beyond cosmetics - personal care products...

Beyond Cosmetics

Medical Devices, Dietary Supplements, and Pet Cosmetics

Ivan Wasserman, Partner, Manatt, Phelps & Phillips, Washington, DC

Christopher T. Gassett, SVP & General Counsel, HSN, Inc. St. Petersburg, FL

Personal Care Products Council 2016 Legal and Regulatory Conference

1

Beyond Cosmetics | Manatt, Phelps & Phillips, LLP

2 First up…..

Cosmetic Devices


3 Food and Drug Administration


4 The Basics: What Is a Cosmetic?


“...(1) articles intended to be rubbed, poured, sprinkled, or

sprayed on, introduced into, or otherwise applied to the

human body or any part thereof for cleansing, beautifying,

promoting attractiveness, or altering the appearance, and

(2) articles intended for use as a component of any such

articles; except that such term shall not include soap.”

―[FD&C Act, section 201(i)]

5 What Is a Medical Device?


“...an instrument, apparatus, implement, machine, contrivance, implant,

in vitro reagent, or other similar or related article, including any

component, part, or accessory, which is …

(2) intended for use in the diagnosis of disease or other conditions, or in the

cure, mitigation, treatment, or prevention of disease, in man or other

animals, or

(3) intended to affect the structure or any function of the body of man or

other animals, and which does not achieve its primary intended purposes

through chemical action within or on the body of man or other animals and

which is not dependent upon being metabolized for the achievement of its

primary intended purposes.”

―[FD&C Act, section 201(h)]

6 So What Is a Cosmetic Device?

Devices used to cleanse or improve the appearance but do not effect the

structure or function of the body.

Examples:

– False eyelashes

– Artificial fingernails

– Loofahs

– Combs

Not regulated as medical devices by FDA. Regulated as consumer products

by Consumer Product Safety Commission.


7 Cosmetic Device or Medical Device: Which Is Which?

FDA will determine which bucket a product falls into by it’s “intended use”

Intended use can be established in a number of ways, but primarily by claims

stated in product labeling, advertising, including on the internet or in other

promotional materials.

Manufacturers and distributors must determine whether their products are

consumer products or medical devices before introducing them into the

market.

Distribution of medical devices is much more heavily regulated, of course!


8 Case Study: Rejuvenique



Product was a battery-operated electrical facial stimulator that applied

electrical current sequentially to various facial muscles, repeatedly

contracting them

Claims associated with the product were “typical” cosmetic claims:

– Creates a gradual reduction in the appearance of fine lines and wrinkles resulting in

a face that looks more youthful;

– That the first change people notice is the appearance of reduced puffiness

of your face;

– It tightens skin and provides increased skin elasticity;

– That lines that come when one grins will be fewer; and

– Wrinkles and bags around one’s eyes will seem less noticeable.



FDA Issued warning letter to Salton, Inc. in July 2000

First of its kind



FDA asserted that the claims indicated that the product was intended to affect

the structure of body

While it objected to some of the claims made, it focused on the way the

product was used

– “[B]ecause the Rejuvenique is intended to affect the structure or function of the

body by providing electrical current to various facial muscles to repeatedly contract

them, it is a device, even if no claims were made for its specific use.”

– “The Rejuvenique is similar in technology to a ‘powered muscle stimulator’ device

identified under 21 Code of Federal Regulations (CFR) 890.5850. The law requires

that manufacturers of medical devices obtain marketing clearance for their products

from the Food and Drug Administration (FDA) before they may offer them

for sale[.”]



510(k) approved in 2001

Indication:

21 CFR 882.5890 – Transcutaneous electrical nerve stimulator for pain relief

a) Identification. A transcutaneous electrical nerve stimulator for pain relief is a

device used to apply an electrical current to electrodes on a patient’s skin to

treat pain.

b) Classification. Class II (performance standards).

a) New Product Code: Stimulator, Transcutaneous Electrical, Aesthetic Purposes (21 CFR

§ 882.5890): NFO


“The Rejuvenique System is indicated for cosmetic use.”

