MONTAGE – Cosmeceuticals – The bridge between cosmetics and pharmaceuticals | Vol. 2, Iss. 4

Dr. Albert Kligman coined the term “Cosmeceutical” in 1984 to describe a category that blends cosmetics and pharmaceuticals. Nearly four decades later, this remains an unclassified category. According to a 2022 brief report by the U.S. FDA, the term "cosmeceutical" has no legal meaning. Despite this, the market is flooded with products claiming to alleviate acne, reduce pigmentation, smooth wrinkles, and address various skin concerns.?

By definition, cosmetics are articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance. In contrast, drugs are defined as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Given these definitions, even common skin concerns such as photoaging, hyperpigmentation, and dryness might require pharmaceutical intervention.?

Cosmeceuticals emerge as a middle ground, offering formulations with active ingredients that are permitted in cosmetics but used in higher concentrations and enhanced with better penetration agents to deliver noticeable effects. The rise of beauty trends and the growing demand for multifunctional products have fuelled the popularity of cosmeceuticals. Consumers today are increasingly aware of active ingredients, seeking scientifically backed solutions for their skin concerns. However, they often encounter overwhelming, and sometimes misleading, information online.?

Dr. Kligman's method for evaluating cosmeceuticals: 1. Can the active ingredient penetrate the stratum corneum and be delivered in sufficient concentrations to its intended target in the skin over a time course consistent with its mechanism of action? 2. Does the active ingredient have a specific biochemical mechanism of action in the target cell or tissue in human skin? 3. Are there published peer-reviewed, double-blinded, placebo-controlled, statistically significant clinical trials to substantiate the efficacy claims?

Despite their widespread use, cosmeceuticals remain in a regulatory grey area. Unlike drugs, they are not subjected to rigorous clinical testing and approval processes. This raises a critical question: in the absence of clear regulations, is consumer safety being compromised? While cosmeceuticals offer promising benefits, the lack of standardized guidelines may lead to inconsistent product efficacy and potential safety concerns. As this category continues to evolve, clearer regulatory frameworks may be necessary to ensure both innovation and consumer protection.

Disclaimer: The scientific content of this publication has been developed and designed by Bregma Science LLP.? The contents herein are referenced from various published works and/or expert opinions. Although greatest possible care has been taken in compiling, checking and developing the content to ensure that it is accurate and complete, the authors, the publisher, its employees or agents, shall not be responsible or in any way liable for any injury or damage to any persons in view of any reliance placed on or action taken basis of the information in this publication or any errors, omissions or inaccuracies and/or incompleteness of the information in this publication, whether arising from negligence or otherwise.