Blurring Lines: COSMETICS and DRUGS

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

robrf@focalpointresearch.net

© Focal Point Research Inc

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