13 Product Codes for Medical Devices

Stimulator, Transcutaneous Electrical, Aesthetic Purposes (21 CFR

§ 882.5890): NFO

Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic

Purposes (21 CFR § 882.5890): NYX

Laser, Comb, Hair (21 CFR § 882.5500): OAP

Light Based OTC Hair Removal (21 CFR § 882.4810): OHT

Light Based OTC Wrinkle Reduction (21 CFR § 882.4810): OHS

OTC Powered Light Based Laser For Acne (21 CFR § 878.4810): OLP

Laser, Cellulite Appearance (21 CFR § 878.4810): OYW

System, Microwave, Hair Removal: MWY

Epilator, high frequency, tweezer-type: KCX


14 FDA Warning Letters

January 3, 2013; Lightwave Technologies, LLC

Lightwave Deluxe L.E.D., the Lightwave Professional L.E.D., and the Lightwave Elite L.E.D.

Products had a 510(k) for:

– Red Light: dermatology, for treatment of superficial, benign vascular and pigmented lesions.

– Red and Blue Light combination: acne and periorbital wrinkles.

– Blue Light: moderately inflammatory acne

– Infrared Light: topical heating relief of minor muscle and joint pain, arthritis and muscle spasm; stiffness; relaxation of muscle tissue; and to temporarily increase local blood circulation

– Got in trouble for additional intended uses: treatment of stretch marks, cellulite, hair loss, and hair restoration

http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm335795.htm






15 FDA Warning Letters

January 9, 2015

Derma Pen, LLC

Manufacturer asserted that the product was a Class I micro-needling skin

dermabrasion device, exempt from premarket approval

FDA disagreed. The product was promoted as: The Dermapen is an

automated micro-needling device, with a disposable tip cartridge, that uses 11

micro-needles to vertically stamp the skin at high speed. The stamping action

of the Dermapen’s vertical tip creates micro-injuries to the skin, stimulating

new collagen production. In doing so, these micro-injuries encourage and

harness the body’s innate ability to regrow and repair the skin through normal

physiological processes. Dermapen is safe and as effective as a fractional

laser or intense pulsed light with a significantly short recovery period.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm4298

99.htm


http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm429899.htm

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm429899.htm

16 FDA General Wellness Device Guidance

January 2015: Draft Guidance on General Wellness Devices

Draft General Wellness Guidance states that the FDA does not intend to

regulate low-risk “general wellness products” as medical devices under the

FD&C Act

What is a general wellness product?

– A product that meets both of the following criteria:

It is intended only for general wellness use

It presents a very low risk to user safety


17 FDA General Wellness Device Guidance, cont.

What is a general wellness use?

– weight management,

– physical fitness, including products intended for recreational use,

– relaxation or stress management,

– mental acuity,

– self-esteem (e.g., devices with a cosmetic function that make claims related only to

self-esteem),

– sleep management,

– sexual function

– intended uses to promote, track, and/or encourage choice(s), which, as part of a

healthy lifestyle, may help to reduce the risk of certain chronic diseases

conditions; or

– intended uses to promote, track, and/or encourage choice(s) which, as part of a

healthy lifestyle, may help living well with certain chronic diseases or conditions.



When does a product present more than a very low risk to user safety?

– Must not present an inherent risk to user safety

If the product meets any of the following, the device is not “low risk”

– 1) is invasive;

– 2) involves an intervention or technology that may pose a risk to a user’s safety if

device controls are not applied, such as risks from lasers, radiation exposure, or

implants;

– 3) raises novel questions of usability; or

– 4) raises questions of biocompatibility.


19 FDA General Wellness Device Guidance – Examples

Exempt

– To promote or maintain a healthy weight, encourage healthy eating or assist with weight loss goals

– To promote relaxation or manage stress when there is no reference to anxiety disorders or other references to a disease or condition

– To address a specific body structure or function, such as increasing or improving muscle size or body tone, toning or firming the body or muscle, enhancing cardiac function, or enhancing or improving sexual performance

Not Exempt

– Sunlamp products promoted for tanning purposes (because of risks associated with exposure to ultraviolet radiation)

– Implants promoted for improved self image or sexual function (because of risk of rupture or adverse reaction to implant materials or implantation procedure)

– Lasers that claim to improve confidence in users’ appearance by rejuvenating the skin (because of risk of skin and eye burns, as well as usability considerations that may be addressed with labeling and other design controls)



Illustrative Example 5: A product is intended to mechanically exfoliate the

face, hands and feet to make the skin smoother and softer.

