Evaluation of Cosmeceutical Ingredients: What the Label May Not Reveal Patrick Bitter, MD. Regulation of Topical Skin Care Products.

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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 1

2 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 Examples: sunscreen, wart remover, dandruff shampoo 2

3 OTC Skin Care Products Standardized labeling required: drug fact label Cosmetic 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 3

4 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 4

5 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 $ 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? 5

6 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, doubleblind, 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 6

7 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 7

8 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 8

9 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 9

10 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 mixed and to ensure smooth application on skin Ingredients to Avoid 10

11 Potentially Harmful Ingredients Sodium lauryl sulfate Parabens Propylene glycol Imadazolidinyl and diazolidinyl urea Synthetic colors and fragrances Ethanolamines Acrylamide Phenol carbolic acid Dioxane Toluene Sodium Lauryl Sulfate (SLS) Anionic surfactant used in cosmetics and personal care products as a cleansing agent Absorption, metabolic, and excretion studies show that SLS maintains residual levels in the heart, liver, lungs, and brain from skin contact Is a skin irritant and may be damaging to the immune system, eyes Parabens Used a preservative in skin care and cosmetics to protect against microbial growth Studies have demonstrated the detection of parabens in breast tumors Related to the estrogen-like properties of parabens and the influence of estrogen on breast cancer 11

12 Propylene Glycol Propylene glycol or ethylene glycol used in many cosmetic and skin care products Serves as a humectant Also used in antifreeze, brake fluid, paint, etc. Chronic exposure may cause skin and eye irritation, CNS depression Imidazolidinyl & Diazolidinyl Urea Used as preservatives to prevent bacterial growth Common cause of contact dermatitis May release formaldehyde when degraded Synthetic Colors & Fragrances Provide no skin benefits May mask product spoilage May cause allergic reactions Not well regulated 12

13 Ethanolamines ph stabilizers When exposed to air from nitrosamines, which can be irritating or toxic Formaldehyde & 1,4-dioxane Considered probably carcinogens by FDA Linked to skin allergies, asthma, developmental and reproductive problems, and cancer Product labels do not have to list them because they are formed during manufacturing process Ingredients likely to contain these: sodium laureth sulfate, peg-100 stearate Acrylamide Found in many face creams Linked to mammary tumors 13

14 Phenol/Carbolic Acid Found in many creams and lotion Can cause circulatory collapse, paralysis, convulsions, coma, or even death from respiratory failure Toluene Found in synthetic fragrances Made from petrolatum and coal tar Chronic exposure linked to anemia, lowered blood cell count, liver and kidney damage 14