APPENDIX III
This document provides guidance in relation to cosmetic/drug interface in respect of product claims.
Products are determined to be either “cosmetic” or “drug” based on two factors:
– Composition of the product, and
– The proposed use (++) of the product
Compositon – The compostion of a product does not necessarily determine its classification. However it is quite possible that an ingredient, or the concentration of an ingredient, may make the product unsuitable for classification of a cosmetic.
Proposed use – According to the definition of the term “drug” and “cosmetic” in respective legislation, the key consideration for the classification of a drug is its proposed use. The claims made in package inserts, in advertisements, and especially in product labels, indicate to the consumers the intended use of the product.
As a general rule, cosmetic products must only make cosmetic claimed benefits; and not medicinal or therapeutic claimed benefits. Any cosmetic claimed benefits made shall be aligned with what is accepted internationally and shall be justified either by technical data and/or cosmetic formulation or preparation itself. Manufacturers / product owners will be allowed to use their own scientifically accepted protocols / design in generating the technical data provided there is justification why such protocol / design is used.