It’s Not Easy Being Green:
Ch ll
Challenges
and
d IInsights
i ht iinto
t
Safety and Clinical Testing of
Natural and Spa Products
Sarah Gilpin
Director, Clinical Safety and Microbiology
Ontario SCC-Education Day
Salon & Spa– Traditional & “Green” Alternatives
September 24th, 2009
• Aveda Corporation
– Launched in 1978 by Horst Rechelbacher as
a manufacturer of plant and flower based
beauty products
– Coined term “aromatherapy”
aromatherapy to emphasize
fragrance and essential oils
– Late 1990’s opened
p
salons,, lifestyle
y stores
and spas and expanded globally
– 1997 Aveda acquired
q
by
y Estee Lauder
• Aveda Corporation
– Located in Blaine, Minnesota- about 30 miles N. of Minneapolis
– Main campus houses all divisions including manufacturing,
fi
finance,
marketing,
k ti
creative,
ti
research
h and
dd
development,
l
t retail
t il
store, etc.
– 680 employees at corporate office and distribution center
– Over 5
5,200
200 salons in N
N. America
America, many more globally
– Over 2,300 spas in the US and many globally across the EU
(Benelux, Italy, UK) to Asia (Taiwan, Japan, Hong Kong, S.
Korea), and others
– 49 Aveda
A d Institutes,
I tit t
including
i l di one in
i British
B iti h C
Columbia
l bi and
d one iin
Melbourne, Australia
• Canadian Destination Spa
Ste. Anne's Country Inn &
Spa
Grafton Ontario,
Grafton,
Ontario Canada
Find this restorative spa an
hour and fifteen minutes east
of Toronto. A stone mansion,
guest houses and smaller,
more private lodging
populate the extensive
grounds—a full 570 acres—
sharing the land with natural
aquifers that offer up their
th
therapeutic
ti waters
t
for
f Aveda
A d
signature spa treatments. A
mud is created from the
waters, and it too is used in
designated spa sessions.
Noted for innovative
treatments and superb spa
cuisine
• How does one become a Director of Safety and
Mi bi l
Microbiology
att A
Aveda
d ((or other
th cosmetic
ti company)?
)?
• BY ACCIDENT!
•
My background
– BA in Biology, MPH in Environmental Health, PhD candidate in
Toxicology
– Worked for 10 yrs at Aveda in the product safety department
– Added oversight of microbiology about 6 months ago
– Main function is to oversee all aspects of product safety and
microbiology of finished products and raw materials
– Testing
g from microbial investigation
g
to safety-in-use
y
studies
– Reviewing product claims in regards to safety and micro and
providing substantiation when necessary
– Post-market surveillance
• Safety Testing
Testing- Why do it?
– To follow the law, “…each ingredient used in
a cosmetic product and each finished
cosmetic product shall be adequately
substantiated for safetyy prior to marketing…”
g
– To protect the company
– To serve our clients,, lead to repeat
p
sales
– To provide scientific integrity to public
p
perception
p
Snuff them out!
Scented candles
are bad for you,
says a new report.
Hurray! Now
women can give
them up! (UK Mail website)
FDA STUDY REAFFIRMS THE SAFETY OF LIPSTICK;
AGENCY SAYS TRACE LEAD LEVELS IN LIPSTICK NOT A
SAFETY CONCERN (PCPC industry alert)
Cosmetics Safety: What's in Your Makeup Bag?
Environmentalists warn the average woman's makeup bag is a
time bomb waiting
g to explode
p
with serious health
consequences. The cosmetic industry and the FDA say there's
nothing to fear. (WebMD website)
• Safetyy Testing
g of Natural Products- The Basics
– Review at ingredient level first- for naturals is
more complicated due to range of differences
i h
in
homogeneity,
i especially
i ll ffor aromas and
d
essential oils
– For new chemistries or proprietary raws
raws, need
to characterize and determine appropriate use
levels
• More challenging for volatiles, new preservatives,
colorants and “functional plant actives”
• A lot of the data is historical use (anecdotal)
• Example of raw material testing of “green”
green
ingredients
Abundance
Xanthorrhoea Preissii Leaf Oil
2000000
1800000
1600000
1400000
1200000
1000000
800000
600000
400000
200000
0
-200000
-400000
-600000
-800000
-1000000
-1200000
-1400000
-1600000
Xanthorrhoea Preissii Leaf Oil
w/Dipropylene glycol
-1800000
-2000000
-2200000
-2400000
-2600000
5.00
Time-->
10.00
15.00
20.00
25.00
30.00
35.00
40.00
45.00
50.00
55.00
60.00
• Safety Testing of Natural ProductsProducts The Basics
–After raw materials are characterized, move to finished formula
prototype dermal and ocular testing
–Non-animal
Non animal models
and human testing
• Safetyy Testing
g of Natural Products- The Basics
– Allergy testing next step- Very challenging with fragrances, essential oils
and botanicals
– 7th Amendment
Amendment- Labeling directive in EU on fragrance compounds;
0.001% in leave-on products and 0.01% in rinse-off products.
