10/31/2014 1 1 Overview of Cosmetics Reseacrh at FDA Nakissa Sadrieh, Ph.D. Director, Cosmetics Division, OCAC/CFSAN/FDA PCPC presentation October 2014 PCPC-October 2014 Outline • Cosmetics regulations in the US • Role of FDA research in the regulation of cosmetics • Examples of OCAC research Strategic planning for future OCAC research 2 PCPC-October 2014 • Used by most consumers every day • Examples: – Moisturizers, other skin preparations – Hair care, hair dyes, hair straighteners – Makeup, nail polishes – Shaving preparations – Perfumes and colognes – Toothpastes, mouthwashes – Face and body cleansers, deodorants – Tattoos • Multi-billion dollar industry • Increasingly global industry Cosmetics – Scope PCPC-October 2014 3
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10/31/2014
1
1
Overview of Cosmetics Reseacrh
at FDA
Nakissa Sadrieh, Ph.D.
Director, Cosmetics Division, OCAC/CFSAN/FDA
PCPC presentation October 2014
PCPC-October 2014
Outline
• Cosmetics regulations in the US
• Role of FDA research in the regulation of
cosmetics
• Examples of OCAC research
Strategic planning for future OCAC research
2 PCPC-October 2014
• Used by most consumers every day
• Examples: – Moisturizers, other skin preparations
– Hair care, hair dyes, hair straighteners
– Makeup, nail polishes
– Shaving preparations
– Perfumes and colognes
– Toothpastes, mouthwashes
– Face and body cleansers, deodorants
– Tattoos
• Multi-billion dollar industry
• Increasingly global industry
Cosmetics – Scope
PCPC-October 2014 3
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2
• Defined in the Federal Food, Drug, and
Cosmetic Act (FD&C Act), Section 201 (i)
• Articles intended for:
– Cleansing
– Beautifying
– Promoting attractiveness
– Altering the appearance
** Excludes “Soap” (alkali salt of fatty acid-CPSC)
Cosmetic
PCPC-October 2014 4
• Defined in FD&C Act, Section 201 (g)
• Articles intended
– For use in the diagnosis, cure, mitigation,
treatment, or prevention of disease
– To affect the structure or any function of
the body of man or other animals
Drug
PCPC-October 2014 5
• Cosmetics must not be adulterated or
misbranded
• The law does NOT provide for FDA pre-
market approval
• FDA’s authority is post-market only
Cosmetics – FDA’s Authority
PCPC-October 2014 6
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• OTC Drug – Monograph or product-
specific pre-market
approval required
– Pre-market evaluation of
safety & efficacy
– GMP regulations
– Establishments & products
must be registered
– Serious adverse events
must be reported
• Cosmetic – Pre-market approval not
required
– No pre-market clearance of
safety or efficacy
– GMP guidelines only
– Establishments & products
not required to be
registered
– Adverse events not
required to be reported
OTC Drug vs. Cosmetic
PCPC-October 2014 7
Requirements for Market • FDA Authority Over Cosmetics
o Under the FD&C Act, cosmetics must not be adulterated
(601) or misbranded (602)
o No pre-market approval of cosmetics, with the exception
of color additives
o Manufacturer bears responsibility for safety of marketed
products
o Manufacturer or distributors should have obtained all
data and information needed to substantiate the safety of
the product before marketing
8 PCPC-October 2014
• Limited legal authorities
• Competing agency priorities
• Significant changes in past 5-7 years – Manufacturing more global
– Alternatives to animal testing
– Increasingly sophisticated technology and complex ingredients
• Nanotechnology
• “Active” ingredients
• Botanicals
Cosmetics - Challenges
PCPC-October 2014 9
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• Safety Evaluation of ingredients
• Adverse Events evaluation and
analysis
• Compliance activities
• Development of Guidance and
Policies
• Research
Examples of Current Areas of
Emphasis
PCPC-October 2014 10
Importance of research in
OCAC • Because cosmetics do not have premarket review, FDA
depends on the following to carry out its mission:
– Published research
– Published position papers from international
regulators
– Industry publications
– Adverse events reports
– Enforcement actions
PCPC-October 2014 11
Cosmetics Research at FDA
A look at selected examples
12 PCPC-October 2014
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Reasons for doing cosmetics
research at FDA • To evaluate the safety of cosmetic ingredients