Skin Res Technol ; Takamatsu T. How can we define cosmeceuticals. Advanced Technology Conference Proceedings. Cosmetics Toiletries. A proposal for rational definition, evaluation and regulation. Arch Dermatol ; Why cosmeceuticals? Dwek AC. The definition of a cosmeceutical. Wittern KP. Cosmeceutical from a European perspective. Urbach W. Cosmeceuticals—The future of cosmetics?
Steinberg D. An American Perspective. Moreover, in the United States, Europe, and Japan, different definitions of cosmetics are used.
The definition of a drug is more or less equivocal on these countries. According to the Food, Drug, and Cosmetic FDC Act, a drug is defined as an article intended for use in the diagnosis, mitigation, treatment, or prevention of disease or intended to affect the structure or any function of the body. In the United States, according to the FDC act of , a cosmetic is defined as an article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, 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 1.
It is noteworthy that in this definition the cosmetic is not allowed to have any activity i.
Bio-active vs Cosmetics Skincare - moanaskincareEUR
The cosmetics directive contains 15 articles. The other 15 articles describe the following topics: overall safety requirements, controlled substances, potential ban of animal testing, inventory of ingredients, labeling, harmonization, product information requirement, procedure for adaptation, list of permitted ingredients, safeguard clause, and implementation. According to the pharmaceutical affairs law, the Japanese definition of a cosmetic is as follows: The term cosmetic means any article intended to be used by means of rubbing, sprinkling or by similar application to the human body for cleansing, beautifying, promoting attractiveness and altering appearance of the human body, and for keeping the skin and hair healthy, provided that the action of the article on the human body is mild.
The Japanese definition is only slightly different from the definition of a cosmetic within Europe. Both definitions allow a cosmetic to have mild activity and possess pharmaceutical activity. This is in sharp contrast to the definition of a cosmetic in the United States.
Moreover, in article 7a of the European cosmetics directive, which describes the product information requirement, it is stated that a proof of effect should be included 2. In the United States, however, a product would be regarded as a drug if a proof of effect was mentioned.
Extensive research on the physiological activity of the skin has provided evidence that even small changes in the environment can modify the activity of skin tissue 3,4. Application of inert creams 5 , humidity, UV light 4 , water 6 , etc. Thus even water or the humidity of the air could be defined as a drug, according to the FDC act! As mentioned by Gilchrest, the Food and Drug Administration asked her to define water as a drug, when water was applied on the skin under experimental conditions 7.
Registration of a product as a drug requires many elaborate and costly procedures; therefore, the manufacturer of a product with pharmaceutical activity would prefer to have the product registered as a cosmetic. In Europe and Japan, cosmeceuticals can be regarded as a subclass of cosmetics; however, in the United States cosmeceuticals can only be regarded as a subclass of drugs. Cosmeceuticals could be characterized as follows: 1 The product has pharmaceutical activity and can be used on normal or near-normal skin.
The definition of minor skin disorders or mild skin abnormalities is difficult and can be regarded as cosmetic indications. Even socioeconomic factors may have an impact on whether a skin disorder is regarded as a disease or as a cosmetic indication 8,9. Nevertheless, in most western countries there is no written consensus that skin abnormalities that are treated by over-the-counter drugs may be regarded as mild skin disorders or may be termed cosmetic indications 9, The procedure for registration of a cosmeceutical should not be as cumbersome as for drugs.
The intended activity of the cosmeceutical for treatment of a minor skin disorder should be demonstrated by clinical studies within the framework of good clinical practice. Moreover, it should be shown that safety requirements are optimal and that no side effects can be expected The safety evaluation is mandatory for cosmetics in Europe, according to articles 2, 12, and In the United States, this would mean that a subclass of drugs cosmeceuticals are registered in a similar manner as over-the-counter products It would be beneficial if these countries could agree on the definitions of cosmetics and drugs and, in so doing, define cosmeceuticals as a subclass of cosmetics.
This would prevent the current situation in which certain products are registered as drugs in the United States sunscreens and as cosmetics or cosmeceuticals in Europe and Japan.
Evidence that cell shedding from plantar stratum corneum in vitro involves endogenous proteolysis of desmosomal protein desmogein. J Invest Dermatol ; — Immunosuppression by ultraviolet B radiation, initiation by urocanic acid. Immunol Today ; — Cosmeceuticals: predicting their influence on compromised skin.
