li></ul><ul><li>It should be stamped </li></ul>
  28. 28. Supplements to Avoid <ul><li>Steroids and Steroid-Enhancers </li></ul><ul><ul><li>Linked to liver toxicity, testicular shrinkage, and increased risk of heart attack and stroke </li></ul></ul><ul><li>Valerian </li></ul><ul><ul><li>Sold as a sleep aid </li></ul></ul><ul><ul><li>Can be dangerous when mixed with alcohol </li></ul></ul><ul><li>Ephedra </li></ul><ul><li>Kava Kava </li></ul><ul><ul><li>Linked to liver damage and liver failure! </li></ul></ul><ul><ul><li>Banned in European countries and Canada </li></ul></ul><ul><li>St Johns Wort </li></ul><ul><ul><li>Interferes with a huge number of medications </li></ul></ul><ul><ul><li>Safety warnings posted in other countries </li></ul></ul>
  29. 29. Some Products without Legitimate Evidence to Support Claims <ul><li>Boron </li></ul><ul><li>Garcinia </li></ul><ul><li>Cambogia </li></ul><ul><li>Nitric Oxide </li></ul><ul><li>Carnitine </li></ul><ul><li>Ginkgo Biloba </li></ul><ul><li>Pycnogenol </li></ul><ul><li>Ginseng </li></ul><ul><li>Glutamine </li></ul><ul><li>Yohimbe </li></ul><ul><li>Whey Protein </li></ul>
  30. 30. Potentially Useful Supplements <ul><li>Omega-3 Fatty Acids </li></ul><ul><li>Quercetin dihydrate </li></ul><ul><li>CoEnzyme Q10 </li></ul><ul><li>Glucosamine/ Chondroitin Sulfate </li></ul><ul><li>Adaptogens </li></ul><ul><li>HMB </li></ul><ul><li>Creatine </li></ul><ul><li>Pre-Probiotics </li></ul><ul><li>Zinc </li></ul>
  31. 31. Regulation of DS
  32. 32. History of Dietary Supplements <ul><li>1994 President Clinton signed Dietary Supplement, Health and Education Act (DSHEA) into law </li></ul>
  33. 33. Regulation of DS <ul><li>Unlike drugs </li></ul><ul><ul><li>DS do not have to be proved safe before going on the market </li></ul></ul><ul><ul><li>federal authorities can act to take them off the shelves if they are shown to be unsafe </li></ul></ul><ul><li>Before drugs or food additives go on the market </li></ul><ul><ul><li>hundreds of research studies must be submitted to the FDA for review of the product’s efficacy. </li></ul></ul>
  34. 34. FDA Enforcement Authority <ul><li>FDA bas the “Burden of Proof” </li></ul><ul><ul><li>Must prove that product is “unsafe” </li></ul></ul><ul><li>After DSHEA, no FDA enforcement unless can prove supplement is “ unsafe ” </li></ul><ul><ul><li>(significant or unreasonable risk of injury) </li></ul></ul><ul><li>FDA must provide 10 days notice before initiating civil proceeding </li></ul><ul><ul><li>Whose idea was this!!!!!!!!!!! </li></ul></ul>
  35. 35. <ul><li>Congress passed DSHEA in 1994 on the basis of two quite questionable assumptions: that supplements are basically harmless, and that supplement makers are honest. </li></ul><ul><li>-Marion Nestle, RD </li></ul><ul><li>Professor of Nutrition, Food Studies, and Public Health at New York University </li></ul>
  36. 37. <ul><li>DSHEA authorized to provide accurate information to consumers </li></ul><ul><li>Label must include: </li></ul><ul><ul><li>Name of each ingredient </li></ul></ul><ul><ul><li>Quantity of each ingredient </li></ul></ul><ul><ul><li>Total weight of all ingredient if a blend </li></ul></ul><ul><ul><li>Identity of part of plant derived from </li></ul></ul><ul><ul><li>Term “ Dietary Supplement ” </li></ul></ul><ul><li>Must contain nutritional labeling information also </li></ul><ul><ul><li>Calories, fat, sodium </li></ul></ul>Labeling of Dietary Supplements
  37. 38. Labeling of Dietary Supplements
  38. 39. <ul><li>DSHEA authorized use of FDA approved “Health claims” on label </li></ul><ul><li>Describe the connection between a nutrient or food substance and a disease or health-related condition </li></ul><ul><ul><li>( diet/disease relationship) </li></ul></ul><ul><li>Statements may be included on the label that give the manufacturers description of the role of the D/S </li></ul><ul><ul><li>Not authorized by FDA </li></ul></ul><ul><ul><li>Manufacturer resp. for accuracy and truth of statement </li></ul></ul>Health Clams
  39. 40. FDA Approved Health Claims <ul><li>Folic acid and neural tube pregnancies </li></ul><ul><li>Calcium and osteoporosis </li></ul><ul><li>Sodium and hypertension </li></ul><ul><li>Fruits and vegetables and cancer </li></ul><ul><li>Dietary lipids and cancer </li></ul><ul><li>Saturated fat and cholesterol and coronary artery disease </li></ul>
  40. 41. Structure and Function Claims <ul><li>Manufacturers may use S/F claims </li></ul><ul><ul><li>Not authorized by FDA </li></ul></ul><ul><li>Must be true and not misleading </li></ul><ul><li>Must be accompanied by disclaimer </li></ul><ul><ul><li>“ This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease” </li></ul></ul><ul><li>Examples: </li></ul><ul><ul><li>“ Calcium builds strong bones” </li></ul></ul><ul><ul><li>“ Antioxidants maintain cell integrity ” </li></ul></ul>
  41. 42. Other Claims: <ul><li>Health-maintenance claims: </li></ul><ul><ul><li>“ Maintains healthy circular system” </li></ul></ul><ul><li>Non-disease claims: </li></ul><ul><ul><li>“ helps you relax” </li></ul></ul><ul><ul><li>“ for muscle enhancement” </li></ul></ul><ul><li>Cannot make maintenance claims about osteoporosis and other “serious diseases” </li></ul><ul><li>Can make health claim about relationship between a product or substance and the disease if approved </li></ul>
  42. 43. How To Choose…
  43. 44. How To Choose…
  44. 45. How To Choose… <ul><li>Look for standardized supplements (USP) </li></ul>
  45. 46. How To Choose… <ul><li>Consult doctor and your pharmacist </li></ul>
  46. 47. Single name supplements <ul><li>Buy only single-name supplements </li></ul>
  47. 48. Too Good to be True <ul><li>Be aware of claims that sound too good to be true </li></ul>
  48. 50. Question???? <ul><li>How many of you are currently taking a supplement? </li></ul>
  49. 51. Summary <ul><li>Not food, not drug </li></ul><ul><li>Supplements not meant to replace foods, but to supplement diet </li></ul><ul><li>Broadly definition under DSHEA (1994) </li></ul><ul><li>No premarket approval </li></ul><ul><li>Must be labeled as “Dietary Supplements” </li></ul><ul><ul><li>“ If it doesn’t have a side effect, it probably doesn’t work.” </li></ul></ul>