– This claim relates to self-esteem and does not refer to a specific disease or medical

condition, and thus is a general wellness claim. In addition, the technology for

exfoliating the face poses a low risk to the user’s safety as it does not penetrate the

stratum corneum. Therefore, this product meets both factors for a low risk general

wellness product.

– Note: However, if the product exfoliates the skin to enhance the delivery of a

topically applied product containing one or more active pharmaceutical ingredients

through the stratum corneum, the product would present inherent risks to the user’s

safety because of its invasive nature. Therefore, then, the product would not be a

low risk general wellness product.


21 Federal Trade Commission


22 Basic Advertising Law Principles

Advertising must be truthful and not misleading.

Claims must be substantiated before being made.

– Express, implied, comparative, efficacy, safety, “scientifically-proven”

Advertisements cannot be unfair (harm to consumers outweighs overall

benefit).


23 Side Note: Ab Belts

FTC v. Telebrands Corp

Settled January 2009

FTC asserted that claims that the abdominal device could

cause consumers to lose weight, inches, or fat and create

well-defined abdominal muscles were false and

unsubstantiated.

Marketers advertised “Ab Force” using visual images of well-

sculpted, gym-clothed bodies wearing the Ab Force device,

with verbal references to other, more expensive ab belts that

were sweeping the nation at the time.

– The FTC alleged that through the product name, text and visual

images, and by comparing their product to “those fantastic

electronic ab belt infomercials on TV,” the defendants made false

and unsubstantiated claims about the product’s abilities.

Marketers appealed all the way to the 4th Cir but lost

Telebrands eventually agreed to pay $7 million in customer

refunds to settle


24 FTC Medical App Case

Acne App Cases: AcneApp and Acne Pwner – October 2011

– Marketers advertised that their smartphone applications could treat acne with colored lights emitted from smartphones or mobile devices.

– Consumers were advised to hold the display screen next to the area of skin to be treated for few minutes daily while the app was activated.

– Alleged deceptions:

Lacked reasonable basis for claim that app effectively treats acne; and

Falsely claimed a study proved AcneApp effectively treats acne.

Settlements bar the marketers from making acne-treatment claims about their mobile apps and other medical devices, as well as the safety, performance, benefits, or efficacy claims about any device, without competent and reliable scientific evidence.

The two marketers of AcneApp also barred from misrepresenting research, tests, or studies.

Civil Penalties: Koby Brown and Gregory W. Pearson, doing business as DermApps, to pay $14,294, and Andrew N. Finkle, doing business as Acne Pwner, to pay $1,700.


25 Self Regulation

National Advertising Division

Electronic Retailing Self-Regulation Program

Voluntary participation

Can be anonymously initiated by competitors

Non-compliance could lead to referral to FTC


26

DERMAdoctor Photodynamic Therapy Laser Lotion

DERMAdoctor, Inc., NAD Case Report #5549, January 2013

Challenged claims:

– “With Photodynamic Therapy you get the same anti-aging red light treatment without the hassle of cumbersome light gadgets, costly doctor visits or post-procedure downtime.”

– “Simply apply this lotion for all day anti-aging benefits, including restoring radiance, minimizing the appearance of fine lines and wrinkles, evening out skin tone and improving elasticity.”

– “Photodynamic Therapy is a red light treatment, daily moisturizer and broad spectrum SPF 30 all-in-one.”

– “It is the new reality in light therapy.”

Decision: NAD recommended that the advertiser discontinue its unsupported claims: “With Photodynamic Therapy you get the same anti-aging red light treatment without the hassle of cumbersome light gadgets, costly doctor visits or post-procedure downtime” and “It is the new reality in light therapy.” NAD also recommended that the advertiser avoid conveying the message that consumers can achieve the same or similar anti-aging benefits from using the product as they would from doctor-administered light therapy treatments in future advertising.


