blurring lines: cosmetics and drugs
TRANSCRIPT
Blurring Lines:
COSMETICS and DRUGSRobert Ross-Fichtner
CAPRA
November 26, 2015
What’s a cosmetic?
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Definition: any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes.
What’s a drug?
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Definition: according to the Food and Drug Act, a drug includes any substance or mixture of substances manufactured, sold or represented for use in:
• the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or the symptoms thereof in man or animal
• restoring, correcting or modifying organic functions in man or animal, or disinfection in premises in which food is manufactured, prepared or kept
Historically…..
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Historically…..
COSMETICS:
Shampoo
Lipstick
Powders
Wrinkle Cream
Nail Polish
Fragrance
“THERAPEUTIC”:
Acne
SPF
Medicated Skin Cream
Antiperspirant
Anti-dandruff
Anti-caries
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Ancient History………..
Cosmetic “Actives”
0.000000000001 %
+
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Cosmetics
How much regulation
should they have????
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How Much Regulation?
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Cosmetics… How much regulation ??
Regulation = F(risk)
Answer this question:
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Cosmetics
How Safe do you feel buying cosmetics?
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Worldwide……
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How Adequate are the World’s Cosmetic Regulations?
How Much Regulation for Cosmetics?
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Regulation = F(risk)
Compare:
Canada
US
EU
China
How Much Regulation for Cosmetics?
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Canada
Hot List
Mandatory Notification
CEPA
Enforcement
How Much Regulation for Cosmetics?
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United States
FDA
States
Counties
+… TWO (Yes 2) new bills in DC
California
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• Risk of cosmetics:
California
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Risk of cosmetics:
…significant
California Safe Cosmetics Act
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“Given the presence of substances in cosmetic products that cause cancer and reproductive toxicity, the heavy use of these products by women of childbearing age, the significant exposure to these products in occupational settings such as nail and beauty salons, the adverse impacts of these substances on human health, the inadequate information about the…..”
How Much Regulation for Cosmetics?
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European Union
Product Information File =? Drug Master File?
Includes……..Full tox assessment
China
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Regulation = F(risk)
Chinese FDA:
3+1 classes
Subpopulations: Pregnant and Lactating
A whole new risk paradigm???
Again…..Worldwide……
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How Adequate are the World’s Cosmetic Regulations?
Answer: We don’t know,
they are all different.
NGOs
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NGOs
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New Technology
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How Much Regulationfor Cosmetics?
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Animal Testing BansHow to assess tox?
Historically…..COSMETICS:
Shampoo
Lipstick
Powders
Wrinkle Cream
Nail Polish
Fragrance
“THERAPEUTIC”:
Acne
SPF
Medicated Skin Cream
Antiperspirant
Anti-dandruff
Anti-caries
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Today…..
COSMETICS:
Shampoo
Lipstick
Powders
Wrinkle Cream
Nail Polish
Fragrance
“THERAPEUTIC”:
Collagen--Plant stem cell
Wrinkles--Radiation
emitting devices
Up/down regulate
melanocytes
mRNA--alter DNA
processes
Hair, eyelash growth
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How Much Regulationfor Cosmetics?
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Regulation = F(risk)
F&D Act
“Drug = restoring, correcting or modifying
organic functions in man …”
How close have cosmetics come?
How Much Regulationfor Cosmetics?
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Regulation = F(risk)
NHPs: 3 Classification
Medical Devices: 4 Classifications
Cosmetics???????
How Much Regulationfor Cosmetics?
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More…..but….how much more?
Global Harmonization?
The Secret:
Regulation = F(risk)
Thank You!
Robert Ross-Fichtner
Focal Point Research Inc.Tel: 905-271-2709 ext 222
© Focal Point Research Inc
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