Abstract
The list of possible cosmetic and antiaging claims of cosmeceuticals is almost endless, and actually increases daily with new discoveries of physiological effects in the skin. Whatever the claim, though, the basic dossier necessary to get away with it all in the eyes of lawyers, regulatory supervisory bodies, and in the end, judges, needs credibility based on data, their quality, their amount, their presentation, and their pertinence to the claim being made. The credibility of efficacy of a cosmetic product should be based on data obtained on the ingredients and/or the finished product. These data may come from studies carried out on human volunteers (such as self evaluation by consumers, with trained investigators, and/or with instrumental methods) or from studies on objects other than human volunteers. This chapter reviews some of the evaluation criteria and widely used methods and protocols and the legal framework for claim substantiation in the cosmetic industry. Several methods, in vitro and in vivo, are being used to establish cosmetic claim substantiation of cosmetics. It is very difficult to study complete finished formulations in in vitro models, as most ingredients (surfactants, preservatives, solvents including glycerin) are not compatible with the fragile cells in monolayer experiments; however, ex vivo protocols have several advantages in such studies. In the evaluation of the veracity of a claimed cosmetic effect, nothing can beat the in vivo (or clinical) tests, as they yield good statistical significance, possibly against a positive benchmark or untreated skin, which can explain, at least partially, the mechanisms behind the observed macroscopic effects.
Published Version
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