Cosmeceuticals

Cosmeceuticals have undoubtedly taken over the personal care industry across the globe. Despite the prevalent confusion about its definition and scope, it would not be an exaggeration to state that almost 30% to 40% of any dermatologist's prescription count across the world consists of a cosmeceutical. The term was coined in 1984 by Dr. Albert Kligman of the University of Pennsylvania describing a hybrid category of products mid-way on the spectrum of 'cosme'tics and pharma'ceutical.' A cosmeceutical is consensually accepted to exert a 'pharmaceutical therapeutic benefit' but not necessarily a 'biological therapeutic benefit.' For Dr. Kligman, cosmeceutical represented “a topical preparation that is sold as a cosmetic but has performance characteristics that suggest pharmaceutical action.” He coined this term around the crucial time of Kligman's experimentation on the anti-aging effects of tretinoin. The scope of cosmeceuticals has been almost exponentially expanding, e.g., with the discovery of alpha-hydroxy acids for exfoliation and skin rejuvenation, different formulations of topical vitamin C, and an overflowing basket of antioxidants, amongst others. The aptness of the term 'cosmeceutical' gained more ground as it represented a new breed of cosmetic products, which provided effects beyond simple cosmetic enhancement but fell short of qualifying for a drug or pharmaceutical. The most practical definition of this term may be - a cosmetic product that is purported to have therapeutic action capable of affecting the skin positively beyond the time of its application. Although the term cosmeceutical is steeped in dermatology literature and dominates academic discussions, symposia, and lectures around the world, it is strangely interesting that almost four decades after coining the term, this category of skincare products is still not formally recognized by the United States Food and Drug Administration (US-FDA) or the European Union. This disparity stems from the differentiation between 'cosmetics' and 'drugs' by the Federal Food, Drug, and Cosmetic Act (FD&C Act) based on their intended use and ability to affect the structure and function of the cutis. Both in the United States and the European Union, a drug is defined as "an article intended for the use in the diagnosis, mitigation, treatment or prevention of disease or intended to affect the structure or any function of the body." In contrast, the FD&C Act of 1938 defines cosmetics as "articles 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. In India, a well-defined Drugs and Cosmetics Act (1940) operates the regulations of cosmetics under the authority of the Central Drugs Standard Control Organization (CDSCO). But CDSCO also recognizes drugs and cosmetics, not cosmeceutical. In a nutshell, it is unfortunate that despite the ubiquitous presence, sale, marketing, and prescription by dermatologists, to date, there is no international consensus. These impact of this deficiency in regulatory nomenclature has far-reaching consequences concerning the essentials of product labeling [prescription or over the counter (OTC)], the stringency of testing protocol, and approval for sale and distribution. In the U.S., for example, in contrast to strict laws for drugs, there is no requirement for manufacturers to demonstrate either safety or efficacy before marketing a product that would otherwise qualify as a cosmeceutical, as is the case for drugs.  The Japanese authorities identify that many skincare products qualify as neither pure drugs nor pure cosmetics in the traditional sense, but a mix of the two, and call them ‘quasi-drugs.’ They permit cosmetics to contain pharmacologically active ingredients, provided that the medicinal effects are mild and the products'safety has been demonstrated. The legal jargon or lack thereof has left a lot of room for ambiguities and ad hoc interpretations resulting in skewed treatment of certain products by different regulatory authorities. The following example exemplifies the ambiguity; the following agents are regulated as drugs in the U.S., and as cosmetics in Europe: antiperspirants, anti-dandruff shampoos, and sunscreens.  Currently, cosmeceuticals are a segregated subclass within the domain of a cosmetic or drug. In Europe and Japan, cosmeceuticals are a subclass of cosmetics; however, in the US, cosmeceuticals can only be considered as a subclass of drugs. Ideally, the registration protocol for a cosmeceutical should not be as complicated as for drugs. Of course, as per Good Clinical Practices [GCP], clinical studies with adequate power should be essential to demonstrate the intended activity of the cosmeceutical for treatment of the particular minor skin disorder or 'condition,' and there must be an assurance that safety requirements are optimal and that there are no expected side effects. In the United States, this implies that a subclass of drugs (cosmeceuticals) are registered similarly as over-the-counter products. The legendary legal controversy on the regulatory labeling of topical minoxidil for male pattern baldness resulted in the assertion that the pharmaceutical activity of a product, rather than the condition it is intended to modify (normal vs. diseased skin), determines whether it is a cosmetic or a drug. The issue becomes more convoluted when the basis of the drug vs. cosmetics differentiation centers on the concentration of the active ingredient. At the moment, sunscreen-containing products are classified as cosmetics, provided the sun protection factor (SPF) is below 4, while high SPF sunscreens still have approval for sale over the counter (OTC). Interestingly, a recent proposal by FDA entails classifying any sunscreen that specifies SPF as a drug.  Similarly, while the FDA regards lactic acid at 12% as a drug, the same ingredient in lower concentrations is permitted in cosmetics. Regrettably, regulations appear to completely ignore the effect of vehicles, stabilizers, and other excipients. For this activity, backed by a plethora of literature on the issue, a cosmeceutical may be characterized as: 1. The product has pharmaceutical activity and is usable on normal or near-normal skin. 2. The product should possess a defined benefit for minor skin disorders (cosmetic indication). 3. The product possesses a very low-risk profile. The term “nutraceutical” was coined in 1989 by Stephen De Felice from “nutrition” and “pharmaceutical.” Another definition by Health Canada states, “a product prepared from foods, but sold in the form of pills, or powder (potions) or other medicinal forms, not usually associated with foods.” Nutraceuticals may be sourced from natural herbs, food industry, dietary supplements market, and the pharmaceutical industry, and now trending towards genetically engineered “designer” foods as well. Although nutraceuticals cover most of the therapeutic areas such as anti-arthritic, digestive problems, prophylaxis, and treatment for cancers, lipid and sugar control, osteoporosis, blood pressure, and depression among others, in context of skin, one can grossly regard a nutraceutical an orally consumed product with cosmeceutical benefits.  Anti-aging in general . Treatment of photomelanosis and photo tanning . Treatment of pigmentation-related disorders like melasma or freckles. Rhytide reduction . Anti-inflammatory. Fat loss . Hair growth . Hair fall prevention . Maintenance of skin tone and clarity of complexion.