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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.

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Presentation on theme: "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."— Presentation transcript:

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


3 For Consumers Hyperbaric 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 products likely regulatory status, and the claims you can make? a)During the planning phase. b)While tweaking the website with your marketing team in response to consumer demand. c)As soon as you have $1 million in revenue. d)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 shampoo Toothpaste with fluoride Antiperspirant deodorant SP50 moisturizer Cosmeceutical

10 1.How do I know if my product is a medical device? 2.How do I get the least burdensome regulatory route to market?

11 Device? (1)Is the product intended for use to cure, mitigate, treat, or prevent a disease? (2)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 1.Not a medical device – no regulation 2.Exempt device – no 510(k) 3.Substantially equivalent to a predicate device – submit 510(k) 1.Class 1: general controls 2.Class 2: general controls and special controls (e.g., performance standards, postmarket surveillance…) 4.No predicate device or Class 3 – submit PMA

19 Dietary Supplement Claims

20 Helps you sleepAcceptableStructure/function claim (like supports sleep). Soothing SleepAcceptableLabel must clarify that product is for the relief of occasional sleeplessness. Helps you sleep if you have difficult falling asleep UnacceptableImplies insomnia cure. Better sleepUnacceptableImplies insomnia cure.

21 Claims ClaimDisease Claim?ClaimDisease Claim? Supports weight loss NOTreats obesityYES Promotes restful sleep NOCures insomniaYES Reduces the desire to smoke NOProvides relief from nicotine addiction YES ****************** Claims (indications for use) matter! *****************

22 Claims ClaimAffects Structure or Function? ClaimAffects Structure or Function? Helps you become more confident NOImproves digestion YES Improves positive habits NOIncreases memory and intelligence YES Promotes good sleep NOStrengthens your nervous system YES

23 Claims

24 FTCUnfair & 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, Ive lost another 27 pounds.

28 Takeaways 1.The alphabet soup of government regulators is powerful. FDA (apples to apps) FTC (advertising) State Attorney General

29 Takeaways 2.Beware the Dark Side of marketing. A lot depends on intended use.

30 Takeaways 3.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 2 nd Arabian Gulf Cooperation Council (GCC) Conference on Traditional & Complementary Medicine CAM Therapie s Referrals to CAM Practitio ners Quirky ideas Integrati ve care (convent ional + CAM)

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

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