Classification of Cosmetics & OTCs

How are cosmetics and OTCs classified in Canada?

In Canada, cosmetics are defined as « any substance or mixture of substances manufactured, sold or represented for use in cleaning, improving or altering the complexion, skin, hair or teeth. » Over-the- Counter products, on the other hand, are used for « (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, or (b) restoring, correcting or modifying organic functions in human beings or animals. »

The classification of products in Canada is based on three criteria:

1. Representation: This includes the product’s indications of use and its claims, but it also includes any pictures, symbols, or implications on the product label, package insert or advertisement.

2. Composition: Some product ingredients are inherently drugs, such as corticosteroids. Other ingredients may have a cosmetic function until a certain threshold, at which point they then have a therapeutic effect. When a product makes a therapeutic claim, there is inherently at least one ingredient in that product that contributes to this effect. Therefore, any substance that supports a therapeutic claim is likely the active ingredient. Therapeutic claims are only allowed on drugs or natural health products, not on cosmetic products.

3. Level of action: Cosmetic products should not be absorbed systemically. Products that are administered through ingestion, inhalation, or by injection are not considered to be cosmetics.