Core content and concepts in drug marketing issues. Outlines FDA and FTC roles. Show marketing materials that go beyond the label. Supports info a reasonable doc would need to prescribe or recommend. From Dr. La Puma's seminar to attorneys and clients learning about dietary supplements and prescription drug marketing and labeling, as of February 2010.

1. © John La Puma, MD Weight Loss Drugs and Dietary Supplements: Labeling, Marketing and Usage John La Puma, MD, FACP Santa Barbara Institute for Medical Nutrition & Healthy Weight http://drjohnlapuma.com

4. © John La Puma, MD Conflict Notice Conflict notice: Dr. La Puma hosts "What's Cooking with ChefMD?" airing on Lifetime TV's "Health Corner" every Sunday at 930 a.m. EST/PST, 830 a.m. CST, since 2006. He wrote and earns royalties from the New York Times bestseller "ChefMD's Big Book of Culinary Medicine" ( http://tinyurl.com/34h8pm ). He co-authored and earns royalties from the Times Bestseller "RealAge Diet" and "Cooking the RealAge Way" with Dr. Michael Roizen, and contributed recipes to Dr Oz and Roizen's #1 "You the Owner's Manual."

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10. © John La Puma, MD Two Essential Marketing Concepts Learned Intermediary Fair Balance

12. photo (c) John La Puma, MD

14. © John La Puma, MD Rx Medications Used, Studied or Promoted Off-Label for Weight Loss 2. Byetta (exentatide injection)...for diabetes control

19. 21 Sample Dietary Supplement Structure and Function Claims Acceptable Unacceptable Maintains cardio function Protect against heart disease Promotes healthy cholesterol level Lowers cholesterol level Promotes healthy joints Reduces pain of arthritis Supports regularity, healthy intestinal flora Alleviates constipation; laxative Promotes urinary tract health Prevents urinary tract infections; improves urine flow in men over the age of 50; diuretic Supports the immune system Helps patients with reduced or compromised immune fxn Reduces stress and frustration Helps cognitive functioning in the elderly Improves absentmindedness Herbal Prozac

22. © John La Puma, MD Dietary Supplements Quality Problems Clinical Consequences with Spiking May have adverse effects *Phentermine, diethylpropion and phendimetrazine People with heart disease, high blood pressure, an overactive thyroid gland, or glaucoma should not use. *Sibutramine People with elevated blood pressure or at high risk for stroke should not take.

28. © John La Puma, MD Industry Response to DS “Marketing Materials that Go Beyond the Label” 4. Why are all materials = to the label? 5. The mandated required disclaimer protects free speech: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

31. © John La Puma, MD

33. (c) nyc.gov 35

34. © John La Puma, MD Thank you for attending! John La Puma, MD, FACP Santa Barbara Institute for Medical Nutrition & Healthy Weight http://drjohnlapuma.com