• Safetyy Testing
g of Natural Products- The Basics
– Safety-in-Use Testing with additional claims if requested
• Ophthalmologist Tested
• Dermatologist Tested
• Non-Acnegenic
• Professional Salon Studies- hair color, perms, scalp treatments
• Professional Facials
– Regimen skin care products targeted for specific skin types
– Often have up to 25 products used in one facial, “customized”
to each guest based on skin type, aroma preference, etc…
leads to 100’s of p
possible combinations- HOW TO TEST??
• Safetyy Testing
g of Spa
p and Natural p
products- Challenges
g
– Time
–
–
–
–
Cost- dermatologist/ophthalmologist tested claim
Aggressiveness of some product types- Heating Masque, Facial Scrub
Targeted populations- Increase cost and time to recruit, travel required
Professional estheticians or salon staff required, hard to find those who
will give up “chair” hours and income, need to train
– Space and equipment needed for professional studies
– Customization doubles or triples efforts, as does retail and professional
use for products
– Raw material supply
pp y is limited in some cases,, makes p
piloting
g and
therefore product acquisition for testing problematic
• Claims and Clinical Testing for Spa and Natural
Products- The Basics
– On site laboratory to quantitatively test finished
products and raw materials for performance on skin
and hair
– Hair studies use tresses to determine quantitative
effects for strength, moisture, UV Damage, color
fading, conditioning
– Skin studies use human volunteers (employees!) to
do on site instrumentation or take home testing
• Claims and Clinical Testing
g for Spa
p and Natural
Products- The Basics for Hair
Hair conditioning
Hair smoothing
Hair strength/ breakage resistance
Hair moisture
Hair elasticity
Product humidity resistance
Frizz prevention
Curl retention
Hair spray dry time
Color fade to UV exposure
Heat damage/damage prevention
Hair diameter
Color fade due to washing
Product build up
Appearance of product coating
Physical condition of hair cuticle
UV d
damage/damage
/d
prevention
ti
Claims and Clinical Testing for
Spa and Natural Products- The
Basics for Hair
Mean Percent Change in Total Work to Comb
0
-0.1
% Change
•
-0.2
-0.3
-0.4
-0.5
-0.6
Treatment
•
Claims and Clinical Testing for
Spa and Natural Products- The
Basics for Hair
• Claims and Clinical Testing
g for Spa
p and Natural
Products- The Basics for Skin
Skin elasticity
Skin firmness
Skin softness
Exfoliation
Skin oil/sebum
Wrinkle reduction
Acne
Sun damage
Skin redness
Blood flow
Barrier integrity
Moisture Loss
Claims and Clinical Testing for
Spa and Natural Products- The
Basics for Skin
Mean TEWL Readings
7.00E+00
6.00E+00
T EW L R ead in g s
•
Control
5.00E+00
4.00E+00
3.00E+00
2.00E+00
1.00E+00
0.00E+00
Baseline
30 Minutes Post-Treatment
Time
•
Claims and Clinical Testing for
Spa and Natural Products- The
Basics for Skin
• Claims and Clinical Testing
g for Spa
p and Natural
Products- Challenges
– Time
– Cost and upgrading of equipment, new probes, new software
– Technician training, GLP oversight of methodology and
validation
– Statistical expertise needed
– Space
S
and equipment needed
– Results have great dependence on environmental factors such
as humidity, temperature
– Validity of results to performance-strength of claims on a
statistical basis vs. reality to consumer
– Need to correlate to safety and sensory results, what trumps
what?
• Claims and Clinical Testing
g for Spa
p and Natural
Products- Challenges
NAD Urges Cessation of Botox-like
Botox like Claims for One Antiwrinkle Product
Posted: August 25, 2009
THE NATIONAL ADVERTISING DIVISION (NAD) OF THE COUNCIL OF
BETTER BUSINESS BUREAUS HAS RECOMMENDED THAT UNIVERSITY
MEDICAL PHARMACEUTICALS CORP. DISCONTINUE THE USE
ADVERTISING OF CLAIMS FOR THE COMPANY’S OTC PRODUCT,
WRINKLEFREE EYES.
FDA takes
increasingly
stern view
on
legitimacy of
cosmetics
claims
Drug Store
News, April
19 2004
19,
October 12, 2005
California law prohibits use of
'organic' label until standards are
set.
• Example of the use of a new natural material- TAMANU
Oil
–
–
–
–
New raw material,
material started looking at in 2002
Found and sourced directly
Helped company petition for an INCI name
Long history of traditional use, use for many topical skin
applications- burns, moisturization, sun protection
– Received samples and first had Aveda’s botanical research
group look at it for chemical make-up
• Example of the use of a new natural materialmaterial
TAMANU Oil
– Characterized as a fixed oil w/ linoleic acid and many
plant actives
– Tested for efficacy and to determine usage level via in
vitro assay
assay- found to be an antioxidant
antioxidant, also an anti
antiinflammatory
– Review of safetyy data- Vendor reports
p
showing
g low
risk of dermal irritation and low sensitization potential.
Aveda safety conducted studies as well.
– Determination made to allow for safe usage level
• Example of the use of a new natural
material- TAMANU Oil
– Evaluated for formulation and product
p
attributes in finished product. Found
applications in the following;
•
•
•
•
Barrier properties
Anti-acne
Hair conditioning
H i moisturizing
Hair
i t i i
– Tested in finished formulas
– Activity key to several successful products