FDA Legal Issues Shape Future of Health Products

1. Our Designer Future: How FDA Legal Issues Shape Human Health–From Medical Devices to Mobile Apps SoCal IP December 4, 2013 Michael H. Cohen, JD, MBA Michael H. Cohen Law Group 468 N. Camden Dr. Beverly Hills, California 90210 (310) 844-3173 www.michaelHCohen.com

2. Warning: This talk has not been evaluated by the FDA.

3. For ConsumersHyperbaric Oxygen Therapy: Don't Be Misled Patients may be unaware that the safety and effectiveness of HBOT has not been established for these diseases and conditions, including: AIDS/HIV Alzheimer's Disease Asthma Bell's Palsy Brain Injury Cerebral Palsy Depression Heart Disease Hepatitis Migraine Multiple Sclerosis Parkinson's Disease Spinal Cord Injury Sport's Injury Stroke

5. Pop Quiz You have a product and a website in the health domain. How early should you get legal counsel and determine the product’s likely regulatory status, and the claims you can make? During the planning phase. While tweaking the website with your marketing team in response to consumer demand. As soon as you have $1 million in revenue. In response to a warning letter from the FDA.

6. FDA Practice Cosmetics: “Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Drugs: “Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”

7. Cosmetics v. Drugs Cosmetics No pre-marketing proof of safety or efficacy Labeling requirements Drugs FDA approval through NDA (proof of safety and effectiveness). Conform to OTC monograph (specify conditions where drug ingredients are generally recognized as safe and effective, and not misbranded.

8. Foods & Dietary Supplements Foods No pre-marketing proof of safety or efficacy Dietary Supplements Vitamins, minerals, amino acids, herbs Regulated like foods, not drugs (no NDA) Cannot make “disease claims” Calcium prevents osteoporosis Can make structure/function claims Calcium builds strong bones* * This statement has not been evaluated by the FDA *This product is not intended to diagnose, treat, cure or prevent any disease.

9. Drug, Cosmetic, or Medical Device?Antidandruff shampooToothpaste with fluorideAntiperspirant deodorantSP50 moisturizer“Cosmeceutical”

10. How do I know if my product is a medical device? How do I get the least burdensome regulatory route to market?

11. Device? Is the product intended for use to cure, mitigate, treat, or prevent a disease? Is the product intended to affect the structure, or function, of the body?

12. General Controls (Class I) Establishment registration Medical Device Listing Premarket Approval (PMA) if no predicate Premarket Notification 510(k), if predicate (unless exempt), or IDE (with clinical studies) Quality System (QS) regulation Labeling requirements Medical Device Reporting No adulteration or misbranding

13. Class of Device Device classification depends on Intended use Indications for use Objective test – shown by all advertising material.

14. Does Your Intended Use Make Your Product a Medical Device Product What it does Claims Classification Materials CDRH Classification Database FDA Device Classification Panels FDA Guidance documents Warning Letters

15. Type of product and what it does Examples of objectionable claims: Acne and skin problems Birth Control Control of Allergies Emotional health Enuresis Hair loss Hearing Loss High blood pressure Hyperactive children *or Adults* Improving vision Insomnia Menstrual Control Migraine headaches Pain Control Psychic healing Wart Removal

16. Device? Intended to affect the bodily function of sleeping Intended to alleviate insomnia Could divert consumers from medication Even though consumers testified product was ineffectual! U.S. v. 23, More or Less, Articles, etc., 192 F.2d 308 (2d Cir. 1951)

17. Medical Device Claims Smoking cessation “Reducing the desire to smoke” – acceptable, if does not imply treatment of nicotine addiction, relief of nicotine withdrawal symptoms, or prevention or mitigation of tobacco-related illnesses. “Smoking cessation”— implies treatment of nicotine and is therefore a disease claim (=device). “can help you reduce or quit smoking habits”

18. Not a medical device – no regulation Exemptdevice – no 510(k) “Substantially equivalent” to a “predicate device” – submit 510(k) Class 1: general controls Class 2: general controls and special controls (e.g., performance standards, postmarket surveillance…) No predicate device or Class 3– submit PMA

19. Dietary SupplementClaims

20. Dietary Supplement Claims

21. Claims

22. Claims

23. Claims

24. FTC—Unfair & Deceptive Practices

25. US - No False Advertising All advertising claims must be substantiated by “competent and reliable evidence.” - US FTC

26. FTC - Substantiation Competent & reliable scientific evidence. “Nighttime magnetic field therapy has a calming and sleep inducing effect on the brain and body due to stimulating production of melatonin, an anti-stressful, anti-aging and anti-infections hormone.” “Neptune Reducing Cream drops pounds and inches from your thighs!!!!”

27. “Today, there exists a safe, all-natural, bio-active weight loss compound so powerful, so effective, so relentless in its awesome attack on bulging, fatty deposits that it has virtually eliminated the need to diet.” “Take it off! And keep it off!” “This product blocks fat before your body absorbs it; the pounds will melt away effortlessly.” “I lost nine pounds during my first week eating just as I always do — going to parties, even eating gobs of vacation goodies, including my favorite food: ice cream. Four weeks later, I’ve lost another 27 pounds.”

28. Takeaways The alphabet soup of government regulators is powerful. FDA (apples to apps) FTC (advertising) State Attorney General

29. Takeaways Beware the Dark Side of marketing.A lot depends on intended use.

30. Takeaways Epistemological chaos reigns. “Deep sleep” is ok but “better sleep” is not.

31. Brave New World High-touch High-tech Emergent

32. Market Trends High-touch High-tech Emergent Health Vitality Wellness Youth

33. The 2nd Arabian Gulf Cooperation Council (GCC) Conference on Traditional & Complementary Medicine

34. Riyadh

35. Accelerating Technological Progress

36. Thank you SoCal IP! Michael H. Cohen Law Group 468 N. Camden Dr. Beverly Hills, California 90210 (310) 749-4029 www.michaelHCohen.com