Titled Classification of Products at the Cosmetic-Drug Interface, this document is an interpretation of the various legal and regulatory texts [1] applicable to drugs and cosmetics in Canada. It aims at providing help both to the industry and to governmental authorities in charge of controlling products when determining whether a specific borderline product is a drug or a cosmetic.
The guidance document, first recalls how drugs and cosmetics are respectively defined according to Canadian federal law, then it proposes three main criteria in order to help making the distinction:
representations made about the product and, first of all, its proposed claim(s),
the composition of the product since, although its composition alone does not necessarily determine its classification, the presence of an ingredient, or its concentration, may make the product unsuitable for classification as a cosmetic or as a drug,
the level of action of the product, considering that in order to be a cosmetic, the product must exhibit a lack of percutaneous absorption and should not have to be absorbed systemically to achieve the effect.
Eventually note that natural health products are only referred in this document as other drugs, from which they are considered to be a subset.
