In the U. S. the FDA has included in the OTC Antiperspirant Final Monograph guidelines that the manufacturer may use in testing for effectiveness. The agency does not require that these guidelines be used but requests that alternate methods and statistical evaluations are subject to FDA approval (4).
The FDA has established in the monograph the minimum standard for effectiveness at 20% sweat reduction to allow a product to be labeled as an antiperspirant. There are no guidelines suggested in the European Cosmetics Directive, however, because there are
many publications on this topic concerning antiperspirant efficacy, and techniques for proving efficacy are well known and readily available in the testing market place.
In Japan, Tagami indicates that the MHW does not specify in the PAL any specific standard test methodology for evaluating the clinical effects of quasi-drugs. It only makes reference to the use of a clinical use test in humans, under conditions simulating actual daily usage, for supplying data to assess the effects and safety of such products (6).