27 Tanda Zap

Syneron Beauty, ERSP Case Report #288, March 2012.

Blue-light acne clearing device.

Challenged claims included:

– “Clears individual acne blemishes fast.”

– “No pain. No irritation. No dryness. And best of all no pimple.”

– “Tanda Zap - Official Site - FDA Approved - Dr Recommended”

– “Sonic vibration: Increases microcirculation to reduce swelling and inflammation while agitating the skin to expose more of the bacteria to the light.”

Challenger argued that though FDA had approved similar products via the 510(k) process, there was no evidence that Syneron had secured such approval for this particular product.

– Additionally argued that the addition heat and vibration to the product precluded it from relying in the prior products in the market for claim substantiation.

Interestingly, once the advertiser agreed to remove references to “FDA Approved,” ERSP had no further comments on whether it was in violation of FDA regulations, but rather focused on whether the individual claims were substantiated.

Concluded that majority of claims were adequately supported by submitted science, including several studies on blue light technology and a device materially similar to Tanda Zap.


28 iGrow Hair Rejuvenation System

Apira Science, ERSP Case Report #298, August 2012

Challenge to claims that product could help women and men with moderate

hair loss regrow hair

ERSP ultimately found most of the product claims to be substantiated (not

women!)


29 Consumer Product Safety Commission


30 Consumer Product Safety Commission

Independent federal regulatory agency created to protect the public from

unreasonable risks of injury associated with consumer products.

Jurisdiction over thousands of different consumer products under the

Consumer Product Safety Act

Must report to CPSC if you have information which suggests that your product

has a defect that creates a risk of injury.

Civil penalties of up to $15 million


31 Example: Conair BabyBliss Pro Hair Dryer Recall

Hazard: The spinning fan within the hair dryer can break apart, striking the

hair dryer’s plastic shell. This causes the plastic to shatter, creating a

laceration hazard.

Incidents/Injuries: Conair received 16 reports of the fan breaking causing the

plastic shell to shatter. The company also received reports of the hair dryers

sparking and smoking. One person sought medical attention for a laceration

to the hand, seven people reported minor cuts.


32 Next …

Dietary Supplements


33 Dietary Supplements

Must be “ingested”

Many ingredient/labeling requirements

Can claim to affect the “structure/function” of the body/skin

Structure/function claims:

– Reduces wrinkles

– Reduces cellulite

– Treats non-cystic acne

– Moisturizes skin

– Firms skin

– Weight loss


34 “Beauty From Within”


35 “Nutricosmetics”: Market Potential

Japan: Collagen Beauty Suppelments currently $2.3 billion

Beauty Supplements 21% overall in 2014

US: Fastest Growing Market 11.2% annual growth rate

Predicted US Sales: $7.4 billion by 2020

Source: Global Industry Analysts

Problem?? Consumer Acceptance


36 Enforcement

FTC 2003: Rexall Sundown Pays up to $12 Million to Settle Charges

“Cellasene” Cellulite Treatment Product

NAD: 2015: New Nordic “Skin Care Collagen Filler”


37 And finally ……

PET COSMETICS


38 FDA CPG Sec 653.100 “Animal Grooming Aids”

Grooming aid labeling bearing direct or implied therapeutic claims or

otherwise representing the product as a drug, such as by label reference to

the presence of an active ingredient, may be considered as a drug and

perhaps new animal drug as defined by Section 201(v) of the Act.

Grooming aids for animals formulated and labeled only to cleanse or beautify

the animal are not subject to the Federal Food, Drug, and Cosmetic Act.


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Beyond Cosmetics

Medical Devices, Dietary Supplements, and Pet Products

Ivan Wasserman, Partner, Manatt, Phelps & Phillips, Washington, DC

Christopher T. Gassett, SVP & General Counsel, HSN, Inc. St. Petersburg, FL

Personal Care Products Council 2016 Legal and Regulatory Conference

beyond cosmetics - personal care products...

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