beyond cosmetics - personal care products...
Post on 18-Mar-2020
0 Views
Preview:
TRANSCRIPT
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
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
3 Food and Drug Administration
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
4 The Basics: What Is a Cosmetic?
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
“...(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?
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
“...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.
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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!
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
8 Case Study: Rejuvenique
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
9 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.
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
10 Case Study: Rejuvenique
FDA Issued warning letter to Salton, Inc. in July 2000
First of its kind
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
11 Case Study: Rejuvenique
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[.”]
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
12 Case Study: Rejuvenique
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
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
“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
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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.
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
18 FDA General Wellness Device Guidance, cont.
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.
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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)
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
20 FDA General Wellness Device Guidance, cont.
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.
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
21 Federal Trade Commission
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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).
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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.
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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.
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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.
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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!)
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
29 Consumer Product Safety Commission
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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.
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
32 Next …
Dietary Supplements
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
34 “Beauty From Within”
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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”
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
37 And finally ……
PET COSMETICS
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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.
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
39
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
40
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
41
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
42
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
43
Beyond Cosmetics | Manatt, Phelps & Phillips, LLP
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
top related