Our Designer Future: How FDA Legal Issues Shape Human Health–

From Medical Devices to Mobile Apps

SoCal IPDecember 4, 2013

Michael H. Cohen, JD, MBA

Michael H. Cohen Law Group468 N. Camden Dr.

Beverly Hills, California 90210(310) 844-3173

www.michaelHCohen.com

Warning: This talk has

not been evaluated

by the FDA.

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

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?

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.

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.”

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.

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.

Drug, Cosmetic, or Medical Device?

Antidandruff shampoo

Toothpaste with fluoride

Antiperspirant deodorant

SP50 moisturizer

“Cosmeceutical”

1. How do I know if my product is a medical device?

2. How do I get the least burdensome regulatory route to market?

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?

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

Class of Device

• Device classification depends on • Intended use • Indications for use

• Objective test – shown by all advertising material.

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

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

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)

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”

1. Not a medical device – no regulation2. Exempt device – no 510(k)3. “Substantially equivalent” to a “predicate device” –

submit 510(k)1. Class 1: general controls2. Class 2: general controls and special controls (e.g.,

performance standards, postmarket surveillance…)4. No predicate device or Class 3 – submit PMA

Dietary Supplement

Claims

Dietary Supplement ClaimsHelps you sleep Acceptable Structure/function

claim (like “supports sleep”).

Soothing Sleep Acceptable Label must clarify that product is “for the relief of occasional sleeplessness.”

Helps you sleep if you have difficult falling asleep

Unacceptable Implies insomnia cure.

Better sleep Unacceptable Implies insomnia cure.

Claims

Claim Disease Claim? Claim Disease Claim?

Supports weight loss

NO Treats obesity YES

Promotes restful sleep

NO Cures insomnia YES

Reduces the desire to smoke

NO Provides relief from nicotine addiction

YES

****************** Claims (indications for use) matter! *****************

Claims

Claim Affects Structure or Function?

Claim Affects Structure or Function?

Helps you become more confident

NO Improves digestion

YES

Improves positive habits

NO Increases memory and intelligence

YES

Promotes good sleep

NO Strengthens your nervous system

YES

Claims

FTC—Unfair & Deceptive Practices

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

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!!!!”

• “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.”

Takeaways

1. The alphabet soup of government regulators is powerful.

• FDA (apples to apps) • FTC (advertising)• State Attorney General

Takeaways2. Beware the Dark Side of marketing. A lot

depends on intended use.

Takeaways3. Epistemological chaos reigns. “Deep

sleep” is ok but “better sleep” is not.

Brave New World

High-touch

High-tech

Emergent

Market Trends

High-touchHigh-tech

Emergent

2009

2013

2018

230 240 250 260 270 280 290

Total Market for Anti-Aging Products and Services (in Billions of U.S. $)

HealthVitalityWellnessYouth

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

CAM Therapie

s

Referrals to CAM Practitio

ners

Quirky ideas

Integrative care

(conventional + CAM)

Riyadh

Accelerating Technological Progress

Thank you SoCal IP!

Michael H. Cohen Law Group468 N. Camden Dr.

Beverly Hills, California 90210(310) 749-4029

www.michaelHCohen.com