Cosmet Toilet ; — Permeability barrier disruption coordinately regulates RNA levels for key enzymes or cholesterol, fatty acid and ceramide synthesis in the epidermis. Arch Dermatol ; — Sunscreen: the ultimate cosmetic. Dermatol Clin ; — Neher JO. Cosmetics by prescription. J Fam Pract ; — Nightingale SL. FDA proposes new labeling for over-the-counter sunscreen products. JAMA ; — Stern RS.
Drug promotion for an unlabeled indication: the case of topical tretinoin. N Engl J Med ; — De Salva SJ. Safety evaluation of over-the-counter products. Regul Toxicol Pharmacol ; — Cunningham Cu-Tech, Inc. Aging skin was to be accepted as an inevitable, irreversible, and trivial consequence of getting old. It became obvious early on that skin damage was an inevitable sequela of the medical use of x-rays; only in the past two to three decades has the extremely damaging nature of ultraviolet radiation UVR become increasingly clear to both scientists and the general population, and attempts to circumvent and reverse such damage have become extremely popular.
In the midst of this chaos, there exist two opposing hemispheres. One is the northern hemisphere, where life is rigid, cold scientific proof is difficult, and only the hardiest survive in the frozen tundras of pharmaceutical bureaucracy and governmental regulation. Advocacy of the term cosmeceutical, as an attempt to compromise and bridge the gap between cosmetic and pharmaceutical, greatly enlivened the debate.
In fact, the debate has forced us to reevaluate what we truly believe, even made us iconoclasts, willing to listen to new ideas.
'Cosmeceuticals' Spur Research But Worry FDA
It has taken place during an era of unprecedented discovery about the structure and functioning of the skin, and the discussion has begun to rise above the former shrill hysteria and is now on a higher plane of logic and scientific facts. Photoaging is the ideal skin condition to focus the debate. On one hand, appearance of the facial skin makes this condition so obvious to the subject and observers, which in turn makes the use of cosmetic products so appealing. On the other hand, only a pharmaceutical product can truly and meaningfully effect change in the substantial pathology of the condition.
The clear demonstration of the clinical efficacy of tretinoin, a pharmaceutically active retinoid topically applied for a cosmetic condition, speaks to the utility of the term cosmeceutical. Cosmetic effect should be at least a partial result of structural or functional change, which can be reproducibly demonstrated by some reliable, accurate, and validated methodology—be it clinical or instrumental. Topical products presently predominate in the discussion, yet nontoxic, systemic substances such as vitamins and naturally occurring substances should also be considered in the definition.
Distinction between intrinsic aging of the skin and photoaging has been repeatedly emphasized, but in the context of this discussion it has little relevance; skin that is visible and cosmetically deteriorated is invariably sun exposed and usually highly sun damaged. In the vast majority of individuals, photoaging overshadows intrinsic changes, especially in the skin of the face, neck, and dorsal forearms 1.
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The terms photoaging and photodamage have frequently been used interchangeably, although we have previously preferred to define photoaging as a process and photodamage as a description of the clinical or histological condition at any point in time. Photoaging begins at a very early time point, even in infancy, as a result of repetitive, chronic exposure of the skin to ultraviolet radiation. Clinical changes recognizable as photodamage may appear in early childhood, especially where exposure is high.
As the process of photoaging continues, additional clinical signs of wrinkling, texture, and pigmentary change become progressively noticeable.
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Cessation of exposure to UVR or treatment allows partial reversal of the clinical and histological change. Both from the clinical and chronological standpoints, the process is a continuum with change possible in either direction. Evaluation for cosmeceutical effect must account for the following specific and distinct needs. These perceptions are more global than specific, and mandate an evaluation that is weighted toward overall appearance but adequately accounts for specific concerns of dryness, texture, wrinkling, skin color, and pigmentary unevenness.
Cosmetic or therapeutic effects produced by the product are important to the consumer, but so are physical aspects of the product itself. A product that is not cosmetically elegant or that is drying or irritating to the skin will be less acceptable to the consumer in spite of alleged pharmaceutical properties. These aspects and physical attributes of cosmetics can be well quantitated by both consumer panel testing of the product as well as by specific instrumentation.
Adequate methodology exists to evaluate rigorously these cosmeceutical aspects. Pharmaceutical testing of pharmacological effect is, by definition, the most stringent, requiring not only adequate trial design and execution but substantially more documentation of statistically significant changes that are also clinically and consumer relevant. This is the area where proper application of biometrics to photoaging is most helpful and important 3.