4/5/11 1 Evaluation of Cosmeceutical Ingredients: What the Label May Not Reveal Patrick Bitter, MD Regulation of Topical Skin Care Products • US Food and Drug Administration (FDA) recognizes two categories of products affecting skin conditions – Pharmaceutical – Cosmetic Pharmaceutical • Intended for use in diagnosis, mitigation, or prevention of disease or intended to affect structure or any function of the body
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5)Evaluation of Cosmeceutical Ingredients 2011...4/5/11 1 Evaluation of Cosmeceutical Ingredients: What the Label May Not Reveal Patrick Bitter, MD Regulation of Topical Skin Care
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1
Evaluation of Cosmeceutical Ingredients: What the Label
May Not Reveal Patrick Bitter, MD
Regulation of Topical Skin Care Products
• US Food and Drug Administration (FDA) recognizes two categories of products affecting skin conditions – Pharmaceutical – Cosmetic
Pharmaceutical
• Intended for use in diagnosis, mitigation, or prevention of disease or intended to affect structure or any function of the body
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Topical Pharmaceutical
• Drugs that penetrate stratum corneum into epidermis
• Have measurable effect on structure and function of skin
Topical Pharmaceuticals
• FDA approval requires proof of effectiveness by double-blind randomized prospective controlled clinical trials
• Product development costs $250 million and takes 7-12 years
Over the Counter Medicines/Skin Care Products
• Use of ingredients at specific concentration ranges can be claimed to treat specific conditions
• Article intended to rubbed, poured, sprinkled, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting structure or function
• Not required to prove marketing claims or conduct safety studies
Cosmeceuticals
• Cosmetic product in which the active ingredient is meant to have a beneficial physiological effect due to an enhanced pharmacological action when compared with an inert cosmetic
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Cosmeceuticals
• Term coined by Albert Kligman MD • Effective cosmeceuticals incorporate a
variety of active ingredients known to impact the pathogenesis of photoaging in a positive way
• Measurable biological action in the skin, but is regulated as a cosmetic because if affects appearance
FDA Position: Cosmeceuticals
• “While the Food, Drug, & Cosmetic Act does not recognize the term ‘cosmeceutical’, the cosmetic industry uses this word to refer to cosmetic products that have medicinal or drug like effects”
Classification Summary
• Cosmetics – Defined and categorized by the FDA
• Pharmaceuticals – Defined and categorized by the FDA
• Cosmeceuticals – Not defined by FDA – Not recognized by FDA as cosmetics – No legal meaning for FDA
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Is This A Good Thing or Bad Thing?
GOOD • Strict interpretation of
Cosmetic act would virtually classify all topical preparations as drugs, which would be detrimental
• Cost to bring product to market via FDA approval costs $250-500 million
BAD • Not necessary to prove
efficacy or safety even when it contains active ingredient that may impact the condition of the skin
Fair Packaging and Label Act
• Requires ingredient listing for cosmetic products retailed to consumers
• All ingredients in product listed in order from most weight to least weight
Evaluating Cosmeceuticals
• Albert Kligman points of cosmetic ingredient evaluation:
– Can the active ingredient penetrate the stratum corneum and be delivered in sufficient concentrations to its intended target in the skin over a time frame consistent with its mechanism of action?
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Evaluating Cosmeceuticals
– Does the active ingredient have a known biochemical mechanism of action in the target cell or tissue in human skin?
– Are there published, peer-reviewed, double-blind, placebo-controlled, statistically significant, clinical trials to substantiate efficacy claims?
Evaluating Clinical Studies
• Gold standard for clinical testing of pharmaceuticals or cosmeceuticals is double-blinded, prospective, controlled, randomized, human clinical against placebo or approved prescription product
Important Parameters in Clinical Data
• Double-blinded • Prospective • Randomized • Controlled • Human test subjects • Against placebo or
approved prescription product
• Utilized finished product
• P-value • Independent research
group
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Natural vs. Organic
Natural vs. Organic Labels
• Natural – Term not defined by regulatory agency so it can
mean anything – Ingredient comes directly from animal or plants
found in nature and is not synthetically created – “natural” does not mean healthier
Natural vs. Organic Labels
• Organic – No precise definition or regulation in skin care – Ingredient comes directly from animal or plants
found in nature – Also, produced emphasizing the use of
renewable sources and environmental consideration
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“Organic” Beauty
• There are currently no standards for organic product integrity
• Organizations working to create universal standards – OASIS – Eco-Cert – USDA
OASIS
• Organic and Sustainable Industry Standards • Some beauty products require chemistry as a
part of production • Promote green chemistry: use of
environmentally friendly chemicals that results in reduced waster and safer products
Eco-Cert
• Certifies standards for natural and organic cosmetics
• 95% of ingredients must be organic for organic label
• 50% organic for natural label • Packaging standards
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USDA (United States Department of Agriculture)
• Specifies standards for food (not cosmetics) labeled organic whether grown domestically or abroad
USDA Position for Food Products
• Organic food produced by farmers who emphasize use of renewable sources and conservation of soil and water to enhance environmental quality
• Organic meat, poultry, eggs, and dairy products come from animals that are given no antibiotics or growth hormones
USDA Organic Food Position
• Produced without using conventional pesticides, fertilizers made with synthetic ingredients, bioengineering, or radiation
• Before product can be labeled “organic”, government-approved certifier inspects facility where food is grown to ensure organic growing standards are met
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Organic Levels
• USDA defines three specific organic levels – 100% organic
• Products contain 100% organically produced ingredients excluding water and salt
– Organic • Products that are at least 95%
– Made with organic ingredients • Products contain at least 70% organic ingredients
What is the Reality?
• Not practical to claim or want 100% organic topical skin care products – Need preservatives to protect product integrity
and shelf life – Synthetic ingredients necessary to keep product